Radical™ Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery (SNIS) 21st Annual Meeting
22 Julio 2024 - 4:00PM
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.
About Radical™ Catheter TechnologiesRadical
Catheter Technologies is a medical device company pioneering the
next generation of endovascular access and delivery products.
Radical Catheter Technologies recently announced US FDA 510(k)
clearance for the first application of this new platform. The 7F
Radical™ Catheter has neurovascular clearance for both femoral and
radial access. The Company’s patented Radical Catheter platform is
constructed with a novel design that it intends to establish as the
new standard in catheter performance across broad applications.
Please visit www.radicalcatheter.com for more
information.
About Neuro Technology Investors
(NTI)NeuroTechnology Investors (NTI) is a leading
physician investment group dedicated to advancing innovative
neurological technologies and those in other specialties from the
medical device sector. Established in 2016 and headquartered in
Palo Alto, California, NTI investors lend their clinical expertise
to add value to groundbreaking companies and accelerate access to
clinical solutions for patients. To learn more, visit
www.themdadvantage.com.
Media Contact:
Tara DiMiliaTellMed
Strategiestara.dimilia@tmstrat.com 908-884-7024