Bluegrass Vascular Technologies, (privately held) and a leading innovator and global manufacturer of lifesaving devices and methods based on the Inside-Out® vascular access procedure, today announced the closing of a $5.0 million financing in convertible promissory notes to a group of qualified investors, including new investors and existing shareholders who participated in previous capital raises.
“This infusion of new capital is important as it supports the commercial expansion of the Inside-Out® technology and our flagship product Surfacer® System in the U.S. and target global geographies,” said Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “We appreciate the ongoing support of our loyal shareholders and the trust new investors have placed in the company as it underscores their commitment and alignment with our vision to improve central venous access related patient outcomes and reduce healthcare costs.”
The Surfacer System employs the novel Inside-Out approach and is the first FDA cleared medical device to facilitate upper body central venous access in patients with venous obstructions or other conditions that preclude access by conventional methods. The Surfacer System received U.S. FDA De Novo clearance in February 2020.
The Centers for Medicare and Medicaid Services (CMS) established a unique Healthcare Common Procedure Coding System (HCPCS) code for procedure associated with the use of the device (C9780) and assigned the procedure to a New Technology APC (1534) effective October 1, 2021 which has a Medicare national average payment rate of $8,250.50.
“The Surfacer System superior clinical performance continues to be demonstrated as evidenced by the expanding list of publications, and acceleration in commercial use,” said Mark Horsey, CFO of Bluegrass Vascular. “With the new CMS code, demand for the Surfacer System is rapidly expanding and is the basis for the strong investor community response to the company’s present financing effort.”
About the Surfacer® Inside-Out® Access Catheter System
The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the right femoral vein and navigating it up through the patient’s venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers. The Surfacer System has received FDA De Novo device clearance in the US and is CE marked in Europe. The device is currently distributed in North America and Europe by Merit Medical, a global manufacturer and distributor of medical devices.