How Do You Mend a Broken Heart?

The Heartbeat Heard Round the World

The KardiaPSI balloon catheter is designed to open a calcified aortic valve. Such BAVs [Balloon Aortic Valvuloplasty] are often used as part of transcatheter aortic valve replacement (TAVR) procedures. A novel procedure performed with Corvention’s reinforced balloon on the tip of a catheter and threaded through an artery in the patient’s leg to his heart, was performed by Dr. Scott Lim through the Canadian Special Access Program at Dilawri Cardiovascular Institute, the cardiac care and research institute of Vancouver General Hospital in Vancouver, British Columbia.

Once positioned inside the heart, the KardiaPSI balloon was inflated under high pressure to open and expand the new valve to its proper dimensions, a procedure not previously possible with any existing medical technology, said Corvention CEO Michael Franklin.

The patient had severe aortic stenosis, preventing the valve from opening properly. It had calcified and blood was not flowing well, starving organs of oxygen. He also had severe aortic regurgitation – the blood was flowing backward, leaking back into the left ventricle and causing it to enlarge and weaken.

“This was an otherwise very healthy and active patient, but his failing valve did not allow him to live his life to the fullest anymore. Having a fully and properly deployed new valve in his heart could make a big difference in quality of life and longevity,” said Franklin.

The patient, a fitness instructor, had several heart issues that had been fixed previously. Fifteen years ago, he underwent open-heart surgery for valve replacement and also had coronary bypass surgery.

“He knew the exact day his valve failed,” said Franklin. “He felt the same way he did the first time, before he received a valve replacement. He told his doctor, ‘I’m short of breath. I can’t get up and move around. I can’t exercise. I have no energy.’”

The doctor confirmed that the valve was not functional. “The remarkable thing is the patient was in fantastic shape, with the exception of his heart valve. He was completely active, with tennis and golf, lifting weights and running. He told his doctor, ‘I don’t have time to recover from open-heart surgery. I want to go running and play tennis this weekend.’”

New Devices, New Options for Physicians and Patients

“Transcatheter heart valves have been transformational for the management of valvular heart disease,” said Franklin. “When a patient’s aortic valve isn’t functioning, next is heart failure, then the organs shut down.”

Before 2012, when transcatheter heart valves became widely available, the gold standard for valve replacement was open-heart surgery, he said. “It is very difficult. It requires sawing down the front of the sternum, routing the blood through a machine, cutting out old diseased tissue and sewing in a new valve. For more than 50 years that was the only option, with a long and painful recovery, including rehab and serious potential complications. It is debilitating.”

Transcatheter technologies allow doctors to treat patients with a minimally invasive procedure, especially suited for those who are older, want a faster recovery or are not good candidates for surgery. The KardiaPSI balloon catheter, if approved, could help physicians further optimize and personalize the management of patients with aortic valve disease, dialing up their treatment millimeter by millimeter.

Like Flipping a Switch

Remarkably, this patient was discharged just four hours after the procedure. Other than his heart, the patient was “an extremely healthy individual,” said Franklin. “He was excited to get back to his active lifestyle. The procedure was on a Wednesday. I heard that he did play tennis that following weekend. He wasn’t wasting any time.”

A First for POBA Medical, Too 

Corvention’s work is supported through a collaboration with Flagstaff’s POBA Medical, which specializes in the design and manufacturing of balloon catheters. For the KardiaPSI device, POBA and Corvention completed the entire process, from raw materials to finished medical product, in Flagstaff.

“Dan Kasprzyk [POBA founder] and his team are incredible partners. We’re in and out of their facility, working side by side with technicians. That level of access and collaboration is rare. Our success and futures are definitely intertwined.”

Franklin has known Kasprzyk for nearly two decades as both a competitor and a customer. When Franklin approached him with the KardiaPSI concept, Kasprzyk immediately saw its potential and encouraged him to consider Flagstaff and Moonshot as a home base.

Founded in 2021, Corvention has been in Flagstaff since October 2024. Moonshot provides the medical startup with laboratory and office space, shared infrastructure and access to a broader entrepreneurial network. About 60% of Corvention’s 900-square-foot footprint is dedicated to lab space for testing and prototyping. “As a small startup, you don’t get lost here,” said Franklin. “We feel like we are part of this community.”

“Corvention is exactly why Moonshot exists – to give startups in rural Arizona the resources, space and community they need to do world-changing work,” said Moonshot President and CEO Scott Hathcock. “When you can develop breakthrough medical technology in Flagstaff and have your first human case save a life, that proves innovation doesn’t require a Silicon Valley zip code. It requires focus, collaboration and believing that entrepreneurs can build transformative companies anywhere.”

Franklin credits Flagstaff’s collaborative culture as a key advantage for startups.

“We were struggling to find a necessary item for our design verification test,” said Franklin. “We reached out to three other medical device companies in Flagstaff. Each of them responded the same day, offering assistance! That level of cooperation is unheard of in bigger markets.”

Growing Need, Global Impact

Weak or failing heart valves are a major and growing global health problem, affecting tens of millions of people worldwide and increasing as populations age. More than 100 million people are estimated to have some form of heart valve disease, a leading contributor to cardiovascular-related illness and death, particularly in older adults.

“Valve disease interventions are a $12-15 billion market globally,” said Franklin. “Two hundred thousand Americans a year need these procedures. Our long-term goal is to improve patient outcomes and make them long-lasting. There is still much to be done to optimize procedural results and extend the durability of these therapies, and we are here for it. Knowing we can help patients in the U.S. and around the world with what we are doing here in beautiful Flagstaff is inspiring.”

The Path Ahead

Today, the startup is awaiting U.S. Food and Drug Administration review for its first product offering. “Our initial focus is meeting unmet needs in structural heart care to enable better clinical outcomes. When patients feel good, they stay active and that changes everything.” Corvention plans to bring to market a diverse portfolio with a new product launch every year.

For Franklin, success is not about awards or recognition. “It’s about bringing new life-changing, life-saving products to doctors’ hands and seeing patients return to enjoying their life, going on vacation, spending time with their loved ones or like this patient, getting back out on the tennis court. That’s what drives me.”

Barry Gibb may have posed the question in 1971, but from a Flagstaff lab, Corvention is helping deliver an answer that beats on. FBN

Courtesy Photo: Corvention has been on the Moonshot Flagstaff campus since October 2024. Moonshot provides the medical startup with laboratory and office space, shared infrastructure and access to a broader entrepreneurial network.