Spryte Medical Gains Breakthrough Device Status for nOCT Tech

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Spryte Medical’s neuro Optical Coherence Tomography (nOCT) technology. 

The FDA’s Breakthrough Device Designation is awarded to innovative technologies that offer significant advantages over existing alternatives in treating or diagnosing life-threatening or irreversibly debilitating diseases. This designation not only recognizes the potential revolutionary impact of nOCT but also expedites its development and review process, supports reimbursement and timely access for patients and healthcare providers.
 
Spryte Medical is also included in the FDA’s new Total Product Life Cycle Advisory Program (TAP), which aims to help speed development of high-quality, safe, effective, and innovative medical devices critical to public health. Participation in the TAP program will provide Spryte with valuable feedback and support from the FDA, further accelerating the path to market for nOCT technology.

“Our engagement with the FDA through the Breakthrough Device and Total Product Life Cycle Advisory Program (TAP), highlights the potential of Spryte Medical’s neuro OCT imaging platform for patients with cerebrovascular disease” Spryte Medical CEO David Kolstad said. “We look forward to working collaboratively with the FDA for the benefit of these patients.”
 
Neuro Optical Coherence Tomography represents a significant leap forward in neurointervention. Unlike traditional intravascular imaging systems designed primarily for cardiology, nOCT is specifically engineered for cerebrovascular navigation. This advanced intravascular imaging technology allows for detailed visualization of the brain’s vascular anatomy at near histologic levels, to provide improved diagnostic capabilities and enhance treatment precision.
 
“Neurointervention has had an incredibly positive impact on the treatment of cerebrovascular conditions. nOCT intravascular imaging will allow us to advance the field even further. With this technology we will be able to better visualize disease and devices, guide our decision making and deliver even better patient care,” noted Dr. Demetrius Lopes, a leading expert in neurointervention. “I have followed the development of intravascular imaging in cardiology for many years. I always believed that OCT information could have an even greater impact in neurointervention outcomes and I am excited to bring the benefits of this technology into the brain for the first time ever. Spryte nOCT was developed specifically with neurointervention in mind and has the potential to overcome the many limitations that prevented its use in the neurovasculature previously. The initial nOCT clinical experience demonstrated consistently the ease of use, safety, and imaging quality. This is a dream coming true… our patients will benefit the most.”
 
Spryte Medical’s nOCT technology offers unparalleled imaging quality, safety, and ease of use, according to Spryte Medical. By providing clinicians with detailed, real-time images of the brain’s vascular structures, nOCT is designed to enable more precise interventions, potentially improving patient outcomes and advancing the understanding of cerebrovascular diseases.
 
Spryte Medical is an intravascular imaging, AI, and data company headquartered in Bedford, Mass. The unique imaging and data platform is purpose-built to accelerate understanding of target diseases, facilitate the development of novel therapies and ensure optimal treatment delivery. Spryte has selected neurovascular disease as the company’s initial area of focus. While intravascular imaging has contributed to significant improvements in cardiovascular care, the fundamental limitations of current technologies have precluded their use in the small, tortuous, intracranial vasculature. Spryte’s technology, however, overcomes these limitations and integrates with established procedural workflow, providing it the opportunity to become the first and only intracranial imaging technology available to clinicians worldwide that enables both intraluminal imaging as well as volumetric microscopy of the neurovascular vessels.