Omeza, a commercial-stage advanced wound care company, raised $8.5 million in Series A funding. Its lead product, OCM, incorporates sustainably sourced marine-derived biological compounds, including fish collagen, to accelerate healing in complex wounds. Applied in various settings, the solution reduces inflammation, disrupts bacterial biofilm, and supports tissue regeneration.
Miracell announced that it has obtained 510(k) clearance from the U.S. FDA for its stem cell extraction system, SMART M-CELL, along with its dedicated kits, the BSC Blood Kit and BMSC Bone Marrow Kit. SMART M-CELL is an automated system that selectively separates and concentrates efficient growth factors from blood and bone marrow. It also produces a multi-cell composition that includes growth factors, white blood cells, and SDF-1α, supporting tissue regeneration and functional recovery.
United Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the company’s investigational liver assist product. The product consists of an external blood circuit and a single-use bioengineered liver sustained outside of the human body to provide temporary support to acute liver failure patients.
Cellbricks Therapeutics has raised €10 million in new funding to accelerate the development of its biofabricated human tissue implants. The company will use the capital to advance translational development of its living, vascularized tissue implants, focusing on preclinical validation and moving closer to human clinical studies.
Aspen Neuroscience’s stem cell therapy improved Parkinson’s disease symptoms for all eight treated patients after one year, with the San Diego biotech now planning for a pivotal phase 3 trial later this year.
ROKIT Healthcare has closed a $41.9 million funding round to expand its FDA‑cleared, AI‑powered 3D bioprinting platform, enabling point‑of‑care fabrication of personalized regenerative tissue patches.
Japan has approved two stem cell-based therapies for Parkinson’s disease and severe heart failure. The first therapy aims to treat Parkinson’s disease by transplanting stem cell-derived neurons into the brain. The second therapy involves placing sheets of stem cell-derived heart muscle cells onto the heart to help stimulate the formation of new blood vessels and improve cardiac function.
StimLabs announced the launch of Architect Fx, an extracellular collagen matrix derived from equine pericardium for wound management. The product is FDA-cleared for treating a wide range of hard-to-heal wounds, including chronic diabetic, venous, and pressure ulcers, as well as traumatic and surgical wounds.
Pandorum Technologies, a biotechnology firm specializing in programmable regenerative medicine, has successfully closed an $18 million Series B funding round. This significant capital infusion, led by Protons Corporate, is earmarked to accelerate the clinical development of its innovative exosome-based therapies.
Nanochon, a Washington, D.C.-based orthopedic device company developing next-generation implants for articular cartilage repair, has announced the close of an oversubscribed funding round, bringing its total capital raised to $11.3 million to date. Nanochon’s lead product, the Chondrograft™ implant, is designed to treat knee cartilage defects by combining regenerative tissue technology with mechanical support.
The U.S. Food and Drug Administration granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation. Avance is a peripheral nerve scaffold approved for sensory nerve discontinuities in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities.
SurGenTec has received expanded 510(k) clearance from the FDA for its synthetic bone graft device, OsteoFlo HydroFiber. The updated clearance broadens its use beyond spinal fusion procedures. The material can now be used to fill bone voids or gaps from trauma, cysts, tumors, or osteomyelitis.
GeniPhys, a medtech innovator specializing in next-generation regenerative collagen polymeric biomaterials, has received 510(k) clearance from the U.S. Food and Drug Administration for its flagship product, Collymer Self-Assembling Scaffold (SAS).
The U.S. Food and Drug Administration approved Abeona Therapeutics’ Zevaskyn, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with the rare skin condition recessive dystrophic epidermolysis bullosa.
The U.S. Food and Drug Administration has granted 510(k) clearance to the BioCharge Autobiologic Matrix, a bioresorbable synthetic implant developed by startup Atreon Orthopedics to enhance rotator cuff repair integrity.
The U.S. Food and Drug Administration approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
US-based bioabsorbable scaffold company, R3 Vascular, has been granted investigational device exemption approval by the U.S. Food and Drug Administration (FDA) to launch its ELITE-BTK pivotal trial of its peripheral arterial disease (PAD) treatment.
The U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).