Orthocell

PAUL ANDERSON

CEO & MANAGING DIRECTOR

(ASX:OCC)

◾ Company Name: Orthocell ◾ Company ASX code: OCC ◾ Key areas: Regenerative medicine ◾ Key Personnel: Paul Anderson, CEO & Managing Director | Alex McHenry, Chief Operating Officer | Dr Stewart Washer, Chairman of the Board ◾ Locations: Perth, Australia ◾ Market Cap as of 15/09/22: $76.90M ◾ 52 Week share price as of 15 September: $0.300 - $0.590 ◾ Company Website: orthocell.com

COMPANY PROFILE

Orthocell is a world-leader in regenerative medicine – a powerful discipline representing a paradigm shift to smarter, more targeted and efficient treatments.

The relatively new field has enormous potential, leveraging the body’s ability for self-repair to reduce pain and return functionality.

Orthocell is dedicated to development of breakthrough regenerative products for the treatment of musculoskeletal disorders. The Company is currently developing and commercialising two regenerative medicine platforms – collagen scaffold medical devices and cell therapies.

Orthocell has established a qualitycontrolled facility at its Perth headquarters. The facility is licensed by the Therapeutic Goods Administration (TGA) for the manufacture of human tendon cells (tenocytes) and cartilage cells (chondrocytes) for the regeneration of damaged tendon and cartilage.

The facility is also certified to ISO 13485 for the manufacture of CelGro™ medical devices including Striate+™ and Remplir™. Orthocell is equipped to manufacture, scale up and export products around the world.

Orthocell recently secured a 25year exclusive patent and trademark licence deal with BioHorizons for the manufacture of its Striate+™ product for dental and oral-maxillofacial procedures. Striate+™ is a resorbable collagen membrane used in guided bone and tissue regeneration.

Under the deal, US-based BioHorizons has agreed to pay Orthocell US $16 million ($23.1 million) in return for the granting of an exclusive licence of intellectual property (IP) for Striate+™.

This was a landmark deal for Australia’s biotechnology sector, contributing undiluted capital to back the Company’s most progressed platform product into key global markets, at scale.

Orthocell is also on track to disrupt the global nerve repair market with its trademarked product Remplir™, giving hope to sufferers of nerve injury.

Every year, millions of people globally sustain peripheral nerve injury as the result of motor vehicle, sporting, workrelated or other accidents, resulting in pain, numbness, burning or tingling, or in extreme cases paralysis.

Surgery to repair damaged nerves is delicate and complicated, and not always successful. Remplir™ assists in re-joining severed or severely damaged peripheral nerves to restore function and sensation.

This unique collagen scaffold provides a non-adhesive barrier structure to protect the nerve and create an ideal microenvironment for the regeneration of damaged peripheral nerves. Remplir™ reduces the need for suturing, is easy to use and results in consistent and predictable return of muscle function to paralysed limbs.

Orthocell’s final data read-out of all patients in its nerve reconstruction trial has shown encouraging results. The follow-up data at 24 months post treatment showed that 85% (23 of 27) of nerve reconstructions resulted in functional recovery of target muscles closest to the reconstruction site.

Patients in the clinical trial had suffered traumatic nerve injuries, resulting in partial or total loss of use of their arms and, in more severe cases, their legs and torso (quadriplegia).

In the Company’s cell therapies division, Orthocell’s OrthoATI™ is a novel Injectable cell therapy addressing tendon damage, which replenishes degenerative tissue with healthy mature tendon cells, reducing pain and returning function with extensive validation of more than 1000 patients treated to date.

OrthoATI™ has significant market potential with currently no non-surgical treatments available to treat chronic tendon injury.

Orthocell is helmed by a world-leading team of experts in medical research, clinical practice, and commercialisation – primed and ready to bring these innovative products to the world.

pioneering innovative technologies for tendon regeneration

KEY INVESTMENT HIGHLIGHTS

JUNE 7, 2022: Final data read-out of all patients in Orthocell’s nerve reconstruction trial shows return of function to paralysed upper limbs. JUNE 28, 2022: Orthocell shares up 35% after securing an exclusive global patent and trademark licence deal with BioHorizons for the manufacture of Striate+™ . SEPTEMBER 7, 2022: Device Technologies appointed distributor for Remplir™nerve repair device, after approval for inclusion on the Australian Register of Therapeutic Goods (ARTG).