Xeltis said today that it launched the Xplore-I clinical trial of its bioresorbable pulmonary heart valve in pediatric patients undergoing a type of reconstructive surgery to treat congenital heart defects. The Dutch-Swiss company, which won humanitarian use device status from the FDA in March, said the feasibility study is designed to evaluate the 6-month survival rate using the […]
Regenerative Medicine
Terumo inks regenerative collab deal with Cognate BioServices
Terumo Corp. (TYO:4543) and Cognate BioServices said today they inked a collaborative cellular and immunotherapy products development deal. Get the rest of the story at our sister site, Medical Design & Outsourcing
Fuji’s Cellular Dynamics launches retinal disease-focused Opsis Therapeutics
Fujifilm Holdings (TSE:4901) company Cellular Dynamics International said today it is launching Opsis Therapeutics, a new venture aiming to develop treatments for patient suffering from retinal diseases. The newly formed business aims to focus on retinal cell manufacturing and application of regenerative medicines for treating retinal diseases, the company said. CDI made the initial seed investment […]
FDA OKs Regentis Biomaterials trial for GelrinC knee cartilage treatment
Regentis Biomaterials said today it won an investigational device exemption from the FDA for a pivotal trial of its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee. The Phase III study aims to evaluate the safety and efficacy of GelrinC compared to microfracture treatment to support pre-market approval for focal defects, which normally occur […]
Spineology makes Musculoskeletal Transplant Foundation its sole allograft supplier
Spinal tech developer Spineology said today that it expanded its relationship with the Muscoloskeletal Transplant Foundation, making it the sole tissue provider for its allograft product lines. The expanded deal makes MTF the sole provider of tissue for Minneapolis-based Spineology’s new Incite cortical fibers bone grafting solution. “MTF has a long track record of delivering safe, […]
Bioventus launches Exogen ultrasound bone treatment in Saudi Arabia
Bioventus said today it launched the Exogen ultrasound bone healing system in Saudi Arabia. The Durham, N.C.-based company’s Exogen is designed to use low-intensity pulsed ultrasound to “help stimulate the body’s natural healing process.” Bioventus touts an 86% healing rate for fractures not healing on their own and 38% faster healing of fresh fractures with […]
Sofregen lands $6.2m Series A
Sofregen Medical said yesterday that it landed a $6.2 million Series A round from Polaris Partners and other founding investors, bringing their total funding raised to more than $11 million. The Medford, Mass.-based company was founded in 2014 to advance silk-based medical technology developed at Tufts University and the University of Pittsburgh for soft tissue […]
Tissue-engineered human liver made from stem & progenitor cells
Researchers at the Saban Research Institute of Children’s Hospital in Los Angeles generated mouse and human tissue-engineered livers from organoid units composed of stem and progenitor cells, according to a study published in Stem Cells Translational Medicine last month. The tissue-engineered liver demonstrated normal attributes such as hepatocytes and blood cells and even restored some […]
FDA approves Kerecis Omega3 SecureMesh fish-skin surgical mesh
Kerecis said today that it won 510(k) clearance from the FDA for its Kerecis Omega3 SecureMesh regenerative surgical mesh for use in lung, bariatric, gastric, colorectal and other surgeries. The McLean, Va.-based company said the Kerecis Omega3 mesh is made from intact fish skin saturated in naturally occurring Omega3 polyunsaturated fatty acids. Kerecis said the material […]
Stanford launches independent study of Fibralign’s BioBridge
Stanford University has begun enrollment in an investigator-led clinical study of Fibralign‘s BioBridge collagen matrix designed for treating secondary lymphedema, the company said yesterday. The BioBridge collagen matrix is an implantable, biocompatible and biodegradable surgical mesh with 510(k) clearance for use in surgery to “reinforce and repair soft tissue where weakness and deficiencies exist,” the company said, […]
Judge blocks FDA’s move to shutter Amniotic Therapies
A federal judge this month blocked the FDA’s bid to force Amniotic Therapies to shut down completely, ruling instead that the maker of placental tissue-based wound-healing products must only cease distribution until a hearing slated for today in a Texas court. The federal safety watchdog ordered the shutdown August 16 and slapped Farmers Branch, Texas-based […]