What Defined November
November was loud.
Not messy-loud — turning point loud.
CMS dropped the 2026 rules. Capital whiplash from October’s $4.37B wound-care correction began to stabilize. Q3 earnings revealed who’s built for turbulence and who’s still underwater. And between IPAWS, Tissue Repair, and nonstop CTP policy updates, the field was buzzing with urgency, realism, and surprising optimism.
Three themes carried the month:
1) Policy clarity arrived.
2) Markets stayed volatile but directional.
3) The industry started reclaiming its narrative.
November felt like the first steady step after a stumble — not triumphant yet, but controlled, strategic, and forward.
💲 Finance & Fund Performance
WoundCareFund Performance — November Snapshot
The WoundCareFund posted a mixed month, with swings tied directly to earnings volatility and policy reaction.
Weekly performance ranged from –3.62% in early November to +3.99% mid-month, ultimately closing the month slightly negative, but ahead of the broader indices on risk-adjusted basis.
The market rewarded companies with clear paths through reimbursement shifts and punished those with exposure to guidance cuts, capital raises, or questionable durability.
Key November Movers:
Organogenesis: +59.64% (strength in Q3, market reset after)
SANUWAVE: +27.07% (Q3 strength + reimbursement optimism)
Treace Medical: –49.60% (guidance collapse)
Sanara MedTech: –29.64% (strategic pivot + platform shutdown)
Spectral AI: –16.36% (post-offering drag)
Despite volatility, the Fund continues to outperform broader medtech indices in weeks with company-specific catalysts — validating the thesis of tightly curated wound and limb salvage exposure.
🧩 Market & Company Updates
Q3 Earnings: The Surge, the Stall, and the Surprise
Big Cap & Mid Cap Highlights
Stryker: $6.1B (+10.3%) — Mako keeps printing; supply issues manageable.
Coloplast: DKK 6.96B (+7% organic) — strong Chronic Care; wound dressings hit by China recall + Kerecis variability.
Globus Medical: $734.6M (+17%) — U.S. MSK strong; integration risk lingers.
Advanced Wound & Regenerative Players
MiMedx: $114M (+35%) — CELERA/EMERGE/HELIOGEN powering a strong rebound.
SANUWAVE: $11.5M (+23%) — UltraMIST growing; reimbursement fog slowing close rates.
Organogenesis: $150.5M (+31%) — beat expectations, drove mid-month rally.
AVITA Medical: $17.1M (–13%) — reimbursement delays clipping momentum.
Diversified & Emerging
InfuSystem: $36.5M (+3%) — wound care up ~115%.
UFP Technologies: $154.6M (+6.5%) — resilient orthopedic + wound demand.
Treace: $50.2M (+11%) — solid quarter overshadowed by brutal guidance reset.
Bioventus: $138.7M (flat, +8% organic) — steady, if unspectacular.
BioStem: ~$10.5M (–43% YoY) but positive Net Income — lean, profitable despite shrinkage.
Spectral AI: $3.8M (–54%) — guidance lowered; investors skeptical.
TELA Bio: $20.7M (+9%) — still unprofitable, but guidance tightened.
MediWound: $5.4M (+23%) — misses targets but expands manufacturing capacity.
Corporate & Industry News
Mölnlycke opens first wound-care mfg site in China — localization + speed advantage.
Kimberly-Clark buying Kenvue for $40B — consolidating consumer wound footprint.
Xtant launches CollagenX — ortho + wound applications.
Orpyx platform selected for $5M NIH trial (400 patients) — major validation for digital DFU prevention.
Solventum acquires Acera Surgical for up to $850M — high-confidence signal in regenerative materials.
Swift Medical wins 2025 Fierce Innovation Award — strong reinforcement for imaging + AI.
Sanara Medtech shutters Tissue Health Plus — reallocates capital to surgical categories.
HMP launches the CTP News Desk — real-time reimbursement + policy hub.
🧠 Policy Pulse — CAMPS, 2026 PFS & OPPS
CMS has now released the 2026 updates to the Physician Fee Schedule (PFS), the Outpatient Prospective Payment System (OPPS), and a series of planned Local Coverage Determination (LCD) reviews—painting a very clear picture of where wound care reimbursement is heading. This year’s set of policies doesn’t just adjust rates; it reshapes expectations around documentation, digital enablement, utilization control, and what CMS considers “reasonable and necessary” across the entire wound care ecosystem.
Physician Fee Schedule (PFS)
No major payment swings, but documentation expectations tighten dramatically.
CMS emphasizes objective, repeatable wound measurement and defensible medical necessity.
Continued support for digital health (RPM/RTM) reinforces longitudinal wound management.
Pressure shifts from reimbursement rate to documentation quality and audit protection.
OPPS 2026
CMS cements site-neutral payment for skin substitutes across HOPD, office, and ASC.
Flat national rate of ~$127.14/cm² reduces historical setting-based margin advantages.
Includes gels, foams, powders, liquids, injectables, sprays — not just sheets.
2.4% payment increase for hospital and ASC services.
CMS signals increased packaging, fewer carve-outs, and stricter oversight of high-variance billing.
Providers will need tighter utilization control and more precise wound sizing and documentation.
New price transparency reporting requirements.
Upcoming LCD Changes (2026)
MACs are preparing stricter LCDs for skin substitutes, stalled wounds, infection management, and debridement.
Expect tougher medical necessity criteria and more specifically defined documentation requirements.
Focus shifts to objective wound data (size, depth, progression), not narrative notes.
LCDs will likely become the heaviest pressure point for denials.
Industry-Level Impact
Reimbursement moves from product-driven to documentation-driven economics.
CTP utilization becomes more conservative and more heavily scrutinized.
Digital imaging, measurement, and serial documentation become operational necessities, not conveniences.
RPM/RTM is increasingly relevant for chronic wound continuity of care.
Big Picture:
The government is forcing the industry toward value-based, transparent, evidence-driven wound care — which ultimately benefits companies that can prove outcomes, reduce variability, and deliver repeatable performance at scale.
CMS is steering wound care into a standardized, data-first era.
Clinics with inconsistent documentation will face rising denials.
Providers leaning into digital workflows will be better positioned for compliance, revenue stability, and better patient outcomes.
⚠️ Special Feature — The True Cost of the Skin Substitute Collapse
How $4.37B Vanished From Wound Care — and Why the Recovery Has Already Started
The last several years delivered a bruising stretch for wound care. Reimbursement uncertainty, DOJ investigations, fraud headlines, and stalled LCDs didn’t just create noise — they created drag. Capital froze. Valuations fell. Deals slowed to a drip. And while the clinical need continued to rise, the flow of investment, innovation, and market momentum was choked off.
This is the first full-scope estimate of the true financial impact — across public markets, private investment, and the opportunity cost that accumulated while the sector drifted in policy limbo.
And the bottom line is simple: the wound care industry absorbed an estimated $4.37B in lost or delayed economic value.
The good news? That tide is turning.
Public Market Impact: $1.62B in Valuation Loss
Across the WoundCareFund’s tracked public companies, policy turbulence and sector reputation risk triggered a broad pullback. This was not tied to fundamentals — it was tied to fear, opacity, and a lack of reimbursement clarity.
Below is a representative snapshot of the modeled pre/post valuation shifts: Note - Public company market caps were tracked using pre- and post-announcement valuation snapshots across all wound-focused companies in the WoundCareFund universe, isolating the portion of market cap movement most closely aligned with reimbursement uncertainty, enforcement activity, and sector-specific policy signals.
Company | Pre-Crisis Market Cap | Post-Crisis Market Cap | Change |
|---|---|---|---|
Organogenesis | $1.1B | $720M | –$380M |
MiMedx | $800M | $560M | –$240M |
Integra LifeSciences | $5.6B | $5.2B | –$400M |
Smith+Nephew (Wound Division) | $3.5B | $3.3B | –$200M |
Polynovo | $1.2B | $1.05B | –$150M |
Avita Medical | $650M | $580M | –$70M |
Aroa Biosurgery | $350M | $290M | –$60M |
Sanara Medtech | $300M | $260M | –$40M |
Next Science | $200M | $180M | –$20M |
Spectral AI | $220M | $200M | –$20M |
Covalon | $100M | $90M | –$10M |
Total Estimated Public Market Impact: $1.62B
This was a crisis of confidence, not capability. The market didn’t lose belief in wound care — it lost belief in the rules.
Private Capital Pullback: $1.85B in Delayed or Lost Funding
The private side absorbed an equally meaningful hit — but one that’s harder to see on earnings calls.
Based on historical funding patterns vs. the downturn, wound care likely saw:
40–60% decline in early-stage deal activity across 24–30 months
Smaller checks (down 25–30% on average)
Growth capital freeze for nearly two years
Delayed evidence programs as companies stretched runway
Fewer clinical trials initiated due to capital rationing (outside of targeted amniotic due to LCD policies)
Cumulatively, this represents $1.85B in delayed or missing private investment that normally would have advanced R&D, trials, commercialization, and evidence generation.
Forward-Looking Loss: $2B+ in Missed Innovation Growth
Capital doesn’t just impact the present — it compounds forward. When the sector lost momentum from 2021–2024, it didn’t just pause growth; it reset the baseline. Using historical investment velocity, typical reinvestment cycles, and evidence-development timelines lost industry growth is estimated at $2.1B-$2.6B in unrealized 5-year innovation value.
Key Assumptions Driving This Model:
Baseline capital gap: ~$1.85B in delayed/missing private investment sets the starting point for lost compounding.
Typical reinvestment cycle: Growth-stage wound companies historically reinvest ~35–45% of capital into R&D, commercialization, and evidence — the freeze effectively removed 2 cycles.
Evidence delay impact: 18–30 months of delayed trials and clinical programs slows adoption curves by 2–3 years.
Exit environment compression: Fewer exits → fewer recycled operators, founders, and capital — reducing innovation velocity.
Compounding factor: Modeling 10–14% annualized innovation-value growth typical of medtech sub-segments.
The Reset Has Started: Systems Are Stabilizing
Despite what the numbers show, we are now entering a fundamentally different phase.
Here’s why:
Draft LCDs provide the first clear differentiation and clinical expectations in years
2026 reimbursement policy shifts toward predictability and site neutrality
Bad actors have been cleared out, improving credibility
Institutional capital is re-engaging as the fog lifts
WiSER and structured innovation scoring elevate true differentiation
Digital wound care, imaging, and biologics are seeing renewed traction
This Is Our Market — And It’s Time We Take Control of the Narrative
Wound care and limb salvage represent one of the most consequential clinical and economic challenges in all of healthcare. The global market is the size of orthopedics — but with exponentially greater downstream impact.
If we want better investment, better innovation, and better outcomes, we must demand better representation. Transparency, evidence, and clarity are how we rebuild trust — and how we prevent the next cycle of stagnation.
This is our market. Our industry. Our responsibility.
🔭 What’s Next — December & Q4 Outlook
Expect December to be dominated by:
• Earnings digestion — especially for companies that guided down or face 2026 reimbursement pressure.
• Capital rotation — investors positioning into year-end for categories with policy clarity.
• Conference follow-up — IPAWS, Tissue Repair, and policy sessions fueling Q1 strategy.
• Outlook battles — early signals for 2026 utilization, site neutrality impacts, and new reimbursement behavior.
• Digital imaging gains — Swift’s award win + rising CAMPS scrutiny will pull imaging into the spotlight.
Q4 earnings prep begins — and with it, the industry will define whether 2026 launches from stability or hesitation.
Closing Thought
The last 18 months tested wound care in ways the outside world barely noticed. Reimbursement upheaval, the great correction, earnings volatility — all stacked fast. But November brought something rare: clarity.
The rules for 2026 are set. The worst of the panic is behind us. Capital is circling again as operators rebuild trust and outcomes-minded platforms rise.
This isn’t the rebound yet — but it’s the setup.
And setups are where smart operators, clinicians, and investors win.
Here’s to turning stability into momentum.
-Scott