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Renovos Biologics was granted Breakthrough Device Designation by FDA for its lead product, RENOVITE BMP-2 (Bone Morphogenic Protein 2).
RENOVITE BMP-2, based on a proprietary synthetic nanoclay gel, is in development as an alternative to currently available bone graft materials. The injectable gel allows precise, localized bone formation at the target site. It contains BMP-2, a growth factor which promotes in-growth of bone forming cells. The nanoclay gel enables highly-targeted bone fusion, as it does not leach BMP-2, with the gel biodegrading as new bone forms.
Dr Agnieszka Janeczek, Chief Executive Officer of Renovos Biologics, said, “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.”
In 2023, Biocomposites made a minority-share interest in Renovos allowing the company to access Biocomposites’ expertise in the development of drug carriers to progress RENOVITE to premarket approval as a carrier for use in spine, trauma and orthopedics. It will further provide Renovos access to Biocomposites’ global distribution network.
Michael Harris, Chief Executive Officer of Biocomposites, said, “The granting of FDA Breakthrough Device Designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market RENOVITE.”
Source: Biocomposites
Renovos Biologics was granted Breakthrough Device Designation by FDA for its lead product, RENOVITE BMP-2 (Bone Morphogenic Protein 2).
RENOVITE BMP-2, based on a proprietary synthetic nanoclay gel, is in development as an alternative to currently available bone graft materials. The injectable gel allows precise, localized bone formation at...
Renovos Biologics was granted Breakthrough Device Designation by FDA for its lead product, RENOVITE BMP-2 (Bone Morphogenic Protein 2).
RENOVITE BMP-2, based on a proprietary synthetic nanoclay gel, is in development as an alternative to currently available bone graft materials. The injectable gel allows precise, localized bone formation at the target site. It contains BMP-2, a growth factor which promotes in-growth of bone forming cells. The nanoclay gel enables highly-targeted bone fusion, as it does not leach BMP-2, with the gel biodegrading as new bone forms.
Dr Agnieszka Janeczek, Chief Executive Officer of Renovos Biologics, said, “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.”
In 2023, Biocomposites made a minority-share interest in Renovos allowing the company to access Biocomposites’ expertise in the development of drug carriers to progress RENOVITE to premarket approval as a carrier for use in spine, trauma and orthopedics. It will further provide Renovos access to Biocomposites’ global distribution network.
Michael Harris, Chief Executive Officer of Biocomposites, said, “The granting of FDA Breakthrough Device Designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market RENOVITE.”
Source: Biocomposites
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
