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- NinaMED Pty Ltd, a newly formed Australian medical device company, secured $13.75 million in financing led by SPRIM Global Investments to develop the NiNA System®, a non-invasive, at-home therapy for overactive bladder. - The NiNA System® targets the saphenous nerve through wearable neuromodulation technology, offering a drug-free alternative for the estimated 550 million people worldwide affected by overactive bladder. - The company obtained exclusive global licensing rights from Toronto-based EBT Medical and appointed Ian Meredith, former Boston Scientific executive, as Board Chair to lead commercialization efforts. - The financing will accelerate clinical development, support an Investigational Device Exemption application, and build operations in Australia for worldwide commercialization of this novel therapeutic approach.
- MediWound's EscharEx VALUE Phase III trial for venous leg ulcers continues enrollment targeting 216 patients, with interim assessment and completion expected by year-end 2026. - The company plans to expand EscharEx development into diabetic foot ulcers and pressure ulcers in 2026 following positive regulatory feedback from FDA and EMA. - NexoBrid manufacturing facility expansion is now fully operational with sixfold increased production capacity, positioning the company for anticipated regulatory approvals in 2026. - MediWound reported $17 million in 2025 revenue and updated guidance projecting growth to $24-26 million in 2026, $32-35 million in 2027, and $50-55 million in 2028.
- The Centers for Medicare & Medicaid Services (CMS) has dramatically reduced Medicare coverage for skin substitutes from 340 products to just 18 evidence-based products for treating diabetic foot and venous leg ulcers, effective January 1, 2026. - All covered products will be reimbursed at a standardized rate of $127/cm², eliminating pricing-driven treatment decisions and allowing clinicians to focus on selecting the most appropriate therapy for each patient. - An additional 154 products have been placed in a discretionary category with 12-month status quo period, remaining eligible for case-by-case payment at Medicare Administrative Contractors' discretion. - The policy changes only apply to diabetic foot ulcers and venous leg ulcers, leaving coverage for other wound types like pressure ulcers unaffected.
- Pharming Group N.V. announced the appointment of Kenneth Lynard as Chief Financial Officer, effective October 1, 2025, following strong first half 2025 financial results. - Lynard brings over 20 years of global leadership experience in life sciences, including senior roles at Gilead Sciences where he contributed to tripling the business following the Pharmasset acquisition. - The appointment marks a strategic move to strengthen financial leadership as Pharming continues executing its growth strategy to build a leading global rare disease company. - Lynard's experience spans both established industry leaders and growth-stage companies, with operational expertise in both U.S. and European markets.
- A clinical study reveals that fish-skin grafts significantly improve healing rates in diabetic foot ulcers compared to standard care. - The fish-skin treatment led to a 44% healing rate after 16 weeks, versus 26% with standard methods, according to the NEJM published study. - Kerecis' fish-skin grafts, derived from Atlantic cod, offer a viral transfer risk-free alternative with regenerative properties. - Coloplast acquired Kerecis for $1.3 billion, recognizing its rapid growth in the biologics wound care sector.
