Puzzle Medical published in prestigious BioWorld journal for its U.S. FDA Breakthrough Device Design

https://www.bioworld.com/articles/503842-puzzle-medical-solves-fda-approval-process-with-breakthrough-device-designation?v=preview

Puzzle Medical’s transcatheter heart pump enables the natural, regenerative properties of the blood to outpace the damage that can occur to blood components when a transcatheter pump is implanted.


Feb. 19, 2021

By David Godkin


MONTREAL – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure. The pump also minimizes trauma that occurs to anti-coagulant components of the blood following the procedure, while ensuring patients can be treated on an out-patient basis, said Puzzle Medical co-founder and CEO Jade Doucet-Martineau.


“Breakthrough device designation is a real game changer for any medical device and for sure a major milestone for us,” Doucet-Martineau told BioWorld. “Not only do we have more interactions with the FDA during its approval process breakthrough designation fast tracks insurance codes hospitals need to be reimbursed for their use of a medical device after approval is granted.”


A fragile patient population


In a healthy adult the heart pumps up to a third of a cup of blood with every beat, nourishing vital organs and other parts of the body. The amount of blood pumped drops precipitously in patients with advanced heart failure, said Doucet-Martineau. Their hearts are weaker. Their daily activities are fewer, and they make repeated trips to the hospital.


Once in hospital the problem only deepens because the options available to people suffering from advanced heart failure are severely limited. Very fragile to begin with, their anxiety rises in the face of a complete heart transplant or implantation of a large heart pump.


“These procedures are very invasive and full of complications, so you need a very strong patient when conducting open heart surgery,” said Doucet-Martineau. Ineligible for the rigors of open-heart surgery, patients with advanced heart failure are instead prescribed cardiac medication “that only offers them a 50% chance of survival within one year of their diagnosis,” said Doucet-Martineau.


Montreal-based Puzzle Medical’s answer is a modular, transcatheter heart pump transported in pieces from a small incision in the thigh or neck to the heart. There, the pieces are unsheathed and reassembled into “a low-risk heart pump for high-risk patients,” said Doucet-Martineau. Don’t other minimally invasive pumps on the market do the same thing? “Not for a fragile patient population with advanced heart failure requiring short as well as full time support,” she replied.


That full time support includes countering the damage done by catheter pumps to critical components of the blood, such as the Von Willebrand factor which prevents excessive bleeding. Blood trauma is particularly noticeable in smaller transcatheter pumps which in order to be effective revolve at very high RPMs, putting at risk the Von Willebrand and other blood factors.


Puzzle Medical’s pump enables the natural, regenerative properties of the blood to outpace the damage that can occur to blood components when a transcatheter pump is implanted. “Our pump was designed to allow regeneration to occur faster than the destruction that occurs and ensure an equilibrium is returned to the patient,” said Doucet-Martineau.


While conceding that smaller transcatheter pumps provide an “amazing” short term solution for patients hospitalized with heart attack, the device must also be plugged into a controller in the hospital wall. In other words, it’s a solution for in-patient care when out-patient care is at a premium. “These days you want to avoid putting patients in hospital beds and allow them to get on with their lives at home,” said Doucet-Martineau.


Validation all round


Continuing acute, in-vivo preclinical implantations begun in 2019 have exceeded expectations, said Doucet-Martineau. This includes a doubling of expected cardiac output and renal perfusion, complete absence of thrombus (blood clots) and assembly of the pump she described as both “elegant and repeatable.”


Those preclinical studies also benefited from the application of the pump by third party clinicians. “Following that, they actually invested in the company,” Doucet-Martineau chuckled. “They really liked the pump which was quite a validation for us.” Bigger news came on June 15, 2020, with the closing of Puzzle Medical’s first convertible debenture financing round led by Canadian entrepreneur Pascal Labrecque.


“Unfortunately, I can’t disclose how much we raised, but I can say we also had VCs from the U.S. and Montreal participate in that round,” said Doucet-Martineau. “We had clinicians and investors from France, Germany, the U.S. and from Canada, so that was even more validating.”


Even more so given the transcatheter pump has yet to complete pre-clinical trails. Human trials are expected to be finished within the next two years, said Doucet-Martineau.