Orthocell Ltd. has achieved US 510k clearance to market and supply its collagen medical device Striate+TM in the US dental bone and tissue regeneration market. The US 510(k) clearance now allows Orthocell to supply Striate+TM in the US dental bone and tissue regeneration market, estimated at USD 500 million per annum. 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. 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.