SofWave Medical Ltd. (TLV:SOFW)
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Jefferies Global Healthcare Conference 2025

Jun 5, 2025

Ariel Sverdlik
Co-founder and CTO, Sofwave Medical

All right. Good morning everybody. This presentation is covered by Safe Harbor, so I'm going to allow everybody a few seconds to review the disclaimer. I'm here this morning to introduce you to Sofwave Medical. We have the next generation patented technology ultrasound beam for safe non-invasive head, neck and body skin regeneration. We have broad 9 FDA clearances for lifting, laxity, wrinkle treatment on the face, neck and the body as well as clearance for cellulite and acne scars. We have a strong revenue trajectory. We sold close to $60 million last year and our revenue grew at a 69% CAGR in the last five years. We have a superior and fast ROI model that I will discuss in less in the following slides. We have a strong market and we operate in what we see of a very strong market dynamic.

The total addressable market is approximately $4 billion and continue to grow. We also look at the GLP-1 agonist as an accelerator for our growth. There's a lot of information and data point about GLP-1 patients. We know that there are tens of millions of Americans and people around the world on GLP-1 losing weight quickly and safely. We also have many data points that showing that many of these patients at 60-65% of them are now considering aesthetic treatment exactly for the kind of solutions that we offer which is lifting skin laxity, treatment of wrinkles on the face, neck and the body. We are operating globally with a direct sales team here in the U.S. and in the U.K. and we operate through 40 distributors worldwide. We are publicly traded on the Tel Aviv Stock Exchange market cap of approximately $210 million.

Finished the previous quarter with over $20 million in the bank, no debt, so we are very well capitalized. The people behind the company, first of all Dr. Shimon Eckhouse is our Chairman and co-founder. Shimon is considered one of the founding fathers of the energy-based device aesthetic treatment. He is the founder of what we know today as Lumenis as well as the co-founder of Syneron, then Syneron Candela that at the time was the largest company in the space. Shimon just started. We are the third large energy-based devices aesthetic company that Shimon has in the space. He's a very well-known entrepreneur in Israel with many exits and successes and he has over 100 patents on his name. Mr.

Luis Cafuri is our CEO, has been in the space for over 25 years, was a leader together with Shimon at Lumenis, then was the CEO for Syneron Candela. We then created the largest company in the space back then and we are very lucky to have him as a CEO for six years now. I've been in the space for over 15 years and overall in biotechnology and life science for over 20 years in both public and private companies. I'm not going to go one by one, but everybody from our Chief Innovation Officer James to our Chief Commercial Officer Miguel, have many, many years of experience in energy-based device. So what is the problem that we are addressing?

The current minimally invasive and minimally ablative solutions in the market have significant show for as we can see, the nice lady here on the picture is 8 hour post Fraxel treatment. Fraxel is a CO2 ablative laser and as you can see there is a significant epidermal damage on this person. These treatments usually require multiple sessions, they are complicated equipment and they require the very skilled practitioner. Many times the physician themselves need to do the treatment. Maybe the biggest downside here is the downtime of this patient. This patient post this treatment is not going to go on any Zoom call, will not go back to her life, will not have a lot of drinks with her friend. She's going to stay at home for anywhere between five, seven and 10 days, which is a quite significant downtime that patients do not like.

In addition to that, ablative, minimally ablative or minimally invasive treatments, including microneedling, have a significant risk for hyperpigmentation and for adverse events. The reason why this person in the picture looked the way it looked is because of the mechanism of action of all the technologies and what everybody is trying to do. Everybody is trying to penetrate the epidermis, the upper layer of the skin in order to reach to the mid dermis at around 1.5 millimeter and induce the thermal injury at about 60-70 degrees Celsius at the mid dermis layer. Why are we trying to do that as we grow older and the reason that we grow older and our face look wrinkled and loose skin and saggy skin is because our body stopped manufacturing collagen and elastin.

By inducing this thermal injury in the dermis layer, this is where the manufacturing of the collagen and elastin in our bodies exist. By inducing this thermal injury, our body goes into a healing process. During this healing process, our body is regenerating again collagen and elastin that help us again to treat the laxity of the skin, the wrinkles, and lift the skin. As I showed before, what everybody has to do, at least the effective technologies out there, they have to penetrate the epidermis layer and create a significant epidermal damage. What we do is our unique disruptive patented technology. We do the same thing. We can penetrate into the dermis layer at around one and a half millimeter and create a large volumetric thermal injury in the dermis layer. Completely noninvasively, we can go through the epidermis with an ultrasound beam.

We have seven ultrasound transducers that you can see on the picture and we do not create any epidermal damage. More than that, we have proprietary cooling technology. If you look at the head of the applicator, it has seven transducers that are actually cold. We are cooling down and protecting the epidermis while we are delivering the ultrasound energy into the dermis layer. It creates a large volumetric injury, which means a shorter treatment time. You can do a full face and neck in 30-45 minutes. It is very safe because it is completely noninvasive. It is easy for the patient as well as for the clinician. The clinician can delegate it to anybody in their clinic very safely and very easily. Everybody in the clinic can do that. There is very limited post treatment swelling of the skin and you get natural result within usually one treatment.

If we look at this picture, this is a picture of a person immediately post Sofwave treatment and if you remember the person from two slides ago, after a fractional treatment, completely red with significant downtime, this person immediately post the Sofwave treatment can go back to their life. This can be a lunch break treatment. She can go back to work, she can go on a Zoom call, she can go drink coffee with friends. There is almost no downtime associated with the treatment. What is our go to market model? We're starting with the fundamental investment in clinical trial and clinical data which achieved us nine FDA clearances, which is pretty unique in our industry.

We invested significant amount of the $50 million that we raised in the IPO on the Tel Aviv Stock Exchange in investing in clinical data because we thought it was important to prove the efficacy of this unique technology. Because we've done all that, we have all the support from the key opinion leaders, both dermatologists and plastic surgeons, that they do a peer to peer sell. You get the top of the top of the derms and the plastic behind you and behind the technology, it's much easier to sell it forward to the rest of the group. We have an in house digital team and this is one of our core competencies. We took upon ourselves to build a brand and to create a brand awareness from the consumer, from the patient up to the clinics. We do it with an in house digital team.

We invest significantly in digital media. I'll talk about the business model in a few slides and you will see that you create economy that works as a partnership between us and the physician. I'll talk more about it when we get to the way we actually sell the device. This is a quick overview of our FDA clearances. We have nine of them. We have area from lifting around the cheek, around the neck. The neck is actually a very difficult area to treat. Nobody want to do ablative or minimally invasive or microneedling on the neck. It's not safe and the efficacy is not necessarily there. We get great results on the neck again with one treatment, completely safely and no downtime. We have physicians who bought the device just for the neck.

It just makes sense as a business to buy it even just for the neck. In addition, for the neck we have a clearance for eyebrow lift. As I mentioned, we also move to the body with clearances for cellulite treatment and for arm lift, which are key and very important for the GLP-1 patient. The go to market and the way we sell the device is we like to call it the frictionless sales model. We do sell a box, a capital equipment to a physician, but we sell the box. The MSRP here in the US is $115,000. The device comes with preloaded 3,000, what we call pulses. It is 3,000 clicks on the applicators that are enough for about 10-15 treatments.

After the initial 10 to 15 treatments, the physician, the clinician need to come back to our website and buy additional pulses, additional clicks of ultrasound on the applicator. Cost of pulse is $1.50. A treatment is on average between 100-250 pulses. Depends on the area that you treat and the severity of the laxity. As you can see, we take a small portion of every treatment and in a very short period of time we built a company that 40% of our revenue are not coming from moving boxes. 40% of our revenue last year, which was over $23 million, came from these pulses, from these treatments that we are selling. More than that, this is a completely virtual consumable. There is no cost of good. 40% of our revenue came from recurring revenue, not from moving boxes.

They came at 100% gross margin. I will talk about our favorable gross margin in the following slides. What we also did, and this is based on a lot of experience and the people behind the company knowing the space very well, we created something that will work in terms of the ROI for the physician very, very well. We talked about the price of the device, which is relatively comfortable at around $115,000 MSRP. A clinic in the US on average can charge $3,000 per treatment. That means that if a clinic does two treatments a week and charges $3,000 and it's a single treatment, as I said, it's short, not a lot of overhead, 30 to 45 minutes. There is no downtime, there is high customer patient satisfaction. They can return their investment on the equipment within four to six months, which is unheard of.

It's usually a year or two years and sometimes even more. We have a consumable, we enjoy from this usage of the device, but on the other end it's a partnership with the physician. We made sure when we build the business model that they return their investment relatively quickly. What we did here on this slide, we looked at everybody about the devices, our devices in the US in the last 12 months. This is every state where we have an install base of greater than two systems. We see that everywhere in the country. Either it's California or Florida or New York or even if we go to the Midwest, when we go to Kansas City and to Iowa or to Wyoming, we see that the ROI in the first 12 months is at 100%, 100%, 200%, 300%.

It goes back to the four- to six-month return on investment. This is the key of our business model and this is a partnership that we are creating. We do not just sell one device, we move one box and we go to the next customer. We create an ongoing partnership, win-win partnership with the physician. They buy the capital equipment. We invest a significant portion of our revenue in brand awareness, digital marketing. Patients are calling, the phone is ringing at the clinic office, patients are coming in, they do the treatment, they get great results, they come back, they bring their friends, the customer buys additional pulses. We invest more in brand awareness. This is the perpetual da Vinci machine. It is an ongoing relationship with the customer. It is not one and done.

This is the strength and the big differentiator in our business model comparing to other players in the field. This is a quick overview of what we do on digital media because it is a key in our marketing strategy and we see that it works very nicely. We have over a million followers on social media. We see 115% growth year over year in monthly visitors to our website and we get a lot of traction. Again, this is part of our strategy to build the brand awareness from the patient level all the way up to the physician. This is actually a cool little story that I am happy to tell in length on one on one meetings. I am not going to tell the full story here, but both Kim and Khloe Kardashian posted an unpaid endorsement on Instagram for Sofwave.

They've tried the device on a few different occasions. They loved it. They tried it again and again and eventually, completely unpaid for, agreed to post a couple of stories. They did one in February. I think they did another one in April. That created a lot of buzz. When Kim and Khloe Kardashian post something on Instagram, there's tons of buzz. We saw the engagement rate online on social media increase to 6.5%. Usually, we see 1.5% to 2%. We see the visitors on the website continue to grow. That was just a very nice endorsement by one of the top influencers in the world. Going back to where we sell, we sell globally in over 40 countries. Here in the US, we sell directly to the physician with a capital sales team of approximately 30 people.

In addition to the capital sales people, we have six PDM practice development managers. Their goal is to make sure that once we sell the box, the physician is successful in launching the device and then increasing the utilization of the device. Again, we do not just sell a box and move on to the next customer. We sell a box and then we start a partnership to make sure that the launch is successful and make sure that the utilization of the device increases every utilization. More pulses, more pulses, more recurring revenue for us. In terms of product newness, you can see the device here. This is the box that comes with the basic, what we call Lift Applicator. The Lift Applicator with the seven ultrasound drop transducer.

We also launched a smaller applicator with only three transducers that is more convenient, comfortable, and efficacious for smaller areas around the eyes and around the lips. All our devices are Wi-Fi enabled, meaning that the clinicians, the physicians, can buy pulses directly from the device and we have online access to the device. We know how many pulses were used, how often the pulses are being purchased on the specific device. That is a lot of data that we have regarding the utilization of the device. We continue to expand our FDA clearances. We got an indication for arm lift, we got an indication for acne scars, and we just launched a few months ago here in the US what we call the Lift HD applicator. It is a similar seven transducer applicator, but it is double width.

Every transducer is double the width and that's important for body treatment because people love to use the technology on the face and the neck and they also like to use it on the body. It is a slower and less effective treatment when you use the regular applicator on the body. We listen to the market and we are just launching this double width body applicator that will make it much easier for the physician and for the patient to do body treatments, whether it's on the arm, on the belly, cellulite. In terms of innovation, we launched last year an EMS electric muscle stimulation device. This is a 4th-generation EMS device, completely wireless that can treat up to 16 different muscle groups at the same time to emulate a complete gym 30 minute exercise by just lying down on the clinic's bed.

What is nice about it, this is a module, this is an add-on to the Sofwave ultrasound technology. Why is that important? It goes back to the GLP-1 story. GLP-1 patients that lose weight quickly and effectively and safely, they get loss of volume on the face, loose skin, a lot of wrinkles, which is everything that we treat with our ultrasound technology. They also lose muscle weight, muscle waste, muscle mass, which is a very important factor that they do not always pay attention to. Therefore, the first thing that GLP-1 patients need when it comes to aesthetic is, first of all, to treat the loose skin, which we do with the ultrasound device. Second of all, we need a solution to stress and bring back the muscle tone.

We provide the full package for every clinic that want to prescribe GLP-1 and have now patients who need the aesthetic treatment by providing skin laxity treatment, skin wrinkling treatment, together with muscle toning. In terms of our financials, we just reported our first quarter 2025 result. We finished the first quarter with $16.7 million. That represented a 25% increase comparing to the first quarter of 2024. The recurring revenue was $7 million. They grew 49%. I'm very happy to report that also the capital sales equipment did grow up 14% as well. That created an overall growth of 26%. If we look at the annual growth on the right hand side, what's nice to see about it, first of all we see how we grew from $4 million in 2020 to almost $60 million in 2024.

We see the blue portion of the bias, the blue portion of the gap keep growing and this is the recurring revenue. It goes back to the uniqueness of the business model of selling capital equipment. 40% is coming from actually utilizing and using the devices. That is a big deal in terms of our quarterly revenue growth. When you go back and look at quarter over quarter, quarter after quarter, all the way from 2020 to 2025, we see a nice steady growth. I'll talk a little bit about the geographical split and where we do business. Approximately 60% of the business is coming here in North America where we sell direct with a direct sales team, as I said. Right behind it we have Asia Pacific with approximately 30% of the revenue. Asia Pacific is a significant growth driver in our business.

We were very proud to announce a couple of months ago in April that we received the Japanese FDA clearance. That was a long process, but we can now sell our devices in Japan as well. We already have an established distributor in Japan, and we are working on launching it as we speak. The Japanese aesthetic market is considered to be one of the biggest ones in the world, and this is a market that we are going to start selling in now. In addition to that, there is another large opportunity that we currently do not sell in, and this is China.

A couple of years ago we signed a collaboration and distribution agreement with HTDK, that's a Chinese company, wholly owned subsidiary of Riverpig Cosmetics, that are taking the device all the way from the regulatory process all the way to eventually market and launch it in China. The regulatory process in China is a little bit longer. It's not an immediate opportunity, it's not a 2025 opportunity, and it's a little bit more of a complex process. The opportunity in China is significant. There are many data points showing that in the next few years the Chinese aesthetic market is going to be as large as the U.S. market. This can be a significant inflection point. Again, it's a longer term and it's more risky because of the nature of the regulatory environment in China.

That is another major opportunity that is currently not in our numbers in terms of our quarterly operating loss and I am very happy to even say operating income. This is on a non-IFRS basis, full disclosure excluding stock-based compensation and some one-time trademark litigation expenses that we had last year. As we can see, the trajectory is very positive. The arrows are pointing in the right direction. We actually generated an operating profit of $1,500,000 in the fourth quarter of 2024. The reason that you see the graph going up and down a little bit, for those of you who do not know the space, there is a seasonality built in in our business. Usually Q1 and Q3 are a little bit weaker. Q2 and more specifically Q4 are a little bit stronger.

That's why you see this graph going up and down. Eventually the trajectory is very, very positive. When we look at our P&L, this is the first quarter. First of all, we discussed the growth in revenue. Second of all, I would like to spend a minute or two on our gross margin. We have a very healthy gross margin of about 76-77% and it's a combination of a good gross margin that we have on the capital equipment but also 100% gross margin that we have on the consumables. That creates a very healthy business with a 76-77% gross margin and improving. We see that we continue to invest heavily in R&D and the sales and marketing. The R&D investments are important for us.

We want to continue to bring new technologies and new applicators and new indications all the time. We see that we narrow our losses quite significantly. As I showed you in the previous slide, in terms of the balance sheet, we had $20.4 million of cash and short term deposits as of the end of March. We narrow our cash burn. We actually generated cash in the third and the fourth quarter of last year. We were almost cash flow break even in Q1 as well. You know, Q1 is a little bit slower quarter in the market. You know, excluding the payments regarding the litigations, the litigation expenses that I discussed before, we narrowed our cash burn quite significantly in the first quarter of 2025 as well.

To summarize, we are delivering the next generation patented energy-based non-invasive ultrasound technology that is disrupting a market and an industry with outdated solutions. Solutions that have significant downtime or do not have any efficacy. We have rapid industry adoption. We achieved 26% growth in the first quarter. We have a lean infrastructure in place. We are only 130 employees. We manufacture in Israel, company is based in Israel. We are very well staged for continued growth and we have the infrastructure in place for that. We have a broad range of FDA clearances, lifting, laxity, wrinkle treatment, all the things that go back to the growing demand in the general market and more specifically for the GLP-1 patients, significant recurring revenue of over 40%. We estimate that we performed over 500,000 treatments since we started to sell the device.

We know exactly how many pulses we distributed to the different devices, so we can estimate the number of treatments and over 500,000 treatments already were performed based on our estimation. We have a significant brand awareness and a digital marketing business model with over 1,000,000 followers on the different social medias. That's it. Happy to answer any questions if there are any, please.

You mentioned that in the U.S. do you sell directly to the end users? Do you sell through distributors as well and which contributes greater in the U.S.?

No, when we go direct, we sell only through our direct sales team and we do not mix the distributor together with our direct sales team. Here in the U.S. it's only with approximately 30 capital equipment sales reps and the practice development managers, and we plan actually to grow it.

We think that we need more feet on the street and we see the demand, we see the brand awareness growing and we think that we will need more people in 2025, at least on the street.

You're selling directly to dermatologists as well as metastatics, please.

The core physicians are the dermatologists and the plastic surgeons, but there are many other physicians who do aesthetic treatments. Beside the physicians themselves, there are all the medical spas, which is a huge market. We feel that we are relatively at the beginning, we're still just tapping the market and opportunity. Most of our sales are to dermatologists and plastic surgeons, but the medical spas are actually another excellent future growth opportunity for us. All right, thank you very much everybody.

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