Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

ORTHOCELL LIMITED Capital/Financing Update 2022

Jul 20, 2022

65477_rns_2022-07-20_1f05ab60-d1b8-456a-bb37-9183e47ed79d.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

==> picture [594 x 145] intentionally omitted <==

Striate+™ global exclusive license and distribution agreement update

  • Orthocell recently signed a global exclusive licence and distribution agreement with BioHorizons Implant Systems Inc. (BioHorizons), one of the largest dental implant companies in the world, for Striate+[TM ] Dental membrane for bone regeneration

  • In consideration of the license granted, Orthocell has received in cash AU $21,461,686 million[1] (USD $14,774,225 million), net of fees

Perth, Australia; 21 July 2022: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) entered into an exclusive patent and trademark licence agreement ( Licence Agreement ) and an exclusive distribution and supply agreement ( Distribution Agreement ) with Delaware corporation BioHorizons Implant Systems Inc. ( BioHorizons ). Under this agreement Orthocell will grant BioHorizons an exclusive licence of two patent families, covering a collagen scaffold for cell growth and a method for producing a collagen membrane, together with associated patent applications, improvements and know-how and the Striate+ trademark (together, the Agreements ). The Agreements were announced on 27 June 2022. Orthocell is pleased to confirm that the consideration due under the Agreements was paid on time, and all provisions remain in full force and effect.

Orthocell Managing Director Paul Anderson, said: We are delighted to have received funds from BioHorizons, solidifying our cash position with A$31.23 million on hand as at 20th of July, enabling us to drive the further development of our Remplir™ nerve product and pipeline of regenerative medicine products.

Striate+™ is a market leading resorbable collagen membrane used in guided bone and tissue regeneration procedures. Its uptake is expected to be driven by surgeons’ preference for high quality, easy to use devices facilitating better patient outcomes. Clinical studies[2] have shown Striate+[TM] supported transition from twostage to single-stage dental procedures, reducing the procedure time by several months. This is of significant interest to patients and clinicians due to potential improvements in efficiency and efficacy of dental procedures.

BioHorizons is part of Henry Schein, Inc. (NASDAQ: HSIC) and a leading global provider of dental implants and tissue regeneration products for dentists and dental specialists. The company has a broad product offering, including dental implants, guided surgery, digital restorations and tissue regeneration solutions for the replacement of missing teeth. BioHorizons products are available in 90 markets around the world. For more information, visit biohorizons.com.

Orthocell will manufacture and supply BioHorizons with quantities of Striate+™ products that embody the licensed IP and grant BioHorizons exclusive distribution rights in respect of those products in the Field. Striate+™ is manufactured by Orthocell at its quality-controlled Good Manufacturing Practices (GMP) licensed facility in WA, using the Company’s proprietary SMRT[TM] manufacturing technology.

1 After transaction costs and assuming 1 United State Dollar is equal to 1.45 Australian Dollars

2 Allan B, Ruan R, Landao-Bassonga E, Gillman N, Wang T, Gao J, Ruan Y, Xu Y, Lee C, Goonewardene M, Zheng M. Collagen Membrane for Guided Bone Regeneration in Dental and Orthopedic Applications. Tissue Eng Part A. 2021 Mar;27(5-6):372-381. doi: 10.1089/ten.TEA.2020.0140. Epub 2020 Sep 10.

==> picture [43 x 28] intentionally omitted <==

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

==> picture [594 x 145] intentionally omitted <==

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: [email protected]

Media enquiries Haley Chartres H^CK Director

P: +61 423 139 163 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 bone and 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 and orthopaedic reconstructive applications. Striate+™ was the first product approved for dental GBR applications and is cleared for use in US FDA (510k), Australia (ARTG) and Europe (CE Mark). Remplir™, for peripheral nerve repair, recently received approval in Australia (ARTG). SmrtGraft™, for tendon repair, is available in Australia under Special Access Scheme or participation in a clinical trial. The Company’s other major products are autologous cell therapies which aim to regenerate damaged tendon and cartilage tissue. Orthocell is accelerating the development of its tendon cell therapy in the US with technology transfer, manufacturing scale up and FDA engagement in advance of a randomised controlled study under FDA supervision.

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.

==> picture [43 x 28] intentionally omitted <==

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