Regenerative medicine firm Orthocell has obtained CE-Mark for its CelGro medical device, allowing marketing within the European Union (EU) countries.
Developed using the firm’s SMRT tissue engineering process, the collagen scaffold device is indicated for use in various dental bone and soft tissue regeneration procedures.
CelGro is designed to target a range of orthopaedic, reconstructive and surgical applications with global commercial potential in current addressable bone, tendon, nerve and cartilage markets.
Orthocell managing director Paul Anderson said: “European regulatory approval for CelGro marks a major milestone for Orthocell as it enables commercial roll-out in the lucrative dental bone and soft tissue regeneration market, where there is a significant and growing demand and market opportunity.
“The CE-Mark also validates the potential of the entire technology platform by endorsing CelGro’s clinical performance and quality manufacturing.”
The approval is expected to support the device’s dental regulatory applications in other key markets, including the US, Japan and Australia.
Orthocell is currently working on forming strategic commercial partnerships for product distribution in Europe and other select regions.
In addition to dental and tissue regeneration, the CelGro technology platform could be used in different neurological, orthopaedic and surgical applications such as peripheral nerve repair, tendon, ligaments, cartilage and bone, general surgery, and urogynaecological procedures.
During clinical studies, the device is reported to have demonstrated improved tissue-ingrowth and repair when used for rotator cuff tendon repair in the shoulder, bone regeneration in the jaw and re-joining of severed or damaged peripheral nerves.