ORTHOCELL LIMITED — Capital/Financing Update 2019

Mar 5, 2019

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Orthocell’s Ortho-ATI® shoulder tendon study on track

• Clinical trial comparing Orthocell’s tendon regeneration therapy (Ortho-ATI®) to corticosteroids on track for recruitment completion by 2Q CY 2019

• Trial undertaken in collaboration with DePuy Synthes Products, Inc., part of the Johnson & Johnson Medical Devices Companies

• Trial aims to assess the effectiveness of Ortho-ATI® for the treatment of rotator cuff tendinopathy and tear, compared to corticosteroid injection

Perth, Australia; 06[th] March 2019: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it is on track to complete recruitment by 2Q CY2019 in its randomised, controlled clinical trial of Ortho-ATI® versus corticosteroid injection, for the treatment of rotator cuff tendinopathy and tear in the shoulder.

Rotator cuff tendinopathy and tear (which manifests as severe shoulder pain) is a common and often difficult injury to treat and affects more than 50% of adults over 50 years of age. Rotator cuff injuries may lead to considerable disability, reduced quality of life, and absenteeism from work, and are a significant burden on healthcare resources. This burden is expected to increase as the population ages, and as a result, new treatments are required that address the underlying pathology of the injury, not just the symptoms.

The objective of this clinical trial is to assess the effectiveness of Autologous Tenocyte Injection (Ortho-ATI®) compared to corticosteroid injection in the treatment of rotator cuff tendinopathy and tear. To be eligible for the trial, patients must have failed previous conservative treatment options, including previous injection treatment and physiotherapy. The trial is led by Clinical Professor Allan Wang (former President of the Australian Elbow and Shoulder Society), Dr Jeff Hughes (current President of the Australian Elbow and Shoulder Society), Dr Jane Fitzpatrick, Dr Travis Falconer and Professor Ming Hao Zheng at the University of Western Australia (UWA).

Orthocell Managing Director, Paul Anderson, said: “Demonstrating the efficacy of Ortho-ATI® for the treatment of rotator cuff tendinopathy is an important element of our product development and partnering strategy. We expect results to show Ortho-ATI® is a durable and effective treatment for degenerate shoulder injuries.”

Chronic tendon pain is a highly prevalent condition. For example, tennis elbow (elbow pain) affects 1-3% of the general population. Ortho-ATI® is at the forefront of a significant addressable market, which is estimated to be >US$7.7bn1 and growing.

In studies conducted by Orthocell to date, Ortho-ATI® has been shown to be a cost effective longterm, non-surgical solution for tendon injuries which are difficult to treat. Ortho-ATI® is available in Australia, New Zealand, and Hong Kong for patients who have failed conservative treatment options such as corticosteroid injections and exercise programs, and have ongoing symptoms.

1 US, Japanese, European and Australian markets

Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.au

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About Ortho-ATI®

Ortho-ATI® is a world leading breakthrough in regenerative medicine – a novel, cell therapy developed to treat chronic tendon injuries (tendinopathy / tendonitis). Tendinopathy places a significant financial burden on the public health care system which is expected to increase as the population ages. Treating physicians and insurers are constantly seeking advances in new treatments that are safe, effective and cost efficient.

Ortho-ATI® addresses these demands by enabling the accelerated regeneration of injured tendons, directly addressing the underlying cause of injury, replenishing degenerative tissue with healthy mature tendon cells (known as tenocytes). The treatment allows patients to return to recreational activities, the workplace and competitive sports. Ortho-ATI® has extensive clinical validation with published clinical data up to 4.5 years post treatment in leading peer-reviewed journals (e.g. American Journal Sports Medicine), clearly demonstrating durability and efficacy as the leading tendon regeneration treatment.

For more information, please contact:

General & Investor enquiries

Media enquiries

Paul Anderson Haley Chartres Orthocell Limited Hales[2 ] Communications Managing Director P: +61 8 9360 2888 P: +61 423 139 163 E: paulanderson@orthocell.com.au E: haley@h-squared.com.au

About Orthocell Limited

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue. Orthocell is moving forward with clinical studies designed to assist in the US (FDA) approval process and has completed its pre-IND meetings with the FDA. 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. Orthocell recently received European regulatory approval (CE Mark) for CelGro®. The collagen medical device can now be marketed and sold within the European Union for a range of dental bone and soft tissue regeneration procedures and is being readied for first approval in the US and AUS.

For more information on Orthocell, please visit www.orthocell.com.au or follow us on Twitter @Orthocellltd and Linkedin www.linkedin.com/company/orthocell-ltd

Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.au