ORTHOCELL LIMITED — Capital/Financing Update 2020

Sep 13, 2020

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CelGro® reaches 300-case milestone under Special Access Scheme

• Over 300 patients treated with CelGro[®] under Special Access Scheme (SAS) approvals

• Approvals were granted by the Therapeutic Goods Administration (TGA) for use of CelGro[®] in nerve, tendon, cartilage and dental maxillofacial bone repair

• The SAS provides surgeons and patients access to therapeutic goods with significant advantages over existing products prior to regulatory approval

• SAS product use provides real-world evidence for the safety and efficacy of CelGro[®] , further validating data collected in clinical trials

Perth, Australia; 14[th] September 2020: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has treated 300 patients via the TGA’s Special Access Scheme (SAS) for its collagen medical device CelGro[®] . Under SAS approval, doctors can prescribe use of therapeutic goods prior to regulatory approval if they can justify that the product has significant advantages for their patient over existing approved products or where there are no approved products currently available.

Orthocell Managing Director, Paul Anderson, said: “ This is an important milestone demonstrating Key Opinion Leaders’ (KOLs) continued uptake and use of CelGro[®] via the SAS. The data collected from these CelGro[® ] cases provides important real-world evidence adding to the effectiveness established in clinical studies as we prepare for first AUS and US approval.”

A patient’s perspective

Adrian is one of the patients treated with CelGro[®] . A catastrophic mountain bike accident in 2017 left Adrian with fractured vertebrae in his neck, resulting in life-changing tetraplegia. Adrian had some movement in his elbows and upper arms, but his hands, torso, and legs were paralysed and he didn’t have enough strength to use a wheelchair on his own. Adrian’s complex and challenging surgery involved CelGro[®] nerve transfer surgery to return function to target muscles. Adrian’s recovery has been impressive. Hear Adrian and his surgeon talk about their experiences, the nerve transfer procedure and his recovery here.

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Real-world evidence for CelGro[®]

Real-world evidence, as compared to evidence from a clinical trial, is increasingly recognised as a valuable source of data to demonstrate performance and safety of a medicine or medical device. Patients in a clinical trial are carefully selected to ensure that outcomes of the trial are comparable across the group, but real-world evidence represents the every-day use of the product in a much

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

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wider patient population. Orthocell is continuing to collect real-world evidence for CelGro[®] in diverse clinical applications, such as nerve, tendon, cartilage and dental maxillofacial bone repair. This data, in combination with our clinical trial data, shows that CelGro[®] is safe and effective.

About the CelGro[®] Platform

CelGro[®] is a collagen medical device platform for soft tissue regeneration and repair applications, manufactured by Orthocell at its quality-controlled Good Manufacturing Practices (GMP)-licensed facility in WA. Orthocell has received market authorisation (CE Mark) of CelGro[®] in the EU for dental bone and soft tissue applications. The CE Mark allows CelGro[®] to be supplied within EU countries, validates CelGro[®] ’s quality manufacturing and product performance, and provides a strong foundation for indication expansion and regulatory approvals. CelGro[®] has also been shown to improve tissue growth and repair in clinical studies using CelGro[®] to augment repair of the rotator cuff tendon within the shoulder, to guide bone regeneration in the jaw and to assist in the re-joining of severed or damaged peripheral nerves. CelGro[®] is a customisable collagen medical device with numerous competitive advantages over existing synthetic and biologic tissue repair devices, particularly in the areas of cell biocompatibility, tensile strength and the promotion of high-quality tissue repair.

Release authorised by:

Paul Anderson Managing Director, Orthocell Ltd

For more information, please contact:

General & Investor enquiries

Media enquiries

Paul Anderson Haley Chartres Orthocell Limited H^CK Director Managing Director P: +61 8 9360 2888 P: +61 423 139 163 E: paulanderson@orthocell.com.au E: haley@hck.digital

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® platform technology, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications. Orthocell has received European regulatory approval (CE Mark) for CelGro® and is marketed within the European Union for a range of dental bone and soft tissue regeneration procedures. CelGro® is being readied for first approval in the US and AUS. The Company’s other major focus is 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.

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

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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.

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