Below The Knee - November Edition

Welcome to the November edition of our monthly summary, where we explore key developments across the wound care, diabetes, foot & ankle, and limb salvage sectors. From earnings season highlights to innovative advancements, here’s what you need to know:

?? Finance Highlights

The latest earnings reports reveal both growth and challenges across the industry:

• MiMedx : $81.7M in Q3 sales (+21%), driven by Amnioeffect, Epieffect, and Heliogen products.
• Coloplast : $984M in Q4 sales (+12%), with advanced wound care growing 10% and Kerecis revenue up 35%.
• Treace Medical Concepts, Inc. : $45.1M in Q3 revenue (+11%), alongside a promising entry into the metatarsal osteotomy market with Nanoplasty?.
• Paragon 28 : $62.3M in Q3 revenue (+18%), driven by 13 new product launches year-to-date.
• Organogenesis : $115.2M in Q3 revenue (+6%), with a private placement deal of $130M announced.
• SANUWAVE : $9.4M in Q3 revenue (+89%), with strong adoption of UltraMist systems.
• Smith+Nephew : $1.4B in Q3 sales (+4%), with wound care up 6.5%.
• Zimmer Biomet : $1.82B in Q3 revenue (+4%), supported by growth in sports, extremities, and trauma segments.
• Stryker – Q3 sales of $5.5B up 12%. Ortho/Spine segment represented $2.3B and up 10.7% YoY.
• 强生公司 - Q3 sales of $22.5B up 5.2%. Drilling way down to our segment, Ortho overall was $2.2B in sales up 1.2% with trauma up 2.6% at $761M, the largest segment within ortho.

Earnings season continues to reflect steady growth across wound care and adjacent markets, bolstered by strategic product launches and partnerships.

?? News & Industry Updates

Key announcements shaping our industries:

• Exactech declared bankruptcy and is being sold to an investor group providing $85 million in financing to fund operations. They currently face more than 2,000 lawsuits from patients alleging the company sold defective implants.
• Smith+Nephew is being pushed by major investors to breakup the business given concerns around strategy and performance of orthopedics. Leading sentiment is that the orthopedics remains a cash-intensive business that depends on the revenue streams from their SportsMedicine and WoundManagement divisions. Two investors suggested a private equity buyer could be interested. One investor described a potential Orthopedics sale as “quite compelling” given the division’s recent struggles.
• Centers for Medicare & Medicaid Services Final CTP Policy: Expanded application limits and adjusted duration provide a clearer pathway for coverage while emphasizing documentation from 4 to 8 apps with strong caution on excess use and a path for duration from 12 to 16 weeks.
• Spectral AI : Progressing toward FDA approval for DeepView AI-Burn system.
• SolasCure : Collaboration with the US Army to evaluate Aurase Wound Gel for combat scenarios.
• Swift Medical : Launched Skin & Wound 2, leveraging generative AI and expanding care across diverse skin tones.
• Fusion Orthopedics : Secured a legal win against Extremity Medical in a patent case.
• BioStem Technologies (OTC: BSEM) announced a signed Letter of Intent (LOI) to acquire commercial-stage products and development technologies from ProgenaCare.
• Geistlich and StimLabs announced a distribution partnership for Derma-Gide which will help both organizations through the upcoming changes to CTP coverage.

?? Spotlight on Innovation

#InnovationsInWound V.3 was introduced and continues to show where growth in #WoundCare is, and where it is going. This version took a deeper dive and began to highlight the work and focus of #AI. Take a look at the full report here:

Other notable advancements:

• The American Limb Preservation Society (ALPS) DFCon 2024 meeting in Anaheim featured cutting-edge discussions on artificial intelligence in wound care, 3D printing, and new technologies like SmartMat and smart home devices. A standout panel, “Digital Discovery,” emphasized the potential of AI and digital tools to revolutionize care delivery.
• Tides Medical: Exploring personalized 3D printing applications.
• Imbed Biosciences: FDA clearance for the first antimicrobial wound dressing with integrated lidocaine.
• Apple: Testing a prediabetes management app, signaling the tech industry’s interest in chronic disease management.

?? Global Awareness

On World Diabetes Day, stark statistics reminded us of the growing diabetes burden: global prevalence has doubled to 14% since 1990, with the US, India, China, and Pakistan accounting for over half of all cases. This underscores the need for innovative solutions in prevention and management.

We have a long way to go, and #prevention must be part of it.

?? Looking Ahead

November marked an eventful period for the industry, from strategic policy changes to groundbreaking innovations. As we transition into December, the focus remains on improving patient outcomes, supporting clinicians, and advancing technology in chronic disease management.

Save the Date: Stay tuned for December’s updates, as we wrap up the year with reflections on 2024’s milestones and a look ahead to what’s next for wound care, diabetes, and limb salvage.

Your insights have shaped these updates—continue to share your thoughts and feedback!

Until next month,

-Scott