(Información remitida por la empresa firmante)
VADUZ, Liechtenstein, Nov. 22, 2023 /PRNewswire/ — RefluxStop™ – Beginning of a New Era of Acid Reflux Treatment
Significant events in the third quarter of 2023
A big milestone was achieved in the U.K. with our first NHS RefluxStop™ implants performed at St. Mary’s Hospital, London, part of the Imperial Healthcare NHS Trust, recognized as one of the most rigorous single payer healthcare systems in the world.
The Interventional Procedures Advisory Committee (IPAC) has now started its review of the safety and efficacy of RefluxStop™. IPAC is part of the U.K.’s National Institute for Health and Care Excellence (NICE), which advises the U.K.’s healthcare body NHS on new health technologies. The IPAC review process is a key step for NHS hospitals to adopt our technology with strong international influence.
A major peer-reviewed article, ‘Laparoscopic Large Hiatal Hernia Repair with RefluxStop: Outcomes of 6 Months Follow-up in 30 Patients’ was accepted in the reputed journal, Journal Surgical Laparoscopy Endoscopy & Percutaneous Techniques (SLEPT), emphasizing the benefit of RefluxStop™ in large hernia patients, a market representing a large unmet need.
RefluxStop™ made a substantial impact at this year’s American Foregut Society (AFS) congress in Dallas, Texas, supporting our U.S. pre-launch market development. One highlight included a surgical panel discussion on RefluxStop™ attended by more than 100 congress participants.
Significant events after the end of the period
The pre-launch of RefluxStop™ in the U.S. is starting with training in Europe by our KOLs for surgeons from more than 10 key U.S. centers. The surgeons will take part in a Cadaver training and Usability study in the U.S. during targeted February 2024, the data of which will be used in our PMA (pre-market approval) application, as requested by FDA (Food & Drug Administration) in the U.S.
The 2nd Annual RefluxStop™ Users Meeting was conducted with more than 50 participants including current and potential RefluxStop™ surgeons and gastrointestinal doctors from the U.S., Canada, UK and across Europe. Top surgeons from around the world gathered for dialogue and learning on the RefluxStop™ procedure.
RefluxStop™ has been successfully operated in 600 patients in Europe.
RefluxStop™ superior cost-effectiveness research has received top recognition at ISPOR, the world’s leading European health-economics conference. Economic analyses for four additional countries have found RefluxStop™ to be more cost-effective than the competition, fundoplication, magnetic sphincter augmentation and PPI-based medical therapy.
The Annual European Foregut Society (EFS) congress included the symposium, ‘Reconstruction of the Anti-Reflux Barrier (ARB) with RefluxStop™- an innovative approach.’ This very successful symposium made a large impact and was moderated by Univ.-Prof. Dr. Schoppmann from AKH Vienna, who was joined by seven other leading GERD surgeons and gastro-intestinal experts from Germany, the U.K., Switzerland, the U.S. and Italy.
Financial summary third quarter 2023
Net sales increased 25% to TEUR 244 (195).
Adjusted gross margin amounted to 94% (94%).
Operating loss (EBIT) increased to TEUR 5,752 (4,581).
Loss after tax amounted to TEUR 5,699 (5,868).
Basic and diluted loss per Class A share amounted to EUR 0.08 (0.08).
Cash and short-term investments as at the end of the period amounted to MEUR 93.8.
First nine months
Net sales increased 50% to TEUR 900 (600).
Adjusted gross margin amounted to 94% (96%).
Operating loss (EBIT) increased to TEUR 14,898 (13,339).
Loss after tax amounted to TEUR 15,768 (16,614).
Basic and diluted loss per Class A share amounted to EUR 0.22 (0.23).
Telephone conference
Implantica will hold a teleconference on 22 November 2023 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://ir.financialhearings.com/implantica-q3-2023
Dial–in
Dial–in numbers to the teleconference will be received by registering on the link below. After registration, you will be provided phone numbers and a conference ID to access the conference https://conference.financialhearings.com/teleconference/?id=5001151
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 person set out above, at 2023-11-22 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.
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