Spryte Medical announced that the FDA has granted Breakthrough Device Designation (BDD) to its neuro optical coherence tomography (nOCT) technology.
Let’s start with this company.
Founded in 2023 and based in Bedford, Massachusetts, Spryte is an intravascular imaging-, artificial intelligence (AI)-, and data-based company.
Its focus: Using the AI-enabled, proprietary nOCT platform to capture—for the first time—high-resolution, intravascular imaging inside the brain.
The goal: Via this system, to accelerate the development of new therapies and collaborate with clinical partners in order to enhance procedural techniques and improve global patient care.
Before we get to this platform, explain this FDA designation.
Not to be confused with a BTD (Breakthrough Therapy Designation), a BDD is intended to expedite the development, assessment, and review process of certain medical devices for premarket approval, 510(k) clearance, or De Novo marketing authorization.
Once granted BDD, a company can receive FDA feedback on their device development via several options, as well as prioritized review for future regulatory submissions of the device.
Nice! Any other FDA-related news?
Yes! Spryte is also being included in the agency’s newly-launched Total Product Life Cycle Advisory Program (TAP), established by the Centers for Devices and Radiological Health.
Its purpose: To “spur more rapid development of high-quality, safe, effective, and innovative medical devices that are crucial to public health.”
And the goal: Similar to the BTD program, TAP seeks to expedite patient access to such medical devices by providing early, frequent and strategic communications with the FDA.
- Plus: The program also coordinates engagement with other key parties for developers of devices with public health importance
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,” the company stated.
Gotcha. Now let’s dive deeper into this platform.
The Spryte nOCT technology is an imaging probe designed to navigate through the brain vessels—a process dubbed “cerebrovascular navigation”—via standard neuro-interventional techniques.
The platform consists of:
- AI-powered console
- Optical module
- Fiber-optic, neuroendovascular probe
- Designed to navigate the brain’s small, tortuous vasculature
And how does it work?
The nOCT imaging probe transports a micro-optical fiber into the brain’s arteries, allowing for imaging to be captured from the inside out.
The system “uses backscattered light to produce these cross-sectional images of biological tissue with micro-meter resolution,” according to the company.
And the intent behind this?
This advanced form of optical imaging—called “intravascular optical microscopy”—provides a detailed visualization into the brain’s vascular anatomy at near-histologic levels.
Its more specific purpose: To enable improved diagnostic capabilities and insights into potential treatments for such conditions as:
- Brain aneurysms
- Ischemic stroke
- Atherosclerotic intracranial disease
So how does this compare to other intravascular imaging systems?
Whereas traditional intravascular imaging systems are typically intended for cardiology, nOCT is designed specifically for cerebrovascular navigation.
Plus, the system is reported to image vessels, disease, and other crucial structures at more than 10x the resolution of other imaging systems (including angiography and cone-beam computed tomography (CT)).
What clinical data is available on it?
Funny you should ask, as Spryte recently announced new research published in Science Translational Medicine regarding the first in-human study on nOCT.
The details: nOCT was performed on 32 patients undergoing routine investigation or treatment for cerebrovascular disease (endovascular procedure).
- The system imaged the anterior and posterior circulation of the brain, demonstrating volumetric microscopy of cerebral arteries
What’s the significance of this?
The study was the first research of its kind to demonstrate the capabilities of intravascular imaging for the brain as well as provide clinicians a better comprehension of the pathology linked to neurovascular disease.
“The initial nOCT clinical experience demonstrated consistently the ease of use, safety, and imaging quality,” noted Demetrius Lopes, a leading cerebrovascular neurosurgeon.
Other research on this technology can be found here.