Fast-growing startup company continues to execute key milestones and begins first in-market use of novel endovascular navigation technology
Surgical navigation startup Centerline Biomedical, Inc. (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 IOPS™ technology platform. The FDA-cleared technology is being deployed at Cleveland Clinic to begin, with other leading institutions to follow, in preparation for larger-scale multi-center 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.
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.”