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Company Profile: 510Kardiac Devices, Inc.

With the global population exceeding 7 billion and thousands reaching an advanced age every day, cardiovascular disease continues to rise and remains the leading cause of death in the US. Catheter-based procedures used to treat a multitude of heart problems ranging from valve disease to rhythm issues are simultaneously increasing as an appealing alternative to invasive surgery. However, catheter technologies and surgical techniques for these non-invasive procedures have gone unchanged for decades.

Scott Lim, M.D., an interventional cardiologist and the Director of the Advanced Cardiac Valve Center at the UVA Health System conceptualized a medical device that would improve outcomes for heart surgery patients, and make it easier and safer for surgeons to execute operations on the left side of the heart.

“Accessing the left side of the heart is becoming so common with catheter procedures that there needs to be a safer, more efficient, and more accurate way to do it,” said Lim.

The current method to access the left side of the heart is a catheter-based procedure known as a transseptal puncture. This technique allows a direct route to the left atrium and minimizes the risk of arterial bleeding. Navigating a catheter through veins in the right side of the heart and puncturing the septum to access the left side is extremely challenging, especially with tools that are hard to control.

Dr. Lim partnered with Jaime Sarabia whose 18 years of experience in medical device ventures include being one of the lead mechanical engineers with the Evalve Corporation which developed the MitraClip heart implant and was acquired by Abbott for $410 million in 2009. Sarabia shepherded Lim’s idea for a device into what is now known as the Lim Transseptal System (LTS).

The LTS is a surgical instrument designed to improve efficiency and precision when crossing the interatrial septum and targeting specific locations within the structure of the heart. The goal of the device is to reshape catheters to better maneuver through the veins and cross from one side of the heart to the other with maximum visibility. 

“Rather than accepting what anatomy gives to you, the LTS will drive the catheter to precise locations giving surgeons a much better starting point and thus better outcomes for patients,” said Sarabia.

In 2015, Dr. Lim and Sarabia worked with UVA LVG to license the intellectual property for the LTS and to launch a new venture, 510 Kardiac Devices, Inc. Since its inception; the company has contracted with a manufacturer, designed six generations of functioning prototypes of the LTS 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.

The UVA LVG Seed Fund invested in the company in 2018 to support the FDA approval process of the device which is on track for 2019. Investment during the early stage of commercialization of a device like the LTS epitomizes why LVG created the seed fund. The impressive professional experience and collaboration between Lim and Sarabia instilled the necessary confidence for UVA LVG to not only invest in the company but to also attract several other investors including Minnesota-based Nexturn, Inc.

“Any new technology, even if it’s fascinating and great, takes money to bring it to market,” said Lim. “But the UVA Licensing & Ventures Group has also been quite generous with their time and their advice. It’s a tremendous partnership for us.”