Startup aiming for FDA clearance to open 'floodgates' on heart surgery simulation software
By Carrie Ghose - Staff reporter for Columbus Business First
Columbus, OH — January 2023 – An Ohio State University spinoff whose AI-guided 3D modeling aims to reduce complications – and deaths – following heart surgery awaits key federal clearances this year to aim it toward “unicorn” territory.
Dasi Simulations LLC started in 2022 with two pilot customers. That grew to 40 hospitals by year-end, including several high-ranking cardiology programs.
One of Columbus Inno’s 2023 Startups to Watch, the Dublin startup aims for 100 clients this year, positive cash flow by mid-2024 and $75 million to $125 million in annual revenue within five years.
“As soon as we get FDA clearance, that opens the floodgates,” said co-founder and CEO Teri Sirset. “In our minds, we think this is a unicorn. … 2023 is going to be a telltale year for us.
“We have a first-mover advantage here,” she said. “We know there will be other companies hot on our tail. Our goal is to get the technology into as many hands as we can.”
The AI software models analyze pre-operative imaging to simulate how a patient’s unique physiology will work with different types of replacement valves and what complications could arise.
The target market encompasses more than 850 heart surgery centers.
Dasi has federal approval for limited use while awaiting full FDA clearance for software as a medical device. The company hopes that approval for use in two valve replacement procedures, as well as the OK from Medicare for insurance payments, comes by the second half of 2023, allowing broader marketing and more uses while eliminating financial barriers for adoption.
“The goal is to become the standard of care and have cost not be an issue,” Sirset said. “When simulation is talked about in this field, we want physicians to think: Dasi.”
Lakshmi Prasad Dasi, the software’s inventor, co-founder and CTO, had been an associate professor of biomedical engineering and surgery at Ohio State University, but left in late 2021 for a joint appointment at a Georgia Tech-Emory University biomedical engineering partnership.
The startup’s licenses are with four institutions and Dasi has filed independent intellectual property.
He founded the company in 2020 with Sirset, who has more than 25 years in medical device sales and navigating the regulatory landscape. Dublin will remain the headquarters, the partners said.
“It’s a pretty cool place to be right now,” Sirset said.
The company raised a $1.5 million seed round a year ago and a regulatory filing in July indicated the start of a new round with a goal of $5 million.
Typically startups do not comment on still-open rounds. Funding also includes $630,000 in grants from sources such as Ohio Third Frontier and federal research. The company has 25 employees.
Clients are using the software to plan surgeries and to retroactively review cases to see how they could have gone better. Some customers are using the software for research they hope to get published. Dasi is offering simulations in some high-risk cases at no charge.
More than a dozen medical device distributors also signed on as partners – effectively an external sales force for Dasi.
Last year, the startup added an experienced operator: COO Sean McKibben, formerly of Mount Carmel Health System, plus sales and finance executives with experience bringing fast-growing companies to IPO or acquisition.
OSU Wexner Medical Center was the flagship customer for the software. Dr. Scott Lilly, an OSU interventional cardiologist, worked with the team to develop the technology and how it’s used, Sirset said. The startup also added Atlanta’s Piedmont Hospital as a client. Most others don’t allow disclosure of their names.
Heart valve failures are the second most common cause of death from heart disease after coronary artery obstruction and about 11 million Americans have heart valve disorders.
Nearly 200,000 valve replacements are performed yearly and half of those are done via a catheter inserted through blood vessels instead of open-heart surgery.
Patients, who obviously don’t want their chests cracked open, pressure for the non-invasive option, Dasi said, but that can present different risks. Complications can include calcium deposits, leaks from poor fit, blood clots and even rupture of the aorta.
“We help the doctors and the patients understand these complex cases and quantify the risks for complications,” Dasi said. “The disease itself is very variable from patient to another.”
Looking at a CT scan, the doctor can’t assess anything but the size of the valve. The software augments that with simulations of how the patient’s unique anatomy would interact with different types of replacement valves – such as if inserting the valve with a stent could push calcium deposits into the aorta, causing disaster.
Since most valves need replacing within 10 years, the software also can simulate those future possibilities and recommend the best pathway to prepare for a lifetime of care.
Nearly 50 patients who were already on palliative care, basically awaiting death, because they were deemed too risky for surgery have been able to obtain procedures after re-evaluation with the software, Sirset said. Of those, half had successful valve replacements.
“We have already made an impact in so many high-complexity cases,” Dasi said. “We were highlighted at major cardiology conferences (in 2022). The physicians who are end-users are already so excited about the technology.”
“With the physicians being a champion for us, it makes our lives a whole lot easier,” Sirset said.