Centerline Biomedical, Inc., announced on January 22nd that the company submitted a 510(k) premarket notification application to the United States Food and Drug Administration (FDA) for its flagship product, the Intra-Operative Positioning System, or IOPS.
IOPS, a non-radiation-based surgical navigation system for minimally invasive surgery, leverages patented anatomical mapping and modeling algorithms and safe electromagnetic tracking technology to provide spectacular and intuitive three-dimensional color visualization and guidance in real time during an endovascular procedure. The technology, originally developed at Cleveland Clinic’s Heart and Vascular Institute, will provide a much-needed path away from the harmful cancer-causing X-ray fluoroscopy which is currently the standard of care, despite severe visualization challenges.
The IOPS technology is able to transform patient scans into a mathematical representation, facilitating computational applications. Initially these models are being applied to the task of navigation, but the company sees a future in which these data in aggregate become the basis of a game-changing analysis and guidance system. Recently appointed chief executive Mark Modica remarked, “We’re like Google Maps for the human body. When Google started working on Maps, GPS and street maps were nothing new. But when they collected enough data about the streets, when they encoded it in a way that made sense to their machines, when they applied AI and machine learning to extract information that had never been encoded before – that’s what made Google Maps a game changer. That is what we will do for the inside of your body.”
Modica, who joined Centerline in December, comes from a background of over 30 years in technology-based startup companies. In various C-level roles he has built, funded, and operated venture-backed startups working in healthcare, security, cloud infrastructure, and machine learning. In addition to being involved in several hundred million dollars’ worth of fundraising, he has navigated exits including two IPOs and several successful acquisitions by Fortune 500 companies.
According to the company’s CTO, Vikash Goel, once the 510(k) is granted by the FDA, it will allow marketing and commercial use of the IOPS system for endovascular aortic interventions. The company plans to expand indications as development continues. Although the review of the submission may depend on a federal appropriations bill or a continuing resolution, the company did receive acknowledgement from the FDA that the submission was received. The company is currently raising Series B funding in anticipation of market entry. Company chairman Dr. Jai Gupta noted the company’s rapid progress towards commercialization. “We are thrilled to have made this submission to the FDA and we look forward to working with the Agency to achieve clearance to market. With Mark raising funds and Vikash at the technical helm, Centerline is exquisitely poised for a market launch later this year.” For further information, please visit centerlinebiomedical.com.