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Clinical Study Shows Long-Term Effectiveness Of Orthocell’s Ortho-ATI™ For Treatment Resistant Tennis Elbow


8/25/2014 9:12:48 AM

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• Ortho-ATI™ shown to be a successful long-term treatment for tennis elbow
• Patients grip strength improved on average by 207%
• Ortho-ATI™ shown to be disruptive technology and a disease modifier

Perth, Australia; 25th August 2014: Regenerative medicine company Orthocell Limited has today released results from a long-term clinical study into its Ortho-ATI™ treatment for tennis elbow that provides evidence of the durability and long term success of this treatment.

The clinical study showed grip strength scores of patients suffering from a severe form of tennis elbow, called chronic lateral epicondylitis, improved by an average 84% at one year after treatment and 207% at an average of 4.5 years after they underwent the Orthocell procedure. This data represents the first long term efficacy data for a stem cell based tendon regeneration treatment, that has been published globally.

“Ortho-ATI™ has proven itself to be an effective and durable long-term solution for degenerate, treatment-resistant tendons” Orthocell Managing Director Paul Anderson said.

Tennis elbow is a painful condition caused by damage and degeneration of tendons in the elbow due to overuse. Current treatments such as steroid injections are limited in their effectiveness and fail to address the underlying cause of the degeneration.

Ortho-ATI™ treats tennis elbow by extracting a small sample of patient’s healthy tendon stem cells, culturing and expanding them in a laboratory and then re-injecting the cells into the damaged tissue to help it regenerate and to significantly reduce pain and inflammation.

“The results are very positive and encouraging for patients affected by painful and debilitating degenerate tendon injuries,” said Mr Anderson. “They show long-term, sustained and statistically significant positive results in a very difficult to treat group of chronic patients.”

The study found a single injection of a patient’s cultured tendon stem cells significantly improved clinical function at the 3 to 5-year follow up of patients who had previously undergone an unsuccessful course of conservative treatment such as exercise and corticosteroid injections. The study was undertaken at the University of Western Australia in conjunction with Sir Charles Gairdner Hospital in Western Australia and was led by Orthocell’s consultant Chief Scientific Officer, Professor M.H. Zheng and orthopaedic surgeon Associate Professor Alan Wang.

The results of the study were presented at the WA Orthopaedic Association conference over the weekend and have been accepted for presentations at the Australian Orthopaedic

Association conference in October, as well as the Australian Sports Medicine conference in Canberra also in October.

Ortho-ATI™ is available in Australia and New Zealand for patients who have failed conservative treatment options such as corticosteroid injections and exercise programmes and have ongoing symptoms. Orthocell’s Ortho-ATITM is manufactured under TGA license #MI-19052008-LI-002420-11.

For more information, please contact:

General enquiries Paul Anderson Orthocell Limited, Managing Director P: (08) 9360 2888 E: paulanderson@orthocell.com.au

Media enquiries Gavin Lower Buchan Consulting P: (03) 8866 1215 / 0414 796 726 E: glower@buchanwe.com.au

Investor Relations Rebecca Wilson Buchan Consulting P: 0417 382 391 E: rwilson@buchanwe.com.au

About Orthocell Limited

Orthocell is a commercial-stage, regenerative medicine company focused on developing products for a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-approved stem cell therapies Autologous Tenocyte Implantation (Ortho-ATI™) and Autologous Chondrocyte Implantation (Ortho-ACI™), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is Celgro™, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approval.

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