STRATA Skin Sciences, Inc. (SSKN)
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Status Update

Sep 20, 2023

Rich Cockrell
President, CG Capital

And welcome to the STRATA Skin Sciences Key Opinion Leader event. My name is Rich Cockrell, the president of CG Capital, a capital markets advisory firm focused on micro and small cap companies in the healthcare space. I will be moderating the call for today. I'm excited about our inaugural KOL event because I believe this company is one of the most undervalued names in our client portfolio. STRATA Skin Sciences is a medical technology company focused on the therapeutic and aesthetic dermatology market. Its products include XTRAC laser, VTRAC excimer lamp systems, and TheraClear X, utilized in the treatment of psoriasis, vitiligo, and other skin conditions. We are here today with Bob Moccia, who has joined the company as of March 2021. Bob is an operator.

He has more than 20 years of executive management experience as President, CEO, and COO of small to mid-size specialty pharmacy, excuse me, spec pharma companies, and over 35 years of global pharmaceutical companies. His expertise in general management, operations, strategic planning, business development, product development, sales, marketing, and building customer-focused organizations. He co-founded Encore Dermatology, and prior to that, Bob was the CEO of PreCision Dermatology. That was later sold to Valeant in 2014. He has completed multiple licenses, acquisitions, partnerships in the dermatology space. Mr. Moccia has held executive management positions at Medicis Pharmaceuticals as the Vice President of Corporate Development, Graceway Pharmaceuticals as President and COO, and Bioglan Pharmaceuticals as President. He has also spent time at Dermik and Stiefel Laboratories in sales and marketing and business development.

Bob has marketed and launched over 30 dermatological products in the U.S. and has created over $1.2 billion of exit transactions. Now, during today's event, we'll first hear from Bob, who will provide a business update addressing the company's current and future growth plans. We will then hear from Dr. Nazareth of Western New York Dermatology and Dr. Hamzavi of Hamzavi Dermatology regarding XTRAC, STRATA's leading device for the treatment of psoriasis, eczema, and vitiligo. For the TheraClear X session, we'll hear from Dr. Bhatia of Oak Dermatology and Dr. Cohen of AboutSkin Dermatology on STRATA's newest device, TheraClear X, for the treatment of mild to moderate acne. After each session, we will open up the call for Q&A. Now, to ask a question, please type your question into the Q&A box, which can be found in the lower left-hand section of your screen.

I'd like to thank today's physicians for their time, for which they've been compensated pursuant to their respective consulting agreements. Now, before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meanings of the federal securities laws, which are pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call do not relate to matters of historical facts or to expectations or predictions of future events, results, or performance.

These are deemed as forward-looking statements. All forward-looking statements included, without limitation, those relating to the company's trends and future financial performance are based upon current estimates and various assumptions. These statements involve risk, material risk and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

Accordingly, you should not place undue reliance on these statements. For a list and description of risks and uncertainties associated with the company's business, please refer to the Risk Factors section of its public filings with the SEC, including the company's Annual Report on Form 10-K for the year ended December 2022. This webcast contains time-sensitive information and is accurate only as of the live broadcast today, September 20, 2023. STRATA disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information or future events otherwise. With that, I'll turn the call over to Bob, CEO of STRATA. Bob, the floor is yours.

Bob Moccia
CEO, STRATA Skin Sciences

Thank you, Rich. I'd like to extend a special thank you to our distinguished panel today, four dermatologists, Dr. Nazareth, Dr. Hamzavi, Dr. Bhatia, and Dr. Cohen, for their time, and I think you're gonna find them extremely knowledgeable about our devices, and we'll give you some good background on how they use them in their practices. As Rich mentioned, STRATA Skin Sciences is a medical technology company dedicated to developing cutting-edge solutions in in-office treatment of life-altering skin conditions. We address large market opportunities in a number of medical indications, about a $38 billion market overall. Our treatment focus is in four areas: psoriasis, vitiligo, eczema, and acne.

We have two FDA main product devices, XTRAC, which is a FDA-approved 308 nm laser for the treatment of psoriasis, atopic dermatitis, and vitiligo, and TheraClear X, which is also FDA approved and indicated for acne. We are the global leader in dermatology eczema laser, and I'll talk a little bit about our international distribution in a later slide. We have a very experienced management team with over 20 years of history in dermatology and sales and marketing, and business development. If you look at our three devices, we basically have treating chronic skin conditions with XTRAC, indicated for psoriasis, eczema, and vitiligo. Large market opportunity in psoriasis, one of the fastest-growing areas in dermatology, a $20.1 billion market. Eczema, another large, fast-growing market, $11.8 billion.

Vitiligo, which is getting a lot of attention recently with some new, newer approved topical drugs like the JAK inhibitors to treat vitiligo, and XTRAC has been a standby and standard for treating vitiligo for a long period of time. TheraClear X, which is indicated for acne, addresses a $5.5 billion market here in the United States. About 20%-25% of all visits to dermatologists are for acne. That's a great opportunity for the company going forward. VTRAC, which is mainly an international device, is not a laser, but it is a phototherapy lamp. It has indications in psoriasis, eczema, and vitiligo. It is an eczema lamp and is used extensively, particularly in Asian markets like Japan, China, and Korea. The company has sustained accelerated growth over the last few years.

We've increased our installed base from 746 in 2019 to 930 installed devices here in the United States. We have a unique partnership model, which will be talked about later in the presentation. We also have an installed base internationally of about 35 devices, up from 12 in 2019. In addition, we sell capital equipment on the international market, and particularly in the Asian market, we've been very successful in selling capital equipment, particularly our XTRAC laser, and we have registrations underway for TheraClear. We've had good revenue growth. Last year, we had 20% growth in revenue overall, and we've given guidance for this year in the range of $36 million-$38 million. We're deploying four key strategies for profitable growth.

One is our expansion geographically into international markets. Two is executing commercial strategy domestically, and that starts with our sales force. We have to execute at the sales force level. We do have a placement model where we place our devices, our XTRAC and TheraClear in dermatology practices, but the key is pull-through. We need to drive usage in those offices, and that is the key focus of our sales force. We're also creating operational efficiencies, move to a cash flow neutral by the end of this year. We've really made a strong effort to manage our costs.

We also have a system in which we own the lasers that we place domestically, and if they've been placed in an office where they're not being used for whatever reason, the doctor's lost interest or maybe be selling their practice, we'll remove those lasers, refurbish them, and then redeploy them, which keeps our cost of goods down and really helps us in overall keeping our costs under control. We're also pursuing bolt-on M&A opportunities and market expansion. About our global business. We are currently in Japan, South Korea, China, Israel, and the Middle East. We have registrations underway in India and Mexico, as well as Singapore and Thailand. So we're strong focused in Asia right now, as well as starting to get into Latin America.

We want to increase our exposure in those areas before we start to tackle Europe and some other areas around the world. When we look at M&A opportunities, we have some criteria that we try to follow. First and foremost, cost and revenue synergies. We look for overlap in sales force, in G&A, manufacturing, and other costs. We also look for complementary devices. We are a medical device company, so we are looking at medical indications such as skin cancers, warts, hyperhidrosis. Those have similar call points to XTRAC and TheraClear, so it keeps us from having to grow our commercial footprint beyond what we currently have, keeps our costs under control. We're also looking at over-the-counter medications that could be complementary to the STRATA portfolio.

We have a sales force that's in there selling in some very strong indications like psoriasis, eczema, and acne, and we think there's an opportunity to add potentially OTC drugs that could be sold from the dermatology practices alongside the therapies that they're using with our current devices. So overall, again, the key investment highlights for the company are addressing a $38 billion market, addressing chronic skin conditions. We have a differentiated treatment, providing a win-win-win for patients, clinics, and payers. We're expanding our international business operations, and we're actively looking for product acquisitions that can open significant growth for the company. And with that, I'll turn it back to Rich.

Rich Cockrell
President, CG Capital

Thank you very much, Bob. For our next section, we'll be on XTRAC. I'd like to introduce Dr. Michael Nazareth. Dr. Nazareth is the President of Western New York Dermatology. He earned his medical and PhD degrees from the State University of New York at Buffalo School of Medicine in Biomedical Sciences. He then completed a dermatology residency at SUNY Buffalo, during which time he trained at the Roswell Park Comprehensive Cancer Center, the Women & Children's Hospital of Buffalo, the Buffalo General Medical Center, and the Veterans Administration Hospital. Dr. Nazareth is a member of the American Academy of Dermatology, the Society for Pediatric Dermatology, and the American Society for Dermatologic Surgery, as well as the American Medical Association and the Medical Society of the State of New York.

Dr. Nazareth works closely with patients of all ages to meet their complete dermatologic needs by offering a comprehensive range of surgical, medical, and cosmetic treatments. With that, I'll turn it over to Dr. Nazareth.

Michael Nazareth
President and Board Certified Dermatologist, WNY Dermatology

Thank you so much, Rich. I appreciate you guys having me on this call today. You know, we're very excited about how we use our XTRAC technology in our office. I'm gonna go through the model a little bit and also how we're using it for psoriasis in particular. So I know it was mentioned before, but just overall, XTRAC is a 308 nm UVB excimer laser. So it delivers light energy just at that wavelength, which has significant benefits for the FDA-approved indications of psoriasis, vitiligo, atopic dermatitis, and leukoderma. I'm gonna be focusing a little bit more on the psoriasis end of things as we move forward here. So psoriasis, in and of itself, affects about 7.5 million people in the United States.

Vitiligo, another 2 million-3 million, and atopic dermatitis, or as you may know it, eczema, about 16.5 million people. These are very visible, skin diseases that have a lot of symptoms. Things like psoriasis and eczema are very, very itchy and bothersome for patients, but they also have a huge psychosocial impact on patients, too, because it makes their skin disease very visible. And that can lead to a lot of issues in their personal lives and also their public lives, so they're important to treat. If you look at those numbers, too, that's about 8%-9% of the U.S. population, that's affected by these diseases.

So the potential number of patients in the country that could benefit from this treatment is huge, and the market growth potential is also very, very significant, as we've personally seen in my practice. So why 308 nms? This is the sort of spectrum of light here, and you can see at the one end, there's gamma rays and X-rays, and the far end is radio waves. We're looking at ultraviolet energy here, and just particularly this one wavelength of very narrow UVB light. And that's important because we don't want to burn patients, right? And, and cause, sunburns and skin burns from the laser energy, which could lead to further damage or potentially skin cancers down the road.

This is delivering energy at a wavelength that just is effective to treat the skin without burning the skin, and therefore is helpful in eliminating some of the lymphocytes in the skin that are attacking the skin, causing these diseases that we're focused on treating. With psoriasis here, the safety and efficacy has been well established in adults and children with psoriasis. I really like that idea that it works on children, too, because a lot of those biologic medications and other things that, you know, you see TV commercials for out there are not indicated for children, or parents are very afraid to use immunosuppressive therapies in their children, particularly in light of the pandemic and other infections, particularly in school-aged children that they face.

So this gives us a very safe and effective treatment, that can deliver energy to the skin in a controlled fashion to clear those plaques of psoriasis without risking immunosuppression or other side effects of a systemic therapeutic target. So obviously works on adults very effectively, too. And then you have this combination treatment idea. So many, many treatments that we use sometimes are just, you know, in and of themselves, but this is a therapy that works very well in combination with other topical medications and also biologic medications. So while many of our patients are on biologic medications and do very well, sometimes they do have breakthroughs, particularly, and I'm located in Buffalo, New York.

You know, wintertime can be very tough here, and when there's that cold, dry weather, the heat kicking on in the house, sometimes that does cause flare-ups of both, you know, atopic derm, but particularly psoriasis. And it's nice for breakthrough to be able to use this device to clear their skin without having to change their whole regimen, give them different creams, or sometimes change their biologic, or oral medication as well. So overall, identifying who's a good candidate here, there's a lot of good candidates. You know, localized plaque psoriasis up to about 10% body surface area is the main target here. Or for people who've had more severe psoriasis and are on therapies that get them mostly clear, but still leave them with a few areas that they need help with.

Those recalcitrant plaques that just haven't responded well enough to topical, systemics or even the biologics. It can be used to treat all areas, including the scalp, elbows, knees, hands, feet, and nails. I wanna call out those two particular ones there with scalp and nails, because scalp is not an area where you can really put cream very easily because it really messes up the hair, and that's a big issue with these patients. They don't want to use topicals on their scalp. The laser works very effectively for that area. The other one is nails. Some patients just have some pretty significant scalp, or sorry, nail disease, and we can't use topicals to treat nails, and one of the treatments before was injecting steroids around the nails, which is extremely barbaric, so we don't really do that anymore.

And this was an indication sometimes where you were forced to move to an immunosuppressive oral therapy or to a biologic medication, but now we've got a great treatment that we can use on the nails without any pain and any other side effects. So very effective for the treatment of psoriatic nail disease. As I mentioned, very effective in treating scalp psoriasis as well. Here, you know, patients are getting two treatments a week, about 48 hours apart, at least. Sometimes, you know, they come in on a Tuesday or a Friday, in my practice, seems to be quite popular. The average time to improvement is about six-10 sessions, and to clearance, about 10-20 sessions. So very achievable goals that we're, we're talking about with our patients here.

You can see the response rate here overall is very, very high, about 40%, you know, to 50% there, of getting that level of clearance that patients are looking for. The average remission rate is 3.5-six months, but longest remission is reported all the way out to 30 months. So unlike a cream where, you know, the minute the patient stop using the cream, their psoriasis tends to come back quickly, this induces longer periods of disease-free remission for patients. It's not a cure, but it's a much more long-lasting treatment for them. These are some really nice before and after pictures here. You can see before that thicker scaling kind of in these areas over here, and then after, nice, nice clearance there, with the patient.

The other thing that, you know, is not captured here is the itching that patients experience. Scalp psoriasis tends to be very, very itchy, which is very troublesome for patients 'cause they can't scratch their head in public because it leads to a lot of flaking, and it's very embarrassing. So not only are we helping it to look good, but we're taking away that key symptom there of itch with this treatment. This is a recalcitrant palmar psoriasis. You can see here what they look like before treatment. And then after only four XTRAC treatments, you can see they're already better. After 12 treatments, they're substantially better, and they're almost clear by the time they get to 16 treatments there. So remember, sometimes we can get decent results by using a cream, but the minute they stop, it starts coming back.

This can induce those longer periods of disease-free remission. With atopic dermatitis too, it's been well established that this works very well, both for hand and foot eczema, as well as other areas, and the prurigo form of atopic derm, which is, you know, become a bigger issue now that some other medications have been approved for it. It's kinda shone a light on this area here. It substantially improves the itch and the actual skin symptoms, and it reduces the abundance of the Staphylococcus aureus colonization of the skin because you're repairing that skin barrier, and our skin really is the barrier to that nasty outside world. The mainstay of severe eczema treatment in our country has become dupilumab or Dupixent lately.

But even then, patients get breakthrough, and being able to use eczema or laser therapy to treat those breakthrough areas has been really efficacious in our patients who are already on dupilumab or the new JAK inhibitors for that matter, too. So again, we're targeting those patients with about 10% BSA or patients who are refractory to topical treatments or who are having breakthrough on their biologic or other medications that they may be taking. You can see here it is very effective in reducing the symptoms in chronic hand and foot eczema. So you can see here, 87% of patients treated are achieving a physician global assessment of zero or one, which is clear or almost clear skin. 69% reduction in that PGA after an average of 13 sessions over six and a half weeks, 'cause remember, we're doing roughly two treatments a week.

About an 11.3-month average duration that patients are remaining disease-free after completing that treatment. It induces these long periods of remission in atopic dermatitis, just as it does for psoriasis. These are some before and after pictures here. You can see here just how nice clearance we're seeing, you know, with the feet and also with these hands and nails in these areas too. This is after 13 sessions, so very efficacious and effective. You know, we've kind of now established how effective this treatment is for atopic dermatitis and psoriasis, but, you know, excimer laser technology is not something new. What makes STRATA's positioning of XTRAC so unique? One of the key reasons I brought it into my practice was the partnership program.

So this is a complete business solution, which includes a series of value-added services beyond just parking the laser in our office and teaching us how to use it. There's a consultation done, with the company to kind of identify how to best position the device, how to market it, how to get it to our patients, and then how to set up those appointments. There's no upfront expenses, which is a big difference with many other companies here. There's just a fee-for-use business model, and that encourages the practices and the company to really push this forward, because the more we use it, the more we're benefiting, and the more we're using it, the more codes we're purchasing from STRATA, which drives their business model, too.

The practice marketing resources and clinical in-service training that we're provided with really is an invaluable service, because helping to market it drives demand. Obviously, there's direct-to-consumer campaigns, but they actually work with individual practices like us to tailor our marketing campaigns with our social media platforms, our radio advertising, our TV advertising, and also just our internal marketing with our email blasts and other things like that. The in-service training is particularly important because we have nurses delivering this treatment to our patients, and I need to make sure that they're very well trained to do that. And then, you know, with the pandemic and things that changed, a lot of turnover and some staff occurred.

STRATA came to our office and trained that new staff and did in-services with our prior staff to make sure that they were using the device in an optimal fashion to get those best results. This is kind of the panoply of value-added support services that's provided, and we talked about the marketing support. The other one that's very valuable, though, is patient assistance coupons. Patients who get approved for the treatments, oftentimes, sometimes will have a copay that they need to pay for that. There is a patient assistance program that returns that copay after a period of time, which encourages usage of the device, and then further on, once patients see the benefit of it, they're much more likely to continue on treatment or use it again in the future if they get a flare-up. Field support service is very important.

If our devices are serviced and staffed regularly by STRATA, if there's a problem with it, they're in the office very quickly to repair it. Laser upgrades, as new technology comes out, they are, you know, changing out the devices or upgrading our devices regularly. Consumables are taken care of by STRATA as part of our fee- for- use. And then just overall, the reimbursement support and handling of prior authorizations. You know, you can go out and get an excimer laser, but your usage of that device is going to end up being very low because the fight to get it covered by insurance companies sometimes is difficult and takes staff time to do that.

STRATA is taking care of these prior authorizations for our practice, which increases the usage of the device in our practice and also helps patients to actually get on treatment sooner, and more effectively. So that is a huge resource because I can't tell you how much time and money we waste on prior authorizations otherwise. And STRATA taking that off of our backs really has helped us to succeed with this use. So that's kind of the end of my section here. I'm gonna throw it back to Rich, to take it from here.

Rich Cockrell
President, CG Capital

All right. Thank you, Dr. Nazareth. Our next speaker is Dr. Iltefat Hamzavi. He's the owner of Hamzavi Dermatology. He has practiced at Hamzavi Dermatology since 2001 and sees general dermatology with a special focus on pigmentary disorder, such as hidradenitis suppurativa or HS. You can call it HS. It's a lot easier, I promise. This is a chronic skin condition that renders lumps and lesions in the armpits and groin area. Dr. Hamzavi received his medical degree from the University of Michigan School and graduated with academic honors in a variety of specialty rotations. He completed his residency in dermatology at Wayne State University and then spent time in Europe training at some of the world's leading skincare centers. In 2001, he completed an advanced one-year laser and photomedicine fellowship at the University of British Columbia in Vancouver.

Dr. Hamzavi is an active clinic researcher and investigates causes and treatments for vitiligo, HS, photomedicine, and other conditions. He also serves as a senior staff physician at the Henry Ford Health System Department of Dermatology, and teaches medical students at Wayne State University. He has co-authored over 300 peer-reviewed papers, which have been cited over 12,000 times in highly respected journals. He also volunteers his time with a variety of nonprofits in education and civic engagement, bringing attention to the debilitating skin diseases. He has served as co-founding chair of the Global Vitiligo Foundation, a board member at the Photodermatology Society, and as President of the Hidradenitis Suppurativa Foundation, or HS. And with that, I'd like to turn it over to Dr. Hamzavi. Go ahead, sir.

Iltefat Hamzavi
President, Hamzavi Dermatology

Thank you, Rich, and congratulations for saying hidradenitis suppurativa, and I appreciate Dr. Nazareth baptizing this process. So, wanted to kind of talk to you a little bit about vitiligo and the use of this technology to treat that. But also, I want to emphasize the fact that this wraparound solution has been very helpful for our patients. So vitiligo is a depigmentation disorder in which you lose color and has a tremendous impact on well-being. For many years, we weren't treating these patients effectively. We're not recognizing the psychosocial impact, but in multiple papers that have come out in the past few months, the level of depression is anywhere from 50%-88%, based upon a survey instrument called the PHQ-9, as well as up to 25% of patients end up on antidepressants.

When you have this type of disfiguring condition on the face, such as these individuals here, and you repigment them with a combination of excimer laser and some of the topical therapies, it has a tremendous impact on their psychosocial health. People and children of color, especially, have a greater degree of impact, and treating these patients earlier really makes a difference. The excimer technology has been around for many years. The capacity of this technology to be used in conjunction with the newer technologies of the topical JAK inhibitors is also enhancing therapy. One of the advantages of this technology is that you can repigment with the technology. With topicals, you can suppress the immune system, but you can't mobilize the color cells to repigment the skin.

The excimer laser has been cited in over 70 peer-reviewed clinical studies with different endpoints and the consistent response, as well as knowing where to treat the patients, which body locations, which patient to use this technology, is well worked out. As many of you know, medicine is a backward-facing field, and it takes us time to figure out this information. Well, we have decades of experience with the excimer laser, and it really accelerates the response of the topical treatments that are coming out. So rather than having two competing options, the new topical treatments are going to require something to repigment the skin, and excimer is perfectly positioned to do that. Specifically, the areas on the body that respond tend to be the face. The face is the area that is most likely to respond, and we're very thankful for that.

Unfortunately, the hands and the feet don't respond as well, and then the other locations of the body have variable responses. But most patients, when they come into our clinics, if they don't have the tips of their fingers involved, we tend to use that option. There's no pigment loss in these particular studies over a year-year follow-up. That data varies compared to whole-body phototherapy, which up to two thirds of patients can lose color. So it may be that the excimer is more effective at retaining the color. We do know that these patients do need maintenance treatments, but we haven't worked out exactly how often that should happen. And when you have pediatric patients, when you add a topical treatment and you have a child who's going to school already being bullied or having psychosocial events, especially in the teenage years, the rate of response matters.

When you add a topical to the excimer laser, you get a much faster response. The initial rates of repigmentation are presented over here. Again, the face does better than other locations, but you have 80% facial repigmentation at the three-year follow-up. You have a high response, and the rate of response is faster. Again, this reaffirms this point that different locations do better. You have complete repigmentation in about 45% of patients in the face. It drops down to less than 10%. The fact that we have that information helps us counsel patients, 'cause the last thing you wanna do is to have a patient tell them to do all these treatments and have no response.

A lot of patients just want hope, and when you're able to say, "Well, we can't really guarantee you that you're gonna get great results on the tips of your fingers, but maybe we can work on your face." And those things kinda come together to try to decide if you wanna pursue this technology or not. But if you don't have that information, you don't have the decades of experience that we have with excimer laser, then it's hard to offer that guidance. But we have that, unlike some of the newer technologies, which are really groundbreaking and exciting, but we don't have that long-term information. And when you look at phototherapy, narrowband phototherapy, and Dr. Nazareth did a very nice job talking about the wavelengths.

Well, excimer and narrowband phototherapy have similar wavelengths, and when you look at the systematic review and a meta-analysis across the world, you find that this UVB light, which is produced by excimer laser as well, slightly different wavelength, also has a good response on the face and other parts of the body, and it takes you about 12 months to get that peak 45 response, 45% of people achieving greater than 75% repigmentation on the face. So these treatments take time. You're almost doubling the response at the 12-month mark, and at the three-month mark, you're only at 10%. You have to explain this to patients from the beginning, and again, with excimer's body of knowledge, the body of knowledge we have with narrowband phototherapy, and then the tremendous demand for care for vitiligo patients, we have that information.

Here's a, you know, a practical experience. You have this wonderful young lady who's going through treatment, and after about six months, she's got complete repigmentation. And the XTRAC, company and the STRATA group is very good about providing us information to allow us to counsel patients. Obviously, I also have my own images, and I also have my own papers to present, but these are things that are very helpful. And here's a young child. In general, segmental vitiligo, which this child has, does not generally respond to excimer laser or phototherapy and topicals, but in the early phases, you can.

If you don't do this, there's a very good surgical option, but why expose this child to surgery when you can repigment that with two treatments a week, 20 treatments, about 10 weeks, and it changes the outlook for this young child over time? There's CPT codes available for excimer laser. It is challenging to get this approved for vitiligo in some markets, and we have some challenges with patients, but it is definitely changing as insurance companies and societies are trying to understand the impact of this condition, especially in skin of color. In younger patients, coverage is improving, but we already have a system of CPT codes. We just have to keep advocating to get it covered. The partnership model, you can get excimer lasers from other companies. You can get excimer light and narrowband phototherapy from other companies, and I've used them.

I've had them in my offices. But the support that it takes to run the system well, to get the prior authorizations, to buy the marketing material, to make sure that you have support for maintaining the devices, the XTRAC partnership program has been best in class, and I can speak to personal experience 'cause I... It's not like I just accepted this. I've tried other companies, and our group has been very, very happy using it, both at the Henry Ford Health System as well as at the Hamzavi Dermatology and Dermatology Specialists clinic. And in our private group, we are very selective about which companies we partner with, and, and we do a lot of very complex medical derm. We're one of the first private groups to do a lot of skin of color.

This is one of our preferred partners to support us in these efforts. Again, Dr. Nazareth baptized this process very nicely. He gave you all the options. But this integrated approach, where you have partnership from field support to laser upgrades. When you buy a laser, many times you spend a lot of money, and the laser never is used. But this model that's been dedicated has been dedicated support for many years and also has been iterative because they take our feedback and improve the process. You're not really buying a device, you're buying a solution, which is very unique in this space, 'cause most laser companies do not provide a solution. They just want you to buy their device, and then they disappear. The XTRAC system does not do that.

So in conclusion, you can deliver this technology to the skin while sparing healthy skin, and you've got multiple options. Psoriasis, vitiligo, atopic dermatitis, we treat all these conditions. And even with these wonderful technologically advanced biologics and targeted JAK inhibitors, we still have breakthrough cases in all these diseases, and there's a reason to use them. In our practice, these advances are actually offering even more of a reason to use phototherapy, and phototherapy is much cheaper for the insurance companies than doing a biologic or biologic alone. And for the patient who has a partial but incomplete response, they can get to significant improvement on a lot of these chronic autoimmune diseases. And the insurance reimbursement is favorable, especially given the overall cost and awareness of these conditions. Happy to take any questions with the rest of the group. Thank you so much for your time.

Rich Cockrell
President, CG Capital

All right, so that wraps up our section on XTRAC. I would like to now open the floor to questions. As I mentioned before, if you'd like to ask a question, please, type that question into the lower box, and we will—I will read the question, and then we will turn it over to the physicians for answers. So the first question is or for the doctors is: Can you discuss the difference in treating children versus adults in psoriasis, in terms of using XTRAC?

Michael Nazareth
President and Board Certified Dermatologist, WNY Dermatology

I can take that. From my practice, we use it quite frequently in both. I think children tolerate this very well. It is not a painful treatment, and I think that that is very important to differentiate because a lot of the cosmetic lasers that are out there do cause some discomfort when are used. If you mention lasers, sometimes people have that connotation that it's gonna hurt, and they don't want to think about it for their kids. But the treatment is not painful, and therefore it is very well tolerated by children.

So, in essence, the treatments that we're doing for children or adults are really not any different other than we usually have if it's a small child, we'll have the child sit on their parent's lap, so we can do it, so they're not intimidated by it because they do have to wear the glasses to protect their eyes because it is a laser. They're clear glasses, so it's not a big deal. But, you know, just that whole process, sometimes the kids expect it to be painful. Then after the first session, they think this is great because they see their skin clearing, and they're literally running through the office, going to the laser room before their parents even can catch up to them. So, they're enthusiastic about it, and it works very well.

In the actual way we're doing it, there really isn't any difference between the adults and the kids other than the fact that the kids are coming back there and sitting there with their parents.

Rich Cockrell
President, CG Capital

All right. I do appreciate that. In terms of the next question, I'd like to understand more how you use XTRAC in combination with topicals when treating vitiligo. I think there's you know been a lot of conversation of sorts in the market in that regard. I'd love to hear your impressions of that also.

Iltefat Hamzavi
President, Hamzavi Dermatology

So the experience with vitiligo is documented in multiple smaller case series, as well as small randomized controlled trials. And in that, the rate of response and the overall response is much faster when you add photons of UVB light or radiation to the skin. So specifically, recently we did, and I was one of the authors on the paper, and I have a conflict of interest. I worked with the Incyte, but we looked at a subgroup analysis. When patients had light therapy added to the ruxolitinib therapy, they ended up getting a much higher response, so a higher percentage of patients achieved VASI 90, which was the highest threshold. And then also, you had a overall better response, so faster and an overall better response when you added those combinations.

In tacrolimus, which is the gold standard still and the one that's not FDA- approved, but has the most information on it, with phototherapy, there's numerous studies showing that combination therapy works. Because, again, a topical immunosuppressive will remove the inflammatory infiltrate. It'll make the soil more appropriate, but does not actually bring the color cells, melanocytes, back unless it happens through a natural process. The excimer technology allows for both a little bit more immunosuppression, but the biggest thing is it allows for melanocyte migration. The advances we're seeing today, outside the excimer, there's only one other option that's coming out, out of maybe 20 trials, that focuses on melanocytes. Everything else is focusing on the immune system. So you create fertile skin that allows for repigmentation, but you still have to repigment. That's where excimer and light come in.

So faster and a greater response, a better response is what you do when you add phototherapy to the upcoming treatments that exist.

Rich Cockrell
President, CG Capital

Yeah. Are you seeing sort of any compliance issues with patients coming in for these treatments? You know, are they pretty consistent in staying on, you know, staying within the realms of compliance in terms of consistently, you know, receiving these treatments?

Iltefat Hamzavi
President, Hamzavi Dermatology

Well, I think for vitiligo, it's a much longer process than psoriasis. Having the marketing material really helps because you have to counsel. This is not gonna be psoriasis. This is not gonna be, you're gonna walk in, and in 10 treatments, it's gonna be clear. I think Dr. Nazareth can speak to that. But for vitiligo, if you don't counsel from the beginning, you don't get compliance. But if you counsel effectively, you tell them which locations will do better, the face will generally do better. You tell them how long it's gonna take. People are ecstatic, and when it works, it is life-altering and across skin types. People are shocked at lighter-skinned Caucasians who refuse to go outdoors because they don't want anybody to see their vitiligo. But when they get repigmented, it's life-altering, and so it's...

Again, counsel properly, very effective, but it is a long process. This is about a year process to kind of get color back in the appropriate body site. I'll allow Dr. Nazareth to kind of speak to psoriasis.

Michael Nazareth
President and Board Certified Dermatologist, WNY Dermatology

I totally agree with Dr. Hamzavi there. It is, a lot easier for psoriasis than atopic dermatitis because they need fewer treatments. Our compliance is really good, but even for vitiligo, I, I think the compliance is good. It's just a longer process. It's all about setting those expectations. You know, it's not gonna be the miracle that they're clear after one treatment, right? Or with vitiligo, it's gonna take a while. So, you know, as long as you're setting those reasonable expectations, I've found compliance to be excellent. The thing that amazes me is, you know, we'll get a snowstorm here in Buffalo, and even on the snowiest days, those patients find their way in.

They do not want to miss their XTRAC treatment, so they are troopers, and even on winter storm warnings and stuff like that, they make their way to the office, and don't ask to reschedule. So I would say compliance is very, very good.

Rich Cockrell
President, CG Capital

Oh, that's good. Good. And can you give me a sense of, you know, like, how quickly their quality of life improves and any patient testimonials that you've experienced directly?

Michael Nazareth
President and Board Certified Dermatologist, WNY Dermatology

So from the psoriasis and atopic end of things, I would say that they improve quite quickly. You know, usually by the time they're on treatment five, six, seven, they're seeing significant benefit. Sometimes they're seeing improvement in the itch before they see, you know, clearance of the actual plaque of psoriasis or atopic dermatitis, which really gives them a lot more hope, I think, to keep continuing on, obviously. And clearly, as those plaques clear, it has a huge positive impact on their quality of life. We've had some that are huge advocates of it too. You know, they're talking to people in the waiting room.

They've wanted to go on to, you know, TV commercials or radio ads or email blasts or stuff to have their testimonials out there because they're just so enthusiastic and so excited to have a treatment. That was big during the pandemic, too, 'cause a lot of people were able to just use topicals plus XTRAC and then didn't need to go on immunosuppressive therapy, which has become a very scary thing now that, you know, the pandemic is still a real factor that's out there. That's particularly true of parents who were very concerned about placing their children on immunosuppressive therapies, where now we can use a topical plus XTRAC.

Iltefat Hamzavi
President, Hamzavi Dermatology

For vitiligo, unfortunately, it takes a lot longer. And so anecdotally, it's about three-six months to shift. But based on the measures, so we have the FDA-approved VASI score, and then we have these other noticeability indexes that are being picked up. And there's a couple of areas. One is there's anxiety of the disease coming back. There is concern about whether or not the pigmentation will match your normal pigment, and then there's also a concern of how fast it'll come back. So if they have a rapid response, then you can imagine that the quality of life improves a little bit faster. If they have a slow response, it takes longer, and even when they repigment completely, they're bothered by the fact that it took so long, and they don't want to reinvest it.

This is much more of a nuanced area within quality of life, but the quality of life of vitiligo patients is so low that even when you're treating, you have a bump. A couple of components of that, it's a little more nuanced than saying everybody does well. They do do better, but it's not across the board.

Rich Cockrell
President, CG Capital

All right. Well, I certainly thank you, Dr. Nazareth and Dr. Hamzavi, for participating in today's call. We're gonna transition over to TheraClear. For that session, we're gonna be hearing from Dr. Bhatia of Oak Dermatology. He is a board-certified and fellowship-trained dermatologist and dermatologic surgeon. He is an internationally recognized expert in dermatologic surgery and cosmetic surgery. His expertise includes facial and body aesthetic surgery, skin cancer therapy, Mohs and reconstructive surgery, laser surgery, and skin resurfacing procedures, including scar reduction and revision. He has helped bring over 25 drugs to the market, including the development of two acne devices. Dr. Bhatia received his medical degree from Northeastern Ohio Universities College of Medicine, where he was inducted into the Alpha Omega Alpha National Medical Honor Society, where he earned awards for both achievement and service.

He completed his residency in dermatology at the Medical College of Virginia Hospitals, where he served as chief resident. Subsequently, he completed an intensive fellowship in Mohs surgery, cutaneous oncology, reconstruction, cosmetic and laser surgery at Skin Care Physicians in Boston, under the direction of leaders in the field from Boston University, Harvard University, and Yale University School of Medicine. Dr. Bhatia is an associate professor of clinical dermatology at Northwestern University's Feinberg School of Medicine. His memberships include the American Academy of Dermatology, the American Society for Dermatologic Surgery, the American Society for Laser Medicine and Surgery, the American College of Mohs Surgery, and the American Medical Association. With that, I'll turn the call over to Dr. Bhatia. Go ahead, sir.

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

Thank you. Thanks for having me today, and really excited to talk about acne and acne therapy, particularly with the TheraClear X device. Acne is the most common skin disease we see in our clinics in dermatology in general. It's the number one skin disease in the U.S. The majority of the cases are mild to moderate, over 90%. So of what comes into the office is a mild to moderate acne. Up to 50 million Americans are affected annually by this, and that's a huge number. That number just seems to keep growing because we see acne now in older and older age groups. Over 50% of U.S. women are experiencing acne in their twenties. 85% of all adolescents experience some degree of acne sometime between 12 and 24 years.

So, you know, it's something that we have been seeing for a long time, we continue to see, and it just continues to grow. You know, when you're targeting acne with different treatments, traditionally we use topicals and oral medications. What we're really trying to do is get to one of the key pathogenic factors, the things that cause acne. If you look at an acne lesion, right, we can kind of show you there's a bunch of things that happen that result in acne. One is follicular hyperkeratinization. That just means the cells are a little sticky, and they get clogged, and so the pores get clogged. The normal dead skin that should be coming out of there can't come out, and it traps the oil and dead skin, which can lead to an acne lesion.

There's also a bacteria called Cutibacterium acnes, which when it builds up inside the follicle, can cause a lot of inflammation. Also, we see increased sebum production that can be a cause of acne as well, where there's more oil being produced, and once again, when it gets trapped, it can cause a problem. And all of these things can lead to inflammation. That's when you get those red, tender papules or nodules, which are, you know, classic acne lesions. So there's a lot of interventions, like I said, for acne. You know, we can do chemical peels, dermal infusion, IPL, intense pulsed light, broadband light, pulsed dye laser, blue light, photodynamic therapy, photopneumatic therapy, as well as these new 1726 lasers like the AviClear and Accure. So these all exist.

These are all treatments that are done in office. So doing treatments in office is nothing new to dermatologists. But there hasn't been anything that's been highly effective. And so that's really kind of where the TheraClear X comes in. It was specifically designed to treat acne in the office, and to do it at all age groups. It's FDA cleared for the treatment of mild to moderate acne, but, you know, I've used it extensively for more severe acne. In fact, I first started using it on the severe acne patients because, you know, sometimes we didn't have an alternative if they couldn't go on some medications or whatnot. And so...

You always, when you're trying something new out, you wanna see, "Hey, how does it work, you know, against the worst cases?" Even though it's cleared for mild to moderate, you know, a lot of us use it for severe. It treats all types of acne, comedonal, pustular, inflammatory acne. The goal here is really to kinda catch this acne, treat it before it leads to scarring and other issues. The other thing about the acne, the TheraClear X acne system is it is very unique. It's a photopneumatic technology, so it combines two modalities. It combines a broadband light, which is basically like a series of lasers together, because as Dr. Nazareth talked about, it's not just a single wavelength, like a laser; it's a broadband light, meaning it covers a lot of different wavelengths.

So that way, you can treat a lot of these different causes that we just talked about. In addition to that, there's the pneumatic part, which basically is vacuum, and so the vacuum is applied. And that vacuum does a few things. It pulls the stuff out of the pores, clears the pores, but then also it pushes the blood out of the way, and spreads the skin pigment too, which allows the light to penetrate deeper. And so these two work very well together to give an effective therapy, and it's very unique in that way. So what else do we use to treat acne in our offices? So obviously, oral medications, topical medications are always there. But, you know, these rely on primarily kids actually taking and using the medications properly.

As we know, compliance with medications is tough, especially when you're a kid. You know, it could be due to forgetfulness, just the inconvenience of doing it. A lot of patients don't want to be bothered by it, and the adverse effects of some of these medications as well. It usually takes weeks, if not months, to see the improvement with oral and topical medications. When people come into our practice, and I write them prescriptions, I say, "Hey, look, you're... We'll see you back in, in six to eight weeks. I don't even wanna see you before then because it's gonna get worse and better," and nobody wants that. Everybody wants immediate results, right? You know, and then there's the side effects. Like I talked about, dryness, irritation, burning, can be, you know, some bleaching effects with some of the topicals.

In contrast to this, you know, TheraClear X takes all this out of the patient's hands, right? And it's really a comfortable in-office treatment that has no downtime. It was specifically designed to be comfortable and safe. And people start seeing the visible improvement in their acne lesions as early as the second treatment. So it's very encouraging. We talked about compliance before. You know, compliance, a lot of times, you know, if something's gonna take a long time to work, it's hard to get people to be compliant, and you have to spend a lot of time educating them. If they start seeing the results, they're coming back. And that's what we see in practice. People start seeing the results early, and so they're highly motivated to come back, and get this done.

Not only do you see improvements in the acne, but you also see improvements... a lot of time acne leaves a little red mark or a brown mark, and since this is broadband light, it actually targets those things too and helps improve those. You get the, get the acne or the medical benefit, but you also get some cosmetic benefit. Once again, it works by two mechanisms of action. Number one is the vacuum, which helps clear the pores, and number two is the broadband light, which really targets the redness, brown, and getting rid of the bacteria, kills the bacteria, and it actually warms up that, that sebum, so it comes out a little more easily, and it reduces sebum production. Using these two modalities, you actually get like four hits on each of those acne lesions, plus the cosmetic benefit....

This is exactly how it works, and, you know, you can see, place the little handpiece over the acne lesion, and then you activate it. First, the vacuum is applied, which extracts the content of the pores, which, you know, is pretty gratifying to see. You can see all that content coming out and, who doesn't like to see that, right? Next, while the skin is maximally stretched, the light activates. Like I said, you know, when the skin is stretched, as when you press your skin, you can see, you know, it blanches, right? That's 'cause the blood's pushed out of the way. Same thing happens when you pull the skin up with vacuum and you push that blood out of the way, the light can actually penetrate deeper.

And that light goes in, and through a porphyrin pathway, it kills the bacteria, but it also heats up the sebaceous glands. It shrinks the sebaceous glands, which decreases sebum production. And then finally, the device releases the skin. This all takes just a matter of a second or two. And so it's a very quick treatment where you can go over the whole face and then treat individual lesions as well. The other thing is it's a very safe treatment because it won't fire unless it has a vacuum seal. And so it makes it extremely safe because the light's kind of contained within the head of the device, and it just won't simply fire unless you have a good seal and the vacuum's activated.

So once again, you know, the vacuum, what it does is it safely removes all the whatever's blocking the pore, right? And opens it up, removes that bacteria, removes all the extra sebum that's built up there, and decreases the acne lesion in itself, and it's quick, and it's comfortable. When you activate vacuum, you stretch the skin, it actually kind of competes with the pain fibers and deactivates the sensation. And so kids love it because when they come in and they get this done, it's completely painless, and it's very quick. Then the light heats up the targeted area and kills the acne bacteria and also decreases production of sebum. So here's just some quick before and afters.

You know, this is a patient that has a lot of acne lesions in the central cheek and on the nose, and, you know, this is after two weeks after a single treatment. So the results are really seen quickly. Not only the results in the reduction of acne lesions, but also if they have red blemishes or brown blemishes, it helps clear those up extremely quickly. And then here, these are more comedonal acne lesions, so the blackheads and the whiteheads. And even with these, because you're heating up that material and then pulling it out, you get evacuation of these, and the skin smooths very quickly. And so this is after three treatments. So when you get quick results, it's highly motivating. The other thing I do want to mention is, this doesn't keep us from putting people on other therapies.

So often we'll start people on oral therapy, or at least topicals. And the other thing I really like about this is, if you're used to writing a lot of topicals in your practice, like retinoids, for instance, they're, they're very good, like Retin-A, or Differin, are very good at opening up these pores. This works in combination because as you kind of, help improve the keratinization and help the opening, you know, It's kind of a one-two punch. You're using your topical, then you use the device, helps clear the pores, and then once the pores are clear, the topicals actually work better. And the patients don't care why they're getting better. They just want to be better. They want to see visible improvement, and so it's very complementary.

We don't stop any of our medications as we use the TheraClearX in our office. So the opportunity here, you know, if you talk to dermatologists, you know, they. The statistics say about 100 acne patients per month per common dermatologist, but you talk to them, it, it's really probably a lot more than that. So one of the things that traditionally dermatologists are used to writing prescriptions, and this is a cash-based procedure, and so this actually helps bridge that pathway from being insurance reimbursed only to a cash-based practice. And so this is a really great gateway device.

You know, dermatologists aren't used to spending a lot on big capital, and so having a partnership program really helps with, A. Getting these devices into the point of care where all the acne patients are, but also gets the dermatologist kind of used to, you know, getting, cash reimbursement, which really is kind of a game changer. You know, as reimbursement, medically, it goes down, it goes down every year. Here it's a way to actually bolster their practices and especially for some, a diagnosis that they see on a daily basis. So, and dermatologists do this more and more, you know, now, you know, they freeze lesions and get rid of things cosmetically.

You know, it's not that uncommon, but this is a great gateway device to get them used to using devices, where they can also make cash payments and still help their patients. The results, like I said, are very quick and lead to high satisfaction, and the patients keep coming back because they see the results. It is quick; it's painless. Both age groups, adults and kids in our practice, it was funny because a lot of the adults with acne were highly motivated and willing to pay, and they started coming, you know, young adult females for their acne and then a lot of them, their children come, and it just keeps building. There's actually two populations that this addresses. It's adults with acne and kids with acne.

And like I said, it's quite fast, painless, and that makes the patients come back, and it removes that whole compliance issue. Additionally, you know, more and more practices sell product in their office. You know, the retail component keeps growing, and so, you know, in our practice, we have aestheticians that administer these treatments. But while they're doing it, they always talk to the kids about skincare and usually end up getting them on a skincare regimen from the office as well. And like I said, it's complementary to all the prescription, topical and oral medications we use. So, you know, last thing I wanted to mention is that, you know, this device, it's really a fourth-generation device. So, you know, it's been refined and, you know, like a fourth-generation fighter jet, right? It's way better than the first generation.

So, the iterations of this that led to the TheraClear X has made it faster, safer, and more efficacious. And so, you know, compared to anything else on the market that is used to treat this, acne, in the office, it's something that it's highly efficacious, fast, painless, and very safe and easy to operate. So... And the patients, like I said, they keep coming back for it, and so it does lead to recurring revenue for the practice. And with that, I'll hand it back over to Rich.

Rich Cockrell
President, CG Capital

All right. Thank you, Dr. Bhatia. So our final speaker today is Dr. Joel Cohen. He is an internationally recognized expert on aesthetics and skin cancer. Dr. Cohen is the director of AboutSkin Dermatology and DermSurgery and AboutSkin Research in the Denver, Colorado, metro area. He was named a top dermatologist by U.S. News & World Report. He was also Castle Connolly Top Doctor from 2013 to 2023, so 10 years. He was also voted by his peers 10 times as one of Denver's top doctors in 5280 Magazine. He is a board-certified dermatologist and fellowship-trained in Mohs surgery, laser, and cosmetic dermatology. Dr. Cohen has published over 294 medical articles and book chapters and has co-authored three academic textbooks.

He lectures every month at national meetings, as well as at many international congresses, and has participated in over 100 clinical trials, including key aesthetic lasers and devices. He is on the teaching faculty at the University of California, Irvine, and as an associate professor of dermatology. He regularly appears on Denver TV stations with over 75 appearances discussing aesthetic issues, dermatology, and skin cancer. He has been a guest many times on Sirius XM, their show called Doctor Radio. Additionally, he's been featured on the Emmy Award-winning show, and everybody knows this, The Doctors. So with that, I'm pleased to present Dr. Joel Cohen. Go ahead, sir.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

Good morning. It's a pleasure to be here, and I'm gonna be discussing my experience using TheraClear in our practice. We've had it for a number of years, dating back to, as Ashish indicated, really some of the original devices that was part of this platform, dating back probably seven or eight years. I run a two-site practice in metropolitan Denver, and we have a lot of insurance patients, but we also have a lot of patients that are cosmetic. This TheraClear platform fits really well into our practice because it differentiates us from other practices in the area in terms of really that buy-in. When people come to a practice and they have long suffered from acne, really their thoughts are, what they—what can they do to make them better, more quickly?

As Ashish went through very nicely, this can expedite your treatment. I think people are frustrated with just the prescriptions for topicals and the prescriptions for oral antibiotics. I'm married to a pediatrician, and we see a lot of kiddos out there who have already lost confidence in the folks that have started to treat their acne, and we really want to give them a confidence booster. This is exactly where TheraClear fits in. I'm gonna be discussing really expediting your acne treatment. In terms of our formulation and the way that we put this into our paradigm to treat, it really fits in nicely for, number one, the kids who have acne, who've been someplace else, and they've stopped using their topicals, either because they're dry or because they didn't see improvement, or because their benzoyl peroxide bleaches their towels.

They wanna see something that is noticeable in the first couple weeks of treatment. We tend to do treatments once a week or sometimes even twice a week, early in the week and later in the week, for about five or six treatment sessions, and really they should be seeing improvement by treatment number two or three, to some degree. We also give them other information about things that can cause acne flares, from diet and milk products to high glycemic foods. Many of these kids, especially young guys, are on protein shakes and whey protein to bulk up, and we know that whey is a stimulus. We're fitting TheraClear into the overall comprehensive treatment algorithm for our patients, but these kids really want to see improvement more quickly.

The other population that it's very common to incorporate are for people who may have an event coming up. So often these patients have had TheraClear before, or a family member has had TheraClear before, and they know that it helps them clear up. So if somebody's sister's getting married or somebody has a bar mitzvah or something like that, we can expedite the improvement. Sometimes it's just before class photos or hockey team photos. We see so many kids that play hockey or lacrosse or football that have significant flares where their chin strap hits, where their forehead area for their helmet hits, and we want to give them improvement. So this is a quick treatment. It's 15 minutes. You don't need topical anesthetic. It is something that people find comfortable.

We don't have to give them any nitrous or Pro-Nox or anything like that, like we do for other procedures, and they should be seeing visible improvement pretty quickly. I think for the other population, in addition to people who've tried things before at other offices and want to see improvement, people who have events, are people who notice that they're having a flare. In a couple of weeks, we're gonna see kids who continue to have flares around the time of exams, and we know that stress is a major stimulus for people with acne, and if we can actually really identify the stressors and, in particular, you know, a time when they may have midterm exams and start treating them early on before these flares really get out of control, we can have really nice results.

This is something that fits into our practice in those three respects, and it helps us differentiate from other practices, and we use it for adolescents. The people who have events oftentimes may be adults, and they realize that this is something that they can implement, that is easy to do, it doesn't have downtime, it can jumpstart their treatment. Really, a lot of people don't want to go on oral antibiotics. We live in the Denver- Boulder corridor, where people are always searching for more natural, types of treatments, and I explained to him that this, this, this is really light. It's focusing on the endogenous porphyrins that the acne bacteria is making in the follicular structures. Many people have concerns about long-term antibiotics, from inflammatory bowel type issues to antibiotic stewardship and resistance, to really just changes in the gut and tolerability.

Some of the antibiotics that are... we use, they actually cause photosensitivity, like doxycycline. In a climate where we have over 315 days of sunshine a year, those are significant issues. We've been able to really implement TheraClear X into our patient practice for many reasons, to get people really nice results. This is a picture of a patient. You can see that, you know, these patients don't clear up, you know, completely, but this is just one treatment in, and this is a major confidence builder. This was from a little clinical trial that we did a few years ago, looking at a series of treatments, and we really want to see improvement. You know, you can see this patient is skin type four, and she really does tolerate this really well.

We're individually treating the areas and the regions of treatment, and at the same time, she's able to use, in the morning, something like a topical benzoyl peroxide cleanser in the shower. She can put a topical formulation on that has an antibiotic and sometimes, you know, one of the other products that we recommend for acne, which is a host of different combination-type products. And then in the evening, we have patients use a retinoid, and they can come into the office. There's really no downtime. It's a 15-minute treatment. Sometimes they'll have a little bit of irritation at the individual lesions that were treated because we're really opening up with the photopneumatic suction, some of these more inflammatory lesions. And I think, you know, you'll see even with the kids, when they have less lesions, there's less to pick at.

So when there's less to pick at, they get less post-inflammatory redness. So the pickers and squeezers tend to be people who early on feel something coming. They start working on a spot, and not only does the TheraClear X help treat their inflammatory acne component, and she showed some of the more comedonal acne, but you can see areas of redness from picking or manipulating recent lesions get better just because that's a target for the light-based treatment as well. So we're really able to take advantage of the fact that these specific wavelengths and these filters are targeting the acne and targeting the follicular structure, and the photopneumatic is opening things up. Plus, we're also treating some discoloration in the reds and the brown range.

So you can see over the course of a couple of treatments, sequentially, these patients are getting better, and many of these patients are being more consistent with their topical regimen just because they're seeing improvement. And we know from many clinical trials out there that it can take four-six weeks to start seeing improvement with the topical regimen, and that buy-in is really tough for kids. I'm the father of three kids. I've gone through this with my kids themselves and said, "Look, if you keep using this topical four-six weeks from now . . . " things will be better, but if we incorporate TheraClear X, they're gonna start seeing improvement in all the parameters of acne, from inflammatory to comedonal, to even the discoloration from some of the recent lesions, more quickly.

So you can see, you know, in the center part of the face where people have more sebaceous gland activity, you can see more improvement in these areas of acne. And then, you know, don't forget about the neck. We see a lot of folks; this happens to be a young woman, but guys tend to have a lot of acne on the neck, especially as they're starting to shave. Sometimes they'll shave against the grain, and they'll get a folliculitis, and we use this to help some of these situations of folliculitis and acneiform lesions as well. So I, I think people hear about TheraClear from our patients very commonly. So we have, you know, friends referring friends or family members sending other family members. But this really fits really nicely into the practice because it, it's a differentiator from many of the other practices.

Not all derm practices that see so much acne are on board with devices, and this is something that you can incorporate for all different areas of acne, early acne, or people who are having flares, or people who've tried other things and just haven't seen results, and they want to do something as a step before they think about going on Accutane. Now that we have the 1726 acne lasers, this is very different. We apply this TheraClear X in terms of right when we're giving people scripts, I, I tell patients, "Listen, I'm gonna give you this prescription. It's gonna take four -six weeks to start working. If you want to really start seeing improvement more quickly, let's book you for TheraClear.

It's not covered by insurance." In our practice, we charge about $150 a treatment, but we try to have them book a series. And by booking a series, they're really seeing the effects of cumulative exposure to the photopneumatic treatment, Theraclear. So we do five, five treatments for about $650. So once a week, or as I said, early in the week and end of the week, sometimes twice a week. So this is a completely delegatable treatment. We have five physicians in our office, but we have four non-physician healthcare professionals who are trained on doing this type of procedure. So typically patients will see a physician as their initial step. They'll evaluate their acne. They'll see what other conditions are going on.

Some young women have things like polycystic ovarian syndrome, so we want to be able to diagnose these things early on and get them on a good treatment plan. And along with that treatment plan becomes a pathway that they can do a treatment that's not covered by insurance, like TheraClear X, and have expedited improvement. And we show patients some of these pictures and show them really a graph of what we expect them to be on. And we also talk about the importance of appropriate topicals, appropriate cleansers, avoiding picking and manipulating, and some of the lesions that are there that we can actually make better in terms of the redness and some of the discoloration. So, TheraClear works well in our practice.

Our staff is educated, knows about it, our patient population knows about it, and I think the pricing makes sense, and we really want to encourage people to do a series of five treatment sessions at least, and then they see the effects of this. And then they know that when they have a flare, or they're kind of seeing the early elements of a flare, they can come in and start booking these treatments and really space things out for control of that flare, perhaps around midterm exams or final exams, or when it's a specific event, they can think about these things as well. And it works well for events because there's really no downtime with this type of treatment either. So, in terms of, you know, overall cost, you can look at different areas.

You know, I practice in, in Denver, so it's not New York, and it's not Los Angeles. I gave, you know, real numbers from our experience, you know, but you'll see on the coast and some of the big cities and more expensive cities, that this is a little bit more expensive. In terms of how this works in our practice, I think this affects multiple pathogenetic factors in terms of opening up the follicle, directly reducing the acne-causing bacteria, Propionibacterium acnes, and then reducing the sebum production, the overproduction. It really allows the topical medications to start working better when you open up the follicular structures. It's really assisting the delivery of these topical medications. Patients can see improvement very quickly.

As I said, within a couple treatments, they start seeing improvement, and I think that helps them with overall confidence in what regimen that their doctor has prescribed for their acne, to stick with it, to see improvement. Really, it's great 'cause there's no downtime, and there's really no significant discomfort. We don't have kids complaining of severe pain, like some other treatments that they may experience, or some of the other lasers that we do. I do a lot of laser resurfacing, and if kids have seen their mom or dad go through a laser experience, there's a lot of explaining to do. I tell them that this is not a laser, it's pulse light, it's filtered light. This is not something that gives a wound, and this is not something that has downtime, and people really tolerate it really well.

The fact that we can really delegate it to people in the office, depends by state, works well in our practice. So we have a room that's often dedicated to TheraClear, that we have one of our healthcare professionals that's set up to do. And sometimes we can even add it on the day of an acne visit, because sometimes these kids come in, or somebody comes in, and they're really distraught with the appearance of the acne. And sometimes by the time they get an appointment, they have an event coming up or school photos or something like that, they, they just want to get this added in, and it's such a quick treatment, it can be an efficient treatment, and the device turns on very quickly. It's not a huge warm-up time.

So this has worked well in our practice for a long time, and this is something that is a confidence booster for our practice and helps us differentiate from other practices. And really, our staff knows and our patient knows that we'll get patients in building their confidence in their topical therapy, people who are noticing a potential flare or the time of a flare, and then people who have an event. And we do run promos. So this time of year, we're back to school. You know, promos are very common to get people in or bring a friend, and it works well, and I think that people have had a really good experience with TheraClear in our practice over the years that we've been using it, and I'm happy to participate in the questions.

Rich Cockrell
President, CG Capital

Questions. And again, if any of you have any questions, please feel free to type your question in the lower section of your screen there. So for my first question, I want to talk to you about, you know, utilization in your practice. I want to get a sense from each of you, you know, like, how often is the device used? You know, do patients prefer topicals or the oral therapies in lieu of this?

And then, you know, I know that some of you touched on how you use that in combination, but I'm really more focused on sort of TheraClear and, you know, sort of what you've experienced in terms of patient utilization in the practices as well as, you know, patients coming in and asking for the device.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

Please, go ahead.

Rich Cockrell
President, CG Capital

Yeah. Yeah. Go ahead.

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

Sure. Yeah. You know, I think as Joel mentioned, people do come in and ask for the device, you know, especially once they know other people that have used it. You know, we hear about it quite a bit, we hear about it on social media as well. As far as, you know, utilizing it with our own patients, you know, it's just become a part of our discussion, just like Dr. Cohen mentioned, that, you know, when we talk about, you know, you're here for your new acne diagnosis, you know, these are our treatment options. This is just one of the treatment options we mention. It's surprising, you know, I think over the years, things have shifted. Before everything used to be, "Well, I'm just gonna do what insurance covers," to, "Hey, you know, it's...

I need my face cleared up quickly," right? Because as soon as you say, "Here's your two prescriptions, you know, it's gonna take six-eight weeks, or it's gonna get worse and better," there's almost instantly an eye roll, either from the parent or the kid, and they're like, "I can't wait six-eight weeks.

I need this fixed yesterday." So I... And we say it just like Dr. Cohen does: "If you'd like to jumpstart your therapy, we can set you up for some TheraClear treatments, and within one-two treatments, you'll notice improvement in your acne." That really, I would say, gets probably in our practice, 25% of the people, kind of 25%-30% interested, and then probably out of those, probably 25%, 30% actually end up getting treatment, sometimes as high as 50%. I think it is, sometimes they're more motivated, like Joel was saying, during prom and, you know, events that are coming up back to school. Yeah, it's definitely something that we've been able to very easily integrate into our practices, and, you know, we have a lot of different providers here that can provide the service as well.

The other thing is, you know, a lot of times the moms are coming in for facials anyways, right? And they're paying this much or if not more, for their facials. And so, you know, the thought of doing this for your kid to get the acne cleared up is not insurmountable, unlike a lot of other laser treatments that are available that are very expensive and have pain and stuff associated with them. Here, a 15-minute treatment that's very reasonably priced, it's really an easy, easy sell.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

You know, I would add to that, that, you know, it depends who the physician discussing the procedure with, and it depends who is in the room or who's checking out, but certain people have a better experience in getting patients to book it. I think if we look at those people, it's not somebody who's, you know, the typical closer. It's often the people who have suffered from acne themselves, who've had firsthand experience incorporating TheraClear, or when I'm talking to patients, I give the example of my kids and my wife. My wife has been on Accutane three times. It doesn't make all acne go away, and at times people are gonna flare. You know, this is something that can fit right in in all those situations.

People just need to have some experience of hearing somebody having had this treatment successfully, and it's not a standalone treatment in our office. We always have patients do prescription products with it, and in many cases, this is helping people see better improvement more quickly with their topical products, in some cases, avoiding going on that oral antibiotic flare.

Rich Cockrell
President, CG Capital

Well, thank you. So the next question: Is there any post-inflammatory hyperpigmentation associated with TheraClear, especially with people of color? Right? I believe it was Fitzpatrick V and VI . Is there... Can any one of you answer that question? With respect to pigmentation-

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

Sure.

Rich Cockrell
President, CG Capital

Hyperpigmentation in people of color. Go, go ahead, Dr. Bhatia.

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

Yeah, we have a very diverse population in our group, and, you know, we see patients of all different skin types, and, yeah, you can safely use it. We safely use it in all the different skin types. And, you know, even if a practice is very, very concerned or a patient is very concerned, you can actually just use it with vacuum initially to clear the pores, get improvement. But what I was talking about earlier was, as far as the technology goes, when you stretch that skin using the vacuum, you actually stretch out all that melanin. And, you know, if you take a dark area of my skin and stretch it, it looks lighter. And so you really kind of effectively decrease their Fitzpatrick skin type by stretching out that pigment.

And the level of light that's used is actually relatively low, so you can safely use it. It also does one of the things we didn't talk about technology-wise, you know, we keep the skin really moist, not only to help achieve a seal, but you also get evaporative cooling, which cools the skin surface and makes it even safer in these darker skin types. So, short answer, long answer is yes, we use it safely in type V and VI skin. It's also been piloted in some of the countries Dr. Bob Moccia talked about in Asia and whatnot. And so, you know, we've been able to effectively and safely use it in pilots with it in patients that are primarily darker skin.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

So from a marketing perspective, I think, you know, a lot of folks out there think that perhaps lasers, and again, this isn't a laser, this is pulsed and filtered light. It is not something that they can typically use in darker skin types. So when we actually have internal photos and promotional materials, we tend to focus on patients who have darker skin, so letting people know that this is a treatment that applies to everybody. So we have little TVs in the waiting room and some of our rooms with little before and after pictures floating by. And we use some of our patient experiences with permission to really advertise that this is something that can be used safely and effectively for different skin types.

Rich Cockrell
President, CG Capital

Okay. Can you speak to the number of sessions on average before seeing any visible results, and the difference between teenagers and adults? If you kind of break that up, and I'll give that to you, Dr. Cohen.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

So, you know, teenagers tend to have their morphology or their pattern of acne tends to be all over the face, and many of these folks are pickers. Many of them come to the doctor, and they just, they haven't had great experiences in getting their acne treated. Sometimes they're starting with a pediatrician. Again, I'm married to one, but reflexively, sometimes, you know, a pediatrician has a lot to deal with during these visits and may just hand out some prescriptions, and that's not the focal point of their meeting. When patients come to a derm office, that's what they're there for. Acne is their evaluation. They're getting their whole appointment dedicated to their acne, and they really have a better understanding that these topical medications are not a magic wand. They're not gonna make things go away right away, and they're not a panacea.

They're not gonna make all their acne go away. So making sure to set expectations with the prescription products is super important. And then secondly, making sure to identify different pathways for these patients. So, you know, they can go the traditional insurance, get the prescription route, and schedule a follow-up visit in six or eight weeks to see how they're doing. And many of those patients lose confidence because they get dry or irritated, or they just don't see improvement. And then the second pathway would be to incorporate the synergies of TheraClear X into their treatment, and by showing them pictures of what to expect, we tend to show patients who start to see improvement within two or three treatments. And again, we really encourage patients to get a package of about five treatment sessions.

Rich Cockrell
President, CG Capital

Okay, and of those treatment sessions, are they in ... I mean, is it once a week, twice a week, or can you just do five over, you know, a two-week period or five-day period? I'm just asking.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

As I said in my presentation, we typically will do once a week, but if patients have something on their agenda, I have no problem doing a treatment early in the week and towards the end of the week, like a Monday and a Friday. That's totally fine as well.

Rich Cockrell
President, CG Capital

Okay, good, good, good.

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

And w-

Rich Cockrell
President, CG Capital

Go ahead.

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

For us, to answer your first question, you know, I kind of always undersell these things, so I tell them it'll take two-three treatments to see improvement. The reality is, in our practice, in our hands, usually one-two treatments, they end up seeing improvement, which is good, keeps them coming back, you know, and keeps them motivated. We have two protocols. We either sign them up for a monthly, or, I'm sorry, a weekly treatment, or if they have a big event coming up, we have our rapid resolution protocol that we kinda come up with, where we bring them in twice a week for two-two weeks. You know, with those people see improvement a little quicker, obviously. It's safe to do a little quicker if you need to.

Most of the time people... You know, society's really changed. They're not very forward thinking. It's everything needs to be now, and I need to be better by yesterday. I'll, I'll-- most of the people, if they can fit it into their schedule, they'll, they'll do the rapid resolution protocol, where it's twice a week for two weeks, and then maintenance treatment, you know, monthly or whatever they need after that.

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

... I think it's important to talk to patients about realistic expectations, and so that they understand what improvement means. So when we say improvement, we're talking about the inflammatory acne lesions that they can feel. When we say improvement, we're talking about some of the comedonal lesions, like blackheads and whiteheads as well, from the photopneumatic treatment. But we also wanna make sure that they're not picking or squeezing or manipulating these spots or doing anything to unroof or irritate them. And sometimes when you explain to kids that this is gonna add some suction to open the follicle and the pore and express some of the sebum that's in there and allow the medication to penetrate better, they think that it sort of reinforces what they've been doing about picking and squeezing to help that.

I just make sure it's very clear that we don't want them to do that. That adds to what they consider the picture of their acne in terms of the redness or the post-inflammatory discoloration or, you know, post-inflammatory hyperpigmentation just from picking and manipulating these lesions. I further explain to them that the device, the TheraClear X, is going to make some of that redness and some of that pigment better in and of itself because of these filtered wavelengths. Leave the spots alone that are there. If they sense something coming up, don't manipulate it or squeeze it. Let the device do its work and let the topicals do their work as well.

Rich Cockrell
President, CG Capital

So after the treatment, it... I mean, does it come back, or do you have to stay on it for a while, or, you know, sort of what happens after they've been treated, you know, during that period of time?

Joel Cohen
Director, AboutSkin Dermatology and DermSurgery

I think there's, you know, a few groups where the people who are really diligent about using their prescription products, when they're also using the TheraClear after their five treatments, many of those patients go on to do their topical products and just be really disciplined about using that, and they have a good experience. For some people who aren't so great about continuing their topicals, or they have significant issues related to their acne from a genetic or hormonal or sometimes from a food component or stress component, those patients will be interested in other treatments. They may still incorporate TheraClear while they start those other treatments, but in some cases, that's Accutane. And in some cases, you know, it's really just a discussion about incorporating brief oral antibiotics so that they can continue their topicals and do some TheraClear.

But eventually, the people with severe inflammatory or disfiguring acne that really have tried TheraClear and aren't great about using their topicals, and things continue to cycle for them and flare for them, you know, we have frank conversations about isotretinoin, Accutane, and then this is where, you know, eventually the conversation about the new 1726 nm lasers come into play, which can function in some people like Accutane, but these are very expensive, and they have discomfort.

So I really conceptualize TheraClear as something that we do early on so that we get people confident in using their topical regimens that we know works for many people, according to clinical trials. And then for those people that may have flares for one reason or another, as we discussed, continue to incorporate TheraClear.

The people who are disciplined about using everything and have incorporated all that, and they continue to have issues, then we have conversations about Accutane and some of the specific sebo-centric lasers.

Rich Cockrell
President, CG Capital

Okay. And then, I have another question, and I apologize to the participants. I know there are a lot of questions, and we're limited in time, and we can, you know, have additional follow-up questions, you know, after the call. Just feel free to email us. But, another question from the audience is, about needle insert and, how to treat correctly due to differentiation of acne depths. So, I'll give that to either one of you, if you'd like to take that question. Dr. Bhatia, go ahead.

Ashish Bhatia
Board-certified, Fellowship-trained Dermatologist, and Dermatologic Surgeon, Oak Dermatology

Sure. You know, typically, most of the time, you don't need to use any type of needle or anything with this. Sometimes our aestheticians do do, quote-unquote, "acne surgery" where we, we actually unroof it with a little needle, but it, it's really just to help open up the pore. But most of the times, the pore, you know, opens up on its own just from the heat and the vacuum. So, it's not, not something we end up doing. You know, you could do the needle insert deeper for nodules and cysts sometimes, but, you know, as, as it's penalized right now, you know, it's really marketed for mild to moderate acne and, and not the severe.

You know, when we do have severe patients, we will go after the nodules with kind of a deeper lancing.

Rich Cockrell
President, CG Capital

Okay. Well, look, we're gonna wrap up the TheraClear X Q&A, and before I turn the call over to Bob, I just want to remind all of our participants that management will be presenting at the upcoming LD Micro Conference on October 4 in Los Angeles. And then, there will be also a Dawson James conference on October 12 in Jupiter, Florida. So for any additional information on that, please contact our representatives over at CG Capital, or you can send an email to sskn@cgcapital.com. I'm gonna go ahead and turn the call over to Bob for any closing remarks. Go ahead, Bob.

Bob Moccia
CEO, STRATA Skin Sciences

Thank you, Rich, and again, thank you to our panel. That was very informative. And lastly, just thank you all who joined the call today. We really appreciate your support, and we look forward to keeping you updated on the continuous achievements of STRATA Skin Sciences. With that, we'll conclude the event.

Rich Cockrell
President, CG Capital

Thank you, guys.

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