Below The Knee - March 2024 Edition

Welcome to the March edition of Below The Knee, your go-to source for the latest in wound care, diabetes, foot & ankle, and limb salvage. We’re breaking down the key earnings reports, highlighting trends shaping the industry, and diving into the biggest commercial moves.

Whether you’re tracking public company performance or scouting for the next big innovation, we have you covered. 

💲 Finance & Earnings Updates 💲

March has been a busy month for financial updates with earnings reports rolling in and key market moves shaping the landscape.

Essity – Q4 sales of SEK 37.8M (+3.2%), full-year sales of SEK 145.6M (-1.1%). Key growth drivers included incontinence products and wound dressings. CEO Magnus Groth announced he will be stepping down in 2025.

Owens & Minor – Q4 revenue of $2.7B (+1.5%), full-year revenue of $10.7B (+3.6%), but a full-year net loss of $362.7M, missing earnings expectations by 42%.

Convatec – 2024 annual sales reached $2.3B (+7.7%), with Advanced Wound Care leading at $743M (+7.4%). InnovaMatrix drove significant growth, up 34%.

ANIKA THERAPEUTICS S.R.L. – Q4 sales of $30.6M (+1%), full-year sales of $119.9M (-1%). The sale of Parcus Medical was finalized, now reported under discontinued operations.

MediWound – Q4 revenue of $5.8M (+9%), full-year revenue of $20.2M (+8%). Growth was fueled by strategic collaborations with Solventum, Mölnlycke Health Care, MiMedx, and Kerecis, along with a prior investment round led by Mölnlycke.

SANUWAVE – Q4 revenue of $10.3M (+47%), full-year revenue of $32.6M (+60%), with projected Q1 2025 growth of 45-55%.

Sanara MedTech – Q4 revenue of $26.3M (+49%), full-year revenue of $86.7M (+33%), supported by an FDA Breakthrough designation and an agreement with BioMimetic Innovations.

Spectral AI – Q4 revenue of $7.6M (+43%), full-year revenue of $29.6M (+64%). Revenue remains tied to BARDA contracts as they advance toward commercialization with an expected FDA submission in 2026.

📢 Industry News & Key Developments 📢

Regulatory & Compliance Updates

• BioStem Technologies (OTC: BSEM) received an FDA Warning Letter for off-label marketing of products including Neofyl, Oropro, Proviscus, and Rheo. They have 15 days to respond.

• Dexcom received an FDA Warning Letter regarding quality management and manufacturing process issues at its San Diego and Mesa facilities. No expected major impact on sales or production.

• Next Science received a Warning Letter from the FDA for violations found during an inspection at the company's Jacksonville facility. Violations cited in the Warning Letter include lack of marketing authorization and failure to report device-related serious injuries to the FDA.

• MiMedx is challenging the FDA on classifying its wound treatment as a biological product, arguing misapplication of regulatory guidelines.

Product Launches & Market Expansions

• Exactech debuted its GPS ankle navigation system and 3D-printed ankle tibial implants to enhance precision in total ankle replacements.

• Forma Medical Inc announced the limited launch of OptimalTMT, a new minimally invasive Lapidus plating system.

• AVITA Medical & Stedical Scientific partnered for expanded manufacturing of PermeaDerm, a biosynthetic wound matrix.

• Orthofix received FDA clearance and CE Mark for TrueLok Elevate Transverse Bone Transport System for limb preservation in diabetic foot ulcers.

• restor3d gained FDA clearance for its Ankle Fusion System.

• Treace Medical Concepts, Inc. launched several bunion-focused products at ACFAS 2025.

• MedCAD secured FDA 510(k) clearance for its AccuStride® Foot and Ankle System, featuring patient-specific surgical planning.

• Medline Industries, LP introduced a new Synthetic Ligament Augmentation Implant for foot & ankle procedures.

• BioLab Holdings partnered with Real Collagen GmbH to develop fish collagen-based wound care products.

Strategic Moves & Market Expansion

• Owens & Minor is exploring the sale of its products and healthcare services segments to focus more on patient-direct and home-based care.

• Sonoma Pharmaceuticals registered its manufacturing facility and five products in the UK, expanding its European presence.

• Hinge Health , a virtual physical therapy firm, reported $390M in revenue for 2024 and has filed for an IPO in 2025.

🚀 Looking Ahead: Market Shifts & New Innovations in Wound Care

Skin substitute spending is under the microscope, with a single case billed at nearly $10M raising alarms over rising costs and reimbursement concerns. While CMS has proposed measures to rein in abuse, delays in implementation leave the future uncertain. With the market ballooning from $1B to $7B in just five years, upcoming regulatory decisions could bring meaningful change, or simply new workarounds.

Meanwhile, earnings season is wrapping up, making it the perfect time to revisit our Wound Care Fund update. We’ll take a fresh look at how public companies in the space are performing, key valuation trends, and investment opportunities. Also on the horizon is an expanded Innovations in Wound Market Map, highlighting where the next wave of breakthroughs may take us. Stay tuned

Thanks for reading. Be sure and stay ahead of the latest in wound care, limb salvage, foot & ankle, and diabetes by following me on LinkedIn for weekly updates. Plenty on the horizon for 2025 with shifting reimbursement policies, M&A activity ramping up, and the continued evolution of AI-driven medtech solutions. Expect further shakeups in the regulatory environment and increased commercialization efforts from emerging players.

What are you watching in 2025 - drop a comment or message me, would love to hear your insights!

-Scott