By Sara Miller, NoCamels -
People plagued by chronic migraines, tinnitus, failing eyesight and even depression could be suffering from a disorder known as pseudotumor cerebri (PTC), an increase in the pressure on the brain whose symptoms resemble those of a tumor.
This pressure, also known as idiopathic intracranial hypertension, is caused by a buildup of blood and cerebrospinal fluid in the brain, when it fails to move properly through the veins that act as a drainage system in the head.
And while treatment for PTC has always been spotty, an Israeli startup has developed a device that can expand the veins in the brain, releasing the fluid and easing the pressure – and the symptoms.
These symptoms are severe and potentially life altering, including eventual blindness, and it is not clear why some people suffer from the disease, although it is more commonly found in young women and people who are overweight.
Vflow co-founder and CMO Anat Horev, who is also head of the Interventional Neuroradiology Unit at Soroka Medical Center in Be’er Sheva, says that PTC was recognized 50 years ago, but it is only in the past few years that the extent of the problem has become truly understood.
“They have a narrowing in the draining veins of the brain,” Horev tells NoCamels. “Therefore there is a horrible feeling of pressure in the head, noise in the ears or pressure in the eyes that actually can limit eyesight.”
And the condition, she says, is more common than previously believed.
Imagine, Horev says, that about 50 percent of patients with excruciating unresponsive migraines have a narrowing in the veins and are not being treated accordingly. Instead, they are going from one physician to another, without any real answers and as a result are becoming a burden on the system.
“We’re talking about millions of patients,” she says. “They’re not functioning, they’re not studying, they’re not working.”
According to Horev, excess weight does play a major part in exacerbating the symptoms of the disease, as it places a greater strain on the neck and chest. And as more and more people are recognized as overweight, there is a fair chance that issue will only become increasingly common.
A study released in March by renowned medical journal The Lancet found that in 2022, more than one billion people worldwide were living with obesity, including 43 percent of adults.
As such, Horev explains, improving the drainage capabilities in the brain would have a major impact on the health of millions of people.
“A very large group of scientists and physicians believe that this is the next thing in improving the quality of life of patients,” she says.
Flexible Solution
The startup’s unique vascular stent, called Viva Stent, is placed in the vein in the brain, directly where it narrows.
“It’s always in the same place [in the brain],” Horev states. “We are not sure why.”
Once the stent is put in place, the patient’s quality of life improves almost at once, with the debilitating symptoms clearing up, she says, adding that many of those suffering from PTC have taken multiple different medications with no results.
“I enjoy performing the procedure, which is low risk, with the patient waking up with immediate symptoms relief,” Horev says.
The entire procedure, from start to finish, takes about one hour.
While there have been previous attempts to use a stent to expand the veins in order to increase the drainage, Horev explains this has always been problematic due to the rigidity of the equipment being used.
There was no device designed specifically for this procedure, she says. Instead a “very short and stiff” off-label stent – developed to deal with a clogged carotid artery – was used. This stent, however, could not adequately contend with what Horev says is the “very sharp curve” on the journey to reach the brain.
Vflow’s Viva Stent, however, is “20 percent less rigid” and with its catheter delivery mechanism flexible enough to navigate through this turn. What is more, Horev says, the stent itself is kept at the back of the catheter during its passage from the groin, where it enters, to the placement site in the vein inside the brain.
She explains that this allows for even greater maneuverability during the procedure. Only when the catheter has navigated the sharp turn is the stent brought forwards and maneuvered into place.
“When the stent is at the back, you can take any turn you like, even a full turn,” Horev says. “Only when we are ready and we crossed the turn is the right time to push [it] forward.”
The stent can also be moved back and forth as it is maneuvered into place, making it even easier to ensure it reaches precisely the right spot, she adds.
Horev founded Vflow in 2021 with its CEO Dr. Bilha Cahana, an experienced entrepreneur with several successful companies already under her belt. The pair have spent the past three years fine-tuning the stent and are now preparing for human trials in Israel.
Once the trial has been completed in Israel, the company plans to conduct a further study in the United States, in order to obtain approval from the US Food and Drug Administration (FDA).
And while there are a few other companies working on a stent for the same purpose, Horev says none are yet on the market.
Furthermore, she says, besides, the stent designed with features specifically for this disease, Vlfow’s device offers a unique delivery system that allows for safe and swift trackability and deployment.
For the past three years, the company has had ongoing investment from the Israel Innovation Authority, the branch of the government dedicated to promoting the national tech sector, as well as personal funding from Cahana.
Various small companies working in the field of medical devices have also invested, but now Vflow is looking for a major investment to see the startup through to the end of the clinical trials.
The company was also a recent finalist in a contest for startups held by Be’er Sheva innovation hub Synergy7 and the Merage Israel Foundation. The two institutions share a mission of promoting technology native to the Negev, and designed the competition to help promising local startups in the sectors of healthcare, cybersecurity and robotics.
And helping to reassure prospective patients is a video created by a filmmaker who has successfully undergone the procedure with Horev.
“It’s very reassuring to see what you’re going into,” she says.
“She did it because she says that it changed her life. She was miserable until then.”
