(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 long term will be dependent on its ability to influence consistent, cost effective outcomes. If the LUNA system ends up being a tool that allows it to to bypass or be a substitution for current standards of care such as vascular ultrasounds and transcutaneous oxygen measurement (TCOM), I believe its adoption will increase under the transition to outcomes-based payments. However, if it remains a nice-to-have extra level of diagnostics, I don’t think it will gain widespread adoption in the majority of wound care settings.

So while this product type currently has a role in the broader treatment spectrum, it will need to demonstrate its value as a replacement for current standard of care to find its way to the majority of settings where advanced wounds are treated. Novadaq’s alliances with innovative firms such as robotic surgery leader Intuitive Surgical, multinational medical equipment powerhouse Maquet, and others are promising signs, but it will still need to navigate the practical and operational nuances of advanced wound care to ensure its solution is relevant beyond the OR and into the care sites where most wounds are actually treated.

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(Above: Attendees view a Novadaq product demo at the SAWC exhibition)

Similarly, California-based Modulated Imaging uses light wave analysis to provide non-invasive, real-time insights into skin-level perfusion (with other similar technologies in development). It is currently undergoing US FDA 501(k) regulatory review. At around $5,000 for the handheld clinical device (the academic/research capital equipment will cost around $80,000), it’s another neat device that too may or may not achieve mainstream adoption in inpatient, outpatient, and SNF settings in the evolving reimbursement environment. An advantage of Modulated Imaging’s solutions is that they are totally noninvasive and quick. However, it will need to prove its cost-benefit in terms of driving faster and better outcomes (such as quickly enabling a provider to know whether they can apply compression, debride, etc. without the need for bilateral arterial studies). If it can demonstrate this, then it has potential for increased utilization under an outcomes-based payment system. But if it becomes just another diagnostic layer that does not drive meaningful clinical decision making, it is unlikely to achieve any sort of widespread adoption in the majority of wound care settings.

One wound diagnostic imaging product that caught my attention was Toronto-based MolecuLight. Although it is still working its way through US FDA approval (it is approved in Canada already), this handheld, low cost device utilizes fluorescent imaging to provide real-time imaging of bacteria distribution at the point-of-care. It definitely doesn’t eliminate the need for wound cultures (to determine the organism(s) and susceptibility), but it can guide the clinician to where in the wound bed to swab, and encourages thorough debridement because the clinician can literally “see” where clinically relevant concentrations of microbes remain. With a reasonable price point, this solution has potential for widespread adoption and integration into clinical practice. MolecuLight CEO Craig Kennedy is also keen to explore partnerships with other innovative diagnostic and treatment firms, providing further avenues for optimizing the impact and effectiveness of this solution.

Moleculights mobile device to visualize surface-level bacteria in and around a wound bed
Above: MolecuLight’s non-invasive mobile device utilizes fluorescent imaging to provide real time detection of clinically relevant bacteria, which can aid in the accurate performance of wound cultures and debridements in any setting

 

3) Assessment/measurement

Many in the wound care industry are familiar with the widely cited statistic that if a diabetic ulcer does not reduce in size by at least 50% within 4 weeks of receiving standard of care, it is very unlikely to ultimately heal without advanced therapies.

Most experts would agree that there have not really been any particularly meaningful and reliable proven predictors of outcomes based on wound measurements since then. However, there is an ongoing debate in the industry regarding whether this may be due to the huge amounts of inaccuracy and inconsistency in traditional (i.e. paper ruler), manual measurements.

However, with the explosion in both the availability and capabilities of mobile technology, automated computer vision-driven wound assessments and measurements are beginning to take hold. Most notably, these assessments measure the actual wound dimensions, rather than measuring each wound as if it were a square or cube as is the case with traditional, paper ruler measurements.

Two startups in this space were on display at SAWC: eKare and Tissue Analytics (both based in the Washington-Baltimore Metro Area). Both solutions use mobile cameras combined with software to deliver consistent, accurate assessments and enable image and measurement tracking over time, through cloud computing and proprietary algorithms.

eKare, via its InSight device, combines an Apple iPad with a Microsoft Xbox Kinect sensor to produce 3D (i.e. length, width, and depth) measurements. It uses hardware and software to provide a 3D solution. The downsides are that in the current version, their hardware is required, which makes it a costlier and logistically less appealing option, especially for clinicians who must move around a facility–or even for a busy wound center where everyone must charge and pass around the device (or rent/purchase multiple units). Also, the relative importance of 3D measurements vs. 2D is not a consensus. From my experience, most providers will be satisfied that if the area of a wound is improving/worsening, that is enough to make a clinical decision even without depth (in cm). More important than the precise depth is usually the type of exposed tissue (fat, muscle, bone, etc.). Virtually any wound care expert would agree that a 0.3cm deep elbow wound with exposed bone is more concerning than a 3.0cm deep stomach wound that has not gone past the subcutaneous fat layer. Perhaps most importantly, the requirement of a physical device to be used creates a host of clinical-operational and logistical challenges for mass adoption.

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Above: One of several wound measurement/assessment solutions on display

Tissue Analytics, on the other hand, is a pure software company, which allows the user to use any mobile device (even their own) to securely run the app and assess wounds. An advantage of this approach is that it involves no hardware, which facilitates both scalability and cost attractiveness. Tissue Analytics is currently only able to offer 2D measurements (i.e. length and width, no depth), though the relevance of wound measurement depth as a predictor of healing outcomes is still a debated topic (as mentioned above), even among leaders in wound care science.

As these solutions become prevalent, more data will emerge regarding the “area vs. volume” debate, which will likely become a key data point for predictive analytics firms and healthcare payers alike. At the same time, literally dozens of new startups are entering this space with both similar and diversified offerings (several were at SAWC, too). The combination of the solution, business model, and execution will be the most important considerations in terms of which succeed and to what extent. Regulatory and reimbursement changes will also play a role, though it’s unclear if that will be a major factor for the mobile wound assessment space in the short and mid-terms.

It is clear that the market for mobile wound assessments and measurements has huge potential, both in traditional care settings (improved outcomes and productivity), as well as in terms of their potential for telemedicine and ability to connect patients with advanced wounds to specialist providers without the need to travel to them regularly.

One thing that is certain is that mobile assessment/measurement solutions have the potential to connect patients to specialty wound care providers faster, more easily, and more consistently than ever before. This alone makes this a very exciting area to watch. These technologies also have huge potential in the areas of dermatology, aesthetics, and related fields that can be impacted with computer vision and workflow delivered via mobile.

 

Conclusion

As the reimbursement model for wound care transitions from fee for service to bundled payments, the diagnostic technologies discussed above will have greater potential to be used. However, the high costs and lack of mobility that comes with expensive capital equipment will remain a major obstacle to widespread adoption, and the leading solutions adopted will need to both have a significant and consistent impact on outcomes, as well as a low price point, to justify their use with most wounds and care sites.

On the other hand, mobile, point-of-care diagnostics (biochemical, imaging, and assessment/measurement) that have potential to both improve outcomes and productivity, while simultaneously reducing costs–at a price point that allows for their widespread adoption, are positioned to be the next big thing in advanced wound care.

Several SAWC presentations discussed the potential for diagnostics to guide and predict wound care. Some, such as Irena Pastar, PhD of The University of Miami Miller School of Medicine suggested that in the future, an EHR’s wound progress page might track several factors, including biochemistry, perfusion, and measurements, and assign a personalized “healing profile” and recommended treatments based on a combination of these three, or other factors.

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(Above: Dr. Irena Pastar was one of several experts suggesting that future wound care EHRs and analytics might create a personalized wound “healing profile” that would merge biochemistry, imaging, measurement, and other data to provide better diagnoses and predictions)

In assessing the many solutions being discussed and showcased, one thing is certain: The race is underway to develop reliable, quick, and cost effective solutions to diagnose and guide wound healing. The first organizations to develop, prove, and commercialize these technologies will be able to create enormous value for patients, providers, and other stakeholders. Whether this will be a single diagnostic/device, or a combination of several products, is yet to be seen. But the recent SAWC was an exciting look at the future of wound diagnostics, to those who are paying attention.

What are your thoughts on the future of wound care diagnostics? What types of solutions would be most valuable?                

How might they have the potential to impact the delivery and business of wound care on a large scale?                                          

Please comment below.

This was part 1 of a 3 part series. View Part 2 and Part 3 here.

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