How Do You Mend a Broken Heart?

More than 50 years since Barry Gibb topped the record charts with his lyrical question, “How Do You Mend a Broken Heart,” Corvention, housed at the Moonshot Flagstaff campus, made history January 7, with what may well be the world's best answer to date. The medical device company's innovative KardiaPSI Balloon Catheter™ – made in Flagstaff – was used in the first human case, restoring a fit 78-year-old's heart and sending him back to the tennis court days after heart surgery.

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 new 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 placed in 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 existing medical technology, said Corvention CEO Michael Franklin.

The patient had severe aortic stenosis, which caused the valve to not open properly. It had calcified and blood did not flow well, starving organs of oxygen. He also had severe aortic regurgitation – the blood flowed backwards, 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 no longer allowed him to live his life. Having a complete 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 problems that had previously been repaired. 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,” Franklin said. “He felt the same way he did the first time, before he got a valve replacement. He told his doctor: 'I'm short of breath. I can't get up and walk around. I can't exercise. I have no energy.'”

The doctor confirmed that the valve was not working. “The remarkable thing is that the patient was in fantastic shape, with the exception of his heart valve. He was fully active, with tennis and golf, weight lifting and running. He told his doctor, 'I don't have time to recover from open heart surgery. I want to run and play tennis this weekend.' “

New devices, new options for doctors and patients

“Transcatheter heart valves have been transformational for the management of valvular heart disease,” Franklin said. “If a patient's aortic valve is not functioning, the next thing 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's very difficult. It requires shooting the front of the sternum, sending the blood through a machine, cutting out old diseased tissue and sewing a new valve in. For more than 50 years, that was the only option, with a long and painful recovery, including rehab and serious potential complications. It's debilitating.

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

Like Flipping a Switch

Interestingly, this patient was discharged exactly four hours after the procedure. Other than his heart, the patient was “an extremely healthy individual,” Franklin said. “He was excited to get back to his active lifestyle. The procedure was on a Wednesday. I heard he played tennis the following weekend. He wasted no time.”

A first for POBA Medical, too

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

“Then Kasprzyk [POBA founder] and his team are incredible partners. We are in and out of their facility, working side by side with technicians. That level of access and collaboration is rare. Our success and future 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 home bases.

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 wider 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,” Franklin said. “We feel like we're 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 that innovation doesn't need a Silicon Valley zip code. It requires focus, collaboration and belief that entrepreneurs everywhere can build transformative businesses.”

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 help! That level of collaboration is unheard of in larger 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 disease and death, especially in older adults.

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

The path forward

Today, the startup is awaiting review from the US Food and Drug Administration for its first product offering. “Our first 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 a diverse portfolio to market 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 into the hands of doctors and seeing patients come back to enjoy their lives, go on vacation, spend time with their loved ones or like this patient, get back on the tennis court. That's what drives me.”

Barry Gibb may have asked the question in 1971, but from a Flagstaff lab, Corvention is helping to provide an answer that rings true. FBN

Thanks to 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.