COS.L Regulatory News (COS)

31 January 2019

Collagen Solutions plc

("Collagen Solutions", the "Company" or the "Group")

ChondroMimetic® Update

Distribution Agreement with Indonesian Partner and Update on CE Mark Process

Collagen Solutions plc (AIM: COS), the developer and manufacturer of biomaterials and regenerative medicines for the enhancement and extension of human life, announces that it has entered into a new license and distribution agreement for ChondroMimetic® with an Indonesian partner, PT Rajawali Mutiara Sejahtera ("Rajawali Medika"). Rajawali Medika will collaborate with Collagen Solutions to obtain regulatory approval and launch ChondroMimetic® in Indonesia with the potential to expand to several other South East Asian countries. Financial terms of the agreement were not disclosed.

Rajawali Medika, based in Jakarta, was founded and managed by highly experienced professionals in sales and marketing of medical devices in the Asia Pacific region. The team's prior experience includes successful hands-on sales and marketing of sports medicine and arthroscopy products with J&J's DePuy Mitek division. Rajawali Medika has a strong network of key orthopaedic surgeons and sales distribution channels in South East Asian countries, experience in conducting professional education programmes and workshops, as well as experience in regulatory affairs to achieve speed to market.

ChondroMimetic® is a minimally-invasive surgically placed scaffold for the repair of cartilage defects in the knee, backed by positive results of an eight-year clinical extension study reported in Q1 2018. The Company has made a submission for a CE Mark for ChondroMimetic® and is currently awaiting further feedback from the Notified Body reviewing the submission. The timing of the CE Mark approval is subject to a due process to be undertaken by the Regulatory Authority, and the previously stated timing of approval by the fiscal year end is therefore uncertain. ChondroMimetic® is not currently approved for sale in any markets.

Jamal Rushdy, CEO, commented: "We are pleased to enter the partnership agreement with Rajawali Medika for Chondromimetic in South East Asia. We will benefit enormously from both their in-depth expertise in the area of sports medicine procedures as well as their regional presence. This agreement adds to other distributor agreements that we have been putting in place in Asia and Europe in order to initiate our launch of Chondromimetic soon after we obtain regulatory approval. We are currently awaiting feedback regarding our CE Mark submission and we will provide an update once new information becomes available and certainly no later than our proposed April trading update."

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