VADUZ, Liechtenstein, Aug. 14, 2025 /PRNewswire/ --
Transforming Clinical Excellence of RefluxStop® into Strategic Market Momentum
Significant events in the second quarter of 2025
- FDA PMA Submission Completed - Submitted third and final module of the U.S. FDA pre-market approval (PMA) application for RefluxStop®, including responses to questions on the second module; Feedback on module 3 expected in the near-term
- Produced and completed initial testing on new multi-cavity production tool for RefluxStop® to support launch of manufacturing in U.S. and manage ramp-up of U.S. production (pending FDA approval)
- Additional preparations for U.S. market launch (pending FDA approval) included U.S. payer and reimbursement activities, finalizing new production facility of RefluxStop® in U.S. and launching our RCT (randomized clinical trial), as a heavyweight cornerstone in building global leadership in acid reflux care
- Positive NICE Guidance in the UK - UK's National Institute for Health and Care Excellence (NICE) issued positive guidance for the use of RefluxStop® in NHS hospitals for patients with ineffective esophageal motility (IOM/IEM), potentially transforming treatment access for millions and influencing global policy
Significant events after the end of the period
- Landmark 5-Year Clinical Study Results - Two peer-reviewed articles were published in Surgical Endoscopy on our pivotal study results; one publication confirmed outstanding long-term safety and effectiveness outcomes, and the second publication highlighted RefluxStop®'s excellent outcomes in food passageway-related sequelae, which is common in standard of care
- Randomized Clinical Trial (RCT) Launch - First RCT comparing RefluxStop® with Nissen fundoplication; patient recruitment underway accumulating patients across participating hospitals. While this trial preparation led to a 20% year-on-year revenue decline for Q2, the impact is expected to ease once study recruitment stabilizes
- Spanish Market Expansion - Three new hospitals added, totaling 19 centers offering RefluxStop® in Spain, with a healthcare sytem receptive for new and better patient care, which is a fantastic launch since 2023
- First UK National Users Meeting - Convened 21 top anti-reflux experts to discuss real-world results, operating technique and the opportunities arising from NICE's positive recommendation
Financial summary second quarter 2025
- Net sales decreased 22% to TEUR 433 (554) due to the launch of the randomized clinical trial with surgeons accumulating patients for the trial.
- Adjusted gross margin amounted to 90% (91%).
- Operating loss (EBIT) decreased to TEUR 4,525 (5,869).
- Loss after tax decreased to TEUR 5,448 (6,431).
- Basic and diluted loss per Class A share amounted to EUR 0.08 (0.09).
- Cash and short-term investments as at the end of the period of MEUR 56.3.
First six months
- Net sales increased 2% to TEUR 1,178 (1,150).
- Adjusted gross margin amounted to 94% (91%).
- Operating loss (EBIT) decreased to TEUR 8,698 (12,956).
- Loss after tax decreased to TEUR 8,212 (9,903).
- Basic and diluted loss per Class A share amounted to EUR 0.12 (0.14).
Telephone conference
Implantica will hold a teleconference on 14 August 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/q2-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=5009464
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 2025-08-14 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.
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
Implantica Q2 2025_ENG | |
https://mb.cision.com/Public/19732/4217816/b64ef09f6f91a4ba.pdf | Implantica publishes Interim Report Jan - Jun 2025 Q2 |
View original content:https://www.prnewswire.co.uk/news-releases/implantica-publishes-interim-report-january--june-2025-q2-302529881.html
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