Back to the ATI results if I may.Importantly for regulatory...

Back to the ATI results if I may.

Importantly for regulatory application (and of course our investments) OCC met its primary in this phase II trial of Surgery vs OrthoATI for severe, chronic treatment-resistant, lateral epicondylitis (tennis elbow) by 15 points - it improved 12 month scores on surgery by 15.7 points in a QuickDash score measure of upper limb disability.

But what does that actually mean? Particularly for patients? Just so we are all very clear, the questionnaire:

https://www.orthopaedicscore.com/scorepages/disabilities_of_arm_shoulder_hand_score_quickdash.html

(opening a jar, doing household chore, carrying a shopping bag....etc)

For statistical comparison purposes this is then converted to a 0-100 scale.

The company perhaps could have given us the exact final figures. I appreciate they do not want to be too bold/brazen in medicine and claims on ATI's superiority over surgery. I will be.

OCC will be reluctant to highlight that the surgery group were still near the 25pt mark. That's essentially saying, by QuickDash scores, the average surgical patient still has 'mild difficulty' at 12 months. The ATI group has already improved to around that mark at only 1 month (with statistical significance to 0.0001 - basically incontestable) following a brief biopsy and later injection, vs invasive surgery! By 12 months for ATI they are far closer to 'no difficulty'.

They use the QuickDash scores to statistically show disability and ATI's superior outcomes over surgery, but lets stop and convert them back, to get an idea of what that actually means for patients. The average surgery patient still shows mild difficulty across QuickDash measures including things like opening jars, carrying shopping, doing household chores, washing themselves, using a knife to cut food, social and recreational activities, etc. The average ATI patient at 12 months shows far closer (15.7 pts closer on a 0-100 scale) to no difficulties.

Studies differ, but most meta-analysis of tennis elbow surgery show around an 85-95% success rate (open surgery usually a little better results than arthroscopic surgery) and 1-2% complication rates!

A typical post-protocol for surgery will be in a splint or a cast for as much as 2 weeks. No use during. NO DRIVING. Keeping the arm dry, etc. Physical work not before 6 to 12 weeks. A rehabilitation program for weeks on range of motion, mild stretching and eventually loading exercises, that will likely be painful until at least 3 to 6 months. You can see this in the pain comparisons, with ATI pain reduction at 3 months better than surgery at 12 months by the graphs (I wish they'd publish the data too).

Having had both surgical interventions and ATI, I can tell you the recovery period quality of life post recovery are a million miles apart. When I had ATI I was give no instruction beyond take it easy! I am sure that has changed and I hope the company advises some mild rehabilitation programs at least - I practiced the equivalent, but essentially within a month, like the ATI cohort in the trial, was back to normal every day life unimpeded. Driving, shopping, lifting kettles and saucepans with water, with unfounded hesitation at first, but soon freely without thought. Very unlikely the case in surgical patients.

Whilst we are all understandably focused on our investments, I am concerned the shopping of ATI to US big pharma partners will impede the speed of ATI gaining TGA approval for Australia beyond the Special Access Scheme. ATI morally needs to be an informed choice option for Australian patients. The average surgical patient faces months of pain and frustration only to still have 'mild difficulties' at 12 months, vs far close to 'no difficulties' under ATI at 12 months.

My experience anecdotal, but the 15.7pt difference on a QuickDash scale does not begin to explain the divergence in quality of life in patients in the 12 months following ATI vs surgery and beyond, until we start converting the final scores back and think what that means for patients - still hesitating perhaps at opening a jar, or lifting a heavier shopping bag at 12 months if a surgical patient, vs near carefree ATI patients.