Reminder - J&J ATI Rotator Cuff clinical trial update coming soon, page-171

The company showed efficacy in CelGro Nerve FDA required 510K regulatory study which was "designed to provide evidence ofsafety and efficacy of CelGro in peripheral nerve repair" (they were always a shoo-in as they did a similar study before).

Because of the unique qualities of CelGro Nerve and the superior results to the comparative marekt leading device they have been talking to the FDA about the best regulatory pathway to secure better remuneration than the bog standard 510K approval route. I'd rather they just get the product to market via 510K, but long-term it may well be the best approach and they are the experts not me.

They've since complemented the evidence with further data from the human repairs in late June, with 75.8% of all nerve repairs (25 of 33) in the clinical study resulted in functional recovery (MRC grade 3 or 4) and in the quadriplegic patient cohort, 76.5% of nerve repairs(13 of 17) at 12 months post treatment (final 24-month results of all patients in the CelGro® nerve regeneration study expected in Q2 CY2022).

Remember the CelGro Nerve application has been in at TGA since July 2020 and I expect something soon there given normal TGA approval timelines. If the company goes down the 510K route with the FDA afterall, then 2021 might not be out of the timeframe. Hoping for more clarification in the results this month.

(Like eveyone else I am getting impatient - but the ATI results are almost here at last).