Significant events in the first quarter of 2025

• Received positive feedback from U.S. FDA on our Clinical Module 2 Premarket Approval (PMA) application. FDA accepted Module 1 containing the quality systems and manufacturing information for RefluxStop™, and this module is now considered closed
• Results from the largest real-world RefluxStop™ study published, involving 79 patients for up to 17 months follow-up in Germany showing median improvement in quality of life questionnaire, GERD-HRQL of 100%
• World-leading and largest hospital in Spain, La Paz University Hospital in Madrid, performed their first RefluxStop™ surgeries
• NHS Chelsea & Westminster Hospital hosted the first Gastrointestinal experts-focused RefluxStop™ educational meeting including 11 gastroenterologists

Significant events after the end of the period

• New study published in Journal of Laparoendoscopic & Advanced Surgical Techniques by Dr. Elshafei from St. Elisabethen Hospital in Frankfurt, Germany showing all preoperative heartburn, regurgitation and swallowing difficulties were completely resolved with RefluxStop™
• An additional three new hospitals performed their first RefluxStop™ surgeries in Spain, totaling 15 centers of excellence offering the RefluxStop™ procedure in Spain within two years from launch
• RCT kick-off meeting conducted with nine key opinion leaders in attendance, led by Prof. Schoppmann, the Principal Investigator of the randomized clinical trial of RefluxStop™ vs. Nissen fundoplication

Financial summary first quarter 2025

• Net sales increased 25% to TEUR 745 (596).
• Adjusted gross margin amounted to 97% (92%).
• Operating loss (EBIT) decreased to TEUR 4,173 (7,087).
• Loss after tax decreased to TEUR 2,764 (3,472).
• Basic and diluted loss per Class A share amounted to EUR 0.04 (0.05).
• Cash and short-term investments as at the end of the period amounted to MEUR 60.3.

Telephone conference

Implantica will hold a teleconference on 9 May 2025 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/q1-report-2025

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://conference.inderes.com/teleconference/?id=5006347 

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

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 2025-05-09 08:00 CEST.

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.