Implantica Ag- tulevaisuudessa implanttia joka lähtöön

Osakkeet
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Implantica advances in Sweden with its medical device RefluxStop™

Implantica AG (publ) today announces that RefluxStop™ will start selling in Sweden with reimbursement by public healthcare.

Implantica will now focus on scaling up its sales force in Scandinavia as it introduces RefluxStop™ to the leading anti-reflux surgeons and centers in Sweden, which will be a second home market due to the company’s significant ties to Sweden and its large Scandinavian investor base. Surgical training will commence initially via webinar and will include representatives from Germany and Switzerland.

“We are very pleased to be able to sell RefluxStop™ on a reimbursed basis to the Swedish market,” said Peter Forsell, CEO of Implantica. “At this stage we will mainly focus on the publicly funded hospitals, and we will extend our registry study to Scandinavia in order to collect data for RefluxStop™.”

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Italiassa ja Espanjassa etenee kaupallistaminen

Implantica makes headway in Italy and Spain with its medical device RefluxStop™
Implantica AG (publ) today announces that the company will start commercializing RefluxStop™ on a reimbursed basis in Italy and Spain based on local/regional hospital agreements.

Implantica will now focus on providing RefluxStop™ to the leading anti-reflux surgeons and centers in Italy and Spain. Surgical training will commence initially via webinar with representatives from Germany and Switzerland until Covid-19 subsides.

“We look forward to continue to develop the KOL (key opinion leader) networks and train surgeons in Italy and Spain and to sell RefluxStop™ on a reimbursed basis based on individual hospital /regional agreements” said Peter Forsell, CEO of Implantica. “At this stage we will mainly focus on the larger anti-reflux centers, and we will extend our registry study also to these countries to collect data for RefluxStop™.”

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Viidenneksi suurin sairaala Euroopassa aloittaa tutkimuksen 25-30 potilaan kanssa liittyen RefluxStopiin. Toivottavasti on tulokset yhtä hyviä kuin Implantican omissa tutkimuksissa.

Implantica announces a milestone achieved for its implantable medical device RefluxStop™
Implantica AG (publ) today announces that one of the largest hospitals in Europe, University Hospital AKH Vienna, will soon commence a study of RefluxStop™ with 25-30 reflux patients, conducted under the direction of Prof. Dr. med. Sebastian Schoppmann.

“We are very pleased that one of the most prominent anti-reflux surgeons, Prof. Schoppmann, will perform the RefluxStop™ procedure, and we are looking forward to begin cooperating with one of the leading anti-reflux surgeons in Europe” said Peter Forsell, CEO of Implantica.

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Eli kuten arvata saattaa niin osakeantia pukkaa. 122kr hintaan tarjotaan uusia osakkeita ja siitä tämän päivän dippi.

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Onko @Pevitaha tai joku muu seuraillut Implanticaa tarkemmin ja löytänyt jotain uutisia viime aikoina? Kurssi tiputellut tasaisesti viime kuukausina, johtuuko uutisten puutteesta sitten :thinking: Oma seurantapositio kohta -50% miinuksella, mutta ajattelin hiljalleen alkaa henkisesti valmistautumaan tankkauksiin kunhan saataisiin jotain päivitystä missä RefluxStopin kanssa mennään. Aivan kauheasti ei tunnu keskustelua tai uutisia löytyvän ainakaan googlettelemalla. Q3 raporttia tulossa kolmen viikon päästä, onko mitään aavistusta tullaanko silloinkaan kuulemaan mitään merkittävää?

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Olen tätä seuraillut ja yrityksessa on tapahtunut vuoden aikana paljon,esim yhdstyi MediSwiss AG kanssa.

MediSwiss AG yhdistyminen laajenti Implantican patentti portfoliota15 tuotteella, joista yksi on kemoterapiaa helpottava implantti joka estää verihyytymien/tulppien muodostumisen.

Yhtiö on myös vahvistanut markkinointi tiimiä uusilla osaajilla sekä yritykseen tullut uusi jäsen Juliette Cook VP Quality & Regulatory Affairs tiimiin. “Julietten vahva kokemus sääntelystrategioiden kehittämisestä ja viranomaishyväksynnän saamisesta useissa maissa maailmanlaajuisesti on Implanticalle välttämätöntä, koska työskentelemme viranomaishyväksynnän parissa samanaikaisesti 30 maassa. Olen erittäin iloinen, että hän liittyy joukkoomme.”

RefluxStopin käyttö on laajentunut uusiin maihin ja sairaaloihin, esim Saksassa ja Briteissä, joissa kummassakin on toteutettu useampi operaatio kyseistä tuotetta käyttäen.

Koulutusta ja markkinointia on laajennettu Italiaan, Espanjaan,Ruotsiin ja Itävaltaan edellä mainittujen maiden lisäksi. Tämän lisäksi RefluxStop sai Uudessa-Seelannnissa myyntiluvan ja yritys keskustelee paikallisten jakelioiden kanssa diilistä alkaa markkinoimaan tuotetta.

FDA hakemus on jätetty viime vuoden puolella ja siitä ei ole kuulunut mitään viime aikoina.

Yrityksellä on kuitenkin jonkin verran myyntiä, mutta tietysti rahaa kuluu tässä vaiheessa olevalla yrityksellä ja rahoitusta on haalittu useampaa kautta vuoden aikana.Tuskin raportti tuo mitään uutta tietoa tähän tilanteeseen.

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Pari päivää taaksepäin Implantica sai palautetta FDA;lta ja he ovat sitä mieltä, että RefluxStop voisi ehkä saada hyväksynnän pelkästään Euroopassa tehtyjen tutkimusten datan pohjalta.

Implantica takes a big step forward in its RefluxStop™ U.S. approval process discussions with FDA
November 8, 2021, 9:59 am
STOCKHOLM, Nov. 8, 2021 /PRNewswire/ – Implantica AG (publ) today announces feedback from its third pre-submission meeting with the U.S. Food and Drug Administration (FDA) for the approval of RefluxStop™. FDA indicated its willingness to accept a Premarket Approval (PMA) submission for review based solely on the existing long-term European data for RefluxStop™, which if approved, would allow for U.S. market entry without a premarket U.S. clinical trial.

Implantica received helpful feedback from the FDA in its recent supplemental pre-submission meeting where the regulatory pathway of RefluxStop™ was discussed. Due to the favorable clinical investigation results of RefluxStop™, FDA has agreed to receive a PMA marketing application based on existing European clinical data alone. Implantica will provide the FDA with additional longer-term safety and efficacy data from its ongoing European clinical investigation at 4.5 year follow-up and thereafter file a PMA marketing application. The company looks forward to cooperating with the FDA and appreciates their support thus far.

“The situation for acid reflux sufferers is very unsatisfactory today with drug treatment potentially causing many long-term serious side effects and existing surgical methods are simply not good enough, causing complications and discomfort. The worst is that 48’000 people die annually from esophageal adenocarcinoma in the U.S. and EU alone since repetitive reflux of acid into the lower esophagus causes cancer, and most of these deaths are caused by acid reflux,” said Peter Forsell, CEO of Implantica.

We are very appreciative of the FDA’s willingness to consider our existing European clinical data for regulatory approval in the U.S. and from my standpoint, as a surgeon in this field, the biggest winner will be the patients," said Peter Forsell, CEO of Implantica."

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Eli alla tiedote uusien tuotteiden kehityksestä. Saksassa kokeiltu ja tutkittu labrassa ruumiilla, että miten uudet kehitteillä olevat tuotteet toimii. Onhan se mukava kuulla, että hommat menee eteenpäin muidenkin tuotteiden osalta eikä vain RefluxStopin.

Implantica AG (publ) announces today advances in development of its pipeline products at a cadaver lab in Germany.

Prototypes of several of the company’s pipeline products have been implanted and tested in cadavers in order to determine key data points and advance development. The products that were tested include UriControl®, AppetiteControl™ and UriRestore® as well as a new version of RefluxStop™, which is designed to treat acid reflux in those patients undergoing a gastric sleeve procedure, representing approximately 600’000 procedures annually.

“Cadaver implantations provide us with key information and are an important step in furthering the product development process. I’m pleased to say that the prototype implantations of several of our pipeline products enhanced our knowledge and provided valueable input to our approval process. We continue our multiple pipeline workstreams and look forward to continue to bring products to market that have such a large impact on millions of people’s lives,” said Peter Forsell, CEO of Implantica.

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Perjantaina kuultaisiin näemmä Q4/2021 tulokset. Kurssi otti tänään kyllä taas reilusti turpaan: käytiin hyvin lähellä ATL:a ja puolessa vuodessa arvosta haihtunut yli 60%. Tästä lafkasta on tosi vaikea löytää mitään tuoreita uutisia, vai etsinkö vääristä paikoista?

Itse siis luovuin tovi sitten seurantapositiostakin, mutta mietin milloin hyppäisin takaisin kyytiin.

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Tämä ketju on ollut hyvin hiljainen. Implantica on kuitenkin ollut hyvin kiinnostava taas viime kesästä alkaen, kun potilaiden seurannan tuloksia julkaistiin.

Nyt FDA on antanut positiivista palautetta, koskien moduuli 2:ta hakuprosessissa. Tämä on kattavin ja tärkein moduuleista. Moduuli yksihän on hyväksytty.

Implantica announces positive feedback received from U.S. FDA of the RefluxStop™ PMA Module 2 submission

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 U.S. FDA has completed its review of the PMA Module 2 submission and provided its feedback, in which the company sees no barrier for responding.

FDA has completed its review of the company’s second modular submission of its PMA, which contained the Clinical Data, Usability Testing, and Labeling information supporting RefluxStop™. FDA has provided Implantica with its written feedback on the content submitted, all of which the company considers to be minor. A response strategy has been identified for the questions raised, and the company sees no impediment to the overall PMA approval process based on FDA’s Module 2 feedback. Responses to the Module 2 feedback will be submitted in conjunction with the final Module 3 submission in the near term.

Dr. Peter Forsell, Implantica’s founder, CEO, and the inventor of RefluxStop, says, "We are thankful for FDA for their review of Module 2 and are pleased to receive their positive feedback on our submission thus far. Module 2 includes the results of the RefluxStop™ clinical study and is by far the most important module for this PMA from our perspective. The 5-year outcomes in conjunction with data reported in the literature are extremely positive and indicate that RefluxStop™ may revolutionize this treatment field. Implantica will, in the near term, submit the last component of our PMA application (Module 3) and work with FDA to bring RefluxStop™ to the U.S. market as soon as possible.”

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Implantica submits the last and final module 3 of the FDA PMA Application for RefluxStop® for US market approval
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Implantica submits the last and final module 3 of the FDA PMA Application for RefluxStop® for US 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 third and final module of the RefluxStop® pre-market approval (PMA) application with the US Food and Drug Administration (FDA), along with responses to the second module.

Implantica submitted the last and final Module 3 of the RefluxStop® PMA application together with the response to Module 2 review findings to FDA yesterday. Module 2, the clinical module, primarily addressed what we believed were minor findings. Module 3 is focused on tests of the product such as bench testing and biocompatibility testing for the RefluxStop® device.

In line with the positive feedback in the FDA PMA application process so far, the latest RefluxStop® data submitted as part of the Module 2 response, as well as in the final Module 3, is quite robust and conclusive in Implantica’s opinion. We hope the newly submitted data and responses will not only continue to meet the stringent requirements for the PMA approval process but also exceed them. The continued process relies to a large extent now on FDA, which will guide Implantica in the coming steps. FDA’s feedback on Module 3 is expected sometime in the autumn.

Inventor of RefluxStop®, Founder and CEO of Implantica, Dr. Peter Forsell, says, “I want to extend my gratitude to U.S. FDA for this thorough evaluation process of every facet of a new technology, such as RefluxStop®. Now more than ever, I believe we are on the cusp of a new generation of much needed surgical solutions for GERD with the potential to transform the standard of care for GERD patients in the U.S…”

Dr Forsell continues, “This is a significant milestone for Implantica, one we all waited for. Undoubtedly, GERD is a grave and growing issue in the U.S. today, impacting approximately 22-27% of adults in the U.S. population. With over 1300 patients treated across nearly 50 centers in Europe and excellent long-term 5-year data results from the pivotal study, I believe RefluxStop® is poised to help these hugely underserved patients in the U.S. and worldwide in the years to come!”

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Loistava uutinen! Eli syksyllä lausunnot lopullisesta tuotteesta ja sitten miljardin asiakkaan markkinalle ”asap” kuten toimari sanoo.

Onkos meillä mitään käsitystä minne asti rahat riittää? Toisin sanoen tarvitaanko uutta antia että tuote saadaan myyntiin asti? Harmittavan vaikea löytää tietoa tästä yrityksestä (tai en osaa etsiä).

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Luvut viimeisimmästä Q1 raportista.

Net sales

During the first quarter, net sales amounted to EUR 745

thousand (596), corresponding to an increase of EUR 149
thousand or 25%. Implantica is currently exclusively marketing
its lead product, RefluxStop™, to selected Key Opinion
Leaders in Europe.
Cost of sales and gross margin
Cost of sales during the first quarter amounted to
EUR 330 (356) thousand. Cost of sales considers two
categories of costs. Firstly, indirect costs of straight-line
amortisation of capitalised development costs relating to
RefluxStop™. Secondly, Other cost of sales, which relates to
direct costs for purchasing goods and services from the
Group’s outsourcing partners.
In the first quarter, adjusted gross margin1
, i.e., gross margin
excluding amortization, amounted to 97% (92%).
Operating expenses and EBIT
In the first quarter, operating loss (EBIT) amounted to EUR
4,173 thousand (7,087), a decrease of EUR 2,914 thousand or
41%.
Research and development costs made up EUR 1,576
thousand (4,327), corresponding to a decrease of EUR 2,751
thousand or 64%. The year-on-year reduction of research and
development costs is primarily explained by the substantial
FDA submission preparation costs in the comparable period.
Also, the costs for patent management and development of
pipeline products decreased compared to the first quarter of
2024.
General and administrative costs amounted to EUR 3,012
thousand (3,000), an increase of EUR 12 thousand constituting
an increase of less than 1%.
Financial income and expenses
Financial income amounted to EUR 1,445 thousand (3,637)
during the first quarter thanks to foreign exchange gains and
interest income. Financial expenses amounted to EUR 32
thousand (20) over the quarter explained by foreign exchange
losses.
Income taxes
The Group reported a tax expense of EUR 4 thousand
(2) in the first quarter. The tax expense for the quarter is
mainly explained by changes in deferred tax assets.
Net earnings
The Group reported a net loss of EUR 2,764 thousand (3,472)
for the first quarter, a decrease of EUR 708 thousand.
Equity and liabilities
As of 31 March 2025, the Group’s equity amounted to EUR
96.6 million (117.0) and the equity ratio was 97%, compared
to 96% at 31 March 2024.
As of 31 March 2025, the Group did not have any interest-
bearing debt.
Cash flow and liquidity
During the first quarter, net cash outflow from operating
activities amounted to EUR 4,525 thousand (6,465).
As of 31 March 2025, Implantica held cash and short-term
investments of EUR 60.3 million. The short-term investments
relate to six months term deposit agreements with an A+
rated Swiss bank.

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Muotoilin varmasti kysymyksen vähän huonosti. Nykyisellä kulurakenteellahan hätää ei rahoituksen suhteen ole, mutta oletan, että uuden tuotteen markkinointiin ja tuotantoonsaattamiseksi tarvitaan merkittävämpää rahoitusta kuin näiden 5000 koeasiakkaan tarpeet vaativat. Onko missään kerrottu näistä suunnitelmista ja arvioitu kuluja?

Edit: jatkan tähän vielä itse. Harjoittelen vasta tekoälyn käyttöä, enkä heti keksinyt kysyä sieltä. ChatGPT arvioi, että FDA-kulut on n. 2,5M€ / kierros ja yleisesti tällaisen tuotteen lanseeraus maksaa n. 10-20M€. En tiedä kuinka luotettavia laskemat ovat, omaan korvaan kuulostaa yllättävän pieneltä?

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Tykkään tästä vertailusta toiseen hoitotapaan ja sen mahdollisiin haittavaikutuksien vs RefluxStop. Aika merkittävästi vähemmän haittavaikutuksia esiintyy RefluxStop vs Nissen :slightly_smiling_face:

Implantica announces publication of the landmark RefluxStop® 5-year clinical study results demonstrating excellent long-term success
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Implantica announces publication of the landmark RefluxStop® 5-year clinical study results demonstrating excellent long-term success
Implantica AG (publ.), a medtech company at the forefront of treatment for acid reflux with its unique device RefluxStop®, a treatment field with 1 billion sufferers, announces the publication of RefluxStop’s extraordinary 5-year clinical data for food passageway-related outcomes in the prestigious journal, Surgical Endoscopy, an official journal of SAGES (American Gastrointestinal and Endoscopic Surgeons) and EAES (European Association For Endoscopic Surgery).

The 5-year study results, where the first published article is about food passageway sequelae, show remarkable outcomes in relation to standard of care, supporting a paradigm shift in treatment of acid reflux sufferers.

The 5 year and end of study results show:

97.9% of patients without any Adverse Event Dysphagia (difficulty swallowing)
97.9% of patients without any Adverse Event Odynophagia (painful swallowing)
95.7% of patients in the study with gas-bloating eliminated, improved or equivalent
100% of the study patients maintained the ability to belch or vomit
In addition to publication in Surgical Endoscopy, this study titled, “Food passageway-related sequelae in the RefluxStop prospective multicenter trial: Patient-centric outcomes of dysphagia, odynophagia, gas-bloating, and inability to belch and/or vomit at 5 years,” was the subject of a very successful SAGES 2025 (California, USA) oral presentation by Dr. med. Jörg Zehetner of Kinik Beau-Site Bern, Switzerland.

Implantica CEO and founder, Dr. Peter Forsell, says, “A few data points from a large recently published literature review on standard of care Nissen fundoplication1 are helpful to provide an indirect comparison and offer some perspective on how extraordinary the RefluxStop® 5-year results are. Nissen fundoplication at 5 years presented with: Dysphagia in 28.9%, gas bloating in 52.7%, and inability to belch and vomit in 39.8%. The difference in outcomes are of such magnitude that they support an edict to a paradigm shift in acid reflux treatment. Publication of this study marks the dawn of a new era in the surgical treatment of GERD, one in which patients will have an innovative surgical treatment available that can restore the natural function of their body with minimal food passageway-related sequelae.”

Dr. Forsell continues, “With a potential U.S. approval, pending FDA approval, in the near future, we are very excited about the opportunity to bring RefluxStop® to highly underserved GERD patients in the U.S. (where the disease affects 22-27% of the U.S. population) where RefluxStop’s unique non-encircling mechanism of action reduces side effects.”

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Toinen julkaisu RefluxStopin viiden vuoden seurannan tuloksista. Eihän tässä voi kuin odotella FDA hyväksynnän tuloksia, jotka toivottavasti tulee tässä lähiaikoina (autumn).

Implantica announces second publication of groundbreaking 5-year results from the landmark RefluxStop® clinical study
07.08.2025
| Non regulatory
Implantica AG (publ), a leading medtech company pioneering advanced implantable medical technologies, today announced the second peer-reviewed publication of the remarkable 5-year outcomes from its CE mark clinical study of RefluxStop®, a revolutionary device for the treatment of acid reflux—a condition affecting over 1 billion people worldwide.

The newly released publication focuses on long-term safety and effectiveness outcomes and complements the earlier 5-year report on food passageway-related outcomes. Both studies were published in the prestigious journal Surgical Endoscopy, jointly produced by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES).

The second publication, titled “Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: A prospective multicenter trial of safety and effectiveness,” provides the ultimate validation of RefluxStop®’s consistent and outstanding clinical performance. Key highlights include:

97.9% of patients were free from proton pump inhibitor (PPI) medication use at 5 years, compared to 100% of patients taking PPIs pre-RefluxStop® surgery.
No device-related adverse events reported over the entire 5-year study period.
Quality of life (GERD-HRQL scores) improved by a median of 90% (IQR), p<0.001.
Acid exposure time in lower essophagus (24h pH monitoring), the only objective acid reflux measure, improved by 90.4%, p<0.001.
Access the 5-year full publications:

Effectiveness & Safety Outcomes
Food Passageway Outcomes
Dr. med. Joerg Zehetner of Klinik Beau-Site, Bern, Switzerland, who presented the study’s findings at the SAGES Scientific Conference in California, says:

“RefluxStop® has demonstrated truly stellar results that significantly improve the quality of life for GERD patients. As a surgeon who has treated thousands of patients in Switzerland from all over the world, the safety profile is paramount to me—and this study confirms RefluxStop® as the safest and most effective surgical option for acid reflux sufferers available today. Over five years, there were no complications such as reherniations, migrations, or dislocations—confirmed via contrast-swallow imaging.”

Dr. Zehetner further noted the superior patient experience:

“It is very encouraging to see that RefluxStop has maintained its crucial anatomical position over time, resulting in excellent sustained long-term patient outcomes. Importantly, RefluxStop® uniquely restores the body’s natural anti-reflux barrier—offering unmatched long-term outcomes and safety as shown in this study. Also, postoperative swallowing difficulties were virtually eliminated—no patients required esophageal dilatation during the study, offering a major advantage compared to traditional GERD surgeries.”

Dr. Peter Forsell, founder and CEO of Implantica, added:

“These 5-year results confirm RefluxStop®’s strong potential to redefine the standard of care in GERD surgery. With nearly 50 RefluxStop® Centers of Excellence established across Europe, Implantica is rapidly growing its clinical and commercial infrastructure to support broader adoption. The company is now preparing for its U.S. market launch, pending FDA approval. As we approach the U.S. launch, we believe RefluxStop® is uniquely positioned to become the gold standard in surgical GERD treatment—offering superior patient outcomes, safety, and long-term cost-effectiveness.

With FDA approval pending, global expansion underway, and increasing clinical momentum, we are focused on unlocking significant value for patients, providers, and shareholders alike.”

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Vahva on luotto firmalla, että FDA hyväksyntä tulee, kun on kehitetty uusi tuotantolaite jolla saadaan nopeammin valmistettua RefluxStopia.

Implantica finishes new multi-cavity production tool for RefluxStop® to support manufacturing ramp-up in the U.S. pending FDA approval
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Implantica finishes new multi-cavity production tool for RefluxStop® to support manufacturing ramp-up in the U.S. pending FDA approval
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the innovative RefluxStop® device for the treatment of acid reflux, a treatment field with over 1 billion sufferers, announces completion and initial validation of a new RefluxStop® U.S. production tool as Implantica prepares for quickly increasing demand from the U.S. and markets worldwide, pending FDA approval.

To ensure patients and surgeons across the globe will be able to access RefluxStop® quickly in the future, Implantica has developed and successfully completed initial testing on two new multi-cavity production tools for manufacturing of larger quantities of the RefluxStop® device. One tool will help support manufacturing ramp-up in Europe and one tool will be used to setup a new manufacturing site in the U.S.

This crucial milestone comes after years of careful planning and rigorous development, representing Implantica’s deepening roots in the United States and commitment to serving future customers across the U.S. and the rest of the world.

Dr. Peter Forsell, founder and CEO of Implantica, says, “After 1.5 years of production tool finalization for the U.S. market, final testing of the new tool in the U.S. is set to begin in the near-term. As we get closer to FDA approval of RefluxStop®, planning to manufacture the device domestically is a critical strategic step for Implantica. It will save shipping costs and eventual custom fees and streamline processes to allow for faster access to the therapy as demand quickly grows. These strategic preparations are key to supporting rapid adoption and scaling business in one of the world’s largest healthcare markets, driving long-term value for our shareholders.”

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Implantican RefluxStop® herätti suurta innostusta American Foregut Society -kokouksessa Yhdysvalloissa ennen FDA:n odotettua hyväksyntää.

Lääketeknologiayhtiö Implantica esitteli happorefluksin hoitoon kehitettyä RefluxStop®-implanttiaan AFS:n vuosikokouksessa Dallasissa, jossa yli 600 johtavaa kirurgia ja gastroenterologia osoitti vahvaa kiinnostusta laitetta kohtaan. Erityisesti RefluxStop®-paneelikeskustelu veti paikalle lähes kaksinkertaisen määrän osallistujia suunniteltuun nähden.

Laite on FDA-hyväksyntäprosessin loppuvaiheessa, ja Implantica valmistautuu jo Yhdysvaltain markkinoille tuontiin rakentamalla infrastruktuuria, varastoja ja tiimejä. RefluxStop® eroaa perinteisistä refluksileikkauksista, koska se ei ympäröi ruokatorvea, mikä vähentää haittavaikutuksia. Menetelmä noudattaa American Foregut Societyn suosittelemia nykyaikaisia anti-refluksiperiaatteita.

Kokouksessa useat alan huippuasiantuntijat – mm. Dr. John Lipham (USC), Prof. Peter Kahrilas (Northwestern), Dr. Tripp Buckley (UT Austin), Prof. Sebastian Schoppmann (Wien) ja Dr. Moustafa Elshafei (Saksa) – toivat esiin laitteen lupaavat pitkän aikavälin kliiniset tulokset ja innovaatiivisen toimintamekanismin.

Implantican perustaja ja toimitusjohtaja Dr. Peter Forsell korosti happorefluksin valtavaa kansanterveysongelmaa: pelkästään Yhdysvalloissa siitä kärsii 73 miljoonaa ihmistä. Hän uskoo, että RefluxStop®:lla on erinomaiset edellytykset nousta ensisijaiseksi hoitomenetelmäksi sekä Yhdysvalloissa ,että maailmanlaajuisesti.

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Implantica’s RefluxStop® sparks strong excitement at the American Foregut Society meeting, ahead of pending US FDA approval

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the innovative RefluxStop® device for the treatment of acid reflux, a treatment field with over 1 billion sufferers, announces RefluxStop® was met with great enthusiasm and positive feedback among 600+ attendees at the 2025 American Foregut Society (AFS) Annual Meeting, further accelerating US pre-launch readiness.

Anticipation for RefluxStop® in the US reached a fever pitch last week as the nation’s top foregut surgeons and gastroenterologists gathered in Dallas for the AFS Annual Meeting. Even though the US launch is yet to come, RefluxStop® was the topic of much sought-after independent presentations by the most esteemed surgeons. In addition, the dynamic RefluxStop® educational panel discussion attracted nearly 120 top surgeons and GI experts, well above the planned capacity, packing the room with great excitement to learn more about RefluxStop®.

As the third and final module of the PMA application nears completion, we see a massive wave of interest emerging from surgeons in the US and worldwide, also witnessed at AFS. Accordingly, Implantica has started to build the necessary infrastructure, inventory, resources, and launch teams to deliver a speedy US rollout upon the PMA approval.

Dr. John Lipham, USC Chief of the Division of Upper GI and General Surgery and Associate Professor of Surgery at the Keck School of Medicine and Past President of AFS moderated the well-attended RefluxStop® panel discussion where the excitement was palpable. The panel featured a lively discussion of the long-term data outcomes and the unique mechanism of action of the RefluxStop® procedure for treatment of acid reflux/GERD with an implant that does not encircle the esophagus.

Dr. Lipham says, “I am very excited for RefluxStop as it comes closer to receiving FDA approval, given the impressive 5-year clinical study results consistent with real-world data from Europe. The way it treats GERD is an innovative approach that is aligned with the latest scientific principles of the Anti-Reflux Barrier (ARB) recommended by the American Foregut Society.”

Dr. Lipham continues, “The AFS’s ARB approach not only focuses on the lower esophageal sphincter but also restores the other critical components of the body’s natural anti-reflux barrier, as is the case with the RefluxStop treatment approach. The RefluxStop does not encircle the esophagus, thus minimizing the side effects commonly associated with traditional anti-reflux surgeries.”

The panel included experts:

Dr. John Lipham, USC Chief of the Division of Upper GI and General Surgery and Associate Professor of Surgery at the Keck School of Medicine, Past President of AFS, served as the Foregut Cancer Program Director and Chief of USC Affiliated Academic Programs of Orange County

  • Dr. Peter Kahrilas, Professor of Medicine at Northwestern University

  • Dr. Tripp Buckley, Director of the Center for Heartburn & Esophageal Disorders Surgeon, Professor of Surgery at University of Texas at Austin

  • Professor of Surgery, Sebastian Schoppmann, MD, F.A.C.S., Head, Upper GI Service at the Medical University of Vienna, Austria, and

  • Dr. med. Moustafa Elshafei, Chief of General and Visceral Surgery at St. Elisabethen Hospital, Germany

Founder and CEO of Implantica, Dr. Peter Forsell adds, “I’m grateful for the dedication of independent surgeons like Prof. Schoppmann and Dr. med. Elshafei, who chose to collect and report RefluxStop® clinical data. Their profound work makes a big difference as we usher in a new generation of anti-reflux surgery with RefluxStop® leading the way.”

Dr. Forsell continues, “Today, 73 million in the US suffer from acid reflux/GERD, it’s a very serious issue with an urgent need for innovative solutions like the RefluxStop® procedure. I am impressed by the enthusiastic welcome RefluxStop® has received from the AFS audience, made up of top US surgeons and gastroenterologists. With excellent long-term clinical outcomes of the RefluxStop® procedure, and such massive interest and demand from US and international surgeons, we feel confident that RefluxStop® has great potential to become the preferred treatment for GERD in the US and the rest of the world.”

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