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ORTHOCELL LIMITED Capital/Financing Update 2017

Sep 5, 2017

65477_rns_2017-09-05_a8b487b6-20c7-45c8-b661-fdf57feb9262.pdf

Capital/Financing Update

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Celgro® positive safety and performance in human hip study

  • Orthocell reports positive safety and tolerability for first 3 patients treated in a clinical study using Celgro® collagen membrane for the treatment of full thickness cartilage defects within the hip joint

  • Study aims to demonstrate safety and performance of Celgro® SMRT Graft® as an augment to hip cartilage surgery

  • Performed in collaboration with leading Australian orthopaedic surgeon, Dr John O’Donnell and St Vincent’s Hospital, Melbourne

Perth, Australia; 6 September 2017: Regenerative medicine company Orthocell Limited (“the Company”) has reported initial positive safety and tolerability for first 3 patients treated in a clinical study using Celgro® collagen membrane for the treatment of full thickness cartilage defects within the hip joint.

The primary objective of the study is to demonstrate the safety and performance of Celgro® when used as augment to assist in the treatment cartilage defects in the hip. Celgro® enhances a technique known as micro-fracture where by small holes are made in the bone surface to encourage cartilage to reform. Celgro® is placed over the cartilage defect to stabilise the clot formed from the microfracture and provide infrastructure to guide tissue repair and regeneration[(1)] .

Orthocell received ethics approval to conduct the study, involving 25 patients from the Human Resource Ethics Committee at St Vincent’s Hospital, Melbourne. Orthocell Managing Director Paul Anderson said: “This is further validation of Celgro’s safety and performance profile and its applicability across a range of clinical applications.”

Celgro® has unique characteristics of cell compatibility, tensile strength and has been shown to actively promote and guide quality tissue ingrowth and repair. Orthocell is currently undertaking other clinical studies using Celgro® to augment repair of the rotator cuff tendon within the shoulder, as an augment to guide bone regeneration within the jaw and to assist in the rejoining of severed or damaged peripheral nerves.

Principal investigator for the study, Dr John O’Donnell said: “Celgro® SMRT Graft® is a novel biological device that has the potential to provide a more effective repair than currently available treatments for osteochondral defects within the hip .”

Celgro® is a biological medical device developed and manufactured in Australia to address unmet clinical needs in the orthopaedic and general surgical soft tissue repair market. The global orthopaedic soft tissue repair market was worth approximately $US7 billion in 2013 and is expected to be worth more than $US10 billion by 2020.

  • (1) Fontana A. A Novel Technique for Treating Cartilage Defects in the Hip: A Fully Arthroscopic Approach to Using Autologous Matrix-Induced Chondrogenesis. Arthrosc Tech. Elsevier Inc.;2012;1(1):e63–8.

For more information, please contact:

General enquiries

Investor and Media enquiries

Paul Anderson Orthocell Limited, Managing Director

Ben Walsh WE Buchan

P: +61 8 9360 2888 E: [email protected]

P: + 61 411 520 012

E: [email protected]

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 tendon, cartilage and 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. 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 approvals.

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