ORTHOCELL LIMITED — Capital/Financing Update 2020

Dec 16, 2020

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CelGro® completes pivotal step in TGA approval process

• Orthocell successfully completes the Australian TGA Conformity Assessment process and initiates market authorisation

• Market authorisation expected Q1 CY2021 enabling the supply of CelGro® in dental bone and tissue regeneration procedures

• Australian reimbursement application in progress

• Orthocell is well positioned to gain US FDA approval in CY2021

Perth, Australia; 17 December 2020: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce a positive update towards achieving Therapeutic Goods Administration (TGA) approval of CelGro® collagen medical device, for introduction into the Australian dental bone and tissue regeneration market.

The TGA has completed its review of the Company’s regulatory application and confirmed that Orthocell successfully demonstrated compliance with the requirements of the Medical Device Regulations (Conformity Assessment) with respect to the safety and performance of CelGro® in dental bone and tissue regeneration procedures. The Conformity Assessment included a review of Orthocell’s quality management system and manufacturing processes.

Orthocell Managing Director Paul Anderson, said: “This is an important milestone for the Company as we continue to commercialise our collagen medical device platform and I am excited to complete this important step towards gaining Australian and US FDA regulatory approval.”

Orthocell has initiated an application to include CelGro® Dental on the Australian Register of Therapeutic Goods (Market Authorisation) to market and supply CelGro® in dental bone and tissue regeneration procedures. This application is largely administrative and is anticipated to be finalised in Q1 CY2021. The Company has also progressed its application to the Prostheses List Advisory Committee for inclusion on the Prostheses List (“PL”) enabling reimbursement by insurers. Inclusion on the PL may be finalised by Q4 CY2021.

With EU approval achieved, KOL’s in place and successful completion of the Australian TGA Conformity Assessment process, Orthocell is well positioned to gain US FDA approval in CY2021 and establish CelGro® as the best-in-class collagen membrane.

The Company believes CelGro® represents a breakthrough in bone and tissue reconstruction and is an area of significant clinical interest to the dental community. Clinical studies and post market feedback have demonstrated that CelGro® provides distinct advantages to assist surgeons deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and higher bone quality compared to the market leading dental membrane product.

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

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Release authorised by Paul Anderson Managing Director Orthocell Ltd.

For more information, please contact:

General & Investor enquiries

Paul Anderson Orthocell Limited Managing Director P: +61 8 9360 2888 E: paul.anderson@orthocell.com.au

Media enquiries

Haley Chartres H^CK Director

P: +61 423 139 163

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®, 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. The Company’s other major products are the 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.

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

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