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ORTHOCELL LIMITED Capital/Financing Update 2020

Feb 4, 2020

65477_rns_2020-02-04_2e1b80e5-99ff-4bf2-8657-bc571e50fa1e.pdf

Capital/Financing Update

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Orthocell receives new patents for CelGro® platform technology

  • Canada and Japan divisional patents granted for CelGro®

  • Patents cover the method of manufacture of collagen medical devices and as an aid in the surgical repair of soft tissue injuries

  • CelGro® patents have been previously granted in the US, Canada, Europe, China, Japan, Singapore, Australia and New Zealand

  • CelGro® is approved for marketing and distribution in Europe with US regulatory study results in Bone regeneration expected Q1 CY2020

  • Global addressable market for CelGro® is in excess of US$4.4bn[1] and growing .

Perth, Australia; 05 February 2020 : Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell”, or the “Company”) is pleased to announce it has been granted Canadian and Japan divisional patents for CelGro®. The patents entitled “Method for Producing a Collagen Membrane and Uses Thereof” provide additional important intellectual property (IP) to protect the platform for soft tissue regeneration and repair applications expiring in June 2033.

Orthocell Managing Director, Paul Anderson, said: “In line with our IP strategy, we are focused on establishing and maintaining protection of our leading manufacturing technologies and treatment processes. Securing a divisional patent for CelGro® in Canada and Japan is another milestone in strengthening our IP position in global markets. This complements the progression of our products through the registration processes in the US, EU and Australia.”

Orthocell has secured 11 patent families covering its portfolio of breakthrough regenerative medicine products, comprising 108 separate patents/applications, of which 78 are granted. CelGro® is a customisable collagen medical device manufactured by the Company at its quality controlled (GMP) facility in WA, using the Company’s proprietary SMRT[TM] tissue engineering process. CelGro® has numerous competitive advantages over existing synthetic and biologic tissue repair devices, particularly in the areas of cell compatibility, tensile strength and the promotion of quality tissue in growth and repair.

In clinical studies, CelGro® has shown to augment repair of severed, or damaged peripheral nerves, the rotator cuff tendon within the shoulder and guide bone regeneration within the jaw. The Company believes CelGro® represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets as well as much wider applications in general surgical and soft tissue reconstructive applications. The global addressable market for CelGro® is in excess of US$4.4bn[2 ] and growing.

Orthocell has a clear commercialisation strategy for CelGro®, accelerating regulatory approvals for bone, tendon and nerve regeneration following recent successful clinical results and growing demand from industry leading clinicians and potential partners for superior regenerative medicine medical devices. The Company is

1 US, Japanese, European and Australian markets

2 US, Japanese, European and Australian markets

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

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on track to submit the US (FDA) CelGro® dental bone and soft tissue repair application and to commence the CelGro® nerve regeneration study for US market approval in Q1 CY 2020.

  • ENDS -

For more information, please contact:

General & Investor enquiries

Paul Anderson Orthocell Limited Managing Director P: +61 8 9360 2888 E: [email protected]

Media enquiries

Haley Chartres H^CK Director 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 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

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