News & Media

News from AMT Medical

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The market introduction of AMT Medical’s Elana Heart Bypass System is well on track. We successfully operated on the first ten patients in Phase I of the SAFE-CAB trial, establishing the safety and feasibility of our Elana Heart Bypass System. The larger Phase II, with 75 enrolled patients, has now started. In addition, final discussions with the U.S. Food & Drug Administration (FDA) have now started to commence the Early Feasibility Trial in the U.S. 

The Elana Heart Bypass System enables less invasive and more standardized Coronary Artery Bypass Grafting (CABG) surgery – for both patients and surgeons. Instead of using needle and thread, surgeons use this innovative clip and laser technology to connect a new bypass graft vessel to the blocked vessel in a more systematic and predictable way. Elana doesn’t necessarily require the use of a traditional heart-lung machine. In fact, it can be used in a less or minimally invasive setting, by completely bypassing the need for open heart surgery.

Click here to read the full Newsletter.

Press Release - AMT Medical on Track to Hit Next Milestones for Revolutionary Elana® Heart Bypass System

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AMT Medical announces today that the company is beginning Phase II of the SAFE-CAB Trial to obtain CE (Conformité Européene) mark of the Elana Heart Bypass System in Europe. Furthermore, final discussions with the U.S. Food & Drug Administration (FDA) have now started to commence the Early Feasibility Trial in the U.S.

“Based on the successful results of the FIH trial, the Elana Heart Bypass System has great potential to become a game-changer for severe atherosclerosis patients, offering fewer risks, less recovery time, and more comfort,” says AMT Medical CEO Rutger Tulleken. “Our solution eliminates the need for sutures and stopping the heart, a great advancement for surgeons and patients.”

Click here to download the full Press Release.

AMT Medical B.V. achieved EN ISO 13485:2016 certification

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It is with great pleasure to announce that AMT Medical has achieved yet another milestone in our quest for excellence. We were thrilled to receive the coveted EN ISO 13485:2016 certificate, proving our unwavering commitment to quality and customer satisfaction.

Click here to download the certificate. 

 

European Innovation Council Accelerator

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We proudly announce that our ELANA project is supported by a multimillion euro grant of the European Union within the European Innovation Council Accelerator grant. Besides the international recognition and significant financial support, we are proud to work on our dream of banishing open heart surgery from the world.

 


Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council. Neither the European Union nor the granting authority can be held responsible for them.

Newsletter #7

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We are standing on the threshold of another exciting year for AMT medical. In 2022 we successfully operated on ten heart patients, proving the safety and feasibility of our ELANA Heart Bypass Solution. After years of climbing, this feels like being on the top of the mountain overlooking the world. In 2023 we will further spread our wings in Europe and the U.S., on our way to banishing open heart bypass surgery from the world, improving the quality of life of heart patients worldwide.

Read more about it in our latest newsletter.

Newsletter #6

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At the 36th EACTS Annual Meeting we proudly presented the very positive results of the first-in-human (FIH) trials for the innovative ELANA Heart Bypass Solution. These trial results represent positive news for both surgeons – and their patients. We’re changing the world of heart bypass surgery.

Read more about it in our latest newsletter.

Press Release

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Milan (Italy), October 8, 2022- The preliminary results of the first-in-human (FIH) trials for the innovative ELANA Heart Bypass Solution have been unveiled today and look promising. At the 36th EACTS Annual Meeting Late Breaking Trials session, Drs. Patrick Klein, cardiothoracic surgeon the St. Antonius Hospital, Nieuwegein, The Netherlands, and Dr. Bart van Putte, principal investigator of the SAFE-CAB trial, announced that the 30-day post-operative outcomes of the open procedure showed 100% of patients to be free of Major Adverse Cardiovascular Events (MACE). In all cases there was no cardiac related mortality or myocard infarction, and no need to repeat the coronary revascularization.

 

Newsletter #5

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In the latest newsletter we proudly shared the news of successfully operating on the first ten patients with the ELANA® HEART technology in a study context. We still feel quite overwhelmed by reaching this milestone, but already have other exciting news to share. Our long-cherished dream is becoming more real every day!

Read more about it in our latest newsletter.

Funding European Innovation Council

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We are proud to announce we are one of the 74 European startups to receive funding form the European Innovation Council.

Newsletter #4

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This spring we took an important next step in our journey to banish open heart surgery from the world, improving the lives of 1 million people who need a bypass each year. After years of preparation, we operated the first ten patients. A huge step on our road to an enormous breakthrough in heart surgery!

Read more about it in our fourth newsletter.

State of the art of sutureless coronary anastomoses

Pre-clinical trial experiences incl, ELANA Heart Bypass Live in a Box.

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Enthusiastic responses and a growing anticipation of how our breakthrough technology will change the future world of bypass-surgery.

This is what was achieved at the 70th ESCVS congress that took place from 20 to 23 June in Liège.

ELANA HEART technology took the stage during a mini symposium with presentations of two primary researchers, Dr. Patrick Klein, cardiothoracic surgeon at the St. Antonius Heart Center, Nieuwegein (the Netherlands), and prof. dr. Stephan Jacobs, cardiothoracic and vascular surgeon at the German Heart Center, Charité of Berlin. 

During the presentation of the pre-clinical trials experience, some  discrepancies have been found in the analysis. The ESCVS-board has been informed and has decided to not publish any official rectification.

Should you have any questions, please reach out to info@amt-medical.nl.

 

New cleanroom

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AMT medical has a new clean room on the innovative campus at the Zonneoord in Ede. This was finished by interflow

Newsletter #3

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The AMT Medical Team wishes you and all the people you cherish a healthy and happy new year. In 2022, we are eager to continue working together on our dream: banishing open heart bypass surgery from the world!

Read more about it in our third newsletter.

Newsletter #2

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A little bit of covid-related delay, but still on track!

Read more about it in our second newsletter.

Participation in ESCVS congress

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We are proud to announce our participation at the Congress of the European Society for Cardio Vascular Surgery (ESCVS) as Platinum Sponsor!

Publication in Innovations

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We are proud to announce that our paper about the 6 months follow-up research to the ELANA Heart Bypass (Trinity-V2-prototype) is published by Innovations.

Interview by Catalyze

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Read more about AMT Medical in the the interview of Rutger Tulleken, CEO of AMT Medical and Getlin Visser, CSO, by our collaboration partner Catalyze.

Newsletter #1

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The AMT Medical Team wishes you and all the people you cherish a healthy and happy new year. In 2021, we are eager to continue working together on our dream: banishing open heart bypass surgery from the world!

AMT Medical in a nutshell

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Curious about AMT in a nutshell? Oost nl produced a video clip about the why, what and how of the ELANA Heart Bypass procedure

Press Release

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During the Covid-19 crisis, AMT Medical secures € 10 million of financing. Funding will be used to bring the ELANA™ Heart Bypass system to the market.
During the Covid-19 period, AMT Medical has gained trust in the ELANA innovation from a regional development fund Oost NL. Existing shareholders NextGen Ventures and Utrecht Holdings (UU/UMCU) are also financing this round. In total, AMT Medical has secured more than €10 million series A and non-dilutive funding to develop their easy to use, ‘best in class’ keyhole coronary bypass technology. A new standard, with lower costs for society, fewer complications, and a faster recovery for the patient.

EFRO Grant

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Together with the St Antonius Hospital in Nieuwegein (Dr. B.P. (Bart) van PutteBart and Drs. P. (Patrick) Klein) and the UMC Utrecht (prof. dr. PAFM (Pieter A.) we are making big steps with our EFRO (“Operationeel Kansen voor West II”) grants. This gives us great help in the development of our unique technology with ELANA Heart Bypass to improve and simplify heart bypass operations. By improving bypass surgery with ELANA Heart Bypass, patients with coronary heart disease can return to their daily life more quickly. The simplification of the procedure makes minimally invasive bypass surgery accessible to patients around the world as many more cardiothoracic surgeons can perform them without a large learning curve thanks to ELANA Heart Bypass. Thanks to these enormous benefits, ELANA Heart Bypass has the potential to become the new standard for heart bypass surgery around the world.

First loan ION+ to AMT Medical

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First loan from Gelderland (a province of the Netherlands) innovation fund for medium-sized company. Innovation from AMT Medical improves the world of open heart surgery

Article "patient saved" in dutch newspaper De Telegraaf (in Dutch)

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KARDIO project

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We proudly announce that our KARDIO project is supported by a multimillion euro grant of “Operationeel Kansen voor West II” within the EFRO 2014-2020 program (Horizon 2020). Next to the international recognition and significant financial support, we are proud to work together with our consortium members who are involved in the application and project.

Article from the Economic Board of Utrecht (in Dutch)

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Collaboration Deutsches Herzzentrum Berlin

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Start collaboration with Prof. Dr. Volkmar Falk and Dr. Stephan Jacobs to prove our technique in the first patients.

Europe: "A paradigm shifting innovation"

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Our ELANA heart (TECAB) project is ranked number 5 out of hundreds of European Grant applications (1 is the highest). Innovative companies from all markets and from over 35 countries could apply and were judged by an independent European expert committee who considered our project to be a “paradigm shifting innovation”.

Next to the international recognition and significant financial support, we are proud to work together with our consortium members who are involved in the application.

 

Collaboration St Antonius Nieuwegein

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Start collaboration with Dr. Bart van Putte. His first PhD started at our Labs in september 2018.

Succesful finished study

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After a succesfull pre-clinical study with 70 subjects, product optimilizations where made

MIT Subsidy assigned

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Together with Xeltis in Eindhoven we receive the MIT grant/subsidy.

Philips buys our supplier

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Philips buys Spectranetics, our partner in Catheter and Laser production. Since this take-over by Philips, they visit us on a regular basis to investigate collaboration.

Capital Raise

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Investment from NextGen Ventures (part of Noaber foundation) and Utrecht Holdings (part of UMCU and UU in Utrecht).

Earlier CE and FDA Elana Brain Bypass

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