Stockholm, March 22nd, 2018 - Peptonic Medical AB (publ) (’Peptonic’ or ’Company’) today announced that it has received the report of the evaluation of its so called Technical File.
The evaluation has been performed by Lloyd’s Register Quality Assurance, Ltd. (LRQA) in England, acting as the Notified Body.
The Company submitted the Technical File in January but due to a heavy work load at LRQA the evaluation report was delayed until now.
The report lists a number of items of the Technical File that need clarification or need to be complemented. It is the view of the Company that these items can be addressed based on the existing documentation on VagiVital® and no further tests are required. Hence, the Company’s response to the evaluation report will be submitted in the near future. This means that the approval of the CE mark can be expected during April.
- We are now convinced that VagiVital® will be granted the CE mark, which has been our goal since May last year when the work started. The slight delay in the time table is due to the delayed report from LRQA, but this has no implications on the time table for the product launch, says Johan Inborr, CEO of Peptonic Medical.
Already in December 2017 the Company’s quality management system was approved according to ISO 13485:2016. This is a prerequisite for obtaining the CE mark for VagiVital®. The ISO certificate was issued to the Company on March 14th 2018 and is valid for three years.
For more information, please contact;
Johan Inborr, CEO
Mobile: +46 708 853 893
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.