April 2016

(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