Radical™ Catheter Technologies, a medical device company pioneering the next generation of endovascular access and delivery products, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Radical Catheter, the first significant advance in catheter technology in more than three decades.
This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery (SNIS) 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors (NTI), which will be used to scale the company and expand the Radical platform.
“While catheters are the foundation of every neurovascular procedure I perform, current gaps in catheter technology fundamentally limit complex life-saving procedures. The operators in this pilot experience consistently commented on a number of advantages to the Radical Catheter, including greater flexibility to access targeted areas, more stability and increased durability,” said Christopher Kellner, MD, cerebrovascular neurosurgeon, Mount Sinai Health System, while presenting the initial clinical analysis. “In our initial case series, the Radical catheter consistently reached further territories of the brain than we are accustomed to with conventional catheters. With this dramatically better performance, I expect to be able to more easily address complex procedures.”
The analysis evaluated a wide array of neuroendovascular procedures including treatments for aneurysms and stroke that were performed by 14 operators across six hospitals in four institutions, consisting of Cleveland Clinic, Mount Sinai Health System, Prisma Health and University at Buffalo. Findings indicate that Radical Catheter demonstrated best-in-class performance, including:
- Catheterization of the target vessel 100% of the time
- Ability to reach an intracranial position in all anterior circulation treatment procedures
- No device failures or device-related adverse events
- Elimination of the need for and use of intermediate catheters in the majority of procedures in which one would have typically been used, due to ease of distal access with the Radical Catheter
In total, this retrospective analysis of 85 neuroendovascular procedures included 72 trans-arterial and 13 trans-venous cases. Of these procedures 62 were elective and 23 emergency cases, with various treatments, including stenting, flow diversion, embolization, and revascularization. This initial experience represents the full range of complex neurovascular cases, including several procedures where other catheters first failed to reach the targeted vessel.
The design features of Radical Catheter’s patented ribbon technology aim to deliver best-in-class flexibility, stability and durability, and also have additional benefits of reducing procedural time and associated risks and costs.
The co-founders of Radical Catheter Technologies, Brian Martin and Martin Dieck are serial entrepreneurs who together have been developing technologies for neurosurgeons for 30 years. During that time they participated in and witnessed the dramatic and rapid advancements of minimally invasive therapies, while the catheters required to deliver these devices only made minor improvements. They set out to develop a novel “radical” design to disrupt the status quo and reset the bar on performance.
The company plans to use the $20 million raised through NeuroTechnology Investors and other investors who have backed the core group over many ventures to expand the Company’s platform and leverage the strong post-clearance clinical data. In parallel, the Company is scaling operations to build a world-class manufacturing organization to support the advanced design of its Radical technology platform and commercial expansion.
Radical Catheter Technologies will be exhibiting their new technology at the SNIS 21st annual meeting, together with other innovative NTI portfolio companies, including Synchron, Serenity Medical and Borvo Medical.