In my view Ortho-ATI is the company maker, while CleGro is aimed at being best in class ATI is a first in class, this IMO is why Johnson and Johnson are involved. 82% success rate to date with treating a condition that will affect between 1-3% of the population. Over 500 patients have already been treated and to date the trials are highly encouraging. In the last study 24 patients were treated for tennis elbow. Following Ortho-ATI® treatment, 88% of patients in the study returned to work. There is little reason to think that the next phase of results will be any less encouraging.
Orthocell Managing Director, Paul Anderson,said: “We are delighted by these results which provide strong evidence that Ortho-ATI® is a breakthrough technology and significantly improves patients’ lives. This novel therapy alleviates chronic pain, restores tendon structure and enables people to return to normal function at home and work. Ortho-ATI® has the potential to delive rsignificant socioeconomic benefits, including improved individual productivity and reduced health care costs.”
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372643
This next study in progress is to prove that Ortho-ATI® outperforms the current status quo in treating rotator cuff injury but it's worth keeping in mind that this first in class therapy is already well along the regulatory process with FDA meetings last year and the CelGro product pre submissions already held.
https://hotcopper.com.au/threads/an...-completed-with-the-fda.4320386/#.XNe7jhQzaUk
Orthocell remains on track to receive FDA approval for CelGro® in dental bone and soft tissue repair in 2019.
When you look at a few other companies in the space it's clear that the milestone of FDA approvals is game changing for these regenerative medicine stocks. With the USA being the largest market for these breakthrough technologies it's no real surprise.
Polynovo (PNV.ASX) got their FDA approval at $145m cap then ran to $765m MC over 3 years
Vericel (VCEL.NASDAQ) got their FDA approval at $110m MC then ran to $919m over 2 years
OCC with a current market cap of just over $50m has applied their technology to hundreds of patients and is seeking FDA approvals for a range of products at a time when the FDA are increasing their focus on regenerative medicine. OCC have the support of Johnson and Johnson, a full suite of IP protection and most importantly products proven to increase the quality of life of those who need it. My thoughts are that this remains undervalued in a substantial way. I mean it traded as high as 99c in 2015 when they first began their journey down the Ortho-ATI pathway, they are getting towards the end of the road now and the SP only a few weeks ago was 11c. Looking at the chart more volume went thru last week than it had done in the last 4 years combined, fair to say the cat is out of the bag....
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