Spinal Fusion Therapy Device Articles & Analysis
11 news found
Isto Biologics, a leader in surgical-based, orthobiologic regeneration technologies and cell-based therapies, announced today the launch of Influx™ Fibrant, an unprecedented line of functional constructs derived from 100% cortical allograft. The cutting-edge line consisting of five new products includes Fibrant Anchor, Boat, Bullet, Pak and Wrap. The Fibrant launch features the patented ...
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc., announced today the U.S. launch of the aprevo® patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement. “We are grateful for our surgeon partners that worked with the company early on to develop a truly personalized solution for patients and to collect the clinical data for improved outcomes,” ...
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed announced today that aprevo® has been recognized by Orthopedics This Week with the prestigious Spine Technology Award. This award was presented at a ceremony today at the North American Spine Society (NASS) meeting in Boston. The award is given annually to exemplary and innovative spine surgery products that improve spine care, as judged by a panel ...
The company is making good progress against this objective and received two breakthrough device designations from the U.S. Food and Drug Administration at the start of 2021 for CognitOss and Chondro3, a biomimetic graft for osteochondral lesions. CognitOss is a single-stage therapy that combines the local delivery of therapeutically appropriate levels of ...
The Company’s second FDA Breakthrough Device designation granted in 2021 Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Chondro3, currently in development as a biomimetic graft for osteochondral lesions. The FDA Breakthrough Device Program is designed ...
FDA’s Breakthrough Device Program helps accelerate patient access to more effective treatments Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to CognitOss, currently in develoment for the treatment of chronic osteomyelitis. The FDA Breakthrough Device ...
Another important step towards its ambition of building a world leading, diversified orthobiologics company Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce the appointment of Keith Valentine as the Non-Executive Chair of the Board with immediate effect. Keith joins with over 30 years’ experience in the orthopaedic industry, encompassing various ...
NASHUA, N.H.–(BUSINESS WIRE)–Vallum Corporation, a medical device company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus® nanotextured1 surface created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology. ...
Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced that it has completed the acquisition of Statera Spine, a pre-operative diagnostics and quantitative data software solution that improves treatment decisions for spine patients. Statera Spine is a software enabled spine imaging analytics ...
Ankasa Regenerative Therapeutics, Inc. (Ankasa), a company focused on pharmaceutical preparations for reactivation of stem cells for organ and tissue regrowth, tissue repair and healing, has received $8.5 million in the first tranche of a $17 million Series A round of financing led by La Jolla-based Avalon Ventures. Other participants in the financing include Heraeus Medical, a global business ...
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since ...