Just trying to put together a pastiche, which might facilitate questions for discussion and to the company by shareholders. Feel welcome to contribute!
Main on market products limited to Australia for now, involving cultivation and implantation of autologous stem cells to tendon (Ortho-ATI) or joint cartilage (Ortho-ACI).
Pipeline products include A. porcine collagen material (Celgro) which may have a large range of applications, eg as a scaffold for bone repair and regeneration, bone void filler, soft tissue, membrane or nerve regeneration, ACL replcement, ligament braiding, mesh repair, eg urogynaecological.
and B. a growth factor/ECM protein formulation (Cell factory) to promote tissue and bone healing. This was validated in a study published in Journal of Tissue Engineering and Regenerative Medicine in 2015, regenerating cartilage in deep cartilage defects, by intra-articular injection in a rabbit model.
and C. laboratory grown tendons. (no product name yet it seems, but an amazing invention)
It is not clear what the next announcement will be, but investor presentations suggest:
1. Ortho-ATI : discussions relating to approval process in Japan, partnering discussions in EU and USA. US phase2 trial for lateral epicondylitis (tennis elbow), pending an Investigational New Drug (IND) application.
2. Ortho-ACI : seeking registration in Japan as well as a strategic partner in Japan. This is the only product of its kind in SE Asia. After Japan, then EU and USA.
3. Celgro : CE Mark (stands for Conformité Européene, for EU regulatory approval) submission 2016, then FDA 510(k) for USA, which can have a significantly longer timeline. 3 studies in evolution - tympanic membrane defect repair (Tympacol), a dental study as part of a bone graft prior to dental implant (Dentacol) and a rotator cuff study, ethics approved Dec 15.
4. Cell Factory: nothing immediately comes to mind from reading the presentations, but last month this product secured a US patent. The research leading to the product was carried out by Professor Lars Lidgren and team. Professor Lidgren is a director of Orthocell and UN Bone and Joint Chair.
Taken together, these are shaping up to be an excellent suite of products.
Regarding the financial side of things, a placement with Empery in November 2015 was completed, at SP .49, ie higher than the recent end of day price.
Also, there are 21, 218 903 options/warrants at present, which I calculate to have a mean exercise price of .564 and which constitute 23.33% of the present total number of shares, which is 91, 200 000.
Cash in bank as of 27 November 2015 was reported as 7 million.
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