Below The Knee | Market Signal

SAWC Fall 2026: The Market Has Moved On From the Skin Substitute Reset. The Evidence Bar Hasn’t.

More than 1,800 people came through Caesars Palace for SAWC Fall 2026. I heard the same thing across clinicians, manufacturers, distributors, and investors: the mood was positive, the talk was about growth, and the industry is (almost/mostly) past the skin substitute disruption of the last cycle. That reading is fair, but it needs a qualifier. The companies drawing attention were not the ones with the loudest booths. They were the ones that arrived with a regulatory, reimbursement, and commercial plan built in that order.

My week started before the exhibit hall opened, at the Alliance of Wound Care Stakeholders annual meeting. The Alliance introduced Julie Rhodovi as its new CEO, and her introduction made a strong first impression. Marcia Nusgart built a tremendous organization, and Julie is well positioned to grow it and advance its work. I’m looking forward to working with her.

Caroline Popper, MD, MPH, Esq. gave an incredibly detailed and wonderfully useful talk on AI in wound care. She framed it plainly: what she presented is a snapshot of October 2026 and not settled law, but the direction is clear. Her themes ran from more objective, automated wound assessment to AI’s growing influence on coverage decisions. The thread through all of it was accountability. As these tools move from decision support toward autonomous action, the question of who is responsible when something goes wrong becomes a core liability issue for manufacturers and clinicians alike.

Her “human in the loop” point should stay with anyone building or buying these tools. A human in the loop only matters if that person can see what the system is doing and has the authority to stop it.

That framing applied directly to the exhibit floor, where WoundScribe launched a six-agent AI platform covering scribing, imaging, charting, coding, healing trajectory, and patient education. Buyers of any tool like it should start with basic questions: what population was it validated on, and who is accountable for acting on its output?

Talks like this one are a good reason to be in the room at the Alliance.

Meanwhile, the fluorescence imaging fight we covered last week (“Coded But Not Covered”) picked up an organized clinical voice. APWCA’s board approved a formal position statement on bacterial fluorescence imaging, aimed directly at the seven proposed MAC non-coverage LCDs. The MAC open meetings start tomorrow.

The story this week: sentiment is up, capital is moving, and new entrants are well organized. The coverage and accountability questions are getting sharper, not easier.

A note to HMP: I had planned to sit in and report on several sessions this week. I couldn’t, because HMP changed its policy and limited exhibitor access to sessions. That change caught all of us off guard. If anyone from HMP is reading this, I’d welcome the conversation. I and a number of industry peers are questioning the decision and what it means for the value of exhibiting and attending for us and our teams. The investment for these meetings expands far beyond booth fees. We plan on these meetings for more than just exhibit hall time, they are foundational for members to learn and listen. Access has always been a strong benefit of attending, if exhibitors can’t attend the talks, twice a year becomes harder to justify.

Piomic: The Playbook, Executed

I was excited to sit down with the Piomic team. They have a large study underway and a regulatory, reimbursement, and commercial strategy that was clearly designed as one plan. Most companies build those three pieces in sequence and then try to retrofit them. So far, Piomic’s execution matches its plan. While not yet commercial - they are well structured, the device looks (and feels) great - it’s production ready. I’m excited to see how this one develops. Christoper Hertz, it’s still early I get it - but well done.

The BTK read: This is the sequencing CMS and the MACs now reward: evidence designed for coverage, not just for clearance. Piomic is a strong one to watch.

Polarity Bio: First-to-Podium

Polarity Bio’s Phase 3 clinical data won the First-to-Podium slot, one of the most competitive presentation selections at SAWC. If you’ve been wondering where Polarity has been, this is the answer. Thank you so much Nikolai Sopko for the chance to sit down and talk through all you have going on.

The BTK read: Phase 3 data at the podium is a different class of evidence from what has historically supported this category. Expect more from Polarity soon.

EmeraNova (formerly BioLab Holdings): A Lot in Play

BioLab Holdings has rebranded as EmeraNova and arrived at SAWC with several announcements. It is adding hyaluronic acid matrix technology to support expansion into new care settings, and it announced a partnership with Kent Imaging to expand access to advanced wound imaging.

I was fortunate to sit down with CEO Jaime Leija and his team. They came across as well organized and well prepared for strong execution. They are making a lot of moves, seemingly all at once - that’s a lot for a company to digest, but feed into a running commercial engine - but growth never comes from sitting idle.

The BTK read: A solid team in a great position, with a lot to execute. The test now is delivering on everything in play at the same time. The Kent partnership is worth watching given Kent’s exposure to both the fluorescence and NIRS draft LCDs. I’ll be watching closely.

Engineered Tissue Solutions (ETS): A Bright Spot in a Settling Category

AJ Ford has built, and keeps building, a solid team at ETS. As the CAMP category settles back into normal, ETS is one of the few companies still growing. It never took part in the pricing games of the last cycle, and it is well established in the acute care market that everyone now seems to be chasing. ETS showed its energy at the meeting, including at its Women Advancing Wound Care event, and their newly formed VT2 clinical symposium.

The BTK read: Companies that stayed out of the pricing games have nothing to unwind under the new payment structure. That is a real advantage right now. ETS is in a good place and is one to watch.

RedMaple Lifesciences: Early, With the Right Ingredients

Alex McCall and William Ash, RedMaple founders, brought real energy to the meeting. They also bring strong alliances, a solid network, and a sensible approach. It’s early days, and there will be more to report - but it was great to meet them, and now their on the radar.

There were so, so many others - it’s impossible to not only see everything but to be able to effectively capture every detail. The takeaway - innovation and growth - these are the leading topics of almost every conversation I had, or heard. If I missed you and you want to chat - please reach out, I truly would love to hear from you.

Coverage | APWCA Issues Position Statement Opposing Blanket Non-Coverage of Bacterial Fluorescence Imaging

On October 1, all seven Medicare Administrative Contractors issued proposed LCDs that classify real-time fluorescence wound imaging as “not reasonable and necessary.” The comment period closes November 14, 2026.

APWCA has now published its response. Its board approved a position statement on October 14. The statement was written by a 15-member author group that includes APWCA President William Tettelbach, David Armstrong, and Lee Rogers. It supports coverage of bacterial fluorescence imaging as an adjunct to clinical assessment, and it opposes blanket non-coverage, which it says the evidence does not justify. Read APWCA’s statement →

The core of the argument:

The BTK read: As the first published response (I know there are multiple in process) to the draft LCDs, this sets the bar, because it answers the question the MACs actually asked. The statement is organized around documented management decisions, which is the outcomes linkage we flagged as the central issue. It is also candid about its limits. APWCA concedes that the evidence is strongest on detection and treatment changes, that downstream outcome data are mostly single-center or observational, and that no cost-effectiveness analysis exists. That candor makes it harder to dismiss.

Two points to watch. First, the device-eligibility criterion separates peer-reviewed evidence, which comes mostly from a single platform, from FDA-reviewed performance data for newer entrants. How the MACs treat that distinction could shape the competitive field if a coverage pathway survives. Second, APWCA is asking for a coverage pathway with safeguards, not unrestricted coverage. That gives the MACs a middle position they can adopt.

APWCA’s statement won’t be the last. The Wound and Hyperbaric Association (WHA) has a response in process, the Alliance is working on its own, and individual manufacturers are preparing company-level comments. There is a lot of activity ahead of the November 14 deadline, and we’ll share each response here as it becomes publicly available.

Disclosure: I hold a commercial role at Swift Medical, whose Swift Ray 1 is among the FDA-authorized devices referenced in the APWCA statement.

Coverage | MAC Open Meetings: Fluorescence (RTFI) and NIRS Draft LCDs

All written comments are due November 14, 2026.

Check each MAC’s site for registration and speaker deadlines. Several have already passed.

Policy | Alliance of Wound Care Stakeholders Names Julie Rhodovi CEO

The Alliance named Julie Rhodovi as its next CEO, succeeding founder Marcia Nusgart, with her role effective January 1, 2027. The Alliance is the primary multi-stakeholder coalition engaging CMS on coding, coverage, and payment for skin substitutes, advanced dressings, and diagnostics.

Rhodovi’s background covers both sides of the reimbursement conversation:

I was able to meet her briefly in Las Vegas and came away impressed. She is well prepared to advance the Alliance, bridge across industry, and contribute meaningfully to the growth of the field.

The BTK read: A CEO with payer, Medicare Advantage, and alternative payment model experience fits where wound care reimbursement is heading. She inherits a strong organization at a demanding moment: draft LCDs on fluorescence and NIRS imaging, an active enforcement environment, and AI beginning to affect coverage decisions. Watch where the Alliance puts its early weight. The diagnostics LCDs are the most immediate test.

Clinical | Energenesis DFU Phase III Enrollment Passes 70%

Energenesis Biomedical reported on its FY2026 Q3 earnings call that enrollment in its DFU Phase III trial has passed 70%. Unblinding is expected next year. The chairman said a positive readout would put the company in control of its next steps.

The BTK read: Another pharmacologic DFU program is heading toward a Phase III readout. Treat the “ball is in our hands” line as investor-call language until the data posts. The milestones to track are full enrollment and the unblinding date.

Regulatory | Conexeu Closes $5M Insider-Led Placement Ahead of Q1 2027 510(k)

Conexeu Sciences closed a $5M private placement led by insiders. The company is still targeting a Q1 2027 510(k) submission for Ten Minute Tissue, an ECM-based liquid that gels at body temperature for irregular wounds. Preclinical, biocompatibility, and stability testing are underway, and the company is scaling manufacturing.

The BTK read: Insider-led rounds signal conviction, but $5M funds a submission, not a launch. The liquid format sets the product apart from sheet and mesh products in physical form. Whether it sets it apart in reimbursement depends on how it is coded and covered, which is still undefined.

Diagnostics | WoundScribe Launches Six-Agent AI Wound Care App at SAWC

WoundScribe unveiled an EMR-connected AI application with six integrated agents: ambient scribing, wound imaging, charting, coding, healing trajectory, and patient education. It targets clinic, bedside, and home care settings.

The BTK read: The coding and healing-trajectory agents sit exactly where accountability and coverage pressure are heading. Integration is a feature, but validation across your patient population is what reduces liability. Buyers should do the diligence before signing.

Imaging | Kent Imaging Partners With EmeraNova

Kent Imaging and EmeraNova announced a partnership to expand access to advanced wound imaging.

The BTK read: Kent is building distribution reach while its two core modalities face draft non-coverage. That makes this partnership a commercial bet on one of two outcomes: the comment period going Kent’s way, or demand that holds up regardless of Medicare coverage.

Sanuwave: A Deficiency Notice - NOT a Delisting

Our October 3 edition called Sanuwave Health’s (NASDAQ: SNWV) Nasdaq notice a delisting warning and said its financial runway was exhausted. Morgan Frank, Sanuwave’s CEO, reached out to clarify the details. Both claims overstated the situation.

On September 23, Sanuwave received a deficiency letter because its market value had been below the $50 million minimum for the Nasdaq Global Market for 30 business days. The letter has no immediate effect on trading. The company has until March 22, 2027, to regain compliance, or it can apply to move to the Nasdaq Capital Market. Sanuwave reported $9.4 million in cash at June 30, and management expects enough liquidity for at least twelve months. We withdraw our earlier suggestion to watch for a bankruptcy filing.

The pressures are still real. Q2 revenue fell 3%, UltraMIST system sales dropped by roughly a third, and full-year guidance has been withdrawn pending the CMS final rule. At the same time, applicator consumables set quarterly records.

The BTK read: This is a valuation problem, not a solvency event. The recurring revenue base is growing while capital equipment sales stall on reimbursement uncertainty. Watch three things: the CMS final rule, Q3 system placements, and whether Sanuwave cures the deficiency or transfers to the Capital Market. We got the tone wrong earlier and are correcting it here. We appreciate Morgan reaching out.

Sources: Sanuwave Form 8-K (Sept. 23, 2026); Q2 2026 earnings release (Aug. 6, 2026).

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 way no market intelligence platform has done before.

intelligence.belowtheknee.co/sign-up →

October 22–24 | Anaheim, CA — DFCon 2026 — JW Marriott (BTK attending)

Three days after SAWC, the DFU specialist audience gathers. Expect the fluorescence and NIRS LCDs, DFU pipeline readouts, and vascular outcomes data to carry over from Las Vegas.

October 20 – 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

December 5–6 | San Antonio, TX — DFUpdate 2026 (Diabetic Foot Update) — UT Health San Antonio

Hosted by the American Limb Preservation Society (ALPS). Pre-meeting workshops are on 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.

SAWC delivered on energy and on the companies worth watching. Next stop is DFCon in Anaheim this week. If you’re there, find me.

-Scott