Thank you for standing by, and welcome to the ImpediMed Limited quarterly results and investor conference call. All participants are in listen-only mode. There will be a presentation followed by a question-and-answer session. If you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. I would now hand the conference over to Mr. Richard Carreon, Managing Director and CEO. Please go ahead.
Thanks, Kelly. Welcome, everyone, and thank you for joining us today. We're hosting this conference call to discuss our 4C for the financial quarter ending 31 December 2021. Joining us on the call today is Tim Cruickshank, our Chief Financial Officer, and Mike Bassett, our Senior Vice President of Corporate and Strategic Development. I'll be referencing the 4C and slides from the quarterly activity report we launched this morning, Australian time. This presentation is a summary of the more detailed 4C. After our remarks, we'll be taking questions. Let me first start off by providing an update on the publication of the PREVENT Trial. The principal investigator, Dr. Sheila Ridner, received notification late last week from the publisher of Lymphedema Research and Biology that the manuscript had been accepted and is scheduled for publication in the coming days. That bit of good news.
Let's start on page 3 of the presentation. Today, we'll be covering three key topics. The ongoing strength of our business, even as hospitalization rates in the U.S. and Australia soared to record levels not seen in previous spikes of COVID-19. Two, we'll review the critical facts of the PREVENT Trial and the feedback we've received from the preprint. Three, the success of the Case Assistance Program in obtaining reimbursement and the foundation that is now in place that will drive unit sales and increased ASPs over the balance of the calendar year. We will also discuss and show data from a hospital on how reimbursement is changing the dynamics of their entire program, and we've included a link into their presentation as well. Turn to slide 4. I'll ask Tim to provide more in-depth analysis of our financials, but just quickly from me.
In what was one of the most challenging environments with COVID Omicron variant spiking, hospitalization rates to record level, and causing disruption across the U.S., most acutely experienced within the healthcare system, the company still delivered very robust results. Some of those highlights are SaaS revenue growing to 71% year-on-year. We maintained our annual revenue run rate of over AUD 10 million and 26% year-on-year growth in quarterly revenue. Post the capital raising, the company is now fully funded to achieve breakeven. We continued to drive double-digit growth despite the ongoing global pandemic, and the leading indicators of our business look very positive. We've made substantial progress with reimbursement over the last quarter, which, together with the pending publication of the PREVENT Trial manuscript, sets us in a strong position to execute our business plan through 2022.
I'll now ask Tim to provide a more in-depth analysis of our financials. Tim.
Great. Thank you, Rick, and good morning, everyone. I'll be taking you through some of our key financial highlights prepared on pages five and seven of the presentation that is open today. All figures presented are in Australian dollars unless otherwise indicated. On slide five, which highlights the key metrics we use to measure the health of our SOZO business. It continued to show solid growth in the quarter met by significant headwinds from the COVID-19 Omicron variant, led by, as Rick stated, 71% growth year-over-year in our software as a service revenue from SOZO. SOZO annual recurring revenue or ARR grew by 7% year-over-year to AUD 8.4 million. The contracted revenue pipeline dipped slightly to AUD 14.3 million in the period.
That small decrease in CRP was attributable to the timing of revenue recognition under the Astro benefit contract, as well as the timing of contracts signed at the end of the quarter. We expect the year-over-year CRP metric to increase on a quarterly basis moving forward. Let's look at two other key metrics for the business, SaaS growth margin and churn rate. SaaS growth margins finished for the half year above 95%. We would expect those strong margins to continue to be in that range over the balance of 2022 as revenue continues to grow. Churn rate remained negligible at 2%. The small impact to our renewal rate of 98% stems from a few small practices with operational and financial constraints due to COVID-19-related challenges.
With the majority of our growth expected to come from large institutions, we would expect churn rates to remain very low. Slide 6. Our land and expand strategy has laid the foundation for accelerated growth as our success with reimbursement begins to take hold. In a very challenging environment this past quarter, we were able to make significant progress in a number of critical areas. While unit sales were no doubt impacted in the quarter by COVID-19, the quality of accounts that were closed were exceptionally high. We added our 36th NCCN or NCI member institution in the quarter. We expanded our footprint in world-class cancer centers such as Memorial Sloan Kettering, and we landed or expanded 10 additional regional cancer centers. Given the headwinds faced, this is tremendous progress.
We've stated since the original launch of SOZO that in the pre-reimbursement environment, the key, the first key to our strategy was to land the technology in these large institutions, which we continue to do. For the second consecutive quarter, more than half of our unit sales were from new accounts, and we have now landed more than 830 units in the market, primarily to large institutions. As we begin to capitalize on the strength of the PREVENT trial data and on the success of the Case Assistance Program and reimbursement, we will now be very well placed to accelerate expansion of our technology in the coming quarters. As a result of this strategy, ARR and CRP for the core and clinical businesses combined remained strong at that AUD 84 million and AUD 14.3 million figure respectively.
As we've stated in the past, we anticipate over 90% margins on the over AUD 14.3 million in CRP when that revenue is recognized in the coming quarters. On slide 7, we look at cash flow. Cash on hand at 31 December 2021 finished at AUD 50.8 million. Cash receipts from customers grew for the 5th consecutive quarter to a record level of AUD 2.6 million. Net operating cash outflows for the quarter came in at just AUD 2.9 million as we maintain our focus on strong financial discipline and our path to cash flow breakeven for the business. In October to November 2021, the company completed a placement and share purchase plan totaling AUD 42.5 million in gross proceeds.
As outlined in the use of funds from that capital raise, the company will be utilizing a portion of these funds in the upcoming quarter in order to make critical investments in things such as advanced inventory purchases to stay ahead of the supply chain, SOZO 2 hardware development costs, software development for critical initiatives such as EHR integration, electronic health record integration, and ESRD clinical trial costs for a renal observational study. We anticipate net cash outflows for Q3 FY 2022 will be in the range of AUD 5.5 million-AUD 6.5 million for that one quarter. As the majority of these investments are one time in nature, we also anticipate that in Q4 FY 2022, net operating cash outflows will drop back below AUD 3 million and continue to decrease over time as sales accelerate.
In summary, in a very challenging environment, the company still continued to take critical steps forward during the quarter, landing and expanding a number of extremely high-quality accounts and which resulted in strong year-over-year metrics for the scale of the business. The success of the capital raise in conjunction with positive momentum with the Case Assistance Program and reimbursement allow us to make capital investments in a number of critical areas of the business, with all of these factors leading to an acceleration of growth over the balance of 2022. We've done this without adding significant recurring costs to the business as we focus on the resources at hand to reach breakeven. Thank you all. Rick, I'll turn it over to you now.
Thanks, Tim. Please turn to page 8. Let me walk you through patient testing from the past couple quarters. I'll be discussing this data from the bar chart on the right-hand side of the page. As I've stated previously, patient testing is a leading indicator for us. Now, for the last two quarters, patient testing has fallen. It first started in the United States and then Australia as Omicron spread, and it's now beginning to recover in that same manner. Hospitalization rates in the U.S. peaked last week and are now dropping. As positivity rates start to standardize, this will be typical cases. We're seeing patient testing slowly recover as well. More importantly, we see data showing our technology as becoming standard of care in major cancer centers. Now, COVID-19 has come in 3 waves: the original strain, the Delta variant, now Omicron.
During the first spike in hospitalizations, only 46% of our installed SOZO devices in the U.S. were testing patients during that spike. Now, during the spike in hospitalizations brought on by the Delta variant, the number of SOZO devices used in testing patients shot up to 69%. During the record spikes in hospitalizations for Omicron variant, 83% of our installed SOZO devices were testing patients. Now, albeit the spikes caused fewer patients to be tested, but many more devices were testing this last time as these patients were brought in for treatment. Now, we believe this shows a growing strength of our technology, evidenced by the continued growth and record quarter for our SaaS revenue. We also believe this shows the impact of our Lymphedema Prevention Program and our newly introduced Case Assistance Program. I'll wrap up with this.
Now, despite depleted hospital resources during these peaks, when patients were brought in for cancer treatment, our technology is considered essential to the patient's long-term care. Of note, we've discussed for a number of quarters the value of the intrinsic value of the company. With well over 350,000 patient tests conducted to date, our ability to make real-time decisions to help improve and grow customers' programs is increasing rapidly. This real-time testing, along with a growing database of patient information and our ability to mine this data, really have allowed us to grow throughout this pandemic. Over the remainder of the financial year, as the Lymphedema Prevention Program and Case Assistance Program continues to grow, we would anticipate seeing an acceleration of patient testing. We truly believe we are at a tipping point. Please shine on.
As I stated earlier, the PREVENT trial manuscript has been peer-reviewed, accepted, and the principal investigator has been notified it will be published in the coming days, first online, and then in print. We are very pleased that the findings of the manuscript were unchanged from the preprint, and the manuscript's very strong conclusions were endorsed by the reviewers. The key messages are as follows. One, the PREVENT trial met its primary endpoint and reached statistical significance. Two, in patients with breast protection using L-Dex, intervention resulted in a 7.9% rate of chronic lymphedema. Compared to 19.2% rate of chronic lymphedema in patients with early detection using a tape measure with a P value of 0.016. Three, this represents an absolute reduction of 11.3% and a relative reduction of 59%.
4, 92% of patients with early detection of cancer-related lymphedema using L-Dex and intervention did not progress to chronic lymphedema. 5, L-Dex showed a statistically significant benefit across all risk factors from the study. This is rarely seen in level one evidence studies and shows the true strength of our technology. Six, lastly and very importantly, the paper concluded these statistically significant results demonstrate that vital bio impedance spectroscopy screening should be a standard approach for prospective breast cancer-related lymphedema surveillance. Now, these are fantastic results, and I want to thank the patients and investigators involved in the PREVENT Trial for their hard work and dedication. This was a serious commitment from all involved. A special note of thanks to Kathryn Schmitz, who has marshaled this study from its inception to its publication. It's taken tenacity, patience, and dedication, but it's well worth it.
It will change the lives of countless cancer survivors and something that all involved can be incredibly proud of. Page ten. Now, it's essential to understand the significance of the PREVENT trial and not only what it means to ImpediMed, but what it means for patient outcomes. What PREVENT proves is that a significant number of cancer survivors need not suffer from lymphedema going forward. To change practice, we must also remove the financial burden from the patients and the providers, and that means obtaining reimbursement. Reimbursement of our L-Dex testing is why we sponsored the landmark PREVENT trial. The trial is a level one evidence study, meaning it's prospective, randomized, and multicenter. As one of the authors noted, the results of this study are practice-changing. We mentioned on our last call that we moved the reimbursement function in-house.
This has allowed us to substantially expand our offerings and establish a Case Assistance Program. Reimbursement assistance programs are a standard industry tool to establish reimbursement for new technologies. Our program is very similar to those used by Medtronic, Stryker, and Abbott, to name just a few. The aims of the program are to assist hospital cancer centers and physicians in filing the necessary documentation to fight denied insurance claims. This is building up case files at key insurance carriers and showing the growing usage and demand for our testing. It ensures key regional and national insurance companies are aware of the latest data, such as the meta-analysis in New England Journal for presenting the PREVENT data upon its publication. The results to date have been outstanding with a number of industry veterans commenting that these high case win rates they've never seen before.
Since we last reported the numbers with the capital raise, you can see the very strong growth in cases are being undertaken. Case wins have grown from 298 to 1,723 and at an incredible win rate of 96%. There are over 100 external appeals we've won, and these are the damaging ones, as insurance companies can be fined up to $10,000 per lost appeal. The program has an additional 1,800 cases still processing, and that number grows daily. Notably, the case wins across the country are across all major carriers. The success of the Case Assistance Program and the pending PREVENT Trial manuscript give us the confidence that we will obtain automatic reimbursement for SOZO L-Dex testing in time.
In parallel, the lead investigators have agreed to submit an application to the NCCN for inclusion of our technology in the cancer guidelines for lymphedema. The application is scheduled to be submitted by the end of this week. For us, all this data points to a technology that can significantly improve patient outcomes becoming available to all at-risk cancer survivors. Page 11. We've touched on the Omicron impacts throughout the presentation, so I won't go over it again. What I will say is, while it was difficult, we did manage to take several very positive steps forward. This includes the corporate accounts team secured a pilot program with a major hospital system and are in advanced discussions with two others. We continue to add and expand our footprint to world-class cancer centers, including Memorial Sloan Kettering and UT Health San Antonio. We landed a major oncology group.
Now, this is the first entry into this critical segment for us. It's really the next phase of our journey. We've widely expanded in a further 10 regional cancer centers. Making progress in a difficult time through winning business in extremely high-quality accounts and establishing pilot work can become very large accounts for the company. We've also covered the success of the Case Assistance Program and the confidence it gives us in our future. This confidence has us setting up the groundwork for an environment where we can not only accelerate sales, but accelerate sales while simultaneously growing our ASPs. We have realigned the sales approach to take advantage of the success of the Case Assistance Program.
We have the right people in the right place with the right focus, and we are investing in the clinical support and reimbursement teams to continue to build out these programs. We have done this without adding significant cost to the business as we focus on the resources at hand to reach breakeven. Page 12. We've touched on a number of these milestones throughout the presentation, so I'll just mention a few. We're very pleased to see the extension and expansion of the AstraZeneca trial resulting in over 410 devices being leased, generating over AUD 5 million in revenue over the life of the trial. We continue to make progress with the heart failure program with Advocate Aurora Health. We see this as a substantial opportunity over time, and the level of engagement remains very high.
It's also good to see our efforts recognized outside the Australian market, with Cogent Security becoming the first U.S. brokerage firm to initiate coverage of ImpediMed. Turning the focus to areas for Q3, a couple key points of note. In oncology, the principal investigators will submit the PREVENT data to the NCCN end this week. We will continue to focus on and expand reimbursement through the Case Assistance Program and engage with potential customers in our key focus areas of breast surgeons, oncology groups, regional and national cancer centers. In heart failure, we'll ensure Advocate Aurora has sufficient resources to be successful, and we'll add additional heart failure programs. In renal failure, we are looking to finalize the initial renal failure study in the coming weeks and commence recruiting this quarter. Slide 14. This is some very exciting information that I'm about to share with you.
We've attached a link to a webinar where that was released last week. It's a presentation of SOZO at the Deaconess Women's Hospital High Pointe in Indiana. The clinicians examine the process of adopting ImpediMed's Lymphedema Prevention Program and the Case Assistance Program. If you have time, I strongly recommend you listen. A couple of points to listen for. The clinicians want to start a Lymphedema Prevention Program, but there's also a financial imperative within their health system. They present their base case. They begin working with our Case Assistance Program. They discuss what obtaining reimbursement does to the economics and improve patient outcomes and the number of cancer survivors they can add to their program. The data on the two slides on page 14 were taken from the 24 slides the clinicians presented.
You will note on the slide on the left, they conservatively estimate their growing at-risk cancer population over the next three years. They split out the estimated measurements by Medicare and private payer. When they looked at potential return on investment, they only considered Medicare because that's the only group they were seeing at the time. You will see the 65 tests a year comes out to a total of $8,255 or $127 per test. They recently began working with our Case Assistance Program. Their slide on the right-hand side now shows their average private payer payment is $212 per test. This represents just over a 50% premium for their geographically adjusted Medicare rate of $127.
We've always stated private payers typically pay a premium to the published Medicare rate, so this is very, very good news. We now have proof positive of insurance carrier now paying at a premium. Jointly, we have helped them submit 152 cases to their private insurance partners. 34 of those cases have already been paid. The other 118 cases are under review with a potential of an additional $25,000 in reimbursement. Now, the significance of this cannot be overstated. Go back to the slide on the left-hand side and let me do the math for you. Go back to year one. Remember, 65 tests on Medicare patients at a reimbursement rate of $125 per year shows $8,255.
98 tests on private pay patients at a reimbursement rate of $212 per test equals $20,776 for a total of $29,031 gross reimbursement. Now, year three is where it gets very interesting. Using the same rates and their cancer patient estimates, the total reimbursement jumps to $225,721 per year. The reimbursement for this size of institution, coupled with significantly improved patient outcomes, is extraordinarily compelling. While you listen to these clinicians discuss their program, I ask that you think about how many lives will be transformed because they are finally getting access to our technology. In summary, it's been a journey. The publication of the PREVENT Trial is just days away and the momentum in the business, we are indeed at an inflection point.
We expect to see both accelerating unit sales and increasing the ASP fees over the balance of 2022. I wanna thank you for your continued support, and we look forward to another transformational year. This concludes our remarks. Kelly, we're now ready to take questions.
Thank you. Your first question comes from private investor, Ian Hyde. Please go ahead.
Hello, and very sorry if I'm number one. Regarding the program now looking forward with all this data we now have, we've got the amount of data that's now present coming out. We've now got these cost analyses that we've just gone through. If we go back say two odd years, there was a bunch of corporate sales that were landed. Now, obviously, I was trying to build some of them and come back. Can you go through any more color on these numbers around how we can now address that?
Down the road, because there's obviously L-Dex, that would be the world is not blind to expansion. How can you do all of this new data and economics that's just now coming out, please?
Certainly, Ian. Thank you for the question. The key accounts that we have, and we have a large number of key corporate accounts across the country with the new data. Once the PREVENT data comes out and with the new data that we have on the cross-sales, we certainly will be re-engaging all of our accounts, both current and new ones and those in the pipeline. Because again, the data has shifted dramatically, and I would say the data shifted dramatically over the last 30 days. We have a plan in place, and we just submitted a full training of our sales organization to take advantage of all of that. That's why we said you're going to be seeing an acceleration of unit sales as well as increasing ASPs.
Sure. Thanks, Richard. Connected with that, you know, you just spent a night on oncology for, is that specifically looking at CPT?
No, that's looking at lymphedema. If I'm a patient today, a cancer survivor, and I've completed my surgery, I not only continue to see that surgeon for the next several years, I'm also handed off to a medical oncologist who's now responsible for my chemotherapy, my radiation therapy, and all of my follow-up. They typically follow their patients for 5-10 years, depending on the cancer type and treatment type. That's always been part of our long-term goal, once you crack that market. Now we do see that as an opportunity for PCF, but with the reimbursement, the way that it's starting to shape up and with the PREVENT Trial, now I've been going and talking to medical oncologists now are very interested.
Because if you think about it for a moment, I'm a surgeon. I'm gonna see that patient for either 90 days, a year, up to 3 years. If I'm a medical oncologist and seeing that patient for 5-10 years, I'm gonna see a lot more lymphedema than possibly that surgeon will. It's in my best interest for my practice and for my patients to address it. That's why we see the opportunity to accommodate going forward.
Sure. Okay. Just touching on PZM, apart from honestly mentioning them as a market there, but generally with, because I believe it's got, reimbursement there, but nothing, if I'm incorrect, there's nothing that you really have in getting it out there in the world, you know, hospitals and clinicians to testing and so on. Information around that.
Okay. I mean, we have approached several key accounts, and several key accounts have approached us, and we have a number of negotiations and discussions going on for putting that into a facility. We have the software that's ready. As the COVID starts to wane over the coming weeks, we believe that we'll be able to start to accelerate all of those.
Sure. Lastly, it's mentioned that you had a meeting with a board or I don't know what word, all the insurers. How did that go and progress in formalizing private payer coverage?
We had a meeting with a group of healthcare companies as part of our advisory board. These are current and former medical policy directors at major centers, and it went extraordinarily well. They looked at the data, they looked at the PREVENT information, and they gave us some very, very sound advice on how to move forward. Some of their advice has actually helped progress our lymphedema, excuse me, our Case Assistance Program and the statistics that I just shared with you, the 96% win rate, some of their advice has been instrumental in helping achieve those levels. They've been very, very good in providing us information on the best way to present it, what data they're looking for, and more importantly, exactly how to lay out our story to them.
We'll continue to use them throughout the process, and once we have the PREVENT Trial, we'll start meeting with the insurance companies, initially over video conference, and then long term, face to face to continue, pushing on the front stage.
Sure. Okay. I have another question for you. Probably an unanswerable question, but any visibility or color around how long it might take for the same stuff to authorize coverage? The other question is obviously NCCN, NCI. I know they don't have any real sense of information pretty much to call, but based upon the data that's out there, plus the PREVENT and the icing on the cake and century items, then you might be getting something that recommends, in your opinion.
Well, we'll submit at the end of the week, and we, you know, I can't tell you. Sometimes they turn it around in 90 odd days and sometimes it takes up to a year. We just don't know. As you know, we're going down two different avenues to obtain reimbursement. Obviously, the NCCN would be the fastest route to that, but also understand with the insurance companies, we've always said that the first part of our journey was to have the PREVENT critically what they were looking for, the level one evidence study. We've got that now. Ian, what is important here moving forward with the insurance companies is to continue to win these cases because it builds up case files that they can see that there is a demand.
Once they have demand, then they allow us to come in and have discussions. As you can see, we have a great track record. We've won almost 1,800 cases. We have another 1,800 in the pipeline. More importantly, we're now able to show this track record to our accounts. We only have a very small portion of our accounts on our Case Assistance Program. With the PREVENT Trial and with an expanded Case Assistance Program, we plan to go out to all of our accounts and show them exactly what we can do to impact their business. We're certainly gonna bring up the information that I just shared with you on data that was presented by Deaconess Hospital.
I think we've got a very robust program, and I think over the coming months you'll start to see the impact of that. But I can't say how long until we get coverage from the insurance companies. Now they're making payments today, which is the first step. The next step after that is coverage. They write a formal coverage policy, and they tell you that you no longer have to provide all of this data, all of this information, and they will just cover X amount of tests per patient per year. I'll take payment right now because it's tangible and it will accelerate our program. Coverage will just be icing on the cake. We expect to get coverage both in the medium to long term.
Sure. Third and another one. How old are these data? Has anyone done any quantitative numbers to show the insurance companies how much money they're gonna save by actually covering L-Dex? Like the cost reduction of treating wounds and lymphedema compared to paying for it and not having it at all in the first place?
That's our job. That's what we have to do when we get a chance to address their medical policy board. We have to go in there and show the data on the costs of not treating. When a patient gets hospitalized for cellulitis and gets an infection, is in the hospital for three days, or they have to wear a compression sleeve, or they then get to a level where they're now on a compression pump, which is about $10,000-$12,000 for a compression pump. All of that is up to us when we go into these policy boards to lay out our case of why sending several hundred dollars a test is a much more cost-effective way for them versus letting the patient go on to develop lymphedema.
I also think the results of the PREVENT Trial showing a 92% reduction, you can't ignore that. That's why I also think that because of the meta-analysis, we've been able to show carriers that you need to start paying for this. The data is compelling. Again, I think with PREVENT, it's just gonna put us over the top. It'll give us the information we need.
Your next question comes from Madeleine Williams with Goldman. Please go ahead.
Hi. For instance, if I could just shift to renal failure. I just would like to, if you could just provide some color on the timeline for the observational and interventional trials. Also maybe give me an idea of what clinical endpoints have been used in the trials.
Yeah. Mike, do you wanna take that?
Certainly. Can you hear me?
Yes.
Excellent. Madeleine, the two trials, the first one being an observational trial where we're collecting data, but also. That'll be across two subsets of patients. The first set of patients will be very stable patients, and the second patients will be the newer patients, which are relatively unstable. We'll be looking at those patients to see whether there are changes in body compositions that aren't being picked up in their fluid amount. The second trial will be the interventional trial, and that's where we'll look to actually intervene and say how much fluid should be taken from those patients on a daily basis.
They come in three times a week for a small dialysis, and we will help collect the amount of fluid that needs to be removed from that session. Currently, we're just using weight, and they look at what they weighed two days ago, what they weigh now. They believe that the increase is also due to fluid. They're up 2 kilograms, and they will take out 2 kilograms of fluid or 2 liters of fluid. The problem is, of course, as their body composition changes, that number will be incorrect. We believe that's why you get such a large number of fluid-related hospitalizations and mortality.
The second study we hope to have in the just beginning of the financial year. We'll be meeting with the FDA after we finish the observational trial. The observational trial we've stressed will only take about 6-8 weeks to complete because we've already got patients lined up ready to go on that. We're only talking about 70 patients, and they're only being followed for one month. What we'll be looking at is for the interventional trial to be determined by the FDA what these endpoints will be. But we do think that we're just looking for non-inferiority in terms of hospitalization, in terms of admissions, to you know, mortality over that period of time that we have the interventional trial going versus the current standard of care.
Again, that's something that we have to determine with the FDA.
Thank you.
Your next question comes from Peter Gregory. He is a private investor. Please go ahead.
Hello. Rick and Tim, thanks very much for your presentation and sharing with us the updates that are happening. If I can just pick up on the previous questions about the renal trial. Do you expect that to go through the process of peer review and publication? What sort of timeframe do you expect until it's you know final and clear? Secondly, with renal, in terms of the patients you're actually expecting you know given a successful outcome of the trial, what sort of profile of patients do you expect it to be?
Is it expected to be, you know, all dialysis events being tested or is this highly specific or just sort of a color as to what you see the target of the patient being there?
Yeah, that's very good. I'm glad you picked that. The second part of the question is, yes, we see it to be used for all patients, and it should be inserted within the current standard of care. Instead of taking patients at the beginning, SOZO can take both measurements as well. You'll be looking at your fluid from the SOZO output from the fluid that could be used in every single case for each patient that come in. What was your first question, Ken?
Just in terms of timing until there's a definite result of the trial.
Again, once we have had the meeting with the FDA, we'll let the market know exactly how long. We're not talking about years. We're talking about 6-12 months type of timing. These patients are readily available for recruitment, so we don't expect the recruitment phase to be long. The most important thing for dialysis will be the FDA approval as opposed to a publication, which the first publications will come, but there's no reimbursement really associated with dialysis treatment. They're essentially all Medicare patients. In that case, it really does come down to acceptance from the dialysis centers as opposed to going for reimbursement.
Okay, that's good. That sounds like a really good opportunity and could come to fruition fairly quickly. I'd also like to ask about the capital raise, about $40 million. Now clearly, part of that is, for want of a better term, funding the continuing business to get to a breakeven point. But also it's clear that there's a significant amount of investment in new things. Would you be able to give a bit more color to what those new things might be, the investment type activities and funding the continuing business?
Certainly, Tim, I know that you had covered that.
Yeah.
You gave some highlights. Why don't you go through that in detail?
Yeah, absolutely, Peter. One of the main things being that renal study that you were just asking about. That study, the costs are baked into you know, our outlook with the capital raise. You've got advance inventory purchases. With all the things that the world has seen with supply chain, we've taken the stance that we're gonna stay ahead of it wherever we can. We're purchasing inventory for our SOZO hardware so that we can continue to manufacture post reimbursement to keep up with demand. You've got a couple of software development projects that will be brought on in terms of that electronic health record integration is one of the key things that we're currently working on now.
Those are the types of investments that we're looking at over the next, you know, let's say 3 months to 3-6 months in terms of critical investments right now.
Peter, we're also investing in SOZO 2 because it's going to be important for us to commercialize in renal failure, and to expand the commercialization of heart failure. SOZO 2 is going to be important. We said we would be bringing that to market this calendar year.
Okay. No, that's great. Thanks very much, and keep up the good work, fellas.
Thank you, Peter.
Our next question comes from Jonathan Scales with Moelis. Please go ahead.
Hi, Rick. Jonathan-
Hi.
Good morning. Just wanted to ask a question, make reference to the average selling price going up. Can you just talk about the rationale for the price increase, what type of pushback you'll get against that, and how you are arguing for it, and what type of percentage increase you'd expect?
Jonathan, when we started down the road with SOZO, it was always our intent to be able to come out with a device that provided us a software as a service platform. It also provided us an opportunity to adjust our pricing either through new indications, new software offerings, new patches, new some things in addition into the chronic health groups and so on. We're gonna take the opportunity at every avenue we can to charge for those extras, if you will, that you can add to SOZO. If you think about it for a moment, the U400 was just a dumb device that provided data, great data, show back electrodes, not a lot you could do with it. SOZO offers us phenomenal opportunities across the board. What I just described was just one small portion of it.
Let's go back to the example that I just did for the reimbursement. When we look at Deaconess, what they did is they showed the three-year, and they would be in a quarter in dollars, right? $225,000, so in US dollars. That would be testing a large number of patients. With that, you can imagine they're gonna need more devices. We're also gonna be in a position to start raising our prices on the out years for SOZO. Right now we have a three-year contract. Typically, that price is set flat rate over the life of the three years. What we're gonna be going to is a more robust contract that as reimbursement continues to build, we would continue to increase our prices under that.
Right now we see that as the second opportunity for us to increase our ASPs. I can't give the order of magnitude because we're still working through those details, but you're gonna be able to see those shortly as we go into market and we start to deal with customers. You can imagine they've got a very, very strong program. Again, I'll use Deaconess's, Deaconess as the example. Even at the year 1, in round numbers, $60,000 all in Medicare private pay, and we've said that our ASPs are typically around north of $1,200 per month for a 3-year contract, plus a small fee on the capital equipment business. Again, just round numbers if we take a look at that, you know, all in, let's say $40,000 over 3 years.
Even under that scenario, if Deaconess was just keeping their same number of patients, they would still be profitable, and we're still in good shape. As they continue to get more patients, and part of what you'll hear when you listen to their tape is their presentation, what you'll hear is that they're getting referrals in because they're getting known for their lymphedema assessment program. As they expand that, we want a piece of that because we need to continue to invest in the business and bring them better ways to manage their patients. We're gonna find every avenue we can and continue to charge them that we believe is valuable for them managing their patients and continuing to improve their outcomes.
If I could just-
We've got a lot going on in this area.
The discussions with product guys about what value bring this and is there a range that is likely hard when you're getting them?
Well, let's put it this way. Reimbursement from private payers to a provider is contractually set up front. They typically use one of those, a negotiated price that they have. In almost every instance is the premium above Medicare. Now there's a lot of things that go into that contract, and understand that a Blue Cross Blue Shield, which is one in Cleveland Clinic, they have a different contractual obligation to another hospital, and so their reimbursement across the street could be different. I think what's in this real world example from Deaconess was a 50% premium, which is really a good premium that you could expect.
I would say that based on Deaconess's reputation, where they're at in the country, that a 50% premium is probably a very good starting point for gauging your model.
Okay. Thanks very much.
Remember the national rate is $121. Deaconess is at $127 because they're in a rural city, and Medicare geographically changes the amount. Just so when you do your modeling on a national scale, you may wanna look at $141, about 50% premium to that.
Your next question comes from David Packham. Please go ahead.
Thank you. Thank you for the presentation and congratulations on the events being published. I'm a nephrologist and I'm a clinical trialist as well as an investor. Really just a statement I'd like to make is that the fact you've been able to achieve publication of events with the discussion unchanged, which I understand is the case, is really quite remarkable because it contains a very strong statement as you alluded to, that this technology should become a standard approach, and that's quite an achievement. My interest in the company really is from the renal point of view, because I'm a nephrologist, and the technology to me seems to have tremendous potential in the improved management of a chronic dialysis patient.
I'm very encouraged that you're working on both these trials, but I'd urge you to make the distinction between end-stage renal failure and chronic dialysis, because where this technology is going to change the life of management in the nephrology space will be on chronic dialysis patients. Just for investors on the call, I think these patients are managed by being weighed before their dialysis treatment and after three times a week. The changes that we actually inflict upon the patients are around 4% of their body weight in fluid that we take off, and you can imagine the potential for medical mishaps with that. Periodically, the patients do BIS by their physicians, that's even on a monthly basis, to see whether what is happening with the weight tallies with what is happening clinically.
Anything that can improve upon that has tremendous potential. I'm really pleased that you're concentrating in that area. My question for you is the observational study going to be done in Australia?
The observational study is going to be done in the United States, and it's going to be done with one of the premier nephrology groups in the U.S.
Okay. It's disappointing.
Yeah, I'm sure. You know, as we start to expand that, we certainly continue to look at Australia as one of the key areas that we do research. As you know, a number of institutions with the current study, Australia, Macquarie, who helped with the study. We're gonna look at the same thing with renal failure as well as heart failure over. It's obvious Australia is our home. It's critical, but in the U.S., from the standpoint that we have a relationship with the FDA, we had breakthrough designation with the FDA. We wanna move quickly. It's imperative that we do the observational study, U.S.-based nephrology.
Okay, I understand the rationale. Thanks.
Thank you. Thank you for your comments as well.
Once again, if you wish to ask a question, please press star one on your telephone and wait for your name to be announced. Your next question comes from Paul Bucco with Piper Sandler. Please go ahead.
Hello, Paul. Yes, good evening, Rick. How are you?
Good. Very good. Thank you. And you?
Yeah. Good, thank you. Just a couple of questions relating to the AstraZeneca revenue. So the SOZO business revenue for the quarter was AUD 2.4 million. Can you give a bit of a breakout of how much of that was the AZ contracts? Question number one relates to that. Secondly, I think you mentioned the AZ contracts in aggregate is roughly a $5 million revenue contract. If you can give us a feel for how long duration-wise there is left and the value of the residual contract.
Certainly. Tim, you wanna take that?
Sure. Yep. AUD 800 thousand this quarter was recognized under the clinical business, which is primarily made up of those AstraZeneca contracts. We have a number of other clinical trial contracts as well. AUD 800 thousand of the AUD 2.4 million. We're roughly a little over halfway on the average contract there, I don't have the exact numbers in front of me, but we've got roughly half of that revenue to go over the coming quarters, in remaining revenue to be recognized. Does that help you, Paul?
Just roughly, will that be over the next 12 months, 2 years? Is it a fairly sort of even distribution? I guess partly what I'm trying to get a flavor for is when that eventually runs off, unless they extend their trial or move to a new trial that would need your device, you know, there'll be a little bit of a small revenue hole, obviously. That's why I'm trying to understand the timing of it.
Great question. Yep, absolutely. Over the next six to 12 months, we'll continue to recognize revenue under the AstraZeneca contract. The remainder of that coming in over that time period. The idea there that the acceleration in the oncology space, where we're primarily focused now on the heels of the success with reimbursement, will more than cover off any of that lost revenue from AstraZeneca. If the timing of acceleration works, yeah, you know, we will be replacing oncology units for those renal trials if those weren't to be expanded or extended.
Okay. Good. Thank you very much.
Absolutely.
Yeah. There are no further questions at this time. I'll now hand it back to Richard Carreon for closing remarks.
Thank you everyone for joining us today. We appreciate your time again and your support, and we're looking forward to the next time that we can report results in Q3. Have a good afternoon. That'll end our call.
That does conclude our conference for today. Thank you for participating. You may now disconnect.