Article Published: July 21, 2014
Article Published: July 21, 2014
By Matthew Pross, Editor
After eight years of technology development, the founders of medical device firm Blue Belt Technologies Inc. were definitely ready to take their smart surgical instruments to market. The startup’s 2011 acquisition by New York-based HealthpointCapital LLC provided the opportunity. Now, less than three years after this pivot, Blue Belt’s Navio robotic surgical platform has been used in more than 350 unicondylar knee replacement (UKR) procedures in the United States and Europe, and is on the cusp of gaining approval for surgical application in two other orthopedic procedures.
“Throughout the eight years of product development, our focus was always on developing the technology to get it to market in order to benefit patients through diverse applications,” Craig Markovitz, co-founder and General Manager of Blue Belt Technologies, explained. “About three years ago, when private equity firm HealthpointCapital acquired us, we were able to transition from a primarily research-oriented company to a market-focused company under the leadership of Eric Timko.”
Markovitz, Anthony DiGioia III, M.D. and Branko Jaramaz, Ph.D. founded Blue Belt in 2003 out of a project initiated at Carnegie Mellon’s Robotics Institute. Markovitz served as the CEO of the company for seven years until the HealthpointCapital acquisition, when Timko was recruited to lead the company’s commercialization efforts.
“Blue Belt has always been a very milestone-driven company,” Timko, President and CEO, said. “Since transitioning the focus of Blue Belt to commercialization, this results-driven culture has enabled us to hit every milestone we have set. First, we sought and received CE mark approval for application of the technology in partial knee replacement (unicondylar knee replacement])surgeries in Europe. Then, we successfully sought FDA clearance for the same surgical application in the U.S.
“Since receiving regulatory clearance to use Blue Belt’s Navio technology in partial knee replacement surgeries, it took 18 months for the system to be used in 100 procedures because of our methodical approach to launching the system,” Timko continued. “We reached that milestone in November 2013 and things have really sped up in 2014 as we are in full-blown commercialization mode. Since then, our system has been used in an additional 250 procedures.”
The Navio system is a robotic surgical platform that combines “intelligent” hand-held bone-cutting instruments with computer-enabled guidance that provides surgeons with a higher degree of precision and consistency through computer-mediated visualization and planning. The system is built on an “open implant-architecture” platform, allowing for multiple supported implant systems.
“The Navio system allows me to offer my patients robotics-assisted partial knee replacement with results that are very accurate. I’m able to use the computer navigation to create a patient-specific plan, visualizing what my post-operative x-rays will look like before making a single cut,” says Brian Hamlin, MD orthopedic surgeon at Magee Women’s Hospital of UPMC. “My partial knee patients are typically able to go home the day after surgery, and perform very well during rehabilitation.”
In addition to application in UKR procedures, Blue Belt is currently seeking regulatory approval for two other orthopedic applications: patellofemoral joint replacement surgery and arthroscopic hip replacement surgery for treatment of femoroacetabular impingement. Due to its ergonomic approach to robotics, the Navio system has potential surgical applications outside of orthopedics as well. Timko said that in the future the technology could be potentially used in other surgical specialties, such as neurosurgery, spinal and otolaryngology (ENT).
“Our technology takes highly specialized surgeries to the masses,” Timko said. “Procedures that used to be incredibly difficult and niche are now becoming more common because of the enhanced surgical capabilities of the Navio system. Surgeons have already realized breakthrough results performing partial knee replacements with the Navio system. We are confident that wider application of this technology within orthopedics and in other specialties will lead to more routine surgeries at lower cost with improved patient results.”
For more information, check out www.bluebelttech.com.