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.
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.
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).