Wound Care Global

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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Welcome to our new site!

Welcome to our new, updated site! In addition to a total redesign, we are pleased to offer several new tools and features. This includes the ability to: Get your free download of The Definitive Wound Care Investment and Partnership Due Diligence Checklist Schedule a consult directly from the site Access wound care business resources …and of course this new content section where we’ll publish insights and other valuable information to empower wound care business stakeholders. We published a lot articles and other content prior to this new website, many of which can still be found here. And of course we will continue contributing to leading wound care / biomedical / healthcare publications such as Today’s Wound Clinic, MedTech Intelligence, Healthcare Business International, The Advisory Board Company, and others. Reach out to us with any requests or questions. And as always…Become a keener wound care executive.

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