Acorai has received a "Breakthrough Device Designation" from the US Food and Drug Administration (FDA) and plans to launch the device in the US in 2025, pending regulatory clearance. The startup recently closed a $4.5 million seed round led by Solardis Health Ventures, with participation from KHP Ventures, Carma Fund, and other investors. The funds will be used for clinical studies as the company works towards FDA approval for clinical use.
Key takeaways:
- Swedish medical device startup Acorai has developed a non-invasive heart pressure monitoring tool that uses proprietary sensing hardware and machine learning software. The device is designed to provide a more accessible way for medical professionals to monitor heart pressures without invasive procedures.
- The device uses a multi-pronged sensing system to pick up different signals through the patient's chest, such as vibrations, sounds, visual read of blood flow and the heart's electrical activity. The raw sensor data is then fed into proprietary machine learning algorithms to estimate intracardiac pressures.
- Acorai's initial target for the heart monitoring product is suspected or confirmed heart failure patients. The company estimates that only about 10% of heart failure patients actually get the invasive procedure, suggesting a large potential market for their device.
- The startup has recently closed a $4.5 million+ seed raise, led by Solardis Health Ventures, with participation from KHP Ventures, Carma Fund and other investors. The funding will mainly be used for clinical studies as the company works towards FDA approval for clinical use.