ORTHOCELL LIMITED — Capital/Financing Update 2021

Aug 22, 2021

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Successful restoration of arm function in people with tetraplegia; results presented at WA AOA

• Successful CelGro® nerve repair study results presented at the 50[th] West Australian Branch Australian Orthopaedic Association (WA AOA) annual scientific meeting;

• Pre-clinical results indicate CelGro® facilitates superior nerve regeneration when compared to the market leading nerve repair device, restoring the sciatic nerve to its pre-injured state with no adverse reactions;

• Clinical results in the tetraplegic patient cohort showed 76.5% of nerve repairs (13 of 17) resulted in functional recovery (MRC grade 3 or 4[11] ) of muscles controlled by the repaired nerve at 12 months post treatment;

• CelGro® nerve regeneration studies demonstrate potential for breakthrough nerve treatment to return function to paralysed upper limbs ;

• Final 24-month results of all patients in the CelGro® nerve regeneration study expected in Q2 CY2022 – with key regulatory milestones progressing in US and AU

Perth, Australia; 23 August 2021: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce the successful pre-clinical and clinical CelGro® nerve repair study results showing superior nerve regeneration and consistent restoration of upper limb function in people with tetraplegia were presented at the 50[th] West Australian Branch Australian Orthopaedic Association (AOA) annual scientific meeting . The WA AOA annual scientific meeting is the industry leading state congress and was attended by highly regarded orthopaedic surgeons, researchers and commercial partners. The congress provided an opportunity to build awareness of the surgeon and patient benefits provided by CelGro®, a best in class collagen medical device.

Orthocell Managing Director, Paul Anderson, said: “Consistently returning function to paralysed upper limbs is the primary goal in this study. I am delighted that the results, demonstrating higher quality outcomes, improved predictability, and consistency of return of muscle function following CelGro® nerve regeneration treatment have been presented at the AOA - a valuable part of our wider commercialisation and physician engagement strategy.”

Australian orthopaedic nerve specialist and clinical trial lead, Dr Alex O’Beirne presented the results of two successful CelGro® nerve repair studies titled: “Development of an epineurial substitute for nerve repair in patients with tetraplegia: proof of concept pre-clinical and clinical studies”. Dr Alex O’Beirne highlighted:

• In the pre-clinical study, sciatic nerves in rats repaired with CelGro® exhibited no inflammation, scar tissue formation or fibro-adhesions . CelGro® integrated into the host epineurium (outer layer of connective tissue of the nerve), was remodelled into natural tissue, and at 4 weeks post treatment, resembled the native sciatic nerve in appearance. For full study results, click here ;

• In the CelGro® nerve regeneration clinical study, seventeen nerve repairs were performed with CelGro® in five quadriplegic patients. Patients demonstrated faster and better results in muscle function restoration, compared to published studies of nerve transfer surgery using the standard method (direct suture). In particular, 76.5% of the tetraplegic nerve transfers (13 of 17) resulted in the best-case clinical

1 British Medical Research Council Grading System (MRC grade), with a score of 0 to 5. A score of zero (0) indicates no nerve connection to the muscle (ie., no recovery), a score of five (5) is given to muscles with normal power/strength. A score of 3 or better is clinically defined as a meaningful functional recovery.

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

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outcome (MRC Grade 3 or 4[1] ) at 12 months post treatment. An MRC Grade 3 or 4 means quadriplegic patients regain a level of independence, enabling them to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of a wheelchair without assistance. For full study results, click here ;

Dr Alex O’Beirne, said: “My goal is to make nerve repairs accessible to more patients by making the surgical procedure simpler and reproducible by other surgeons. This study has demonstrated a consistent return of arm and hand function following nerve transfer surgery with CelGro®. The tetraplegic patient results are particularly promising, with improved results at 12 months post treatment compared to the literature. CelGro® is increasing the success rate and efficiency of nerve transfer surgery. Seeing patients regain enough independence so that they can be involved in family life and return to work is very rewarding.”

Significance of results and next steps?

The Company believes CelGro® to be an important step forward for improving nerve repair surgery. Its ease of use, consistent and predictable high-quality outcomes which are achieved in a shorter timeframe compared to other methods, will empower surgeons to improve the lives of patients with these complex injuries.

CelGro®’s global addressable market in peripheral nerve repair is estimated to be worth more than US$7.5 billion per annum, with approximately 3,000,000[2] procedures that could use CelGro® completed each year.

With positive 12-month data in hand from the CelGro® nerve regeneration trial, Orthocell continues to prepare for discussions with FDA on the approval pathway and also with US insurance companies (or ‘payers’) and key opinion leaders to finalise the commercialisation approach for registration and reimbursement.

Release authorised by Paul Anderson, Managing Director, Orthocell Ltd.

For more information, please contact:

General & Investor enquiries

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

2 Addressable markets include US, Japanese, European and Australian markets. Referenced papers were used to derive specific assumptions in the procedure potential estimates. Papers used include both U.S. and OUS databases and studies.

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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 forwardlooking 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