WOUNDCARE FUND — WEEKLY PERFORMANCE SNAPSHOT
WoundCare Fund: −0.93% NASDAQ: −1.49% | S&P 500: −1.00% | Dow Jones: −1.43%
The WoundCare Fund closed the week down −0.93%, outperforming the broader market in a risk-off stretch. Not a great week — but relatively speaking, this is what holding up looks like.
Key Movers — Downside
Avita Medical — −12.01% After a strong prior run, this looks like a reset. Names tied to advanced therapies and procedure-driven growth tend to see sharp pullbacks when momentum cools or expectations get ahead of execution. Investors remain focused on utilization trends and the pace of commercial expansion.
Organogenesis — −9.43% Continued pressure here points to lingering uncertainty in the skin substitute and CTP segment. Reimbursement dynamics, policy scrutiny, and utilization trends remain front and center — and the market is not giving anyone the benefit of the doubt right now.
Covalon Technologies — −7.88% Likely a mix of small-cap volatility and profit-taking following recent strength. Companies in advanced dressings and infection prevention are still working to prove consistent scale and margin expansion, which can lead to choppy trading in uncertain markets.
OPENING SHOT
BARDA Writes a $31.7M Check. The CMS Lawsuit Heats Up. AI Gets a Regulatory Green Light.
A $31.7M BARDA award dropped for Spectral AI's DeepView burn imaging system. Value-based care organizations filed an amicus brief in support of CMS's skin substitute payment restructuring — adding legal weight to a rule the industry has been fighting for months. The FDA quietly rewrote the AI regulatory playbook in January, opening a wider lane for clinical decision support tools. Advanced Medical Solutions posted record 2025 results. Kane Biotech landed a VA distribution deal. And NanoBioFab is turning wounds into early warning systems.
The policy environment is moving fast — and not always in the same direction at once. CMS is tightening the skin substitute category while the FDA is loosening its grip on digital health. For companies building at that intersection, the week's news is worth reading carefully.
WOUND CARE
Investment | Spectral AI Lands $31.7M BARDA Award — DeepView Burns Brighter
Spectral AI (MDAI) announced March 18 that BARDA has advanced $31.7M in additional funding to accelerate development of the DeepView System, its AI-powered burn wound imaging platform. This non-dilutive funding is on top of $54.9M already committed under a contract valued at up to $150M. Spectral is also contributing $9.7M to total development costs. The DeepView System is being developed for use in emergency departments, burn centers, and trauma settings — including as a medical countermeasure for mass casualty burn incidents.
The BTK read: this is strategic government investment in AI-driven wound assessment, not a research grant. BARDA is betting on DeepView as a triage tool for burn mass casualties, where only 250 burn surgeons exist in the U.S. for 40,000 annual hospitalizations. Pending FDA market authorization, the commercial opportunity is real — and the government-funded development path significantly de-risks the path to clearance.
Market | Advanced Medical Solutions Reports Record 2025 — Woundcare Recovers, Surgical Leads
Advanced Medical Solutions (LSE: AMS) reported record full-year 2025 results on March 18, with Group revenue of £228.9M — up 29% — driven by the first full-year contribution from Peters Surgical and continued organic momentum. The Woundcare division returned to growth, with revenue up 9% to £45.5M following restructuring measures. Surgical division revenues grew 36% at constant currency to £183.5M. Adjusted EBITDA rose 24% to £49.9M; net debt declined to £50.5M. The company raised its dividend 10% and guided FY2026 revenue and EBITDA in line with current market forecasts (consensus: £244.6M revenue). The woundcare story here is a turnaround-in-progress: restructuring measures are working, commercial synergies from acquisitions are contributing, and long-term supply agreements are expected to provide stability through 2026. Not a high-velocity wound care name, but a disciplined operator with a recovering segment that bears watching.
Regulatory | CMS Skin Substitute Rule Gets Legal Backup — Amicus Brief Filed in CAMPs Litigation
On March 18, healthcare law firm Arnall Golden Gregory filed an amicus brief in The CAMPs Initiative v. HHS, the pending federal lawsuit challenging the CMS rule that restructured Medicare reimbursement for skin substitute products. The brief was filed on behalf of value-based care organizations — including ACOs and physicians in value-based models — arguing that CMS acted within its authority and that the prior reimbursement structure created incentives that drove escalating Medicare expenditures. The legal argument is pointed: the old payment model contributed to fraud, waste, and abuse, and the new rule supports the broader goals of quality improvement and cost control.
The BTK read: this is the first significant third-party legal support for the CMS position in this litigation. If value-based care organizations are willing to go on record defending the rule, it signals that the political coalition backing the restructuring is broader than just CMS. Companies betting on a full rollback of the skin substitute rule should be paying attention to how the legal record is developing.
Innovation | NanoBioFab Is Building a Smoke Detector for Wound Infections
NanoBioFab, a Frederick, Maryland-based startup, is developing RAPID-iNose — a wearable nanosensor array that continuously monitors gases released by wound pathogens to detect infection before it is clinically visible. The platform combines patented nanomaterial sensors with AI algorithms to identify pathogen signatures in real time, without laboratory testing or invasive sampling. The company has secured over $8M in government contracts, including a SBIR Phase II award from the Defense Health Agency, and has received TEDCO investment. The technology is pre-commercial and still in development, but the clinical concept is sound and the military application is well-funded. For the wound care market, early and non-invasive infection detection is one of the most consequential unmet needs — particularly for diabetic foot ulcers and pressure injuries where delayed diagnosis drives amputation. This one is worth watching.
Innovation | 3D-Printed Chitosan Patches Show Promise for Chronic Wound Healing
Researchers at the University of Mississippi published results in the European Journal of Pharmaceutics and Biopharmaceutics this week demonstrating a 3D-printed scaffold made from chitosan and plant-derived antimicrobials for chronic wound healing. The biodegradable, customizable patch acts as a wound scaffold — encouraging cell growth while delivering antimicrobial agents without organic solvents or traditional antibiotics, reducing the risk of bacterial resistance. The patch degrades in situ, eliminating need for removal procedures. Pre-clinical stage. The relevance: this is the convergence of additive manufacturing, biomaterials, and anti-biofilm strategy that is starting to appear repeatedly in wound care research. It won't be a commercial product soon — but the research direction signals where next-generation chronic wound treatment is heading.
Market | Kane Biotech Lands VA Distribution Deal — Federal Channel Opens for revyve
Kane Biotech (TSX-V: KNE) announced March 10 that it has signed a distribution agreement with Marathon Medical Corporation, a federally verified Service-Disabled Veteran-Owned Small Business, to access the VA, DOD, and Indian Health Services procurement channels with its revyve Antimicrobial Wound Gel line. The company simultaneously announced it is building a national contract sales force. Kane's revyve platform has three FDA 510(k)-cleared formats and two Health Canada-approved formats; the biofilm-disruption mechanism is the clinical differentiator. The federal channel access is meaningful: the VA manages one of the largest chronic wound patient populations in the U.S., and SDVOSB distribution partnerships provide streamlined procurement pathways into a historically difficult-to-penetrate system. Small company, but a smart commercial move.
LIMB SALVAGE
Regulatory / AI | FDA's New AI Guidance Opens the Lane for Clinical Decision Support in Wound and Vascular Care
In January 2026, FDA Commissioner Makary released updated guidance on Clinical Decision Support Software and General Wellness products — the most significant digital health regulatory shift in years. The key change: software that provides a single, clinically appropriate recommendation for provider review is no longer automatically classified as a regulated medical device. Under the prior 2022 guidance, a single-output recommendation triggered device status. Now it can qualify as non-device CDS if it meets other statutory criteria — including transparent, clinician-reviewable logic and no autonomous clinical decision-making. The broader wellness guidance similarly expands the scope for non-invasive wearables estimating physiologic parameters. The
BTK read: this matters directly for wound imaging, infection detection, and vascular diagnostic tools currently in development. Companies like Spectral AI (DeepView), NanoBioFab (RAPID-iNose), and emerging wound documentation AI platforms are all building in spaces where this guidance shift changes the regulatory calculus. If your tool provides a clinician with a recommendation they can independently evaluate and act on, the path to market just got shorter. FDA has signaled more AI-specific guidance is coming — watch the CDRH guidance agenda for the policy on Device Software Functions, currently being reissued as draft guidance.
Regulatory | FDA 510(k) Spotlight — Pace Surgical Clears Ultra Compression Screw for Foot & Ankle
Pace Surgical, operating within Runway Healthcare's MedTech venture studio, received FDA 510(k) clearance for its Ultra Compression Screw System, targeting foot and ankle reconstruction. The company plans a limited release in select surgical centers followed by a broader commercial rollout later in 2026, alongside anatomical locking plates and screws. This is a new entrant in a category dominated by Treace Medical, Paragon 28 (now Zimmer Biomet), and Arthrex — worth tracking as Runway's capital-efficient studio model has produced clinically differentiated products in orthopedics before. Also notable from the prior period: BlueOcean Global's Excelsior External Fixation System (K253291), cleared January 2026, introduces a limb salvage fixation platform specifically designed to address the intersection of bone reconstruction and soft tissue management in Charcot, DFU, and complex trauma cases — guided by the FASTR (Fixator Assisted Soft Tissue Repair) framework. First-of-kind integration of fixation and soft tissue strategy in a single system.
FOOT & ANKLE
Market | Stryker Begins Recovery — But the Supply Chain Questions Aren't Going Away
As of this edition, Stryker is reporting partial system restoration following the March 11 Handala wiper attack. The company has not disclosed a full recovery timeline or a public accounting of the financial impact. The American Hospital Association confirmed awareness but reported no confirmed long-term supply disruptions as of mid-week. Hospitals that disconnected from Stryker's LifeNet platform during the outage are beginning to reconnect. What hasn't returned to normal: the underlying conversation about single-supplier concentration in orthopedic and podiatric surgical supply chains. The Stryker attack has surfaced procurement conversations that health systems hadn't been having — about backup supplier qualification, contract continuity provisions, and device management security. Foot and ankle surgeons and OR coordinators who haven't reviewed their Stryker dependency in the past ten days should do it this week.
THE SIGNAL
The Regulatory Environment Is Splitting in Two — and the Smart Money Is Positioning Accordingly.
Two major regulatory storylines are running in parallel right now — and they're pointing in opposite directions.
On one side, the FDA is loosening its grip on digital health and AI-enabled clinical tools. The January 2026 CDS guidance update represents a genuine expansion of the non-device safe harbor for software that supports — but doesn't replace — clinical judgment. For companies building wound imaging, infection detection, and vascular diagnostic tools, the regulatory lane just got materially wider. Spectral AI's BARDA award, NanoBioFab's sensors, and a growing pipeline of wound documentation AI platforms are all better positioned today than they were twelve months ago.
On the other side, CMS is tightening its grip on reimbursement for skin substitutes and cellular tissue products — and it's getting legal cover to hold that position. The amicus brief filed this week by value-based care organizations in the CAMPs Initiative litigation is the clearest signal yet that the CMS restructuring has a broader political and legal coalition behind it than just the agency itself. Companies that were waiting for a full rollback of the December 2024 commentary need to recalibrate. The restructuring is not going away.
The companies that will perform well in this environment are the ones that can read both signals simultaneously: build AI-enabled tools under the new regulatory framework, and demonstrate clinical and economic outcomes that justify reimbursement under a tighter CMS standard. Those aren't competing strategies. They're the same strategy.
SAWC Spring is three weeks out. The conversations in Charlotte will be worth paying close attention to.
Watch this week: Sanara MedTech Q4/FY2025 results expected March 24. Listen for any commentary on CTP channel dynamics, site-of-care trends, and what management is seeing in utilization post-CMS December commentary.
📅 UPCOMING EVENTS
March 24 Sanara MedTech Q4/FY2025 Earnings — Earnings call. Watch for wound care channel commentary and any signal on CTP utilization trends post-CMS restructuring.
April 8–12 Diabetic Limb Salvage (DLS) / Wound Healing Foundation — Washington, DC / MedStar Georgetown The premier multidisciplinary event on diabetic limb preservation. Faculty span vascular surgery, podiatry, wound care, and research. Essential for anyone tracking the clinical intersection of diabetes, amputation prevention, and advanced wound care.
🔥 April 8–12 🔥 SAWC Spring / Wound Healing Society Annual Meeting — Charlotte, NC World's leading interdisciplinary wound care conference. This year carries more weight than usual. Expect focused sessions on CMS skin substitute restructuring, site-of-care migration, AI-assisted wound documentation, and the reimbursement landscape post-December 2024. Three weeks out. Mark the calendar.
See you next week. — Scott
Below The Knee | belowtheknee.co - Independent market intelligence for wound care, limb salvage, and foot & ankle. Not subscribed yet? → [click here]
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