Renovos Biologics gains FDA Breakthrough Device Designation for Renovite
Betsy Goodfellow | January 4, 2024 | News story | Medical Communications | FDA, Musculo-skeletal disorder, Renovos Biologics, breakthrough device designation
Renovos Biologics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its lead product Renovite Bone Morphogenic Protein 2 (BMP-2).
The Renovite BMP-2 is a synthetic nanoclay bone fusion gel in development as a “safer and more effective alternative to currently available bone graft materials,” according to the company’s press release.
It is intended to be easy-to-use, allowing for precise, localised bone formation at the targeted site.
Dr Agnieszka Janeczek, chief executive officer at Renovos Biologics, commented: “We are very pleased with the Breakthrough Device Designation from the FDA, being among just one hundred or so companies granted this designation in orthopaedics since the programme’s launch in 2015. This designation is a major milestone in our development journey. The accelerated regulatory feedback and prioritised review will shorten the time to market and allow faster access to expanded treatment options for patients suffering from degenerative disc disease.”
Michael Harris, chief executive officer of Biocomposites, Renovos’ investor, added: “The granting of FDA Breakthrough Device Designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market Renovite – a next-generation drug carrier. At Biocomposites, our expertise in this field ideally positions us to support and enhance Renovite’s progress towards pre-market approval.”
Betsy Goodfellow
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
