Implantica AG Submits Final Module for FDA Approval of RefluxStop

June 24, 2025 — Implantica AG, a Swiss-based medical technology company specializing in medical implants and instruments, has made significant progress in its efforts to gain market approval in the United States for its innovative device, RefluxStop. The company, primarily listed on the Swedish Stock Exchange, announced the submission of the final module (Module 3) of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA).

Key Developments:

  • Submission of Module 3: Implantica AG has submitted the third and final module of the PMA application for RefluxStop, along with responses to the findings from Module 2. This submission marks a crucial step in the FDA’s approval process for the device, which is designed to treat acid reflux—a condition affecting approximately 1 billion people worldwide.

  • Positive Outlook: The company expressed confidence in the robustness and persuasiveness of the data submitted, particularly in response to Module 2. Implantica anticipates that the FDA’s feedback on Module 3, which includes product testing such as bench tests and biocompatibility assessments, will be received by autumn.

  • Market Potential: RefluxStop represents a significant advancement in the treatment of acid reflux, offering a unique solution in a field with a vast patient base. The successful approval of this device could position Implantica AG as a leader in the medical technology sector, particularly in the treatment of gastrointestinal disorders.

Financial Context:

  • Stock Performance: As of June 22, 2025, Implantica AG’s stock closed at 41.6 SEK. The company’s market capitalization stands at approximately 2.36 billion SEK. Over the past year, the stock has experienced fluctuations, reaching a 52-week high of 51.7 SEK on August 25, 2024, and a low of 22 SEK on April 6, 2025.

  • Investor Sentiment: The recent developments regarding the FDA approval process are likely to influence investor sentiment positively, given the potential market impact of RefluxStop’s approval.

Conclusion:

Implantica AG’s submission of the final module for FDA approval is a pivotal moment for the company, with the potential to significantly enhance its market presence and financial performance. Stakeholders and investors will be closely monitoring the FDA’s response, which is expected in the coming months.