Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary neuro Optical Coherence Tomography (nOCT) Technology

Spryte Medical, a pioneering company in advanced medical imaging technologies, proudly announces that its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognition underscores the transformative potential of nOCT in neurointervention and cerebrovascular treatment.

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 pleased to be 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 that are 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.

Neuro Optical Coherence Tomography (nOCT) 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.

Dr. Demetrius Lopes, a leading expert in neurointervention, commented on the breakthrough designation:

"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. 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."

“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” said David Kolstad, Chief Executive Officer of Spryte Medical. “We look forward to working collaboratively with the FDA for the benefit of these patients.”

Spryte Medical’s nOCT technology promises to revolutionize the field of neurointervention, offering unparalleled imaging quality, safety, and ease of use. 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 our understanding of cerebrovascular diseases.

For more information about Spryte Medical and its breakthrough nOCT technology, please visit www.sprytemedical.com.

About Spryte Medical: Spryte Medical is an intravascular imaging, AI, and data company headquartered in Bedford, Massachusetts. 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 for the benefit of patients worldwide. 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.

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