OPENING SHOT
The Numbers Are In. The Market Told the Truth.
This was the week the wound care sector stopped speculating about Q1 and started reporting it.
MiMedx went first. Net sales came in at $59 million — down 33% year over year — as wound care revenue collapsed 60% under the weight of the January 1 Medicare reimbursement reset. Surgical grew 13%. The wound business absorbed the damage. Coloplast followed with a guidance cut, zeroing out its Kerecis growth outlook for the year. Aroa delivered the week's lone unambiguous bright spot — full-year revenue beat guidance by double digits, fueled by 52% Myriad growth.
Three companies. Three very different stories. One consistent variable: whether your revenue was exposed to the outpatient skin substitute channel determined your Q1 outcome more than anything else in your control.
The other major story of the week came from Washington. CMS and FDA jointly announced the RAPID coverage pathway — a structural change to how Breakthrough Devices move from FDA clearance to Medicare reimbursement. For a market that has been defined this year by what reimbursement takes away, this is a signal about what it might give back — and to whom.
Also this week: a DOJ seizure that put an uncomfortable number in the public record. From $256 million in 2019 to over $10 billion by 2024 — the skin substitute billing surge that drove the January 1 reset is now at the center of federal fraud enforcement. That backstory matters for understanding why CMS moved when it did.
BTK INNOVATION INDEX — 283 COMPANIES. ONE INDEPENDENT SCORE.
Every company in this edition is indexed. Innovation Velocity, Clinical Evidence, Technical Differentiation, Regulatory & Reimbursement, Strategic & Commercial Activity, Brand & Market Signal — scored on merit, no exceptions.
The Q1 earnings cycle is sorting the sector in real time. The Index shows where each company sat before the reset. The divergence you're seeing now is consistent with what the scores already implied.
Three tiers: Early Access $495 / Standard $995 / Enterprise + Advisory $3,500.
WOUND CARE
Earnings | MiMedx Q1: Wound Down 60%, Surgical Up 13%, Guidance Cut to $260–$290M
The numbers are now on record. MiMedx reported net sales of $59 million for Q1 2026, compared to $88 million in Q1 2025 — a 33% decline. Wound care revenue fell 60% to $22.6 million. Surgical grew 13% to $36.4 million, led by AMNIOFIX, AMNIOEFFECT, and double-digit growth in the particulate portfolio.
Management cited new Medicare reimbursement policies that led to significant industry-wide confusion across nearly every care setting, compounded by inconsistent implementation by Medicare Administrative Contractors, which created additional challenges for providers and patients. The WISeR prior authorization model was specifically called out as a source of severe claims-processing friction.
Management lowered full-year revenue guidance to $260–$290 million and forecasts a return to profitability in Q3, with cost reductions and sustained surgical growth expected to contribute — but recovery in wound care remains uncertain.
The company ended the quarter with $142 million in net cash and initiated a $100 million share repurchase program, signaling financial stability even as it navigates the most disruptive reimbursement transition in the sector's recent history.
The BTK read: The 60% wound care decline is the number the market needed to see to calibrate what "slow recovery" actually means in dollar terms. The important signal from the call is the intra-quarter trend — March was flat versus January and February, and April has been similar. There is no visible acceleration in wound care recovery. The floor may be in; the bounce is not. Surgical is now the operating thesis. MiMedx is being restructured to compete in a smaller, cleaner, more defensible wound care market on the other side of this transition. Whether that transition lasts two quarters or two years is the open question.
Earnings | Coloplast Cuts Guidance — Kerecis Growth Zeroed Out for FY2026
Coloplast revised its full-year FY2025/26 financial guidance, lowering expected organic growth to 5–6% from a prior target of approximately 7%. The driver: Kerecis is now expected to deliver approximately 0% organic growth for the full year — down from a prior expectation of approximately 10% — reflecting significant sales disruption from the Medicare reimbursement change in the outpatient setting.
Kerecis posted 0% organic growth and 0% EBIT margin in Q2, while growth in the inpatient setting remained at a healthy double-digit level. Advanced Wound Dressings declined 2% organically, reflecting a product return in China and a soft quarter across European markets.
The rest of the Coloplast business performed well. Chronic Care, Continence Care, Voice & Respiratory, and Interventional Urology all posted solid growth. The wound and tissue repair division is carrying the full weight of the outpatient disruption.
The BTK read: Coloplast paid $1.3 billion for Kerecis in 2022 based on a growth thesis that depended heavily on outpatient skin substitute utilization. That thesis ran directly into the January 1 reset. The inpatient business is intact; the outpatient business is structurally impaired. This is a company that built right but deployed into the wrong channel at the wrong time — one of the four BTK company archetypes from the Q1 Capital Signal analysis (see that here). Recovery here depends on whether the outpatient market normalizes or permanently contracts. The guidance revision suggests Coloplast is now planning for the latter.
Earnings | Aroa Biosurgery FY26: Revenue Beats Guidance — Myriad at 52% Growth
The week's outlier. Aroa Biosurgery reported full-year FY2026 revenue of NZ$104 million in actual terms — above its full-year guidance range of NZ$92–100 million. Constant currency revenue of NZ$101 million represented 21% growth versus FY2025. Management credited strong growth to a 52% year-on-year boost in Myriad portfolio sales, which exceeded internal expectations.
Normalised EBITDA is expected to come in at NZ$11–12 million on an actual basis, materially above FY2026 constant currency earnings guidance of NZ$5–8 million. Aroa also reported a positive net cash flow of NZ$5 million over the full year.
Myriad's positioning matters here. As a bioscaffold used predominantly in surgical and reconstructive settings — not the outpatient skin substitute channel — Aroa has operated largely outside the CAMP disruption zone. Its Symphony product, designed for the outpatient wound care setting, is now being positioned as an opportunity in a market where competitors are exiting or contracting.
The BTK read: Aroa is one of the clearest validation signals this week for a thesis BTK has been developing: the companies built for surgical, inpatient, and reconstructive applications are outperforming while the outpatient skin substitute segment resets. Myriad at 52% growth against an industry backdrop this disruptive is a product-market fit signal. Symphony's commercial ramp — targeting the disrupted outpatient channel from a position of strength rather than desperation — is the story to watch in FY2027.
Regulatory | CMS and FDA Launch RAPID Coverage Pathway for Breakthrough Devices
CMS and FDA jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, designed to expedite Medicare access to certain FDA-designated Class II and Class III Breakthrough Devices. The pathway allows CMS and FDA to work together with innovators earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions.
Under RAPID, CMS will issue a proposed National Coverage Determination the same day an eligible device receives FDA market authorization, triggering the required 30-day public comment period. This streamlined approach could enable predictable Medicare national coverage and payment as soon as two months after market authorization, compared to approximately a year or more under the current pathway.
For the BTK market, the immediate relevance is direct. The Efemoral EVSS holds FDA Breakthrough Device designation for infrapopliteal CLTI indications. Organogenesis ReNu completed its BLA submission this week. WoundScribe-on-Wheels and platforms like it represent the AI-native documentation and delivery infrastructure being built to support this transition. The RAPID pathway is the reimbursement on-ramp that makes the commercial case for investing in Breakthrough Device development viable.
The BTK read: CMS gave with one hand in January and took away with the other. The RAPID pathway is the give-back — and it's targeted precisely at the innovation layer of the market, not the volume-based skin substitute channel that was restructured. For companies with Breakthrough Device designations in wound care, limb salvage, and vascular intervention, this is a material change in how quickly innovation converts to reimbursable utilization. This story deserves a dedicated deep-dive — watch for a white paper treatment in an upcoming edition.
Regulatory | Organogenesis Completes BLA for ReNu — A Strategic Pivot Encoded in a Filing
Organogenesis completed its rolling Biologics License Application submission to the FDA for ReNu, a cryopreserved amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. The company initiated the rolling BLA in December 2025 with non-clinical modules and completed the package with clinical and CMC modules on April 28, 2026.
Knee OA is estimated to affect nearly 31.1 million Americans, projected to grow to 34.4 million by 2027.
This is the first BLA submission for a cryopreserved amniotic suspension allograft in this indication. It represents Organogenesis executing the same bifurcation strategy being played out at MiMedx — investing in the surgical and musculoskeletal pipeline while navigating reimbursement disruption in the wound care segment. Q1 earnings report May 7.
The BTK read: The ReNu BLA is Organogenesis signaling where its long-term value creation thesis now lives. A successful approval would create a reimbursement pathway in a massive, underpenetrated musculoskeletal indication that sits entirely outside the CAMP disruption. For a company under sustained wound care pressure, this is the most important regulatory filing it has made in years. Watch the May 7 call for guidance on the FDA review timeline and commercial preparation.
Commercial | BioLab Holdings and SweetBio Partner — The Non-Human Distinction Matters
BioLab Holdings announced a strategic distribution partnership with SweetBio to expand access to its APIS bioengineered wound product through BioLab's national distribution network. APIS is the first and only wound care product to combine UMF-certified Mānuka honey, collagen derivative, and hydroxyapatite — formulated to support every stage of the healing cascade from bacteria reduction through remodeling.
The clinical positioning is deliberate. APIS is non-human, containing no placental, umbilical, or other human tissue — a distinction that simplifies the regulatory and billing landscape and opens a more straightforward path for clinicians looking for high-performance alternatives.
The BTK read: The non-human distinction is not incidental — it's a calculated positioning move in a market where human tissue allografts are under intense regulatory and billing scrutiny. SweetBio is building a clinical story around a product that operates outside the most disrupted billing category while delivering performance within the same continuum of care. The BioLab distribution network gives it national reach. This is exactly the kind of commercial infrastructure formation that happens when a reimbursement reset creates white space.
AI & INNOVATION | WoundScribe-on-Wheels: The First AI-Native Platform Built for Mobile Wound Care
WoundScribe AI announced the launch of WoundScribe-on-Wheels, a dedicated program and platform built specifically for mobile wound care companies and independent wound clinicians delivering care in skilled nursing facilities, assisted living communities, group homes, and private residences. The platform is designed to eliminate operational and clinical barriers limiting mobile wound care at scale, returning 3 to 4 hours per day to clinicians through AI-powered imaging, automated documentation, and billing.
The BTK read: Mobile wound care has been structurally underserved by technology since the model was invented. WoundScribe-on-Wheels is the infrastructure layer that makes it commercially scalable. Given the accelerating site-of-care shift being driven by the CAMP reimbursement reset — wound care providers actively migrating patients from outpatient offices to home and SNF settings — the timing here is not coincidental. The DME and mobile wound care growth arc is building. We're developing a dedicated white paper on this trend — more ahead.
Enforcement | DOJ Seizes $2M from Pasadena Wound Clinic — and the Numbers Behind the Seizure Explain Why CMS Moved
A Pasadena-based advanced wound care clinic, Expert Wound Care PC, is accused of defrauding Medicare for millions in reimbursements for skin graft substitutes and skin grafts that were never performed on patients. A federal judge granted a request to seize $2,039,792 from the clinic's bank account. From September 2025 to April 2026, Expert Wound Care submitted more than $46.6 million in Medicare claims for skin substitute products and wound care services. Medicare approved payments of approximately $34 million on those claims.
Federal agencies note that skin substitute billing surged from approximately $256 million in 2019 to more than $10 billion by 2024 — a surge that helped trigger new rules and tighter oversight. The DOJ has formally designated Southern California a high-risk environment for health care fraud.
Expert Wound Care's percentage of total beneficiaries receiving substitute skin grafts was 38.5%, more than six times the national average of 6%. Its percentage of total allowed amount for substitute skin grafts was 99.9% — more than double the national average.
The BTK read: This case is exhibit A for why the January 1 reset happened. A market that grew from $256 million to $10 billion in five years was not driven by patient need. It was driven by billing behavior. The enforcement action validates the CMS rationale at the exact moment the sector is debating whether the reimbursement change was appropriate. For companies with differentiated, evidence-based products and legitimate clinical positioning, the fraud enforcement wave is a tailwind — it accelerates market cleanup and removes the arbitrage players who distorted pricing and utilization. The companies that built right are increasingly competing against fewer, weaker alternatives.
THE DME QUESTION: IS THE NEXT GROWTH WAVE ALREADY BUILDING?
The wound care sector is navigating a reimbursement contraction in the outpatient setting. But a parallel story is building in a different part of the care continuum — and it's pointing in the opposite direction.
The U.S. DME market has grown from $60 billion in 2020 to $85 billion in 2024 and is projected to exceed $110 billion by 2028, driven by demographic shifts, payer alignment toward home-based care, and innovations in device technology. Within that market, the wound care and enteral segment represents approximately 15% of total DME revenue — and it is being actively reshaped by the same CMS reset that is disrupting the outpatient clinic channel.
The thesis: as outpatient utilization contracts, wound care delivery migrates toward home health, SNFs, and mobile providers. The DME infrastructure serving those settings — devices, dressings, platforms, and software — becomes the growth corridor. The companies that anticipated this migration, or are pivoting toward it, are positioning for a structural tailwind.
WoundScribe-on-Wheels is one data point in this thesis. The growth in mobile wound care hiring BTK tracked in the Q1 Capital Signal — 156% commercial hiring surge — is another. The BioLab/SweetBio partnership, explicitly structured around care settings outside the disrupted outpatient channel, is a third.
BTK is developing a dedicated white paper on the DME question — the site-of-care shift, the growth drivers, the companies positioned to benefit, and what it means for reimbursement architecture beyond 2026. Watch for it in an upcoming edition.
FOOT & ANKLE
Earnings | Zimmer Biomet Q1: Solid Performance, CFO Transition Announced
Zimmer Biomet reported first quarter net sales of $2.087 billion, an increase of 9.3% on a reported basis and 2.9% on an organic constant currency basis. Adjusted diluted earnings per share were $2.09, an increase of 15.5%. The company updated full-year 2026 financial guidance. Zimmer also announced a Chief Financial Officer transition this week.
Zimmer Biomet's foot and ankle portfolio and its lower extremity reconstruction business are relevant reads for the BTK surgical corridor — particularly as the sector tracks where procedural volume is migrating post-reimbursement reset.
Q1 2026 EARNINGS WATCH — UPDATED
The reporting cycle is now in motion. Here's the updated calendar:
MiMedx (NASDAQ: MDXG) — Reported April 29 ✓ Net sales $59M, -33% YoY. Wound -60%, Surgical +13%. Full-year guidance $260–$290M. Return to profitability targeted Q3. See full analysis above.
Organogenesis (NASDAQ: ORGO) — Reports May 7 Q1 will be the first full read on how the CTP environment hit Organogenesis in the period. The ReNu BLA completion this week adds a pipeline narrative to the call. Watch for wound care revenue trajectory, ReNu FDA timeline commentary, and any updated guidance.
Treace Medical Concepts (NASDAQ: TMCI) — Reports May 13 Lapiplasty procedure volume recovery and commercial model scaling are the key signals. This is a foot-and-ankle read, but the broader BTK surgical corridor matters.
Avita Medical (NASDAQ: RCEL) — Reports May 14 Cohealyx interim data and burn center utilization are the primary watches. Whether Q1 commercial momentum in RECELL justifies the prior rerating.
Sanuwave Health (NASDAQ: SNWV) — Full Q1 Report Expected Mid-May Preliminary $9.6–$9.7M already in market. The full call adds color on the deal pipeline that slid out of Q1 and full-year guidance reaffirmation.
Coloplast — Guidance Cut Announced April 23 ✓ Full H1 results expected in May. Kerecis at 0% organic growth; full-year guidance cut to 5–6%. See full analysis above.
Aroa Biosurgery (ASX: ARX) — Preliminary FY26 Results Released ✓ Revenue NZ$104M, above guidance. Myriad +52%. Full FY26 results due by May 31. See full analysis above.
📅 UPCOMING EVENTS
May 6–8 | Bremen, Germany 🔥 EWMA-DEWU 2026 — Messe Bremen The 36th European Wound Management Association Congress, co-hosted with the German Wound Congress. 5,000+ attendees, 150+ exhibitors. The must-attend European wound care event of 2026.
May 14–15 | Austin, TX 🔥 Advanced Wound Care Summit (AWCS) — Marriott Downtown The business of wound care — investors, BD leaders, payors, distributors, multinationals, regulators. First major post-Q1-earnings commercial gathering. The room to be in this month.
May 31–June 2 | WOCNext 2026 WOCN Society annual clinical gathering. Strong nursing and advanced practice track.
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 The national gathering for podiatric medicine. Four full days.
September 10–11 | New Orleans, LA 🔥 IPAWS & Tissue Repair Summit (Kernexus) — The Ritz-Carlton Three tracks: tissue repair, post-acute and mobile wound care, CAMPs market dynamics.
September 14–16 | Louisville, KY 🔥 NAWCO HEAL Conference 2026 The National Alliance of Wound Care and Ostomy's annual conference. Clinical, regulatory, and reimbursement tracks across wound, ostomy, and continence.
September 23–27 | Kuala Lumpur, Malaysia 🔥 World Union of Wound Healing Societies (WUWHS) 2026 The quadrennial global congress of the wound healing community.
October 15–18 | Las Vegas, NV 🔥 SAWC Fall 2026 — Caesars Palace Co-located with NPIAP Fall Conference. New Mobile Wound Care Track for 2026. The full wound care team's fall gathering.
October 22–24 | Anaheim, CA 🔥 DFCon 2026 — JW Marriott Anaheim Resort ALPS's global interdisciplinary diabetic foot conference.
December 9–12 | Phoenix, AZ Desert Foot Multi-Disciplinary Limb Salvage & Wound Care Conference — Sheraton Phoenix Downtown
Below The Knee | belowtheknee.co Independent market intelligence for wound care, limb salvage, vascular intervention, and foot & ankle. Not subscribed? → belowtheknee.co/newsletter Forward this to one person in your network who works in this space.
See you next week. — Scott