Implantica Successfully Completes MDSAP Recertification Audit

VADUZ, Liechtenstein, Oct. 6, 2025 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the innovative RefluxStop device for the treatment of acid reflux, a treatment field with over 1 billion sufferers, announces the successful completion of its Medical Device Single Audit Program (MDSAP) recertification audit, renewing certifications for Europe, the United States, Canada and Brazil.

The audit was conducted last week by Implantica's notified body, BSI, reaffirming the company's commitment to maintaining the highest international standards in quality management and regulatory compliance. The MDSAP enables a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple jurisdictions, streamlining global compliance efforts.

Applications for Canada and Brazil are planned for submission in 2026, following completion of the U.S. Food and Drug Administration (FDA) inspections at Implantica's Malta site and its manufacturing facilities.

Additionally, Implantica has received confirmation from the FDA that the upcoming inspections will proceed as scheduled, despite the ongoing U.S. government shutdown. However, the 100-Day Meeting has been rescheduled by the FDA and moved forward one week to Friday, October 10^th, to ensure full attendance of all review personnel.

Dr. Peter Forsell, CEO and founder of Implantica, says, "Successfully completing the MDSAP recertification audit once again demonstrates Implantica's unwavering dedication to patient safety, product quality and regulatory excellence. As we continue to expand our global presence, maintaining world-class standards across every market is fundamental to bringing our breakthrough implantable technologies to patients in need."

This successful audit marks another important milestone for Implantica as the company continues to advance its mission of transforming the treatment of chronic health conditions through innovative smart medical implants.

For further information, please contact:
Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): [phone]
[e-mail]

Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm.

The company's Certified Adviser is FNCA Sweden AB, [e-mail]