Protaryx Medical has picked up $8.3 million to develop its device for precision transseptal access to the left atrium for use during structural heart and catheter ablation procedures.

The funding includes nondilutive grants and a seed round totaling $3.2 million, as well as the recently closed $5.1 million series A financing led by Ajax Health, with participation from returning investor University of Maryland (UM) Ventures. Its device is not yet available for sale in any market.

In addition to the investment, Ajax Health leaders Doug Koo, CFO and managing director, and Aftab Kherani, chief medical officer and managing director, will join the Protaryx board.

“We are pleased to include Protaryx in the Ajax portfolio, and I'm personally excited to join the board to move this innovative company forward,” said Koo. “We have been impressed with the team and the potential of this unique technology to fill a growing clinical need in cardiovascular care.”

Emerging from stealth mode

Terri Burke, CEO and co-founder of Protaryx

“Myself and my co-founder Jim Gammie – he’s the cardiac surgery chief at UM – we decided to work on this device … quietly and thoughtfully for a little while,” Terri Burke, CEO and co-founder of Protaryx, told BioWorld when asked why the company decided to emerge from stealth mode at this time. Gammie also is the founder of Harpoon Medical Inc., which was acquired by Edwards Lifesciences Corp. in 2017. For her part, Burke crossed paths with Gammie when she led global marketing and business development at Edwards.

Harpoon Medical focused on mitral valve repair devices while the heart is beating. The agreement with Edwards involved an initial cash payment of $100 million and up to $150 million in milestone payments over the next decade.

During his company’s April 23 first-quarter earnings call, Edwards CEO Mike Mussallem noted that the Harpoon beating heart mitral valve repair system is available commercially in Europe, “and we plan to launch it as the environment stabilizes.” In the U.S., the FDA had recently given the green light to start the pivotal trial with that technology.

Gammie and Burke are now hoping for the same success with this venture. “So, we took a little bit of a similar approach; we wanted to take our time and really work through [the] concept phase. And we were fortunate to have not only grants, but seed funding behind us,” she added. Now, with the closing of the series A, the two thought it was time to let the world know about its innovative technology.

Burke went on to tell BioWorld that the technology was borne out of frustration with current offerings for transseptal access. Gammie was an early adopter of catheter-based mitral valve repair technology. However, “he questioned why was this particular step – access to the left atrium – so difficult to master, and why did it have such a substantial learning curve.” He thought there was a better way – a way that is simpler, as well as more reliable and easily reproducible.

“Out of that came what we think is a real first-in-class device that has a unique aspect … in that it has independent steerability in three axes.” To that end, it aims to deliver more control and precision in terms of accessing the left heart.

At this point, the company is working through its regulatory strategy, but it does expect its product to be available on the market either in late 2021 or early 2022. “And that’s really what we’re using this series A to drive toward – to continue the development through regulatory clearance.” To that end, the U.S. and Europe are the company’s initial targets.

Looking ahead, the company is eyeing several underserved populations that it thinks could benefit from this streamlined procedure, Burke explained. She highlighted mitral regurgitation patients – both repair and replacement – as well as catheter ablation technology and left atrial appendage closures. “And then, certainly, we think a lot about the overall market, and we continue to talk with strategic companies about our technology, so that we’re aware of what they’re developing, because our goal is really to make sure that we’re compatible with all different types of therapeutic devices.”

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