FDA Approval of RefluxStop® – Strategic Preparation Sets the Stage for Success
Significant events in the second quarter of 2026
- RefluxStop® sales increased by more than 60% compared with the prior-year period, reflecting continued commercial growth across key European markets
- Largest independent RefluxStop® study to date published in Nature’s Scientific Reports, reporting mid- to long-term safety outcomes in 602 patients across 22 centers in six European countries, with serious safety events and reoperations below 2%
- Clinical, health-economic and reimbursement evidence further strengthened, including new Italian cost-effectiveness data and the addition of a seventh InEK-reporting hospital in Germany supporting the reimbursement pathway
Significant events after the end of the period
- FDA PMA approval secured for RefluxStop®, opening the U.S. market and enabling the start of U.S. commercial launch activities
- U.S. market entry underway, with expansion of the U.S. organization and establishment of logistics and distribution infrastructure
- European market presence continued to expand, including the 20th Center of Excellence in Spain at MD Anderson Madrid and new Centers in Switzerland and the UK, bringing the European network to more than 60 Centers of Excellence
Financial summary second quarter
- Net sales increased by 66% to TEUR 717 (433).
- Adjusted gross margin amounted to 94% (90%).
- Operating loss (EBIT) decreased to TEUR 4,200 (4,525).
- Loss after tax amounted to TEUR 3,987 (5,448).
- Basic and diluted loss per Class A share amounted to EUR 0.06 (0.08).
- Cash and cash equivalents as at the end of the period of MEUR 41.7.
Financial summary first six months
- Net sales increased 34% to TEUR 1,574 (1,178).
- Adjusted gross margin amounted to 94% (94%).
- Operating loss (EBIT) decreased to TEUR 8,058 (8,698).
- Loss after tax amounted to TEUR 8,267 (8,212).
- Basic and diluted loss per Class A share amounted to EUR 0.12 (0.12).
Telephone conference
Implantica will hold a teleconference on 21 August 2026 at 15:00 (CEST) 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
If you wish to participate via webcast, please use the following link:
https://implantica.events.inderes.com/q2-report-2026
Dial-in
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/q2-report-2026/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 person set out above, at 2026-08-21 08:00 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 inside the body, and a wireless energizing platform designed to wirelessly power implantable devices through intact skin. These investigational devices are intended to facilitate remote changes to treatment, potentially saving cost for society.
Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit www.implantica.com for further information.