COS.L Regulatory News (COS)

10 March 2015

Collagen Solutions Plc

(the "Company" or the "Group")

FDA 510(K) Clearance for NovaBone products

Collagen Solutions plc (AIM: COS), the developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and in-vitro diagnostics, is pleased to announce that its customer NovaBone Products LLC (NovaBone) has received the following 510(K) clearances from the US Food and Drug Administration (FDA). These products have been developed by NovaBone using medical grade collagen supplied by the Collagen Solutions Group. This supply is made by both Collagen Solutions and by its wholly owned subsidiary, Southern Lights Biomaterials.

Collagen Solutions provides the highest quality, medical grade biomaterials to support medical devices and other products for regenerative medicine across an increasingly wide range of applications and clinical indications. Collagen Solutions and Southern Lights have been providing specific medical grade collagen materials to NovaBone for a number of years and is pleased to see that these collagen-based products have received FDA 510(K) clearance in the US.

NovaBone is a privately held biomaterials company based in Florida, USA. The Company was established in 2002 with a focus on developing bone graft substitutes based on advancements in biomedical engineering that would meet the specialised needs of orthopaedic and dental surgeons. Their products have been available for over 10 years and been used in over a million clinical applications with unparalleled success validating the safety and efficacy of the NovaBone technology.

Dr Stewart White, Chief Executive Officer of Collagen Solutions plc said: "These three FDA clearances reinforce our strategy to release the embedded value we have created in manufacturing medical grade collagen products for our customers. Once we are identified as the source of raw material and that has been included as part of the regulatory submission process, it is highly likely that we will be supplying collagen for those products for their entire life cycle. The importance of our part in our customers' future is emphasised by the recent acquisition of Southern Lights, whose separate supply to NovaBone will continue."

"These three products are entering the high value added area of collagen based bone grafts and wound care products which is a rapidly growing market for novel products. That is, the bone graft market in the US is estimated to be worth US$3.3 Billion, whilst the wound dressing sector is worth around US$3 Billion."

The US regulatory clearances achieved by NovaBone further endorse the long and strong relationship we have with our customers. Through robust partnerships we offer technical support and reliable supply to our customers who are then able to provide the necessary collagen safety information to regulatory agencies to support market clearance for their finished devices. This is a significant success for the NovaBone team."

Enquiries:

Further information:

NovaBone MacroForm and Bioactive Strip devices are osteoconductive bioactive bone void fillers used for orthopaedic applications. The devices are a mixture of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive glass particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen component facilitates hydration with bone marrow aspirate and handling for application to the surgical site. During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.

NovaTape & NovaPlug Dental Collagen Wound Dressings are soft, white to off-white, resorbable collagen dressings produced from cross-linked purified collagen derived from bovine hide. The dressings are intended for the management of oral wounds and sores. The thickness and pore structure of the dressing allow it to absorb fluids and blood at the defect site, thereby maintaining a moist environment. The dressings resorb within approximately 14 days of implantation.