Below The Knee | Market Signal

The Channel Is the Product Now

Two announcements this week make the same point from different directions. Mölnlycke will co-promote AROA’s Endoform in U.S. post-acute care. Solventum received a combined-use clearance that pairs Restrata with V.A.C. Therapy. Integra’s Q3 results show the other side: Tissue Reconstruction is still declining, and the products under the most pressure are the ones facing new competitors.

Under a flat-rate payment structure for skin substitutes, price no longer separates products. Reach, workflow, and indication do. Small and mid-size matrix companies are deciding whether to build that reach themselves or rent it. Strategics are deciding which products to attach to the franchises they already own. Expect more deals like these two before the cycle settles.

DFCon wraps this weekend in Anaheim. Full coverage from the floor runs in next week’s edition.

Coverage | MAC Open Meetings: Final Stretch

Four open meetings remain on the RTFI and NIRS draft LCDs. Written comments are due November 14.

Registration to present comments at Noridian’s meeting closes October 29 at 9:59 pm PT. We’ll keep posting association and manufacturer responses as they become public. noridianmedicare

Disclosure: I hold a commercial role at Swift Medical, which makes an FDA-authorized fluorescence imaging device.

Skin Substitutes / CAMP | Mölnlycke to Co-Promote AROA’s Endoform in the U.S.

AROA signed an exclusive agreement with Mölnlycke Healthcare US to co-promote Endoform in the U.S. post-acute setting, effective October 16. Financial terms, fees, and duration were not disclosed. AROA keeps ownership of Endoform and continues to manufacture, distribute, and supply it. FY27 guidance is unchanged at NZ$115–125 million in total revenue. AROA says the deal lets it focus on Myriad in surgical settings and Symphony in the outpatient setting. Aroa Biosurgery Taps Mölnlycke to Push Endoform in the US, Guidance Holds +2

The BTK read: This is AROA deciding where its own sales team earns the highest return, and the answer is not Endoform. Endoform has been through a partner before. Hollister launched and commercialized it starting in 2011, and AROA bought it back in 2018. A co-promote with undisclosed terms is easier to unwind than a license. For Mölnlycke, an ECM product gives post-acute reps more to offer in accounts where they already sell dressings. Watch whether Endoform growth shows up in AROA’s next quarterly report. wikipediaaroa

NPWT / CAMP | Solventum Clears Combined Use of Restrata and V.A.C. Therapy

FDA granted 510(k) clearance for combined use of Restrata Synthetic Electrospun Fiber Matrix and Solventum V.A.C. Therapy. The clearance follows Solventum’s acquisition of Acera Surgical in December. Restrata degrades via hydrolysis, and Solventum says the pairing may allow fewer dressing changes and less disruption to the wound bed. Solventum Announces FDA 510(k) Clearance for Combined Use of Restrata™ Matrix and Solventum™ V.A.C.® Therapy* +2

The BTK read: Restrata itself has been cleared for years. What’s new is the label. A combined indication gives Solventum’s NPWT reps a reason to carry a matrix into every V.A.C. conversation, and it gives competing NPWT companies a question they now have to answer. A 510(k) is not outcomes data. The claim of fewer dressing changes needs real-world numbers before it means anything to a buyer.

Skin Substitutes / CAMP | Integra Q3: Wound Reconstruction Still Declining

Integra reported Q3 revenue of $411.2 million, up 2.3%. Tissue Reconstruction fell 2.2% to $107.1 million. Growth in DuraSorb and PriMatrix was offset by declines in MicroMatrix and Integra Skin. Wound Reconstruction Solutions came in at $81.5 million, down 2.9%. Management said its updated outlook reflects more measured expectations for parts of Tissue Reconstruction. INTEGRA LIFESCIENCES HOLDINGS CORP - Form 8-K - FY2026 +2

The BTK read: The split inside the portfolio is the story. On the Q2 call, management said new competitors were pressuring MicroMatrix, and that pressure hasn’t eased. Products with a clear clinical position are growing. Products competing mainly on price are not. The SurgiMend relaunch is slated for Q4 and is the next data point. marketbeatsec

Skin Substitutes / CAMP | PolyNovo: FY26 Results Resurface

PolyNovo’s FY26 results, released in August, recirculated this week. Group sales were A$138.4 million, up 16.7%. U.S. sales were A$102.1 million, up 15.6%. NovoSorb MTX sales were A$12.6 million, up 89.6%. For the Americas, the company plans to submit the PMA, launch NovoSorb SynPath, and extend its outpatient presence. asxinvestorpa

The BTK read: The BTM PMA filing is the event to watch. Its regulatory pathway determines how BTM fits into the outpatient payment structure.

Advanced Wound Dressings | Kane Biotech Adds Stevens for Canadian revyve Distribution

Kane signed The Stevens Company to distribute revyve in Canada and is showcasing the product at the Wounds Canada National Hybrid Conference. The deal follows a non-exclusive agreement with Ontario Medical Supply in September. bnnbloomberg

The BTK read: Kane is rebuilding through a multi-distributor network after its prior exclusive U.S. distribution agreement ended. Distribution coverage is no longer the constraint. Sell-through is. Watch revenue, not the number of partners. barchart

Clinical | Recce’s Phase 3 Diabetic Foot Infection Trial Goes to the DMC

An independent Data Monitoring Committee will review unblinded data from Recce’s Indonesian Phase 3 trial of R327 Gel for diabetic foot ulcer infections. Recommendations are expected as soon as mid-November. sharecafe

The BTK read: Three points. First, this is an infection trial scored on the Lipsky scale, not an ulcer-healing trial. Second, the company’s commentary on blinded data cannot show a treatment effect. Third, the timeline has slipped: Recce originally expected the interim readout in Q1 2026, with a possible launch the same year. For the U.S., the more useful signal may come from the Australian arm, a 208-participant non-inferiority comparison against antibiotics. stockheadbiotechdispatch

Pharma | Flen Health Moves Its DFU Enzyme Therapy Toward a U.S. IND

AGC Biologics will develop and manufacture recombinant lactoperoxidase and glucose oxidase to support Flen Health’s planned IND and a U.S. Phase II trial. The therapy builds on Flaminal. chemxplore

The BTK read: Flen is taking a product with a long device history in Europe through a U.S. drug pathway. That route is slower and more expensive, but it produces a different class of evidence. The first milestone is the IND.

Capital | Rezera Files for IPO to Fund NLRP3 Program in PAD

Endpoints News reports that Rezera (formerly NodThera) has filed for an IPO. Its oral NLRP3 inhibitor, ruvonoflast, met its primary hsCRP endpoint in the Phase 2 RESOLVE-1 trial. The company plans a Phase 3 registrational trial in PAD in the first half of 2027. allsci

The BTK read: Lowering an inflammatory biomarker is not the same as changing limb outcomes. The Phase 3 endpoint will decide whether this matters to the limb salvage audience. A walking-distance endpoint makes it a claudication story. Amputation or major adverse limb events would make it a limb salvage story. Watch the S-1 for the trial design.

Wound care, limb salvage, foot and ankle, and vascular: all scored, indexed, and monitored. Real-time capital signals. Curated news and alerts. AI-powered queries.

intelligence.belowtheknee.co/sign-up →

October 26 – November 5: MAC open meetings on the RTFI and NIRS draft LCDs (see table above)

November 6 | Virtual: WoundCon Fall 2026

November 14: Comment deadline for the MAC RTFI and NIRS draft LCDs

Mid-November (expected): CY2027 PFS and OPPS final rules

December 5–6 | San Antonio, TX: DFUpdate 2026 (Diabetic Foot Update), UT Health San Antonio. Hosted by ALPS, with pre-meeting workshops December 4.

December 9–12 | Phoenix, AZ: Desert Foot, Multi-Disciplinary Limb Salvage & Wound Care Conference

Not subscribed? newsletter.belowtheknee.co. Forward this to one person in your network who works in this space.

Next week: DFCon in detail and the last of the MAC open meetings. If you were in Anaheim and want to compare notes, reach out.

-Scott