Below The Knee | Market Signal

The CEO Who Told Congress the Fraud Was the Discount Just Showed You What the Discount Was Covering

MiMedx reported Q2 2026 results this week that make the roundtable testimony from two editions ago concrete. Wound segment net sales fell 61 percent year over year to $25.1 million, the direct result of the Medicare reimbursement changes that took effect January 1. Total net sales fell 35 percent to $64.4 million, and the company posted a $14.8 million net loss against $9.6 million of net income a year earlier. This isn't an abstract policy debate anymore. This is a real company's wound care business getting cut nearly in half by the same reform its own CEO was in Washington explaining the need for ten days earlier.

MiMedx's answer arrived in the same release. A $350 million cash-and-stock acquisition of Sanara MedTech, $35 per share, a 46 percent premium, funded partly by a new $300 million term loan from Hayfin Capital. Post-close, MiMedx expects roughly 75 percent of its revenue to come from surgical products and 25 percent from wound care, a full reversal of where the company has lived for most of its history. Capper called it a transformational combination. Read plainly, it's also an exit. Capper spent the roundtable describing the mechanism that inflated the CAMP category. The earnings call ten days later describes what happens to a company still living inside that category once the mechanism gets shut off, and the strategic answer is to leave.

Sanara brings CellerateRX Surgical Powder, BIASURGE, and a Breakthrough Device-designated bone fixation product working toward a 2027 launch, none of it exposed to CAMP reimbursement risk the way MiMedx's wound business is. The combined math works on paper: 2027 revenue projected above $400 million, adjusted EBITDA margin above 20 percent, more than $20 million in run-rate synergies. What it signals about the category MiMedx is leaving behind is worth sitting with on its own. If the company that's spent the last three years positioning itself as the reform voice for skin substitutes is now moving three-quarters of its revenue away from the category, that's a real data point about where the smartest capital in this space thinks it's headed.

Here's the week.

We are just 42 days away from conference season heating up - and at BTK we are starting off in New Orleans. Below The Knee is the Official Market Intelligence Partner for IPAWS & Tissue Repair Summit 2026. Hope to see you there!

September 10–11 | The Ritz-Carlton, New Orleans, LA Hosted by Kernexus Med Comms

ipawssummit.com →

Regulatory | CMS Proposed LCD Affirms Medicare Coverage for AOTI Topical Oxygen Therapy

CMS issued a proposed Local Coverage Determination confirming that topical oxygen therapy is reasonable and necessary for diabetic foot ulcers that have failed four weeks of optimized standard care, opening access for roughly 69 million Medicare enrollees to AOTI's TWO2 therapy. AOTI already holds 75 percent share of the topical oxygen market with coverage across 26 states, and the LCD is expected to finalize within a year.

The BTK read: Worth noting this lands in the same month CMS is being hammered in Congress for the opposite kind of decision, over-permissive reimbursement in CAMP. This is the counter-example. A narrowly scoped LCD tied to a specific failure-of-conservative-care threshold, for a therapy with an established evidence base and a dominant single-player market share, is a clean template for how CMS can expand access without repeating the pay-first-ask-billing-pattern-questions-later mistake that built the skin substitute crisis in the first place.

Investment | MiMedx to Acquire Sanara MedTech for $350M

MiMedx and Sanara MedTech entered a definitive merger agreement under which MiMedx will acquire all outstanding Sanara shares in a cash-and-stock deal valued at $35 per share, a total enterprise value of approximately $350 million. Sanara shareholders will receive $33.00 in cash plus 0.4735 MiMedx shares per Sanara share, a 46 percent premium to Sanara's 30-day volume-weighted average price. MiMedx is financing the cash portion with a new $300 million term loan from Hayfin Capital Management, which also replaces its existing credit facility. Both boards approved unanimously, with closing expected by year-end pending Sanara shareholder approval and HSR antitrust clearance. The deal nearly doubles MiMedx's surgical revenue and is expected to push combined 2027 revenue above $400 million.

The BTK read: This is covered in full in the Opening Shot above, but the standalone numbers are worth having on record: MiMedx Q2 net sales of $64.4 million, down 35 percent year over year, wound revenue down 61 percent, surgical revenue up 15 percent to $39.3 million on continued AMNIOFIX and AMNIOEFFECT strength. The company reiterated full-year guidance of $260 to $290 million and continues to expect adjusted EBITDA to approach breakeven in 2026. Shares fell around 5.7 percent in after-hours trading despite revenue landing in line with estimates, which reads as the market pricing the acquisition's execution risk and financing cost more than the quarter itself.

Also this week, briefly: An FDA advisory committee recommended expanding access to six peptide compounds, including TB-500 and KPV, being explored for wound healing and inflammatory conditions, though the FDA has not made a final decision and the clinical evidence base remains limited.

Market | Boston Scientific Beats Q2 on FARAPULSE Momentum, Then Announces Job Cuts

Boston Scientific reported Q2 2026 net sales of $5.44 billion, up 7.5 percent reported, with adjusted EPS of $0.86 beating consensus of $0.83. Cardiovascular grew 8.3 percent, led by the FARAPULSE pulsed field ablation system following AVANT GUARD AF study results presented at Heart Rhythm 2026. Interventional Cardiology and Vascular Therapies delivered $1.33 billion in sales with 12.1 percent organic growth. The same week, the company unveiled a new restructuring plan including 2026 job cuts and launched a $500 million cost-reduction initiative.

The BTK read: A beat-and-restructure combination in the same reporting cycle is worth watching rather than reading as contradictory. Boston Scientific is investing hard behind FARAPULSE and vascular therapies growth while trimming elsewhere, which is a normal large-cap playbook, but the job cuts are worth tracking for any regional sales or clinical support impact in the vascular intervention and peripheral markets this platform follows.

Regulatory | FDA Advisory on Boston Scientific ENROUTE Transcarotid System

The FDA advised against using specific lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System catheters due to arterial sheath tip separation, after one serious injury was reported since July 9. Tip separation could require endovascular or surgical intervention and may lead to embolism or stroke.

The BTK read: A safety advisory on a neuroprotection device used specifically to prevent stroke during transcarotid procedures is a serious one regardless of company size. Worth watching for a follow-up recall classification and whether this affects procedure volume in the interim.

Market | Merit Medical Beats Q2, Raises Full-Year Guidance

Merit Medical reported Q2 2026 revenue of $418.8 million, up 10 percent reported and 9 percent on an organic, constant-currency basis, beating the high end of its own expectations. Non-GAAP EPS came in at $1.19, up 18 percent year over year, with non-GAAP operating margin improving to 22.6 percent from 21.2 percent. Vascular Intervention was a standout inside the print: the Foundational Vascular Intervention line grew 19 percent reported to $41.7 million, and Therapeutic Vascular Intervention grew 7 percent to $34.4 million. CEO Martha Aronson pointed to particular strength in U.S. sales, up 10 percent year over year and ahead of expectations. Merit raised full-year 2026 guidance to $1.631 to $1.643 billion in revenue (from $1.612 to $1.634 billion) and non-GAAP EPS of $4.25 to $4.35 (from $4.01 to $4.15).

The BTK read: This is a clean beat-and-raise with the vascular intervention lines doing real work, not just riding a soft comp. Worth noting Merit's cash position and $697 million in available borrowing capacity as of quarter-end, which leaves room for further tuck-in M&A on top of the View Point and C2 CryoBalloon deals already integrated this year. A name to watch if the vascular intervention consolidation trend continues into H2.

Also this week, briefly: Humacyte announced FDA acceptance of its IND application for a first-in-human study of its coronary tissue engineered vessel in coronary artery bypass grafting, the first new off-the-shelf conduit option in 40 years for a procedure performed more than 400,000 times annually in the U.S. AngioDynamics announced it will participate in the Needham and Canaccord investor conferences in mid-August, continuing to present its seventh consecutive quarter of double-digit MedTech segment growth.

Market | Anika Therapeutics Beats Q2 with 16% Revenue Growth

Anika Therapeutics reported Q2 2026 revenue of $32.6 million, up 16 percent year over year, with adjusted EPS of $0.42 against a consensus estimate of negative $0.08. The OEM channel led with $18.7 million in revenue, while the commercial channel grew 17 percent.

The BTK read: A clean beat against a consensus that expected a loss is a meaningful swing, and the diversified OEM-plus-commercial mix is worth noting as a structural strength heading into the back half of the year.

Clinical | MediHoney Wound Care Gel Faces Lawsuit Over Contaminated Skin Lesion

A lawsuit alleges MediHoney wound care gel was contaminated and caused a skin lesion infection in a patient, raising product sterility questions in the honey-based antimicrobial dressing segment, alongside similar prior sterile-solution suits against SteriCare and McKesson.

The BTK read: A single product liability suit isn't a category signal on its own, but it's worth tracking alongside Gentell's move into consumer manuka honey below. Sterility and quality assurance scrutiny tends to follow growth in a segment, not lead it.

Also this week, briefly: PolyNovo reported FY26 revenue growth of more than 16 percent, driven by continued U.S. expansion and adoption of NovoSorb MTX. Gentell acquired First Honey, a manuka honey consumer health brand, expanding from institutional wound care into OTC consumer channels. Amferia achieved ISO 13485 certification following its recent FDA De Novo clearance for a peptide-based antibacterial wound dressing. McKesson launched a WoundCare Essentials Kit bundling standard wound care supplies for home and facility settings.

Market | Zimmer Biomet Beats Earnings, Gets UBS Upgrade

Zimmer Biomet reported earnings per share of $2.09, beating consensus of $1.86, on revenue of $2.09 billion against expectations of $2.07 billion. UBS Group upgraded the stock to strong-buy, citing execution and foot and ankle portfolio integration.

The BTK read: The foot and ankle integration callout is the relevant piece for this platform. A ratings upgrade tied specifically to that segment's progress is worth watching as a proxy for broader orthopedic reconstruction demand in limb salvage-adjacent care.

Market | Conmed Surges 10% on Private Equity Takeover Reports, Then Posts Solid Q2

Conmed shares jumped as much as 10 percent after-hours after Bloomberg reported private equity firms have approached the surgical device maker about acquisition interest, with the company working with advisers on strategic options. Days later, Conmed reported Q2 2026 net sales of $343.5 million, up 6 percent organically, with adjusted EPS of $1.38, up 20 percent year over year, partly aided by a $0.21 tariff refund benefit, led by its AirSeal insufflation platform and Buffalo Filter smoke-evacuation products.

The BTK read: A PE approach landing the same week as a genuinely solid quarter is a strong setup for Conmed regardless of whether a deal materializes. Worth watching this one closely; a take-private of a surgical platform this size would be a signal about broader medtech consolidation appetite in adjacent surgical and lower limb intervention markets.

Also this week, briefly: Axogen made a strategic investment in Trace Biosciences to fund Phase II and III trials of Nerve Trace, a real-time nerve fluorescence visualization technology with FDA IND clearance, supporting a potential NDA pathway for intraoperative nerve identification during peripheral nerve surgery.

Clinical | First Clinical Study Confirms Fluorescence Imaging Feasibility in Orthopaedic Surgery

The first published clinical study demonstrating the feasibility of fluorescence imaging in orthopaedic surgery has been released, marking a milestone for intraoperative visualization technology in musculoskeletal procedures, with direct implications for tissue perfusion assessment in lower limb reconstruction and limb salvage.

The BTK read: Real-time perfusion assessment is exactly the kind of adjacent-technology proof point that tends to migrate into foot and ankle and vascular-adjacent surgical settings once it's established elsewhere. Worth tracking Moleculight's next move here.

Also this week, briefly: ParaNano appointed Rod Whitson as Chairman and Lora Spencer, Esq. to its board of directors, a leadership expansion worth watching as a possible signal of fundraising or commercial scaling ahead, though the nanotechnology company's direct relevance to wound and vascular medtech remains unclear without further product detail.

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BTK Wound Care Fund (5D): +0.005% S&P 500: +0.19% | Dow Jones: +0.41% | NASDAQ: +0.37%

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The BTK read: Sanara's move is the MiMedx deal premium landing directly in the fund, and Conmed's is the PE takeover buzz from Lower Limb Reconstruction above, both covered in full in this edition. BioStem's -21.70% is worth sitting with alongside MiMedx's own 61 percent wound revenue decline this week; it looks less like a company-specific problem and more like the CAMP reimbursement reset repricing the whole category at once. Integra's -11.62% despite an EPS beat and reaffirmed guidance is the odd one out here, and worth watching next week for whether that's Sanara-deal-adjacent noise or something specific to Integra's own read on the wound reconstruction space.

Educational model portfolio. Not a real fund. Not investment advice. Performance is model-calculated and unaudited.

August 4 — LeMaitre Vascular (LMAT) and InfuSystem Holdings (INFU) both report Q2, InfuSystem before market open.

August 6 — AVITA Medical (RCEL) and Organogenesis (ORGO) both report after market close the same day.

Already behind us this week: MiMedx, Integra LifeSciences, and Anika Therapeutics all reported July 29, and Merit Medical, Boston Scientific, Zimmer Biomet, and Conmed also posted Q2 results, all covered in full above.

August 6–9 | Nashville, TN — APMA Annual Scientific Meeting — Gaylord Opryland

September 10–11 | New Orleans, LA — IPAWS & Tissue Repair Summit (Kernexus) — The Ritz-Carlton (BTK Official Market Intelligence Partner)

September 14–16 | Louisville, KY — NAWCO HEAL Conference 2026

September 17–20 | Bengaluru, India — DFSICON 2026 (23rd Diabetic Foot Society of India Conference, in collaboration with ALPS, FIP, IADFS)

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

Early December (dates TBD) | San Antonio, TX — DFUpdate 2026 (ALPS, in partnership with UT Health San Antonio)

December 9–12 | Phoenix, AZ — Desert Foot, Multi-Disciplinary Limb Salvage & Wound Care Conference

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See you next week,

-Scott