REG - Surgical Innovations - CE mark validation indicated for CELLIS range
RNS Number : 0597ZSurgical Innovations Group PLC29 August 2018
Surgical Innovations Group plc
("SI", "the Company" or the "Group")
CE mark validation indicated for CELLIS range
Surgical Innovations Group plc (AIM: SUN), the designer and manufacturer of innovative medical technology for minimally invasive surgery, provides an update relating to the CELLIS range of products supplied to its UK distribution business, Elemental Healthcare Limited ("Elemental") by Meccellis Biotech SA ("Meccellis").
Following the withdrawal of their previously held CE mark, Meccellis have today 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 enables Meccellis and Elemental to resume selling the CELLIS range of products.
Further to 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, with a subsequent automatic renewal period of two years, subject to meeting minimum purchase obligations. This agreement, and the new CE mark, cover some exciting and innovative new products which are due for launch in the UK market during 2019.
Formal certification is anticipated within four to eight weeks, during which period Group management are 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 the Company's interim results for the six-month period ended 30 June 2018 on Tuesday 11 September 2018.
This announcement includes inside information as defined by Article 7 of the Market Abuse Regulation No. 596/2014 and is disclosed in accordance with the Company's obligations under Article 17 of those Regulations.
For further information please contact:
Surgical Innovations Group plc
Nigel Rogers, Executive Chairman
Tel: 0113 230 7597
Melanie Ross, COO & CFO
WH Ireland Limited (NOMAD & Broker)
Tel: 0113 394 6600
Tim Feather
Walbrook PR (Financial PR & Investor Relations)
Tel: 020 7933 8780 or si@walbrookpr.com
Paul McManus
Mob: 07980 541 893
Lianne Cawthorne
Mob: 07584 391 303
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