Orthocell gains after dental membrane approved in Australia
Health & Biotech
Link copied to
Orthocell (ASX:OCC) shares have hit their highest level in a month after the regenerative medicine company announced its CelGro collagen membrane for dental surgeries had been approved for use in Australia.
Inclusion of CelGro on the Australian Register of Therapeutic Goods yesterday follows its approval by the Therapeutic Goods Administration last week.
Managing director Paul Anderson said Australian approval was a “significant inflection point” for Orthocell and positions it well for approval of its products for nerve and tendon repair.
Orthocell says it is now focused on achieving reimbursement by insurers as an approved prosthesis.
The company also hopes to gain US approval next year for the collagen membrane, which is made by Orthocell in Western Australia.
While other dental membranes are on the market, Orthocell says clinical studies and post-market feedback indicates that CelGro offers superior handling and tissue integration than the leading products.
One study showed dental patients treated with CelGro generated enough new bone to stabilise their implant and complete treatment in four months, compared to eight with standard care.
Orthocell says that there’s been little innovation in the biologics membrane market, which it sees as worth an estimated $US1 billion ($1.3 billion) a year.
At 11.36am, Orthocell shares were up 4.9 per cent to 43c, and earlier traded as high as 46c, their best level since November 25.