Radical Catheter Technologies’ 8F Neurovascular Catheter Receives US FDA 510(k) Clearance, Second for the Best-in-Class Ribbon Technology Platform
Company Announces New Headquarters, a State-of-the-Art Manufacturing Facility to Expand Commercialization of the Radical Neurovascular Catheter Portfolio to Include a Wide Range of Sizes and Indications Enhancing Efficiency and Precision in Neurosurgery
CAMPBELL, Calif., Jan. 15, 2025 (GLOBE NEWSWIRE) — Radical™ Catheter Technologies, a pioneering medical device company focused on advancing the next generation of endovascular access and delivery, and a NeuroTechnology Investors (NTI) portfolio company, today announced its second 510(k) clearance from the U.S. Food and Drug Administration (FDA). This marks another milestone achievement for Radical Catheter Technologies and highlights the unprecedented potential of its catheter technology. Built on the same patented platform as Radical’s 7F catheter, the first FDA-cleared product from the Company, the 8F provides a second size and enlarged inner diameter to greatly expand therapeutic options. Further, the announcement of the Company’s move to a state-of-the-art manufacturing facility underscores Radical Catheter Technologies’ commitment to scaling operations and creating a world-class manufacturing entity that supports the continued advanced design of its Radical platform and facilitates the process of commercial expansion.
“I am pleased with the growth and accomplishments related to the Company’s key strategic objectives to set a new standard in neurovascular access and delivery,” said Brian Martin, co-founder and CEO of Radical Catheter Technologies. “First, the rapid clearance of the 8F Radical Catheter, following the clinical success of the 7F, marks a critical milestone toward offering a comprehensive range of sizes and indications for neurovascular procedures. Second, the construction of our world-class manufacturing facility, completed last month, supports the Company’s highly anticipated growth. This state-of-the-art facility ensures we can accommodate large volume orders for the full platform of catheters.”
Martin Dieck, Radical’s Chairman and co-founder, concluded, “Our clinical experience has been remarkable, consistently demonstrating the best-in-class performance of our FDA-cleared catheters at initial commercial sites. The Radical Catheter has firmly established itself as a workhorse, capable of navigating everything from routine procedures to the most complex and challenging cases. We are encouraged by the field performance to date, as highlighted by direct physician feedback and reinforced by robust replenishment orders from our initial clinical sites. In the coming months, we plan to achieve additional milestones that will expand our platform further and propel us into a full commercial launch.”
The Radical Catheter features patented, next-generation ribbon technology that delivers exceptional flexibility, stability, and durability. This design also provides unmatched mechanical advantages, leading to quicker procedures and lower risks and costs. Guided by NTI, Radical Catheter Technologies is enhancing its operations to establish a top-tier manufacturing organization that will support the innovative design of its Radical technology platform and facilitate its commercial growth.
Imran Chaudry, MBBS, Neurointerventional Radiologist at Prisma Health Systems in Greenville, SC, and an investigator in the clinical evaluation studies of the 7F, has been using the Radical Catheter over the past year and commented, “I look forward to using the 8F catheter where this technology can benefit an even greater number of procedures and patients in my practice. Thus far, my experience with the 7F has been stellar, and it has become a mainstay catheter for daily use. It delivers first-in-class performance, exceeding expectations and making complex cases much easier, particularly where other catheters would face challenges.”
Following presentations at various global neurosurgery meetings, including the Society of NeuroInterventional Surgery (SNIS) Annual Meeting, the Congress of the World Federation of Interventional and Therapeutic Neuroradiology (WFITN), the Congress of Neurological Surgeons (CNS) Annual Meeting, and the International Stroke Conference (ISC), the Company has established its Radical Catheter platform as the next generation of neuro and endovascular access and delivery devices.
About Radical™ Catheter Technologies
Radical Catheter Technologies is a pioneering medical device company focused on advancing the next generation of endovascular access and delivery. Radical Catheter Technologies has received two US FDA 501(k) clearances for the 7F and 8F applications of its novel 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 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 DiMilia
TellMed Strategies
tara.dimilia@tmstrat.com
908-884-7024
