VagiVital® awarded CE mark
Stockholm, May 31st , 2018 - Peptonic Medical AB (publ) (’Peptonic’ or ’Company’) today announced that its first-to-be-launched product - VagiVital® - has received the CE Mark from Lloyd’s Register Quality Assurance, Ltd. (LRQA) in England, acting as the Notified Body for the product.
In December 2017, the Company’s quality management system was approved according to ISO 13485:2016 and in January 2018, the Company submitted the Technical File for assessment for the CE Mark. Due to a heavy work load at LRQA the issuance of the CE Mark was delayed until now.
- We are very pleased to have overcome this last hurdle for launching VagiVital®. Also, this means we can stay with the initial time plan for the launch, says Johan Inborr, CEO of Peptonic Medical.
The CE Mark certification for VagiVital® is initially valid for three years and can be extended thereafter.
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 31st May 2018.
About Peptonic Medical
PEPTONIC Medical is an innovative Swedish development company. Our vision is to offer safe and effective treatments for women suffering from vaginal atrophy during menopause and after.
VagiVital™ is a trademark of PEPTONIC Medical. The product is hormone free and is being commercialised for the non-prescription use for the treatment of vaginal atrophy.
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.
In July 2014, PEPTONIC Medical was listed on the AktieTorget stock exchange (www.aktietorget.se, ticker: PMED) in Stockholm.
For more information: www.peptonicmedical.com
VagiVital™ is a 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. estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects.
PEPTONIC Medical plans to launch VagiVital™ as a non-prescription self-care product in 2018.