Implantica finishes new multi-cavity production tool for RefluxStop® to support manufacturing ramp-up in the U.S. pending FDA approval

VADUZ, Liechtenstein, Aug. 13, 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 completion and initial validation of a new RefluxStop® U.S. production tool as Implantica prepares for quickly increasing demand from the U.S. and markets worldwide, pending FDA approval.

To ensure patients and surgeons across the globe will be able to access RefluxStop® quickly in the future, Implantica has developed and successfully completed initial testing on two new multi-cavity production tools for manufacturing of larger quantities of the RefluxStop® device. One tool will help support manufacturing ramp-up in Europe and one tool will be used to setup a new manufacturing site in the U.S.

This crucial milestone comes after years of careful planning and rigorous development, representing Implantica's deepening roots in the United States and commitment to serving future customers across the U.S. and the rest of the world. 

Dr. Peter Forsell, founder and CEO of Implantica, says, "After 1.5 years of production tool finalization for the U.S. market, final testing of the new tool in the U.S. is set to begin in the near-term. As we get closer to FDA approval of RefluxStop®, planning to manufacture the device domestically is a critical strategic step for Implantica. It will save shipping costs and eventual custom fees and streamline processes to allow for faster access to the therapy as demand quickly grows. These strategic preparations are key to supporting rapid adoption and scaling business in one of the world's largest healthcare markets, driving long-term value for our shareholders."

For further information, please contact:
Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): +41 (0)79 335 09 49
nicole.pehrsson@implantica.com 

Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. 
The company's Certified Adviser is FNCA Sweden AB, info@fnca.se

The information was sent for publication, through the agency of the contact person set out above, on August 13, 2025, at 08:00 a.m. (CET).

About Implantica

Implantica is a MedTech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop®, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit www.implantica.com for further information.

About RefluxStop® 

RefluxStop® is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It's unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GERD involve encircling the food passageway to support the lower esophageal sphincter's closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit. 
In contrast, the RefluxStop® device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower esophageal sphincter in its original, natural position. 
The RefluxStop® mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux.

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Media Contact:
Implantica AG
Juanita Eberhart, VP Marketing & Advocacy
M: +1 925-381-4581
juanita.eberhart@implantica.com 

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