Puzzle Medical Devices Inc. Announces the Successful Completion of Its First-in-Human Study With Its ModulHeart Breakthrough Percutaneous Heart Pump

MONTREAL, July 25, 2022 — Montreal-based Puzzle Medical Devices Inc., announced the successful completion of the company’s first-in-human study to evaluate the performance of its ModulHeart percutaneous heart pump designed to reduce cardiac afterload and improve renal perfusion in patients with advanced heart failure (HF).

Four patients had ModulHeart deployed to provide circulatory support while undergoing high-risk percutaneous coronary intervention (PCI) procedures. All patients experienced improvements in cardiac and kidney function. Additionally, the ModulHeart device was successfully deployed, activated, and removed, with no procedural or device-related complications.

“I am extremely pleased with the first series of cases performed. Device implantation and explantation were easy and technically successful. The pumps functioned as expected and provided patients with significant improvement in hemodynamic parameters. I am excited about Puzzle Medical’s progress and the potential for this device to disrupt HF treatment,” said Dr. Philippe Genereux, interventional cardiologist at the Gagnon Cardiovascular Institute at Morristown Medical Center, New Jersey, USA.

Puzzle Medical designed the ModulHeart device for patients with advanced HF who are not candidates for heart transplant or surgical mechanical circulatory support. The device’s modular design allows for hemodynamic support through multiple pumps anchored in parallel in the descending aorta. The design is expected to enable safe percutaneous implantation, with low risk of bleeding, stroke, and pump thrombosis, while providing sustained symptom relief, reduced re-hospitalizations and improved overall quality of life.

“ModulHeart has the potential to solve the clinical unmet need of patients that have conventionally received medical therapy with poor outcomes, by allowing a paradigm shift towards offering a safe percutaneous heart pump,” said Jade Doucet-Martineau, CEO of Puzzle Medical. “The past years of trailblazing execution that have led to achieving this ambitious milestone are a reflection of the dedication and enthusiasm of our entire team, backed by world-class advisors and investors. The achievement of this first-in-human study makes us more confident than ever for upcoming milestones towards commercialization of our solution for advanced HF.”

About Puzzle Medical Devices Inc.

Puzzle Medical Devices Inc. (www.puzzlemed.com) is developing the ModulHeart, a modular percutaneous heart pump for patients with advanced HF that has received FDA Breakthrough Device Designation. The initial indication being pursued for the ModulHeart device is for in-hospital therapy of acute decompensated heart failure (ADHF).

Caution: the ModulHeart is not approved and not for sale in any geography.

For information, please contact Jade Doucet-Martineau, Co-Founder and CEO, jade@puzzlemed.com.