PERTH, Australia--(BUSINESS WIRE)--Australian-based regenerative medicine company, Orthocell Ltd (ASX:OCC, “Orthocell” or the “Company”), has achieved US 510k clearance to market and supply its collagen medical device Striate+TM in the US dental bone and tissue regeneration market.
Orthocell Managing Director, Paul Anderson, said: “US approval is a significant inflection point for our Company, and we are now primed to partner and distribute this product. I look forward to working with our leading dental surgeons to introduce the new global brand, Striate+TM – previously branded as CelGro® dental – to make a meaningful impact in the US market.”
The US 510(k) clearance now allows Orthocell to supply Striate+TM in the US dental bone and tissue regeneration market, estimated at US$500 million per annum1. The Company will now pursue negotiations with multi-national dental companies for US marketing and distribution rights, with Orthocell to retain manufacturing of the finished product.
Striate+TM has been approved for use in dental bone and tissue regeneration procedures including, but not limited to, dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets and guided tissue regeneration procedures in intrabony periodontal defects.
Leading US dental surgeon, Dr Pamela Ray, said: “Striate+TM has exceptional handling qualities - when manipulating, it remains dimensionally stable and unrolls easily back to the original size. It has great tensile strength and does not deform when hydrated. I am excited by this innovative product and its potential. I believe it will assist with improving patient outcomes and I look forward to working with the team at Orthocell as it enters the US market.”
The 510(k) clearance follows the Company’s application submitted to the FDA in May 2020. The FDA determined that, for the indications above, Orthocell's Striate+ is substantially equivalent to a predicate device and can therefore market Striate+ in the US. Striate+ has, based on surgeon feedback, distinct advantages over other similar products and may assist surgeons to deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and improved bone healing.
With US, EU and Australian market approval achieved and key opinion leaders (KOLs) actively engaging with the program, Orthocell is well positioned to secure a distribution partner and establish Striate+TM as the best-in-class dental resorbable collagen membrane.
