Ann: Appendix 4C - Quarterly, page-2

An excellent quarterly report packed with promising news from a company that is very inconsistent on information (this one full of info').

Further data from the ATI vs corticosteroids trial on the large proportion of crossover patients who understandably wanted ATI after steroids failed alongside the on average 4 failed prior treatments (this has been the main stay of my arguments and investment - this treatment works and can save some people from what are often semi-disabilities that afflict massive sections of the elder population with unmet needs)

They are in clear discussion with the FDA on how to get this to market - presumably with a US partner, the most likely DePuy (J&J)

"In light of the initial study results, the Company is accelerating its US commercialisation plans with technology scale up, FDA engagement and commercial preparation activities being advanced to support a Phase 2b randomized controlled study for FDA submission."

That's a big deal. A potential FDA approval submission based on a Phase 2B trial (on their consultation) is a very unusually easy path for approval and commercialisation - sounds to me the US staff and/or J&J connection may be influencing here.

ATI vs surgery recruitment complete and patient likely treated this quarter - lets hope as a standalone trial, unlike the ATI vs steroids, the company does an initial results update on recruitment as has been its past tendency. This also forms the basis for TGA application in my opinion.

CelGro Bone (Straite's) introduction via the Seattle Study Club unfotunately delayed, but clearly revenues there beginning to show in clear revenue growth (albeit low absolute levels):

	OCC qtrly	2021	4Q	378
1	(000's)		3Q	356
2			2Q	328
3			1Q	206
4		2020	4Q	218
5			3Q	179
6			2Q	232
7			1Q	118

I expect growth to continue there with Europe, US and Australian initiatives finally showing some returns to their credit.

Not quite as big as ATI in my opinion, but the big one for CelGro, Nerve (or Remplir). The company communicated poorly again, when it decided to forego the 510K route (which the FDA approved CelGro Bone [Straite]) for more lucrative routes with the FDA long-term, but didn't clarify this much in 2nd half 2021. Relief to finally hear the company during "the quarter,the team commenced interactions with the US FDA regarding the appropriate US regulatory pathway, what data is needed to support expedited review and reimbursement positioning".

Even more promising for me in terms of share price and 2nd half 2022 and 2023 revenue growth finally raising this company, combined with Straite revenues, to become cash flow positive, is the following:

"The Company believes its application meets the requirements of the TGA and is on track for approval."

I am expecting a Remplir (CelGro Nerve) approval from the TGA imminently. The application went in July 2020. The TGA is being clearly tardy in this one and we can't really blame the company.

We all saw what the share price did on initial Remplir results in Australia. When they at long last get TGA approval, anytime now, this company finally takes off, one hopes.