Restore Medical Secures $23M Series B to Advance Transcatheter Heart Failure Device Following FDA Breakthrough Designation
核心洞察
Restore Medical (搜索) closed a $23 million Series B financing round co-led by Pitango HealthTech (搜索) and a global strategic partner to advance its novel transcatheter heart failure therapy.
The funding will complete the company's ongoing European feasibility study and launch a U.S.-based clinical study following FDA Breakthrough Device Designation granted in 2024.
Early clinical data from the European study demonstrated promising long-term safety and efficacy, including meaningful improvements in ventricular reverse remodeling and hemodynamic performance.
Restore Medical (搜索) Ltd, a clinical-stage MedTech company developing transcatheter therapies for heart failure, announced the successful closing of a $23 million Series B financing round. The round is co-led by Pitango HealthTech (搜索) and a global strategic healthcare partner, alongside the European Innovation Council (EIC) Fund, and continued support from existing investors including Peregrine Ventures (搜索) and another strategic partner.
The funding will support completion of Restore Medical (搜索)'s ongoing European feasibility study, which has demonstrated promising long-term safety and efficacy data, including meaningful improvements in ventricular reverse remodeling, hemodynamic performance, and patient functional capacity. The investment will also support the launch of a U.S.-based clinical study, following the Breakthrough Device Designation granted by the U.S. Food and Drug Administration (FDA) in 2024.
Novel Transcatheter Approach Addresses Treatment Gap
Restore Medical (搜索)'s unique transcatheter approach introduces a new minimally invasive therapeutic option for heart failure patients who have limited effective treatments today. The company's device-based therapy aims to restore hemodynamic balance and improve clinical outcomes for patients worldwide.
"We are proud to have the support of such a strong and diverse group of partners, including two global strategic investors, the European Innovation Council Fund (搜索), and leading VCs such as Peregrine Ventures (搜索) and Pitango HealthTech (搜索)," said Gilad Marom, CEO of Restore Medical (搜索). "Their confidence in our vision, team, and technology is a powerful endorsement. With encouraging clinical data and FDA Breakthrough Device designation, we are well positioned to advance this technology toward making a meaningful impact for patients worldwide."
Addressing Critical Unmet Medical Need
Heart failure remains one of the leading causes of hospitalization and mortality worldwide, particularly in patients with Heart Failure with reduced Ejection Fraction (HFrEF). Despite advancements in pharmacological treatments, a significant portion of patients remain symptomatic and at high risk of repeated hospitalizations, impaired quality of life, and premature death.
Jonathan Glazer, MD, Partner at Pitango HealthTech (搜索), emphasized the clinical urgency: "Heart failure remains one of the greatest unmet needs in medicine, both clinically and economically. As a clinician and executive in healthcare systems, I have seen firsthand how urgent the need is for better solutions. Restore Medical (搜索)'s innovative approach, compelling early data, and exceptional leadership made it a clear choice for us to co-lead this round."
Clinical Development Strategy
The Series B funding will enable Restore Medical (搜索) to complete its European feasibility study and initiate U.S. clinical trials. The company's transcatheter device has already shown encouraging results in the European study, with data demonstrating improvements in key cardiac parameters and patient functional capacity.
The FDA's Breakthrough Device Designation, granted in 2024, provides Restore Medical (搜索) with expedited regulatory pathways and enhanced communication with the agency throughout the development process. This designation is reserved for devices that provide more effective treatment for life-threatening or irreversibly debilitating diseases.
Restore Medical (搜索) is led by CEO Gilad Marom and was co-founded by Stephen Bellomo (CTO), Dr. Elchanan Bruckheimer (Medical Director), and Aaron Feldman. The company began operations within Peregrine Ventures (搜索)' Incentive Incubator and is backed by leading investors with strong experience in healthcare and innovation.