'To the moon' – Ohio State spinoff gets FDA approval for heart surgery simulation software
By Carrie Ghose – Staff reporter for Columbus Business First
Columbus, OH — June 6, 2023 – Lakshmi Prasad Dasi opened the email from the U.S. Food and Drug Administration, then the attachment.
The inventor and CTO of DASI Simulations LLC called his co-founder, CEO Teri Sirset, as she was driving to the Dublin office.
“He’s just like, giggling, and I go, ‘Whaaat’s going on?'” Sirset said. “And then I’m the one that screamed, actually, bounced around and caused a ruckus.”
The startup’s AI-guided 3D modeling software for visualization and planning of heart valve replacement surgery received FDA clearance on May 30 as a medical device, DASI Simulations announced Tuesday. That means wider marketing, use in more procedures and insurance reimbursement.
“It’s really another thing important to note that it takes years and years for products to get cleared,” Sirset told Columbus Inno in an exclusive interview. “We managed to get this cleared in record time – 15 months.”
Someone wrote on the break room whiteboard: “To the moon!”
DASI Simulations spun out of Ohio State University in December 2019, and in early 2022 launched a pilot with two customers, one of them being OSU Wexner Medical Center.
Heart surgeons at more than 50 heart centers nationwide are using the software in some form. But so far, only two were paying; DASI Simulations has largely not charged for use while collecting efficacy data, Sirset said. Nearly 20 clients are in the process of signing on.
With the FDA approval, the company is preparing to livestream surgeries and present at major cardiology conferences.
“Our physicians that currently utilize us are an organic sales force for us, where they’re talking to their colleagues,” Sirset said. “This is revolutionizing how (they) pre-plan these procedures.”
One of Columbus Inno’s 2023 Startups to Watch, the startup aims for about $1 million in software subscription revenue in the coming year and $125 million in annual revenue within five years, she said. That represents about 15% of procedures, so there’s room to grow from there.
DASI Simulations had federal approval for limited use of the software, called Precision Tavi, but the extra step of full medical device clearance allows use in more procedures – and, more importantly, a Medicare code that means federal and commercial insurance can pay for it.
“It allows us to go full-blown commercialization now,” COO Sean McKibben said. “I think the investor community will respond really well to FDA clearance.”
As it expands sales, the startup could seek to raise a Series A venture capital round next year. The 13-person company also has a second product going through the FDA process, complementary AI software analyzing more structures in the heart.
“(FDA clearance) gives us the credibility to investors, for them to know that this company is here to stay – and that we mean to become the standard of care,” Sirset said.
The AI software analyzes pre-operative 3D imaging to simulate how a patient’s unique physiology will work with replacement valves of different manufacturers and sizes as well as what complications could arise. Today that process is done by hand, measuring a 2D image with a ruler.
“We have a retrospective database, where dozens of patients would be alive today, had our technology existed a number of years ago,” McKibben said.
In 2020, Ohio State published a study on using the software to plan 600 procedures. Out of 28 cases that would have been deemed too risky for surgery under manual measurement, the software found a valve that fit in 22 – clearing them for the replacement and preventing further damage to the heart.
“For the first time, physicians can literally predict what will happen when they use device A compared to device B, and be able to then make their decisions more personalized for that patient,” Dasi said.
The target market encompasses more than 850 heart surgery centers. Nearly 100,000 aortic valve replacements are performed yearly.
Dasi developed the software while an OSU associate professor of biomedical engineering and surgery, working side by side with medical center surgeons frustrated with the lack of tools for planning valve replacements, leading to that 2020 study.
He left in late 2021 for a joint appointment at a Georgia Tech-Emory University biomedical engineering partnership in Atlanta, splitting his time between academia and the startup.
“To make an improvement in … overall patient outcomes was really what was driving me,” Dasi said. “I knew that something disruptive like this would not just be picked up by the valve companies. It requires persistence from us as founders to really walk this through, all the way to commercialization, all the way to reimbursement.”