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™.”
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™.”
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.
Onko @Pevitaha tai joku muu seuraillut Implanticaa tarkemmin ja löytänyt jotain uutisia viime aikoina? Kurssi tiputellut tasaisesti viime kuukausina, johtuuko uutisten puutteesta sitten 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?
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.
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."
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.
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.
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.”
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!”
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).
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.
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?
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?