Category: Innovation

Rafael Mazuz recently sat down with Morgan Stanley's US Medtech Equity Managing Director, Patrick Wood, at their NYC global HQ to discuss some of the investment mistakes as well as high level trends and dynamics in the advanced wound care sector.

The MedTech Moment: Wound Care Expert Insights

Earlier this week, Diligence Wound Care Global’s Managing Director Rafael Mazuz visited Morgan Stanley’s Global HQ in NYC to spend some time with Morgan Stanley’s Managing Director of US MedTech Equity Research, the incredible Patrick Wood! Here’s a link to the podcast episode we recorded (12 min): The MedTech Moment – Ep. 6: Woundcare Expert Insights On this special episode of The MedTech Moment, Morgan Stanley’s Pat Wood is joined by Rafael Mazuz from Diligence Wound Care Global to talk about common analyst mistakes, trends, and competition in the Wound Care market. Specific and related companies discussed on this episode include: Solventum (formerly 3M Health Care / Acelity / KCI / Systagenix), Smith + Nephew, Coloplast, Convatec, Medline, Mölnlycke Health Care, and more. Are these the types of insights that make you more confident in your wound care business and investment decisions? Contact us to discuss the advanced wound care medtech, biotech, services, and investment opportunities. Most importantly, don’t get hit with bad wound care business decisions!

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Upcoming Wound Care Conferences & Events (UPDATED 28 March 2024)

Upcoming Wound Care and Related Conferences, Meetings, Exhibitions, & Industry Events There used to be a couple of solid online lists of wound care industry events that are no longer maintained. The current ones are either too US focused, ignore ecosystem conferences (ex: home care), and/or include meetings that are not very relevant, or in some cases of questionable reputation and value…so I decided to make my own! If I am attending / faculty / speaking / moderating a session, and have a discount code, I will put it in the Remarks section. Is there a wound care (or adjacent-yet-relevant) industry event that is relevant to our audience and not listed above? Interested in Wound Care Global’s Rafael Mazuz to attend as faculty, moderator, chairperson, pitch competition judge, or another capacity? If so, contact us, providing as much detail as possible.

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Coloplast Acquires Kerecis: Key considerations and implications by Diligence Wound Care Global

Coloplast’s acquisition of Kerecis: Considerations and implications

Coloplast’s announcement is the latest large and significant advanced wound care (AWC) industry deal. As the high level details have already been thoroughly disseminated by press releases and news aggregators, our analysis of the Danish multinational’s acquisition of Kerecis will focus on: What makes this deal noteworthy in the context of the current advanced wound care (AWC) landscape and Coloplast’s positioning, especially in the US AWC market? What are the potential tailwinds and headwinds that Coloplast will encounter as they integrate the Kerecis business org, portfolio, and platform? Why is this deal noteworthy? Aside from its 10-figure price tag and a high multiple on revenues relative to other recent AWC transactions, this deal is also a possible tipping point whereby now roughly half of the top wound care MNCs operating in the US now have biologics / skin substitute / allograft / CTPs (cellular and tissue-based products) to their portfolios. (Side note: There is a recent effort, including a consensus paper published in the Journal of Wound Care [JWC], to begin referring to this segment by the more accurate term, CAMPS [cellular, acellular and matrix-like products]). Does this mean that the rest will follow suit? No–and some have intentionally avoided this segment–for very valid reasons as well. On the other hand, it has become clear to most of the major global wound care brands that to simply innovate around the edges of their core dressings and bandages, if they do not have some other competitive advantage (ex: full service logistics, manufacturing, digital health, remote monitoring, etc.), will eventually render them obsolete. However, beyond these relatively surface-level points, this deal is significant for the following reasons: 1. Only a handful of players have successfully achieved commercial penetration at scale There are around 100 advanced wound care CTPs available in the US, which makes up roughly half of the global AWC market overall, and the overwhelming majority of AWC CTPs. However, relatively few players have managed to successfully take this AWC category from concept to successful commercialization in the years since wound care has been on the map with specialized care settings and reimbursement. Indeed, various platforms based on everything from dehydrated porcine, bovine, ovine, and equine (pig, cattle, sheep, and horse) tissues, to autologous cells, cell culture banks, and human cadaver skin, to various amniotic and placental tissues, to collagen derived from bio-engineered plants, to bioactive glass and other synthetic materials have all been shown to contribute to healing in complex wounds and burns. However, of these ~100 products / platforms, only a handful of companies have achieved significant commercial traction to date (some of these companies have multiple AWC CTP products in their portfolios): Organogenesis Smith+Nephew (portfolios acquired from Healthpoint and Osiris Therapeutics) MiMedx Integra Life Sciences Kerecis A few others could be added, depending on the thresholds considered, such as: Convatec (via its acquisition of Triad Life Sciences in 2022) Medline Life Net Health (acquired the combined Bioventus-Misonix-Sol Systems wound portfolio earlier this year) MTF Biologics PolyNovo So out of ~100 technologies, only about ~5-10 have significant commercial traction. Of these, Kerecis and its fish-derived Omega3 platform has been the fastest growing company in this segment for multiple years. 2. International presence + viability Of the CTP companies mentioned above, most of them have virtually no presence outside of the US (OUS), and/or their OUS focus is on a different part of their business (i.e. not AWC / burn care or CTPs). Again, almost the entirety of wound care CTP usage today is in the US. When you attend US wound care conferences, the CTP companies’ booths are among the largest, busiest, and most elaborate in the exhibition hall (and a large proportion of their booth’s footprint if they have multiple product lines). Yet if you attend the increasing number of international wound care conferences (as we do), most of the same companies listed above are nowhere to be found–or perhaps just a small brochure or poster in the corner. Even large multinationals like Smith+Nephew may have a major presence or sponsorship, but they are unlikely to make their CTPs a major commercial focus, in many cases not even bothering to register the products overseas. I won’t go into details here of the many reasons for this, but suffice it to say that they include: Reimbursement / willingness to pay out of pocket Market and stakeholder awareness: of advanced wound care overall, and specifically of CTP use cases for wounds and burns Regulatory, sourcing, logistical, and cultural challenges, for example: some markets require human tissue products to be sourced from local populations, or to undergo a level of material safety processing/testing (ex: heat) that offsets their clinical effectiveness or proper and timely shipping + storage of such products becomes too complex or costly. Sources of cells / tissues may not meet local cultural or religious guidelines However, Kerecis in recent years has been increasingly present in the global wound care markets. Do they make up the majority of their revenues? Certainly not. However, the platform’s pricing elasticity, regulatory, and sourcing characteristics, combined with increased awareness overall, solve many of these issues. As such, in recent years (even pre-Covid), it was not uncommon to see Kerecis–or one of their third party distributors–with a presence at burn and wound care industry conferences across EMEA, APAC, and LATAM. Kerecis also has some complementary, mostly consumer-focused, wound and skin products (that Coloplast can likely competently commercialize through their channels), as well as a pipeline of more complex surgical reconstruction and repair-focused products based on the Omega3 platform. However, the core of their business at the time of the deal is still their fish-derived lines of wound, surgery, and burn grafts. In short, not only was Kerecis the fastest-growing CTP firm in the US prior to Coloplast’s acquisition, but they also were uniquely able to demonstrate at least some initial traction in less traditional and emerging markets where wound care biologics and CTPs

Coloplast’s acquisition of Kerecis: Considerations and implications Read Post »

Net Health Acquires Tissue Analytics

Today (14 May 2020), Net Health, a leading specialty health software firm with particularly successful market penetration in US wound clinics, announced the acquisition of Tissue Analytics. The entire TA team will remain and join the Net Health organization. This development is significant to the advanced wound care and adjacent industries for many reasons. By integrating the TA platform and team, Net Health will now have (among others): The ability to follow patients across all care settings: From the hospital, to home, and everywhere in between (including even DME [durable medical equipment], which it has already integrated for many manufacturers and distributors). Best-in-class EMR integration competencies. Strong data and predictive analytics capabilities (TA Cofounder and CTO Josh Budman will assume a leadership role which includes predictive analytics). Powerful clinical trials capabilities, which can now leverage vast amounts data from a massive number of outpatient wound care clinics and other care settings, combined with rich product, procedure, and outcomes data. Partnerships across top industry players, which Net Health and Tissue Analytics had independently developed, will now benefit from economies of scale (technical, analytical, and commercial alike). Tissue Analytics was backed by a broad range of institutional and strategic investors, including Dreamit Ventures, digiTx Partners, Chinese conglomerate Tencent, Mölnlycke Health Care, Intermountain Healthcare, and Penn Medicine. Net Health is a portfolio company of The Carlyle Group, Level Equity, and Silversmith Capital Partners. Lastly, it was a great honor to serve on the Tissue Analytics board of directors for the past two years. I look forward to continuing to collaborate with the combined Net Health and Tissue Analytics organization in other ways, as they continue to drive innovation in the wound care and specialty health IT space.

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Followup Q&A from The Business of US Wound Care webinar

Followup Q&A to April 2020 Business of US Wound Care for Executives eLive Event [Video]

For those of you who joined our recent (April 2020) eLive interactive events on The Business of US Wound Care for Executives (with Healiant Wound Training Solutions), have no fear. Firstly, we have scheduled our upcoming events for May 28th and June 3rd, 2020 respectively. The May 28th session will be more strategic in nature–tailored more for senior management, marketing strategists, investors, and the like, perfect for those crafting their corporate, portfolio, or investment strategy in advanced wound care. The June 3rd session will mostly focus on short-term sales and marketing planning, as well as tactical execution. As such, sales managers, account executives, clinical product specialists, and relate supportive roles are most likely to benefit. Of course, for those seeking a 360 degree view of both the strategic and tactical dimensions of advanced wound care, attending both sessions is complementary and will provide those perspectives. There were so many astute questions from the participants at both events, that regardless of whether or not you joined, we’re making the follow-up Q&A available as a resource to all. Watch below: Finally, if you’re interested in a deeper due diligence of some of the themes discussed in the video above, check out the article I wrote back in November 2017, What the Recent Healogics Developments Can Teach Us About the Future of Wound Care. It still remains very relevant today, even 2.5 years after its initial publication (as of this writing), and despite the impact of COVID-19 on advanced wound care. Whether you joined our recent events, plan to join in the future, or have a stake in the implications of commercial and operational wound care developments, contact us to discuss your unique wound care business situation.

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A visualization of the reduction in weekly wound care clinic patient volumes in early 2020 vs. 2019

COVID-19: Preliminary Operational and Commercial Wound Care Insights

Advanced wound care’s position in the evolving COVID-19 landscape Global economies have been slammed by COVID-19 in the first part of the year. Some biomed sectors, such as PPE, respiratory, and telemed solutions, have seen unprecedented demand for increased production/availability and new innovation alike. On the other hand, orthopedics, plastics, and other service lines with a traditionally large mix of elective consultations and procedures, have absolutely been hit hard. Generally speaking, healthcare systems have taken a hit as they shift clinical resources from their most lucrative revenue drivers to critical care preparedness and treatment. However, when it comes to the supply and demand interplay of COVID-19 on the advanced wound care industry, the results are more nebulous. Even across geographies, the question of whether wound care is an “essential” service line is currently being interpreted differently, depending on who you ask. For example, in several countries across Europe, most wound care clinics are closed. In the US, most wound care clinics remain open–though a significant number are operating on a part time (ex: Tuesdays and Thursdays only, or only half-day hours). Of those operating on a full-time schedule, many are seeing significant patient volume reductions compared to the same period in 2019. From both operational and commercial perspectives, the implications are significant. Forward-thinking executives and investors need to understand and actively plan for the possible scenarios and consequences of their actions (or lack thereof). The operational data, on-the-ground insights, and their implications [T]he keenest wound care executives and investors use real world data not just for making claims about physical products (though that is important, too). By combining data analytics with on-the-ground insights to stress test operational and commercial hypotheses, firms can stay one step ahead of the news cycle. The result is the ability to out-plan, out-invest, and out-compete in the wound care arena, and to be prepared for the possible consequences of their moves. Anecdotally, year-over-year (YOY) volume reductions range from 10% to 40% or more. The figure below shows data, collected and analyzed by Tissue Analytics from across several US clinics that use its wound care measurement and assessment software. It shows a very clear YOY reduction in weekly patient visits of around 5% in early March 2020, steadily growing to 25% as of 17 April 2020 (the most recent data published as of this writing): According to Tobe Madu, the Tissue Analytics data scientist who conducted the analysis, “For this analysis we looked at outpatient clinics since these are the facilities most likely affected by the COVID-19 lockdown mandates. Only clinics that were fully integrated with Tissue Analytics as of the first week of 2019 were considered. The data points presented in weekly intervals corrects for daily fluctuations and reveals a clear decreasing trend for patient visits.” Of critical importance is also the notion of whether the reductions in patient encounters are among existing patients who may be told by their providers to come at less frequent intervals (ex: fortnightly instead of weekly), or perhaps the patients themselves decide to skip appointments, ostensibly due to COVID-19 fears. Likewise, relaxed US telemed reimbursement and restrictions allow for easier remote monitoring and consultations even as clinic-based visits dip. In such cases, we might expect to see a short-term stabilization once a new comfort level in terms of visit frequency vs. COVID-19 risk is met. Clinically, wounds may heal more slowly (lower frequency of debridement, fewer advanced product applications, less utilization of HBOT, etc.), but would supposedly still allow for effective patient triage in most cases. Alternatively, are patient volume reductions driven by a reduction in new wound care patient admissions to the clinic? In other words, are patients in treatment during the early months of of 2020 continuing to come as normal until healed (around ~8 to 15 weeks on average, depending on the case mix and clinical outcomes of the particular facility), yet new wound patients are hesitant to schedule their first appointment? If this is the case–which my gut told me is more likely–then we might expect a continued patient volume free-fall, combined with a major risk of tragic clinical outcomes (including amputation, sepsis, and death) from delayed treatment in the coming weeks and months. Many of these patients will eventually burden emergency rooms, inpatient acute care units, and SNFs, who will inevitably treat the fevers, weakness, elevated white blood cell counts, and other presentations as COVID-19 until test results and a full clinical assessment confirm that the patients’ neglected wounds are the more likely root cause of the symptoms. I asked Tobe from Tissue Analytics about my hypothesis: That patients already receiving treatment pre-pandemic may be likely to continue, but that new patients with wounds may not be scheduling new admissions. If so, then the drop in patient visit volume would be likely to continue beyond the current 25%. Tobe was able to work his data analytics magic to dig into this, too: Tobe further articulated what the above data visualizations tell us: “When we compare the pre-lockdown (wks. 3-11) and post-lockdown (wks. 12-16) period, new patients account for 15% of the decline in average outpatient clinic visits per week. Last year, for the same time period, new patients represented a mere 3% of the increase in total patient visits. The decline in new patient visits appears to be a legitimate concern moving forward even though new patients only represent ~10% of the patient population.” Of course, a larger facility sample size and a few more weeks of data would be beneficial. Likewise, Tissue Analytics’ outpatient customer base may skew towards larger, IT-resourced health systems. Having said that, the data pattern suggests one of two possibilities, either: We may not yet have seen a bottom for outpatient wound center visit volumes. Wound care center operations are fueled by new patient admissions. If new patients are not being admitted to post-acute settings (a good amount are likely ending up in acute settings), then we might expect an ~8-15 week lag for the most severe

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Live polling from the AAWC-Desert Foot 2019 track on Digital Health and Clinical Operational Best Practices

Underappreciated Advanced Wound Care Opportunities in 2020 and Beyond

Despite the overwhelming majority of R&D, regulatory, sales, marketing, and corporate finance focus in the advanced wound care (AWC) sector being on physical advanced wound care products, many of the greatest opportunities to drive outcomes–and profitability–exist in the realm of wound care service delivery. This concept was further developed by senior management from several of the leading global AWC brands in the well-received executive panel session we facilitated in Gothenburg, Sweden earlier this year at the EWMA Conference. Keeping with this theme, several of the speaking engagements, articles, partnership explorations, and related advisory we have performed towards the end of this year have revisited this idea. We will share some areas of particular interest below. Calling all forward-thinking AWC professionals Whether you’re in AWC or an adjacent sector (dialysis, diabetes, vascular, ortho, plastics, home care, etc.), or affiliated with a service provider and/or payer organization (ACO, IDN, HMO, CCG, VA)…if you’re seeking to partner with like-minded, forward-thinking executives, payers, health systems / facilities, clinicians, and investors on the types of initiatives discussed in the remainder of this article, get in touch to describe your unique approach and what you and your colleagues stand to gain and could bring to the table. We’ll confidentially use this to explore if there are existing or future collaboration opportunities to accelerate your goals within the Diligence Wound Care Global network. When you have the wound care “Hardware,” but what you need is the “Software” This concept was eloquently articulated a couple of years ago by one of our Singaporean clients…During a tour of several large, well-equipped, generously-staffed, high volume wound care facilities in several countries as part of the early experience program, he witnessed firsthand the lack of administrative support, uniform processes, data analytics, and relative ability to influence key (external) decision makers among the potential customer sites. Immediately after one such customer visit, he turned to me and exclaimed, “They have plenty of ‘hardware,’ but what they need is ‘software!’” In addition to the educational and networking opportunities, we had the opportunity to contribute as faculty at The Association for Advanced Wound Care (AAWC)’s track at The 2019 Desert Foot Multi-Disciplinary Limb Salvage Conference in Phoenix, Arizona earlier this month. One of the topics, Bringing Together Best-in-Class Clinical, Operational, and Technological Approaches to Delivering Advanced Wound Care: An Interactive Panel Discussion, leveraged live polling of the AWC clinicians and administrators in attendance to draw attention to some very surprising yet highly relevant and underappreciated stakeholder pain points and related market needs. Barriers to adoption of new products and technologies Firstly, if you were to ask the average commercial or medical affairs AWC (or more broadly speaking, medtech) professional about the key activities needed to gain adoption, they would likely list the following product-centric factors among their top three replies: Presenting and communicating scientific and clinical evidence Education and training of staff Initial trialing and feedback Strikingly, the live polling results as articulated by actual AWC users and customers suggest exactly the opposite, with their top three barriers overwhelmingly being: [Navigating] administration and bureaucracy Financial pressures to always choose the cheapest or on-contract option Logistics (too many supplies to order, stock, etc.) The audience-reported feedback is consistent with our experience as both an AWC customer and strategist, and is equally as relevant in the non-US markets as it is in the US. Stated differently, even when discussing a topic such as adoption of new AWC products, the key barriers are ironically related to services (management, administration, logistics, etc.). This concept was eloquently articulated a couple of years ago by a Singaporean client, a seasoned global marketing executive in the midst of a best-in-class product pre-launch across nine Asian markets. During a tour of several large, well-equipped, generously-staffed, high volume wound care facilities in several countries as part of the early experience program, he witnessed firsthand the lack of administrative support, uniform processes, data analytics, and relative ability to influence key (external) decision makers among the potential customer sites. Immediately after one such customer visit, he turned to me and exclaimed, “They have all of the ‘hardware,’ but what they need is ‘software!’” The phrase stuck with us throughout that engagement and beyond, anytime we encountered care delivery that was inconsistent, inefficient, unscalable, or otherwise not meeting its full potential despite adequate physical resources (in other words, the vast majority of AWC facilities and providers) . In fact, improving stakeholders’ “software” for delivering care then became a critical parallel activity alongside the traditional “hardware” sales and marketing activities during the actual launch phase, with major dividends in terms of building customer trust and branding for the distributor and their products alike. Clearly, the misalignment on AWC “hardware” (tangible facilities, products, and staffing) vs. “software” (intangible processes, protocols, tech, analytics, business/financial models, and other enablers) is something holding the sector back from its full potential on a global scale–and thus represents a phenomenal opportunity for non-AWC and AWC firms alike. Barriers to adoption of digital health (mobile assessments, diagnostics / imaging, telemed, analytics, etc.) Another highly instructive live audience poll from the event specifically zoomed in on the top barriers to adoption of digital health (literal “hardware” and “software,” not to be confused with the figurative “hardware” and “software” described above). The results are here: Once again, just like with physical product adoption, the most pressing challenges to adoption of digital health faced in the real world are overwhelmingly managerial, administrative, and financial in nature. This begs the question: Why do so few digital health initiatives in AWC actually address these gaps? One might even argue that the majority of AWC digital health creation and marketing activities are not even taking aim at the right problems to solve. But even putting that point aside, can these issues of how to secure budgeting, viable business / financial models, and integrations (both technical and practical) be effectively tackled by individual corporations and health systems alone? At what point does there need to be more cross-pollination beyond just

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EWMA 2019 and Executive Industry Forum: Unlocking the Commercial Potential of the US & Asia

The European Wound Management Association (EWMA) conference in Gothenburg, Sweden earlier this month was a great success. We witnessed several important advanced wound care innovations and announcements: From new approaches for addressing nonviable tissue and infection, to CTPs (cellular and tissue-based products) which are financially viable in non-US markets, to sensors and other digital health approaches, to further exploration of companion diagnostics and strategic pivots by leading companies–the signs were all there to those who knew what to look for. Each one of these topics could be the subject of a lengthy analysis. Yet this post will focus on the EWMA Executive Industry Forum, which is one of the few (perhaps the only) setting where top executives from multiple leading firms get the chance to interact live and share their visions with the broader business and investment community. Executive Industry Forum Interaction Report We incorporated live polling of our executive and investor audience throughout the forum. So let’s begin by sharing the actual Event Interaction Report (note that not all options add up to 100% because poll participants were able to select multiple responses): Click here to view the Event Interaction Report or scroll down in the embedded version below: Some takeaways: United States Advanced Wound Care Trends, Challenges, and Opportunities: Poll participants were most concerned with the reimbursement, healthcare economics, and regulatory frameworks. This was followed by a perceived lack of clinician education / training / specialization. Challenges related to language, culture, and local competition were of least concern. Some of our panelists articulated the unsustainable nature of the US fee-for-service model, and how that must change. Others expressed less concern regarding the sustainability of the system as a whole, but acknowledged the reality of new dynamics. In the words of one executive on our panel, “It used to be that in the US, you could have a better product, and charge a premium price, or you could have a slightly inferior product, but at a slightly lower price. Now, the expectation is that your product will be both better and less expensive.” There was some optimism from the panel around the HEOR (healthcare economics and outcomes research) models which have been built out in Europe and other markets, which may get some mileage in the US given the recent market forces trends; However, overall there also seemed to be quite a bit of hesitation as to whether the AWC industry as a whole has figured out / made enough progress in this area to “put their money where their mouths are” and actually take their products and protocols to the payers with a guaranteed outcome. One area where most of the panel agreed (at least those who spoke to this topic) is on the need for some better standards in the industry–whether for product claims, clinical trial design, or others. On the topic of recent high levels of M&A and digital health activity/investment, the consensus from the panel is that it is not just a fluke, and will absolutely continue into the foreseeable future. Asia Pacific Advanced Wound Care Trends, Challenges, and Opportunities: Poll participants were most concerned with local competition (distribution, price points, established relationships, etc.) and the lack of / difficulty in establishing a regional presence by the principal firm (i.e. needing to rely on local distributors for sales, marketing, and support). Interestingly, intellectual property (IP) concerns were cited by a minority of survey participants. Yet our executive panel did seem to express significant concern about it, explaining how such risk impacts all decisions, from product design to partnership selection. Compared to the poll on the US a few minutes prior, the challenges concerning Asia were much more varied (no individual option reached a 50% majority), implying that participants view AWC challenges in Asia as more diverse and dynamic. A majority (52%) of poll participants considered China (followed by Japan) to be the greatest mid to long term AWC opportunity in Asia–a perspective that the panelists seemed to echo–yet there was still enthusiasm around all of the Asian geographies given as options. We discussed the demographics of an aging population and the practical remnants of the “One Child Policy” on healthcare needs such as advanced wound care: A couple (two people) caring for four parents plus their own children, and how that impacts the time and financial resources to deal with conditions such as chronic wounds. In addition to aging, the sheer size of the population (China and India alike), the socioeconomic trends, and the potential for local partnerships were all highlighted by the panel as drivers they consider when evaluating the commercial potential of specific Asian markets. The concept around what is allowed in Asia from a legal and regulatory perspective was discussed: For example, it is not uncommon in many Asian markets for healthcare providers to be proprietors of product distributorships, or for product manufacturers to openly own and operate their own healthcare / wound care service lines. Still, even our executive panel admitted to fundamentally struggling with wound care in Asia. They all appreciated the opportunity, and some offered up some victories in terms of establishing local partnerships and driving educational efforts. Yet admittedly, none have managed to “crack the nut.” One of the executives who came from a pharma background remarked how for most big pharma companies, China is their second or third largest market–with many times more sales and marketing reps there compared to countries in Western Europe. When it comes to advanced wound care, however, the relationship is totally flipped. We discussed some of the digital and educational initiatives each company has explored in recent years, and which components might be leveraged to drive AWC in Asia (and in other markets, too). Each of the participating firms have some form of digital strategy and presence, but they have begun to manifest themselves in different forms at each respective organization. Final Thoughts All in all, our Executive Industry Forum was extremely well received. Several companies hold global team meetings

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Consolidation, M&A Integrations as a Competitive Advantage, and Other Advanced Wound Care Industry Insights from 1H 2019 and SAWC Spring [Video]

At the recent Symposium on Advanced Wound Care (SAWC Spring 2019), there were several interesting developments and companies to watch (scroll down for a video interview we did with one of them). But without a doubt, the major advanced wound care (AWC) industry theme in the first half of 2019 has been consolidation. Given the increasing size and frequency of recent deals in the sector, it also may be time to discuss if, when, and how executives and investors might potentially begin to look at companies’ handling of post-M&A integrations as a core competency–and perhaps even an opportunity to develop new competitive advantages? Recent corporate activity To be clear, M&A activity in this space has been ramping up for years. To recap just a few: 2017: Integra Life (IART) Science’s acquisition of Derma Sciences Organogenesis’ (ORGO) acquisition of NuTech Medical Essity (ESSYY)’s acquisition of BSN Medical 2018: Acelity’s acquisition of Crawford Healthcare Mölnlycke Health Care’s acquisition of SastoMed Urgo Medical’s acquisition of SteadMed Medical Yet both the quantity and scale of activity in just the fist half of 2019 alone is essentially unprecedented. At least six deals, three of them mid-to-large (by AWC industry standards, not necessarily when compared to medtech or pharma overall), and all of them strategic, occurred: 1H 2019: 3M Company’s (MMM) acquisition of Acelity (KCI + Systagenix) for $6.7 billion including assumption of $2.4 billion in debt (expected to go through later this year) Smith & Nephew’s (SNN) acquisitions of Osiris Therapeutics for $660 million and Leaf Healthcare for an undisclosed amount Misonix’s (MSON) acquisition of Solsys Medical for $97 million in stock, plus assumption of $20 million in debt Mölnlycke Health Care’s acquisition of M&J Airlaid Urgo Medical’s acquisition of Realm Therapeutics (Vashe) Perspective and significance The 3M-Acelity and S&N-Osisis deals are both considered very large relative to historical activity in the AWC sector. In particular, 3M and Acelity were both “Top 6” AWC players before the acquisition, and the combined entity will command a very significant scale, particularly in the US (about half of the global AWC market), but also in the rest of the world, where Acelity traditionally lagged but had impressive growth leading up to the acquisition, and 3M already has a solid presence. The S&N-Osiris deal pulls a top regenerative medicine company (with a particular AWC focus) into the portfolio of a “Top 6” AWC firm. Before the acquisition, S&N already had what we might casually be referred to as “tissue growth acceleration” products like Oasis and Regranex, in addition to active healing assets such as PICO (single-use NPWT) and Santyl (collagenase ointment for enzymatic debridement). While clinically different, those products shared similar sales call points, reimbursement support infrastructure, and other considerations to the Osiris portfolio. The Leaf acquisition, while certainly much smaller in size, is in line with strategic trends in the AWC space overall: Pressure ulcer prevention and offloading is among the skin and AWC product segments with the most focus in recent years. Moreover, it put S&N particularly head-to-head with Mölnlycke (who acquired patient turning, positioning, and offloading device firm Sundance Systems in 2016), with both companies claiming their respective foams, adhesives and turning/offloading systems as a three-pronged approach to pressure injury prevention and care. Pressure ulcer prevention and treatment has become such a key battleground in the AWC sector that it was the subject of a lawsuit filed by Mölnlycke in 2017, claiming misleading and unsubstantiated advertising. As of May 2019, both firms continue to assert their respective skin and pressure injury portfolios, even as multiple new entrants have launched solutions for prevention, early detection, and treatment. Prior to this new round of major acquisitions, if there were such as title as “most comprehensive and sophisticated AWC portfolio,” Acelity and S&N would likely have been the top contenders. After all, both companies boasted solutions for most key categories of AWC therapies, and each had several assets with significant market share in their respective categories (debridement, traditional NPWT, disposable NPWT, etc.). The timing of the above acquisitions couldn’t have been more exciting, as each firm bolted on multiple asset classes which too enjoyed significant account penetration and market share (single-use compression, film dressings, CTPs, etc.). The developments were almost like watching two racers neck-and-neck, when both simultaneously increase their pace. At the same time, the “rules” of the sport are evolving in real time, with reimbursement and pricing pressures, continuum of care, digital health and wearables, prevention, diagnostics, and the global markets shaping the terrain ahead. Although overshadowed by the massiveness of the 3M and Smith & Nephew deals, Misonix’s purchase Solsys Medical was also significant. Why? Because traditionally, most of the major cellular and tissue product (CTP) / biologics / allograft / “skin sub” product firms’ portfolios are pure plays in that space (they might have different formulations or sizes). Likewise, debridement is a crucial wound care need, with relatively few options on the market considering how important proper wound bed preparation is for wound healing. Almost none of the other advanced products–CTPs, NPWT, dressings, ointments, rinses, and even diagnostics, are effective if they cannot come into contact with viable tissue (and if the “chronic” wound is not turned into an “acute” wound). At the same time, selling debridement products, especially those involving a capital equipment component like Misonix, can be complex. In this sense, at least on its surface, the combination is a good fit that significantly expands the reach and offerings of two companies that each benefit from the others’ portfolio and team. Although a smaller deal than the 3M and S&N ones above, care must of course be given to the actual integration efforts as well. The last two deals listed (Mölnlycke-M&J Airlaid and Urgo-Realm Therapeutics) are smaller and appear to be driven by control of sourcing, protection of intellectual property (IP), and other vertical integration considerations: Important roll-ups, but likely not to be viewed as game-changers. However, they also come just months after other important M&A activity by both Mölnlycke and Urgo alike–and

Consolidation, M&A Integrations as a Competitive Advantage, and Other Advanced Wound Care Industry Insights from 1H 2019 and SAWC Spring [Video] Read Post »

Perspectives on Smith & Nephew’s Announced Acquisition of Osiris Therapeutics Today

What happened? Smith & Nephew (NYSE: SNN) will be acquiring Osiris Therapeutics (NASDAQ: OSIR) for $660M. The investment, announced today, potentially repositions Smith & Nephew within the CTP (cellular and tissue-based products) space. If the deal goes through, it will be Smith & Nephew’s most significant M&A deal within that space since the acquisition of Healthpoint (Santyl, Regranex, and Oasis were the key products) for $782M in 2012. Speaking of Santyl, Israel-based MediWound–a firm that is also developing topical debridement products to compete with Santyl–has also announced news today: CEO Gal Cohen will be stepping down, after 12 years with the company. He will be replaced by CFO and COO Sharon Malka. Many are watching closely as MediWound–and some other players/products in the space–prepare to launch products which would compete with Santyl. Santyl has largely been considered a cash cow in the wound care space. But back to the Osiris M&A news: The CTP (also casually referred to as “graft” or “skin substitute”) space has been growing very fast over the past decade, virtually entirely driven in the US. The emergence of different technologies to extend the shelf life of such products has simplified logistics during this period as well. One of the major breakthroughs has been Osiris’ own development and implementation of Prestige Lyotechnology to keep living cells viable without the need (and cost/logistical hurdles) involved with cryo-preservation. What are some of the underappreciated points to consider? Most of the focus about the M&A announcement has been on: Existing sales/sales growth Strong R&D Clinical trial assets and know-how Potential synergies with S&N’s other divisions The above points are fair game and relevant for sure. Especially for non-wound care/regenerative experts, they look great on a whiteboard or slide deck. But digging a bit deeper, we can take a slightly more nuanced look at the potential pros and cons for S&N: Underappreciated points encouraging the acquisition For the types of products they focus on, the Osiris sales and marketing apparatus is among the best in the wound care and regenerative medicine industry. The ability to drive case-based (as opposed to tender-based) sales in both the surgical/acute and post-acute settings with complex, high-margin products, is not one to take for granted in this sector. With the proper integration, structuring, and execution, sales executives with those specialties could in theory accelerate sales of other advanced S&N products, including single-use NPWT (PICO) and some of the former Healthpoint portfolio as well. Much of S&N’s PICO commercial team in recent years has been made up of former Healthpoint executives. Side anecdote: perhaps the best wound care sales representative that called on me when I directed US-based wound care centers was a Healthpoint rep who joined Smith & Nephew as part of the 2012 acquisition. He stayed with Smith & Nephew for some time, and grew his territory’s business significantly. He eventually left S&N due to a perceived lack of advancement opportunities in line with his performance. S&N had among the most full-service and diverse advanced wound care portfolios pre-acquisition. Even compared to some of the other “Top 6” wound care companies, they have been able to offer deeper discounts in exchange for higher utilization of their portfolio. In some cases, they have offered orthopedic and wound care products together “at risk,” guaranteeing replacement products for surgeries at no charge, should the wound fail to heal. In the mid to long term, today’s acquisition may be used to further strengthen that offering. Despite being a multi-billion dollar segment and one of the fastest growing in healthcare, there are not many firms with significant revenues and commercial footprint, yet who are small enough for a major player to acquire. In other words, there are several large, and many, many small players, but not many mid-sized ones to feed an acquisition. Often, the ones who might be otherwise attractive targets find themselves caught up in legal, regulatory, reputational, or other crises. At the time of this announcement, Osiris does not seem to have any such issues. Underappreciated points challenging the acquisition As mentioned above, the Osiris commercialization team has an excellent reputation in the industry. S&N sees the Osiris workforce, of about 360 people, as relatively easy to integrate. Again, this may be a case of everything lining up nicely on the presentation and spreadsheet, but it could be more difficult in practice. Over the past couple of years, Smith & Nephew has lost many of their most talented executives, who often cite a slow-moving, bureaucratic, and risk-averse corporate culture as the reasoning. This corporate culture many not mesh well with the drive that is ingrained in so many Osiris account executives and managers. On the other hand, Smith & Nephew has gone through a senior leadership change in recent months as well. If the acquisition goes through as announced, it will be interesting to see how many of the top-performing Osiris sales and marketing executives are still around in the next few years. Perhaps the biggest unknown in the wound care regenerative medicine space is the issue of reimbursement. Recently, there have been some small but potentially foretelling reimbursement developments pertaining to CTPs in the US. Government and payer policy can be extremely tricky to predict, but this is a segment which is heavily influenced by it. Companies like Osiris Therapeutics, Organogenesis Inc. (NASDAQ: ORGO), Integra LifeSciences (NASDAQ: IART), and Acelity [update: 3M (NYSE: MMM) announced it would acquire Acelity less than two months after news of this S&N-Osiris acquisition broke] have historically led the sector with investment in R&D and post-market surveillance trials. However, regulators and payers alike are increasingly asking the question, “Is it enough?” Among industry, this is a tough one: On the one hand, most wound care patients have so many comorbidities that traditional pre and post-market clinical trials in this space are designed such that they exclude vast amounts of patients because traditional investigators otherwise do not know how to control for those variables. The result is that the enrolled patients–both in

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Confused by Recent Wound Care Digital Health Developments and Their Implications?

In many ways, the pace of innovation in advanced wound care can feel slow compared to other areas of medtech. As a result, many from across the spectrum are understandably confused by recent digital wound care news and developments. Relative to the rest of the sector, this segment is evolving at light speed. Many wound care firms are at various phases of formulating, testing, and executing their digital health strategies. Others are waiting on the sidelines a bit longer before determining if and how to become involved, and whether to develop that competency in house, outsourced, or via partnerships. Investors are wondering if this is the next major growth opportunity for wound care, especially due to the interest from payers, healthcare IT, and other tech stakeholders, beyond the product and service providers already engaged. Since there is significant interest in this topic, Diligence Wound Care Global and Tissue Analytics have created an overview of this space and its potential, published on Wound Source at the following link: https://www.woundsource.com/blog/wound-care-devices-apps-integrations-and-analytics-digital-health-platform-overview-industry The content is indeed sponsored (in order to increase its reach). However, it absolutely does reflect the state of wound care digital health opportunities. It also highlights recent choices made by players in the space, as well as the legitimate potential manifestations and implications for the management and delivery of advanced wound care. We researched and authored the piece and stand by the overview and outlook as presented as of publication.

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Diligence Wound Care Global Managing Director Rafael Mazuz Joins Tissue Analytics Board as Independent Director

We’re thrilled to share this important announcement (read the official press release here). But even before getting into the details of the features and capabilities of the Tissue Analytics (TA) platform, it’s important to convey why we decided to stake our reputation on this particular innovative skin and wound care company in the digital health space. After all, we serve top wound care brands, from dressings and compression therapy, to negative pressure wound therapy (NPWT), to cellular and tissue products (CTPs), to pharmaceuticals, and everything in between. We work diligently to raise the bar for every client, for every product and service, across every market. Then why, when it comes to the mobile assessment, integration, and analytics segment, have we aligned with a specific firm? Because we see firsthand what they have delivered for our clients. Over the course of several years, we have had a chance to evaluate most of the solutions in this space, visited and worked with hundreds of facilities and clinicians, and advised scores of leading and rising product firms. This allowed us to see the platforms–and the teams behind them–operating in the real world of wound care business. Some companies had great teams but were clueless about market needs or security requirements to protect sensitive health data. Other solutions were overly cumbersome and expensive. Some simply lacked the honesty and integrity standards that are critical to our institutional investor, MNC / SME / startup, and trusted healthcare services partners and their brands. In contrast, Tissue Analytics is well-liked and has consistently delivered for wound care stakeholders, including real-world use cases such as: Objective, accurate, fast, and cost-effective multi-site clinical trials (obeservational + interventional; pre + post-market) resulting in faster and cheaper go-to-market execution Marketing strategy execution and long term brand value for a major global distributor launching new products across multiple markets simultaneously Turnkey full integrations across major EMRs (almost unheard of in the healthcare industry), resulting in faster deployments and fewer IT (expensive!) resources Exponential ROI from reduced operational, regulatory, and compliance expenses and penalties Connecting data from digital and smart diagnostics (perfusion, temperature, pressure, moisture, infection, etc.) seamlessly with EMRs, care navigators, and clinicians Empowerment of field-based, non-wound-certified clinicians via virtual wound care services (telemedicine) 3D rendering of wound depth and surface models without the need for external hardware attachments Best-in-class analytics capabilities, which opens up machine learning (ML), artificial intelligence (AI), risk sharing, and many other “holy grails” of wound care (and healthcare overall) As our clients increasingly dealt with forces and developments such as: Expiration of IP and (perceived) commoditization / lack of differentiation across multiple product categories High costs and enrollment periods for even small (<100 patient) trials at a small number of sites Difficulty for less-established players to penetrate the market Increased influence by healthcare systems, MCOs, and wound care management firms over purchasing and treatment decisions Reimbursement pressures and documentation scrutiny (in the US) Lack of options for treatment and usage data insights from across the continuum of care …we simultaneously observed and interacted with the TA team as a result of our normal business activities. It became clear that in the midst of such a turbulent era in the industry, TA is a hi-tech engine to help deliver the captain, crew, and passengers to their destination faster and more efficiently. It’s also the best solution to connect all of the new digital-enabled and smart devices, diagnostics, telemed services, and other emerging wound care innovations (and the data points they generate) with the providers and other stakeholders. Without a seamless conduit for that information, those solutions will struggle with real world adoption. TA is the front-runner to be that conduit. In the coming weeks and months, many more industry collaborations will be announced. They involve some of the most cutting edge companies in this space partnering with Tissue Analytics on impressive, next-generation initiatives that are raising the bar for the development and delivery of advanced wound and skin care. Many of the innovations in development and launching are great ones to integrate with the TA platform, too–removing obstacles to adoption of such solutions. In fact, multiple companies we work with are already eyeing TA as the cornerstone of their new product commercialization plans. Rest assured that regardless of whether wound care stakeholders leverage Tissue Analytics, another digital solution, or shy away from this dimension of the industry completely, Diligence Wound Care Global will remain a radar and GPS to guide them safely and with confidence. Update: As of April 2020, Tissue Analytics, Inc. has been acquired by Net Health, Inc. Become a keener wound care executive. Are you a health care, services, and/or medtech executive involved in skin and wound care? Do you have strategic, operational, R&D, or marketing goals that might be executed in a more successful, cost effective, and agile manner by leveraging new digital health platforms such as Tissue Analytics? Get in touch to discuss your unique wound care business challenge and whether Tissue Analytics might be part of the solution.

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What We’ve Been up to in 2018 Q3 – Q4 and What It Means for the Global Wound Care Business Outlook

What We’ve Been up to in 2018 Q3 – Q4 and What It Means for the Global Wound Care Business Outlook A tour around the wound care world The past few months of 2018 have been quite packed and exciting for us at Diligence Wound Care Global. We wanted to share some of what we’ve been doing and learning during Q3 and so far in Q4 this year (while keeping in mind that most details of our business activities are highly confidential). Most importantly, we’ll highlight relevant insights along the way which will help empower you to be confident in your wound care business decisions. Kicking it off with education, networking, investment, and innovation in the US… Following an educational yet fun conference during The American Podiatric Medical Association (APMA)‘s national meeting in Washington, DC, we were tapped for multiple wound care due diligence cycles throughout the mid and late summer. In between, we found time to contribute to the September edition of Today’s Wound Clinic. We also conducted strategic advisory sessions with a relatively new client in the Midwestern US to assess and consult on their commercial strategy and next moves. With the availability of so many different wound care products for treating etiologies and symptoms, a new-to-wound-care, Asian client who once attended a conference with me joked, “It’s like a night market! So many options!” He may have been new to wound care, but his assessment was spot on. Even for experienced wound care clinicians, the options can seem overwhelming. But with the right strategy, positioning, and execution, it’s possible for a strong product to rise above all the noise. Taking that approach, we’re excited to be working with this new American innovation to get it in the hands of as many clinicians–and in the wounds of as many patients–who might benefit from it. …to Europe for a new perspective on an old problem… When we conduct portfolio assessments, advisory sessions, and workshops for our corporate strategy and business development clients, we stress that the focus should be on solving stakeholders’ clinical, operational, and financial needs, as opposed to purely filling gaps based on traditional product categories. It was with this principle in mind that we traveled to Europe to meet with a very early stage startup client in the university incubator/fellowship environment. One of the things that is most exciting about the need their new solution is addressing is that it helps to solve one of the areas of wound care delivery that has not received much attention or innovation for many years. As we work with them to hone in their development and commercialization life cycles around the true market needs, we can tell that by the time it’s ready for launch, it will be very much on point. We’re looking forward to sharing more details in the coming months. …then Eastward to Asia… Those who know and follow Diligence Wound Care Global’s work are aware that aside from North America and Europe, we are heavily involved in the evolution of wound care across Asia Pacific, with engagements throughout the region at any given time. Q3 (and Q4) this year was (and will be) no different: Internal and external stakeholder competency development We began this leg of the trip by supporting a well-respected, MNC industry client in building and developing their wound care competencies across multiple markets. This included the creation of best-in-class training assets, face-to-face facilitation of “zero to hero” wound care ecosystem training, and interactive role playing and similar exercises. We delivered this for both the sales and marketing teams (field and corporate), as well as the key support roles involved with each market such as medical affairs, training, and regional leadership. Yet our planning and groundwork activities do not end there. At the same time as we’re delivering value for internal stakeholders, this particular client has the foresight to also drive value for its external stakeholders. In other words, beyond simply selling the “features and benefits” of its products (which are great ones), our role is to support our client in “raising the bar” on wound care services management and delivery throughout the region. Important everywhere, but especially in this part of the world, the goal of creating long-term relationships and partnerships has been at the core of their success. To further that goal, we met with C-Suite executives, physicians/surgeons, and nursing staff in every market we visited. The internal stakeholders we trained each morning and afternoon duly benefited from joining for the external stakeholder meetings in the evenings–via both a deeper appreciation of their customers’ ecosystem and pain points, as well as the stronger rapport that goes along with that. Although unrelated to the above engagement, this vision of furthering the clinical-operational-financial delivery of wound care was also articulated to us during a recent meeting with the CEO of a leading global product firm. In fact, from where we sit, most of the top-performing wound care executives are viewing the future of the industry through this trend (though the road maps they are each developing are unique). These and other concepts for wound care global success will be presented and discussed in greater detail during our session at SAWC Fall 2018 (see below for details and a registration discount code). “Raising the bar” for wound care delivery One particular activity during this recent trip was especially memorable and instructive: Participating as faculty for The Philippine Orthopedic Wound Care and Diabetic Limb Society, which is the newest of 12 sub-specialty groups under The Philippine Orthopaedic Association (other sub-groups include sports medicine, spine, trauma, hand, shoulder, and pediatric ortho). What I experienced there left me with a sense of optimism about the future of wound care in this part of the world: From the effectively delivered presentations from interdisciplinary perspectives, to the motivation of attendees to setup their own wound care centers, the prospects are indeed bright. …and full circle back to the United States (around the globe). By mid-September, some crucial M&A scouting, exciting

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Why Mölnlycke’s Acquisition of SastoMed Is a Big Deal

What happened? Today (2018.07.02), Mölnlycke Health Care announced its acquisition of SastoMed GmbH. Mölnlycke is of course known in the industry as a top global wound care (also wound prevention and surgical) product brand, particularly in Europe and the United States. SastoMed, a much smaller German firm, was a subsidiary of SanderStrothmann GmbH, a company which assesses, formulates, and produces cosmetic, skin, and medical products for hundreds of well-known global brands. SastoMed has developed and commercialized two wound care products at the heart of this acquisition: Granulox, a hemoglobin spray that delivers oxygen from the surrounding air into to the wound bed via facilitated diffusion (see this article for a video + discussion). Granudacyn, a hypochlorous wound irrigation solution for cleaning, moistening, and rinsing of acute, chronic, and contaminated wounds, and 1st and 2nd degree burns. Why is it important? There have been multiple wound care M&A and JV deals in recent history, including: Integra’s acquisition of Derma Sciences Acelity’s acquisition of Crawford Healthcare The formation of Appulse as a JV by the principals of Hollister’s divested key wound care products (Hydrofera Blue and Endoform) …and several others (with more expected!) Yet despite the volume of wound care activity, this deal is unique and significant for a variety of reasons: Innovation Significance Both Granulox and Granudacyn are innovative products beyond what we normally see in the industry. Let’s briefly recap why: Granulox There exist dozens of negative pressure wound therapy (NPWT) devices, over 80 allografts, and hundreds of dressings and pressure offloading solutions. Clearly, not all wound care products in each category have the same levels of efficacy, quality, and cost-effectiveness, yet as a whole, these categories are clearly becoming increasingly saturated and sensitive to reimbursement and other economic factors. But what about solutions for delivering oxygen to hypoxic wounds (most chronic wounds are hypoxic)? Historically, the only options for these patients have been: Vascular procedures (bypass surgery, stents, etc.): These overcome blood vessel blockages and are important procedures not going away anytime soon. Indeed, the other options listed below are not substitutes for improving the underlying circulation addressed by vascular procedures. However, such procedures and are both invasive and expensive, so not every patient is a good candidate. Revascularization benefits also apply primarily to the large blood vessels, often having less impact on microvasculature, which is a key challenge for many types of chronic wounds (such as diabetic ulcers and pressure ulcers). Systemic medications (blood thinners, diuretics, etc.): These are and will continue to have important roles in cardio-vascular management (circulation, edema management, etc.), and they aim to help balance negative impacts of certain co-morbidities. Still, many chronic wounds will require additional oxygen to optimize healing–especially at the wound surface and surrounding microvasculature. Hyperbaric oxygen therapy (HBOT): Thousands of patients receive and benefit from this treatment daily (the vast majority are in the US). However, it requires proper functioning of the patient’s blood vessels in order to be effective (and to be approved for reimbursement in the US), and there is a steep drop-off in perfusion between treatments. The high cost, long treatment time (~2-3 hours per day for ~20-60 days), contraindications, low availability (outside of the US), limited indication coverage, and recently heightened regulatory scrutiny and cost pressures mean that while HBOT is and will continue to be an important wound care tool, it is not enough to meet the large and growing need for wound oxygenation solutions. Topical oxygen devices (besides Granulox): The growth of this category in recent years underscores both the increasing awareness and need for tools to combat wound bed hypoxia. On the other hand, the existing alternatives have the following limitations: Difficulty overcoming the exudate (moisture) barrier: A thin layer of just 0.1mm of moisture, such as is found on most wounds and between the cells, blocks 99% of oxygen diffusion from the air to enter the wound bed (hemoglobin molecules such as in Granulox can break that barrier, which is why the mechanism of action is referred to as “facilitated diffusion [of oxygen]”). Incompatibility with many other treatments: Application of most topical oxygen products limits clinicians’ choices for which dressings can go on top (often, the dressing is part of the delivery mechanism). Granulox can be used together with most standard and advanced wound care products. Granulox is the only hemoglobin-derived oxygen transfer product for wound care. But most importantly, Granulox complements all of the above treatment options. So it does not disrupt clinical practice, but rather is a readily available adjunct treatment to initiate oxygen delivery which overcomes many of the hurdles making wound oxygenation such a challenge. The ~100% reduction in slough buildup and ~50% reduction in pain for Granulox patients across all wound types are two more underserved clinical needs (in addition to the increased oxygenation / 50% faster healing) that make this a very innovative development. Granudacyn Natural and pH balanced: Hypochlorous Acid (HOCl) is produced by the human body as part of the immune system, and innocuously breaks down into water and a salt. As such, Granudacyn can be used inside body cavities and will not impact cellular tissue products (CTPs), which makes it complementary to Mölnlycke’s surgical business in addition to wound care. The importance of balanced pH in wound healing is also well documented. Excellent stability: Many otherwise high potential wound cleansers suffer from a relatively short shelf life. Granudacyn can be stored for a minimum of 18 months, which is plenty for any typical wound care setting. Strategic Significance Prior to this acquisition, the focus of Mölnlycke’s wound care business had primarily been on prevention (offloading, reduction of wound/periwound trauma and irritation) and passive healing (moisture balance, infection management, etc.). Granudacyn of course strengthens their wound management (and surgical) portfolio(s), but with Granulox, it can be said that Mölnlycke has now established a significant position in the field of active healing. Stated differently: Pre-acquisition Mölnlycke had products to optimize the wound bed and surrounding area via the body’s own healing process. Post-acquisition Mölnlycke can now offer its customers active acceleration of tissue regeneration,

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Key takeaways from the 2018 European Wound Management Association Conference (EWMA 2018)

EWMA 2018 (9-11 May) has just come to a close in beautiful Krakow, Poland. This annual global wound care conference is wonderful, bridging scientific, clinical, and industry stakeholders from around the world (most other annual wound conferences tend to draw from relatively regional audiences). Here are four key takeaways: 1. Less influence from reimbursement dictates With a global audience, the relative importance of product reimbursement diminishes (but doesn’t disappear), and there is a higher emphasis on product innovation, practicality, and cost-benefit trade offs. Clinicians visiting the exhibition booths were interested in many less-conventional treatment options than we typically see with those focused on North American and Western European settings. For example, I observed an in depth discussion between a group of Indian clinicians and a vendor at the booth of a new technology that is struggling with reimbursement in the developed markets. Since all of their patients pay cash for advanced wound care–whether a cleanser, advanced dressing, NPWT, allograft, or this particular new therapy–the value proposition to these clinicians was on a relatively level playing field with other treatment options, and they therefore demonstrated considerable interest. Even Poland (where the conference was hosted this year) is an emerging market, with many similar cost considerations. Accordingly, there was an abundance of Polish wound care providers and distributors attending, and I spent a lot of time learning from their discussions and which clinical, operational, and financial challenges and solutions had their attention. I often find that observing interactions between clinicians and vendors yields more valuable insights than discussing with each party separately. 2. What’s on industry’s mind… For those of us who know senior management and investors in the industry, it’s always enlightening to pay attention to which sessions and booths they show up to (and their level of interest / engagement). When one looks around the room and sees key decision makers from several major companies attending the same session, it reveals an implied interest in particular clinical solutions, therapies, or companies. This was apparent in Krakow this year. Wound care executives were also eager to learn how to better commercialize existing products internationally, especially in the emerging markets–with a renewed openness to new business models. 3. Creative approaches to existing and new technologies Dr. Huei-chun (Josephine) Tang, Chief of both Plastic Surgery and Wound Care at An-Nan Hospital in Tainan, Taiwan presented a very compelling e-poster series of patients with PAOD (peripheral arterial occlusive disease) who received KCI’s VAC NPWT at the regular -125 mmHg pressure setting after revascularization. In my experience, some wound care providers I worked with are concerned about using NPWT in PAOD patients–and that’s quite understandable, as ensuring adequate oxygenation is a top clinical goal and many worry that the various NPWT components or mechanics might interfere with local perfusion or create minor skin injuries that can deteriorate into complex wounds. But as Dr. Tang demonstrated in her series, together with revascularization, debridement, and especially an emphasis on good multidisciplinary communication among the care team, certain patients with arterial ulcer diagnoses may still benefit from NPWT at the normal pressure setting. None of the patients in the series had a major amputation after receiving the therapy. Dr. Colin Krueger, Head of Surgery and Robotic Surgery and at Immanuel Klinik in Berlin, Germany discussed a novel use for hypochlorous acid (Granudacyn). While it’s most frequently used as a wound cleanser solution, he has also been applying it during cases of necrotizing pancreatitis. Since the solution turns into water and salt, he creatively uses it as a lavage during laparoscopic surgery, and in doing so has seen the mortality rate for his patients drop from around 30% to 0%. He walked the audience through a recent, complex case, including the diagnostic, medical, and surgical approach taken to achieve the positive outcome. The audience was impressed by the innovative yet sensible use of the product beyond just open wounds. Likewise, Dr. Borripatara Wongpratchum (“Dr. B”), plastic surgeon at World Medical Center in Bangkok, Thailand impressed the audience by demonstrating how aggressively yet holistically treating necrotic toes in a very complex patient, he was able to regenerate virtually all of the tissue! The audience was in awe, because even “top” wound care clinicians would accept as fact that the necrotic regions of the toes must be totally amputated (hopefully addressing the underlying causes in parallel), with the actual wound care only beginning post-amputation. Yet with debridement, moist dressings and NPWT, application of hemoglobin spray (Granulox), IV antibiotics, offloading, PRPs, and an acellular dermal matrix, Dr. B and his team were able to “resurrect” the dead toes, eliminating the need for amputation. I didn’t believe it until I saw it–so for those who missed the session, I’ll let the photos speak for themselves: 4. The Innovation Symposium At Alira Health’s Advanced Wound Care Innovation Symposium, one of my favorites among all global wound care conferences, all four companies participating presented innovative solutions to key wound care challenges–from practical usage to gene editing and other novel microbiological approaches. After the presentations, a round of questioning by the judges, and deliberations, the €20,000 first place prize was awarded to SastoMed, who presented their Granulox hemoglobin spray (used on over 65,000 patients in over 40 countries, but not yet registered in the US). If you missed Alira Health’s EWMA session, you can get the flavor of the first-place winner from my interview with SastoMed Founder and CEO Michael Sander at SAWC Fall 2017 below: We’re already looking forward to EWMA 2019 (5-7 June, 2019…not next month!), which will be held in Gothenburg, Sweden.

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