An aneurysm grew for three years in the brain of a Texas resident named Noreen, eventually numbing her eye and the entire left side of her face.
If this dangerous bulge in the blood vessel burst, it would cause bleeding in the brain.
After two unsuccessful attempts to reach and seal Noreen’s aneurysm through vascular access — without opening her skull — Dr. John Barr contacted Israeli startup Bendit Technologies.
Barr had read about Bendit’s unique steerable microcatheter that enables the surgeon to bend or rotate the tip of the microcatheter as it threads its way along the twists and turns of blood vessels leading to the treatment target in the brain.
Although the device had not yet received approval from the US Food and Drug Administration, the FDA let Barr try it on a compassionate use basis in January 2022 at the University of Texas Southwestern Medical Center.
Within minutes, Barr reached the aneurysm with Bendit’s flexible microcatheter and safely sealed it.
Noreen’s daughter emailed Bendit after the procedure: “I want you all to know how thankful we are for the creation of this device and allowing us to use it. This means everything to us,” she wrote.
She said her mother had been on disability for six months and was now able to go back to work.
“I can never express how big of an impact this company has had on our life.”
Stroke is #1 burden on US healthcare
Bendit CEO Yossi Mazel shared that email, with permission, to illustrate why 30 major American medical centers want to buy this vascular navigation device and why more than 30 neuro-interventionalist surgeons have invested their own money toward its commercialization.
Mazel explains that the most well-known reason to thread a catheter through arteries from the groin or wrist area is to unblock blood vessels around the heart without open surgery.
But in addition to cardiac catheterization, he says, a fast-growing use of vascular access is to deliver treatment to the brain — either to remove life-threatening clots causing strokes or to seal aneurysms so they won’t burst and cause a cerebral hemorrhage.
The first use case alone is huge, he says. “The No. 1 cost burden on the American health system is stroke survivors, so if by improving vascular access and navigation we can impact that, it’s significant.”
The stroke and aneurysm markets together comprise hundreds of thousands of procedures per year. And the numbers are rising quickly both in the US and China, says Mazel, with the latter country increasingly shifting to an artery-clogging Western diet.
Meeting of the minds
“In vascular access procedures, physicians use guidewires and microcatheters — long, thin tubes that get pushed into the brain. But controlling their tip is very difficult, especially when a blood vessel bifurcates” like a fork in the road, Mazel says.
Oz Cabiri, a mechanical engineer specializing in medical devices, knew that microsurgery can fail when clinicians struggle to steer the microcatheter through the vascular system.
In 2013, Cabiri brought together experts in laser cutting technology and the quality and regulatory field to brainstorm a solution — a microcatheter with a controllable tip that bends and twists to get where it needs to go.
Cabiri is founder and CTO of the 20-person Bendit Technologies in Petah Tikva, which has raised about $20 million from its founders and from Varian Medical Systems, Indaco Venture Partners and private investors in the United States and Israel.
Bendit’s first model received FDA clearance in 2019 for periphery treatments. Subsequent models designed for use in neurology and cardiology followed, and in 2022 the FDA cleared the newest version for US sales. The technology is based on a robust intellectual property portfolio.
Mazel says Bendit is doing a controlled release at five US hospitals including Southwestern Dallas. Many more prominent hospitals, from the West Coast to the East Coast, have requested the device.
“We want physicians at those five initial hospitals to show more use cases and we want to see that they are reordering the device before we go further,” Mazel says.
Gearing up for when that time comes, Bendit is shifting the manufacturing of the device from Israel to a catheter maker in Miami and is in conversations with several large medical device companies that would potentially acquire the Israeli startup.
“Bendit is an R&D company,” Mazel explains. ““Eventually one of the big multinational companies in the field will likely be interested to add it to their portfolio.”
For more information, click here.