Heart failure start-up, Acorai, advances towards regulatory approval in crucial next stage

Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.

Acorai is developing a first-of-its-kind, scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide. Their heart monitor has demonstrated accuracies comparable to the invasive gold standard in a 400-patient feasibility study and consists of a unique, patented hardware technology and proprietary machine learning system.

The first of the patients in the Acorai MLG Study (Machine Learning Generalisation) [NCT05835024] was enrolled at Royal Brompton and Harefield Hospitals by Dr. Owais Dar and his team. Dr. Dar is a cardiologist specializing in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research programme at Harefield Hospital. Dr. Dar said, "This is a fantastic achievement after over a year of planning to get to the stage of final testing of the Acorai device in a clinical setting. If the same accuracy is shown within this global study as previously shown in their 400-patient study, then I have no doubt that Acorai will transform how we identify and manage patients with heart failure".

Acorai will expand its clinical studies to other European and US sites over the coming months, with an overall recruitment target of 1200 patients. This expansion will start with Dr. Dar's colleague Dr. Colm McCabe, a specialist in pulmonary vascular disease at the Royal Brompton, followed by Rigshospitalet (Copenhagen, Demark) and Cardiovascular Center, OLV Hospital (Aalst, Belgium). Amongst their internationally renowned clinical collaborators is Duke Clinical Research Institute DCRI, (Duke University, USA), operating as the core lab for the study to ensure the highest study quality and independence.

Acorai's foremost US clinical collaborator is Saint Luke's Mid America Heart Institute (Kansas City, MO), led by principal investigator Dr Tim Fendler. Saint Luke's is anticipated to be the first US[1]enrolling site on September 11th, 2023. Dr. Fendler said that the first global enrolment in London was "an exciting step on the journey of Acorai and the development of their heart monitor. At Saint Luke's, we constantly strive to lead in cardiovascular research, as evidenced by our rich history - extending from the pioneering legacy of the first primary coronary angioplasty performed in the early 1980s at our Institution, to ongoing innovation at the forefront of developing and implementing patient reported outcome as tools to guide patient care and optimize quality of life in coronary artery disease, heart failure and other conditions; and our leading role in the latest advances for heart failure therapeutics. We look forward to collaborating with Acorai, whose heart monitor may have the potential to 'change the game' in diagnostics, monitoring, and treatment of patients with heart failure."

A significant milestone in the development of Acorai

The 1200-patient Acorai MLG study will run in two phases, with the first phase concluding after 920 patients, and will be used to finalize its machine learning algorithms for final testing. The second phase will commence at the beginning of 2024 and will support the final software validation and regulatory application for clearance and approval for use within US and Europe.

This study builds upon the success of a similar protocol conducted by Niklas Bergh (Sahlgrenska University Hospital, Gothenburg, Sweden) and Göran Rådegran (Skåne University Hospital, Lund, Sweden) with the first generation of the Acorai Heart Monitor, which concluded in June 2023 with a total of 400 patients enrolled.

Acorai's CEO Filip Peters said, "Our focus from day one has been to generate robust clinical data with world-leading clinical partners. The shared vision of our investors and clinical partners in bringing transformative products to heart failure patients has allowed us to develop a medical device built on robust scientific evidence and which is able to address deep unmet clinical needs". Jakob Gelberg, Chief Technology Officer and Co-Founder, commented, "It has been a hard effort over the past months to get all the final preparations in place, with an extraordinary team that has continuously come together to meet the challenges that arose."

Matthew Mace, Chief Scientific Officer, added, "We are honored to have the pedigree of clinical partners for our upcoming MLG study, almost 2 years in the making and 4 years since company formation. Well done to the wider Acorai team; the work ahead has just begun. We are confident that the upcoming study will show comparable results to those that supported our Breakthrough Device Designation and, therefore, will pave the way for De Novo clearance.

Why Acorai is a game changer in Heart Failure

The prevalence of heart failure is a significant concern worldwide, affecting more than 64 million people. In the United States alone, around 1 million of the 6 million individuals with heart failure are hospitalized each year due to their condition. Unfortunately, 30% of patients return to the emergency room within less than a month of being discharged, resulting in poor quality of life and a cost of over $100 billion to the US healthcare system.

Intracardiac pressure monitoring (ICPM) is the single most effective way to manage heart failure patients, but within the hospitalized and clinic environment, only invasive methods exist to assess this vital parameter accurately. The Acorai device's non-invasive handheld form factor could improve access to ICPM and potentially reduce time and cost. It has been shown that access to these vital signs can improve the quality of care for patients, yield better health outcomes, and result in significant cost savings. Acorai aims to be able to enable the deployment of ICPM across the broader healthcare system for use by Healthcare professionals to aid the assessment and personalized treatment of patients with heart failure.

Acorai's forward view and market expansion

Acorai is now fully focused on raising its Series A round to secure FDA clearance by the end of 2024, with full commercial launch expected in 2025.

Acorai recently graduated from the Mayo Clinic Platform Accelerate program and is currently part of the Cedar-Sinai accelerator in Los Angeles. Over the coming months, Acorai will have a significant presence across the US and Europe while initiating their clinical study sites, with the management team based in L.A. for the duration of the accelerator (August thru October).

Be sure to reach out to discuss investment or partnership opportunities and interest in US study sites participation. Additionally, Acorai will have a presence at ESC Amsterdam (Aug 25-28), CV Transforum, Austin, TX (Oct 6-8), HLTH Las Vegas (Oct 8-11), LSX Copenhagen (Oct 10-11) and TCT in San Francisco (Oct 23-26).