Orthocell receives ethics approval for pivotal Ortho-ATITM tendon study

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Regenerative medicine company Orthocell (ASX:OCC) has announced it has received ethics approval to conduct a study comparing surgery for severe tennis elbow to its minimally invasive cell therapy Ortho-ATI injection.

The study will be conducted by two of Australia’s leading elbow surgeons with ethics approval received from The Avenue hospital in Melbourne, which is part of the Ramsey Health Care group, and follows publication of Orthocell’s positive pilot study results announced in April 2015 in the American Journal of Sports Medicine.

Patient recruitment will commence in Q3 2016. The study is designed to show that a single noninvasive treatment of Ortho-ATI is superior or equivalent to the more costly and invasive surgical intervention for the repair of severe, treatment resistant Lateral Epicondylitis.

"This program will support the continued demonstration of clinical efficacy and the cost effectiveness of Ortho-ATI as a minimally invasive injectable treatment for resistant tendon injuries of the elbow," said the company.

According to Orthocell Managing Director Paul Anderson, “Demonstrating equivalence or superiority of Ortho-ATI to the standard surgical approach which, for tennis elbow, has a mixed success rates is an important element of our growth strategy. We expect a repeat of the results that showed OrthoATITM was a durable, curative and cost effective treatment for degenerate tennis elbow injuries.”

Trial co-investigator and Orthocell Chief Scientific Officer Professor Ming Hao Zheng added: “As the population ages and degenerate tendon conditions become much more prevalent, doctors and patients are seeking cost effective, minimally invasive and evidenced based treatments to alleviate symptoms that affect their mobility and quality of life. This study is an important step toward validating Ortho-ATI™ as a viable alternative to surgery.”