Blue Belt's Navio PFS System receives CE Mark approval

Feb 24 2012

Blue Belt Technologies, Inc., a medical device company focused on developing the next generation of "smart" surgical instruments providing precise robotic control for use initially in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology ("ENT"), announced today that it has received CE Mark for the Navio™ PFS System.

The Company's initial market application in Europe is for Unicondylar Knee Replacement ("UKR") which is commonly known as partial knee replacement. A partial knee replacement is surgery to replace either the inside (medial) or outside (lateral) compartment of the knee with an implant. Partial knee replacements are bone-sparing and have been shown to provide better surgical outcomes for patients with cartilage damage contained to a single compartment when compared to total joint replacement. The majority of partial knee replacement surgeries are currently performed using instruments which can be inconsistent and lead to high revision and retreatment rates.

Blue Belt's Navio PFS System incorporates patented technology to provide additional control to surgeons via an intelligent, handheld, cutting tool coupled with powerful surgical planning and navigation software. The Navio PFS System provides the surgeon with a layer of safety and enhanced accuracy while performing bone shaping tasks through less invasive incisions. Jess Lonner, M.D., who is an Associate Professor of Orthopedics at Thomas Jefferson University and Co- Chair of Blue Belt's Scientific Advisory Board, said, "There is a growing role for partial knee replacement surgery as patterns of arthritis become better understood, particularly given the changing demographics and expectations of our patients. The capacity for pairing conservative unicondylar bone preparation with a unique level of precision sets the Navio PFS System apart from conventional technologies and should contribute to rapid functional recovery and enhanced durability."

Eric B. Timko, President and Chief Executive Officer of Blue Belt Technologies went on to say, "We are very pleased to receive CE Mark for the Navio PFS System. This initial clearance represents a significant milestone for Blue Belt and our efforts to become a leader in the field of Unicondylar Knee Replacement by providing the physician with a robotic instrument that provides for an accurate and consistent placement of the UKR implant, leading to a better outcome for the patient. We are excited to begin executing on our commercialization strategy in Europe and introducing the Navio PFS System to the physician community."