29 August 2018 – CE mark validation fro CELLIS range
Following the withdrawal of their previously held CE mark, Meccellis have announced that they have received confirmation of their new CE mark for the complete CELLIS range of biological matrix products used in breast and abdominal wall reconstruction surgery from their Notified Body, PCBC. This is significant as it enables Meccellis and Elemental to resume selling the CELLIS range of products. As a result of this, Elemental and Meccellis have entered into an extended agreement providing Elemental with exclusive UK distribution rights in respect of the CELLIS range for a period of three years expiring in June 2021. There is also a subsequent automatic renewal period of two years, subject to meeting minimum purchase obligations. This agreement covers some innovative new products, which are due for launch in the UK market during 2019.
Formal certification is anticipated within the next couple of months. During this period Surgical Innovations will be working closely with Meccellis to optimise inventory logistics for the UK market. The Elemental sales team will engage with UK customers during this time to facilitate orderly replenishment of CELLIS products once availability information becomes clear. A further update will be provided in due course and a trading update will be issued together with interim results for the six month period ended 30 June 2018, due to be released on 11 September. We rate the shares as a BUY.