OPENING SHOT
The Market Is Moving. On Multiple Fronts.
Spectral AI received its FDA De Novo for the DeepView burn assessment system on Monday. Conexeu Sciences entered the Nasdaq. A nurse-built clinical AI agent targeting Medicare's documented $177 million surgical dressing documentation problem launched commercially. Three very different companies. Three very different bets on where this market is heading — all moving to the same phase in the same week.
The earnings cycle continues to run in parallel. Sanara MedTech posted 19% growth and its first full quarter of profitability as a surgical pure-play. Aroa Biosurgery tripled EBITDA. MediWound's Phase III trial slipped one quarter while a $197 million BARDA contract for NexoBrid landed in the same report. The channel and evidence positioning thesis keeps printing in the data.
The field is moving. Here's the week.
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WOUND CARE
AI & Innovation | RENA Launches — A Nurse-Built Clinical Agent Targets the $177M Documentation Problem
Nancy Morgan, RN, BSN, CWHS — founder of the Wound Care Education Institute and co-creator of the Wound Care Certified credential — announced the commercial availability of RENA (Real-time Evidence-based Navigation Agent). RENA is an AI clinical agent developed to support wound care documentation, clinical decision-making, and claim-readiness at the point of care, designed for use by clinicians, home health agencies, EMS providers, DME suppliers, health systems, and community-based programs serving rural, territorial, and underserved populations.
The problem it targets is well-documented. CMS's 2024 Medicare Fee-for-Service Supplemental Improper Payment Data reports approximately $177 million in improper payments for surgical dressings in a single year, with a 57.6% error rate for surgical dressing claims — with CMS attributing many of these improper payments to missing or insufficient clinical documentation. RENA operates as a real-time point-of-care agent, integrating with existing clinical platforms and EHRs through modular APIs, focused on documentation quality and evidence-based decision support.
Morgan co-created the Wound Care Education Institute and the Wound Care Certified credential, with her education initiatives having trained more than 150,000 clinicians and supported over 40,000 credentialed practitioners. The Academy of Prescribers in Wound Healing (APWH) is positioned to license the technology to health systems, DME providers, and federal programs.
The BTK read: The clinical credibility here is real. A tool built by the person who trained a significant share of the wound care workforce, targeting the specific documentation failure mode that CMS has quantified at $177 million annually, is a credible product-market fit argument. The question is distribution — the target settings span home health, post-acute, outpatient, EMS, VA, and IHS, which is a wide and fragmented channel to cover. Enterprise licensing and federal program pathways are the right go-to-market framing. Worth watching how this intersects with the broader AI documentation stack being built by a growing list of companies — the documentation infrastructure layer of wound care is getting crowded, and clinical credentialing of the underlying tool may be the differentiator that matters.
Regulatory | Spectral AI Receives FDA De Novo for DeepView® — Burn Assessment Enters Commercial Phase
Spectral AI (Nasdaq: MDAI) announced that the FDA granted De Novo Classification for its DeepView® System on May 26, 2026, authorizing commercial distribution in the United States. The system is intended for use in burn centers, trauma centers, and emergency departments. The device combines multispectral imaging with a proprietary AI algorithm, providing clinicians with a data-driven assessment of whether areas within burn wounds are unlikely to heal within 21 days and may require significant medical intervention — with image acquisition taking 0.2 seconds and full AI classification requiring approximately 20 to 25 seconds. The system is trained against a database of over 340 billion pixels of burn wound image data and has received $31.7 million in BARDA support.
The BTK read: De Novo is the right pathway for genuinely novel technology — it creates a new predicate classification that competitors will eventually use. The clinical value proposition is well-defined: objective Day 1 assessment of healing potential eliminates the subjectivity currently driving inconsistent surgical decision-making in burn centers. The commercial challenge is equally well-defined — burn centers are a concentrated, relationship-driven channel where adoption depends on clinical champion development and health-economic evidence. BARDA backing helps institutional credibility. Q1 2026 saw a 40% revenue decline driven by completion of a major contract phase; the clearance converts a development-stage company into a commercial-stage one. Execution is the next test.
REGENERATIVE MEDICINE
Commercial | Conexeu Sciences (Nasdaq: CNXU) — A Platform IPO Worth Watching, With Caveats
Conexeu Sciences commenced trading on the Nasdaq on May 21, 2026, entering public markets as a preclinical-stage regenerative tissue platform company. The company's CXU™ platform is a patented bioregenerative extracellular matrix designed to scale across multiple addressable markets — wound care, breast reconstruction, and aesthetic medicine — without reformulation. The first product expression, Ten Minute Tissue™, is a CXU-based injectable ECM that transitions to a stable gel at body temperature in approximately ten minutes. A second expression, the B.R.E.A.S.T.™ matrix, is a 3D-bioprinted regenerative scaffold designed to gradually resorb as the patient's own tissue replaces it. The company is targeting a 510(k) submission in early 2027 for its initial indication. IP protection spans the U.S., EU, Japan, and Australia with no royalty or licensing obligations.
The BTK read: The platform architecture is genuinely interesting — a single ECM formulation that can address wound care, reconstructive surgery, and aesthetics from the same underlying material is a structurally different thesis from most biotech IPOs. The decade of university preclinical research and the multi-jurisdiction IP are credible foundations. That said, editorial transparency requires flagging: the prominent article circulating this week on Conexeu is a paid promotional piece distributed by USA News Group on behalf of the company, with a disclosed conflict that the publisher owns shares. The underlying facts about the Nasdaq listing and the CXU platform are real — but the framing is promotional, not analytical. Conexeu is pre-revenue, pre-clearance, and pre-510(k) submission. This is a watchlist story, not a commercial one.
FINANCE | Q1 2026 Earnings
Sanara MedTech (Nasdaq: SMTI) — 19% Growth, Surgical Pivot Delivers First Full Quarter of Profitability
Sanara MedTech reported Q1 2026 revenue of $27.8 million, up 19% year over year, beating the consensus estimate of $26.9 million. EPS came in at $0.04 per diluted share against an anticipated loss of $0.04. Gross margin improved to 93%. Soft tissue repair sales increased 21% year over year, led by CellerateRX Surgical Powder and BIASURGE, with broader market penetration, geographic expansion, and growth across the independent distribution network. Adjusted EBITDA reached $4.3 million, up from $2.7 million in Q1 2025. The sales force expanded to 43 representatives across more than 4,000 hospitals and 1,400 facilities. Q2 2026 revenue guidance was set at $28.5–$29.5 million, with full-year guidance maintained at $116–$121 million.
The BTK read: Q1 2026 was the first full quarter in which Sanara operated as a pure-play surgical company following the discontinuation of its Tissue Health Plus segment. The 19% growth and return to GAAP profitability in the seasonally weakest quarter validates that strategic call cleanly. The surgical channel is structurally insulated from the outpatient reimbursement disruption — no CAMP exposure, no billing risk, 93% gross margin. Management's conservatism in not raising guidance despite the Q1 beat is probably the right posture going into a back half that needs to sustain the growth rate implied by the full-year range.
MediWound (Nasdaq: MDWD) — EscharEx Trial Slips One Quarter, NexoBrid BARDA Contract Strengthens
MediWound reported Q1 2026 revenue of $1.5 million, down from $4.0 million in Q1 2025, with full-year 2026 revenue guidance reaffirmed at $24–26 million. The EscharEx Phase III VALUE trial is advancing with interim assessment and enrollment completion now expected by end of Q1 2027. The quarter was impacted by delayed BARDA-related income and shipment postponements, both since resolved. More than 30 sites are now active across the U.S., Europe, and Israel, with recruitment progressing more gradually than anticipated due to operational factors rather than safety or efficacy concerns.
On the NexoBrid side, Vericel received a 10-year BARDA contract valued at up to $197 million covering NexoBrid procurement and potential blast-trauma indication development. MediWound also announced a new Medline collaboration, adding to a partnership roster spanning all major advanced wound care companies. A Phase II study of EscharEx in DFUs and an investigator-initiated trial in pressure ulcers are both planned for H2 2026.
The BTK read: A one-quarter trial slip driven by site activation complexity and patient recruitment in an older VLU population is an operational explanation, not a safety flag. The interim sample-size reassessment expected by end of Q1 2027 is the pivotal read. The $197 million BARDA contract for NexoBrid is a substantial strategic anchor that de-risks the balance sheet while EscharEx matures. Full-year guidance reaffirmation at $24–26 million requires a significant H2 ramp — Q2 results will be the first confirmation point.
Aroa Biosurgery (ASX: ARX) — FY26 Revenue NZ$103.9M, EBITDA Triples, FY27 Guide Steps Back for Investment
Aroa Biosurgery reported FY26 revenue of NZ$103.9 million, up 23% year over year and above the top end of guidance. Normalised EBITDA tripled to NZ$12.6 million, well above the guidance range of NZ$5–8 million. Product gross margin held at 85.5%. The Myriad portfolio grew 54% on a constant currency basis, now exceeding OviTex revenue for the first time. The company generated NZ$5.1 million in net cash and holds NZ$27 million in cash with no debt.
FY27 normalised EBITDA guidance was set at NZ$8–11 million, below the FY26 print, reflecting approximately NZ$9 million earmarked for scaling Myriad commercial capabilities and supporting the Symphony launch. OviTex revenue through TELA Bio is expected to remain flat in FY27 — a notable shift from prior growth assumptions, with management now treating the TELA Bio partnership as the cash cow rather than the growth engine.
The BTK read: The FY26 result is the cleanest Aroa has ever printed. The FY27 guide stepping back from NZ$12.6 million is deliberate reinvestment, not a performance concern. The 54% Myriad constant-currency growth achieved with the same FY25 sales headcount is the most important data point — it demonstrates operating leverage is real before the company accelerates investment. Watch the Symphony launch timeline and clinical data as the primary FY27 catalyst.
📅 UPCOMING EVENTS
May 31–June 2 | 🔥 WOCNext 2026 — WOCN Society annual clinical gathering.
June 21 | St. Louis, MO — St. Louis Wound & Vascular Symposium, Hilton Frontenac.
August 6–9 | Nashville, TN 🔥 APMA Annual Scientific Meeting (The National) — Gaylord Opryland.
September 10–11 | New Orleans, LA IPAWS & Tissue Repair Summit (Kernexus) — The Ritz-Carlton.
September 14–16 | Louisville, KY 🔥 NAWCO HEAL Conference 2026
September 23–27 | Kuala Lumpur, Malaysia 🔥 WUWHS 2026
October 15–18 | Las Vegas, NV 🔥 SAWC Fall 2026 — Caesars Palace.
October 22–24 | Anaheim, CA 🔥 DFCon 2026 — JW Marriott.
November 6 | Virtual — WoundCon Fall 2026.
December 9–12 | Phoenix, AZ — Desert Foot Multi-Disciplinary Limb Salvage & Wound Care Conference.
Below The Knee | belowtheknee.co Independent market intelligence for wound care, limb salvage, vascular intervention, and foot & ankle. Not subscribed? → newsletter.belowtheknee.co Forward this to one person in your network who works in this space.
See you next week. — Scott