Market Movers | Innovation Signals | Wound Care Watchdogs

Welcome to the June edition of Below the Knee, your go-to monthly dispatch covering what’s moving, what’s merging, and what’s making waves in wound care, foot & ankle, and limb salvage.

Let’s dive in 👇

🚀June Market Movers🚀

From the WoundCareFund.com public company tracker

The WoundCareFund posted solid gains, narrowly trailing large-cap and tech indices in June, but still reflecting strong investor appetite for wound-focused innovation. Not a bad month for a vertical most still call “niche”.

WoundCareFund index performance for June 2025

Top 3 Movers of June:

• Spectral AI (MDAI): +52.15%
  AI diagnostics gets its moment. Strong Q1, strong pipeline, and growing investor appetite for AI in clinical wound imaging.

• Organogenesis (ORGO): +37.59%
  Riding the wave of bullish analyst upgrades and positive reimbursement signals. A strong showing for one of the most polarizing names in the space.

• TELA Bio (TELA): +36.62%
  OviTex momentum is real. Market enthusiasm is building behind their biologic-synthetic hybrid as adoption grows in complex closure.

Honorable Mentions:

• SANUWAVE (SNWV): +25.23%
  Shockwave therapy gets commercial muscle. New leadership and renewed execution drive gains.

• Next Science (ASX:NXS): +20.00%
  Biofilm disruptor goes ballistic. Investors are finally catching on to the clinical upside of its Xbio® platform and recent U.S. traction.

• Aroa Biosurgery (ASX:ARX): +17.41%
  Driven by strong full-year results, international growth momentum, and investor confidence in its soft-tissue regeneration pipeline.

Underperformers Explored

• MediWound (MDWD): -12.90%
  MediWound’s minor dip in June followed the release of its Q1 financials: $3.96M in revenue, below the $5.20M consensus, though EPS beat expectations (–$0.07 vs. –$0.65). The earnings call emphasized progress toward EscharEx Phase III data and completion of its VALUE pivotal VLU trial. However, shortfalls in top-line revenue and negative burn (–110% net margin) prompted profit-taking, even amid renewed analyst optimism.

• Celularity (CELU): -9.26%
  Shares slumped following a formal notice from Nasdaq for failing to file its Q1 2025 Form 10-Q on time triggering a 60-day compliance window. This type of regulatory misstep often undermines investor confidence, especially in early-stage biotech companies. With ongoing cash constraints and cell therapy development costs, the notice highlighted governance and operational concerns.

• Avita Medical (RCEL): -8.48%
  Despite strong Q1 revenue growth (+67% YoY to $18.5M) and the RECELL GO surgical device winning MedTech Breakthrough’s “Best New Surgical Tech” award, the stock dropped in June due to a Q1 earnings miss—reporting –$0.53 EPS versus –$0.39 expected, and weak device adoption trends. Margin erosion was noted (84.7% vs. 86.4% prior year), and investors remain cautious about the company’s ability to convert new hospital accounts, scale its broader product portfolio (e.g., Cohealyx), and meet 2025 profitability targets.

Each of these companies shows real momentum, but June reminded investors that execution, operational discipline, and milestone delivery are unforgiving. Positive announcements aren't enough - markets demand follow-through.

💡Innovation Index Highlights💡

In June, we kicked off the WoundCareFund Innovation Index series by diving into the two most dynamic sub-segments in wound care and limb salvage: Vascular Intervention and Measure & Assess.

Vascular Intervention – Top Ranked Segment (Score: 6.45)

This space is moving fast and cutting deep—literally. Vascular intervention leads the pack in innovation by tackling the most urgent patient needs in CLI and PAD. Regulatory tailwinds, blockbuster M&A, and device evolution (think DCBs, stents, and atherectomy) have created a wave of momentum.

• Shockwave Medical – The new standard for treating calcified lesions with intravascular lithotripsy.

• Cardiovascular Systems, Inc. – Orbital atherectomy pioneer, reshaping how PAD is treated.

• Avinger – Merges real-time imaging and therapy in one system.

• LeMaitre Vascular – CLI-focused surgical toolkit across grafts, patches, and more.

• LimFlow – Taking on no-option CLI with deep vein arterialization tech.

Measure & Assess – Rising Star (Score: 5.94)

Far beyond digital rulers, this segment is transforming wound visualization into intelligent, reimbursable, and AI-driven workflows. The tools here aren’t just pretty pictures—they drive decisions, speed healing, and improve outcomes from clinics to home care.

• MolecuLight – First to mainstream fluorescence imaging at the bedside.

• eKare – Combining 3D measurement with AI analytics for clinical and trial use.

• Kent Imaging – Non-invasive perfusion insights at the push of a button.

• MIMOSA Diagnostics – Compact, real-world ready tools for tissue oxygenation.

• Swift Medical – Scalable, enterprise-grade imaging platform powered by a massive dataset.

Check out the full Index and Scoring system here

📰June Industry News📰

Clinical & Regulatory Actionables

• BioStem wraps enrollment in its DFU BioREtain trial—signaling a near-term data catalyst in Q3–Q4.

• SolasCure’s Aurase Gel scores FDA Fast Track for venous leg ulcers—potential fastest-to-market wound gel in 2025.

• Kent Imaging launches the Plantar-Palmar Index, offering a new non-invasive ABI alternative for PAD screening—positioning imaging at the gateway to vascular intervention.

Paradigm Therapeutics

Secured $12.6M from Eshelman Ventures, pushing total funding to $25.1M for its whole-body topical therapy focused on epidermolysis bullosa. This rare-disease platform could significantly disrupt both specialist and broader wound-healing markets as it advances R&D and prepares for validation data.

Empo Health

Launched their intelligent foot imaging and monitoring scale—a remote tool for diabetic foot ulcer surveillance. Powered by imaging and weight tracking, backed by a $7M funding round, the system is now rolling out in clinics to drive early interventions and reduce amputation risk.

Smith+Nephew (SNN)

Entering the UK ambulatory surgery center (ASC) market with a pilot orthopedic ASC, marking the first of what will expand to 10 centers in coming years. This vertical integration positions Smith+Nephew to influence both surgical closure care and downstream services, potentially reshaping outpatient limb-salvage delivery.

Optum Reverses Course on DPM Status

Optum backtracked on a proposed reclassification of podiatrists (DPMs) as allied health professionals, reaffirming their status as physicians. This reversal safeguards DPM-led care pathways in limb salvage and ensures continued access to full clinical roles—including surgical, wound-care, and reimbursement pathways.

Houston Podiatric Medicare Fraud Charges: $45M Drain

A podiatrist in The Woodlands, Dr. David Jenson, and his business partner Néstor Refael Romero Magallanes have been charged with orchestrating a massive Medicare fraud scheme involving over $90 million in claims and more than $45 million in reimbursements. Operating under their company “Doctor’s Inc.,” the pair allegedly billed Medicare for unnecessary applications of expensive “second skin” bioengineered skin substitutes, often misrepresenting the procedures as treatment for wounds, swelling, or pain. They fabricated medical records, falsely claimed Medicare coverage to patients, and continued billing even after federal authorities issued a warning in early 2023.

National Health Care Fraud Takedown

The DOJ’s June 2025 National Health Care Fraud Takedown charged 324 defendants in schemes totaling over $14.6 billion in intended losses, marking the largest coordinated enforcement action in the department’s history. Among the targeted areas was a major focus on fraudulent wound care, where providers billed Medicare for medically unnecessary or non-reimbursable skin substitute grafts and wound care services. The DOJ specifically highlighted schemes involving unsupervised treatments, duplicate billing, and use of unqualified staff to provide high-cost procedures. In one case, a wound care clinic allegedly billed Medicare for services not rendered by a physician or qualified provider but instead by unlicensed personnel, sometimes while the billing physician was out of state. Another case involved a clinic inappropriately using amniotic skin substitutes, resulting in millions in fraudulent claims.

The scope of the alleged fraud is staggering: prosecutors are now seeking to seize $13 million in bank assets and $69 million in cryptocurrency tied to the case. According to the indictment, the defendants used the funds to bankroll luxury lifestyles, including private jet travel, jewelry, and crypto investments. Both men have pleaded not guilty and are currently out on bond. Jenson’s attorney maintains that all procedures were medically necessary, but federal prosecutors paint a picture of systemic abuse targeting Medicare for personal gain.

These actions underscore heightened federal scrutiny around skin sub billing, wound grafts, and site-of-service abuse - a direct compliance warning shot to the limb salvage and foot/ankle care community where skin subs and biologics are frequently used.

CMS Targets Low-Value Care with New WISeR Model

CMS has officially launched the WISeR Model (Wasteful and Inappropriate Services Reduction), a new six-year voluntary program aimed at curbing unnecessary or low-value care in Original Medicare. The model leverages AI and machine learning tools—under licensed clinician oversight—to flag services that have historically demonstrated questionable clinical value, including skin substitutes, nerve stimulators, and knee arthroscopies for osteoarthritis. Starting in January 2026, the model will pilot in six states (NJ, OH, OK, TX, AZ, and WA), with applications open through July 25, 2025. Tech partners selected by CMS will support pre-payment reviews or optional prior authorizations, with provider participation incentivized through performance-based rewards and the opportunity to “gold card” out of future review if compliance remains high. The initiative is built to reduce waste (which accounts for an estimated 25% of U.S. healthcare spend) without limiting patient access or coverage. With the rise of AI in healthcare, WISeR is an early signal of CMS’s intent to modernize FFS Medicare oversight—blending automation with clinical judgment to enforce evidence-based care while minimizing administrative burden.

🎙️ What It All Means — Big Picture

This month’s headlines say two things loud and clear: opportunity and oversight are both ramping up. While innovative wound care platforms—from biologics to AI imaging—are hitting stride in markets and trials, regulatory enforcement is sharpening. With billions being claimed (and clawed back), compliance isn’t optional—it’s mission‑critical.

🔦Innovation Index Spotlight - Avita Medical🔦

Avita Medical is a regenerative medicine innovator, commercializing in-hospital Spray-On Skin™ therapies. Their flagship RECELL® System has treated over 30,000 patients globally, providing FDA‑approved therapy for burn and full-thickness wounds, and now expanding aggressively into acute closure markets.

They also scored an impressive 7.05 on the Innovation Index Score. While their stock took a hit in June, they have a lot of good activity to counter:

Key Product and Differentiators

RECELL GO & GO mini:

• Enables bedside autologous skin cell suspension—using just a 1 cm² sample to treat up to 80 cm² of wound area.

• Launched the GO mini in February 2025 for trauma centers, offering disposability and streamlined use

Why It Matters

• Expanding clinical footprint: Going beyond burns into trauma and surgical closures—positioning RECELL as a suite solution rather than a standalone device.

• Scalable tech: GO versions enhance consistency, training efficiency, and adoption in busy OR settings.

• Economic value: Proven hospital savings strengthen reimbursement push and sales engagement.

The Takeaway

• Broader adoption potential across burns, surgical, trauma, and even chronic wounds.

• Profit milestone in sight: 2025 guidance targets profitability by Q4, underpinned by product diversification and execution

Avita Medical is evolving fast—transforming from a single-use burn device into a full-suite acute wound platform. With compelling real-world data, economic impact, regulatory approvals, and a widened TAM, they’re no longer just a hopeful—they’re a market mover.

Thanks for reading — and for advancing wound care below the knee and beyond.

👋 Got news? New launch, trial, or market play? DM me or hit reply—we spotlight rising players every month.

— Scott
Publisher, Below the Knee
LinkedIn | WoundCareFund.com