Bone Therapeutics and Kasios to Collaborate on Novel Product for the Optimisation of Spinal Fusion Procedures

GOSSELIES and GILLY, Belgium and L'UNION, France, November 17, 2014 /PRNewswire/ --

Companies to develop a novel product combining Bone Therapeutics' cell therapy product ALLOB^®  with Kasios's synthetic bone substitute

BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the fields of bone diseases and orthopaedics and KASIOS, the synthetic bone substitute specialist, today announce a two-year collaboration to develop a novel product for spinal fusion procedures. The collaboration combines Bone Therapeutics' allogeneic^[1] osteoblastic cell therapy product ALLOB^® with Kasios's synthetic micro-granules bone substitute. The project is subsidized by the Government of the Walloon Region.

Bone Therapeutics and Kasios believe the combined product offering will create a novel approach to spine fusion, where previous methods have failed to provide the three essential properties required for bone formation^[2] in this specific indication: osteoconduction, when bone graft material serves as a support for new bone growth; osteoinduction, in which immature cells are recruited and stimulated to develop into bone-forming cells or "osteoblasts" and osteogenesis, the production of new bone. Bone Therapeutics' allogeneic osteoblastic cell therapy product ALLOB^® has already shown bone forming properties including osteoinduction and osteogenicity, as well as excellent safety and efficacy in preclinical studies.

Combining Bone Therapeutics' ALLOB^® cells with Kasios^®  TCP's osteoconductive micro-granules has the potential to enhance 3D growth and bone growth in spine fusion, bringing advantages in stability and structure. Osteoconduction is particularly key in spine fusion procedures, where larger fracture areas create a need for more structural support, which Kasios' micro-granules can provide.  

A number of methods have been developed and proposed to promote spinal fusion, such as ceramics, cadaver bones, osteoinductive growth factors or undifferentiated stem cells. However, non-union of bone and persistent pain following spinal fusion intervention is still common so further improvements in the procedure that improve safety and efficacy are still strongly needed.

Enrico Bastianelli, CEO of Bone Therapeutics, commented: "We are excited by the collaboration with Kasioswhich positions both companies at the forefront of development into an innovative new approach to spine fusion.Kasiosis a leader in synthetic bone substitutes and we look forward to what we hope will be a very fruitful collaboration as we seek to advance novel solutions for spine fusion."

Nicolas Guéna, CEO of Kasios,  commented: "We are delighted to be collaborating with Bone Therapeutics and we believe there are significant synergies between our approaches. By combining our bone substitute with ALLOB^®, we aim to benefit from increased bone regeneration efficacy, while our technology provides superior 3D support for new bone formation."

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1. Where cells are derived from a healthy, universal donor, rather than the patient.
2. Oryan et al., Journal of Orthopaedic Surgery and Research 2014, 9:18

About ALLOB^® 

ALLOB^® is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed for the treatment of bone diseases. "Allogeneic" means that the cells are harvested from a healthy, universal donor, as opposed to "autologous" where the cells come from the patient him/herself. ALLOB^® is currently tested in two Phase I/IIa clinical trials for the treatment of delayed union fractures and lumbar fusion for degenerative disease of the spine. ALLOB^® also has the potential to be administered systemically to treat orthopaedic conditions such as osteogenesis imperfecta, a rare genetic bone disease characterized by bone fragility and fractures. ALLOB^® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.

About Bone  Therapeutics 

Bone Therapeutics is a leading biotechnology company specializing in the development of innovative regenerative therapies for the treatment of orthopaedic conditions. The current standard of care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative products containing regenerative osteoblastic/bone forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.  

PREOB^®, Bone Therapeutics' autologous cell product, is currently in pivotal Phase III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for treatment resistant osteoporosis. ALLOB^®, its allogeneic cell product, is in Phase II for the treatment of delayed union fractures and lumbar fusion for degenerative disease of the spine. The Company also runs preclinical research programs and develops product candidates. 

Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics' regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 9 patent families. Further information is available at  http://www.bonetherapeutics.com 

About Kasios 

Kasios specializes in the development, manufacture and commercialization of synthetic bone substitutes for use in orthopedics, spine and dental surgery. The Company's expertise in biomaterials comes from its team of calcium phosphate experts, recognized for their knowledge in developing new products designed to this fast growing market. Kasios works in compliance with international quality standards applied to the field of medical devices (ISO 9001: 2008 BS EN ISO 13485 2012) that satisfy the unified regulatory requirements which allows the Company to provide the highest standard of quality to its customers. 

Founded in 2001, Kasios is headquartered in Gilly - Belgium and L'Union - France. 

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.  

For further information, please contact:

Bone Therapeutics SA
Enrico Bastianelli, Chief Executive Officer / Wim Goemaere, Chief Financial Officer
Tel: +32(0)2-529-59-90
info@bonetherapeutics.com

Consilium Strategic Communications
Amber Bielecka, Mary-Jane Elliott, Jessica Hodgson and Lindsey Neville
Tel: +44(0)20-3709-5708
Bonetherapeutics@consilium-comms.com