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Implantica submits FDA PMA application Clinical Module 2 for RefluxStop™ for U.S. market approval

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces the submission of the second clinical module of the Premarket Approval (PMA) application to the US FDA for RefluxStop™ along with responses to the FDA’s findings from the first module.The second module submitted earlier this week for the RefluxStop™ PMA is the most crucial module of the three-module process for FDA approval. The outcome of our clinical study

Implantica presents the third quarter 2024 on November 15 at 15:00 CEST

Implantica AG (publ) invites investors to a presentation of the third quarter 2024 at 15:00 CET on November 15. The interim report for the third quarter will be published at 8:00 a.m. CET on the same day.The presentation will be in English via an audiocast with teleconference: If you wish to participate via webcast, please use the following link: · https://ir.financialhearings.com/implantica-q3-report-2024 If you wish to participate via teleconference, please register on the link below. After registration, you will be provided the phone number and a conference ID to access the

Implantica announces highly successful 2024 American Foregut Society meeting where RefluxStop® received remarkable pre-launch market feedback

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, is pleased to report an impressive level of support from a large number of U.S. doctors who are interested to start with RefluxStop®* after launch, pending FDA approval, driven by the very solid clinical results from the 5-year CE-study and real world outcomes from multiple centers that mirror these excellent results.Over 600 of the world’s top anti-reflux surgeons, gastroenterologists, and other experts met to discuss treatment innovations in foregut diseases at the American Foregut

Implantica welcomes 23 top anti-reflux surgeons from 17 leading centers in the first User meeting in Spain, 1.5 years post country launch

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces that the first Spanish User meeting took place over two days in Alcalá de Henares, with surgeons gathering for peer-to-peer learning, training and to exchange experience on the standardized RefluxStop™ surgical technique, 1.5 years after the first RefluxStop™ procedure took place in Spain.Dr. Juan Carlos Ruis de Adana at Hospital Universitario de Getafe says, “For any new and revolutionary treatment, such as the RefluxStop procedure, it is crucial for a surgeon to commit to

Implantica shares a landmark review article on standard of care Nissen Fundoplication anti-reflux surgery – in light of the recently announced excellent RefluxStop[TM] 5-year results

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, reports on the results of the recently published landmark study in the European Surgery Journal , “Looking back on a gold standard: a systematic literature review of laparoscopic Nissen fundoplication as an anti-reflux treatment option”.This study, conducted at Karolinska Institutet (Sweden), a literature

Implantica announces finalization of remarkable 5-year pivotal CE mark study results and gears up for the Module 2 submission of PMA application to FDA for RefluxStop™

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, announces finalization of the 5-year CE mark study results as part of the upcoming Module 2 submission (of 3 modules) of the RefluxStop™ premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA).Implantica has prepared responses to FDA’s feedback from Module 1 to be submitted together with Module 2 of the RefluxStop™ PMA application. Module 2 is

Implantica conducts first national RefluxStop™ User meeting with 21 participating surgeons, 1.5 years after launch in Italy

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, had the pleasure to host a regional full day User meeting with 21 surgeons attending last week in Milan to exchange experience and train on the standardized surgical technique, just 1.5 years after the first RefluxStop procedure took place in Italy.As part of the RefluxStop™ continued education and development program, Implantica is now hosting regional User group meetings for peer-to-peer exchange of unique experiences and learnings among top RefluxStop™ surgeons. As the adoption of

Implantica announces excellent data from an independent study of 158 RefluxStop™ patients from two centers in Germany – presented at the AUGIS meeting in UK

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, reports that the study “Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis,” shows over 90% improvement in GERD quality-of-life scores in patients 2 years after the procedure.The study was recently presented at the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS) 2024 Conference. AUGIS promotes high-quality training programs, such as this Scientific

Implantica mourns the death of board member Prof. Dr. Klaus Neftel

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces with regret that Prof. Dr. Klaus Neftel, a member of the Implantica Board of Directors, has passed away.Prof. Dr. Neftel was appointed as a director of the Implantica Group in January 2018. He was the former Chief of Internal Medicine at the Ziegler Hospital in Bern as well as a Professor at the University of Bern. He was also the Editor of the Swiss Medical Forum and previously developed and lead an internet portal for a nationwide CME (Continued Medical Education) program.

Implantica publishes Interim Report January – June 2024 (Q2)

RefluxStop™ is on a wave of success – carried by a multitude of published studies with excellent outcomes from leading European Reflux-centersSignificant events in the second quarter of 2024 · Module 1 review of Premarket Approval (PMA) application for RefluxStop™ completed by US FDA · Findings presented, all of which Implantica considers to be minor · Decided to submit response to Module 1 together with Module 2 submission · NHS Trust University Hospital Southampton started performing the RefluxStop™ procedure · NICE IPAC evaluation process assessing reimbursement of

Implantica announces RefluxStop™ pivotal 4-year study results published in the prestigious journal Surgical Endoscopy

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces excellent long-term safety and clinical 4-year outcomes with the RefluxStop device (in the prospective multi-center CE study), which have recently been published in the prestigious journal, Surgical Endoscopy, an official journal of SAGES (American Gastrointestinal and Endoscopic Surgeons) and EAES (European Association For Endoscopic Surgery), entitled “Treating acid reflux without compressing the food passageway”.Results from the study confirm that 4-year outcomes mirror

Implantica announces another landmark real-world RefluxStop™ study demonstrating excellent outcomes published in a prestigious top-tier journal

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces another key milestone with an independent study demonstrating robust safety and significant improvement in GERD symptoms after the RefluxStop™ procedure published in Swiss Medical Weekly , a prestigious top-tier journal.The leading GERD researchers at Hirslanden Klinik Beau-Site Hospital in Bern, Switzerland, conducted an independent study of the first 40 RefluxStop™ procedures performed by Dr. med. Joerg Zehetner (Prof.

Implantica presents the second quarter 2024 on August 21 at 15:00 CEST

Implantica AG (publ) invites investors to a presentation of the second quarter 2024 at 15:00 CEST on August 21. The interim report for the second quarter will be published at 8:00 a.m. CEST on the same day.The presentation will be in English via an audiocast with teleconference: If you wish to participate via webcast, please use the following link: · https://ir.financialhearings.com/implantica-q2-report-2024 If you wish to participate via teleconference, please register on the link below. After registration, you will be provided the phone number and a conference ID to access the

Implantica announces excellent RefluxStop™ investigator initiated study results published in Scientific Reports, a Nature journal

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces the independent study “Multicentric short term and safety study of ineffective esophageal motility (IEM) patients treated with RefluxStop device” was recently published in Nature Scientific Reports.This investigator-initiated independent multicenter study was conducted at the General Hospital of the Medical University of Vienna, Austria, and King Edward VII Hospital in London, UK, from 2021 through 2023. All 40 patients had Ineffective Esophageal Motility (IEM)

Implantica announces continuing progress in modular PMA application to FDA for RefluxStop™

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, announces that the Module 1 review of the company's FDA premarket approval application (PMA) submission is progressing as expected.Upon completion of its review of Module 1, the first of three modules to be submitted in our PMA, FDA provided Implantica a list of deficiencies, all of which the company considers to be minor. No major issues have been identified by FDA thus

Implantica launches RefluxStop™ advanced education program in Spain

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, brings together top anti-reflux surgeons in Spain to create a community of excellence to share RefluxStop™ data, insights, and the best practices, driving advancements in the surgical treatment field of gastroesophageal reflux disease (GERD).During June and July 2024, more than 15 anti-reflux surgeons and gastroenterologists from seven leading reflux hospitals across Spain participated in RefluxStop™ advanced education events covering the latest clinical outcomes data, surgical

Implantica announces new health-economics data publication showing RefluxStop™’s superior cost-effectiveness for the Swiss healthcare system

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, reports the study, “Analysis of Cost-Effectiveness in Switzerland for a New Implantable Device to Treat Chronic Gastroesophageal Reflux Disease,” was published recently by the Journal of Medical Economics %20is,MSA%5D)%20in%20selected%20cases)1.The comprehensive health economic analysis published in this study found that RefluxStop™ is highly likely to be a cost-effective treatment for GERD

Implantica announces further expansion of RefluxStop™ access in the UK NHS public Hospital Network

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces that another NHS Trust hospital, the University Hospital Southampton, a leading public teaching hospital in the south of England, is now performing the RefluxStop™ procedure.General and Clinical Lead for Upper Gastrointestinal Surgery, Consultant Surgeon Mr. Fergus Noble, undertook the RefluxStop™ procedure to treat severe GORD in a 30-year-old female with a hiatus hernia and oesophagitis.  He says: “The patient is doing well following surgery; she recovered quickly and

Bulletin from the Annual General Meeting of Implantica AG

Today, May 22, 2024, the annual general meeting (the “AGM”) of Implantica AG (publ) was held in Ruggel, Liechtenstein. The general meeting resolved to adopt all of the board of directors’ resolution proposals. A summary of the resolutions adopted at the general meeting is set out below.The general meeting adopted the annual report 2023 consisting of the statutory financial statements and the consolidated financial statements of Implantica AG for the financial year 2023, acknowledging the reports of the auditors. The general meeting resolved to carry forward the net loss for the financial

Implantica publishes Interim Report January – March 2024 (Q1)

RefluxStop™ on path to become standard of care for acid reflux treatmentSignificant 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

Implantica announces the eighth RefluxStop™ center of excellence in Italy

Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, welcomes a new hospital performing the RefluxStop™ procedure in Italy, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone.In late March 2024, Prof. Antonio Agrusa, supported by Prof. Sebastiano Bonventre and Prof. Giorgio Romano, performed four RefluxStop™ procedures at the Azienda Ospedaliera Universitaria Policlinico “Paolo Giaccone” in Palermo, Sicily. All four patients have recovered from surgery and are experiencing relief from the relentless symptoms of chronic GERD

Implantica presents the first quarter 2024 on May 15 at 15:00 CEST

Implantica AG (publ) invites investors to a presentation of the first quarter 2024 at 15:00 CEST on May 15. The interim report for the first quarter will be published at 8:00 a.m. CEST on the same day.The presentation will be in English via an audiocast with teleconference: If you wish to participate via webcast, please use the following link: · https://ir.financialhearings.com/implantica-q1-report-2024 If you wish to participate via teleconference, please register on the link below. After registration, you will be provided the phone number and a conference ID to access the

Implantica’s RefluxStop™ is now available in seven hospitals in Spain adding two new centers of excellence

Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, announces that Dra. Beatriz Guil of Universitario de Canarias in the Canary Islands and Dr. Carlos Milliani of Universitario de Fuenlabrada in the Madrid Region are offering their patients the RefluxStop™ procedure.More patients in Spain will have access to the innovative RefluxStop™ procedure now, given that a total of seven anti-reflux centers of excellence in the country regularly perform the procedure. “It’s a new day we’ve long awaited in the world of surgical GERD treatment,”

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