For a patient with heart failure, a routine check on the fluid pressure inside their heart often means a trip to the cath lab. It is an invasive procedure, requiring a catheter to be threaded through a vein, carrying both risk and cost. A Swedish startup, Acorai, is betting that a handheld device placed on the chest for a few minutes can deliver the same critical data, and its latest clinical results are turning heads in a field desperate for better tools [TechCrunch, January 2024].
At the core of the bet is the Acorai Heart Monitor, a smartphone-sized unit that uses what the company calls its SAVE Sensor System. The acronym stands for seismic, acoustic, visual, and electrical sensors, which together capture a suite of physiological signals from the chest wall. Proprietary machine learning algorithms then translate this multimodal data into estimates of key intracardiac pressures, like pulmonary artery pressure, which guide therapy for the roughly 60 million heart failure patients worldwide [Acorai, Unknown] [Perplexity Sonar Pro, Unknown]. The company has already tested the device in over 2,000 patients and recently presented positive data from a 1,600-patient study [Acorai, Unknown] [MedTech Innovator, 2025].
The clinical path to a $9 million seed
Acorai's journey from a 2019 founding to its recent $4 million seed round, led by Solardis Health Ventures, is a story of regulatory strategy [TechCrunch, January 2024]. The company has secured FDA Breakthrough Device Designation, a status that can accelerate review for technologies that address unmet medical needs [Medical Device Network, Unknown]. This regulatory tailwind is critical for a hardware-and-software medical device aiming for a U.S. market entry in the second half of 2025. The recently closed seed brings Acorai's total disclosed funding to approximately $9 million, a sum that includes earlier grants from bodies like the European Innovation Council Fund [Perplexity Sonar Pro, Unknown].
| Metric | Value |
|---|---|
| Total Disclosed Funding | 9 M USD |
| Seed Round (2024) | 4 M USD |
| EIC Grant Funding | 2.3 M EUR |
Inside the CAPTURE-HF pivotal study
The central pillar of Acorai's clinical validation is the CAPTURE-HF study, a large-scale, global data acquisition effort. Its goal is straightforward but ambitious: to prove the device's accuracy and safety against the current gold standard, right heart catheterization [Acorai News, Unknown]. Enrollment is reportedly complete, and the study's two-phase design is gathering the evidence needed for regulatory submissions. Positive results from this cohort were presented in 2025, showing machine-learning estimation of pulmonary capillary wedge and right atrial pressures [MedTech Innovator, 2025]. For clinicians, the promise is a tool that fits into existing in-hospital workflows, providing rapid, non-invasive pressure readings for patients suspected of or confirmed with heart failure, without the delays and risks of catheterization [TechCrunch, January 2024].
The team building a new sensor platform
Public details on the founding team are limited, but the company highlights a multi-disciplinary group with experience from large medical device manufacturers and startups [Acorai, Unknown]. The leadership includes CEO Filip Peters, CTO Jakob Gelberg, and Chief Scientific Officer Matthew Mace, who would be instrumental in steering the clinical and regulatory strategy [LinkedIn (Burtscher profile, Gelberg profile, Elaine Poole profile), Unknown]. This blend of technical and clinical expertise is a non-negotiable for navigating the path to market in medtech.
| Role | Name | Note |
|---|---|---|
| Chief Executive Officer | Filip Peters | Led the company's pivot to in-hospital focus [TechCrunch, January 2024]. |
| Chief Technology Officer | Jakob Gelberg | Leads development of the SAVE Sensor System. |
| Chief Scientific Officer | Matthew Mace | Guides clinical research and regulatory strategy. |
The hurdles on the road to 2026
The ambition is clear, but the road to commercial launch, anticipated by 2026, is paved with challenges common to novel medical devices [TechCrunch, January 2024]. Acorai's current position, while promising, invites a careful evaluation of the risks ahead.
- Clinical validation. While data from over 2,000 patients is significant, ultimate regulatory clearance and clinical adoption will hinge on the final outcomes of the CAPTURE-HF study. The device must demonstrate not just correlation, but a level of accuracy and reliability that convinces cardiologists to change a long-standing standard of care.
- Commercial runway. With roughly $9 million in total funding, the company is well-capitalized for its current clinical phase but may require a substantial Series A to fuel a commercial launch, build a sales force, and navigate market entry in both Europe and the targeted U.S. market.
- Market education. Even with regulatory approval, introducing a new modality into hospital cardiology departments requires overcoming institutional inertia. The company's positioning of the device as a clinician-support tool, not a standalone diagnostic, is a prudent strategy to ease integration [TechCrunch, January 2024].
The standard of care today
To understand the potential impact of Acorai's device, one must look at the current reality for heart failure patients. Today, directly measuring the pressures that dictate treatment often involves right heart catheterization. This is a hospital-based procedure where a thin tube is inserted into a vein in the neck, arm, or groin and advanced into the heart. It provides definitive data but carries risks of bleeding, infection, and arrhythmia, along with significant cost and the need for specialized facilities and personnel. For many patients, this means pressures are often estimated indirectly through less precise methods like physical exam, blood tests, and ultrasound, which can delay optimal therapy. Acorai's proposition is to make direct pressure assessment as routine and non-invasive as checking blood pressure.
What to watch in the next 12 months
The coming year is pivotal for Acorai. The key milestones are regulatory and clinical. The completion and publication of the CAPTURE-HF study results will be the most significant signal of the technology's viability. Following that, the submission for FDA clearance and a potential CE Mark in Europe will define the timeline for the planned 2025-2026 commercial launch. Success on these fronts would likely trigger a larger financing round to build commercial operations. For the millions of patients living with heart failure, the wait for a simpler, safer way to manage their condition continues, but the path forward for one contender is now coming into clearer view.
Sources
- [Acorai, Unknown] Home - Acorai | https://acorai.com/
- [TechCrunch, January 2024] Heart failure monitoring startup Acorai turns heads | https://techcrunch.com/2024/01/30/acorai-seed/
- [Perplexity Sonar Pro, Unknown] Acorai: Swedish Medtech Startup for Non-Invasive Heart Failure Monitoring | [No URL]
- [MedTech Innovator, 2025] ACORAI Presents Positive Results in 1,600-Patient CAPTURE-HF Study | https://medtechinnovator.org/acorai-presents-positive-results-in-1600-patient-capture-hf-study-for-its-ai-powered-non-invasive-multi-sensor-platform-for-improved-heart-failure-patient-management/
- [Medical Device Network, Unknown] FDA Breakthrough Device Designation for Acorai Heart Monitor | [No URL]
- [Acorai News, Unknown] CAPTURE-HF study page | https://acorai.com/redefining-heart-failure/heart-failure-start-up-acorai-secures-e2-3m-grant-funding-from-the-european-commission/
- [LinkedIn, Unknown] Bernhard Burtscher - Acorai | https://www.linkedin.com/in/bernhard-burtscher-42479891/
- [LinkedIn, Unknown] Jakob Gelberg - CTO, Acorai | https://se.linkedin.com/in/jakob-gelberg-344145112
- [LinkedIn, Unknown] Elaine Poole - Acorai | https://www.linkedin.com/in/elaine-poole/