By Janelle Mallett, Veins 1 Staff
Patients with end-stage renal disease, due to irreparable kidney failure, must have their blood purified outside the body as much as three times a week. Biolink Corp, a medical device start-up in Middlebury, MA, raised $15.6 million in a private financing to advance the development of its vascular access system in the United States and to fuel the product's European introduction.
Biolink's product, Dialock, is a vascular access tool designed to reduce common complications associated with hemodialysis. Vascular access products are used to access the blood easily, but conventional devices do not last long, have a high rate of infection, and blood clots, and limit blood flow. Some of these products also protrude from the neck or chest, an unappealing quality for many patients. Studies show that other products have also compromised the heart's function by increasing the cardio load.
Biolink believes that its device can solve many of these problems. Its Dialock device consists of a titanium port, two catheters, and a liquid solution used between dialysis treatments. Surgeons implant the device beneath the skin in the upper chest area. It connects to the catheters between treatment to fight off thrombosis, blood clotting, and infection.
Several sites in Europe, where most elements of the device are already approved, have reported a high rate of patient self-access with the devices, opening up the possibility for Dialock to compete in the home-based hemodialysis market. The company plans to complete the U.S. human clinical trials for Dialock later this year. Once these trials are complete, the company will apply for marketing approval with the Food and Drug Administration.
The market for vascular access devices is $3 billion worldwide, including the money spent on access procedures and the repair and replacement of old devices. Frank Prosl, founded Biolink four years ago; he is also known for his innovations in chemotherapy access devices.
Patients who will be starting hemodialysis treatments should work with their health-care team to learn how the treatments work. Consult your doctor about the different types of vascular access to ensure that the blood is easily and efficiently removed and replaced, while causing the least complications. For more information about vascular access for hemodialysis, visit:
Stringer, Judy. "Financing Gives Biolink Device Plans New Blood." Mass High Tech. Feb 14-20, 2000.