Cleveland Clinic spin-off startup Centerline Biomedical completes its first human patient trials in the U.S. with IOPS

Surgical navigation startup Centerline Biomedical (Centerline), a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series clinical cases in the United States as it begins limited launch of its innovative Intra-Operative Positioning System (IOPS) technology platform.

The IOPS is a 3D GPS-like surgical navigation technology that allows for surgical precision and controlled, simplified complex procedures, and reduced radiation exposure for patients and healthcare professionals. The FDA-cleared technology is being deployed at Cleveland Clinic to begin, with other leading intuitions to follow, in preparation for larger-scale multicenter clinical studies.

First employed clinically overseas in October 2019, IOPS™ offers an alternative to the heavy dependence on 2-D fluoroscopic X-ray imaging in minimally-invasive vascular surgery. Cleared as an adjunct to fluoroscopy for descending aortic interventions, IOPS™ provides interactive, color, 3-D visualization for precise surgical navigation of guidewires and catheters manipulated inside the body.

Founded in 2014, Centerline Biomedical is based on technology developed at the Cleveland Clinic. Centerline’s mission is to develop advanced navigation systems that initially target interventional vascular procedures.

Cleveland Clinic vascular surgeon Dr. Behzad Farivar performed the surgery. This first U.S. clinical case represents a leap forward for the technology, which has rapidly progressed from initial concept to today’s commercially-ready solution. “Considering we were in the research lab a scant 5 years ago, we couldn’t be more excited about kicking this series off,” commented Vikash Goel, the company’s CTO. “This positive first experience confirms our belief in our technology’s value and transformative potential.”

This milestone comes on the heels of several key achievements made over the past year, including achieving FDA clearance, closing on $10 million of financing, and recruitment of high-powered personnel for key operational, sales, and advisory roles. “We continue to execute on our goals despite the challenging times our world faces,” said Centerline CEO Philip D. Rackliffe. “Transitioning back to providing elective care will be a tumultuous process for hospitals, and clinical experts believe IOPS™ can help streamline this process with enhanced safety.”