Thank you. The one o'clock appointed hour has arrived, so welcome everyone to Pacific Edge's annual shareholder meeting. My name is Chris Gallaher. I'm the Chairman of Pacific Edge, and I now declare the meeting open. Today's meeting is both in person, and we have an online audience as well. We're pleased to welcome you all here today, and those of you attending online on the platform provided by our share registrar, MUFG Corporate Markets. I will provide you with further instructions as we progress through the meeting, but if you encounter any issues, please refer to the virtual meeting online portal guide, where you can phone the helpline on 0800 200 220. For those of you physically here, I have a few points of housekeeping. Can I please ask you to turn your mobile phones off?
Toilet facilities are near the door where you came in, and if the fire alarm does go off, just follow instructions from staff. I'd like to start by introducing your board, and unfortunately, we have an apology, first off, from Sarah Park, who is this morning sitting in the Hawke's Bay Hospital minus her appendix. So, Sarah is an apology. We have Anatol Masfen, going left to right, Anatol Masfen, Bryan Williams, Tony Barclay, Pete Meintjes, our CEO, Mark Green, and Anna Stove. We also have some members of our senior management team here, including Peter, Grant Gibson, our CFO, and David Levison, down the back, our President of Pacific Edge Diagnostics in the U.S. Our auditors, PwC, are also in attendance today and represented by Audit Partner, John Dixon. Welcome, John. We now move to the agenda.
We will follow the agenda set out in the notice of meeting, which was sent out to shareholders on the fifteenth of August. Peter and I will both give a short presentation, then you will hear from David Levison, who will give us a presentation on the medical affairs part of our business. We'll then take you to questions as a panel before moving on to the formal resolutions for consideration today. After that, I hope you will join us for a cup of tea. Firstly, to apologies, we have three. Sarah Park, clearly, Dr. Viola Palmer, and Allan McColl. Now, I'd like to make a few remarks on the past financial year and reflect a little bit over the last eight and a bit years that I have been your chairman. Oops, that's the wrong one.
There we go. It is great to be back in Auckland. We were here, I think, a little while ago. We started alternating meetings between Dunedin and Auckland. This year has been a curate's egg for Pacific Edge. We have made some significant progress and experienced some notable challenges in the 2024 financial year. I am proud of the work that we've done as a team to navigate the complexities of our environment, while at the same time delivering clear-eyed and focused value to our shareholders.
I will turn to this, we'll turn to this in a moment, but as today marks what is likely to be my last, and final annual meeting as chairman of Pacific Edge, I do want to take a few moments to reflect on what has been an incredible journey, and to set out for you my continuing confidence in the future of the business. When I was first approached to join Pacific Edge back in 2016, I was intrigued. I had spent my year in, senior leadership roles in industries miles away from bladder cancer diagnostics. But at the same time, I could see that my corporate and governance expertise could add some value. I was excited about the potential and its ambition to be a global leader.
I clearly remember meeting with Bryan Williams, then Director David Band, and former CEO, Dave Darling, for lunch in Melbourne, and their passion and excitement for what the global future could be for Cxbladder, a technology developed out of Otago University by old alma mater, by Professor Parry Guilford, was palpable. The clinching factor was that Pacific Edge is from and based in Dunedin, the city where I grew up and went to university. The role represented a great opportunity to get involved in a business that had the potential to be a global leader and a success story from Dunedin. Shortly after joining the board, a very personal experience cemented my conviction for our future. A very close friend of mine in Melbourne has been battling bladder cancer for 20 years.
He has had 13 recurrences and has endured 52 cystoscopies, a procedure that he, like many bladder cancer patients, has found to be invasive, painful, with a heightened risk of infection and a bit undignified. He reached a point where he was going to stop undergoing any more cystoscopies, and after 52, I can understand why. I arranged for him to take one of our tests. However, because Cxbladder was not yet incorporated into the standards of care in Australia, his urologist wouldn't accept the results. His disappointment was real. Here was a test that could have spared him the repeated pain and indignity of cystoscopies, yet he wasn't able to use it. Thankfully, he's still alive today, but this experience reinforced to me the real-world impact of what we are trying to achieve at Pacific Edge.
We're not just improving diagnostic accuracy, we are giving people a better quality of life. It also made clear to me that it's not enough just to have a very good test. We must also have a test that urologists will adopt and use, and it's that second goal that has been the challenge and focus of Pacific Edge, both before I started and ever since. When I joined the board, the team, led by former Chief Executive Dave Darling, had made significant strides in bringing the vision to a reality. We were selling the test in New Zealand, had established operations in the U.S., and had gained certification for our U.S. laboratory with a clear focus on gaining Medicare coverage in the U.S., the largest reimbursement opportunity in the world.
One of the earliest achievements during my tenure that set us on the right path was the February 2018 adoption of Cxbladder Triage into the Canterbury Community Pathways for Primary Care Referral. This milestone demonstrated that our product was not only clinically useful, but also aligned with real-world healthcare needs. Fast-forward to 2020 , when we achieved two of our most significant goals, and it was clear that our vision of Cxbladder becoming incorporated into global standards of care was within our grasp. The first achievement was, after years of groundwork, the commitment by Kaiser Permanente, one of the largest healthcare providers in the U.S., to begin adoption and paying for our tests.
A move that was later followed by the introduction of our in-home sampling kit during the COVID pandemic, and later by the integration of Cxbladder into its standard of care. These significant milestones represented a significant endorsement of our product and a real reward for what had been years of effort by our team. As Pete will set out shortly, we've seen consistent growth in test volumes from Kaiser, and we expect this relationship to be a key part of our U.S. business into the future. The second milestone achievement was the 2020 decision by Novitas, the Medicare Administrative Contractor for our laboratory in Hershey, Pennsylvania, to approve Medicare reimbursement of our tests.
This decision not only provided an important validation of our technology, it was a decision that promised to underpin our drive towards financial sustainability, delivering on the commitments we had made to shareholders who had loyally supported us through multiple capital raisings. It was in this environment in 2021, that we asked investors for the capital to support the company to realize these significant opportunities and others that had surfaced around the world. After this, Dave Darling retired after a long career at Pacific Edge, and we recruited Pete Meintjes, a Kiwi working in Boston, to drive the growth that these two milestones promised.
Peter spent his first six months positioning the company for growth and expansion, with a significant increase in the sales team, the creation of a new medical affairs team to educate the urological community on the clinical value of our tests. He also reconfigured our clinical development program to entrench our coverage and position our tests for inclusion in guidelines, a goal which, if achieved, has the potential to rapidly accelerate test growth and adoption. We were rewarded with a rapid acceleration and demand for our tests, and then the rug was pulled out from under us in 2022, when Novitas issued a draft decision to restructure the way genetic testing is covered, with a specific impact on Cxbladder, among others.
While we had always recognized the need to strengthen the basis on which our tests had Medicare coverage, with new evidence, this approach to determining coverage was a black swan event. It was completely unforeseen, and while it's not specific to Pacific Edge and Cxbladder, it has had a profound effect on the company. For over two years, we have been in a state of uncertainty, waiting for a final determination. This challenge has tested the resilience of our team, our board, and our shareholders. We've had to make difficult decisions to preserve cash and restructure the business, to ensure that we can weather what we see as a decision by Novitas to deny patients continued access to tests deemed medically necessary by the physicians who order them.
It's not been an easy time, but I am proud of how we have responded. We've shown remarkable resilience. Under the leadership of Pete and his team, we have restructured our sales force, and while it was a painful and regressive move, it has made us more efficient and focused on profitability. We have reconfigured the business to focus on the launch of our new tests with enhanced DNA biomarkers, Detect Plus and Monitor Plus, and more on that later... We accelerated the publication of our STRATA study, and this has meant the strongest evidence yet of Cxbladder's clinical value is not only included in Novitas' current deliberations, but also the American Urological Association's review of its guidelines relating to hematuria evaluation.
We have, meanwhile, continued to build our clinical evidence base, positioning ourselves to regain coverage or secure new opportunities, no matter what the outcome of the Medicare decision. Turning now to reflect on financial year 2024. Thanks, Pete. Our financial results for financial year 2024 are a testament to our resilience. Operating revenue grew 22% to NZD 23.9 million, despite the challenges posed by the reduction in commercial test volumes in the second half of the year. Volumes increased by 3%, and we saw a strong and pleasing 18% improvement in the average U.S. sales price per test. We ended the year with NZD 50.3 million in cash reserves, as our cash burn fell sharply in the second half of the year, reflecting the difficult but necessary restructuring we undertook.
I believe that these results demonstrate the strength and potential and of our business, even in the face of uncertainty. The determination shown by our team, from the boardroom to the lab, has been nothing short of extraordinary, and I want to thank everyone for this commitment and effort. I have every confidence that we are well prepared for whatever may come next. Looking ahead, there are several key catalysts that will shape the remainder of the year and into next year. First is the pending decision from Novitas on the Medicare reimbursement for our tests. We are confident that over the longer term, our clinical evidence program will position the company for a positive Medicare decision.
However, we do remain uncertain if recent developments are sufficient to change the evidence review by Novitas, despite the concerns that we have noted with that review, and the terrific support we've had from the American Urological community. The second milestone is the AUA's review of hematuria guidelines, which are currently on foot. Clear or positive language for the use of biomarkers, such as ours, would be used as a basis for Medicare coverage reconsideration in the event of a non-coverage determination. We are also awaiting a pricing decision for our new product, Detect Plus, the next step on our path to commercialize this test. Any one of these decisions in our favor, as Peter will discuss shortly, could have significant positive outcomes for Pacific Edge and our shareholders.
I do wanna take this opportunity to pay tribute to Pete Meintjes and his team for the way that the company has dealt with the with the challenges we've had to deal with since we first became aware of the Novitas ruling back in 2022. Their perseverance, persistence, and optimism has been remarkable and a credit to Pete, in particular, who has never wavered in his commitment and belief in the long-term prospects for Pacific Edge. Before closing, I would like to touch on changes in governance. Over my tenure, which is now into its ninth year, the board has undergone significant evolution and has benefited greatly from the recruitment of Sarah Park, Anna Stove, Mark Green, and more recently, Tony Barclay. These directors have brought diverse perspectives and expertise that have enriched our discussions and enhanced the quality of our decision-making.
Their contributions have been complemented by those of our longer-serving directors, Bryan Williams and Anatol Masfen, whose experience and deep institutional knowledge has been critical to Pacific Edge's growth and success. Bryan's expertise in cancer research and Anatol's deep strategic understanding of the business have provided continuity and stability during times of change and challenge. The board's supportive and collaborative structure has been the cornerstone of our ability to face challenges head-on while staying focused on the longer term. This cohesion has ensured that even in times of uncertainty, we remain steadfast in our mission and are well prepared for the future. As I mentioned earlier, this is likely to be my last, and final annual meeting as your chairman. I had originally planned to step down at the end of this year. I did advise the board regularly.
Then when I got to the ripe old age of seventy, and after nine and a bit years and eight and a bit years in the role, it was time for me to dial back and hand the reins over. The continuing uncertainty over our Medicare coverage has understandably made recruitment of a new chair difficult. At the board's request, I have agreed to stay on as chairman until we get clarity on the Medicare decision and can then move forward with the recruitment process and effecting a smooth handover. Mark Green, who will be stepping down at the end of the month. His wife has been appointed to a very big role with Suntory, based in New York, and his family have moved to the U.S.
Mark has been a terrific director who has brought a skill set and perspective to our board table, that we will miss. We wish him well. I do note that directors have not had an increase in their fees for three years. This year, in our current circumstances, the board felt it was not appropriate to ask shareholders for an increase. However, we must move fees to a market level at some point soon if we are going to attract excellent directors to our board. A big personal thank you from me to the current board and directors that have served before them. You have been a fantastic group of people with whom to share the highs and lows of the last eight and a bit years. As I prepare to step back, I remain confident that Pacific Edge is well-positioned for success.
With our world-leading products, Pete Meintjes and his committed team, and solid governance, we're on the path to achieving our long-term goals. Finally, I want to express my deep appreciation to our shareholders. Your unwavering support, particularly during challenging times, has been a source of strength to me, the board, and the company. Many of you have stood by us through periods of uncertainty, trusting in our vision and the potential of our technology. Your patience has been remarkable. It is this long-term commitment and belief in our mission that has enabled Pacific Edge to continue to innovate and grow, even in the face of adversity. It's been a privilege to serve as your chairman, and I'm confident that with your continued support, Pacific Edge will thrive and grow in the years ahead. Thank you, and with that, I will now pass you back to Pete.
Good afternoon, everybody. My name is Dr. Peter Meintjes. Just a quick word to Chris, and Chris, acknowledging that you're not yet stepping back, and in fact, stepping up to navigate the board through continued choppy waters, I want to extend a thank you from myself and on behalf of my management team and from the whole company across all of the geographies that we serve, predominantly New Zealand and the United States. Thank you for your governance of the company, thank you for your stewardship of the board, and thank you for your unwavering commitment to our investors. Before we dive into my presentation, I'd also invite Bryan Williams, Deputy Chair of Pacific Edge, to just say a few words to Chris.
Oh, thank you. Thanks. Thanks, Pete.
When Chris mentioned that David Band, myself, and Dave Darling met with him in Melbourne eight and a half years ago to convince him to accept a position as chair of our board, there were a number of things that were attractive about Chris, but I have to say that supporting the Highlanders was one of them. The fact that he was a University of Otago graduate was another, but also just his international experience in high-level financial management of very, very large companies was certainly something that we were interested in bringing into our company. It's been fantastic to have Chris on board. I'm not sure that many of our shareholders realize how much effort Chris has put into the company.
It's resulted in really weekly or more than weekly meetings with Pete. Not so many meetings with me, but certainly keeping me abreast of what was going on. It's really been terrific, Chris. Your engagement has just been really wonderful, and I think it's been. We can see that in how the company has faced these headwinds and are moving forward. Very pleased to have your support for these eight and a half years. Chris is going to be difficult to replace. We're gonna have to have a long and detailed search, and as he mentioned, we really can't do this until we can see our way past our current situation. It wouldn't be appropriate to bring on a chair at this point in time.
But I, I'm sure we will be able to find somebody, and I'm not so sure that they'll be able to hold a candle to Chris, but we will hope we will get there. So the other major thing that we faced was during not long after Chris joined, was Dave Darling decided to retire after I think 17 years running Pacific Edge, and that left us with a real challenge to recruit a new CEO. And it was a difficult task. It was Chris and myself, and I think Anna, you were engaged in that as well. And we really. There was a dearth of candidates, very difficult. We scoured Australia and New Zealand, and then we went international, and we were delighted to be able to recruit Pete.
I don't think Pete realized what he was getting himself into. I mean, we were looking very positive at that stage. But he has really steered the company through an extraordinary period, and we're really been a terrific recruit, and Pete and his team have been amazing in this particular time, so thank you, Pete, and thank you, Chris, for helping Pete get on board and move forward. Thank you.
Thank you, Bryan, and just continuing the thank you, 'cause Mark Green is retiring. Mark has provided a fantastic alternative perspective on many occasions at the board that has been very constructive to me personally, and helped challenge me to be a better CEO. And so with Mark stepping back, thank you very much. Appreciate it, Mark.
All right, on with the show. So, one of the things that we believe is important to emphasize here about Pacific Edge and how we're evolving as a business is, and particularly with additional reporting requirements that come our way, is that Pacific Edge is founded on delivering positive outcomes for society.
The story Chris told you about his friend with 52 cystoscopies and 13 recurrences is, while a quite extraordinary clinical case, is the reason we do what we do. Because we envisage a world where the early cancer, sorry, the early diagnosis and better treatment of cancer is within reach of everyone. We are founded on values where we are committed to our customers' success, which is obviously the urologists who use our tests on patients. We are guided by evidence, and of course, that's a recurring theme in how we drive medical policy and coverage and reimbursement. We support our teammates, and I'm delighted to have not only my board here with me, but also my management team, who will be available to answer questions afterwards. We are transparent and trusting.
We operate, you know, with a heavy number of people in Dunedin and also a large number of people clustered in Hershey, Pennsylvania. David will talk a little bit about that team when it's his turn, but that also means that there is the Gulf of the Pacific Ocean between our two organizations, and we also have people operating out of Australia, operating out of Christchurch, and so it's very important that you have strong, trusting relationships with these colleagues, particularly in remote and hybrid working situations, and we take that value very seriously as well, and when we are together, we take the opportunity to celebrate as we will do tomorrow night as a board. Moving on, so many of you have seen this slide a number of times from me now in our.
In how we create value for shareholders, focused primarily on adoption, retention, and revenue generation in the short term, evidence, coverage, and guidelines in the medium term, and of course, research, development, and innovation in the long term. But we also have several foundations that underpin our value creation, and those you will find as recurring themes throughout my talk to you today. On the financial matters, we do note, of course, as in our annual report, growth has slowed this year. The Medicare uncertainty has created challenges for us as a business. We have reduced the number of salespeople, and we have larger territories for everyone to manage in the United States. That has impacted our business.
But nonetheless, global total laboratory throughput did increase 3%, driven predominantly from the first half of last year rather than the second half. Our global commercial test volumes increased by 2%, and again, driven predominantly by U.S. growth and predominantly by the volume of our Detect test. But importantly, risk stratification during hematuria evaluation using Triage and Detect is the largest market opportunity, and is reflected in our current volume mix. So, it makes sense that Detect and Triage are by far the majority, because that is the largest market, and that is where we are concentrating our sales efforts. So all of these figures have been presented previously in quarterly updates, annual report.
But to hammer home, we understand that with smaller territory, sorry, larger territories and fewer salespeople, that getting test volume through the door has been a challenge for us as an organization. But the things that we have been able to control in the meantime have been really positive. So the average number of tests per account executive and the average number of tests per clinician are generally increasing. And so this shows that we are operating a more efficient business, positioning us well for when we have certainty again. We've also looked at the Asia-Pacific market. Obviously, that's the largest component of the Asia-Pacific market is actually New Zealand. We are largely saturated in New Zealand. There's not a huge opportunity for growth here. It's a mature market.
But the kinds of things that we can do are for those DHBs that are regular Monitor users. We can migrate them to use more Triage. For those that are regular Triage users, we migrate them to using more Monitor. And for those who are using Triage in the urology setting, we migrate those to using them in the GP setting. And so those have predominantly been our goals here. But we've also taken steps to make ourselves more efficient in Asia-Pacific as well, and that is reducing the number of studies that we had.
And it was common practice to offer urologists, you know, a small study before moving them into commercial volume, and we now just move on the back of our clinical evidence straight to commercial testing, and we're finding that to become increasingly effective. And that's particularly important as we go into Asia, where we have not really run any studies, but we are still seeing volumes start to come off the back of that. So we're extending our reach into the Asia-Pacific market through a distributor network. So we work with a number of different distributors across the region. Some of these will work, some of these might not, and that's okay.
As we mature as a business in the Asia-Pacific region, we hope to, you know, we will work on keeping the partners that are working well for us and changing the partners that are not. But we want to. You know, while we are, at this point in time, and probably for the foreseeable future, a U.S. focused enterprise, as Chris mentioned, the largest single contract that we can get worldwide is a contract with Medicare, is local coverage determination. We do believe it is important to diversify our business and to operate in other jurisdictions and bring our world-leading tests to more geographies. The biggest step we've taken, in this direction has happened this year. I think I spent a bit of time on this at the financial results back in May.
But STRATA is a paradigm-shifting study, and it was recognized as such at the AUA conference in May this year. It has been published in the Journal of Urology, which is the number one urology journal on the planet. And it showed a clinically significant change in the reduction of cystoscopies, when physicians were provided with a Cxbladder Triage results. So this is fantastic for physicians and fantastic for patients, and it's being recognized in a number of, you know, by being published in the Journal of Urology. And as I think we show later, also in an editorial that has recognized that as well.
We passed this information on to Novitas, even though the comment period for the draft LCD has been closed, because we think it's important that they are aware that these changes are happening, even though they are still considering the draft, and we will also continue to use the STRATA data to improve the Detect Plus algorithm, and David will actually talk a little bit about that on a slide in his section, so this is actually the slide I was meaning, that the Journal of Urology, an entirely unsolicited editorial popped up in the Journal of Urology the other day, highlighting the impact that non-invasive biomarkers can have on reducing cystoscopies. Essentially, the thesis of the product that we sell, but recognized independently and published in that journal.
One of the things that, that we, updated the market on last week was about the AUA microhematuria guidelines and, what appears to be happening there. So the AUA has commenced a review of the microhematuria guidelines. It's a little unusual that, they would notify, people that this is happening. Usually, they assemble an amendment group that is, just a small group of, people that we wouldn't know that it's happening, and then they would, and then they would make the recommendations internally. So what this suggests is that, the draft that has been put together by the smaller group has some changes that they want to make sure, are the changes that the community wants to make. So they have sent it out for broader review through a peer review process.
Again, in a move that is a little unorthodox, they have allowed people from industry to participate, and so in that peer review, our Chief Medical Officer will participate in that process. All of that will not be known to me, will not be known to anyone else at Pacific Edge, while they take that through a very important process for the AUA community. What, of course, we know is that you know, we're not the people who will be commenting to the AUA on our behalf will not be doing it really on behalf of Pacific Edge. They'll be doing it on behalf of the evidence.
They will be highlighting what the evidence means and what it means for clinical practice, and that's why this is so significant. Clear positive language, as Chris also highlighted, would be used as the basis for a Medicare coverage reconsideration request. Of course, only if it is needed in the event of a non-coverage determination. Also, as already highlighted, so genetic testing for oncology, which is the draft LCD proposed by Novitas, has been granted an extension. There is a lot that we don't know about why this has happened, but we were advised, you know, pretty much on the anniversary of when it was set to retire, that it had been extended after we queried with Novitas what the status was.
And so we have an ongoing dialogue with Novitas and CMS on a procedural basis to see where this leads. We don't yet have a reliable timeline. They have not committed to that. But what is important is that all outcomes still remain possible. That means they could have listened to our rebuttals, our notice and comment. They could have looked at our new evidence. They could have made a change to what they think should be in the final version. They could have read all of that and ignored it and made no changes. That is possible. But they could also have said that this doesn't appear to be the right approach and retire the LCD and look for another way to cover genetic tests.
So, all of those remain possible. Many of those are favorable. Of course, at least one is not favorable for Pacific Edge. How are we addressing this in the medium term? So that's the kind of short-term uncertainty that's been looming over our heads, and of course, it's sort of a head down, bum up kind of situation. We have been making sure that all of the evidence that we are generating are the kinds of things that will not just change physician behavior, but will also change how Medicare will cover the test or to reexamine the Novitas evidentiary review. So we've got a long list here of things we, well, things we've already accomplished. We have already published the STRATA data. We have already published the automated RNA and DNA extraction.
Specifically to establish the analytical validation of Triage, Detect, and Monitor. Ordinarily, an analytical validation publication is not really a catalyst for coverage. It's insufficient on its own. But there were some specific comments in Novitas's evidentiary review that meant that this kind of publication may assist us in in avoiding losing coverage or regaining coverage as well. The marquee things for everyone to pay attention to here, though, are the clinical validation studies of our future products, as Chris highlighted. So that's DRIVE, the clinical validation of Detect Plus, the MicroDRIVE study, that's number seven. Those are the primary clinical validation of Detect Plus studies.
But there are a number of other ones, and this list may be slightly longer than the ones we put in our last quarterly update, and our last annual report, as we extend this list and get certainty around some of these approaches. But we're also going to publish the analytical validation of Detect Plus. We're also going to publish with a concordance study that uses the Triage result and a Detect Plus result to show that should Triage, the evidence from STRATA, should Triage, that be sufficient to guide AUA inclusion in the guidelines, then what we wanna do is demonstrate concordance between our new product and our current product, and so that study is also quite important.
And then we also have real-world experience data being generated at Kaiser with our Triage product. And that is something where we don't control the timelines, but David and Tamer in the U.S., in particular, are working very hard to make sure that the evidence that comes from that supports all of the other evidence in our clinical, in our core clinical evidence generation program. I won't go through all of the lists. Some of those are longer term. You can read them for yourself, but this establishes very clearly a program of analytical validation, clinical validation, clinical utility to DRIVE coverage policy.
Emphasizing, you know, our relationship here with Kaiser Permanente, you know, we're, I'm personally loathe to single them out, and I often get asked by analysts and investors, you know, how... What is the specific volume doing at Kaiser? We're obviously never going to report on that kind of thing, but what I think is very important is to give you a qualitative picture of the dynamic between ourselves and Kaiser Permanente. Dave Darling did fantastic work years ago, establishing a high-quality partnership with Kaiser. And that is something that David Levison and Tamer have done a fantastic job continuing with them. Kaiser have submitted an abstract to the Western Section of the AUA. While there is the high-level AUA, there are also sectional conferences throughout the year.
The Western Section is the largest of those and the one that's relevant to California, where they practice. And the abstract focuses on 1,563 low-risk patients in the Kaiser Permanente Southern California health system with no history of gross hematuria, or who refused cystoscopy. And they show that 1,200 of those patients avoided invasive cystoscopy, improving patient satisfaction, urology access, and lowering the overall cost of care. And lowering the cost of care, of course, is very important to the Kaiser Permanente system. It's very important to other capitated systems like New Zealand DHBs and other government-funded payers. And so this is expected to flow on to become a peer-reviewed publication, and that is what I was referring to on the prior slide as real-world evidence from the Kaiser Permanente system.
And we'll be able to use this real-world evidence. Even though it's not a randomized controlled trial, it is a form of clinical utility, and it is a form of evidence that is very powerful, particularly for private payers, who might accept that we have clinical utility, but they still wanna know whether it works in the real world before they start to pay for our tests. So long term, the accumulation of all this evidence continues to be very important. Obviously, I always get asked about how we will handle both a negative and positive outcome from the impending Novitas determination about Medicare coverage or non-coverage.
So of course, if Novitas either retires or accepts some of our rebuttals and our new evidence, then that would be an affirmation of our coverage, and we would have a strategic review with management and our board to determine how we would accelerate the adoption of our tests. Of course, we have planned, and we've talked to our investor base regularly about this through various communications of our response to a loss of coverage. We have best-in-class legal advice in the United States. As a small brag in this particular situation, the former 2IC to the office of the general counsel inside HHS is one of our lawyers for exactly this kind of situation.
So, we've spent the time to build the right partnerships in the United States, and we have the best possible advice. Further review of the structure of our operations, if there are areas where we can save, then we will find them, and to continue to explore other strategic options, those all remain available to us. That short term notwithstanding, the long-term value creation strategies will continue, and that's underpinned by our clinical evidence generation program to get into the AUA and NCCN guidelines, and for increased coverage certainty. And our third pillar of value creation is research, development, and innovation. And here we have been focused on Detect Plus and Monitor Plus. We've also been focused on simplifying Cxbladder. There are many reasons that we are doing this.
The first is essentially for efficiency gains, to make sure that we can reduce the technician time, lower the cost of goods, lower the turnaround time, increase the throughput, and increase the automation to have smoother and more reliable and more efficient operations. We also aim for our future aspirations to be IVD ready, with a kittable version of Cxbladder tests for decentralized deployment for international market expansion, but we have not yet fully committed to that roadmap. Analytical validation of automated end-to-end lab operations for RNA and DNA workflows. This has actually already been achieved. That is the analytical validation of Detect, Triage, and Monitor that I mentioned earlier. And so that is now published.
We've also, after the announcement from the FDA, that they planned to end their enforcement discretion, or at least modify how they are enforcing or not enforcing their enforcement discretion. We have updated our IVD framework, we've updated our quality management system, and we take a view that this is important for us to maintain a defensive strategy here around IVD. There are still lawsuits that have not been resolved, but as of the fifth of May this year, the FDA did change how they enforce enforcement discretion. And there are additional obligations on Pacific Edge until those cases are resolved. But we have, we operate in a compliant framework today. We understand what those new requirements are.
We know when we need to be compliant with them, and shareholders should take comfort at the fact that we are just working towards those goals with a modest incremental investment in our quality management system. We also continue controlled engagement with industry and academic research and development collaborations to address unmet clinical needs in Cxbladder, and this is how we think about the long term. At this juncture, I'm going to ask David Levison to give you a little bit more insight into our PED USA operations.
Thank you, Pete, and let me just begin by giving my praise to Chris as well. As many of you may know, I joined the board for several years, right after Chris became chairman, and it was a privilege and an honor to serve on the board with him and then take this role to run the U.S. business. So, Chris, thank you all for. Okay, let's focus on the U.S. for a minute. As everybody knows, that is the dominant market that we serve today. Let's start with an overview of the U.S. healthcare market, since we are sitting here in Auckland, New Zealand, and you may not be as familiar with our marketplace. Three hundred and thirty-five million people in the U.S., the vast majority of them have some type of healthcare insurance.
About 7% or 8% of them are uninsured. That number has actually come down quite significantly over the last 10 or 15 years. Of the remaining 300 million people that have insurance, health insurance in the U.S., roughly split, about two-thirds of them are covered by commercial plans, and I'll talk about that in a minute. The other third are covered by plans that are funded by the federal government, publicly funded plans. So up on the top right-hand corner, you'll see the publicly funded plans, Medicare, Medicaid, Veterans Administration. Those kinds of insurance plans tend to have very few options. You can choose either choice A or choice B, maybe choice C, and there's very little or no out-of-pocket expense to the patient.
Those plans are eligible for folks that are over 65, that have been working, to folks that are indigent at low income levels, also folks that are either in the retired veterans or current veterans, actually, or current military, and folks that have disabilities of some sort. But the large majority of the patients in the U.S. are covered by commercial insurance plans. They fall generally into two categories: preferred PPOs or Preferred Provider Organizations, and HMO, Health Maintenance Organizations. PPOs tend to be. I just give you a sense of the commercial insurance. These tend to be plans that are supported by employers. So Pacific Edge in the U.S. has a plan for our employees. We contribute some of the money for that plan, but the employees contribute the other, the majority of the dollars to cover that plan.
Cigna, UnitedHealthcare, Aetna, some names you may have heard, are the dominant players in the U.S., tends to have a wide choice of plans. You can have plans for people that are young, that don't think they're gonna have many medical expenses versus people that have lots of kids that, you know, need more dollars in their plans. So lots of choice, wide choice of plans and wide choice of physicians. You can go basically to any physician you want to in the country under a PPO plan. Compare and contrast that to an HMO, Health Maintenance Organizations, which Kaiser is one type. They tend to be fewer options. You have to go to the doctors that are in that plan. You can't go outside of that without some referral. So they tend to be lower cost, but also lower choice.
Okay. Now let's dig down into the urology market, which, as you know, is where we focus. Three hundred million insured or three hundred and thirty-five million people in the U.S. covered by just about 14,000 urologists. Most of those urologists can be employed in a couple of different settings. Can be employed by a large academic institution, could be part of an integrated delivery network that has hospitals and clinics, could be part of a multi-specialty clinic where they have urologists and cardiologists and orthopedic surgeons, or they could be in individual standalone urology practices. Could be one doctor, could be five doctors. So there's a wide variety of the way these urologists interact with the healthcare system, interact with patients.
There are a couple of trends that I want to highlight that are really wind at the back of what Pacific Edge fundamentally does. So at the first level, historically, most urologists and most clinicians in the U.S. were independent solo practitioners or in small groups. They were their own small business, basically. Over time, more of those clinicians have started to become salaried employees at large institutions. Over the next several years, a higher percentage of urologists in the country will start to be salaried employees than small business owners. So that's a fundamental change, and that is wind at our back for Pacific Edge, when you become a salaried employee and you don't make more or less money, depending on how many patients you see and how many procedures you do, you tend to focus more on efficiency, and that's what our products do.
They provide efficiency to the marketplace. Second trend that I want to highlight is we are retiring more urologists today than are coming out of medical school in the U.S., which means the number of urologists that can serve that three hundred and thirty-five million is going down. On top of that, we have what's called, what we refer to as a gray tsunami in the U.S., which is aging population, that's the gray part. Older people tend to be higher users of urological services, so that we've got more people using more services, and the number of clinicians are going down. That really works to an efficiency issue of where. And I'll show you, I just got to go back. One slide ahead. And I'll show you in the next slide, sort of how that plays out.
So this is a graphic that we've used with CMS, with insurance companies, with Novitas. It really demonstrates very nicely, visually, what the value of our products are. On the left-hand side, you'll see the American Urological Association. The AUA guidelines say anybody that comes into a doctor's office that has blood in the urine, hematuria, should get a full workup, including a cystoscopy. Okay, we'll talk about cystoscopy in a minute. So you do 100 patients come in, you got to do 100 cystoscopies, 100 full workups, to find the three to five patients that actually have cancer. That's the way it works today. With the use of our product, in this case, the Detect product, the original Detect product, the one that we're selling today, you run those 100 patients with Detect. 78 of them will have negative or low scores in Detect.
You can send those patients home. You don't need to do full workup. You take the 22 that do not have low Detect scores. You put them through a full workup, including cystoscopy, you know, and you still find the three to five patients that have bladder cancer. That's the efficiency that our products produce. So all those trends I talked about in the last slide, this is the way it gets helped. Can I get a little glass of water? Thank you. The U.S. has multiple functions in our organization. Thank you.
And I clicked the wrong button. Here we go. And I thought I'd just briefly sort of walk you through the different functional areas and some of the things they do. Top left-hand corner, medical affairs. Pete's already mentioned that. Clinicians and medical professionals, they're tasked with educating the clinicians about the use of our test, about the clinical data. They work hand in hand with our sales team, but they are - they're really peer-to-peer selling. It's amazing. I can go in and talk to a clinician and say two sentences. If my colleague that has an MD says those same two sentences, they listen to that one more. So it really is an important function of all of our selling efforts. The sales team are sales professionals that also know about urology. They're tasked with calling on, and educating, and operationalizing, the clinic practices that we sell to.
As Pete said, we have relatively large territories right now, so they're spending a lot of time not only in the offices, but also on the phone, and on text, and on video, to communicate with the practices that they can't get to as frequently as they used to. That goes hand in hand with the marketing team, that's responsible for creating all of our marketing literature, our conference attendance, all of those kinds of organizational things. They also do some fun things. You can see the top middle picture, where it looks like there's a little bit of a cartoon. That's Cuppy. We have a mascot called Cuppy. Cuppy is a cup because you have to provide your urine in a cup, and it is a mascot that the physicians and the practice members love.
We have that little cardboard cutout that we take to our conferences, and people come up, and they take pictures with it, and they put it on their social media. It's amazing how much they love Cuppy. At bottom left-hand side, our customer care team. That's a team that does a variety of things. They're the problem solvers. When something doesn't go well, the customer care team steps in over the phone to fix the problem. They also do other parts of our operational life. For example, we have about 10% of our kits go directly to patients' homes, so they can provide the sample and then send it back to us. All those kits are created and sent out by our customer service team as well. Then our lab operations team, bottom middle.
We have a team in Hershey of about 15 folks. Lab operations do everything the same way all the time. You don't want any variability, so it tends to get a little bit routine, but we've got some great opportunities as we're training this lab staff about the next generation product, Detect Plus, and other kinds of things. So we've got a really great lab staff in the Hershey facility. And then the market access and reimbursement team, we don't talk about them as much. They're responsible for making sure we get paid, and so it's a really important function. They do everything from making presentations to insurance companies, to health plan providers, those kinds of things. But they also work with individual patients.
If a patient has a question about, "Why did my insurance do this?" or, "Why didn't I get paid?" All those kinds of things, the market access team takes care of those issues as well. Turn our attention a little bit to Detect Plus and our next generation products, as Pete's already sort of highlighted for you. I won't spend too long on this slide, but a couple of things to note. On the left-hand side, you can see the two products we currently have in the hematuria evaluation sector here, both Triage and Detect. As we move forward to the right-hand side, those will be combined into a Detect Plus product, and we'll also have a Monitor Plus product going forward.
What you can see in the graphic on the bottom with all the numbers, that the Detect Plus product has better performance across all of the metrics than either our Triage or current Detect products do today. And that's really a testament to Justin and his team for the great work they did in the lab and creating the algorithm. We actually have done some additional work in the lab, that shows that we can have even better performance in this, and we'll be able to update the market when we publish that, clinical validation. So the key message I want you to take away from this slide is, Detect Plus, with the DNA markers, in addition to the RNA markers, is a better product for the same problem we're solving.
It will be a fundamental change in the way we can talk about the product in the marketplace, because it really does have significant more clinical value than we're able to deliver today. We are getting ready for commercialization, but we're being very disciplined about the way we do that. We've set ourselves some milestones, some stage gates, that we need to finish and cross before we are willing to go to the market with Detect Plus. Those two primary stage gates are making sure we've got a price that reflects the clinical and economic value of our Detect Plus product. And secondly, that that price is reflected in decisions by Medicare that we can reliably get paid for that product. Because we are getting paid for Detect Plus, we don't want to roll out a new product that we don't get paid for.
That wouldn't make any sense. So we're doing a lot of work in the background in anticipation of a future launch of Detect Plus. You can see some of the things that are listed here, adding capabilities and capacity to the U.S. lab. Right now, we're running the U.S. lab one shift, five days a week. As we roll out Detect Plus and our volume starts to improve, we're going to have to go to multiple shifts, probably more than five days a week, and we can do all that within the footprint of the Hershey laboratory that we have right now. We need to Pete already mentioned about simplifying the laboratory workflow for improved efficiency. We're already doing that. Much of that work's been done. We have thought long and hard about what does the sales force look like today? What can we cover today?
What does it need to look like when we go to a Detect Plus launch, particularly if we're in guidelines, that fundamentally changes the way we talk to clinicians about our products. So we would need to have more people, more feet on the street, more medical affairs folks, to do that, but we're being very cautious about making those investments until we meet those milestones. And we're preparing for the launch, the typical kinds of things. What does the launch mean to look like? What's the market materials look like? All those kinds of things we can do in advance because we know already what the Detect Plus product looks like. Detect Plus pricing, one of the key milestones we need to reach before we move to full commercialization.
This is simply a sort of a timeline of the way this process happens. It typically is about eighteen months between when you inform the government that you want a new product in the marketplace, and they give you the price for that. So we started this process back in May of 2023, when we submitted our application for a new code for Detect Plus. We're working through that process. We fundamentally believe, and we made presentations to Novitas, to CMS, to which is Medicare, to all these groups that need to make this decision. We've done it in open panel forums. We've also done it in private meetings. We've really covered the landscape in terms of making sure our messages gets across.
We still don't yet have a resolution on what that price is going to be, and the process is gonna go to get that price. We expect that going forward, and we'll be able to update the market as soon as we know that definitively. The other part of us thinking about both potential guidelines, inclusion, growth, Detect Plus, is making sure that we've got the foundations and the fundamentals to grow at the speed that we can in this very large market opportunity. We've got really good systems today. They need to get better for us to accelerate the growth. My next couple of slides sort of talk about different aspects of that fundamental growth strategy that we have.
This one talks about creating the stickiness and the long-term market share, and there are several ways that we need to improve our organization to do that, and they're listed up here. Electronic medical records, and I'll talk more about that in the next couple of slides. We've already done that with some of these providers. A Pacific Edge portal, that you'll see a little video on here in a moment, and then a pathology lab integration. So right now, most of our customers fill out a paper form to order our test.
In today's day and age, where you can get any piece of information from a couple of clicks on your computer, order virtually any product with a couple of clicks, we need to provide that same level of service to our customers going forward, and that's really what we're doing with all these efforts. Down at the bottom, it's an interesting graphic that we put together that says, where are all the different places that our digitalization, our integration with our customers, can add benefit? I won't go through all those. I'll highlight just two of them. In the middle, where it says test ordering, still, instead of filling out a paper form, wouldn't it be nice just to click a couple of buttons? Because you already have the information about this patient in your electronic medical record.
Just have that converted over, hit a button, and says, "Send the test to us." That's exactly what we do with Kaiser, by the way, and it helps us on the back end, because when we get a sample in the door, instead of having to take the paperwork that's been written and type it into a computer system, it all comes electronically. The other piece that I will highlight is the receiving results, the second from the right. That's an area where we electronically provide the results to the clinician, not only on an individual basis, but it's all nicely formatted and organized, so if you wanna see the results for all your patients in the last two weeks, you can go look at that, or you can wanna see all the results for patients that had negative scores and what happened to them.
All of that is available to them with these new interfaces that we're developing. And with that, let me show you a-- have them start a video. This is a customer portal that we've not yet rolled out, but it will allow virtually any clinician that wants to order our product to order it in a much more automated way. Video, please. So that's just a sample of what our customer portal look like. I have to give a shout-out to Andy and his digital team that really collaborated with the U.S. team on putting this together. So it's not only the ease and efficiency of being able to have all that information electronically provided, but the.
We get a lot of tests in the U.S. that don't have all the information we need, so we have to turn around and call back the clinician and the practice and get the information. They can't, they can't finish this until it's right, which is the real value. I've talked about Kaiser. We've made a lot of progress since I was last here speaking to you at the ASM. So last November, with Kaiser, we fully integrated our Cxbladder systems into their electronic medical record, electronic health record. And that's a two-way interface, basically, where any Kaiser clinician in Southern California can go to their EMR system they use to order everything else, pull down our products, order them. That will send a request to the patient to come in and provide a sample.
That sample then gets sent to our laboratory in Hershey, Pennsylvania. When we get that sample in Hershey, Pennsylvania, we simply scan the barcode on that sample, and all the information that's needed to run that test are sitting there electronically. It took a lot of effort. It took a lot of work. Again, Andy and his team were instrumental in that, but it has allowed us to significantly improve our performance, both in the laboratory, and make a much easier process for Kaiser to use our products. Right now, we are only in Kaiser Southern California, which is about a third of the overall Kaiser business. Literally, a couple hours before I got on the airplane to come to Auckland, I was with Kaiser Northern California folks, talking to them about how we make the transition from Southern California to Northern California.
The data that Pete talked about that we're developing with Kaiser will be extraordinarily helpful. We'll be able to leverage some of the digital integration work we've done in Southern California, but they are really different entities, and so there's some more, things we're gonna have to continue to do to get to Northern California. I'll talk a little... This is the last one, and this is a more recent one. Lumea is a software company in the U.S. that has a digital pathology platform that they roll out. Part of that digital pathology is a piece of software called Biopsy Link, or, or Bx Link, and it is used by pathologists and some urologists to order all kinds of tests, not just ours.
With the help of the digital team, we've been able to integrate our Cxbladder products into that Biopsy Link software. We just rolled it out about two weeks ago. It just went live two weeks ago. I heard over the weekend that we should be getting our first samples in the door that are using Biopsy Link this week. So fingers crossed. But just another example of the broad set of efforts we're going through to make it easier for our customers to deal with us. And this is the last piece of it, which is not only do we need to make it easier for our customers to work with us, we need to make it easier for us to work with ourselves. And we've got opportunities to improve our lab operations that Pete already talked about.
Our customer service team, you know, is still working too much on a manual basis. We need to get software, and we're working now to get them software so they can sort of create task lists, so they know when everything's being done at any given time, and we can track some metrics for that. We've got an operational plan with Daryl's help to sort of scale to 250,000 tests per year and beyond. How do we do that with our current footprint? When do we have to hire new people? When do we have to get new systems, new equipment? All of that stuff is well underway.
Product development and the decrease in our costs, deeply in the cost of running these tests, not only from a people standpoint, but from all the reagents and those kinds of things. And I'm really pleased and impressed with all the work that's been done in advance of the growth to make sure we know how to grow in a very efficient manner. And before I turn it over to Pete, I just want to reemphasize again that we have certainly been through some choppy waters here, but the prospects for the future of Pacific Edge is really strong, and I'm really excited that we have all the work that's been done and is ongoing. Pete? Stand in for Tamer.
Thank you, David. Of course, I am not Dr. Tamer Aboushwareb. Tamer is celebrating his wife's fiftieth birthday in the United States, so happy birthday, Alicia. And so I will be moonlighting as my own Chief Medical Officer for this afternoon. So, what does our evidence generation program do? We seek to make change, specifically to the little. Sorry, this thing doesn't actually highlight on the screen. But we want to make change to medical policy. We want to make change to reimbursement policy. We want to make change to the standard of care, and we want to make change to clinical practice. And so you can see that in the evidence use column there of the diagram that we have up there. How do we do that?
We build it on strong foundations, and those foundations are analytical validation, which is that the evidence of a test is repeatable in the lab and for a given indication in population. With clinical validation or clinical validity, evidence that a test works in the same way in an independent population from the one that it was tested in, or developed in, rather, and then clinical utility evidence that a test changes clinical practice. In the hands of a physician, typically, prospectively recruited, randomized, controlled trials, and then real-world evidence, which is a type of clinical utility evidence, but not from a randomized controlled trial. The verification of real-world use of the test in clinical practice, usually through regular use of the test by physicians.
And so all three of, all four of those evidence types look to facilitate that change, and they are targeted at three different audiences. So the healthcare payers are the ones that change the medical policy and the reimbursement policy. The professional societies are the ones that update and change the standard of care, and the urologists are the ones that ultimately change their clinical practice. And, of course, when we think about the guidelines, there are multiple there, the American Urological Association, NCCN, and, the European Association of Urology. So as we look to establish AV, CV, and CU for each of our products, where are we? So we have AV for all of Cxbladder, Triage, Detect, and Monitor.
We have clinical validity for Triage, Detect, and Monitor, and we have clinical utility for Triage, Detect, and Monitor, and we're working on those of our new products, and so as we reach those milestones, we obviously intend to advise all of our investors, and many of those are coming very soon. So, specifically, the clinical evidence for Detect Plus will be established with DRIVE, AUSSIE, and Micro-DRIVE, as mentioned, with the catalyst for coverage that I spoke to earlier.
And we also have the opportunity to develop clinical utility on an accelerated timescale, a form of concordant clinical utility for Detect Plus, by running a concordant study, which is a comparison with Triage, because they have a shared clinical pathway, but one where Detect Plus has superior performance characteristics. That we're hoping to deliver in Q2 2025. But the level one clinical evidence, the game-changing clinical utility study, the sort of irrefutable evidence, is coming from the CREDIBLE study, which is longer term, and we're hoping to enroll the first patient in that study towards the end of the year. Monitor Plus is in earlier stages, but again, it'll go through exactly the same rigorous process of AV, CV, CU, real-world evidence, to get where we need to be.
So we supplement our core clinical evidence generation program with independent research. And these studies listed here are predominantly what are called investigator-initiated trials or IITs. And so we partner with prestigious organizations and well-known investigators to achieve all of these things. We're generally looking at questions that are of interest to both them and us, and we provide a level of support. So patient preference and satisfaction of biomarkers versus cystoscopy. That's never gonna be a core evidence generation clinical trial, but it's really important to know what patients actually think. And that helps to get the Cxbladder name associated with those outcomes. Review of the Canterbury experience, there has been a review already. I think it was in 2019, but they now have five more years' experience.
And so we are looking forward to an update of how they've been practicing with Triage. Can biomarkers specifically Detect Plus be used to screen patients at risk of bladder cancer? I get asked this, I was asked it earlier today. Can your test be a screening test? The shorter answer is if it's validated as a screening test, it can be. But those are typically very, very large clinical studies. This particular study is run by Dr. Yair Lotan, who is known to a few of you as one of our key opinion leaders. And it's looking at using actually a urinalysis as the primary screening tool, but then automatically sending someone for bladder cancer to see.
Sorry, to receive a Cxbladder test, to see how that would, you know, make the process more efficient. Can biomarkers be used to report on therapy success? You guys have seen the patient journey pathway. It was in David's slide deck today, but it's been in numerous slide decks from Pacific Edge over the last couple of years, and so that's adding value in a different part of the patient journey and looking at that. Can Cxbladder be used to assess the response to BCG? BCG is used in after a transurethral resection of a bladder tumor, so after the tumor has been excised by a TURBT, to get the residual disease that is potentially hanging around, we wanna know, did we get it all?
And can Cxbladder Monitor be used for that purpose? Can Cxbladder be used for surveillance of muscle-invasive disease in patients that have been spared their bladder? This is a uniquely interesting one. This really changes the care for an indication of patients that we are not currently involved with. This patient is unfortunately, very, very sick. They have muscle-invasive disease. The cancer is in their blood. It has invaded the muscle wall. But the physician has decided, the urologist has decided this patient maybe will spare their bladder, because that's usually the treatment, is to cut the bladder out. We'll spare this bladder. We'll treat them aggressively with various therapies, and then we'll see whether or not that has actually worked for them.
Bladder sparing is, in my opinion, one of the futures for bladder cancer patients, and so it'll be fantastic if we can demonstrate a role in this group of patients based on our existing tests. And a randomized controlled trial of apalutamide in non-muscle invasive bladder cancer. This is an opportunity to work essentially with a researcher that's working with a pharmaceutical company at the NIH. Ed Messing is a highly respected emeritus-level researcher in bladder cancer. And so the opportunity to work with him on this study and show whether there is an interaction with a therapeutics company or with a therapeutic option is very important, very valuable. And the bullet right at the bottom there, these are.
From Pacific Edge's perspective, these are very low cost. We're not spending millions of dollars per trial. These are investigator-initiated. We pretty much pay for the running of the tests, and we support them if they have questions, and they are the ones driving this research, but this kind of program keeps Cxbladder at the cutting edge. It potentially opens up new indications, and it keeps us at the forefront of people's minds when they want to know more about bladder cancer diagnostic, non-invasive options. Engaging our key opinion leaders for clinical excellence and advocacy is something that differentiates where we are today from three years ago.
When I took over as the chief executive, I had already started talking to the board about the need for a medical affairs team, which we have assembled under Tamer. But it's important to qualitatively highlight for you what we do that's different. And firstly, the profile of people that we employ in a medical affairs team is different. These are non-practicing physicians, typically, that we bring into the team, or people with similar qualifications, PhDs, PharmDs, etc , that can have peer-to-peer conversations with the physicians. David also had a nice anecdote about that. But we engage our key opinion leaders to. It's, yeah, it's how we activate these key opinion leaders that really matters, and the function of these key opinion leaders that really matters.
We review protocols in our clinical trials. At every SUO meeting, Society of Urologic Oncology, we convene our clinical advisory board, and we get them to essentially tell us whether or not they think the protocol that we've put together for this clinical study is going to generate the type of evidence that they will ultimately say, "Yes, that's the type of evidence we want. That's the type of evidence that will drive behavior change." They will advocate for our product's evidence. Again, that's very important. They don't advocate for our products for no reason. They advocate for the evidence that we have put together. Based on the published clinical evidence, they will then help communicate that. They provide guidance informally.
We're in regular communication with all our KOLs, and we provide-- they provide that guidance formally as part of our clinical advisory board, and they speak to other physicians on our behalf. So it's a very common question when a salesperson is in a new sales situation, say to the doctor, or the doctor says to them, and say, "Do you have anybody else I can talk to that's already using your product?" And in fact, we can roll out a list of people. Maybe he even did a residency program with one of them back in the day. That sort of thing is really powerful. Some of our KOLs are not clinical advisors.
They sit on our clinical trials, and they're involved in the core evidence generation, IITs, and registries, which we're not currently running, but we hope to reestablish when the economic situation justifies it, and they author research publications on basic science and health economics for us, so if you have read any of the publications that have come out in the last little while from Pacific Edge, you should take a note of the author list and which organizations and which individuals we are working with. Some of them may be on this list. These are some of our key clinical advisors and consultants, and I'm not going to read through the list. This is more for people to be able to look at afterwards, but we do wanna highlight a couple of things here.
Many of these folks that we engage with on a regular basis and that provide their advice when we are designing protocols in our clinical studies are members of guidelines committees, and education committees, and research committees within the AUA, NCCN, and other professional organizations that are relevant in urology. And so we wanted to highlight this, and it's actually, if I'm honest, so we have been a little bit remiss to not have updated our website, which we have done today as well, to make sure that you are aware, and you can go see the same list on our website. The older list had not been updated for quite some time, and this is the list that we've been using since we've had a medical affairs team.
So with that, actually, we'll just move to the summary and the outlook. And then we'll, Chris will take you through the next part of the program. So we continue to manage our cash prudently, and I haven't talked a lot about that. I think Chris did. David, obviously, was able to give you some insight into some of the things we've been able to develop, both on the digital side and the evidence side. But we do continue to manage our cash prudently. We understand the situation we're in, and while we establish coverage certainty. We will continue to preserve, do everything we can to preserve reimbursement for our existing portfolio of tests. We focus on the clinical evidence for Detect Plus and Monitor Plus, for guidelines inclusion, and increased coverage certainty.
We are focused on clinical operations, in profitable territories, non-Medicare revenue streams, and we're focused on cash collections. David mentioned the market access and reimbursement team, they are very important. They are a key focus for me as a chief executive. And we emphasize the clinical and economic value of Cxbladder in our sales messaging. We acknowledge that there are some headwinds. There's a possible non-coverage determination from Novitas, even on this new proposed LCD that has been granted an extension, as Novitas follow the appropriate notice and comment procedure. There is also possible negative physician or patient response to the enhanced patient responsibility that we have, while we navigate the uncertainty.
But there are also there are more catalysts than there are headwinds, and probably the most important thing is that we have we have actually weathered this storm now for more than two years. The first announcement from Novitas came in 2022. So we now see this as there are more catalysts than headwinds, acknowledging, of course, that those headwinds are real. There is a possible inclusion of Cxbladder Triage in AUA microhematuria guidelines amendment as a consequence of the STRATA publication that we've made earlier this year. There is also the possible retirement of the proposed Novitas LCD. There is also the possible re-coverage determination in the event of loss of coverage on the new proposed LCD after following appropriate procedure.
And there is the possibility of crosswalk or provisional pricing for Cxbladder Detect Plus, a greater margin than we currently enjoy on our existing products, which could have a meaningful impact to our business. So, that's all for me for today. Myself and my management team will be here afterwards, and of course, we're gonna be here for questions in the meantime as well. Chris?
Thank you, Pete and David, and Pete standing in for Tamer. We now come to the formal part of the meeting, the matters which require resolution of shareholders and which were outlined in the notice of meeting. There will be an opportunity for shareholders to ask questions on each matter being put to shareholders. For the sake of good order, could shareholders please relate their questions directly to the matter being considered? When I do call for questions, can shareholders present in the room please raise your hand and wait until a microphone is provided to you before clearly stating your name and whether you are a shareholder or a proxy holder. Slide 44. Online attendees can submit questions by clicking the Ask a Question button in the virtual meeting platform. Now moving to resolutions.
A poll will be held on each of the resolutions. Shareholders joining us here today have already been given your shareholder voting card. If you are a shareholder and did not register on arrival and wish to vote, please make your way to the registration desk outside the room, and staff from MUFG will assist you. Please mark your voting intention for each resolution on your voting card, which will be collected at the conclusion of the meeting. Shareholders joining online will be able to cast their vote using the electronic voting card received when online registration is validated. Sorry about this. To vote, this is very detailed. To vote, you will need to click Get Voting Card within the online meeting platform. You will be asked to enter your shareholder or proxy number to validate.
Please then mark your voting card the way you wish to vote by clicking For, Against, or Abstain on the voting card. Once you have made your selection, please click Submit Vote on the bottom of the card to lodge your vote. Please refer to the Virtual Meeting Online Portal Guide, or use the helpline specified if you require assistance. Voting will remain open until five minutes after the conclusion of the meeting, and the results of the vote will be announced on the internet today. Each resolution set out in the notice of meeting is to be considered as an ordinary resolution, and as such, must be approved by a simple majority of the votes cast by shareholders entitled to vote and voting on the resolution. The outcome of proxy votes will be displayed for your information after the voting on all resolutions.
Resolution number one concerns the reappointment of our auditors, PricewaterhouseCoopers. I now propose that shareholders record the reappointment of PricewaterhouseCoopers as auditor of the company and to authorize the directors to fix their remuneration for the ensuing year. Are there any questions on this resolution? Nope. Are there any questions from shareholders in attendance online?
Not on this resolution.
Thank you, Grant. There are no questions on the matter. Please mark your voting cards in the way you wish to vote by ticking or clicking For, Against, or Abstain in the appropriate place on the voting card. How long do we give for this? All done. What a mouthful! Resolution two is the reappointment or reelection of two of our directors. But before moving to those resolutions, if I can ask our retiring director, Mark Green, just to say a few words.
Can I come up?
Yeah, you can come up here, Mark.
Is it working? Great. Look, before I say anything about the board or the company, I'd just like to thank and congratulate the young gentleman at the back who, without being asked, gave up his chair at the very beginning of the meeting, so a lady coming in could sit down. So great manners. Thank you. Didn't go unnoticed. Thank you, Captain, for letting me say 30 seconds, I think I've been limited to. Unlike Chris, who mentioned why he came on the board, I'm an Auckland Rugby supporter, so I can honestly say I was not attracted to Pacific Edge's Dunedin roots. I can agree that his comments around Pacific Edge, in respect of having a team of dedicated, passionate members, that goes right through to the board.
And all of that team want to see this company achieve global success. No one's with Pacific Edge for their job or their role. They're here to try and achieve something much bigger, not necessarily for themselves, but for the company, its shareholders, stakeholders, and ultimately, New Zealand. Pacific Edge is endowed with a great bunch of humans, and they're all striving for this goal. As a director, I have been proud to have sat with and challenged the Pacific Edge team. Thank you for your words there, Pete. I'd like to thank them all for their diligence towards the company and their patience of me. To Chris, I would like to offer a special thank you.
As far as chairs and captains go, he has been outstanding, and Pacific Edge is extremely lucky to have access to his ongoing dedication and skill sets. Over my career, I've been around many boards. I've had the benefit of observing and participating and advising, and Pacific Edge is absolutely lucky to have Chris nine years of his services and potentially a little bit longer as it transitions. To my fellow board members, executives, and the Pacific Edge team, thank you.
For your commitments to the company, particularly over the last two years, with its challenges, and ongoing coverage uncertainty. Regardless of the coverage outcome, the company has strategies ready to consider and to action, and Pete's done a great job of outlining what those are today in terms of positive, negative, and some of the great work going on. Finally, thank you to the Pacific Edge shareholders who originally supported my appointment and have been supportive of the company over a number of historic capital raises. While there's still uncertainty over coverage, there are significant positives that the company can definitely look forward to. Thank you, all.
Thank you, Mark, and others who have said some kind words. It's all very humbling. First up, we have the re-election of Anna Stove to the board. In accordance with NZX Listing Rule 2.7.1 , Anna Stove retires by rotation, and being eligible, has offered herself for re-election. Anna's biography is listed in the notice of meeting. From that, you'll be aware that she has a successful track record in leading and driving transformational change within the healthcare sector. The board has determined that Anna is an independent director for the purposes of the listing rules and unanimously supports her re-election. I now propose that Anna Stove, who retires by rotation and is eligible for re-election, be re-elected as a director of the company, and I now invite Anna to say a few words.
Thank you, Chris. Excuse me, I've just got a bit of a cold. [Foreign language] . Good afternoon, everyone, and thank you for the opportunity to speak in regard to my re-election to the Pacific Edge board. You'll know from my bio that I've had significant global business experience, having held a variety of senior executive roles within Asia Pacific and Europe, and prior to stepping down from corporate life, I was also the New Zealand general manager of GlaxoSmithKline Pharmaceuticals. Since joining Pacific Edge, I've a proven track record of strategic oversight and effective boardroom leadership. I bring a collaborative yet decisive approach to board discussions.
I'm also the chair of the Pacific Edge People and Culture Committee, where we've put much-needed systems, processes, and policies in place, which has helped to foster a culture of accountability and transparency. Excuse me. My strengths in risk management, stakeholder engagement, and ESG issues ensure that I contribute to sound decision-making and robust governance practices, ultimately enhancing organizational value and sustainability. I truly believe in this company, and I'm very excited about the growth opportunity ahead for Pacific Edge, and I believe that I have the right international business experience to support management to maximize their plans. Thank you for considering my re-election.
Thank you, Anna. Are there any questions from shareholders on this resolution?
Yes. Jane Carter. I'm a shareholder. Do you have shares in the company, Anna?
Yes, I do.
Any further questions for Anna? Nope. If there are no questions on the matter, is there anything from shareholders who have joined us online?
No questions.
No questions. Thank you, and please mark your voting cards in the way you wish to vote by ticking or clicking for, against, or abstain in the appropriate place on your voting card. Just a minute, that's all we need. Can I now move to resolution three, which concerns the re-election of Anatol Masfen to the board? And I have to go through this rigmarole again. In accordance with NZX Listing Rule 2.7.1, Anatole Masfen retires by rotation, and being eligible, has offered himself for re-election. Anatol's biography is listed in the notice of meeting, and we acknowledge that Anatol has been a board member for more than sixteen years.
While this tenure is beyond the 12 year period identified in the NZX Corporate Governance Code as a factor that may cause questions as to independence, the board values Anatol's extensive knowledge, and experience that he brings to the table. The board is satisfied that he continues to bring independent judgment to bear on issues before the board and acts in the best interests of the company at all times. The board, therefore, unanimously supports his re-election, and I now would ask Anatole to say a few words.
Thank you, Chris, and good afternoon, ladies and gentlemen. Look, yeah, it's hard to believe it's been 16 years, but, you know, I'm very proud of the people that stand to the right of me or sit to the right of me in the directors and the management of Pacific Edge. It's a long game, and it's been longer than most of us had hoped, especially those that have been shareholders in the company. I've. I'm 54 years old. I've got a daughter just finishing university that was five years old when I started this journey, and a son that's just finishing school that was three years old or two years old when I was first elected as a director.
But look, I'm absolutely 100% still committed and passionate to the cause. You know, for, for many, many reasons, and the reasons that, Pete, alluded to before, the company is in a far better position than it's ever been in. As far as, you know, being a real business and the prospects looking forward. And I'm 100% committed to, you know, putting my time and effort in, you know, at least for another stint.
It may not be the whole three years, but you know, the priorities are you know, to get these key decisions underneath us and behind us, and to replace Chris, who's been an absolutely magnificent Chairman, and you know, by far the best Chairman I've seen in you know, the multiple or dozen boards that I've been associated with over the years, and to replace Chris you know we really do need to know what direction the company is going in to get the right person for that job. I believe that I've got the skills really in planning and strategy and capital markets.
Not necessarily so brilliant in the ongoing layer and layer and layer of, yeah, the other stuff that we have to do, which makes it very, very difficult to find people to put their hand up for directorships these days. And just on that, you know, we do very much as a board welcome nominations from the shareholders and, you know, it is something that if you know someone that's appropriate or might be appropriate, look, we love to hear from them because it's, you know, the process of getting, you know, that succession planning, and I've been involved in it with a lot of the appointments here. It really is, you know, finding someone who's passionate, who's not necessarily doing it for the money.
You know, it's not. So the normal process doesn't really apply in a business like this. So anyway, probably enough from me, but yeah, I've been on pretty much all the subcommittees, but I think the next, you know, and currently head of the capital committee, or will be, and yeah, we've just got a few more steps to go, and then, you know, we'll be there. So 100% appreciate your support, and you know, it's a privilege to serve as a board member.
Thank you, Anatol. Please mark your voting cards in the way that you wish to vote by ticking or clicking for or against, or abstain in the appropriate place on the voting card. That completes voting on the resolutions. At this time, I'd like to advise the outcomes of proxy votes that were lodged in respect of each of the resolutions. I'll not read them out, but they will be shown on the screen. Coming? Oh, here we go. That's a good vote of confidence in the company, the board, and the resolutions that have been put to you.
I would now like to give shareholders the opportunity to ask questions, whether related to the presentations, the financial statements, or the management and governance of the company. Shareholders online can continue to provide questions through the portal, and we will also address questions from the room. Are there any questions from shareholders?
We've got one online, so I think we just alternate between online. So I'll start with the online one.
Yeah, sure. Yep.
Okay. This one's probably one for Pete. There's another AUA guideline for diagnosis and treatment of non-muscle invasive bladder cancer. The guideline was amended in 2024 . It was mentioned Cxbladder as a novel urinary biomarker, but is yet to show any language to include Cxbladder as part of the guideline. What's the difference between this guideline and the one for microhematuria? Which one is more important as Cxbladder is now successfully included in the microhematuria guideline? Will the other guideline potentially get amended?
It's a fantastic question, very nuanced. So we have two products or two major areas in which we have products, hematuria evaluation and surveillance. The non-muscle invasive bladder cancer guidelines are the same as that's the surveillance pathway, that's the product Monitor. And so guidelines are typically product level specific comments. And so the favorable mentions in the non-muscle invasive bladder cancer guidelines were with respect to Monitor. And so what is different between that and the microhematuria guidelines, which is where hematuria patients are evaluated, is the STRATA publication. So now there is level one clinical evidence from a randomized controlled trial that is part of what they are considering for the hematuria guidelines, and that is what we think separates this situation from that situation. I hope that answers the question.
Thanks, Pete. I think we have one from the floor.
Richard Eyers, I'm a shareholder. With all the research and that you're doing, are you sort of looking at any other testing that may show other issues?
Other cancers?
Yes.
Yeah. Pete?
Yeah, so, when you look at the patient journey slide, so first of all, I'll address it in two parts. When you look at that patient journey slide, where you go from genomic screening, asymptomatic screening, patient management, and then, therapeutic intervention, surveillance, we can consider products outside of where we offer today, hematuria evaluation and surveillance. There are other areas of value along that pathway. We don't. And those, some of which were, some of them we're exploring with the IITs, but right now, we're generating clinical evidence for defined patient populations for the existing value propositions of our products. But to your larger question, like, are we looking outside of bladder cancer for, you know, for other opportunities?
More at a theoretical level by evaluating other companies, other technologies, reading the literature, because we are very focused on what we have to do right now. Until we have you know shown commercial success, and not just research success, because we already have that, and we've got a fair degree of clinical evidence generation success as well. We've got to have the commercial success for our existing products, then we can look to expand into other cancers, other disease states. But routinely, that is a topic that I challenge my management team in strategy sessions to come to the table with opportunities, and it will be part of discussions that the management team will have with the board about future directions.
But probably the last part of the way that I'll answer that question is: How do we think about this? Like, what would a good opportunity look like? Well, the first thing is to start with what is an unmet clinical need? And to, you know, for that, you've got to be interacting regularly with patients, you've got to be regularly interacting with physicians, which, of course, our in-market teams do. And we believe that unmet clinical need comes largely from, again, our medical affairs team, looking at those opportunities, and then evaluating, in our R&D team, what technologies do we either have or do we see in the literature that support a product that could address that unmet clinical need? So that's how we want to solve that problem.
Great, thank you. I've got a question around the Novitas LCD. There's two components to this. So to what extent could the Novitas LCD for Pacific Edge be held up by concerns about other companies using genetic testing? And then the second part of that question is as well, is what is the impact of the Novitas LCD on expansion into other countries?
Grant, could you just read the first part of that question again, Grant?
Sure. The question revolves around: To what extent could Novitas LCD for Pacific Edge be held up by concerns about other companies using genetic testing?
We are part of a group of companies that this LCD impacts. This is not specifically targeted or designed at Pacific Edge. So, I'm pretty confident, Pete, that we don't have an issue in that space. Now, the second piece of that was, could the Novitas decision impact our moving into other markets or new countries?
Yeah, it's. Yep. Does the Novitas LCD, does it hinder our expansion? Is it being looked at by other countries?
Well, I don't believe it does, and others may have a view. Kaiser pay no regard to the Novitas decision, for example. The Novitas folks are concerned with Medicare and Medicare only. So, it certainly doesn't. It certainly helps to have a positive Novitas decision when you are going into new markets and able to say, "We have this ticket from the U.S.," but it's not determinative. And I can ask Pete or any of the other directors if they might have a view on that. Bryan?
You know, part of the Novitas, I guess, rationale for looking into this was really the avalanche of SNPs, small nucleotide polymorphisms, that were introduced as part of a diagnostic pathway, and they all asked for coverage of these. There was really an avalanche, and they decided to then just take any sort of genetic-based test and throw it into the mix, and then have a look at the LCDs and perhaps retire them. So that was the driver for this. As you know, our test is completely different. It's not nowhere near a SNP, and so we really position ourselves completely differently. But the other companies that are in with us do have tests that are somewhat similar to ours, and that are a nd these companies, together with us, are querying and quizzing the Novitas decision.
I understood the first question to be slightly different, as well, just that are there actions that other companies could be taking that could cause this to continue to be delayed? And absolutely. There are other companies that are affected by this. There are large hospitals, even professional societies, like the LUGPA Association and stuff. They could be taking actions that we are not aware of that could be driving further delays. And in fact, you know, we think we are taking some of those actions ourselves, by making Novitas aware of the advancements that we continue to make, every time we make those. That is happening as well, but there's definitely no meaningful impact of a non-coverage determination by Novitas on international markets. Those are separate.
The longer Novitas extend, the more opportunity we have to provide them with further information. Pete? Any more online, Grant?
Yes, there is. Once we get a resolution regarding Medicare, Medicare coverage, are we open to acquisition? So I assume that means to be acquired. Has acquisition ever been on the cards?
It's in the minds of others. It's not in our minds in terms of us putting the company up for sale. If acquirers sitting there looking and watching, and I'm sure there are, that's for them. And we would deal with that with them if it ever popped up. But yeah, I'll leave that there. The acquisition is in the minds of others, not ours. Yes, Aaron?
Thank you. Aaron Bhatnagar, shareholder. Firstly, my congratulations to the senior leadership team and the board for the incredible efforts to conserve cash over the last year, given the amount that you've got and what you needed to do. But I just want to make sure that, with all the savings that are being made, that you are still going to make sure that you have a proper and decent investment, particularly around the medical affairs team that you have, 'cause I see that as being the engine for growth for this company over the next eighteen months to two years, given the large number of studies that are coming down the horizon. Notwithstanding the fact that there's opportunities that you've taken to deliver on success by making sure that the medical affairs team is properly resourced and staffed, and that Tamer, in particular, is well supported.
Thank you. That's a great question, Aaron. No company has ever cut costs its way to greatness, and we're very conscious as a board that we need to, even in the event of an adverse decision from Novitas, there are functions and parts of our business that we would not touch until we get recovered, and medical affairs would be one of those people. So, you're very conscious of that, Aaron. There could be a period where we are waiting. If we lose coverage, and we have to get recovered, then the medical affairs team will be front and center of getting us recovered.
Thank you. And, if I may, with the second question, I understand that CMS has recently issued a request for information to the market of Medicare Administrative Contractors, the, the MACs out there, over the various jurisdictions. Is this something that the board is familiar with, or is it something that's best answered by the senior leadership team? And if so, the Jurisdiction L, which I believe is the one that Pacific Edge operates in, in Pennsylvania, is been cited by CMS as an opportunity for some kind of consolidation. And is there a potential impact to Pacific Edge from that?
You have deep knowledge of our company, Aaron.
I can take that one, Chris.
David L. or Pete, either all can take that one.
I can take that one. So, yes, J15 is. Pennsylvania does fall in J15 for, I think it is, Medicare Part C and hospice care. But for Part B, which is what we operate under as a clinical test, it is not part of the proposed consolidation, so we're actually not affected. Notwithstanding, Medicare does make these kinds of consolidations from time to time, and it could affect us in the future. But right now, it's not something we have to be concerned about.
Thank you. Thanks, Pete, and thanks, Aaron. Anything else online, Grant?
Yeah, there is still a few. In the event of a negative Novitas LCD decision and continuing cash burn to that point, and the current financial losses available could be exhausted within circa two years, what options are being considered for the future funding of the firm?
So I can respond to that in a couple of ways. We, for the next day and a half, are putting ourselves in a room, as management and board, to look at our, strategic pathways with both a, coverage or continuing coverage outcome and a non-coverage outcome. And some of what will fall out of that is capital and cash. At the moment, we sit with, a, a healthy cash balance. It was NZD 50.3 million at the end of the financial year. And we've always set the objective of managing our coverage within that sum of money.
The pathways that open to us, depending on which, what the outcome is from, Novitas, we'll be going through over the next couple of days. But, be assured that we are planning, and strategizing for both outcomes. One will be a coverage outcome, the other will be an acceleration, growth acceleration outcome. We'll be looking at how we fund that over the next couple of days.
Great. Thank you. This one's more specific just to New Zealand. If Cxbladder can save medical insurers money, why does Southern Cross exclude cover for Cxbladder?
Pete?
To be perfectly honest, I don't have a good answer for that question, but it is actually rare that Southern Cross is needed, so since the contracts we have are mostly with DHBs, and the value proposition of our product is for patients who have microhematuria or non-muscle invasive bladder cancer, the DHBs that we have contracts with, they would be covered if they enter either one of those pathways, so the insurance is not relevant.
However, there is a subset of patients, and this is just one example, where patients might choose to, you know, they might not have the appropriate symptoms to enter the pathway, and still want to get the test, and they are covered by other insurance companies. I understand NIB does pay for it, but Southern Cross does not, but in that situation, the cost is actually just, it is just a cost to the system. It's not actually avoiding any other procedures, so it may even make sense from the insurance company's perspective. There is a subset, there is a syndrome called Lynch Syndrome, where patients have a 3%-5% chance of having bladder cancer.
They also have a significantly higher risk of having other cancers, and they are surveilled for that, and that is a specific situation in which we think the current pathways don't adequately address the medical need. And so either the DHBs need to update their pathways and support that as well, or we would need to get insurance companies on board for that limited situation. It's a relatively small number of patients, but we still take that seriously, and that may create the opportunity to reestablish conversations with Southern Cross.
Great, thank you. Last two questions.
Thanks, Peter. We've got a couple from the floor. I think on the left, on the left top, and then we'll come to you.
I'm John Andrews. I'm a shareholder.
Hi, John.
The test, Cxbladder has got Medicare coverage, had it for several years and still has it?
We're still being paid, yes.
Yeah. And also, you now have Kaiser integration. So why aren't the test volumes ramping up?
Good question. Pete, I think Pete referred to it before. One of our responses to the draft LCD was to take our sales force down from-
I think it was about 30.
Thirty to nine. And those nine people were then tasked with servicing much larger areas. You also had the publicity in the urological marketplace that our test was under question mark. And so it's just been, in the second half of the financial year, it was just a lot harder to get the test volumes up. Now, that's from the Medicaid side, from the Medicare, Medicaid side. On the Kaiser side, we've seen month on month volumes increasing, so that's been encouraging. But until this Novitas decision is made, we just have that, yeah, we are running lean, we are preserving cash. You know, ideally, we would still have thirty people out there, but we just, you know, the prudent thing to do was to conserve our cash.
Yeah, the
Pete, you might want to add.
Yeah, there's another element to that answer. And look, this is something we've not published data that would make it obvious to you as an investor of this dynamic. But, you know, prior to any Novitas decision, the number of tests, so this test efficiency that we've brought to everyone's attention in terms of number of tests per salesperson, that was actually not high enough on average, to make it so that sales reps are paying for themselves. So every sales rep I added was costing the business money because we were not yet efficient enough at selling the right messages, leveraging our medical data, etc , etc .
So there was a necessary reduction in sales force to ensure that we reduced the sales force more than we lost volume, and that's exactly what we saw. So we now have it at a point where sales reps are do cover their own costs. So at the appropriate time, we can, when we add a sales rep, that will now, you know, that will actually drive the efficiency forward rather than backwards. So now, that is because we have increased the ASP, that's the market access team and reimbursement, that's using clinical data better, it's reducing cost of goods and wastage through operational improvements. It's all kinds of things.
But the single biggest step change that will change the number of, you know, what is the number of tests a salesperson needs to bring into the business to pay for themselves? That is the pricing question that sits before us for Detect Plus. If we get a better price for essentially the same number of tests, and we've not discussed, you know, we've discussed in vague terms with investors, that yes, it would increase the cost of goods for a test, but actually the margin would be greater than the cost increase. And that dynamic we've described for investors would change what it means to operate a sales rep. So again, I'll just make up some numbers to give you, to make it really clear.
If it takes today 150 tests for a rep to pay for themselves, and with new pricing, it takes 50 tests for a rep to pay for themselves, but a good rep can do 150, now I've got a whole lot of headroom that comes through, right? So those are made-up numbers, just for clarification. But that's the kind of dynamic that we are looking at with the if we get a good price for Detect Plus.
Microphone up to the front here, please.
Thank you. Yes, Colin Dawson, shareholder and previous director of Pacific Edge. I'm interested in the, hi, guys. Interested in the dynamic, of, a test becoming a standard of care eventually, and what all those steps are before the marketplace as a whole says, "You've got to be there or be square." So it's encouraging, and David, you said that there's a move towards salaried urologists as opposed to urologists that say, "Well, I'm charging $2,000 a pop on a cystoscopy, and you're telling me I won't be able to do that anymore?" And that's it. But where is that dynamic? Because you've got clinical utility, you've got some good publications.
When do you think, perhaps a question for you, Peter, when do you think, the company would be in a situation where people in the marketplace might say, "The United States is a quite hard, you know, medico-legal environment. If something isn't done, they could be open to issues with their malpractice cover and so on and so forth." So where do you think would - What needs to happen? Is it more studies? Is it a bigger study, a broader clinical comparative study before the company may be in that position where it's be there or be square?
Yeah. So, look, great, great question. And, the foundations of the answer to your question, lie in the quality of clinical evidence. It's not more studies, it's the right studies. And that's why I emphasize the quality of our clinical advisors, and the process that we go through. When we develop a protocol, it's developed by, and no disrespect to any predecessors, it was developed by scientists in the past, and they're smart people. But now we make sure that if they're developed by scientists, they're checked by doctors, to make sure that we are developing the right analytical validation, clinical validation, and clinical utility studies, that will be accepted by the community. But the milestones that you should look for as investor are all the ones that we're talking about.
So historically, if there is a local coverage document or medical policy that already exists, you only needed to demonstrate analytical validation and clinical validation for your test to be paid and to get covered. If there is not a medical policy that says you can use this test for this purpose, and you have to establish medical policy, that requires a higher standard of evidence. You have to show clinical utility before there's even a policy, and that's really the situation we're in for Detect and Triage. For hematuria evaluation, we are going to establish medical policy first. And then we can say. And that requires clinical utility, not just clinical validation. Now, that's why STRATA is so important. It is clinical utility, but it's clinical utility for Triage.
And the future of our business, I've mentioned, is the Detect Plus product and the Monitor Plus product. The CREDIBLE study is basically like the STRATA study. It has a lot of similarities, and it will show the same endpoint. I've talked about it very directly in some of the shareholder letters where it, yes, it's about AV, CV, and CU, but it's also about the right patient populations and the right clinical endpoints to the study.
You can have the right patients and the wrong clinical endpoint, and you don't demonstrate utility, and you can screw it up. We believe that we are not screwing it up because we verify this with our clinical advisory board, who include guidelines panel members and other experts. And they say, "If you generate this kind of evidence, and it shows a 50% reduction in cystoscopies, for example, we would accept that as a community." That's the kind of process we step people through, and I think that is the way to do it.
Any more online, Grant?
Yes, there is s ome years ago, if I remember rightly, Pacific Edge was looking at colon cancer markers. What's happened with that research?
Hmm, Bryan, I think so. Yeah. I've not heard the word colon cancer for the last five years.
No, no, there's been. I mean, we keep a watch on this. As you probably know, the Fecal Occult Blood Test is out there when you test feces, obviously. That's run out in Australia. Kind of interesting that Australia should do that. They do it until you're seventy-five, then they tell you you're too old. You can just go away and die from your bowel cancer. It's been quite successful, though, so that and that's, it's also used in the U.S. It's quite a reasonable test. But no, there's been no, we've not focused on bowel cancer.
It's also accurate, I mean, Pacific Edge has intellectual property in cancers that's not bladder cancer, right? But we have not spent the time.
It might be bladder cancer, Pete.
Yeah.
It's not colon cancer.
No, that's right. So we have intellectual property in cancers outside of bladder cancer, like colon cancer. But those were patented a long time ago in the biomarker discovery stage of Pacific Edge. Many of them are ending, nearing the end of their life. And we don't have plans commercially to go into colon cancer at this time, as the other directors have said.
Yeah.
Yeah, sorry. We've reviewed that patent portfolio quite recently, Pete and myself and others, and taken a look at it, and we've discontinued paying for some of those patents because we did not think that that was going to be part of our future pathway.
Grant, more?
Yes. Why isn't Pacific Edge actively pursuing other significant markets, for example, Japan, U.K., and Europe, instead of concentrating on USA while we're waiting out for Novitas?
We've always said that the greatest market opportunity for us is the U.S., by a magnitude of pick a number. We have started to sow some seeds into Asia, Pete, with the appointment of Glen Costin, and we're now getting some test volumes and signing some distribution agreements. But we are living within our means at the moment, and while the Novitas uncertainty is there, we're prudent and cautious about what we do. If we had unlimited resources, yes, absolutely, but we don't.
Great, thank you. Just two more. Are you looking in, at litigation in the event of non-coverage decision by Novitas?
Pete?
It obviously depends on what happens and whether there is grounds for it. But we have lawyers who are familiar with the issue, and they have advised us under which situations litigation might be a productive avenue for us, and under which situations it would not be productive. And so we haven't. It depends on what Novitas actually does, as to whether or not we have an avenue to pursue. Just one thing I would caution in my answer, which is a lot of folks use the word litigation as a proxy for really, really large dollars being spent.
And we've looked at that carefully as well, because there are simply, you know, we're not talking about millions and millions of dollars, and if we were, we wouldn't be pursuing the avenue. It's really that simple. Because for us, there is a point at which spending money on lawyers is less likely to yield a good result when contrasted with spending money on developing additional clinical evidence and just solving the problem that way. So all of those conversations, in much more detail, have been had at board level. And we are prepared to go down that path in a narrow set of circumstances where we believe it would be productive for us.
I'll just add a comment to that. It's, look, it's an issue that we've, it has come up at the board, and being non-Americans, it's suing your major customer is always something that sort of, you're going, "Hello?" But I'm assured by Pete and Dave that in the U.S., it's very common practice, so we bow to them. Next, Grant.
All right, this is the last question. Are there a growing number of competitors offering bladder cancer tests, and does Pacific Edge remain a first-mover type advantage, the commercial use of bladder cancer tests?
Bryan, then Pete.
Yes, there are a number of other tests out there. They range in specificity and sensitivity. I think ours is still superior to any other test that's currently being promoted. Most of them are not covered.
Yeah, what, what I would add to that is, again, it matters a lot what indication you're talking about. There are a number of products that advertise something like cytology, but better, and that is distinctly not what we're offering, right? We have a very high negative predictive value. We are offering, physicians the opportunity to de-intensify patient workup, after, you know, as a risk stratification tool for hematuria patients. And we are not, we're not trying to be another cytology.
That's very, very important, because this is actually by far the larger market, which is why we differentiate that way. So while there are other companies, that have products that, at a marketing level, have, that would appear to be competitors with us, most of them focus on positive predictive value, not negative predictive value. Most of them, or none of them, have clinical utility data, which, of course, we now do have. I believe Pacific Edge maintains its first-mover advantage, so.
Thanks, Pete. That's it online. Is there anything else from the floor? Anyone else? No? Well, I think we're nearing the end. Just a couple of closing thoughts from me. I hope that, like me, you have all, you all see the huge opportunity that remains in front of the company. And it's gratifying, there was no instruction from me or the board to Pete and his team, not to have eyes up and out when we're gonna be spending the next day and a half together.
We are looking. The Novitas thing will be what it is. The end game remains the same, and, you know, the optimism and positivity of the team has been terrific. So, with that, I will sign off. Thank you for your support over the last eight and a half years. I'm a shareholder, and will continue to be for quite some time. So, all the best, and thank you for your attendance today.