Bioconnect Systems Gains CE Mark Approval for Optiflow Anastomotic System

Innovative Surgical Implant Enhances Surgeon's Ability to Create Arteriovenous Fistulae for Dialysis Access

AMBLER, Pa.--(BUSINESS WIRE)--Bioconnect Systems, Inc. today announced CE mark approval for the Optiflow™ Vascular Anastomotic System. The Optiflow™ enhances a surgeon’s ability to create precise vascular connections. The initial indication is the creation of an arteriovenous fistula needed for vascular access in hemodialysis patients.

“The Optiflow System aligns well with global initiatives to increase the rate of fistula placement and improve their function. We are encouraged by the results from our recent European clinical study.”

Prabir Roy-Chaudhury, MD, PhD, Professor of Medicine in the Division of Nephrology, University of Cincinnati, commented, “The creation and maintenance of vascular access in dialysis patients remains a major clinical challenge. While initiatives such as Fistula First are increasing the rate of fistula placement, studies have shown that up to 60% of these fistulae are not suitable for dialysis between four and five months after creation. Thus, there is a huge unmet clinical need for therapies which can improve fistula function and maturation. Early clinical experience suggests the Optiflow may improve patient outcomes for dialysis access.”

Adam Dakin, Bioconnect's President & CEO, added, "The Optiflow System aligns well with global initiatives to increase the rate of fistula placement and improve their function. We are encouraged by the results from our recent European clinical study."

About Dialysis Access

Approximately 350,000 patients in the US receive hemodialysis. Vascular access is required for hemodialysis and thus has a major impact on quality of life and cost of care. CMS spends over $1 billion per year on dialysis vascular access. Despite government sponsored initiatives such as Fistula First, less than 60% of prevalent patients in the US dialyze via an arteriovenous fistula.

About Bioconnect Systems

Bioconnect Systems is a med-tech company focused on improving dialysis access. The company's venture capital investors include Fidelity Bioscience, Cardinal Partners, and MentorTech Ventures.

Note: The Optiflow is an investigational device and not available for commercial use in the United States.