VADUZ, Liechtenstein, May 15, 2024 /PRNewswire/ --
RefluxStop on path to become standard of care for acid reflux treatment
Significant events in the first quarter of 2024
- Submitted Premarket Approval (PMA) application for RefluxStop to U.S. FDA
- First of three modules submitted
- Next two modules to be submitted in estimated 2 three-month intervals
- One time costs of EUR 2.5 million attributed to the FDA process including the Usability study during Q1
- Completed Human Factors Validation Study with 16 U.S. surgeons as part of the FDA PMA process
- 20 U.S. foregut surgeons trained on the RefluxStop procedure in preparation for the Usability Study, a very successful U.S. pre-launch activity
- First-ever public tender win for RefluxStop in Italy achieved by Ospedale di Moncalieri Turin
- 3-year public tender, funded to full list price by the public healthcare system
- Second public hospital purchase agreement win in Italy at IRCCS Saverio De Bellis in Bari, Italy to buy the RefluxStop devices to full price
- Norway opened as a new country performing RefluxStop. First five surgeries successfully performed at Akershus University Hospital in Oslo
Significant events after the end of the period
- First in the country public tender win in Spain for RefluxStop at Hospital Universitario de Getafe, a public hospital in Madrid
- Landmark, >25 hospitals in our target markets in Europe successfully operating with RefluxStop
- Six scientific presentations and abstracts presented at the 2024 SAGES annual scientific meeting in Cleveland, Ohio
- Two peer-reviewed scientific papers published on real-world RefluxStop results by Dr. Joerg Zehetner on large hiatal hernia patients and those with ineffective esophageal motility
Financial summary first quarter 2024
- Net sales increased 94% to TEUR 596 (307).
- Adjusted gross margin amounted to 92% (95%).
- Operating loss (EBIT) increased to TEUR 7,087 (4,870).
- Loss after tax amounted to TEUR 3,472 (4,758).
- Basic and diluted loss per Class A share amounted to EUR 0.05 (0.07).
- Cash as at the end of the period amounted to MEUR 80.1.
Telephone conference
Implantica will hold a teleconference on 15 May 2024 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
https://ir.financialhearings.com/implantica-q1-report-2024
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.financialhearings.com/teleconference/?id=50049901
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 2024-05-15 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
https://news.cision.com/implantica/r/implantica-publishes-interim-report-january---march-2024--q1-,c3981611
The following files are available for download:
https://mb.cision.com/Main/19732/3981611/2797509.pdf | Implantica Q1 2024_ENG |
https://mb.cision.com/Public/19732/3981611/b3f7a6a5ae3390b9.pdf | Implantica publishes Interim Report Jan - Mar 2024 Q1 |
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