Laplace Interventional advances life-saving heart valve technology with $22m funding round

Laplace Interventional, a Minnesota-based medical device company pioneering transcatheter tricuspid valve replacement technology, has secured $22 million in Series C financing to accelerate the development of its innovative treatment for tricuspid regurgitation (TR). The investment was led by a global strategic investor, with additional backing from Aphelion Cardeation, Unorthodox Ventures, and returning investors Engage Venture Partners, JWC Venture, and Features Capital.

The company intends to utilize the capital to complete its Early Feasibility Study (EFS) and progress toward a pivotal study approval, a critical milestone in securing regulatory clearance for wider clinical use. Laplace Interventional’s approach offers a minimally invasive alternative to traditional open-heart surgery, providing a potential breakthrough for patients suffering from severe tricuspid valve disease.

What Makes Laplace Interventional’s Tricuspid Valve Technology Unique?

Tricuspid regurgitation is a condition in which the tricuspid valve fails to close properly, allowing blood to flow backward into the right atrium. The condition is associated with heart failure, arrhythmias, and reduced quality of life, yet it remains underdiagnosed and undertreated compared to other valvular disorders. Traditional surgical interventions are often high-risk, particularly for elderly or frail patients, making transcatheter tricuspid valve replacement a promising alternative.

Laplace Interventional’s device is designed to be delivered via catheter, eliminating the need for an open-heart procedure. This minimally invasive technique can significantly reduce recovery time and postoperative complications, making treatment more accessible to patients who may not qualify for traditional surgery.

Dr. Brandon Jones, Interventional Cardiologist and Medical Director of Structural Heart at Providence St. Vincent Medical Center, noted that initial results from the Laplace Early Feasibility Study have been encouraging. He explained that three patients who received the device were discharged within one to two days and were doing well post-procedure. He also emphasized the ease of deployment and intuitive design of the Laplace system, particularly in navigating complex cardiac anatomies.

How Will the Series C Funding Accelerate Clinical Research?

With 22 patients enrolled in the United States and a total of 25 globally as part of the Early Feasibility Study, Laplace Interventional is preparing to expand patient recruitment and refine its technology. The Series C funding will support ongoing clinical trials, bolster regulatory submissions, and pave the way for a pivotal study—a key step toward obtaining FDA approval and potential commercialization.

In addition to financing clinical research, the investment round has brought strategic leadership expansion. As part of the deal, Ned Scheetz, Founding Managing Partner at Aphelion Capital, has joined Laplace Interventional’s Board of Directors. His extensive experience in healthcare investments and medical technology innovation is expected to provide strategic guidance as the company scales its research and development efforts.

Why Are Investors Betting on Transcatheter Tricuspid Valve Replacement?

The funding round underscores growing investor confidence in transcatheter valve therapies, a market that has expanded rapidly following the success of transcatheter aortic valve replacement (TAVR). While TAVR has become a widely accepted alternative to open-heart aortic valve surgery, transcatheter mitral and tricuspid valve technologies are still in the early stages of clinical adoption.

Aphelion Cardeation, one of the new investors in this round, has a history of supporting disruptive cardiovascular technologies. The firm, which aligns its investment strategy with the American Heart Association’s mission, sees Laplace Interventional’s technology as a potential game-changer for tricuspid regurgitation treatment.

“Laplace’s innovative solution for tricuspid regurgitation has the potential to transform care for millions of patients worldwide,” said Ned Scheetz of Aphelion Capital. He emphasized that the company’s commitment to minimally invasive heart valve technology aligns with the broader healthcare industry’s push toward less invasive, patient-friendly treatments.

What’s Next for Laplace Interventional and Its Regulatory Pathway?

Despite promising clinical results, Laplace Interventional’s device remains in its development phase and has not yet received approval from the U.S. Food and Drug Administration (FDA) or other regulatory bodies worldwide. The company has issued a cautionary statement, clarifying that the technology is not yet available for commercial use.

With the Series C funding secured, Laplace Interventional is focused on completing its Early Feasibility Study and preparing for a pivotal clinical trial, which will generate the robust data required for regulatory submission and market approval. If successful, the company could emerge as a leader in the transcatheter tricuspid valve replacement market, providing a lifesaving alternative for patients who currently have limited treatment options.

The growing demand for minimally invasive structural heart therapies, coupled with the increasing recognition of tricuspid regurgitation as a serious condition, positions Laplace Interventional at the forefront of a rapidly evolving market. As clinical trials progress, the company’s developments will be closely watched by investors, cardiologists, and regulatory agencies alike.