RefluxStop® US Launch Coming Closer, pending FDA approval
Significant events in the fourth quarter
- FDA completed six pre-approval inspections during the quarter - including manufacturing sites, Quality System and BIMO inspections (clinical trial) - all successfully concluded without major findings, as reported in the closing meetings, marking a significant milestone in the PMA review process.
- FDA reviewed and provided feedback on our questions related to FDA's feedback on all three modules of our PMA in the 100-day meeting, and as per Implantica's review, the final steps to FDA approval looks promising.
- First RefluxStop® procedure successfully performed at Careggi University Hospital in Florence, marking strategic expansion into a leading Italian center of excellence.
- More than 30 scientific articles published on RefluxStop® by year-end 2025, including five new papers in Q4, strengthening clinical and economic evidence, accelerating global acceptance, and supporting future reimbursement opportunities.
Significant events after the end of the period
- Secured over €1.2 million in new multi-year public tender approvals in Italy, strengthening RefluxStop®'s position within the national healthcare system and advancing the pathway toward broader adoption and permanent reimbursement in Europe.
- Added Klinikum St. Georg in Leipzig as a new RefluxStop® center of excellence in Germany, strengthening our strategic footprint and supporting our reimbursement strategy through the planned INEK DRG adjustment process. The RefluxStop® procedure already has its own code in the DRG system in Germany but requires >200 operations from so-called INEK hospitals, which are a small number of hospitals that report all costs related to the procedure, necessary to define the reimbursement.
Fourth quarter financial summary
- Net sales increased 20% to TEUR 530 (442).
- Adjusted gross margin amounted to 92% (90%).
- Operating loss (EBIT) increased to TEUR 7,393 (7,174), including an impairment expense relating to capitalized R&D of TEUR 1,259.
- Loss after tax amounted to TEUR 7,188 (7,339).
- Basic and diluted loss per Class A share amounted to EUR 0.10 (0.10).
- Cash and short-term investments as at the end of the period of MEUR 48.9 (64.6).
Full year financial summary
- Net sales increased 7% to TEUR 2,073 (1,936).
- Adjusted gross margin amounted to 93% (92%).
- Operating loss (EBIT) decreased to TEUR 20,523 (25,466).
- Loss after tax amounted to TEUR 19,815 (23,686).
- Basic and diluted loss per Class A share amounted to EUR 0.28 (0.34).
Telephone conference
Implantica will hold a teleconference on 25 February 2026 at 15:00 (CET) with Peter Forsell (CEO), Andreas Öhrnberg (CFO), and Nicole Pehrsson (Chief Corporate Affairs Officer). Please see the dial-in details below to join the conference:
Webcast:
https://implantica.events.inderes.com/q4-report-2025
Dial-in:
numbers to the teleconference will be received by registering on the link below. After the registration, you will be provided phone numbers and a conference ID to access the conference
https://events.inderes.com/implantica/q4-report-2025/dial-in
For further information, please contact:
Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): +41 (0)43 505 20 57
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
This information is 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 persons set out above, at 2026-02-25 08:00 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 energising 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.
