Peptonic Medical AB (“Peptonic” or “Company”) today announced that that the DQS Medizine GmbH (DQS-MED) certification committee has approved the takeover of the CE mark concerning the Company’s self care product VagiVital®.
The reason for the change is that Lloyds Register Ltd. (Peptonic’s former Notified Body), a company based in the United Kingdom, lost the accreditation to issue CE mark, when they discontinued that part of their business.
During August and September, Peptonic Medical’s technical documentation was reviewed by DQS-MED. It has now been approved and future VagiVital® batches be marked with DQS-MED’s CE marking number (0297).
The change of Notified Body has not affected the availability of VagiVital® in the market. This, as already manufactured and released products with CE marking from the Lloyds Register have been sold without restriction on the market.
– It is fantastic that we have managed to transfer our CE mark from Lloyds to DQS-MED so quickly. This is in light of the fact that there is a huge lack of capacity for accredited companies that have the right to issue CE marks, says Johan Inborr, CEO of 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 10th October 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.