DASI Simulations is Scaling Up Fast

With FDA Approval, Onboarding Dozens of Hospitals, and Hiring Strategic Talent, DASI Simulations is Scaling up Fast

When a medical technology company receives FDA clearance for its first product, it’s a huge accomplishment that opens many doors.

Visionary dreams become the next steps. Hospitals, physicians, and insurance providers want to talk. The inspired entrepreneurs and scientists building such a company become even more tenacious about signing up early adopters and saving lives.

That scenario describes the exciting 2023 journey of DASI Simulations. This young, medical technology enterprise received FDA clearance for Precision TAVI, the first FDA-approved, AI-driven, predictive modeling tool for heart valve replacement procedures.

Using AI to Help Deliver Rapid Precision Medicine for Heart Valve Replacement

Teri Sirset, CEO, and Lakshmi Dasi, Ph.D. CTO founded DASI Simulations in 2020.

“Dr. Dasi is an extreme visionary and was using artificial intelligence (AI) in 2013 before so many people knew what it was. It was exciting to be on the cutting edge of something that was going to be so disruptive,” Sirset said.

More than five million Americans are diagnosed with heart valve disease each year. For many of those, highly skilled physicians and surgical teams replace faulty heart valves in a widely used procedure called TAVR (transcatheter aortic valve replacement).

DASI’s Precision TAVI allows these physicians to predict and visualize the interaction between various heart valve replacement devices and a patient’s unique anatomy. The simulation helps physicians and surgical teams deliver the expected surgical outcomes in heart valve replacement procedures.

AI in Healthcare Is a Learning Opportunity for All

“Esteemed healthcare professionals and reputable institutions acknowledge the need for continuous improvement and express enthusiasm for leveraging our technology to enhance patient care,” Sirset said. “Our commitment to flexibility with valves and personalized solutions has garnered a positive reception without encountering resistance from stakeholders. In light of the growing impact of AI in healthcare, coupled with the anticipation of FDA clearance, our trajectory aligns perfectly with the evolving landscape of medical advancements.”

That “right place” has been engaging with the Centers for Medicare and Medicaid Services (CMS) to establish Medicare reimbursement codes for Precision TAVI. FDA approval opened the path for the reimbursement process between providers and payers (hospitals, Medicare, Medigap, and private insurance companies). Prevision TAVI is a new FDA classification category—SaaS (software as a service) classified as a medical device.

“Breaking new ground proved to be a formidable challenge. DASI’s initial FDA submission faced rejection just before last year’s holidays,” shared Sirset. “It was a heart-wrenching moment for the team and for me personally. I needed to find a way to uplift them, but to my surprise, they were the ones uplifting me. It speaks volumes about the resilience of this team—they refuse to be disheartened by setbacks.”

“The FDA clearance process was a learning curve for us and for the FDA,” said Taylor Becker, DASI’s Director of Product. “They are learning so much about AI in healthcare, and we are on the cutting edge. That’s why the FDA put us through such a rigorous validation and verification process. They had to be extremely accurate, very strict, and clearly define the acceptance criteria. It was a collaboration—they validated us on hundreds of cases.”

Building Out Company Structure and Founding Team While Keeping Patients at the Center

“Patient care is at the center of everything we do at DASI. It’s like nothing I have ever experienced,” Sirset said. “We have zero experience in doing so many things, we teach ourselves and motivate ourselves. Our employees are so solution-oriented when we fail, they try something else. it’s all about being driven by caring about the patients. Last year we had three users. This year we have more than 75. That’s 1200 percent growth.”

Adding people has been a sprint. From participating in Rev1’s Customer Learning Lab in May 2021 to today, DASI Simulations has grown to almost 25 employees and contractors working full-time.

“Less than three years ago, we initiated our journey at Rev1, occupying a single room. Today, as we undergo significant expansion, we are strategically aligning all the components—onboarding new staff and integrating with hospitals simultaneously. The process poses its challenges, especially as we bring in a number of new team members. As we evolve, we maintain a highly discerning approach to recruitment and culture-building. Nonetheless, our team embraces this duty with unwavering dedication each time they enter the workplace,” said Ann Patterson, Chief People Officer.

Taylor Becker sums it up.

“I wouldn’t get a valve put in my heart unless my medical team had a DASI Simulation,” she said. “We are growing with pains. We get knocked down and get back up. We are building a team that is so focused on putting the patient first that the patient is at the core of every decision. Our goal is to provide the highest quality computational technology anywhere a medical device interacts with the human anatomy.”