- RENOVITE® BMP-2 is being developed as an alternative choice to bone graft supplies for interbody spinal fusion
- It’s the first product based mostly on RENOVITE®, Renovos’ novel nanoclay therapeutic supply platform for precision regenerative medication
KEELE, England, Jan. 4, 2024 /PRNewswire/ — Biocomposites, a global medical units firm that engineers, manufactures and markets world main merchandise for regenerating bone and managing an infection in bone and gentle tissue, is happy to announce that its investee firm, Renovos Biologics (Renovos), has been granted Breakthrough Machine Designation by the US Food and Drug Administration (FDA) for its lead product, RENOVITE® BMP-2 (Bone Morphogenic Protein 2).
RENOVITE® BMP-2, based mostly on a proprietary artificial nanoclay gel, is in improvement as a safer and simpler different to at the moment accessible bone graft supplies. The simple-to-use, injectable gel permits exact, localised bone formation on the goal web site. It accommodates BMP-2, a progress issue which promotes in-growth of bone forming cells. The nanoclay gel allows protected, highly-targeted bone fusion, because it doesn’t leach BMP-2, with the gel biodegrading as new bone kinds.
Dr Agnieszka Janeczek, Chief Govt Officer of Renovos Biologics, stated: “We’re very happy with the Breakthrough Machine Designation from the FDA, being amongst only one hundred or so corporations granted this designation in orthopaedics because the programme’s launch in 2015. This designation is a serious milestone in our improvement journey. The accelerated regulatory suggestions and prioritised overview will shorten the time to market and permit quicker entry to expanded therapy choices for sufferers affected by degenerative disc illness.”
Michael Harris, Chief Govt Officer of Biocomposites, stated: “The granting of FDA Breakthrough Machine Designation is a transformational step for Renovos, supporting its aim to quickly develop and produce to market RENOVITE® – a next-generation drug provider. At Biocomposites, our experience on this area ideally positions us to help and improve RENOVITE®‘s progress in direction of pre-market approval.”
The FDA’s Breakthrough Machine Designation program is meant to assist present sufferers extra well timed entry to medical units which have the potential to offer simpler prognosis or therapy of life-threatening or irreversibly debilitating situations, by dashing up the event, evaluation and overview course of. Breakthrough designation is just granted after preliminary proof has been offered demonstrating an affordable expectation that the gadget will present important benefits over customary of care. The designation will permit Renovos to have extra frequent interplay with the FDA’s regulatory specialists when getting ready its submissions, adopted by prioritised critiques.
Biocomposites is a global medical gadget firm that engineers, manufactures and markets world main merchandise to be used in an infection administration in bone and gentle tissue. Based mostly in Keele, UK, it has international operations throughout Europe, USA, Canada, China and India. Biocomposites is a world chief within the improvement of modern calcium compounds and polymers for surgical use. Its merchandise regenerate bone and goal an infection dangers throughout quite a lot of specialties, together with musculoskeletal an infection, orthopaedics, trauma, spine, foot and ankle, podiatry and sports activities accidents. Biocomposites merchandise at the moment are utilized in over 120,000 procedures each year and offered in additional than 40 nations world wide. Biocomposites has a minority-share curiosity in Renovos Biologics.
Please go to biocomposites.com to study extra.
About Renovos Biologics
Renovos is a regenerative medication firm and a specialist developer of RENOVITE® artificial nanoclay for medical use. Stemming from analysis on the College of Southampton, UK, Renovos’ proprietary RENOVITE® expertise drastically improves the efficiency of a variety of regenerative medication merchandise, with first targets in orthobiologics. RENOVITE® presents a novel mechanism of motion, providing unprecedented retention of therapeutic brokers on the goal web site of restore, mitigating their results to a exactly managed space, making a step-change enchancment of their efficacy, security and ease of use, in biodegradable and injectable formulations, appropriate for minimally-invasive purposes.
Please go to renovos.co.uk to study extra.