Below The Knee – Market Signal

WoundCare Fund: –4.85% (week ending Mar 5, 2026)

Sharp underperformance vs. broader markets. The decline was driven by concentrated selloffs in a few names — not broad portfolio weakness.

NASDAQ Composite: +0.59%
Dow Jones Industrial Average: –2.64%
S&P 500: –0.38%

🔽 Treace Medical Concepts (TMCI) –33.81%

The sharp drop follows continued investor concern around procedure growth and competitive pressure in the bunion correction market. Treace has faced ongoing scrutiny around adoption trends for its Lapiplasty platform and overall growth trajectory. When expectations reset in a high-growth orthopedic name, the market reacts fast and hard. Q4 revenue came in at $62.5M, down 9% YoY, and FY2026 guidance of $200–212M implies continued declines through at least Q3. The fundamentals — 80%+ gross margins, 3,300+ surgeon relationships, $115M in available liquidity — haven't deteriorated. The market is repricing the timeline, not the business model. Worth watching closely as new product launches (Lapiplasty Lightning, SuperBite, SpeedXM) are expected to inflect volumes in H2.

🔽 Organogenesis (ORGO) –21.62%

Weakness reflects the collision of a record Q4 ($225.1M, +78% YoY) and a guidance reset that stopped investors cold. FY2026 guidance of $350–420M landed roughly 25–38% below 2025 actuals — and well below consensus. The mechanism is CMS: December 30 commentary withdrawing LCD coverage policies and raising questions about discarded product reimbursement created clinical confusion heading into Q1. Utilization froze. Management expects material recovery in H2 as regulatory clarity returns and PMA-backed products (Apligraf, PuraPly AM) gain share in the restructured market. The near-term pain is real and well-documented. The medium-term thesis — that CMS is effectively filtering toward evidence-backed biologics — favors Organogenesis's portfolio. But the market needed to see the 2026 number to believe it.

🔽 Integra LifeSciences (IART) –12.71%

Shares moved lower under continued pressure on the wound reconstruction and regenerative segments, where growth has been uneven. Investors are closely watching execution in the tissue technologies business as Integra works to stabilize performance across its surgical and advanced wound portfolios. The company has been in a prolonged period of reset — operational issues, management transitions, and a narrowing of strategic focus. Until there's a clear inflection signal in the tissue tech segment, expect the stock to trade with a skeptical premium on any positive news and an outsized discount on any miss.

Organogenesis (ORGO) | Reported Feb 26

Organogenesis delivered a genuinely exceptional Q4 — then immediately buried it with guidance. Q4 net product revenue came in at $225.1M, up 78% year-over-year and 50% sequentially, with advanced wound care driving nearly all of it at $217.2M (+83% YoY). Full-year 2025 revenue hit $563M with net income of $37M and adjusted EBITDA of $98.1M — strong, clean numbers with no debt and $94.3M in cash. The beat was real. Then came 2026: management guided full-year revenue to $350–420M, a 25–38% decline versus 2025, with Q1 expected to fall approximately 50% year-over-year. The driver is specific and documented — CMS's December 30 commentary on discarded skin substitute products created what CEO Gary Gillheeney called "clinical confusion and material disruption in the market," freezing clinician utilization even of PMA-approved products in the first two months of 2026. Management does not believe the discarded product commentary should apply to PMA-classified products and expects the issue to resolve favorably. The strategic read: Organogenesis is investing through the disruption — a new Smithfield, RI manufacturing facility scaling Apligraf and PuraPly AM, a rolling BLA submission for ReNu expected to complete H1 2026, and a plan to re-commercialize Dermagraft. The company expects significant market share gains in H2 2026 as weaker competitors exit a restructured reimbursement landscape, with a return to normalized growth targeted for 2027. The thesis is coherent. The timeline is uncomfortable.

Treace Medical Concepts (TMCI) | Reported Feb 27

Treace reported Q4 2025 revenue of $62.5M, down 9% year-over-year, with the decline driven entirely by a deliberate product mix shift toward lower-ASP bunion procedure offerings — not volume erosion. Gross margin held at 80.6%, essentially flat with Q4 2024, which is the number that matters most for understanding the underlying business quality. Full-year 2025 adjusted EBITDA loss improved 64% to $3.9M, and the company used $27.3M in cash — down 46% from 2024 — demonstrating real operational discipline alongside the portfolio expansion. For 2026, Treace guided revenue of $200–212M (a 0–6% decline versus 2025) with Q1 expected to step down roughly 27% sequentially, followed by improving year-over-year growth rates in each subsequent quarter. The mechanism for recovery is clear: Lapiplasty Lightning and IntelliGuide PSI launching in H2, along with SuperBite compression screws and SpeedXM midfoot fusion plating, together expected to expand addressable TAM by approximately $300M. The broader story is a company that entered 2025 as a Lapiplasty business and exited it as a comprehensive bunion solutions platform — now addressing approximately 100% of technique preferences across all four major bunion deformity categories. Q4 case volume growth accelerated over Q3, and 25% of the 3,300+ active surgeon base had already adopted one or more new systems within two quarters of launch. For the limb salvage community, the structural correction story matters: foot and ankle deformity is upstream of wound complications in the diabetic and PAD patient populations, and a more fully utilized Treace portfolio means better structural outcomes feeding into better wound outcomes downstream.

MediWound (MDWD) | Reported Mar 5

MediWound reported FY2025 revenue of $17.0M, down from $20.2M in 2024, with Q4 specifically impacted by the U.S. government shutdown delaying budget approvals and the initiation of new contractual agreements with BARDA. The revenue decline is real but contextually narrow — it's a contract timing issue in a company whose underlying operational trajectory moved meaningfully forward in 2025. The expanded NexoBrid manufacturing facility is now fully operational at sixfold prior production capacity, with commercial supply subject to regulatory approvals expected in 2026. Year-end cash was $53.6M — up from $43.6M at end of 2024, supported by a $30M registered direct offering — giving the company a solid runway for the clinical programs ahead. On EscharEx, the Phase III VALUE trial in venous leg ulcers (216 patients, ~40 sites across the U.S. and Europe) remains on track, with interim assessment and enrollment completion expected by year-end 2026. The clinical program is expanding in H2 2026 into diabetic foot ulcers (Phase II) and pressure ulcers (investigator-initiated trial) — a simultaneous three-indication development strategy that underscores both the ambition and the differentiation of a concentrated bromelain-based enzymatic mechanism. B. Braun joined the EscharEx clinical consortium this week, bringing the partner roster to six strategics — Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, and now B. Braun — each with established wound care commercial infrastructure. Management reaffirmed 2026–2028 revenue guidance of $24–26M, $32–35M, and $50–55M respectively. The 2028 number assumes EscharEx approval. The partners are a form of commercial optionality that doesn't show up in the income statement yet.

Solventum (SOLV) | Reported Feb 26

Solventum closed out its first full year as an independent company with Q4 net sales of $2.0B — down 3.7% reported but up 3.5% organically, with the reported decline reflecting the September 2025 divestiture of its Purification & Filtration business. Full-year 2025 adjusted EPS reached $6.11, ahead of guidance of $5.98–6.08, with operating margins landing at 20.5% — within the company's 20–21% target range. For wound care specifically, the MedSurg segment delivered $1.2B in Q4 with 3.2% organic growth; within that, Advanced Wound Care grew 1.7%, driven by NPWT performance, with SKU rationalization creating an ongoing headwind in certain advanced dressing categories. The strategic move of the quarter was the completed acquisition of Acera Surgical for $725M upfront plus up to $125M in contingent payments — adding a synthetic tissue matrix platform operating in what management described as a billion-dollar market growing at 10%, with the company positioned in the higher-growth synthetics subcategory. Acera is expected to be a double-digit grower and Solventum called it a "force multiplier" for Advanced Wound Care given existing commercial infrastructure. For 2026, Solventum guided organic sales growth of 2–3%, adjusted EPS of $6.40–6.60, and operating margins of 21–21.5%. Tariff headwinds of $100–120M in 2026 (roughly double 2025) are the primary risk to margin expansion. The long-range plan targets 4–5% organic growth and 23–25% operating margins — a credible path for a company that has now established its independent commercial infrastructure, rationalized its portfolio, and reduced debt by approximately $2.7B from the P&F divestiture proceeds.

Coming Up:

📅 Sanara MedTech – March 24 | Q4 and FY2025 results

Watch for: Continued commentary on CAMPs market dynamics post-CMS LCD changes. Any update on Q1 2026 utilization trends from skin substitute manufacturers will be a leading indicator of how long the "clinical confusion" period lasts.

RecovryAI Wins FDA Breakthrough Device Designation for Post-Surgical AI Platform
FDA Breakthrough Device Designation for RecovryAI's post-surgical AI platform accelerates the regulatory pathway and formally validates the clinical need. In the 2026 Innovation Index, Wound Imaging, Assessment & Workflow is the fastest-growing category we track at 8.5% CAGR — this designation signals that SaMD platforms in post-surgical monitoring are moving from promising to validated. Strategic acquirers are watching this space closely. (Source: Medical Economics)

Solventum (SOLV) Q4 2025 Earnings
Solventum continues to execute on its post-3M independence strategy, expanding its advanced wound care portfolio beyond NPWT. The Acera Surgical acquisition — up to ~$850M — is integrating into the broader wound ecosystem platform. Platform builders are broadening their moats, not waiting for disruption. (Source: Earnings call transcript)

SAWC Launches Mobile Wound Management Live – Four-Part Education Series
SAWC's new virtual series specifically targets clinicians operating in home-based, post-acute, and community settings. This is an education initiative, but it's also a market signal: site-of-care decentralization is now the baseline, not the trend. When wound care's premier clinical organization formalizes mobile-setting education, the infrastructure is following where patients already are. (Source: SAWC / Times-Mail)

MediWound Expands EscharEx Clinical Development Consortium
B. Braun joined the EscharEx program this week, alongside Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, and MIMEDX. Six strategic partners co-investing in a Phase III debridement program is not incidental. Each relationship represents a potential distribution pathway and a form of market access diligence. (Source: MediWound press release)

Humacyte (HUMA) Presents at TD Cowen 46th Annual Health Care Conference
Humacyte continued building its institutional narrative around the Human Acellular Vessel as a multi-indication vascular platform — not a single-product company. Trauma, dialysis access, and peripheral arterial disease are all on the roadmap. The HAV's bioengineered, immunologically inert architecture has no direct competitor. (Source: TD Cowen conference transcript)

Sanara MedTech to Report Q4 and FY2025 Results on March 24
Mark the calendar. Sanara's positioning at the intersection of wound care products and care delivery infrastructure makes its earnings a useful read on outpatient and community wound center economics. (Source: GlobeNewswire)

The skin substitute market is being restructured in real time. The companies that treated reimbursement clarity as optional are now learning it was load-bearing.

On December 30, 2025, CMS issued commentary withdrawing LCD coverage policies for skin substitutes and raising questions about reimbursement for discarded product. The clinical community froze. Organogenesis CEO Gary Gillheeney described the result as "clinical confusion and material disruption in the market." Q1 2026 will carry that disruption in full.

But here's the part that matters strategically: this is not a market contraction event. It's a market reordering event.

CMS has been telegraphing this direction for years. The LCD withdrawal is a mechanism for pushing the market toward products with stronger clinical evidence — specifically, PMA-cleared and BLA-approved biologics — and away from the fragmented, often undifferentiated landscape of 510(k)-cleared CAMPs that expanded rapidly under permissive coverage. The discarded product commentary adds utilization discipline on top of coverage discipline.

In the near term, everyone takes the hit. Clinicians don't distinguish between "products CMS is squeezing" and "products CMS is protecting" when they get conflicting signals. They pause. That pause is Q1.

In the medium term — H2 2026 and into 2027 — the reordering becomes visible. Companies with PMA-backed assets, documented clinical outcomes, and established billing infrastructure will emerge with larger share in a slightly smaller, but far more defensible market.

The Skin Substitutes / CAMP category in the 2026 Innovation Index carries a 7.0% CAGR but an Innovation Score of only 5.93 — the lowest among high-growth segments. That gap between market growth and innovation density is exactly what the CMS policy is designed to close. The 32 companies in this category will not all survive the next reimbursement cycle in their current form. Expect consolidation to accelerate in H2 2026 as coverage clarity returns and the strategic acquirers identify which assets have the documentation and evidence to win under the new rules.

Bottom line: CMS didn't break the skin substitute market. It raised the floor on what it takes to participate in it. That's a slow-moving advantage for the companies that already cleared the bar, and a structural problem for the ones that didn't.

While skin substitutes absorb the market's attention this week, the most interesting wound prep development sits one category over: enzymatic debridement. MediWound's EscharEx is advancing into a Phase III VLU trial, a Phase II DFU program, and an IIT in pressure ulcers — simultaneously. That's unusual clinical ambition for a company at this scale.

Wound Prep Market: $2.4B CAGR: 7.2% Innovation Score: 5.89 Companies Tracked: 10

Collagenase-based debridement (Santyl) has held the market largely alone for years. Not because it's the best solution — but because there hasn't been a credible, scalable alternative. EscharEx is NexoBrid's chronic wound analog: a concentrated bromelain-derived enzyme concentrate originally proven in burns, now being systematically validated across chronic wound types. If the VALUE trial delivers, it represents the first new enzymatic debridement modality with Phase III RCT evidence for VLUs since collagenase gained widespread use.

The six-partner clinical consortium around EscharEx is worth examining beyond the headline. Each partner — Solventum, Convatec, Mölnlycke, Essity, MIMEDX, Coloplast/Kerecis — is a strategic channel partner with existing wound care market access. Their co-investment in the clinical program creates soft distribution commitments before commercial approval. This is how a small-cap company builds a commercialization path without a $200M sales force: you let the market come to you through clinical partnerships.

Full Wound Prep competitive analysis and company scores available at belowtheknee.co

March 6–7 🔥 MAJOR EVENT

CAMPs Wound Care Summit — West Palm Beach, FL

The most relevant event in the biologics space right now. 350+ attendees including KOLs, payer representatives, and commercial leadership from Organogenesis, MiMedx, and the major CAMP manufacturers. With the CMS LCD changes live and Organogenesis just reporting a guidance reset driven by coverage disruption, this event will serve as the first real-time industry response to the new reimbursement landscape. If you're tracking biologics or have commercial exposure to CAMPs — this is non-negotiable attendance.

March 17–18

Wound Care Today 2026 — Telford, UK

Hands-on skills, product demonstrations, 50+ exhibitors. European market focus. Useful for tracking where international adoption differs from U.S. dynamics — particularly relevant on NPWT portability and advanced dressings.

April 8–12

DLS/WHF — Diabetic Limb Salvage Conference — Washington, DC — MedStar Georgetown

The Diabetic Limb Salvage (DLS) Conference, co-presented with the Wound Healing Foundation (WHF), is the premier multidisciplinary event on diabetic limb preservation. Faculty include leading vascular surgeons, podiatrists, wound care specialists, and researchers.

🔥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 sessions specifically addressing the CMS skin substitute restructuring, site-of-care migration evidence, and the expanding role of AI-assisted wound documentation. Mark the calendar now.

Below The Knee is an independent market intelligence newsletter covering wound care, foot & ankle, and limb salvage markets. Analysis and opinions are solely those of the author and do not constitute investment advice.