The University of Virginia Licensing & Ventures Group (LVG) Seed Fund announced today its fourth investment – 510 Kardiac Devices, Inc. (510 Kardiac). 510 Kardiac is an early stage medical device company developing novel technologies for cardiovascular surgical procedures.
The investment will accelerate the company’s efforts to obtain FDA approval for the Lim Transseptal System (LTS), a surgical instrument designed to provide increased control and visibility for physicians targeting specific locations within the structures of the heart. During catheter-based operations, the most effective way to access the left atrium of the heart is through transseptal punctures. The LTS device aims to increase the precision and effectiveness of the technique during advanced cardiac procedures.
Dr. Scott Lim, the namesake of the device, is an interventional cardiologist and the Director of the Advanced Cardiac Valve Center at the University of Virginia Health System. He co-founded 510 Kardiac with the company’s current CEO, Jaime Sarabia, a mechanical engineer with more than 18 years of experience in medical device ventures.
“Our investment in the 510 Kardiac LTS device at this early stage epitomizes why UVA created this Fund,” says Bob Creeden, Managing Director of the UVA LVG Seed Fund. “By showing institutional support for a UVA developed technology, we attracted several other investors including Minnesota-based Nextern Medical to help fund the company through their next stage of development.”
Since its inception in 2015, 510 Kardiac has contracted with a manufacturer, designed six generations of functioning prototypes of the LTS device and conducted a successful pre-clinical study. In preparation for regulatory approval and initial commercialization, the company implemented a quality control system with completed molds, packaging, and labeling design for the device. Each of these components along with a sound regulatory plan ensures that 510 Kardiac is well positioned to seek FDA approval of the LTS device.
“We are grateful to have support from the UVA LVG Seed Fund as we prepare for FDA approval and approach commercialization of the LTS device,” says Jaime Sarabia, CEO of 510 Kardiac Devices. “Our team has worked through the necessary research and development, and we believe this device will significantly improve the functionality, visibility, and precision needed to perform transseptal punctures.”
Like the three other companies in the UVA LVG Seed Fund portfolio, 510 Kardiac underwent an extensive due diligence process and earned approval from the Seed Fund Committee. The committee is comprised of five UVA alumni who are all leaders in early-stage investing and startup development.