PR95521

TEL AVIV, Israel, April 19, 2022 /PRNewswire=KYODO JBN/ --

BENDIT Technologies [ https://www.bendittech.com/ ], a company focused on the

development of a steerable microcatheter platform, announced today that it has

received U.S. Food and Drug Administration (FDA) 510(k) clearance for its

Bendit21 microcatheter for treatment in the neuro, peripheral, and coronary

vasculature. The clearance was received several months after the successful

first use of the Bendit21 neuro catheter in the USA in two life-saving

procedures.

The Bendit21 Steerable Microcatheter is equipped with a steerable distal tip,

controlled by a 'steering slider' on the proximal steering handle. Endovascular

specialists can bi-directionally rotate the tip by simply turning the torque

knob on the steering handle. These advanced steering and torqueability

maneuvering capabilities are intended to enable navigation with or without

guidewires, more precisely, and accurately, through all vasculatures, and

potentially expanding indications, enhancing safety and saving procedure time.

"We already have FDA clearance for the peripheral indication. Now that we have

received 510K clearance for the Bendit21, with expanded indications for neuro,

coronary and peripheral, endovascular specialists can begin utilizing the full

potential of our steerable microcatheters," stated Yossi Mazel, BENDIT CEO. "We

are planning a commercial release in the coming months in select medical

institutions in the United States."

Professor Alejandro Berenstein, MD, a Clinical Professor of Neurosurgery,

Radiology and Pediatrics, and Director of the Pediatric Cerebrovascular Program

at the Mount Sinai Health System in New York and board member at BENDIT added,

"The Bendit technology presents a transformative paradigm in endovascular

navigation that will revolutionize the way we access the vasculature, and will

improve treatments throughout the arterial and venous systems, especially in

the brain".

Rich Cappetta, Bendit Chairman of the Board, concluded, "This is an important

achievement for BENDIT Technologies. The Bendit21 steerable catheter technology

is a game-changer in endovascular medicine, and I would like to congratulate

the Bendit team for their successes, paving the way for additional devices to

add to the company's R&D pipeline."

About BENDIT Technologies

BENDIT Technologies is a medical device company developing breakthrough

technologies for steerable microcatheters, providing surgeons with

3D-controlled bending and navigation capabilities. The company's patented

technology reduces the complex catheterization procedure to a single step and

enables quick and accurate outcomes. The company has previously received FDA

clearance and CE Mark for the Bendit 2.7 microcatheter with an indication for

peripheral use.

Visit www.bendittech.com.

Contact:

Yossi Mazel

info@bendittech.com

Source: Bendit Technologies