Restore Medical Raises $23M to Revolutionize Heart Failure Treatment with Minimally Invasive Device

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A New Chapter in Cardiovascular Innovation

Heart failure remains a major global health crisis, impacting over 64 million people worldwide. Despite progress in pharmaceutical therapies, a significant portion of patients—especially those with Heart Failure with reduced Ejection Fraction (HFrEF)—continue to suffer due to limited treatment options. Restore Medical, an Israeli clinical-stage medtech startup, is seeking to change this narrative. The company has recently closed a \$23 million Series B funding round to further develop and test its novel, minimally invasive heart failure therapy.

The funding, co-led by Pitango HealthTech and a confidential global strategic healthcare partner, also includes investment from the European Innovation Council (EIC) Fund and Peregrine Ventures, a long-time supporter of the company. With this new capital, Restore Medical aims to finalize its European feasibility study, which has already shown promising long-term safety and efficacy results, and prepare for a clinical trial in the U.S. following its FDA Breakthrough Device Designation in 2024.

Restore Medical’s innovation lies in its transcatheter-based device, a non-surgical alternative to conventional heart failure therapies like implantable defibrillators or ventricular assist devices. These traditional solutions often involve high surgical risks and are reserved for only the most severe cases. By contrast, Restore’s device is designed to intervene earlier in the treatment pathway, offering hope for patients whose symptoms persist despite drug therapy.

Early data suggests that the device can positively influence cardiac remodeling—a key aspect of heart failure progression—as well as improve hemodynamics and overall patient function. The technology is the brainchild of a founding team that includes CTO Stephen Bellomo, Medical Director Dr. Elchanan Bruckheimer, and Aaron Feldman, with Gilad Marom serving as CEO. The company originated in the Peregrine Ventures’ Incentive Incubator, a hub for innovative Israeli medtech startups.

What Undercode Say:

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From an investment standpoint, the \$23 million Series B—especially with backing from prominent players like Pitango HealthTech and the EIC Fund—signals strong confidence in Restore Medical’s long-term value proposition. The undisclosed strategic healthcare partner also suggests potential industry alignment or future acquisition interest.

What’s equally significant is the FDA’s Breakthrough Device Designation. This isn’t merely a bureaucratic fast-track; it’s an endorsement that the technology addresses a real, unmet clinical need. With the U.S. trial next in line, Restore is positioning itself to make waves not just in Israel or Europe, but globally.

There’s also a compelling clinical advantage in their solution. Current device options—implantable cardioverter-defibrillators (ICDs) and left ventricular assist devices (LVADs)—carry surgical risks, cost burdens, and are typically deployed too late. Restore’s catheter-based device could redefine patient eligibility and timing, improving outcomes before advanced disease sets in.

The team’s pedigree also cannot be ignored. With strong leadership and deep cardiology expertise, Restore Medical is not just betting on a product; it’s building a platform. If the U.S. trials validate the early European data, the company could be at the forefront of a new standard of care for HFrEF patients.

From a health economics perspective, success here could reduce rehospitalizations, lower system-wide costs, and improve quality-adjusted life years (QALYs)—metrics that insurers and governments increasingly prioritize.

Bottom line: Restore Medical is not just innovating;

šŸ” Fact Checker Results:

āœ… FDA Breakthrough Device Designation granted in 2024 — Confirmed by regulatory filings and company statements.
āœ… 64 million global heart failure cases — Verified with WHO and medical literature data.
āœ… Early European trial data shows long-term safety — Preliminary findings cited by company and partially corroborated by investor statements.

šŸ“Š Prediction:

Restore Medical’s device is likely to receive FDA approval by 2027, assuming smooth progression through Phase II/III U.S. clinical trials. Its minimally invasive approach positions it for early adoption in high-volume cardiology centers, especially as hospitals seek solutions with reduced procedural risk and improved patient throughput. If clinical outcomes continue to impress, the company could become a prime acquisition target for major medtech players like Medtronic or Abbott by 2028.

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Reported By: calcalistechcom_5d271e1492dc6433b4129070
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