What Defined December
December felt less like a holiday slowdown and more like a stress test. Markets swung, reimbursement narratives shifted again, and regulators reminded everyone that claims, wording, and “creative interpretation” still have consequences.
The theme: evidence wins, documentation matters, and the cost of ignoring reality just went up.
💲 Finance — WoundCareFund Market Pulse (December Wrap-Up)
December was volatile — not chaotic, just brutally honest. Capital rotated toward companies with regulatory clarity, stronger balance sheets, and credible reimbursement footing. Everyone else felt gravity.
Overall, the WoundCare Fund finished December slightly negative, but it outperformed major indices during broader pullbacks — a sign that investors are quietly sorting the space based on durability, not hype.
Leaders stood out for evidence and direction:
Axogen surged on strong revenue growth, profitability, and confidence ahead of the Avance BLA.
Integra benefited from favorable reimbursement posture for its regenerative portfolio.
Organogenesis moved higher as ReNu progressed toward a rolling BLA and analysts warmed up.
PolyNovo gained from the narrative that its economics may improve under shifting policy.
Laggards felt the consequences of uncertainty:
Celularity absorbed repeated pressure — cash runway, dilution risk, and an FDA warning letter created a credibility overhang.
Spectral AI slipped as investor enthusiasm cooled in the absence of fresh catalysts.
Treace was hit by growth concerns paired with ongoing losses.
What the market is actually saying:
Regulatory clarity = premium.
Evidence and comparative data = pricing power.
Cash without a path doesn’t impress anyone anymore.
Reimbursement risk is now priced first, not last.
This wasn’t a “bad” month — it was a repricing month. And repricing tends to reward operators who can prove clinical value and survive the policy reset. The rest? They’ll be fundraising… creatively.
📢 Market & Company Updates
HMP Global launched CTP News Desk – orienting the field to the 2026 transition (and including your interview on payer pressure, evidence and realignment).
Kuros began enrollment in ASTRA — MagnetOs vs autograft in ankle/hindfoot fusions.
BioStem expanded Medicaid coverage to 13 states for VENDAJE.
Kent Imaging x NHMS — exclusive U.S. distribution; big statement for imaging-driven documentation.
Vohra will pay $45M over alleged billing practices — painful but clarifying for the industry.
MPM launched TripleHelix at-home kits + provider portal.
MolecuLight became available via Oracle Marketplace (FHIR integration).
MCT + Derm Education Foundation — AI-driven wound/skin platform.
SANUWAVE added UltraMIST to Healogics GPO.
HMP Global launched WoundCon365 — always-on education.
LifeNet acquired T3 to advance biopreservation tech.
Organogenesis cleared to begin rolling BLA for ReNu.
Arizona Medicare skin-substitute fraud case — 15-year sentences. Message received.
NPIAP partnership expansion for 2026 meetings.
MPM expanded collagen manufacturing with 510(k) capability.
The common thread: better data, stronger workflows, and tighter scrutiny across the ecosystem.
🏛️ Policy Pulse — Jan 1 Isn’t a Date. It’s a Line in the Sand.
We’re heading into a year where reimbursement stops rewarding muscle memory and starts rewarding discipline. Not theory — operational reality.
Here’s the clearest framework I can give you:
What’s real. What’s rumored. And where you’d better be focused.
✅ What’s Real (Effective Jan 1)
1️⃣ Site-neutral pressure is now baked into the cake.
Alignment between the Physician Fee Schedule and OPPS is reshaping economics.
Translation: where care happens matters less — whether it was justified matters more.
Implication: High-cost care without airtight documentation becomes indefensible.
2️⃣ Objective measurement isn’t optional anymore.
WiSer infrastructure and broader data initiatives are tightening utilization visibility. We’re moving toward:
clear wound trajectory tracking
earlier payer intervention
fewer “trust me, it was necessary” approvals
Implication: If you can’t show wound progress, expect denials or audits.
3️⃣ LCDs may be gone — but scrutiny is not.
Yes, the LCDs vanished. No, concern and need to focus is over.
Payers pivoted from rule lists to medical necessity evaluation, case by case. That actually raises the bar.
Implication: Evidence, assessment rigor, and decision logs now carry the day.
4️⃣ Prior auth + audits are coming sooner in the care process.
Expect more pre-checks, more utilization flags, and more payer “conversations” — early.
Implication: Providers who can’t back up their choices in real time will spend 2026 playing defense.
5️⃣ Marketing claims now sit under a spotlight.
The FDA warning letter to Celularity wasn’t random. It was a message.
Implication: Over-promising on outcomes or biology isn’t “creative branding” anymore — it’s risk.
🗣️ What’s Rumored (And Worth Paying Attention To)
None of this is guaranteed — but signals are loud:
Comparative effectiveness becoming table stakes.
“Better than placebo” isn’t convincing anyone. Expect pressure to prove relative value.Skin substitute utilization frameworks evolving.
More uniform guardrails and clearer expectations could surface — not restrictive, but structured.Real-world evidence gaining policy influence.
Not as a replacement for trials — but as a tie-breaker.More DOJ/insurer actions where financial intent looks questionable.
The Arizona case won’t be the last. Compliance is suddenly a competitive strategy.Increased payer alignment across regions.
Variability is inefficient. Expect harmonization slowly tightening the system.
📌 The Punchline
This isn’t “tightening reimbursement.”
This is a new operating model for wound care.
Medical necessity, measurable progress, defensible decision-making — that’s the game.
The companies and clinics that embrace it will thrive. The ones that don’t will complain about “unfair payers” while watching revenue evaporate.
Bluntly: adaptation is now a clinical skill.
And the industry leaders who master it will own the next decade.
🎯 Where Everyone Needs to Focus (Providers, Industry, & Distributors)
For Providers
Document like an auditor is sitting behind you.
Measurements. Rationale. Progress. Failure before escalation.Adopt tech that reduces ambiguity.
Imaging, measurement, decision support — not gadgets, guardrails.Use biologics intentionally — not reflexively.
Every application should read like a medically necessary decision, not habit.Train your front desk and coders.
Most revenue loss happens before a clinician touches the wound.Audit yourself quarterly.
Fix problems internally, not after a payer does it for you.
For Industry
Evidence packages must grow up.
Outcomes + economics, not anecdotes + aspirational decks.Run comparative studies — even if they’re uncomfortable.
CMS is telling you what matters. Believe them.Build products that make compliance easier.
If your tech doesn’t reduce audit exposure, you’re behind.Rebuild GTM messaging.
Talk about workflow, ROI, and audit safety — not just “innovation.”Partner differently.
Win alongside clinicians, not at their expense.
For Distributors
Vet inventory through the lens of necessity.
Stock products aligned with measurable outcomes and compliant usage.Educate clinicians proactively.
Provide data, not just availability — show why and how products meet policy requirements.Align contracts with evidence-based care.
Flexible distribution strategies that support compliant clinical decision-making win loyalty.Track utilization trends in real time.
Identify gaps, anticipate payer scrutiny, and proactively manage demand shifts.Partner with industry for workflow solutions.
Distributors who help providers navigate audits, documentation, and prior authorizations will remain essential.
🎙️ Podcasts & Conversations — Expanding the Conversation
December was a month of conversation, collaboration, and influence — the kind of engagements that make Below the Knee more than just a newsletter. These weren’t casual appearances — they were opportunities to share critical insights, validate our work, and reach new corners of the wound, limb salvage, and foot & ankle community.
Bobber Biotech Webinar — I joined Rob Odell and Matt Lawhon, J.D., on this distributor-hosted session to discuss reimbursement realities, technology adoption, and how tools like Swift Medical are helping providers navigate the 2026 reset. Bobber Biotech is an engaging partner and this session highlighted collaborative problem-solving across the industry.
🔗 Watch the webinarLife of Flow Podcast — Hosted by two respected vascular surgeons, this platform allowed for a deep dive into the uncomfortable truths of wound care today: reimbursement pressures are breaking the model, and adaptation isn’t optional. We explored what leaders should do next, how innovation fits in, and why objective data and compliance-first workflows will define success in 2026. The discussion was insightful, practical, and — honestly — a lot of fun.
🔗 Listen here
Why this matters:
These engagements amplify the Below the Knee brand, extend its reach to clinicians, distributors, and investors, and demonstrate that our insights aren’t just commentary — they’re actionable guidance. Participating in collaborative, high-quality platforms like these validates the work we do, reinforces our credibility, and expands our influence in shaping the conversation around wound care, limb salvage, and foot & ankle innovation.
✅ 2025 Key Themes & Trends — What the Year Really Looked Like
1. Reimbursement Redefinition Was the Dominant Narrative
2025 was defined less by isolated news and more by a systemic shift in how wound care gets paid. CMS’s 2026 policy changes — especially around PFS/OPPS site neutrality, documentation expectations, and the removal of LCDs — reshaped the economics of wound care. Providers and companies alike had to rethink how services are justified, documented, and defended.
Site-neutral payment became entrenched, especially for skin substitutes.
Documentation and measurement shifted from “nice to have” to central to revenue integrity.
Prior authorization and audits began moving earlier in the clinical workflow.
Takeaway: 2025 wasn’t about rate changes — it was about structural reimbursement evolution that forces clinical and commercial discipline.
2. Evidence & RWE Became Competitive Advantage
Across the year, the industry saw a clear premium placed on real-world evidence and comparative data:
Innovation Index segments like Vascular Intervention and Measure & Assess gained traction because they leaned into quantifiable outcomes.
Polls and community feedback repeatedly signaled skepticism of “biologic everything” without data to back it up.
Takeaway: Parties with objective, defendable clinical data outperformed the chatter — and 2026 reimbursement rules will only accelerate this.
3. Digital Tools & Objective Measurement Went From Buzz to Business Case
Imaging, AI, and analytics emerged as real decision support, not just glitzy tech:
Beyond 3D measurement and AI analytics, companies like Swift Medical, MolecuLight, Kent, Mimosa were highlighted for turning measurement into clinical decisions and defensible utilization.
Takeaway: Tools that make documentation objective and reproducible are now must‑have infrastructure, not optional upgrades.
4. Compliance and Enforcement Intensified
The DOJ’s headline enforcement activity and Medicare fraud takedowns were more than news — they were wake‑up calls that compliance now directly affects market confidence and capital.
Enforcement touched both clinical and product usage patterns.
Industry players recognized that compliance isn’t just risk management — it’s market sustainability.
Takeaway: 2025 made it clear: compliance failures have real financial and reputational consequences.
5. Capital Flows Bounced Between Volatility and Discovery
Market performance across public wound care stocks reflected nuanced investor behavior:
Early surges on clinical/regulatory wins were balanced by pullbacks where evidence or runway were questioned.
Investors increasingly priced execution clarity, reimbursement durability, and real data — not just pipeline promise.
Takeaway: Capital wasn’t absent — it was choosy. Execution beat speculation.
6. Innovation Followed Utility, Not Hype
The Innovation Index and market watchers repeatedly highlighted spaces progressing toward measurable impact:
Steady or growth‑oriented categories included:
Vascular intervention and limb salvage, reflecting hard clinical need.
Measure & Assess technologies, because they solve real workflow and documentation challenges.
Adjunct therapies paired with clear reimbursement pathways.
Less momentum was seen in:
Segments perceived as overhyped without robust clinical data.
Takeaway: 2025 rewarded innovations that integrate into real world practice and reimbursement logic.
7. Strategic M&A Returned with Purpose
Mid‑year bustling M&A told a story:
Acquisitions weren’t random — they filled strategic gaps (bioelectric dressings, ASC expansion, diagnostics).
Takeaway: Buyers focused on portfolio diversification, reimbursement resilience, and value chain extension.
📌 What This Means for 2026
Across 2025, three big catalysts converged and gave December its headline weight:
Reimbursement is now measurement‑driven, not price‑driven.
Digital and clinical evidence infrastructure isn’t a luxury — it’s mission‑critical.
Capital and compliance are shaping who thrives vs. who survives.
These trends didn’t just show up — they cemented a new operating model for wound care, limb salvage, and foot & ankle innovation.
🚀 Looking Ahead — 2026 Opportunities
January isn’t just a reset — it’s a launchpad. The companies, distributors, and providers who focus on what truly matters will define the next era of wound care and limb salvage.
Providers: Embrace documentation rigor and leverage digital solutions — imaging, measurement, and workflow tools aren’t just conveniences; they’re shields, revenue protectors, and differentiators.
Industry: Build and communicate clear evidence packages, accelerate RWE, and design products that make compliance easy — the market rewards clarity, not ambiguity.
Distributors: Expand portfolios strategically, align inventory with evidence-backed clinical demand, and become trusted partners for providers navigating a complex reimbursement landscape.
The message is simple: 2026 favors operators who measure, prove, and adapt — and who focus on solutions, not obstacles. There’s risk, yes — but the opportunities are bigger than ever. Those who embrace technology, evidence, and collaboration will emerge stronger, more influential, and positioned to lead the market.
Onward! Let’s make this year transformative - Below The Knee.
— Scott