Controlling body announces approval for increased shelf life of Epiprotect
The Company’s notified body has announced that increased shelf life, from 1 to 3 years, for the products in the Epiprotect series is approved. The approval was obtained after audit of necessary tests and documentation.
ECM is the Company’s notified body and is in accordance with the EU directive for medical devices, responsible for the Company’s compliance of the rules of the directive. As previously announced, the products in the Epiprotect-series have received CE-mark after approval of ECM.
The Company has performed all necessary tests to further increase the shelf life to 5 years and intends to submit an application to ECM shortly, to have the documentation approved.
A long shelf life is of strategic importance since it both facilitates an efficient production process at the same time as it is being requested from distributors to further incentivize keeping of a larger stock.
”There is currently a long waiting time for all types of regulatory approvals in Europe which has delayed this announcement. We are however happy that we now have a longer shelf life on these products since it will facilitate our sales as it reduces the risk for expiring products with our distributors.” Says the Company’s CEO Petter Sivlér.
This disclosure contains information that S2Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 15-06-2022 13:01 CET.
Contact Details
Petter Sivlér – CEO, S2Medical AB (publ)
Telephone: +46 (0)8-70 000 50
E-mail: petter.sivler@s2m.se
Certified Adviser
Vator Securities AB
Telephone +46 (0)8-580 065 99
Website: www.vatorsec.se
E-mail: ca@vatorsec.se
About S2Medical
S2Medical AB (publ) is a medical technology company that develops and sells innovative wound healing products for the entire wound healing process, with a focus on burns and chronic wounds. The company has developed eiratex®, a new cellulose-based material for healing severe burns and chronic wounds. The material heals wounds effectively and thereby reduces both suffering for patients and costs for health care.
Share's ticker: S2M
Share's ISIN-code: SE0011725084