AMT Medical

News from AMT Medical

On track to hit the next milestones with the Elana^® Heart Bypass System

Date

September, 2023

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.

Delivering Phase II in Europe

In 2022 we successfully operated on ten patients with coronary heart disease, proving the safety and feasibility of our Elana Heart Bypass System. The procedures were performed by Dr. P. Klein, cardiothoracic surgeon at the St. Antonius Hospital, Nieuwegein, The Netherlands, and Dr. B. van Putte, principal investigator of the SAFE-CAB trial. In this study, for the first time in history, a sutureless bypass procedure is performed on the human beating heart. After 16 years of preparation, investments, laboratory tests, pre-clinical studies, constant refinement, and perfecting, we have now succeeded. For cardiac surgery, this is a big step towards a gigantic breakthrough. The SAFE-CAB trial Phase II has now commenced with a further 75 patients in 2023 at the St. Antonius Hospital, Nieuwegein (NL), and at Amsterdam Medical Center, Amsterdam (NL). Together we are making great strides in revolutionizing CABG surgery. The results will be used to achieve a European CE mark required for the commercialization of the Elana Heart Bypass System.

“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.”

Rutger Tulleken
Chief Executive Officer, AMT Medical

Operating the first patients in the US

AMT Medical is very active on the other side of the ocean as well. We are making every effort to operate the first 10 patients in the US in early 2024. We succeeded in connecting renowned names to the study, such as Professor H. Balkhy, M.D., from UChicago Medicine, a pioneer in the field of minimally invasive and robotic cardiac surgery. We are currently closely cooperating with the FDA and expect to receive their permission to start the US clinical trials in the beginning of 2024. After this, the first ten patients in the US can be operated with the Elana Heart Bypass System in an open setting, which is another huge milestone for cardiac bypass surgery. After Phase I, we hope to launch a groundbreaking multicenter trial in the US including 300 patients in the second half of 2024. This will allow AMT Medical to enter the US market and improve the lives of a large group of Americans needing bypass surgery.

Investors are taking an interest

Our work is financed by various grants and investments. In 2022, for example, our hard work was rewarded with the prestigious European Innovation Council (EIC) Accelerator grant of 2.5 million euros. To bring the Elana Heart Bypass System to the attention of investors, we have recently attended several summits. At the LSI Emerging Medtech Summit Dana Point (US), our CSO, Idgar van Kippersluis, presented the Elana Heart Bypass System as a new “Gold Standard” for treating society’s biggest killer. AMT Medical was also present at MedInvest and this month we will be presenting at LSI Europe. We notice a serious interest from many investors now that the Elana Heart Bypass Procedure has proven itself in patients and we are taking bold steps towards the EU and US market.

A growing organization

Steadily and surely moving towards the market introduction of the Elana Heart Bypass System requires extra effort and expertise from our organization. Fortunately, many professionals love to embark on our adventure. In the first half of the year, we welcomed the following new colleagues strengthening and widening the expertise of our team:

Jorrit Kelderman
Chief Financial Officer

Rachel Derksen
Director Clinical Affairs

Femke Valkenburg
Quality & Regulatory Manager

Yuri van Buren
Cleanroom employee

We operate under the principle “together we are better”, fostering collaborations with clinical specialists, advisors, and investors. Our diverse team, with an extensive history in R&D innovations, quality assurance, regulation, and clinical solutions, is well-equipped to realize its goals.

Our own Academy

Part of the market introduction is training surgeons on how to perform the Elana Heart Bypass Procedure. We do this with internal training and our own Elana Academy which we aim to expand towards continuous education in September.

Our Elana Academy is a training and education center aimed at helping a new generation of surgeons explore and ultimately adopt a next-generation technology. Our Elana Academy includes:

Practical tutorials and training for healthcare professionals. This includes two CME-accredited courses that dive into the theory of CABG surgery and the emergence of next-generation Elana Heart Bypass Technology – all delivered by world-renowned experts.
The ability to schedule bespoke one-to-one Elana training sessions with our experts – who gladly answer all questions.
The usage of the extensive video library providing in-depth explanations and tutorials on the technology from influential cardiothoracic surgeons and renowned scientists.
Hands-on training through our Elana Skills Lab sessions, which give surgeons practical experience of the technology in real-life models.

Staying up to date with the latest medical technologies and treatments is important to us. That’s why our Clinical Team recently hosted an internal training session on heart and cardiovascular diseases. Over the course of two days, we took a deep dive into the intricacies of Coronary Artery Disease (CAD) and CABG. We explored the latest research and techniques and discussed the best ways to implement these practices in our own work. Including, of course, the Elana Heart Bypass System.

News from AMT Medical

On track to hit the next milestones with the Elana® Heart Bypass System

On track to hit the next milestones with the Elana^® Heart Bypass System