Sanuwave: Questions to Morgan Frank | Value Bridge
Archieve - Everything Morgan Frank Said
Business Summary
SANUWAVE is a wound care company built around UltraMIST, a portable, FDA-cleared device with razor-and-blade economics. The system lists at $35,000 and each treatment consumes a single-use applicator priced at about $100, with reimbursement averaging $420 per session. In 2024, SANUWAVE generated $32.6 million in revenue, up 60%, with operating income of $5.4 million and adjusted EBITDA of $7.2 million. Q4 2024 gross margin reached 77.9%, compared to 58% a year earlier, reflecting manufacturing scale. The company exited 2024 with 1,047 systems in the field, including 374 sold that year, and under 1% U.S. market penetration. Guidance for 2025 calls for $48–50 million revenue (47–53% growth). Consumables represent 55–65% of revenue and drive recurring sales. Debt stood at about $27 million, with refinancing underway to lower costs and a stated goal to retire it fully within 18–24 months from operating cash flow. The company holds 140 patents covering ultrasound and shockwave technologies and has monetization agreements providing upfront cash and potential revenue share.
Catalysts & Milestones
2022 - Recapitalization led by Manchester Explorer Fund; governance and board strengthened
2023 - Returned to profitability; achieved OTCQB relisting; doubled production capacity to 100 units/month
2024 - Revenue of $32.6M, up 60%; gross margin reached 77.9%; 1,047 UltraMIST systems in field
2025 - Second-source applicator manufacturing operational in Q2; guidance of $48–50M revenue (47–53% growth)
2026 - Applicator redesign expected to add 350–400 bps gross margin improvement
Investment Highlights
Revenue grew 60% in 2024 to $32.6M, with operating income of $5.4M
Gross margin reached 77.9% in Q4 2024, up from 58% prior year
Consumables contribute 55–65% of revenue, driving high recurring sales
Installed base of 1,047 systems with under 1% market penetration
2025 revenue guidance of $48–50M, up 47–53% year over year
Future Growth Drivers
Expansion of sales force beyond 13 reps with full U.S. coverage
Applicator redesign to boost margins by 350–400 bps starting 2026
Penetration of nursing homes, skilled nursing, and mobile wound care providers
Reimbursement expansion across five places of service including home health
Clinical data moat from studies and real-world outcomes supporting adoption
Risk Factors
Carrying $27M term debt; refinancing still in process
Reimbursement risk from CMS code changes despite recent increases
Revenue concentrated in UltraMIST, now 99% of total sales
Customer acquisition cost of 10–15% of sales may weigh on scaling
Manufacturing redesign execution risk with phased margin benefits in 2026
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Capital Allocation
17/04/2025 How are you addressing debt and the IP settlement?
Debt is the one remnant of SANUWAVE’s messy past. We reduced it through a note exchange but still carry some balance. Our plan is to continue paying it down from operating cash flow. We are evaluating whether refinancing could create flexibility, but our overarching focus is de-leveraging steadily while growing profitably.
On intellectual property, we reached a settlement that protects our portfolio and reduces litigation risk. I cannot disclose every detail, but it eliminates an overhang and allows us to focus resources on expanding Ultramist rather than legal disputes. Together, debt reduction and IP resolution put us in a stronger position to be valued on the merits of our business rather than legacy issues.
17/04/2025 What is your plan for refinancing and paying down debt?
We currently have about $27 million of term debt. It was incurred when the company’s footing was weaker, so rates are high. With Q3 and Q4 results showing clear improvement in EBITDA and operating margins, we can now sit down with stronger lenders and refinance at lower rates. Our goal is to pay the debt off fully within 18–24 months from operating cash flow.
We also have a partnership with a large intellectual property assertion firm involving legacy shockwave patents in cardiovascular applications. They already paid us $2.5 million for an option. If they exercise it, we receive a mid–single-digit millions cash payment, which we will immediately use to pay down debt. If their assertion is successful, we share in the proceeds. Importantly, we no longer need cash to run operations, so every dollar received can go toward stripping down the capital structure. Ultimately, I want a simple structure—around 8.6 million basic shares, no debt, and more than $200 million of net operating loss carry-forwards, ensuring no taxes for some time. That would make adjusted EBITDA and cash flow converge closely.
09/05/2025 What are you seeing regarding debt and refinancing opportunities?
Our debt is not cheap, and we are looking at refinancing opportunities. It is premature to say anything definitive, but this is a top priority. We are exploring a number of options and feel good about the likelihood of improving our interest rate.
08/08/2025 Any update on refinancing the senior secured debt?
We viewed refinancing primarily as a cost of capital decision, weighing debt versus equity. After running an internal process, we received several attractive term sheets and have chosen one. We are now working to close it. While I cannot yet name the counterparty, we believe the lender and terms will be viewed favorably, representing a significant improvement over our existing facility.
Competitive Advantage
15/11/2022 How strong is the company’s IP, and what is your strategy for possible infringements?
We are very fortunate to have a strong patent portfolio. Our science team and the Ultramist predecessor team did a very good job ensuring use cases are covered, with over 50 patents currently issued or pending.
There are certain verticals where we believe companies may be infringing on patents—either published but not yet issued, or already issued. We were first on this technology, so it is foundational, and others may be in violation.
Our approach is to communicate effectively with those parties and always seek a peaceful resolution. While I don’t have anything to report today on monetization, that is the path we follow. We prefer friendly resolution but are prepared to act aggressively if needed.
22/03/2024 Status of patents and Shockwave discussions?
As you saw in our 8-K, we announced an intellectual property deal earlier this month. There is not much detail I can provide in this forum, but it is fair to assume SANUWAVE remains very aware of the value of its intellectual property portfolio and continues to look for ways to realize it.
17/04/2025 How does SANUWAVE’s product demonstrate value to patients, physicians, and payers?
It works through what I call a virtuous cycle: evidence drives reimbursement, which drives usage, which leads to better outcomes and more evidence. At the end of the day, there are three constituents—the patient, the physician, and the payer. The payer wants proof that a treatment improves outcomes and lowers costs. A Mayo Clinic study on deep tissue injuries in ICU patients is a good example. These injuries are common in immobile patients and can progress into severe wounds. In a two-arm study, patients treated with standard of care saw 70% progress to Wagner stage four or beyond, meaning full thickness wounds exposing bone, muscle, or tendons—serious injuries that often require surgery and risk loss of limb or life.
In contrast, 80% of patients treated with Ultramist resolved at stage two or less, essentially a partial thickness wound similar to a bed sore. When the difference is between 80% bed sore versus 70% bone-deep, it is a clear outcome improvement. That result was a key driver in Ultramist becoming standard of care at Mayo Clinic.
17/04/2025 How long does your IP protection last, and where do you see SANUWAVE in 2–5 years?
Our intellectual property portfolio is rolling. Some patents date back years, while others—especially broad application and technology patents around Ultramist—were issued recently and have nearly full terms remaining. We continuously add new filings to extend protection. Looking forward, we are actively considering what Ultramist 2.0 will look like. It will focus on making the product easier and stickier for clinicians, more effective for wound care, and, critically, able to generate large volumes of high-quality clinical data.
That data moat is the strongest long-term defense. As adoption grows, more data accumulates, and the product becomes the standard of care. In two years, I expect SANUWAVE to be a debt-free, profitable, cash-generating leader in wound care with broader market penetration. In five years, I want us to be positioned as the dominant evidence-based solution, protected by both IP and data scale. The business evolution has been three acts so far: 2023 was digging the car out of the mud, 2024 was rebuilding it, and now in 2025 we are taking it out on the track. For the first time, we have the luxury to ask: where do we want to take it? That’s the exciting part of the next stage.
09/05/2025 Any developments on patent assertion agreements or related legal actions?
We entered into an intellectual property assertion agreement with an outside firm last year. They paid us $2.5 million for an option to pay a mid-single-digit million amount, take the patents into a special purpose vehicle, and begin assertion. If successful, we share profits on the back end.
Details of the process are private and outside of our control, but we are pleased with our partner and think they are making good progress. I cannot provide more specifics at this time.
08/08/2025 Can you discuss the value and scope of your 140 patents?
SANUWAVE holds a large patent portfolio covering shockwave and ultrasound technologies. Some patents provide core protection for our operations, while others support extensions of what we can do with the UltraMIST platform. In the past we have monetized certain patents, including a relationship with a partner interested in applying our shockwave patents to vascular conditions.
Last year that partner paid us $2.5 million for an option to pay a mid-single-digit million fee to assert selected patents, with a revenue share on collections. We also receive periodic interest in licensing or acquiring patents. While I cannot share further concrete details at this time, the portfolio represents a strong foundation and potential source of value beyond core operations.
Competition
15/11/2022 How does Ultramist compare to negative pressure wound therapy, how do you view the need for a complete product line, and what are your plans for inpatient vs. outpatient/nursing home markets?
Negative pressure came on the market around 1998 with Kinetic Concepts, KCI, and it grew from zero to $4–5 billion as a category. It took time because physicians were asking, “What am I doing putting a vacuum cleaner on a wound?” But it became the standard of care. Unfortunately, as wound care claims grew, CMS pushed down pricing, and reimbursement for negative pressure has been impacted dramatically. In some cases, it’s no longer profitable for wound care centers to operate them. It remains a wonderful product clinically, but financially it’s become a burden.
To be successful, we always talk about the three P’s: payers must be happy because they’re not overpaying; physicians must be happy because it’s clinically efficient and they can make money; and patients must be happy because their wounds are healing. With negative pressure, physicians have struggled financially, and payers have squeezed them. It is still widely used in surgical/post-surgical settings.
For Ultramist, we have the three P’s. Clinically it is excellent, so patients are happy. Reimbursement at $450–520 per treatment is fantastic, making it likely the highest gross margin product wound care practices use. Payers are happy because it falls under the price umbrella of other modalities like skin substitutes and hyperbaric therapy. Overall, it’s a winning combination. We also have a head-to-head study coming out in early Q1 that compares Ultramist to negative pressure, showing the savings generated when shifting to Ultramist. We’ll use that to drive adoption among commercial payers who have not yet come on board.
On inpatient vs. outpatient: during COVID, nursing home patients could not be transported to hospitals or outpatient centers, so treatment moved to the edge—in nursing homes and at home. This was new, but it worked. Now we see growth from providers treating patients directly in nursing homes, often 15 at a time, then moving on. This prevents bed sores, improves nursing home quality scores (and thus reimbursement), and is more efficient than transporting patients. Home care and nursing home wound care are trends we see continuing for years
On product line: currently we’re very happy with dermaPACE and Ultramist. We also have BroomShield in development, an ultrasound patch for use between visits. For now, our strategy is partnership rather than building a complete in-house product line. Combination therapy is becoming more common—physicians use Ultramist along with fish skin, amniotic tissue, or hydrogels. We also work with diagnostic providers to help shape protocols. So today, a complete standalone product line isn’t essential. In the future, it may be, but right now our focus is on supply and meeting demand.
17/04/2025 What does the competitive landscape in wound care look like?
The industry offers many modalities. Hyperbaric chambers were popular years ago but are less common now given the lengthy, specialized procedures and mixed efficacy. Negative pressure therapy shows some effect but requires patients to remain connected to devices for weeks or months, making it cumbersome. Skin substitutes are used often in conjunction with Ultramist, especially by mobile wound care providers. In practice, our biggest competition is traditional methods—antibacterials, antimicrobials, gels, salves, and bandages. That “this is how we’ve always done it” mindset dominates wound care today. Once clinicians see Ultramist’s mechanism and outcomes, it is compelling. With less than 1% market penetration, there is still enormous white space.
Financials
15/11/2022 Can you expand on operating expense reductions, gross margins and supply chain, and procedure volumes returning to normal levels?
On expenses: reductions came largely from eliminating consultants hired to help catch up filings when we were late. Those costs were high—legal, audit, consultants—and largely went away after we staffed up internally under our CFO. That saved about $1.4M per month. The manufacturing move from Georgia to Minnesota also reduced costs by consolidating teams and facilities. Sales efficiency has improved: a smaller team (from ~15–16 to 9) has been highly productive, driven by consumables and larger customers. Additional savings will come from automation projects. Cuts are made only when they don’t hurt sales. The biggest impact will show up in Q4, with some additional benefit flowing into Q1.
On supply chain: last year we were affected by labor shortages at suppliers and specific material shortages (e.g., Tyvek, saline). We were on allocation for applicator pouches, and some practices struggled to get saline. Those were external. Internal issues were resolved after the August capital raise, which allowed us to restart manufacturing for consoles, wands, and dermaPACE. Currently, no material supply chain issues, though inflation has raised costs.
On gross margin: Q3 margins were reported at 85%, up from 58% a year ago, but that included an inventory adjustment. Guidance remains at 75% going forward, with 9-month results at 77%, up 19% from the prior year.
On procedure volumes: underlying demand is strong—diabetes cases are rising, driving higher incidence of wounds. Nursing shortages are affecting some wound centers, but growth in skilled nursing facility and home-based care has offset this. Wound procedures are less deferrable than knee or hip replacements: untreated wounds risk infection and amputation, so care demand persists. Volumes at wound centers are back to pre-COVID levels, even though staffing remains tight.
12/05/2023 Were the higher professional service costs one-time?
Yes, they were largely one-time. During the quarter, we had several SEC initiatives, filed one assessment, and regained listing on the OTCQB. These unique events drove professional service costs, but we do not expect them to recur.
Overall, operating expenses have been increasing much slower, about 4.57%, compared to revenue. This demonstrates the effectiveness of our cost control initiatives that began last year.
08/11/2024 How many systems this quarter were from the new higher-margin manufacturing versus older sources?
Just a few at the end of the quarter, as the new manufacturers only came online near the end of Q3. We still had inventory from prior sources, so the margin impact was limited this quarter. In Q4, we expect to see another uptick in gross margin as cost of goods sold comes down on systems from the new contract manufacturers.
08/11/2024 When will the $26 million secured debt and $1.3 million note in default be resolved?
The $1.3 million note has already been repaid and is no longer an obligation. The default on the LH expansion debt was due to noncompliance with a $5 million minimum cash covenant, which has since been met. We are no longer in default or forbearance on any debt obligations.
17/04/2025 How would you describe SANUWAVE’s business model, growth, and financial performance?
It fits together into a very attractive model. We have high gross margins, 77.9% in Q4, with 55% to 65% of revenues coming from consumables. In 2024, we generated $32.6 million in revenue, up 60% year over year. Operating income was $5.4 million, and adjusted EBITDA was $7.2 million. While I know many dislike adjusted EBITDA, we use it because our capital structure caused significant non-cash charges. It helps clarify the company’s actual cash generation. For 2025, we guided revenue of $48 to $50 million, representing 47% to 53% growth. The opportunity is huge, with a $45 billion U.S. wound care market. The addressable base is broad: roughly 30,000 nursing and assisted living facilities, 15,000 skilled nursing facilities, more than 10,000 physician offices, 2,200 wound care centers, and many mobile providers treating patients at home.
CMS is also pushing a “care to the edge” initiative, shifting treatment from hospitals to where patients already are. This reduces strain on hospitals and leads to better outcomes. For elderly patients with compromised immunity, transporting them into hospitals often increases infection risk. Avoiding infections like methicillin-resistant staph in a diabetic foot ulcer can prevent costs of $500,000 to $900,000. Recently, CMS expanded reimbursement codes to include nursing homes, skilled nursing, assisted living, and patient homes, which has been a big driver. Our Ultramist system itself weighs just 7 pounds, is portable, and can be learned in 30 minutes by a physician, nurse, or physical therapist. Treatments take 3 to 20 minutes, average 6, and are effective in reducing wound size, speeding healing, easing pain, killing bacteria, reducing biofilms, and promoting blood flow and revascularization.
17/04/2025 How are sales, system adoption, and market penetration progressing?
Consumables continue to show steady growth, though with some seasonality. Q1 is always a step down from Q4 in wound care, and last year was also affected by a price hike. Still, Q4 2024 was a record quarter with $10.3 million in sales. We ended the year with 1,047 systems in the field, including 135 sold in Q4 and 374 sold across 2024. That means 36% of all Ultramist systems in use were sold in the last 12 months, yet we are still under 1% market penetration.
When I became CEO, SANUWAVE was a show-me story. Over the last 23 months, we focused on building trust by setting forecasts, delivering on them, and demonstrating profitability. We have now guided for six consecutive quarters and met or exceeded guidance every time. That consistency, along with growth in operating income and adjusted EBITDA, shows we can be profitable while scaling. Customers—especially large ones considering hundreds of systems—want to know we will be here long-term to supply applicators. Sustained profitability is the best way to prove that. For Q1 2025, we guided to $8.4 to $9.0 million in revenue and pre-announced that we will report between $9.1 and $9.3 million, above the range.
17/04/2025 What drove gross margin improvement to 77.9% in Q4, and how should investors view margins going forward?
System pricing in Q4 was consistent with Q3, so margin improvement was not price-driven. Instead, it came from lower manufacturing costs after standing up two new contract manufacturers in Q3. Q4 also had minimal non-recurring engineering (NRE) expense, giving a clean view of the new cost structure.
Margins may fluctuate slightly in 2025 as NRE related to new applicator lines runs through, depending on how much can be straight-lined versus expensed. Variability may be 100–150 basis points quarter to quarter. Sustained margins in the high 70s remain realistic, with Q4 serving as a representative baseline absent one-time items.
08/08/2025 How will the new applicator design impact gross margin and EBITDA leverage?
The purpose of the new applicator design is to increase capacity and reduce cost. We expect to pick up about 350 to 400 basis points of additional margin on applicators once the new design flows through. Because we carry roughly six months of applicator inventory, the benefit will phase in gradually, with the impact becoming visible in early 2026. We use blended cost as our cost basis, so improvements will show steadily over time.
Operations
15/11/2022 Are you current with all filings, and do you expect to remain current? How would you characterize staffing and ability to sell into demand?
On the filings, we’re current. We actually had the Q done really on time and early, and the team filed it yesterday. They’re already starting on the K today. We have a great finance and accounting team. Our goal when we brought on our CFO, Tony, was to have her staff up and get rid of the consultants. The people and talent she brought on are fantastic. Minnesota, especially Eden Prairie, has a lot of good medical device talent, so we’re finding a good team to come on board.
On the sales force: obviously, if you’re going to sell it, first you have to build it. Once we have more products flowing from manufacturing increases in Q1, that’s when we want to put more sales feet on the street. The balance of the next year is really about matching sales capacity to sell what we can make with manufacturing capacity to make what we can sell. These are like two pistons that have to work in synchrony—too much of one and not enough of the other creates problems.
There are also a lot of top-notch salespeople looking for jobs right now. Skin substitute players are seeing treatment counts per patient drop from 10 to 2, plus price caps and eligibility limits. Salespeople notice this fast, and when doctors say they can’t make money anymore, reps start looking for alternatives. That works in our favor, since many of the markets we want to enter aggressively are the same markets where salespeople are actively seeking new opportunities. To the extent we can hire those who know how to hit the ground running, this is an unusual opportunity, and we intend to take advantage of it.
03/04/2023 What will peak production look like in the next few quarters?
We’ve brought production back online after some delays, mainly from long lead items. Right now, we’re at about 40 new products per month, with plans to reach 100 by year-end. The ramp will double through the summer and reach that 100-unit pace in new production. Alongside this, we’re doing refurbishment to help fill gaps. On the applicator side, which generates over 50% of revenue, our partner has already expanded capacity and is running about 20% ahead of demand. They should be able to increase by another 70% to 80% by the end of the year, supporting a 100% production increase overall.
03/04/2023 What will production ramp look like at year-end and in six months?
We’re doubling from the beginning of the year, but the ramp is gradual. On the system side, it depends on employee ramp-up and inventory, which builds month by month. We expect 60–80 units per month by midsummer, then 100 per month by year-end, with average selling prices in the high 20s. That translates to about 500 devices for 2023 and over 1,200 next year. For single-use applicators, customers typically use two to four cases monthly, so with our installed base, we’ll need around 1,000 cases weekly, about 4,000 a month.
12/05/2023 Will supply constraints persist throughout the year, and which products are affected?
The supply constraints are primarily with UltraMIST. Its production line was inactive for a period and restarting took longer than expected to ensure consistent, high-quality output. We are close to the point where I am confident we will have the supply we need on a weekly basis, though we are not there yet.
I do not expect this to last a year. It appears we are nearing resolution. We are targeting more than 400 devices for the year, and our main focus is meeting demand across the full year.
10/11/2023 Will you bring device or applicator manufacturing in-house?
It is something we always consider, but we have no plans at this time. Standing up in-house manufacturing is a heavy lift, and our current partners can likely execute more efficiently and with better supply-chain access. If we were generating $200 million to $400 million in revenue, the equation might change, but I do not see that occurring in the next year or two.
22/03/2024 How can doctors get involved in trialing SANUWAVE products?
Contact information is available on our website. Tim Hendricks, our Head of Sales, would be glad to hear from anyone interested in trying the product. Doctors or partners can also reach us through our customer service department on our newly revamped website.
08/11/2024 Status of transition to new manufacturers for systems and disposables?
On the system side, we completed the transition to two new contract manufacturers and are now receiving about 25 to 30 systems per week, which is going well. On the applicator side, we are finalizing a redesign to eliminate a few ultraviolet steps in production. Once the design is complete, we will cut new, larger molds and expect a second source for applicators with the new design to be operational in Q2 2025. Our goal is to maintain multiple sourcing to avoid any single point of failure.
08/11/2024 What about the material weaknesses in internal controls noted in the 10-Q?
It is not uncommon for companies our size to have material weaknesses. We are addressing them by hiring a full-time employee dedicated to remediation, reporting directly to both our CFO and the board’s audit committee. These issues are well within our ability to fix and are actively being worked on.
08/11/2024 Are you conducting or planning new clinical or validation studies?
We already have strong data on UltraMist and a growing base of users with positive experiences. The focus now is on bolstering claims with real-world data, which insurers and CMS increasingly value. Several users have repositories of data and are eager to work with us, so we expect to compile results over the next year.
We are also evaluating prospective studies that could support new claims. There are a couple of areas under consideration that we believe could be managed efficiently and yield data highly beneficial to the company.
21/03/2025 Can you provide updates on confirmatory studies and new studies that could expand UltraMIST use cases?
Now that the company is on stronger financial footing, we can focus again on research. We have reengaged with key opinion leaders and researchers, and some of our customers have significant data repositories. At least one or two papers or posters are expected at SAWC this year, including an interesting new application of the product, though I do not want to preempt those announcements. Those will mostly be retrospective analyses, but we are also considering prospective studies.
Several past studies showed promising results but were underpowered. For example, in 2015 we had a split-thickness donor site study with only 27 patients that still hit statistical significance on time to reepithelialization and nearly hit significance on wound recurrence at 6 weeks. Standard of care showed a 45% recurrence rate, while UltraMIST was only 8%. That outcome was compelling despite a 0.6 p-value. Replicating with a larger study could confirm a meaningful benefit. Recurrence rates are a major cost driver and clinical concern in areas like diabetic foot ulcers, so further validation could be impactful. We expect to have concrete plans for new studies within the next quarter or two.
17/04/2025 How does Ultramist improve patient outcomes compared to traditional wound care?
The cost of care drops dramatically, and healing time falls from 16 weeks to 8.2 weeks. Patients want to get better, and they want wound care that is not miserable. Traditional methods like sharps debridement involve scraping necrotic tissue from wounds, which is painful. Ultramist provides non-contact, pain-free debridement with immediate pain reduction afterward, unlike most alternatives. Patients often ask when their next Ultramist session is scheduled, which is rare in wound care.
Physicians want their patients to heal, but they also need a viable business model. Ultramist is reimbursed under CPT code 97610. We are the only company with clinical evidence proving it can be billed for non-contact use, and the code itself names our product and its precursor. Reimbursement ranges from $400 to $700 per procedure, up from around $170 to $180 just a few years ago, with the nationwide average at about $420. A session lasts 3 to 20 minutes, averages 6 minutes, and can be performed by nurses, physical therapists, or doctors. Each procedure uses a consumable applicator with a $100 list price, while the system itself lists at $35,000. It takes about 85 procedures to pay off a system, and together these economics generate blended gross margins in the high 70s.
17/04/2025 How is SANUWAVE managing manufacturing and scaling production?
We outsource manufacturing. Two contract manufacturers build Ultramist systems, one builds applicators, and a second source is being added. All manufacturing is U.S.-based, and nearly all components are domestic. We use vertically integrated partners, so tariffs and trade issues have not materially affected us. In January, we began cutting steel for a new four-cavity applicator mold, which will simplify assembly by replacing UV cure adhesive steps. This should improve automation, reduce cost, and raise margins when live in Q4 2025.
As of last month, capacity was about 10,500 applicators per week, targeted to rise to 24,000 by year-end. On systems, we currently produce about 25 per week, with the ability to double within 60 days if needed. We stockpiled long-lead components, so we have ample inventory of systems and parts. Ultramist now represents 99% of revenue, as the older Dermapace and Profile shockwave products have essentially faded. This focus allows us to scale efficiently without foreseeable disruption.
17/04/2025 How do you ensure customers actively use Ultramist after purchase?
We have split our commercial team into sales and commercial operations, with the latter focused on driving utilization. We maintain steady engagement with customers through check-ins, sharing new research, and showing fresh applications. For example, if a poster is presented at a conference, we bring that insight back to customers to encourage adoption. Our operations team also reviews wound care billing codes at facilities, identifies patients who could benefit, and advises on use cases.
This approach has evolved into an ongoing education curriculum, helping customers understand where Ultramist fits best and where other modalities may be more suitable. By staying close to customers and continuously showing value, we maximize utilization. When we can sit down side by side with providers and review real cases, adoption and consumable usage naturally follow.
09/05/2025 What is the typical time from initial conversation to receiving a purchase order?
We see a wide range. Some inbound inquiries come directly to our corporate email, asking for a price quote, and those can close within a few days. Larger customers, where negotiations are more complex, often take much longer and are still ongoing.
Overall, timelines range anywhere from a couple of days to several months. As customers get bigger and the capital outlay grows, the time frames tend to stretch.
Growth
11/08/2023 Any comments on the dermaPACE product?
Thanks for the question. We are still actively selling dermaPACE units both domestically and internationally, as well as the Profile system that serves the orthopedic market in the U.S. It was not a focus on the conference call since it represents a relatively small portion of SANUWAVE’s revenue.
It is a product we hope to place renewed focus on in coming quarters. For now, we anticipate UltraMIST will remain more than 95% of SANUWAVE’s revenue in the near term.
13/08/2024 Can you provide actual numbers on UltraMIST or SANUWAVE units, new customers, and their impact on costs and returns?
The list price of an UltraMIST system is about $35,000. We are not capturing the full list price, but we are capturing much more than before. Our model is like razor-and-blade, where the real revenue comes from applicator sales tied to each procedure. We track this internally through what we call tax rate, which measures how many cases of 12 applicators a system uses per week. While we have not disclosed this number publicly, consumables revenue has been rising significantly each quarter and is the main driver of growth.
In terms of customer acquisition, we operate three channels. First, a direct sales force that has grown from two reps at the start of the year to nine now. Second, a group of 1099 distributors paid only on placed units. Third, our internal noncommissioned commercial sales operation, which acts as both business development and sales. Overall, the cost of acquisition is likely in the 10% to 15% range of sales, varying by channel.
08/11/2024 Of the 124 systems sold this quarter, how many went to large sophisticated customers versus small buyers?
It is difficult to break it down that way. We can say that a few new customers ramped aggressively in Q3, and between a couple of large customers they had a significant effect on the quarter. We try to avoid disclosing detailed data on which customers are buying how much.
08/11/2024 Why does international revenue appear sluggish compared to U.S. growth?
International sales are almost entirely tied to dermaPACE and Profile. Our primary focus remains UltraMist in the U.S., where the opportunity is much larger. Since UltraMist is not cleared in the EU, we do not plan to prioritize international expansion near term. We would rather focus on one market and succeed than split resources and underperform.
21/03/2025 How is the new head of sales changing strategy versus last year, and how is it going so far?
We started 2024 with two salespeople and ended the year with nine. We will likely end Q3 with about nine again, though three of them will be different from the group we had at the end of Q4. The change in strategy reflects a shift toward a deeper, more consultative sales approach, where we go beyond the easy economics and instead build long-term partnerships. We aim to be integrated into customers’ treatment plans, therapy protocols, and even patient enrollment guidelines.
This type of sale is more top-down and involves engaging larger customers. We restructured the sales force and leadership to reflect that, bringing in Tim Wern as our new head of sales. Tim was the number two under our Board member Jeff Blizzard when Jeff was Head of Sales at Aviomad, and together they grew that company from $50 million to $400 million. He comes highly recommended, and we are excited to see him and Jeff working together again.
21/03/2025 How would you characterize Q4 UltraMIST placements in terms of large enterprise orders versus small one- or two-unit orders, and what does that mean for 2025?
We sold a number of one- and two-unit systems in the quarter, and we were pleased to see many new customers. Some existing customers also expanded significantly, with one large customer ordering nearly 20 systems. So, it is a mix. For planning purposes, we assume ongoing smaller orders and steady uptake from existing customers, while treating larger potential deals as upside. It is still early in understanding how bigger customers will roll out, whether all at once or in stages, so detailed guidance is difficult at this point.
Internally, we are preparing to handle large opportunities by building inventory. We currently manufacture UltraMIST systems at about 25 per week and are working to double that on 60 days’ notice, which is the challenge I gave to our operations team. We are close to being able to achieve that.
21/03/2025 Can you manage large customer orders to avoid lumpy revenue in any given quarter?
If a customer wants systems in the field, that is our goal because systems in the field drive consumable sales and get more patients on care. We would prefer to deliver them earlier rather than later. When giving guidance, we focus on the base rate of business that we can rely on and do not build forecasts on the assumption of large one-time deals every quarter.
That said, when those opportunities arise, we want to be ready to move quickly and take advantage.
17/04/2025 How do you view SANUWAVE’s opportunity and market positioning today?
This is a very rare situation. In nearly 30 years, I have seldom found a market this large with so much white space. We are past the early hurdles, as the company is fully commercial and FDA cleared. The next hurdle in this industry is reimbursement, and SANUWAVE has nationwide CMS reimbursement at Schedule One. In fact, CMS rates were increased substantially a couple of years ago.
Wound care is a much larger market than most realize, at $45 billion in the US, and I believe that estimate is low. Medicine is shifting toward an evidence-based paradigm, restructuring reimbursement around efficacy and cost effectiveness. That dynamic plays to our strengths. We have a highly differentiated product, backed by an extensive intellectual property portfolio, and positioned well to benefit from these changes.
17/04/2025 Where is Ultramist gaining the most traction, and how do nursing homes benefit?
We are seeing strong adoption in nursing homes and skilled nursing facilities, where the fit is natural. Patients are already there, making it easy to deliver treatment three times a week, which is optimal early on. For nursing homes, patients who were previously expensive become profitable because diabetic and venous ulcer patients are reimbursed at higher rates, but their downstream costs are large. By treating wounds in-house, facilities avoid sending patients to hospitals, retain occupancy, and improve quality-of-life outcomes. Preventing bed sores also protects CMS quality scores, which affect reimbursement across the board.
17/04/2025 How is your sales model evolving as you scale, and what contributed to 2024 success?
We began 2024 with just two salespeople, primarily using a direct model with limited distributors. By year-end, we had nine salespeople and had shifted toward a consultative approach. This model focuses on building long-term partnerships rather than quick sales, and it requires a different type of salesperson—more experienced, senior, and used to selling high-ticket medical devices to CFOs, COOs, and CEOs rather than only therapy managers.
As SANUWAVE has grown, it has become easier to attract top talent. Joining us no longer feels like a risky career move but rather a chance to participate in a profitable, fast-growing company. We have been turning over parts of the sales team to align with this strategy. At the start of 2025, we hired a new head of sales, Tim, highly recommended and a protégé of our board member Jeff, who previously led sales at Abumed. Together they built that company from zero to $400 million in sales. We are excited to reunite that expertise and combine it with our chief commercial officer, Nancy Gilmore, whose market knowledge and organizational skills are central to prioritizing opportunities and structuring the sales process. This combination gives us confidence in scaling effectively.
17/04/2025 How are you expanding sales coverage and marketing to drive awareness?
We ended Q1 with nine salespeople, three of whom were new since Q4, and we plan to hire another three or four quickly. That will give us full national coverage for the first time. We are also launching a more structured marketing effort—attending conferences, symposia, and building visibility so Ultramist is better known. A key tipping point is shifting from sales calls that begin with “what is Ultramist?” to having real mindshare where people are already familiar or even referred by peers. We are also beginning to engage with larger, more sophisticated customers who could purchase several hundred systems. These sales have longer cycles, but our team now has the experience to manage them. Internally, we call this the “elephant list,” and we are learning how to close elephants.
17/04/2025 Why had Ultramist’s potential not been realized before SANUWAVE’s stewardship?
It is a complicated history. The product was originally developed by a company run by engineers. They built an excellent device but lacked reimbursement and capital, so traction was slow. They eventually ran into financial trouble and sold it. Successive owners were also thinly capitalized or distracted. Cellularity, one owner, focused its capital on early-stage biotech programs, leaving Ultramist as a back-burner asset. When SANUWAVE acquired it in August 2020, COVID made commercializing a new device extremely difficult.
Ironically, the pandemic helped. “Care to the edge” delivery models—treating patients where they are—gained traction out of necessity, and they proved to be better for patients, providers, and payers. Since SANUWAVE took over, reimbursement rates increased from about $120–$180 to an average of $420, and eligible places of service expanded to include nursing homes, assisted living facilities, and patient homes. These changes, combined with stable capital and focus, created an ecosystem where Ultramist could thrive.
09/05/2025 Can you quantify system placements across smaller and larger customers, and how that may look going forward?
Thanks, Carl. Good to catch up. That sounds simple but is actually complicated to delineate. For example, we have customers that are large chains of nursing homes or long-term care facilities, but each facility buys individually and makes its own decision. Whether you count those as a single large customer or many small ones changes the picture.
If we treat those chains as single entities, we had 58 new customers in Q1. Defining big versus small is tricky since some customers grow rapidly. A group that is at five or ten units now could reach 40 or 50 by year-end. It is more about our ability to grow with each customer than about labeling them large or small.
09/05/2025 Within the total addressable market, where are you seeing success, and what types of wounds is the product mainly used on?
We do not get clear visibility into patient-level data because of HIPAA rules. Providers hold the patient records, and we do not see details such as exact wound types. We talk with practitioners to understand how they are using the product and share insights across providers, but we cannot track the exact number of diabetic foot ulcers, venous leg ulcers, burns, or other wounds. All of it is billed under the same code, so that data is not accessible to us.
09/05/2025 With Tim joining, how is the sales strategy evolving compared to six months ago?
We are essentially continuing the strategy we developed in the latter half of last year, focusing on engaging larger customers at a higher level. We wanted senior, seasoned sales executives who are accustomed to selling in the more executive-facing parts of facilities. It has been interesting to see how people with strong medical device backgrounds, even if not wound care, bring a fresh approach. That has started to build real momentum.
The core strategy remains the same. We see strong opportunities with nursing homes and skilled nursing facilities that have their own clinical groups. At the same time, the mobile and home health care space is growing rapidly, and we are making strong outreach there, along with doctors’ offices and hospitals. At this stage, we estimate we are only at about 1% market penetration. The focus now is deciding what to prioritize and where to allocate resources.
08/08/2025 Do you expect to expand beyond 13 sales reps?
Right now the focus is on getting everyone fully trained and performing at a high level. The group feels qualitatively strong, with good collaboration and best practice sharing. We may add a few more reps this year and are considering whether sector-specific hires or regional managers make sense, as U.S. coverage still involves large territories. For now, we believe we have true national coverage, but modest expansion is likely.
08/08/2025 Which patient types or facilities are targeted in the October marketing program?
We are moving toward a “market of one” approach, tailoring marketing by wound type, patient type, and user type. This includes targeting mobile wound care providers, nursing homes, skilled nursing facilities, hospitals, podiatry practices, and wound care centers. The goal is to differentiate and tailor the offering so clinicians see how the product fits into their practice. Success depends on building trust and reaching critical usage levels so that the product becomes widely recognized and recommended across regions.
08/08/2025 How are you approaching large “elephant hunting” accounts with the new team?
We were recently added to the approved vendor list at one of the largest U.S. hospital chains, creating a significant opportunity. We are engaging with organizations that have several hundred locations. Our new key accounts representative joined in mid-July, so it is early, but momentum is building. Large accounts vary: some hinge on a single national decision maker, while others require winning site by site once approved. Penetrating these networks tends to reach a tipping point where the question shifts from “why should I use this?” to “why aren’t you using this yet?” We are working toward that critical mass.
Outlook & Guidance
16/08/2022 What is the plan to get back on OTCQB and eventually list on NASDAQ?
Great question. Let me first address OTC, then NASDAQ. We were moved to the OTC gray markets in September last year when we did not get our 10-Ks filed on time. Since then, we have caught up with filings and moved to the OTC Pink Sheets. The application to move to OTCQB has been started and could take anywhere from two to ten weeks. The group we’re working with expects it to be on the faster side. Once approved, we’ll inform investors. This will enable broader market maker participation, solicited bids, and smoother transactions for individual investors through more brokerage firms.
The next step is NASDAQ. We’re working with our investment adviser, Kestrel, and have made governance improvements, such as an independent Board and separating the CEO and Chairman roles. We added three new Board members in April and another as part of a recent transaction. Requirements include a track record of timely filings and certain balance sheet conditions. This likely won’t occur in 2022, but in early 2023. The recent raise requires us to achieve a NASDAQ listing, making the company investable for institutions. We now have the right team in place to build the accounting and finance function, stay timely with filings, and execute on this process.
16/08/2022 What would success and revenue growth look like for SANUWAVE in 2023?
The wound care market is undergoing significant change, and our product belongs in every wound care center treating chronic wounds. That represents billions of dollars in opportunity. As the saying goes, you eat an elephant one bite at a time. Our focus is execution—adding evaluations, placing devices, ensuring usage, and penetrating markets. The goal is to heal wounds, save lives, generate economic returns for centers, and deliver cost savings for payers.
We offer a unique situation: physicians can earn more using our product while payers save money and wounds heal faster. The only constraint is resources to build out effectively. With the recent capital raise, we can scale supply chain, hire the right sales team, and expand clinical work to target private payers more aggressively. These are the initiatives we are pursuing to ensure success in 2023.
15/11/2022 Looking a year out, what would success look like? What are the hurdles for DermaPACE reimbursement and revenue, how will the revenue mix split between Ultramist and DermaPACE, and what about international growth?
Ultramist is a wonderful product with fantastic reimbursement today. Clinically it is strong, it’s lightweight and mobile, and it’s the easiest success path for our sales team. Patients are happy, physicians earn money, and payers save money relative to other therapies. That’s the winning combination, and Ultramist is the lead dog right now. It’s only eight pounds, so nurses can easily bring it into nursing homes, which makes it even more compelling. Ultramist will continue to be the driving force.
DermaPACE will also grow next year. We got our first product ramp in October. When you move manufacturing facilities, you must go through recertification, which stalled DermaPACE this year, but it is back on track. We’ll have more supply at year-end and then a very consistent flow starting January. The move was not only for cost savings but also to get all talent under one roof. That purpose has been achieved, and supply will be stable going forward.
Internationally, we see large opportunities in both new and existing markets. Our South Korean partners just received reimbursement, so we expect a sizable ramp there. In Brazil, the partnership is having tremendous success and should contribute over $1 million next year, if not more. Italy and Europe are performing well, and the Middle East is also showing strong progress. Now that we can ship again after completing the facility move, the focus is on ramping those markets.
15/11/2022 How are you approaching high-utilization accounts and best practices for consumables? What would you deem success a year from now?
We are making a concerted effort as we put product in the field to focus on accounts with high attach rates—those using a lot of consumables. We have an average of a little over 26 per month being used, but some accounts are using over 100. A lot of mobile wound care providers are going through very high numbers of applicators.
It’s a matter of serving more accounts like that and spreading best practices to existing ones so they get more use out of the devices they already have. On success a year from now, it’s premature to provide guidance, but we can point to console production increasing from 240 to 600 units and applicator production from 5,400 per week to 24,000 per week. That should give some indication of what we are preparing to address.
12/05/2023 Can you expand on reimbursement across different places of service?
In my experience, a strong device reimbursement spans multiple places of service, such as hospitals and other settings. UltraMIST has reimbursement in hospitals, including wound care and inpatient, and also strong reimbursement in private offices through Medicare at Place of Service 11.
Our fastest-growing channels are Home Health, where mobile practices treat patients in their homes (Place of Service 12), assisted living facilities (Place of Service 13), and nursing homes, which are quickly becoming our top channel. The results go beyond reimbursement to include benefits for chronic wounds and deep tissue injuries. Having reimbursement in five places of service gives us multiple dynamic channels to pursue.
12/05/2023 Should investors assume breakeven or profitability going forward?
Our goal this year is profitable growth, as we cannot rely on returning to the markets. Breakeven is about $1.8 million per month with 75% gross margins. That equates to roughly 25 systems, plus or minus, and we are tracking close to that.
Once supply is resolved, demand will not be an issue. We have a backlog of customers waiting for product, so we expect to cross into profitability once supply constraints are fixed.
10/11/2023 What is the current state of dermaPACE and outlook going forward?
Our dermaPACE business was slower in Q3, and we are reassessing its direction. We are reviewing international channels to determine which are most likely to deliver results, as well as two U.S. channels, particularly in cash-pay applications that do not require extensive studies and reimbursement work.
We are also considering participation in longer-term studies that could generate data to support attractive reimbursement opportunities. Products without nationwide codes are always more challenging, so we are weighing immediate versus long-term opportunities. While the update may sound vague, we expect to provide more concrete plans within a quarter.
10/11/2023 Can you update on merger approval, timing of the vote, and any hurdles?
We filed our amended S-4 last Friday in response to SEC comments on the first draft, so the process is now back in their court. We expect another round of comments, which is typical, and assuming those are straightforward, we are aiming to close the deal this year. Of course, some factors are outside our control, which limits predictability.
On closing conditions, we are in good shape on our side. The main remaining items are the shareholder votes, the SPAC public warrant exchange, and financing. We are targeting $13 million of capital in the deal and currently have approximately $9 million committed before formally raising the rest. I believe we are within striking distance and will push to close the deal this year.
10/11/2023 Are you concerned about shareholder support for the merger vote?
I do not believe so. Their holders appear supportive, our holders appear supportive, and I see no indication that either side does not want to proceed.
10/11/2023 What is your production capacity outlook for devices and applicators?
We have reached a weekly double-digit cadence on system production, which puts us in good shape for the next quarter. Looking into 2024, we expect system capacity to be two to three times higher than in 2023. On applicators, which are critical to the company, demand will require meaningful expansion next year.
We are pursuing a minor redesign to make applicators more manufacturable, which should free capacity by simplifying assembly. With Andrew Walco leading efforts, we have made strong progress on both systems and applicators. I am confident in our ability to expand capacity significantly next year.
22/03/2024 When should investors expect the exchange listing to be completed?
If all these matters were within our control, I could give a time frame. Now that we have our financials, we are capable of finalizing pro formas and filings. However, the completion of an exchange listing depends on external groups and factors outside our control. Our hope is that it will not be long, but I hesitate to provide a precise timeline since the process remains somewhat opaque.
22/03/2024 Is a legal matter delaying the merger?
No, it is not a legal matter. The timing is tied to completing pro formas, SEC filings, and the finalization of the exchange listing.
13/08/2024 How are you generating more sales, and will publicity help given the low share price?
Our focus has been on first cleaning up the capital structure so investors can properly value the business on its fundamentals. The current note and warrant structure makes it difficult to assess the true share count and market cap. Once those fundamentals are clear, we believe the story will stand out.
At present, many investors avoid a stock priced at fractions of a cent. This is why we are working to bring the stock price to a more respectable integer level. With my 30 years of capital markets experience, I believe that once the stock is positioned more appropriately, we will be able to expand outreach and gain far more attention from The Street.
08/11/2024 Should we expect margin step-ups on systems in Q4 and on applicators in 2025?
Correct.
08/11/2024 What are you seeing in the new customer pipeline?
The top of the funnel is the best we have ever seen, though it looks different than before. These are larger, more sophisticated customers who could become much bigger buyers. Their decision process is slower because buying 100 systems is very different from buying two. We are still learning what it takes to move them through the funnel, but we are excited. Over the next several quarters, it feels like we could be turning a corner.
08/11/2024 Outlook for operating expenses and salesforce size next year?
We started the year with three salespeople and, despite some turnover, now have nine. We expect to be at 11 by mid-month, which gives us traction, particularly with larger customers. Headcount increases do add to operating expenses, but not proportionally. Q3 included some expenses tied to the October transaction and nonrecurring engineering costs for new production lines. Despite headcount growth, operating expenses in Q4 should be roughly flat with Q3, with modest growth across 2025. Swing factors include weather and potential additional clinical studies. Overall, using the Q4 dollar level as a base is reasonable.
08/11/2024 How soon do you expect to be cash flow positive, and will more debt be needed?
The company was cash generative in Q3. We have not issued formal guidance, but based on what we have said regarding operating expenses and revenue expectations for Q4, investors can do reasonable math from there.
17/04/2025 Where do you want SANUWAVE to be in five years?
We are entering the next stage of our corporate cycle. In five years, I would like Ultramist to be so embedded in the wound care lexicon that “I misted it” becomes a verb. I want it to be universally understood as standard of care. That is the vision—broad adoption and recognition at scale.
17/04/2025 What is the incremental contribution margin on growth, and how much revenue drops to the bottom line as you scale?
This is one of the strengths of our capital-light model. Once the new applicator design is in production, we expect gross margins to improve by another three to four points, potentially moving into the 80% range. At that point, after paying commissions and operating expenses, there is no reason we should not sustain dropping roughly 50 cents of every incremental revenue dollar to operating income. That kind of leverage can move the needle meaningfully as we continue growing. Our large net operating loss carry-forwards also mean we will not be paying taxes for years, further enhancing cash conversion.
09/05/2025 Any upcoming conferences or events we should expect in the next few months?
We are starting to consider additional conferences and non-deal roadshow activities for later in the year, but nothing is definitively set at this time. We will provide updates as those plans evolve.
Risks & Macro
17/04/2025 How exposed are you to CMS reimbursement changes, and how do you protect against that risk?
Anything reimbursed by CMS can always change, but the last major move on our code was upward. Annual adjustments are usually small percentage tweaks applied broadly. The best way to protect reimbursement is to prove the product works. CMS wants to know whether it is effective and cost efficient. Now that we are well funded and stable, we are partnering with sophisticated users to gather data, publish papers, and present at conferences. For example, we will present posters at SAWC at the end of this month. We are also exploring new indications, one of which represents a potential $2 billion opportunity. Some may require modest clinical work, but nothing difficult.
Another safeguard is to prevent code abuse. Our code is narrow, specific, and not widely applicable to other devices, which makes it easier to police. When others try to use it inappropriately, we can push back. By keeping the code clean and continuing to show strong value for money, we strengthen our case for reimbursement stability. That approach has already delivered pricing increases and place-of-service expansions, though with CMS there can never be 100% certainty.
Personal Questions
17/04/2025 Can you walk us through early career experiences and how you became CEO of SANUWAVE?
Sure. My business partner, Jeb Basser, and I founded Manchester Explorer Fund in 2004. We have run it together for 22 years as a highly concentrated activist fund specializing in life sciences. We typically take between 10% and 40% positions in the companies we back, acting as long-term, hands-on investors, though not usually this hands-on. Our fund led SANUWAVE’s recapitalization in August 2022, and I became chairman then. By early 2023, the board and I began discussing the need for a leadership change, and in May 2023, I stepped in as CEO.
It has now been 23 months. From the start, it felt like a complete renovation of the business. We rebuilt the company almost from the ground up, with about 70% of employees new since I started. The goal was to make the company operationally effective, capable of capturing its opportunity, and to clean up the capital structure so it could be valued on its business rather than its complicated cap table.
17/04/2025 What makes this a passion project for you, and how does Ultramist impact patient care?
This is a huge market with tremendous white space, and what excites me is aligning the incentives of patients, payers, and providers while delivering real outcomes. On a personal level, it became tangible when my uncle developed a Wagner Stage 4 wound after a systemic staph infection. He was treated at a leading Florida hospital with traditional wound care—gauze, antiseptic, and a plan to wait months for swelling to subside before surgery. I was not satisfied with that approach, so we arranged for him to be treated at home with Ultramist by a mobile wound care provider.
The results were dramatic. After just five treatments, tissue granulation was visible. Within three weeks, the wound was mostly closed, and by March 28—about six weeks in—it was fully healed, pain-free, without scarring, and with rapid return of hand function. That is the difference Ultramist can make. When people ask about competition, the real competition is outdated wound care practices still used in hospitals today. This is what motivates me and underscores why SANUWAVE has such an important role to play.
Other
03/04/2023 When will management provide the next updates?
If investors want to speak with management, we’re glad to set that up outside blackout periods. Q1 results will be released in May, and we’ll share other updates throughout April and May. We appreciate everyone’s support and look forward to keeping shareholders informed.
Disclaimer:
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Sources
Earnings Calls
youtube.com/watch?v=FC0GISpguo4&t=1s&pp=ygUVc2FudXdhdmUgTW9yZ2FuIEZyYW5r
Very thorough thank you