Peptonic Medical AB (“Peptonic” or “Company”) today announced that it has entered an agreement with DQS Medizine GmbH (DQS-MED) which means that DQS-MED will become Peptonic’s Notified Body.
The reason for the change is that Peptonics current Notified Body, Lloyds Register Ltd., a UK-based company, no longer will have the right to issue or maintain CE-mark certificates in case of a so called ‘hard’ Brexit. Recently, Lloyds Register Ltd. has announced that it will cease its certification operations regardless of the form of Brexit.
This week DQS-MED has audited Peptonic’s quality system with only one minor remark. Next, the technical flie of VagiVital will be reviewed by DQS-MED.
It is the opinion of Peptonic that the change of Notified Body will not affect the availability of VagiVital on the market. Product that has been released for the market can be sold without restrictions.
- We are pleased to have engaged DQS-MED and thereby have secured the availability of VagiVital regardless of Brexit and in light of the announcement by Lloyds Register, says Johan Inborr, CEO at Peptonic.
For more information, please contact;
Johan Inborr, CEO
Mobile: +46 708 853 893
This information is information that Peptonic Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 20th June 2019.
VagiVital®is a patent pending hormone free self-care product for the treatment of vaginal atrophy and vaginal dryness. The product has been tested in randomised clinical studies (vaginal atrophy) with very positive results both for objective (vaginal pH and proportion of superficial cells in the vaginal mucosa) and subjective (most bothersome symptoms, such as vaginal dryness, vaginal irritation/itching, dyspareunia and dysuria) parameters. The magnitude of symptom relief is on par with that demonstrated with e.g. prescription estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects.
VagiVital®was launched in Sweden as a non-prescription self-care product in July 2018 (see www.vagivital.com).
About Peptonic Medical
Peptonic Medical is an innovative Swedish medical development company. Its vision is to offer safe and effective treatments and relief for women specific diseases and medical conditions.
VagiVital®is a registered trademark of Peptonic Medical. The product is hormone free and is being commercialised for the non-prescription use for the treatment of vaginal atrophy (VA) and vaginal dryness. The pipeline of Peptonic Medical also includes Vagitocin®, which is an oxytocin-based vaginal gel for the treatment of VA. This product candidate is in clinical development phase 2. The development of Vagitocin® is on hold pending additional data on i.a. the mechanism of action.
Since July 2014, the Peptonic Medical share has been traded on the Spotlight Stock Exchange (www.spotlightstockmarket.com, ticker: PMED) in Stockholm, Sweden.
For more information, read About Peptonic