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Est. tid*
2026-02-19 08:00 Bokslutskommuniké 2025
2025-10-31 08:00 Kvartalsrapport 2025-Q3
2025-08-14 08:00 Kvartalsrapport 2025-Q2
2025-05-16 N/A X-dag ordinarie utdelning IMP A 0.00 SEK
2025-05-15 N/A Årsstämma
2025-05-09 08:00 Kvartalsrapport 2025-Q1
2025-02-14 - Bokslutskommuniké 2024
2024-11-15 - Kvartalsrapport 2024-Q3
2024-08-21 - Kvartalsrapport 2024-Q2
2024-05-23 - X-dag ordinarie utdelning IMP A 0.00 SEK
2024-05-22 - Årsstämma
2024-05-15 - Kvartalsrapport 2024-Q1
2024-02-16 - Bokslutskommuniké 2023
2023-11-22 - Kvartalsrapport 2023-Q3
2023-08-24 - Kvartalsrapport 2023-Q2
2023-05-26 - X-dag ordinarie utdelning IMP A 0.00 SEK
2023-05-25 - Årsstämma
2023-05-12 - Kvartalsrapport 2023-Q1
2023-02-17 - Bokslutskommuniké 2022
2022-11-15 - Kvartalsrapport 2022-Q3
2022-08-23 - Kvartalsrapport 2022-Q2
2022-05-11 - X-dag ordinarie utdelning IMP A 0.00 SEK
2022-05-11 - Kvartalsrapport 2022-Q1
2022-05-10 - Årsstämma
2022-02-18 - Bokslutskommuniké 2021
2021-11-24 - Kvartalsrapport 2021-Q3
2021-09-17 - Extra Bolagsstämma 2021
2021-08-24 - Kvartalsrapport 2021-Q2
2021-05-12 - Kvartalsrapport 2021-Q1
2021-04-19 - X-dag ordinarie utdelning IMP A 0.00 SEK
2021-04-16 - Årsstämma
2021-02-25 - Bokslutskommuniké 2020
2020-11-18 - Kvartalsrapport 2020-Q3

Beskrivning

LandLiechtenstein
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
Implantica är verksamt inom medicinteknik. Bolaget är specialiserat inom utveckling av medicintekniska produkter. Produktportföljen är bred och inkluderar implanterbara medicinska instrument, som vidare används för behandling av sjukdomar som berör matstrupen. Utöver huvudverksamheten erbjuds även service och tillhörande kringtjänster, särskilt inriktat mot eHälsa. Verksamheten drivs globalt med störst närvaro inom Nordamerika samt Europa.
2025-02-12 08:30:00

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, is pleased to announce that the FDA has accepted Module 1 of the company's premarket approval (PMA) application, and that this module is now considered closed.

Module 1 contained the quality systems and manufacturing information for RefluxStop™, including the production and packaging information. FDA's review has been completed in full and the quality systems/manufacturing module is now considered closed by FDA. Prior to formal PMA approval of RefluxStop™, FDA will perform a pre-approval inspection of the production sites to ensure the RefluxStop™ manufacturing facilities, methods, and controls are in compliance with the applicable requirements of the Quality System regulation (21 CFR part 820).

Implantica's founder, CEO, and inventor of RefluxStop, Dr. Peter Forsell says, "We are grateful to FDA for their substantive review and acceptance of our Module 1 submission. We look forward to receiving FDA's feedback on Module 2, which is expected in the very near-term and is - from our perspective - the absolutely key module that includes the remarkable 5-year Clinical study outcomes of RefluxStop™."

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

The information was sent for publication, through the agency of the contact person set out above, on February 12, 2025, at 08:30 a.m. (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 energizing 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.

About RefluxStop™
RefluxStop™ is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It's unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GORD involve encircling the food passageway to support the lower oesophageal sphincter's closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit.

In contrast, the RefluxStop™ device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower oesophageal sphincter in its original, natural position.

The RefluxStop™ mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux.

Newsroom
https://www.implantica.com/media/media-kit

Community
https://ch.linkedin.com/company/implantica
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Media Contact:
Implantica AG
Juanita Eberhart, VP Marketing & Advocacy
M: +1 925-381-4581
juanita.eberhart@implantica.com