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Helping cardiovascular disease treatment across Europe

To recognize World Heart Day, let us highlight how digital medical devices (DMDs) help patients and physicians treat cardiovascular disease (CVD).

Cardiovascular disease accounts for approximately 32% of deaths worldwide and 37% of deaths in the European Union annually. Thus, it is important for us that EIT Health-supported start-ups help advance digital transformation in cardiovascular care across Europe.

 “DMDs make use of best-in-class technology to ensure that patients are treated with the utmost accuracy and efficiency. By adopting DMDs in the management of CVD, we invite better patient outcomes whilst empowering cardiologists with the tools to do their jobs as effectively as possible. Overcoming the challenges and addressing specificities of DMDs regarding clinical evidence generation, regulatory evaluation assessment and HTA assessment for reimbursement procedures is of prime importance to facilitate access for patients of innovative digital products.”- says Jean-Marc Bourez, CEO of EIT Health.

It is often hard for start-ups to launch digital medical devices given fragmented regulatory landscapes across Europe. Despite regulatory constraints, EIT Health plays a critical role in assisting the growth of young enterprises developing DMDs and pushing the needle on fair market access to life-saving technologies.

Recently chosen by the French Ministry of Health and EUNetHTA, EIT Health will supervise the work of the European Taskforce for Harmonised Evaluation of DMDs. The ultimate purpose of this group is to offer a standardised strategy for European evaluation, hence aiding national appraisal and reimbursement for DMDs by health insurance organizations. Such initiatives will guarantee that Europe provides a level playing field for patients seeking access to the novel therapies being developed by CVD-focused start-ups such as Acorai and inHEART.

Acorai and inHEART are two examples of start-ups that are pioneering groundbreaking CVD management technology. As participants in EIT Health programs and recipients of EIT Health financing, both start-ups have gained access to a wealth of resources and knowledge, allowing them to overcome obstacles on the way to market entry:

  • Acorai – is a non-invasive intracardiac pressure monitoring device used to assist minimize re-hospitalizations and death rates associated with heart failure. The company took part in EIT Health’s Gold Track program, a tailored scaling program that connects potential start-ups with top-tier life science advisers. Acorai plans to conduct a pivotal trial with doctors next year, followed by outcome studies and a commercial launch in 2024.

 

  • inHEART– offers a cloud-based software system that converts preoperative medical imaging into a 3D digital twin of the patient’s heart, allowing cardiologists to tailor and optimize each patient’s treatment approach for shorter operation durations and improved procedural success. inHEART competed in both the EIT Health Catapult Competition and the Bridgehead Competition. EIT Health funds clinical trials and health economic research for the start-up. The startup is attempting to obtain funding.

 

“In addition to helping us raise capital, working with EIT Health has given us access to advisors who have injected a cumulative 150+ years of valuable industry experience, knowledge, and insights into our business that we would not have had access to otherwise. EIT Health’s support has enabled us to pivot our business model to better navigate Europe’s complex regulatory landscape, which has brought us one step closer to our goal. We now hope to accelerate studies with the aim of enabling equitable patient access to our DMD across Europe.” – says Matthew Mace, Sales Director at Acorai.

EIT Health’s funding and mentorship has been instrumental to inHEART launching a successful product, attracting investors and generating awareness. Our participation in EIT Health programmes enabled us to craft a market access strategy that overcomes common challenges facing start-ups, such as those related to achieving reimbursement. With EIT Health’s support, we are confident that we will be able to deliver our technology to more cardiologists across Europe.” – says Todor Jeliaskov, Chairman and CEO at inHEART.