ORTHOCELL LIMITED — Regulatory Filings 2021

Jan 27, 2021

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Novel Surgical Treatment for Tendon Repair

• Publication of novel tendon repair surgery combining a collagen medical device with the patient’s own tendon cells

• CelGro®combined with Ortho-ATI® is effective in returning a patient to normal function has been published in the International Journal of Case Reports

• 63 year-old patient failed conservative and surgical treatment options suffering pain and disfunction over 15 years, prior to CelGro® plus Ortho-ATI® surgical treatment

• 6 months post treatment, the patient’s pain had settled and was walking without a limp

• Results further validate Ortho-ATI® and CelGro® as an innovative solution to repair degenerate tendons.

Perth, Australia; 28[th] January 2021: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce the publication of a successful case study focussing on the combination of CelGro® collagen medical device and autologous tenocyte implantation (“Ortho-ATI®”) for the surgical repair of a large degenerate tear of the gluteal medius tendon. The case study was published by internationally recognised orthopaedic hip specialist surgeon Dr John M O’Donnell and sports and exercise doctor A/Professor Jane Fitzpatrick. The case report supports Ortho-ATI® and CelGro® as durable, long term solutions for degenerate, treatment resistant tendons that can be used on their own or in combination. The case report may be viewed here: Gluteal Tendon Regeneration Publication.

Treating physician, Dr John O’Donnell commented, “Gluteal tendinopathy and tendon tears are a common and debilitating injury that is often difficult to treat, especially in older patients who are less likely to benefit from surgery. This case study highlights the exciting potential of Ortho-ATI® in combination with CelGro® as a novel therapy for torn gluteal tendons requiring surgical repair. I am delighted by these results providing long-lasting improvements returning the patient to normal function.”

Gluteal tendinopathy can result in severe hip pain and is a common cause of disability affecting up to 23.5% of women and 8.5% of men aged between 50 and 79 years. Gluteal tendinopathy injuries may lead to considerable disability, reduced quality of life, and absenteeism from work, and are a significant burden on healthcare resources. The current standard of care including corticosteroid, platelet-rich plasma (PRP) injections or surgery, either lack an evidence base for long-term efficacy, or suffer from variability in failure rates and full restoration.

This case report was designed to assess the role and effectiveness of CelGro® when combined with Ortho-ATI® to treat chronic degenerative gluteal tendinopathy in a 63 year old woman. The patient suffered from chronic right sided hip pain for over 15 years which significantly affected her ability to sleep, work and exercise. The patient underwent numerous conservative treatment options (including physiotherapy, load management, platelet rich plasma and corticosteroid injection therapy) and right hip replacement surgery - all without success. In 2016, the patient suffered a full thickness tendon tear (rupture) of the gluteus medius from the insertion of the greater trochanter

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

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(hip bone), confirmed by MRI of the hip, also noting significant atrophy and degeneration of the tendon.

Ortho-ATI® plus CelGro® treatment process and results

The patient underwent open surgery in April 2017 where the gluteus medius was anatomically repaired. CelGro®, acting as a carrier and scaffold for Ortho-ATI® (patients own cultured tenocytes) was then sutured over the repaired tendon. Both CelGro® and Ortho-ATI® were manufactured at Orthocell’s TGA licensed facility prior to surgical implantation.

Pain and function improvement was reported by the patient at the 12-week post-implantation review. At 6 months post treatment, and a physiotherapy led strength-based exercise program, the patient reported that pain had settled and was walking without a limp. She had normal function in the hip at 12 months. A structural improvement in the tendon was confirmed by repeat MRI.

Orthocell Managing Director Paul Anderson, said: “ The positive case study is a global first supporting the combination of CelGro® and Ortho-ATI® to provide a durable solution to treat severely torn tendons. This is an exciting pipeline application combining our leading products CelGro® Ortho-ATI® and is a ground-breaking approach that continues to place OCC at the forefront of tendon regenerative medicine.”

Orthocell intends to leverage this case report showing CelGro® and Ortho-ATI® results in high quality tissue repair to further position the medical device and cell therapy as best-in-class regenerative medicine products that can be used on their own or in combination. Further performance studies are planned to assist in establishing the effectiveness of the combined product.

Release authorised by:

Paul Anderson Managing Director, Orthocell Ltd

For more information, please contact:

General & Investor enquiries

Paul Anderson

Orthocell Limited Managing Director

Media enquiries

Haley Chartres H^CK Director

P: +61 423 139 163 P: +61 8 9360 2888 E: haley@hck.digital E: paulanderson@orthocell.com.au

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

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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 CelGro®, a collagen medical device which facilitates tissue repair and healing in a variety of dental, nerve and orthopaedic, reconstructive applications. Orthocell recently received FDA 510(k) approval for Striate+, the first application of the CelGro® platform for dental GBR applications. Striate+ is also approved in Australia (ARTG) and Europe (CE Mark) for the same. The Company’s other major products are the cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue respectively. Orthocell is moving forward with Ortho-ATI® clinical studies designed to assist in the US (FDA) approval process and has completed its pre-IND meetings with the FDA.

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

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan,” “predict,” “project,” “target, ”potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for is product candidates. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

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