Wound Care Global

Conferences & Events

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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Exhibitions, & Industry Events There used to be a couple of solid online lists of wound care industry events that are no longer maintained.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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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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SAWC Spring 2019 Activity

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

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2019 AAWC Pressure Ulcer Conference 2019 Feb - Diligence Wound Care Global

Debrief: Association for The Advancement of Wound Care (AAWC) 2019 Pressure Ulcer Summit [Video]

The Association for The Advancement of Wound Care (AAWC) has just wrapped up its pressure ulcer summit in Atlanta, Georgia.  Highlights included: The patient journey International participation and sharing of approaches (Switzerland, UK, Ireland, Mexico, and others) A pressure ulcer workshop Technical and scientific discussions Challenges and opportunities across the continuum of care Advocacy for policy changes (lobbying) Administration, operations, billing, and related session Showcasing of new technologies for prevention, early detection, and treatment Many attendees shared very positive feedback that they appreciated being able to dive deep into the pressure ulcer diagnosis, etiology, and treatment delivery, as opposed to covering many types of advanced wounds at a basic, surface level. In keeping with this approach, the next AAWC conference/education series will be a Wound Infection Summit to dive deep into the unique considerations for prevention and management of those wound types. Immediately following the summit, I had the opportunity to sit down with Kara Couch MS, CRNP, CWS. In addition to her active clinical role at The George Washington University Hospital’s Wound Healing and Limb Preservation Center and multiple scientific and editorial advisory board positions (including Today’s Wound Clinic together with Diligence Wound Care Global Managing Director Rafael Mazuz), she is also a board member and Secretary of The AAWC. We discussed a range of topics, including product standardization, organizational structures and collaboration models for wound care programs, KPIs and metrics, digital health, and prevention. Watch the full interview below:

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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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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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Granulox Haemoglobin Spray Application

Is This The Most Innovative Wound Care Product Since Negative Pressure Wound Therapy? [Video]

Like many of my wound care colleagues, I have experienced and worked with hundreds of wound care products. Some are basic yet effective, while others are both advanced and powerful. There are also many complex yet under-impressive options out there. Recently, I’ve had the pleasure of collaborating with a new innovation that really has the potential to disrupt the clinical, operational, and financial status quo: Granulox by SastoMed. At the recent SAWC Fall 2017 in Las Vegas, I sat down with Cofounder and CEO Michael Sander to discuss. Watch the interview below:   In summary, there is an unmet need for a product like Granulox: The role of hypoxia (lack of oxygen) in wound healing problems is well documented and affects most difficult-to-heal wounds to some extent. Existing topical oxygen treatments are not effective because even a very thin layer of water/exudate (which covers most wounds) blocks 99% of external oxygen from entering the wound bed. Current systemic and advanced treatments, such as revascularization surgery and hyperbaric oxygen therapy (HBOT) have their own unique risks, costs, and other limitations–though they can still be used with Granulox, which is an adjunctive treatment (and it can be used with almost any other products/procedures like xenografts, autografts, offloading, and most advanced cleansers and dressings to enhance their benefit). By leveraging the body’s natural mechanism of oxygen delivery (facilitated diffusion via hemoglobin), Granulox: Doubles healing speed. Eliminates slough recurrence in virtually all wounds within four weeks (it’s not a substitute for debridement, but it reduces/prevents the formation of new slough between dressing changes). Cuts pain in half without the use of drugs, patches, or gels. Does so for practically any wound etiology (type), is compatible with most other products and procedures, and without the added operational and financial burdens of many other advanced wound products. I also find it fascinating that it has been used on over 60,000 patients and sold in 31 markets (40 including in-process registrations) to date, not yet including the US–traditionally the largest wound care market by sales. When it arrives in the US (by far the largest advanced wound care market), its potential is enormous. As such, I’m very excited for this product to be available in the US as it works its way through the US FDA process. Until then, if a loved one or I were to have a complex wound and were still able to travel, I might even suggest they travel to Thailand, Malaysia, Germany, The UK, Poland, Turkey, Mexico, or the dozens of other markets where clinicians have access to this potential game changer. SastoMed also has some other innovative products and indications marketed as well as in their pipeline, too. The most impressive wound care cases and data I’ve seen in my industry career have come from combining Granulox with other well-known and accepted advanced therapies to “push the boundaries” of what even experienced clinicians believe is possible. Adding effective, easy oxygen delivery to the provider’s toolbox has really begun to raise the bar where it’s available. With increasing HBOT documentation and reimbursement pressures in the US market, additional scrutiny of cost per healed wound, and of course the skyrocketing number of chronic wounds, this reinforcement couldn’t have come sooner.   Update: Nine months after the original publishing of this article, SastoMed was acquired by Mölnlycke Health Care, a leading wound care and surgical solutions company.  

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Recent Wound Care & Regenerative Medicine Innovation Trends

(20 Jun 2016) Following is the final article in a series reviewing emerging advanced wound care and regenerative medicine trends and implications for the future of the industry. Part 1 focused on wound diagnostics approaches. Part 2 analyzed corporate strategy and positioning among the major wound care players. Part 3 will look at emerging innovative therapies, trends, and opportunities.   Emerging Innovative Therapies In my prior post on trends in advanced wound care and regenerative medicine, I stated that the most successful of the next generation of therapies will need to simultaneously deliver high levels of clinical efficacy and cost effectiveness. In this post, I will demonstrate that it is possible for solutions to both meet these criteria and still be highly creative and innovative. Due to my background in both wound care services management and product commercialization, innovators and entrepreneurs in this space often approach me for clinical, financial, operational, and strategic insights before and during early-stage commercialization. The result is that I get an inside look at many emerging solutions, even before they get a lot of attention. However, for many of those solutions, I have also committed to refrain from discussing material aspects of their business. Although I cannot disclose all of the emerging innovations and therapies I have had the opportunity to be involved with, I will share a few exciting ones (and my thoughts on them) that I have no formal business or financial relationships with and can therefore discuss freely:   1) Compression Therapy Meets Smart Materials Ask any vascular, podiatric, or wound care clinician about compression therapy and they will tell you, “It works great–when the patients use it!” Indeed, chronic venous efficiency and related comorbidities are the causes of many advanced wounds (venous leg ulcers), and can exacerbate treatment of others such as traumatic, surgical, and diabetic leg ulcers. In addition to chronic leg ulcers, swelling, blood clots, and other issues can be mitigated with compression therapy. Traditional compression stockings can be uncomfortable and difficult for patients to put on without assistance. This can be due to age, arthritis, poor mobility/flexibility/dexterity, and related issues. Pneumatic compression pumps, which use air chambers to squeeze fluid out of the legs, can also be effective. Yet due to their cost, bulk, and cumbersomeness, patients tend to refuse the modality, or use it for just a few days or weeks before compliance drops. Moreover, they cannot easily bring the pump with them to work, vacation, and other places. It’s no surprise that partial or non-compliance with traditional compression is about 79%. Finally, from the point of view of the physician/clinician/case manager/administrator who is usually the one facilitating the order, the multiple specific documentation requirements and order forms can be a huge hassle compared to ordering traditional compression. (Above: ElastiMed Founder & CEO Omer Zelka demonstrates a prototype of his smart-material-based compression therapy device at the May 2016 IATI Biomed Conference in Tel Aviv) Enter ElastiMed. ElastiMed is using smart materials to develop a wearable compression therapy device to improve circulation in the lower extremity. The lightweight stocking presents patients with a comfortable, easy-to-wear, highly effective and affordable treatment option. The garment, which can be put on effortlessly like a normal sock, holds a lightweight battery. The battery sends regular pulses of low energy through the stocking, which allows it to contract and “massage” the leg, much like a pneumatic compression/lymphadema pump. In short, by using nanotechnology, their solution combines the the mobility and cost effectiveness of a traditional compression stocking with the comfort, ease-of-application, and clinical effectiveness of a compression pump. According to Founder and CEO Omer Zelka, “I was a student of electrical engineering when I found out about the materials, fell in love with the technology, and constructed an improvised lab at home. When I reached a breakthrough with the materials, I started looking for the right application for it…After talking to countless physicians—and especially to patients—I began to understand the pain that people with these conditions experience: The current compression stockings on the market are uncomfortable and very difficult to put on and take off. With the majority of people being elderly or suffering from arthritis, wearing a compression stocking becomes Mission: Impossible. In most cases, they just stop using the stocking, which leaves them vulnerable to DVT, lymphedema, and other venous diseases or conditions such as chronic wounds.” Patient-centric? Check. Clinically efficate? Check. Price attractive? Check. I believe that Elastimed’s technology has the potential to disrupt the medical compression therapy industry, and as a result, to have a significant impact on the delivery of advanced wound care and related chronic venous disease. My industry sources recently informed me of at least one major advanced wound care company that is attempting to develop a similar smart materials compression product as well. Leading traditional compression therapy firms fighting to differentiate such as BSN Medical (who just announced they are looking to be acquired or listed), Convatec, 3M, medi, Sigvaris, Tactile Medical, and even athletic compression firms like Under Armour and Nike may eventually look for these types of new platforms–though wound and compression companies also tend to be a bit slower moving and conservative than many other areas of medtech.   2) Growing & Harvesting Human Collagen from Plants As of this writing (June 2016), there are something like 60+ soft tissue related allografts / CTP (cellular and tissue products marketed in the US. Generally, I would not advocate that this is an underserved market in need of new entrants. However, sometimes there are innovative approaches to this space, with implications beyond wound care. CollPlant (TLV:CLPT) is such a technology. CollPlant has developed a method of genetically modifying tobacco plants so that their leaves grow human collagen, which are then harvested and turned into allograft/biological products for chronic, surgical, and related wound care/regenerative medicine applications. Their VergenixFD gel and VergenixWD matrix products were recently awarded CE approval and distribution in some Western European markets. At this time, they are simultaneously working on the necessary clinical trials to gain US FDA approval as well. Why tobacco plants? In ideal conditions, they can grow to a height of two meters (six feet) in one month. Also, their large leaves allow for relatively large quantities of

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Setting up the exhibition hall at the Spring 2016 Symposium on Advanced Wound Care (SAWC)

The Race To Assemble The Ultimate Advanced Wound Care Portfolio: An Analysis of Corporate Strategies and Trends

(26 Apr 2016) Following is part 2 of 3 in a series of posts reviewing emerging advanced wound care and regenerative medicine trends and some key implications for the future of the industry. Part 1 focused on emerging wound diagnostics approaches. Part 2 will analyze corporate strategy and positioning among the major wound care players. Part 3 will look at emerging innovative therapies, trends, and opportunities.   Putting things into perspective I’m fortunate to interact regularly with sales representatives, product specialists, regional managers, and executives in both clinical and corporate settings. But there is something unique and valuable about attending key industry conferences and trade shows. The ability to walk around and see each firm’s portfolios showcased, to play devil’s advocate with product managers, chief science officers, and CEOs, then to walk over to another booth and toss their competitors’ talking points at them, yields priceless insights. Beyond investor presentations and press releases, seeing corporate strategy and competitive dynamics in the exhibition setting is an inherently valuable experience that puts industry trends in perspective like no other.   US advanced wound care is unique By my analysis, there is no segment in US healthcare expanding their portfolios and product lines faster and more intensely than advanced wound care. To this point, I have created the following chart which lays out the major product lines by category, highlighting some of the recent portfolio additions and acquisitions among the major wound care players. It also shows where each player has potential gaps in their portfolio (to be discussed below). This chart will serve as a reference for the rest of this post: Assembling comprehensive portfolios Corporate competitive dynamics are in full swing in the advanced wound care space. Being in a heavily regulated industry, costs of compliance and sales are tremendous. As a result, once companies have overcome market entry regulatory hurdles, they are under massive pressure to ramp up sales in order to capture market share and generate a satisfactory ROI on their costly investments. There are two primary incentives for companies to have comprehensive wound care portfolios: Firstly, when a brand and its sales force have successfully penetrated care sites and captured market share, economies of scale allow add-on products to be sold at a lower marginal cost (because the accounts and relationships already exist). This is especially true for product classes that do not require a large amount of end-user education (such as skin cleansers, foams, alginates, collagens, etc.). Secondly, having a comprehensive portfolio allows for companies to negotiate broad, competitively priced contracts with clinics, SNFs, home health agencies, hospitals, and even entire healthcare systems/ACOs (which we have increasingly seen during the end of 2015 and into 2016). As long as a firm’s sales force is not overwhelmingly distracted by the quantity of products or care sites, there is usually value in having multiple related and complementary products in their “bag.” If the quantity of products grows too large, there are ways to deal with this scenario as well. Strategies include segmenting reps by: a) care site (inpatient vs. outpatient vs. SNF vs. home health, etc.), or b) by product category (dressings vs. allografts vs. NPWT, etc.). Due to the inherent overlap between both care sites and products used, I generally consider it valuable to have at least a small portion of the sales professionals’ bonuses linked to team performance, which incentivizes collaboration and cross-coverage (but too much may disincentivize top performers, which is a huge risk). The above incentives are significant. Combined with the overall growth and trajectory of the need for wound care in the US, the result is virtually all of the major firms racing to fill holes in their current portfolios, with a goal of most of them to ultimately become fully integrated wound care product providers.   Identifying the trends: predictions and competitive dynamics There are a number of important wound care trends that can be inferred solely based on the above chart–but there are also other aspects of corporate strategy, culture, and even the personalities of individual executives to consider. These can have a significant impact on each firm’s strategy. To claim that every firm has the goal of filling every product category is overly simplistic and probably not the case. However, there is a clear overarching trend towards assembling comprehensive wound care portfolios because of the economies of scale and distribution synergies discussed above, as well as due to the evolving clinical and financial landscape. For the remainder of this post, I’ll discuss some of the related trends that I have observed and deduced.   Trend 1: Product categories and future predictions As US wound care moves towards bundled payment models, many vendors will likely take a more active part in the risk sharing for healing outcomes. In my opinion, future products most likely to be acquired/licensed by the major players will need to be highly cost effective while of course influencing positive clinical outcomes. Specifically, I predict that the most significant activity will be in the following categories: 1) Offloading (total contact casts (TCCs), positioning, etc.); 2) Skin care and wound cleansers; 3) Disposable NPWT; and 4) Wound diagnostics (the topic of my recent post). Lately, there has been an enormous volume of new biological/allograft products hitting the US market. Many of these have been driven by recent changes in the fee-for-service reimbursement model for this product class. Bundled payments will once again cause a shift in usage. This clinically important yet relatively expensive category will continue to play an important role in wound healing, but the focus will shift towards those products with attractive associated characteristics and costs (not just purchase price, but storage ease/cost, preparation/application time, etc. as well). Vendors of these products may even introduce new pricing and distribution models, such as only receiving payment if the product results in certain clinical outcomes, or packaging diagnostics with the product, which might better match the right patient with the right product at the right time. Other high potential innovations such as SevenOaks Biosystems’ outpatient full-thickness autologous skin grafting system (based on technology developed by dermatologist

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SAWC Spring 2016 Registration- Photo

Three Key Wound Care Diagnostics Trends from The Spring 2016 Symposium on Advanced Wound Care (SAWC)

(20 Apr 2016) Following is part 1 of 3 in a series of posts reviewing emerging advanced wound care and regenerative medicine trends and some key implications for the future of the industry. Part 1 will focus on wound diagnostics approaches. Part 2 will analyze corporate strategy and positioning among the major wound care players. Part 3 will look at emerging innovative therapies, trends, and opportunities. The Symposium on Advanced Wound Care (SAWC), the wound care industry’s largest conference and exhibition, wrapped up its Spring 2016 event last week at The Georgia World Congress Center in Atlanta. SAWC is a valuable opportunity to keep a finger on the pulse of emerging science and technologies in wound care, especially those at the academic and research levels, whose potential for application and commercialization will unfold in the coming years. SAWC is also a chance to catch up with colleagues old and new, and to get a glimpse into the future of wound care science, strategy, and delivery.   Introduction: Searching for the “magic bullet” (or “bullets”) of wound care diagnostics There are hundreds of advanced wound care dressings and ointments, scores of biological and allograft products, dozens of surgical procedures, and multiple options for negative pressure wound therapy (NPWT) at the wound care clinician’s disposal. Yet reliable, instant, instructive, cost effective, point-of-care diagnostics for wound care are virtually nonexistent. As a result, wound care in most settings has remained more of an art than a science, with nearly as many approaches to care as there are providers. However, at last week’s SAWC, new classes of wound care diagnostic and assessment tools have begun to emerge. They have the potential to disrupt the industry in a major way. For discussion purposes, I’ve categorized them into three practical categories: Biochemical, imaging, and assessment/measurement:   1) Biochemical Scientists are increasingly discovering that the chemical makeup of a wound bed is able to provide key information about its ability to heal, far beyond what can be inferred from visual inspection alone. Most key research in this area involves a type of enzyme called proteases, which are typically found at very high levels in non-healing wounds. Additionally, the ratios of a specific class of protease (called MMPs) can impact healing and potentially predict whether or not certain advanced therapies (such as an allograft) will be successful. Fortunately, excessively high MMP levels can be lowered within minutes with readily available modalities such as sharp debridement and application of collagen, among others. However, there is still uncertainty and debate as to whether “balancing” the MMP levels in a wound will improve its ability to heal, or if the atypical levels are symptoms of other systemic issues that must be addressed. In either case, the biochemical makeup of the wound bed is an area receiving increasing interest and attention. Several years ago, Systagenix launched a diagnostic in the UK called WOUNDCHEK, which measured protease levels in the wound bed. But the test took long to produce a result, the result was binary (i.e. simply “high” or “low”) and the kit was too expensive (almost as much or more than the actual advanced therapies it was intended to recommend for or against), so it never gained widespread use as a practical or widespread diagnostic tool. Recently, a Boston-based startup by the name of Sano LLC believes they may have solved the protease/MMP diagnostic challenge. They are developing a fast, low cost, point-of-care diagnostic that not only identifies protease levels, but quantifies the specific MMPs that can impact wound healing and provides an actual value (i.e. a scale of 1-to-5). By solving the underlying issues inherent in WOUNDCHEK, Sano’s solution has the potential to not only assess the wound, but to drive treatment algorithms as a result. If successful, they will be the first cost effective, point-of-care biochemical diagnostic for chronic wounds. The implication of this is both better clinical outcomes (without needing to send samples to a lab, which may be irrelevant by the time the patient returns for followup), as well as the potential for millions (or even billions) in cost savings for expensive, advanced products placed on hostile wounds without the proper wound bed preparation. Kara Spiller, PhD, a biomedical engineering professor at Drexel University and a leading expert on the effects of biomaterials on chronic wounds, is also conducting research on this topic. Her preliminary results show tremendous potential. She is focusing on the particular ratios, not just levels, of certain inflammatory to anti-inflammatory markers in the wound bed (her approach could be applied to ratios of MMPs or other biomarkers, too). Understanding the right ratios throughout the healing process could potentially lead to not only improved diagnoses, but personalized treatments as well. Modalities could be recommended based on the inflammatory/anti-inflammatory properties of existing, readily available wound therapies. In theory, a treatment approach focused on bringing biomarker ratios in line with those found in acute (i.e. healing) wound beds, could be an equally or more relevant aspect of the wound’s ability to heal than its size, color, tissue type, moisture level, or other traditionally assessed characteristics. Leveraging MMP levels and ratios is an exciting emerging trend in the biochemical diagnostics space. The first firm(s) to successfully commercialize a solution (whether based on MMPs or other useful biomarkers) that combines effectiveness and utility, at a reasonable price point, has potential to revolutionize the clinical decision making process for wound care.   2) Imaging Like biochemical diagnostics, reliable point-of-care maging solutions have traditionally been lacking in advanced wound care. However, this year’s SAWC had a strong showing in this emerging category. Novadaq’s [Update: later acquired by Stryker in 2017] line of point-of-care visual perfusion assessment equipment provides a real time look at blood flow. The company launched its wound care-focused LUNA fluorescence angiography solution based on the prior success of its SPY Elite system in the OR setting. LUNA was slow to gain any traction when it was launched, due to the outpatient wound care and skilled nursing facility (SNF) settings’ low appetite for capital equipment expenditures. The company has since rolled out its per-use “pay-per-LUNA” pricing, which charges the customer based on a percentage of reimbursement as long as a minimum number of procedures are done per month, quarter, etc. Regardless of the short-term pricing and billing nuances, its value in the

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