29th September 2022
Today we recognise World Heart Day by highlighting the ongoing need to facilitate the widespread adoption of digital medical devices (DMDs) to unlock more efficient and effective treatment of cardiovascular disease (CVD) across Europe.
With CVD accounting for an estimated 32 percent of deaths worldwide and 37 percent of deaths in the European Union annually, we are committed to ensuring that start-ups developing cutting-edge solutions for CVD can deliver their technologies to patients and physicians. In doing so, we pledge continued support for start-ups in navigating the complex path to market access.
Jean-Marc Bourez, CEO of EIT Health, commented: “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.”
Start-ups often struggle to launch DMDs given fragmented regulatory landscapes across Europe and limited resources. For example, evidence requirements around reimbursement and how clinical trials are carried out differ greatly from country to country – representing regulatory and financial hurdles that are not conducive to the broad uptake of DMDs.
EIT Health plays a pivotal role in supporting the development of fledgling businesses developing DMDs and pushing the needle on equitable market access to life-saving technology, despite regulatory challenges. Recently selected by the French Ministry of Health and EUNetHTA, we will coordinate the work of the European Taskforce for Harmonised Evaluation of DMDs. The overall goal of this group is to enable a harmonised approach for European assessment supporting national appraisal and reimbursement by health insurance organisations for DMDs. Such efforts will ensure Europe offers a level playing field for patients getting access to such innovative products that CVD-focused start-ups like Acorai and inHEART are developing.
Matthew Mace, Sales Director at Acorai said: “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.”
Todor Jeliaskov, Chairman and CEO at inHEART added: “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.”
Acorai and inHEART are examples of start-ups pioneering breakthrough technologies to manage CVD. Having both participated in our programmes and as beneficiaries of EIT Health funding, both start-ups have accessed a wealth of resources and expertise, enabling them to overcome setbacks on the path to market entry:
- Acorai – is a medical device for non-invasive monitoring of intracardiac pressure to help reduce re-hospitalisations and lower mortality rates due to heart failure. The start-up participated in EIT Health’s Gold Track programme, a tailor-made scaling programme that pairs promising start-up companies with top-flight life science advisors. Acorai is looking to launch a pivotal study with clinicians next year, followed by outcome studies and a planned commercial launch in 2024.
- inHEART– provides a cloud-based software solution that transforms preoperative medical images into a 3D digital twin of the patient’s heart, enabling cardiologists to individualise and optimise each patient’s treatment strategy for reduced procedure times and greater procedural success. inHEART participated in EIT Health’s Catapult Competition as well as the Bridgehead Competition. EIT Health provides funding for the start-up’s clinical trials and health economic studies. The start-up is looking to secure reimbursement.
- WHO, (2022). Cardiovascular diseases. [online] Available at: <https://www.who.int/health-topics/cardiovascular-diseases>
Escardio, 2019. Fact sheets for Press. [online] Escardio.org. Available at: <https://www.escardio.org/The-ESC/Press-Office/Fact-sheets>
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