Below The Knee - October 2024 Edition

🔎 In Focus: October Market Highlights

The past month has seen impressive advancements across wound care and associated fields, marked by capital investments, regulatory updates, and emerging technologies. Here’s a round-up of the key highlights:

💲 Financial Updates

Several companies in our industry released their Q3 earnings or announced their schedules:

MiMedx dx –Q3 sales of $81.7M up 21%. Growth in all sites of service. Key drivers - Amnioeffect, Epieffect and Heliogen products, challenges with sales and customer turnover and declines of Axiofill.

Celularity Inc. - preliminary results of >$24M in revenue. Previous guidance of $26.9M for the period with full year 2023 revenue of $22.8M.

Smith+Nephew – Q3 sales of $1.4B up 4%. Trauma/Extremities up 3.5% and Wound was up 6.5%.

Zimmer Biomet – Q3 sales of $1.82B, up 4%. Sports, Extremity, Trauma and CMF as a segment were up 7.3%.

Stryker – Q3 sales of $5.5B up 12%. Ortho/Spine segment represented $2.3B and up 10.7% YoY.

Johnson & Johnson - 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.

• Treace Medical Concepts, Inc. - Scheduled for 11/5

• AVITA Medical - Scheduled for 11/7

• Solventum - Scheduled for 11/7

• Organogenesis - Scheduled for 11/12

• Paragon 28 - Scheduled for 11/12

Cuprina Wound Care Solutions is anticipated to go public on Nasdaq under the ticker CUPR, following the trend of increased public investment in chronic wound care solutions. Additionally, SANUWAVE simplified its cap structure by implementing a reverse stock split, followed by a $10.3 million equity-only PIPE led by institutional investors.

📢 News Highlights

Major Developments:

• 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.

• Orpyx® secured $20 million for its Sensory Insole system aimed at preventing diabetic foot ulcers.

• Paragon 28 is navigating multiple legal and financial challenges, including a class action lawsuit for financial misstatements and inadequate internal controls.

Technological Milestones:

• Swift Medical unveiled "Skin & Wound 2," integrating AI for equitable wound care.

• Sky Medical Technology Geko device, designed to stimulate blood flow, demonstrated a 68% improvement in healing for venous leg ulcers and a projected annual NHS savings of up to £420 million.

• Wound AI, launched by VANTIQ, Telemedicine Solutions, and NTT DATA, offers real-time wound care recommendations and integrates directly with EHRs.

Regulatory Insights:

• The FDA has taken action in the biologics space, sending warning letters to companies distributing unapproved amniotic fluid-derived products. Additionally, Dr. Michelle Tarver was appointed as the new head of the FDA's device division, signaling ongoing oversight shifts.

🚀 Spotlight on Innovation

The innovation landscape has been bustling, with emerging trends in AI, smart bandages, bioprinting, and remote monitoring reshaping wound care and foot & ankle treatments:

• Artificial Intelligence: Significant AI integration was highlighted at #SAWCFall2024, where companies demonstrated advancements in imaging, analysis, and patient portals. MolecuLight’s imaging studies showed a reduction in medication prescriptions, emphasizing the role of imaging in clinical decision-making. Six AI-focused posters, including some featuring ChatGPT applications, underscored AI’s growing influence.

• Connected Health: FeelTect introduced a smart compression wrap, a streamlined solution for vascular leg ulcers (VLUs) that enhances patient and provider control over compression adjustments.

• 3D Printing: Tides Medical launched a clinic-based 3D printing system, allowing adipose tissue harvesting and formulation into patient-specific grafts, a novel approach that challenges traditional treatment methods.

📚 Research and Studies Spotlight

Research continues to underpin innovation with several noteworthy studies:

• BioStem Technologies (OTC: BSEM) reported strong results for BioREtain® in diabetic foot ulcer healing.

• MolecuLight presented data indicating an 84% sensitivity rate for biofilm detection, surpassing traditional methods and validating fluorescence imaging as a valuable diagnostic tool.

• Kerecis, MediWound and Aroa Biosurgery Limited are spearheading studies in cellular tissue products (CTPs), aligning with regulatory guidance and demonstrating the industry’s commitment to robust clinical data.

🔗 Industry Events Recap

October was packed with events, from #SAWCFall2024 to the American Society of Podiatric Surgeons (ASPS) Annual Meeting in New Orleans. Key highlights from these gatherings included:

• SAWCFall2024: Over 1,600 clinical attendees, a sold-out exhibit hall, and an expanded poster section reflected robust engagement. Standout innovations in wound care included advancements in AI, regenerative reconstruction protocols for limb salvage, and smart bandages.

• ASPS Annual Meeting: Attendees discussed market expansion, product innovations, and celebrated Smith+Nephew’s RENASYS EDGE NPWT System’s win at the Red Dot Design Awards.

Thank you for tuning into this month’s edition! For the latest updates and insights, make sure to follow along each week, and stay connected for real-time innovations and strategic trends across #woundcare, #limbsalvage, and #foot&ankle

See you next month!