Below The Knee | Market Signal

Q3 Answered One Question. It Left Four Open.

Nearly every company exposed to the skin substitute flat rate has now reported. Q3 settles one question: the size of the hit depends on how much of a company’s revenue came from outpatient CAMP. Organogenesis, almost purely outpatient wound care, fell 70%. MiMedx fell 45%. Coloplast’s biologics fell 12%. Smith+Nephew’s bioactives fell 8.8%. Solventum’s Advanced Wound Care grew 1.5% organically. The less a company depended on outpatient skin substitutes, the less it lost.

It also shows what kind of business holds up. Inpatient and acute businesses grew. AVITA, almost entirely inpatient burn, grew 53%. Vericel’s Burn Care grew 52%. Coloplast’s inpatient biologics grew about double digits. MiMedx’s surgical line grew 9%.

What Q3 does not show matters as much. Year-over-year declines are measured against 2025, a base inflated by the billing practices the flat rate was built to end. Some of that 70% was spend that was never going to last. Whether volume has bottomed, whether evidence will ever earn a price premium, and how the 2027 rules land are all still open. The scorecard below separates what the data supports from what it doesn’t yet.

The MAC comment period on the imaging LCDs closes Saturday, November 14.

Supported by the data:

1. The impact scales with outpatient CAMP exposure. Seven companies, one consistent ranking. This is the clearest result of the year.

2. Site of service decides exposure, but surgical alone doesn’t protect a company. Inpatient and acute lines grew at Coloplast, AVITA, Vericel, and MiMedx. Organogenesis’s surgical line fell 19%, so product position matters as much as setting.

3. Balance sheets are splitting the field. MiMedx management presented surgery as its main growth engine at a Canaccord forum on November 11, while the Sanara acquisition still awaits FTC review. MiMedx reported $121 million in cash and no debt. Organogenesis ended the quarter with $26.9 million against a $22.4 million quarterly adjusted EBITDA loss. Two companies hit by the same policy are now on very different timelines. ad-hoc-news

4. Payment uncertainty alone changes what customers buy. Sanuwave sold 40 UltraMIST systems in Q3, down from 155 a year earlier, while applicator revenue rose 2%. The company said the proposed 97610 changes led customers to take a wait-and-see approach through the quarter, which, together with a market for used units, significantly hurt system sales. Patients kept getting treated. Practices stopped buying equipment while the rate was pending. That’s one company, but the mechanism is clear and will likely show up for other equipment-plus-disposable models whenever a code is under review. biopharmawatch

Not yet supported:

1. Whether volume has bottomed. Organogenesis grew about $2 million sequentially, and MiMedx reported wound care center volume growth. Those are two data points, and both are hospital-based. No company is reporting office-setting volume. Q4 and Q1 are the first real tests.

2. Whether evidence earns a premium. The rate is flat across FDA pathways, so Q3 can’t show whether a PMA product outperforms a 361 HCT/P. CMS won’t revisit that until CY2028 rulemaking.

3. Whether devices are absorbing displaced spend. Smith+Nephew devices grew 10.7%. Solventum grew 1.5% organically. One company isn’t a trend.

4. The 2027 rules. The conversion factor cut, the same-day E/M reduction, and the remote monitoring limits all take effect in January. No Q3 number reflects them.

The BTK read: The flat rate didn’t shrink wound care evenly. It sorted companies by site of service and balance sheet. Companies whose revenue doesn’t depend on the outpatient CAMP rate, whether through inpatient, surgical, devices, or a drug pathway, are reporting growth. Companies that do depend on it are reporting declines and, in at least one case, a financing question. Expect M&A to follow the same line: strong balance sheets buying assets that sit outside the flat rate.

Coverage | Imaging LCD Comments Close Saturday

The comment period on the proposed RTFI and NIRS non-coverage LCDs ends tomorrow, November 14. Palmetto’s non-contact NIRS non-coverage dates to 2023 under L39385, other MACs are newly proposing NIRS non-coverage, and fluorescence imaging is a new non-coverage proposal from all seven Part B MACs. CPT 97611 takes effect January 1 with national pricing either way. cms

The BTK read: After the deadline, the MACs review comments and publish responses with their final LCDs. There’s no fixed date for that. Clinical comments that describe a changed treatment decision speak most directly to the MACs’ evidence critique.

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

Skin Substitutes / CAMP | Audit Appeals Are Starting to Win

CareCloud says its Empower unit helped a wound care provider successfully appeal about $3 million in alleged Medicare overpayments involving skin substitute grafts, after helping another provider overturn more than $1 million at an administrative law judge appeal. The company is building wound care into a growth line for its revenue cycle and compliance services. globenewswire

The BTK read: The flat rate addressed future billing. Recoupment of past billing is a separate track, and it’s now in the appeals system. Vendor marketing is not case law, but the pattern is worth watching. Practices facing 2023–2025 audits carry a cash risk that doesn’t show up in any manufacturer’s earnings.

Burns / Acute | AVITA Gets New Physician Codes for 2027

AVITA announced a national Medicare physician payment framework for RECELL procedures. A new family of physician billing codes for skin cell suspension autografting takes effect January 1, 2027. avita

The BTK read: AVITA’s growth comes from the part of the market the flat rate doesn’t reach: inpatient, acute, and procedure-based. National physician codes remove one of the reimbursement problems behind its 2025 slowdown.

Wound Therapy | Sanuwave Responds to the 97610 Cut

Sanuwave responded publicly to the CY2027 final rule for CPT 97610, the code UltraMIST bills under. As covered last week, the office rate falls to $317.68 from roughly $400, and the hospital outpatient rate rises to $235.04. Sanuwave expects a significantly larger cut in 2028 absent further rulemaking, and called the final rule the beginning of the discussion, not the end. biospace

The BTK read: This is the same pattern as CAMP: office rates fall and hospital rates rise. Sanuwave has said hospital outpatient is a growing focus, and the rate change makes that shift necessary. The 2028 phase-in is the larger risk, and it can only be changed in next year’s rulemaking.

Burns / Acute | AVITA: Revenue Up 53%, Guidance Raised Again

AVITA reported Q3 revenue growth of 53%, gross margin of 84.0%, and raised full-year 2026 guidance to $92–94 million from $86–89 million. U.S. RECELL revenue rose about 20% sequentially, and Cohealyx revenue rose 21% to $2.1 million. The company ended the quarter with about $10.5 million in cash. AVITA

The BTK read: This is one of the strongest results in the scorecard and a clear counterexample to the CAMP decline. Two cautions: management attributed about $1 million to seasonal burn volume, and $10.5 million in cash leaves little margin if the Q4 breakeven target slips.

Burns / Acute | Vericel: Burn Care Up 52%, Epicel and NexoBrid at Records

Vericel reported Q3 revenue up 26% to $85.4 million. Burn Care revenue grew 52% to $18.0 million, with Epicel at $12.7 million and NexoBrid at $5.3 million. Epicel had its highest quarter since launch, and NexoBrid commercial revenue grew 54% year over year. The company raised Burn Care guidance to $54 million from $46–50 million. Vericel ended the quarter with $236 million in cash and investments and no debt. sec

The BTK read: This is the second inpatient burn business in the scorecard reporting strong growth. Two qualifiers: $3.0 million of the quarter was BARDA procurement revenue, which is contract-driven rather than organic demand, and summer burn seasonality likely helped, as it did at AVITA. One more connection: NexoBrid is MediWound’s product, licensed to Vericel in the U.S. Vericel’s NexoBrid sales are growing while MediWound’s own revenue fell 34%, which shows where the commercial economics of that product sit. earningswhispers

Wound Therapy | Sanuwave: System Sales Down 74%, Applicators Up 2%

Sanuwave reported Q3 revenue of $8.6 million, down 24%, and a GAAP net loss of $1.4 million compared with net income of $9.7 million a year earlier. It sold 40 UltraMIST systems, down from 155 a year earlier and 82 in Q2, while applicator revenue rose 2% to $6.9 million. Gross margin held at 77.3%. The company ended September with $6.6 million in cash after paying about $2.3 million under sales tax voluntary disclosure agreements. biopharmawatch

The BTK read: Applicator revenue held, so clinical use held. Revenue fell because practices stopped buying equipment while the 97610 rate was unsettled. The final rule removes the uncertainty but locks in a lower office rate, so whether system sales recover depends on how many buyers are in hospital outpatient departments. With $6.6 million in cash, Sanuwave has limited time to wait for that.

Pharma / Drug | MediWound: Revenue Down, Phase III on Track

MediWound reported Q3 revenue of $3.6 million, down 34%, and a net loss of $6.0 million as R&D spending rose for the Phase III EscharEx VALUE trial in venous leg ulcers. Enrollment is on track to finish by Q1 2027. The company received another $3.3 million in U.S. Department of War funding for NexoBrid and closed its post-quarter offering at $17.25 million, up from the $15 million announced. yahoo finance

The BTK read: Revenue isn’t the story here. The company is funding a drug-pathway trial that sits outside the flat rate, and the larger raise extends its runway to the enrollment milestone.

Diagnostics | Spectral AI: Revenue Down 25%, First DeepView Placements in Q4

Spectral AI reported Q3 revenue of $2.9 million, down 24.7%, a $3.7 million net loss, and $11.2 million in cash. The first 30 DeepView systems are being built for BARDA-supported deployment at U.S. burn centers, and the company has applied for a CMS NTAP. spectral ai

The BTK read: NTAP is an inpatient add-on payment. Spectral is pursuing the same inpatient, acute path as AVITA and Vericel, away from the outpatient imaging LCDs.

Foot & Ankle / Limb Reconstruction

Vascular | Humacyte: Symvess Revenue Up 151% Sequentially

Humacyte reported Symvess sales of $1.0 million in Q3, up 151% from Q2 and up from $0.7 million in Q3 2025. The number of hospitals ordering grew to 49 from 34. October sales were $0.8 million, and the company expects Q4 sales to at least double Q3. It plans to file a supplemental BLA for ATEV in dialysis access in November 2026. Humacyte ended September with $64.9 million in cash after burning $15.0 million in the quarter. biospace

The BTK read: The growth rate looks impressive, but the base is about $1 million a quarter against $15 million in quarterly burn. October is the real signal: it nearly matched the whole third quarter. The dialysis sBLA is what could change the company’s size. Symvess’s vascular trauma indication is a narrow market.

Earnings Roundup

Skin Substitutes / CAMP | MiMedx: $400 Million Surgical Company, Pending FTC

At the Canaccord forum, MiMedx said surgical contributed $40 million of Q3’s $62 million and reported $121 million in cash with no debt. Management expects the combined company with Sanara to generate about $400 million in first-year revenue with adjusted EBITDA margins above 20%, pending FTC review. investing.com

The BTK read: FTC review is the gating item for the first sizable CAMP-to-CAMP deal under the flat rate. A clean close would support the scale argument. An extended review would slow every similar deal behind it.

Skin Substitutes / CAMP | RegenLab Heads to Nasdaq With a Contested Patent Record

RegenLab USA, which is preparing a Nasdaq IPO under the ticker RGNA, is seeking to raise up to $20 million, according to its amended prospectus. That’s up from the $18 million terms set in October. RegenLab reported about $49.2 million in 2025 revenue, 62% of it from its RegenKit PRP line. Its December 2025 exclusive U.S. distribution agreement with MiMedx for RegenKit-Wound Gel included a $5 million upfront payment, received in January 2026, and up to $5 million more tied to sales milestones. sec

A paid wire release this week laid out RegenLab’s patent history. According to the EPO’s legal-event record, European patent EP3403659B1, covering thrombin serum and PRP compositions, received a revocation communication in March 2026, and RegenLab has appealed. The release also cites a 2019 UK High Court ruling invalidating an earlier RegenLab patent, which the EPO Board of Appeal left revoked in 2023, and a U.S. ITC complaint RegenLab withdrew in 2019. financialcontent

The BTK read: Consider the source first. This is a paid release from an unnamed author. Its primary-source links check out, but it was written to raise doubts before the IPO. On the substance, the MiMedx agreement isn’t expressly tied to the contested European patent, and a European revocation under appeal doesn’t decide anything about U.S. protection. The real question is what the S-1 risk factors say about U.S. patent coverage for the wound gel. For MiMedx, the exposure is small: up to $5 million in remaining milestones on a distribution line, not a core asset. This item says more about how a small regenerative device IPO gets scrutinized than about MiMedx.

Accelerator | EmeraNova Launches Catalyst

EmeraNova launched Catalyst, a four-month accelerator for wound care, tissue restoration, and regenerative medicine startups, with up to $200,000 per company. dealroom

The BTK read: This matches the Q3 Capital Flow pattern of small early checks and few later rounds. Accelerators can fill the seed gap. They don’t fill the Series A gap.

NPWT | Bechtel Medical Clears First Combined NPWT and Topical Oxygen System

Bechtel Medical received 510(k) clearance for Wound VOX, which the company calls the first cleared device combining negative pressure wound therapy and topical oxygen in one system. prnewswire

The BTK read: Clearance establishes that the device can be sold. It doesn’t establish how it gets paid. NPWT and topical oxygen each have their own coverage and coding history, and a combined device has to fit into one of them or make the case for a new path. Payment is the commercial milestone to watch.

Diagnostics | Kent Takes SnapshotNIR to Aged Care in Australia and New Zealand

Kent Imaging named IPCIUM the exclusive distributor of SnapshotNIR to aged care providers in Australia and New Zealand. The device is integrated into IPCIUM’s care platform, which sends results directly into resident records and facility dashboards, with alerts and automated documentation. IPCIUM is a Brisbane-based company whose platform combines imaging, clinical workflow, telehealth, and remote monitoring for residential aged care, home care, and community health. kent imaging

The BTK read: This is a non-Medicare channel, announced five days before the MAC NIRS comment deadline. Whatever the timing, the model is worth noting. Aged care facilities buy on preventing pressure injuries and saving staff time, not on Part B coverage, and placing the device inside a care platform makes it part of the workflow rather than a separate procedure to bill. If NIRS non-coverage is finalized in the U.S., channels where the buyer pays directly and doesn’t depend on Medicare coverage become more important. Long-term care is the comparable U.S. setting.

Disclosure: see above.

Diagnostics | MolecuLight Achieves FIPS 140-3 Validated Encryption

MolecuLight achieved FIPS 140-3 validated encryption for MolecuLightDX+, a federal cryptographic security standard often required for VA and government procurement. prnewswire

The BTK read: Federal facilities don’t depend on Part B LCDs, and FIPS validation is often required to sell into them. Like Kent’s aged care deal, it builds a channel that doesn’t depend on Medicare Part B coverage.

Disclosure: see above.

Workflow | Net Health Adds Ambient AI Documentation to WoundExpert

Net Health added native ambient AI documentation to WoundExpert, turning visit audio into structured chart fields. The company says the feature draws on more than 100 million wound assessments. net health

The BTK read: Two weeks after buying Sanara’s clinical AI assets, Net Health is building AI into the system of record. Standalone wound documentation vendors now compete against a feature of the EHR.

Briefs

Reported since last issue: AVITA, Vericel, Artivion (Nov 5), Treace, Orthofix, Spectral AI, Sanuwave, Sonoma, Humacyte, MediWound (Nov 12).

Medtronic confirmed it will report on Tuesday, November 24. Aroa lists November 26 as an indicative date for its half-year results. Convatec and Aroa are the last two wound care reports of the quarter. After that, Q3 is fully in. medtronicaroa

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 on the platform.

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

November 18: Convatec trading update

November 24: Medtronic fiscal Q2

November 26: Aroa half-year results (indicative)

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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-Scott