Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary neuro Optical Coherence Tomography (nOCT) Technology
July 22 2024 - 8:00AM
Business Wire
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240722486759/en/
Media Contact Tara DiMilia 908.947.0500 x700
Tara.DiMilia@tmstrat.com