Implantica receives FDA approval for RefluxStop® - Opening the U.S. market

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announced today that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for RefluxStop®, the company's implant-based treatment for gastroesophageal reflux disease (GERD). The approval allows Implantica to begin commercial launch activities in the United States, the world's largest medical device market.

FDA approval represents a transformational milestone for Implantica and follows the FDA's full review of the RefluxStop® PMA application, including the long-term clinical evidence supporting the 5-year safety and effectiveness of the therapy. RefluxStop® is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, without encircling or applying pressure on the food passageway.

Dr. Peter Forsell, CEO and founder of Implantica, says, "FDA approval of RefluxStop® is a defining landmark for Implantica and the culmination of many years of clinical development, scientific work, and rigorous regulatory review. Most importantly, it means that we can now bring RefluxStop® to the United States, where an estimated 78 million people suffer from acid reflux 1. We enter the U.S. market from a position of strength, with a substantially more mature clinical and commercial foundation than is typical for a newly approved medical device. RefluxStop® already has several years of commercial experience in Europe, close to 1,800 patients treated, more than 60 Centers of Excellence across nine European countries and published five-year clinical outcomes. Combined with our longstanding scientific engagement with many leading U.S. surgeons and experts, we believe this provides a strong foundation to launch and scale RefluxStop® in the U.S. market.

FDA approval changes our focus from preparation to execution. As the world's largest medtech market, the United States represents a substantial commercial growth opportunity for Implantica, and we are very excited to begin the U.S. launch of RefluxStop®. The initial rollout will be targeted, focusing on selected leading U.S. centers and reflux surgeons. Commercial adoption is expected to build gradually, reflecting the physician training and site activation required to establish RefluxStop® at each center. Our focus will be on disciplined execution, high-quality surgeon training, and building a solid commercial foundation for sustainable long-term growth."

El-Serag, H.B., et al., Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut, 2014. 63 (6): p. 871-80.

For further information, please contact : Nicole Pehrsson, Chief Corporate Affairs Officer Telephone (CH): +41 (0)43 505 20 57 [email protected]

Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, [email protected] This information constitutes insider information that Implantica AG 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, on August 20, 2026, at 23:05 CEST.

About Implantica Implantica is a medtech company focused on bringing advanced implantable technologies into the body designed to improve patient outcomes and quality of life. The company's lead product, RefluxStop®, is an FDA approved and CE-marked implant for the treatment of gastroesophageal reflux disease (GERD) with the potential to transform the standard of care in anti-reflux surgery, supported by strong long-term clinical outcomes. In addition to RefluxStop ®, Implantica has developed a broad, patent-protected product pipeline partly incorporating two platform technologies: an eHealth platform designed to enable communication with and remote monitoring and control of implants ...