Below The Knee | Market Signal

The Flat Rate Shows Up in the Numbers

MiMedx’s Q3 is the clearest look yet at what the CY2026 skin substitute payment change did to a CAMP income statement. Wound care center volume grew, both sequentially and year over year. Wound care sales fell 71%. That gap is the flat rate. Units held up. Price reset. Revenue followed price.

The rest of MiMedx’s quarter shows what the response looks like: grow surgical, get back to positive adjusted EBITDA, monetize IP through a $25 million license, and add scale with the pending Sanara acquisition. Our Q3 Capital Flow Report, out this week, shows capital moving the same way across the market. It went to scale, to regulated pathways, and to adjacent lanes. Very little went to early-stage core wound care. Policy pressure is also moving past CAMP. A proposed Medicare change to remote monitoring could undercut the business model behind many of the digital tools on display at SAWC and DFCon.

DFCon remains one of the leading meetings for limb preservation, and the theme in Anaheim was energy, much of it from people new to the field. A 14-year-old founder exhibited his digital imaging company, SoleIQ Health. A 16-year-old presented a poster on spectral imaging in DFU. Dr. Alexandria Armstrong, who grew up at the center of wound care, presented data that shows her building her own path. The program followed the same direction. One session covered the next-generation digital ecosystem: remote monitoring, human-AI collaboration, AI chatbots, and smart offloading. Another covered imaging: perfusion MRI, dynamic NIRS, multi-sensor devices, and Kent Imaging’s new PRISM algorithm, which ties spectral imaging data directly to the patient’s vascular workup. Even the CAMPs discussion, from Brian Lepow and Lee Rogers, was about product selection and evidence rather than survival.

The question underneath all of it was whether these tools reach more patients, sooner, with data that changes what a clinician does next. That question is no longer only clinical. The meeting took place in the same month the MACs proposed non-coverage for NIRS and fluorescence imaging, and CMS proposed changes that threaten vendor-run remote monitoring. The draft LCDs dominated the hallway conversations, including after the Kent session. Detecting more isn’t enough to protect coverage. The technologies that keep it will be the ones with evidence that management and outcomes changed. That standard will separate DFCon’s most promising technologies over the next 18 months. The patient panel, which closed the meeting, made the same point more simply than any session did.

Coverage | MAC Imaging LCDs: Last Open Meeting and Two Weeks of Comments

Noridian’s November 5 open meeting, covering both real-time fluorescence imaging (RTFI) and near-infrared spectroscopy (NIRS), is the last one scheduled on the proposed non-coverage LCDs. Written comments are due November 14. The RTFI proposals were posted at all seven A/B MACs. According to the Wound and Hyperbaric Association, the NIRS proposals cover five: CGS, NGS/Wellpoint Federal, Noridian, Palmetto, and WPS. The proposals address coverage only and do not change payment rates. cms

The Wound and Hyperbaric Association has set up two separate letter campaigns, one for RTFI and one for NIRS. Each takes a few minutes, and each LCD number links to the MAC’s proposed policy. If you want to weigh in, sign both:

Add your voice: → WHA proposed LCD campaigns

The BTK read: A separate CY2027 PFS code for fluorescence imaging and a proposed non-coverage LCD can exist at the same time. A code establishes how a service would be paid. It does not establish that it’s covered. Comment volume doesn’t decide an LCD, but specific clinical comments that describe how imaging changed a management decision go directly to the evidence gap the MACs cite. Generic support letters don’t.

Remote Delivery | Proposed Rule Threatens Vendor-Run Remote Monitoring

KFF Health News reports that a proposed federal rule would halt Medicare reimbursements for providers who use health technology companies to administer remote monitoring for their patients. Some large academic health systems build their own devices or use their own staff to review data, but most facilities contract with health tech companies. Use is still small but growing fast: only 1% of traditional Medicare patients use remote physiologic monitoring, and its cost is a small fraction of overall spending. KFF

The BTK read: This matters more to limb salvage than the 1% figure suggests. Smart offloading, remote temperature monitoring, and home wound surveillance run on remote monitoring codes, and nearly all of them use the vendor-administered model the rule would cut off. Health systems with their own monitoring staff would be unaffected. Independent podiatry and wound practices would not. Watch whether the final rule narrows the change to fraud-prone arrangements or applies it across the board.

Skin Substitutes / CAMP | Smith & Nephew Steps Up Lobbying on Payment Rules

Smith & Nephew is lobbying on the Medicare physician fee schedule and hospital outpatient payment rules for skin substitutes, the products CMS moved to a single payment rate. A recent disclosure put its Q2 2026 lobbying spend at $490,000. Separately, an opinion piece in The Well News argues that Medicare’s skin substitute fraud reflects a pattern, not an isolated failure. legis1

The BTK read: Lobbying spend rises when final rules are close. CY2027 PFS and OPPS are expected mid-November. The flat rate was CMS’s response to the same fraud the op-ed describes, so expect the agency to defend the structure and argue over the rate. Strategics with surgical and NPWT portfolios can absorb the outcome, the companies with the most at stake have the smallest lobbying budgets. We are all waiting anxiously.

$824 Million, and Where It Actually Went

Wound care and limb salvage recorded 10 capital events and $824 million in disclosed capital in Q3 2026. Medtronic also closed its $650 million acquisition of SPR Therapeutics. The total looks healthy. The distribution doesn’t.

Strategic and public capital took 92% of disclosed dollars, through two acquisitions and one public follow-on. Venture narrowed to $63.25 million across six rounds, down 21% from Q2. TYBR Health ($30M) and Piomic Medical ($25M) made up 87% of it, and the other four rounds were each under $5 million. Capital followed regulatory status. Peripheral nerve repair took $408.7 million, led by Axogen’s $200 million BioCircuit acquisition and $208.7 million public offering in the same September week, after Avance’s BLA approval. And CAMP consolidation started: MiMedx/Sanara, at about $350 million, is the first sizable CAMP-to-CAMP deal under the $127.14 per sq cm flat rate.

About $15.8 billion in signed acquisitions is expected to close by year-end: Boston Scientific/Penumbra ($14.5B), H.B. Fuller/Advanced Medical Solutions (about $942M), and MiMedx/Sanara (about $350M). If Penumbra slips into 2027, Q4 closes drop to about $1.5 billion.

The full report includes the complete deal log, a quarter-over-quarter comparison, how Innovation Scores line up with acquisitions, the Q4 timeline, and 2027 trends to watch. It’s available to any registered BTK Intelligence user, free tier included:

Download the Q3 2026 Capital Flow Report →

Vascular | Boston Scientific Cuts 2026 Guidance a Third Time

Boston Scientific reported Q3 revenue of $5.14 billion and cut full-year growth guidance to 4.25%, from an initial 10.5–11.5%. A cyberattack disrupted ordering, manufacturing, and shipping, costing about $150 million in Q3 revenue. Watchman fell 6% and electrophysiology fell 5%. medtechdive

The BTK read: For this audience, the question is Penumbra. At $14.5 billion, it accounts for 92% of the pending Q4 pipeline in our capital report. The deal is signed and shareholder-approved, so a guidance cut doesn’t change the terms. It does change the environment the deal closes into. A buyer missing in its two headline franchises will be under pressure to show acquired growth quickly. For peripheral thrombectomy, that could mean faster cross-selling or a harder cost review. Watch the close date and the first post-close commentary on peripheral vascular.

Skin Substitutes / CAMP | MiMedx Q3: Wound Care Down 71%, Surgical and IP Fill the Gap

MiMedx reported Q3 revenue of $62 million, down 45% year over year. Wound care sales fell 71% under Medicare reimbursement pressure, and surgical sales grew 9%. The company returned to positive adjusted EBITDA, reported wound care center volume growth both sequentially and year over year, and received a favorable federal court ruling on AXIOFILL’s regulatory classification. In the same week, MiMedx signed a $25 million patent license with an unnamed wound care competitor, resolving infringement allegations related to its placental biologics portfolio. The licensee pays $5 million a year for five years, and the first installment has already been received. mimedx

The BTK read: Volume growth alongside a 71% revenue decline is a pricing reset, not a demand problem. The volume figure covers wound care centers only, and the release doesn’t break out other sites of service. Surgical is now carrying the company, which explains Sanara. The license shows the other adjustment: under a flat rate, an IP portfolio that once protected pricing becomes a revenue line. $5 million a year doesn’t offset the wound care decline, but it is high-margin cash and a signal to other placental tissue companies that MiMedx will enforce. The AXIOFILL ruling matters more than either headline, because regulatory classification decides which payment structure a product falls under. Watch for the licensee’s name in a 10-Q, whether other companies settle, and how much of 2027 guidance depends on surgical.

Advanced Wound Dressings | Essity Q3: Net Sales Up, Organic Flat

Essity reported Q3 net sales of SEK 36.1 billion, up 4.1%, while organic sales declined 0.3% amid market and cost pressure. yahoo finance

The BTK read: The gap between reported and organic growth means the increase came from outside the base business. Medical solutions is where Essity has room to grow organically, so the segment detail matters more than the group number.

Capital | RegenLab USA Sets Terms for $18 Million IPO

RegenLab USA, a regenerative medicine device company, set terms for an $18 million IPO, according to Renaissance Capital. renaissance capital

The BTK read: An $18 million IPO is closer to a venture round on a public exchange. With Q3 venture concentrated in two rounds, small IPOs are one of the few remaining routes for companies between seed and scale. Pricing and the S-1’s reimbursement section will show what public investors will pay for regenerative exposure right now.

Diagnostics | MolecuLight Named Frost & Sullivan’s 2026 Wound Imaging Company of the Year

Frost & Sullivan named MolecuLight its 2026 Global Company of the Year in wound imaging, citing its leadership in fluorescence-based bacterial assessment. prnewswire

The BTK read: The timing matters more than the award. It lands inside the MAC comment period on fluorescence imaging. Industry recognition helps with hospital buyers and investors. It doesn’t address what the draft LCDs say is missing, which is evidence that imaging changes outcomes. Expect every imaging company to lean on whatever third-party validation it has until November 14.

Skin Substitutes / CAMP | L&C Bio Wins U.S. Patent for ECM Gel Dressing

L&C Bio received a U.S. patent for technology that combines processed human skin ECM particles with hyaluronic acid, the basis of its MegaCure gel dressing. The company says the gel format suits irregular wounds where sheet products are impractical. Protection previously covered Korea and China. sedaily

The BTK read: A patent is not a U.S. market entry. The questions are the regulatory pathway and how a human-tissue gel would be classified and paid. Those answers decide whether this is a U.S. product or a U.S. patent.

Workflow | ModMed Names Co-Founder Dan Cane Chief AI Officer

ModMed appointed co-founder Dan Cane as Chief AI Officer. The company is focusing on AI tools for scheduling, prior authorization, and claim denial appeals in specialty practices, including podiatry, dermatology, and orthopedics. modmed

The BTK read: ModMed has a large presence in podiatry, so its AI priorities show where practices feel the most friction. Prior authorization and denials are at the top, ahead of any clinical use. As coverage tightens on CAMP and imaging, denial management becomes a revenue function. The practice management system may end up mattering more to a product’s adoption than the product’s sales rep.

Clinical | Applied Biologics Publishes Interim CAMPX Results

Applied Biologics published peer-reviewed interim results from the CAMPX randomized trial of XWRAP, a single-layer amniotic membrane, in chronic DFUs. Across 129 randomized patients at 19 sites, XWRAP plus standard of care reached 31.2% complete closure in the per-protocol population, compared with 21.4% for standard of care alone, with greater wound area reduction. Confidence intervals cross 1.0. business insider

The BTK read: Three qualifiers. The data are interim. The comparison is per-protocol, not intent-to-treat. And the confidence intervals cross 1.0, so the closure difference is not statistically significant. Running an RCT is the right move for an amniotic product under the flat rate, and the publication is worth having. The final analysis is what payers and formulary committees will use.

Pharma | Liraglutide and DFU Healing: A Randomized Trial Reports Faster Closure

A newly reported randomized trial found that liraglutide sped DFU healing. We haven’t yet seen the full trial design and publication. Earlier evidence was indirect. In a post hoc analysis of the LEADER cardiovascular outcomes trial, liraglutide significantly reduced amputations compared with placebo, but showed no difference in foot infections or peripheral revascularization. The smaller STARDUST trial, which randomized 55 people with type 2 diabetes and PAD, found that liraglutide increased peripheral perfusion measured by TcPO2 over six months. bioengineer

The BTK read: A trial designed around healing would be the first direct test of what the post hoc and perfusion data suggested. Check the sample size, whether glycemic control was matched across arms, and the closure endpoint. GLP-1 use in the DFU population is already high, so the practical question isn’t whether wound clinicians will see these patients. It’s whether GLP-1 status should change how a wound is managed and how trials are stratified.

Pharma | Merakris Plans Phase 2/3 for MTX-001 After FDA Pre-IND Meeting

Merakris Therapeutics says it is advancing a potentially pivotal Phase 2/3 strategy for MTX-001 following a pre-IND meeting with FDA. yahoo finance

The BTK read: A pre-IND meeting is guidance, not clearance. The IND filing and its trial design are the milestones. The direction matters, though. A drug pathway puts a product outside the flat rate, which is the same regulatory premium that showed up in Q3 capital.

Research Briefs

Four early-stage items this week, none of them close to market:

On the clinical side, HMP’s “Beyond Negative Diagnostics” makes the case for clinical judgment in limb salvage surgery when imaging and testing come back negative. bioengineer hmp

The BTK read: Read the ML risk model and the HMP piece together. One argues for more algorithmic risk detection. The other argues that tests miss things a surgeon doesn’t. Both are true. The tools that win will help clinicians judge, not replace their judgment. The preclinical items are early-signal only. Mouse and in vitro results are a long way from a 510(k).

Reported in the last two weeks: J&J (Oct 13), Abbott and Integra (Oct 21), Essity, Boston Scientific (Oct 28), MiMedx, Stryker, and Merit Medical (Oct 29).

Estimates are based on prior-year timing. Confirmed dates come from company releases.

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. The Q3 Capital Flow Report is now on the platform.

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November 5: Noridian open meeting on the RTFI and NIRS draft LCDs

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

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Next week: the last MAC open meeting, and the Solventum, Organogenesis, and Smith+Nephew numbers.

-Scott