Centerline Biomedical Successfully Completes First Preclinical Study

May 25, 2016 | News

Endovascular Navigation Innovator Centerline Biomedical Successfully Completes First Preclinical Study
In vivo study bolsters commercialization efforts

Cleveland, Ohio: Centerline Biomedical, a Cleveland Clinic spinoff company, successfully completed its first preclinical study evaluating its innovative endovascular navigation technology, IOPS, at the world-renowned Lerner Research Institute on Monday, May 2nd.

Centerline’s advanced surgical navigation system was shown to provide the surgeon with a precise 3D “GPS-like” tool without the harmful effects of radiation currently associated with X-ray fluoroscopy. Specifically, catheters and guidewires were easily visualized on the IOPS display, and the system allowed for excellent accuracy in navigating through the arteries.

The successful completion of this first preclinical study is a significant step in Centerline’s development efforts. Company President Dr. Vinod Goel stated, “We are excited about reaching this important milestone as we launch our campaign for Series-A financing. This study is an important step in taking us to our goal of FDA regulatory submission, with market entry targeted in the third quarter of 2017.”

Endovascular surgeries such as stenting currently rely on X-ray fluoroscopy, which exposes surgeons and patients to cancer-causing radiation. X-ray imaging also provides limited two-dimensional visualization, making navigation and positioning a challenge.

The study, led by Cleveland Clinic surgeon Dr. Matthew Eagleton, an international expert on minimally-invasive aortic surgery, demonstrated IOPS’ ability to provide non-radiation-based navigation with superior visualization compared to fluoroscopy.

“Preclinical evaluation of the IOPS system verified the ability to use this navigation system in manipulating through the aorta and its branches in the absence of radiation-inducing fluoroscopy,” said Eagleton. “This will be a game-changer in the era of endovascular therapy.”

Centerline Chairman and CEO Dr. Jai Gupta added, “This highly innovative IOPS technology has the global potential to impact positively the lives of a large number of patients and caregivers alike.”

About Centerline Biomedical:
Centerline Biomedical, Inc., a Cleveland Clinic spinoff founded in 2014, is a joint venture of G2 Group Ventures and Cleveland Clinic that is commercializing the Intra-Operative Positioning System (IOPS), an innovative 3D endovascular surgical navigation technology that aims to reduce radiation exposure to patients, surgeons, and other caregivers while improving outcomes and reducing health care costs. Centerline has a working manufacturing prototype of IOPS, which was used in this preclinical study.