Helsingborg-based medical device startup Acorai recently closed an oversubscribed series seed equity round, securing over $4.5 million in funding from investors such as Solardis Health Ventures, KHP Ventures, Carma Fund, and other US investors to finance clinical studies and advance regulatory approval. This funding success follows a prior boost of €2.3 million in non-dilutive grant and €10 million in future equity financing from the European Innovation Council (EIC). Acorai, specializing in a non-invasive intracardiac pressure monitoring device to improve heart failure management globally, plans to utilize these funds for ongoing clinical studies, particularly the CAPTURE-HF study, and to further propel the regulatory approval process. The company aims to complete essential clinical testing and prepare for a larger capital raise, gearing up for the anticipated commercial launch of its monitoring system in 2025.
Acorai focuses on developing a non-invasive intracardiac pressure monitoring device. This innovative technology is designed to improve the management of heart failure for a global patient population exceeding 64 million individuals. Acorai’s flagship product, designated as a Breakthrough Device by the US FDA, relies on the patented SAVE Sensor System, integrating proprietary hardware and machine learning. The company’s mission is to address unmet needs in acute heart failure workflows, aiming to bring about a paradigm shift in how patients with heart failure are managed in both traditional and acute care settings.
After designation as a Breakthrough Device by the US FDA in August 2023, Acorai started its global clinical study, CAPTURE-HF, and aims to have its monitoring system ready for clinical use. Concluding in 2024, the study aims to demonstrate the performance of the device through a 1200-patient catheterization study.
The Chief Clinical Advisor to Acorai, Dr Andrew J Sauer, commented, “With CAPTURE-HF, the team has really focused on the science to enable the fullest use of this device when it hits the market. This funding further validates that Acorai is a uniquely positioned company to change the paradigm of how patients with heart failure are managed in traditional and acute care settings. To my knowledge, this is the only company that has recognized and is adequately addressing the glaringly obvious unmet need within the acute heart failure workflow”. He added, “Raising capital in this environment is tougher than it was even 18 months ago, so it’s a huge achievement of the management team and an example of how truly scalable this platform could be in the right hands … congrats”
The Team, led by Filip Peters, Jakob Gelberg, Kasper Bourdette, and Matthew Mace, is planning the completion of their study in 2024, and through active engagement with regulators, Acorai is targeting US market access by 2025.
The focus now is to complete clinical testing, targeting a larger capital raise ahead of commercial launch in 2025. Acorai will continue to have a presence at conferences through 2024 with upcoming trips to THT, Boston and ACC, Atlanta for CSO Matthew Mace and CEO Filip Peters presenting at VIVE in Los Angeles in February and the LSI Emerging Medtech conference in Dana Point in March.
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Originally published on ArcticStartup : Original article