DASI Simulations Receives FDA Approval for Precision TAVI, its Revolutionary Heart Care Solution
DASI Simulations, a pioneering healthcare technology company that was developed at the Ohio State University, has obtained FDA approval for its flagship product, Precision TAVI. Leveraging advanced artificial intelligence (AI) and individualized computer predictive modeling, DASI Simulations aims to significantly enhance patient outcomes, improve lifetime planning, and reduce costs associated with the treatment of structural heart disease.
DASI Simulations, founded by Chief Executive Officer Teri Sirset, and esteemed researcher and Chief Technology Officer, Lakshmi (Prasad) Dasi, Ph.D., FACC, FAIMBE, empowers heart teams with invaluable insights to ensure the provision of optimal care for individual patients, tailored to their unique circumstances and anatomy. “Our groundbreaking technology enables us to create a digital twin of each patient, Dasi said. “Healthcare professionals can test out different options to see which would work best before moving on to the real patient. This helps recognize the potential for complications ahead of time and makes the actual procedure in the operating room easier with no surprises.”
Heart valve disease affects more than five million Americans annually, with a significant portion of patients requiring surgical intervention to replace the damaged valve. Over a lifetime, multiple interventions may be necessary, underscoring the criticality of comprehensive care planning. Transcatheter aortic valve replacement (TAVR), a minimally invasive procedure, has emerged as the gold standard for replacing diseased aortic valves. TAVR involves accessing the heart through a small incision in the leg or groin and using advanced imaging techniques to precisely place a new replacement valve. In 2021 alone, over 91,000 TAVR procedures were performed, reducing the need for high-risk open-heart surgeries. DASI Simulations handles using the technology and then communicates the results with hospitals—reducing the need to train hospital staff and streamlining the process.
“The market that we're addressing really touches everybody,” said Teri Sirset, Founder and CEO of DASI Simulations. “This technology is software as a service. This means we do all the simulations for them in the cloud. And then we provide the reports back to them for use to do shared decision making with the patient and the family.”
DASI Simulations’ groundbreaking approach has paved the way for the first-ever FDA approved personalized computer simulations in the heart valve space. Despite the typical lengthy approval process, DASI Simulations achieved this significant milestone in less than 14 months. The technology was first developed at Ohio State in 2015. Some of the students who were in Dasi’s lab are now full-time employees for the company.
“We have an awesome team of engineers who worked tirelessly throughout this process,” said Teri Sirset, Founder and CEO of DASI Simulations. “We did a lot of clinical studies to show the improvement in patient outcome and the efficacy of the technology itself.”
The foundational technology behind Precision TAVI was initially licensed through Ohio State and subsequently through an inter-institutional agreement involving, Georgia Institute of Technology, Emory University, and Piedmont Hospital Atlanta.
Ohio State’s Technology Commercialization Office (TCO) has emerged as an essential partner linking groundbreaking research to the marketplace. With Ohio State innovators making groundbreaking discoveries in fields with significant implications for human welfare such as healthcare, manufacturing, mobility, energy, and security, the TCO plays a pivotal role. Taking charge of safeguarding intellectual property, licensing cutting-edge technologies, and orchestrating coordination among various institutions, the TCO has played an enabling role with DASI simulations.
"Ohio State University's Technology Commercialization Office works closely with innovative university researchers and companies delivering impactful solutions to the market, like DASI Simulations," said Kevin Taylor, Sr. Associate Vice President of Technology Commercialization at The Ohio State University. "We are excited to see Precision TAVI receive FDA approval and look forward to DASI Simulations continued success.”