Implantica AG Receives Positive Feedback from the U.S. FDA on RefluxStop® PMA Module 3

Switzerland‑based implant manufacturer Implantica AG announced that the United States Food and Drug Administration (FDA) has reviewed the final Part M (Module 3) of its pre‑market approval (PMA) submission for the RefluxStop® device and has issued encouraging feedback. The company, listed on the Swedish Stock Exchange and trading at 74 SEK per share as of 22 September 2025, described the response as “positive” and outlined its next steps.

Key Points of the FDA Review

  • Feedback Timing: The FDA completed its assessment of the final module on 24 September 2025 and communicated its findings to Implantica via a formal review packet.
  • Overall Assessment: Implantica’s management characterises the FDA’s comments as favourable and believes the outstanding issues can be addressed efficiently.
  • Upcoming Interaction: A meeting between Implantica and the FDA is scheduled for 3 October 2025 to discuss the optimal strategy for responding to the remaining questions and requests.
  • Expected Response Window: Depending on the outcome of that meeting, Implantica expects to submit its rebuttal or clarifications within a few weeks to a few months.

RefluxStop® – A Novel Solution for Acid Reflux

RefluxStop® is a minimally invasive implant designed to alleviate symptoms of gastro‑oesophageal reflux disease (GERD), a condition affecting an estimated 1 billion people worldwide. The device represents a new technology that could offer an alternative to medication and more invasive surgical procedures. Implantica’s founder, Dr. Peter Forsell, highlighted the significance of the FDA’s feedback, noting that it brings the company one step closer to a U.S. market launch.

Market and Investor Context

  • Stock Performance: The share price has fluctuated within a 52‑week range of 22 SEK to 83 SEK, with a closing price of 74 SEK on 22 September 2025.
  • Market Capitalisation: Approximately 4.3 billion SEK.
  • Strategic Implications: Successful approval of RefluxStop® would open a sizeable U.S. market for Implantica and could strengthen its position among medical‑device innovators on the Stockholm exchange.

Next Steps for Implantica

  1. October 3 Meeting – Discuss FDA’s outstanding queries and refine the response strategy.
  2. Response Submission – Provide detailed clarifications or additional data as required by the FDA.
  3. Regulatory Outcome – Await a formal decision, which will determine the timeline for U.S. commercialization.

Conclusion

The FDA’s positive review of RefluxStop®’s final PMA Module 3 marks a pivotal milestone for Implantica AG. Should the company successfully navigate the remaining regulatory requirements, it could secure a foothold in the lucrative U.S. medical‑device market, potentially driving growth for both its shareholders and the broader medtech sector.