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ORTHOCELL LIMITED Capital/Financing Update 2015

Sep 15, 2015

65477_rns_2015-09-15_2f06f01d-fb95-4f6e-ab4d-19911c33a5a3.pdf

Capital/Financing Update

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Further detail in relation to Orthocell ‘cell factory’ and general update

  • Orthocell provides further detail in relation to cell factory pipeline product and recent data

  • Abstract information summarized and link to abstract is included with this release

Perth, Australia; 16 September 2015: Regenerative medicine company Orthocell Limited (“Orthocell”) provides further detail in relation to the data presented at the 2015 European Bone and Joint Infection Society in Estoril Portugal (“EBJIS”) held 10-12 September, referenced in its release yesterday morning.

In particular, Orthocell notes that the data does not relate to Orthocell’s primary product focuses, which are the development of a stem cell treatment for the regeneration of human tendon tissue and the development of collagen based scaffolds for the reconstruction and regeneration of soft tissue injuries within the body. The data relates to a pipeline opportunity which is in development for Orthocell, and relates to intellectual property relating to the harvesting of tissue specific growth factors to aid in tissue healing and repair. The study reported at EBJIS was an early in-vitro study and further study is required to both validate and translate these findings, before human clinical studies can be considered.

As set out in the original announcement on 15 September 2015, the study further supports Orthocell’s innovative intellectual property around the generation of ‘tissue specific’ growth factors for the regeneration of cartilage and bone and follows on from the cell factory work for the cartilage injuries that was announced by Orthocell in July 2015.

On 16 July 2015 the Company announced the publication of data in the Journal of Tissue Engineering and Regenerative Medicine demonstrating that growth factors derived from cells cultivated in a controlled ‘cell factory’ in a quality controlled laboratory, when concentrated and used as an intra-articular injection and or combined with scaffolds, regenerated articular cartilage defects. Orthocell reported that these growth factors represented a promising treatment for cartilage loss in a rabbit animal model. As further announced by the Company on 24 July 2015, further study is also required to both validate and translate these findings, before human clinical studies can be considered.

As outlined above, the EBJIS study validates the concept using bone specific growth factors to aid in the regeneration of serious bone defects. The purpose of the study was to examine whether growth factors that may leak from a bone cavity could synergistically enhance the osteoinductivity of a bone void filler (Cerament™) as measured in a skeletal muscle cell line. A link to the abstract is available here:

http://prgmobileapps.com/AppUpdates/ors2015/Abstracts/abs1992.html.

Cerament™ is produced and marketed by BONE SUPPORT AB, a company with whom Orthocell has an ongoing relationship and is exploring a potential research collaboration as

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outlined in the Company’s release on 8 December 2014. Discs of Cerament™ were seeded with the muscle cell line and manufactured growth factors were also seeded onto some of the muscle cell line and Cerament™ discs, while others were left as a control. The discs with the growth factors were shown to express osteoblastic proteins, which may suggest that after stimulation, stem cells may migrate from the muscle to the underlying bone defect to assist with bone regeneration.

The study presented at the EBJIS meeting may provide support for the harvesting of native bone proteins, rather than using recombinantly produced proteins to regenerate bone, but as outlined above, further study is required to both validate and translate these findings, before human clinical studies could be considered.

Orthocell continues to focus on building its business and profile and pursuing potential growth opportunities. In this regard, Orthocell continues to progress discussions with a number of third parties in relation to the development and commercialization of its products and with potential investors in relation to raising capital to continue to progress its development pipeline. If the Company decides to proceed with any collaboration with a third party or potential investor, then the terms of any collaboration or raising will be determined taking into account market conditions at the relevant time, the stage of development of the relevant asset or assets and the Company’s needs at that time. Orthocell will keep the market informed.

For more information, please contact:

General enquiries Investor relations Paul Anderson Rebecca Wilson Orthocell Limited, Managing Director Buchan Consulting P: (08) 9360 2888 P: 0417 382 391 E: [email protected] E: [email protected]

Media enquiries

Gavin Lower Buchan Consulting P: (03) 8866 1215 / 0414 796 726 E: [email protected]

About Orthocell Limited

Orthocell is a commercial-stage, regenerative medicine company focused on regenerating mobility for patients and our ageing population by developing products for a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGAapproved stem cell therapies Autologous Tenocyte Implantation (Ortho-ATI™) and Autologous Chondrocyte Implantation (Ortho-ACI™), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is Celgro™, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.