Stroke is one of the world's leading causes of death. In Israel it is the number-four mortality factor after cancer, heart disease, and diabetes; worldwide it is the third leading cause of death. Stroke is also the world's leading cause of disability, as it leaves those who experience and survive it with functional and cognitive deficits.
The Inretio medical device company notes that technological and medical developments have made heart disease less dangerous than before. Now, medical-device development is moving into the sphere of stroke treatment, with similar advanced technologies but a need for greater subtlety and precision.
Patent registered overseas
Inretio was founded six years ago by Raviv Vine, following the death of a family member from stroke. Having realized that the stroke devices then on the market were inadequate, he established Inretio, where he currently serves as CEO, in order to develop a more effective and exact means of removing blood clots from the brain.
"Inretio's innovative method treats blood clots in a different and more precise manner; the product envelops the clot and effectively "traps" it in a special kind of net made of 40-micron-thick nitinol fibers (nitinol is a type of metal), then removing it from the brain in one piece. In this method, the brain and the body are protected from blood clot remains or fragments. Wrapping the clot keeps it from disintegrating in the body on its way out of the body," Vine explains.
He adds that Inretio has now completed the development of its first product, and has conducted a clinical feasibility study on animals. The validation stage, which will begin in late February, is expected to last seven months and will be conducted with the US Food and Drug Administration (FDA). According to Vine, once the process has been concluded and approval received, the device will be tested in a human clinical trial. "The device patent has been submitted, registered and approved in the United States, and is in the process of being registered in Europe and China," Vine says.
"What is distinctive about our device is its ability to open up its "net" on the far side of the blood clot; this unique little net opens in such a way that it separates the clot from the brain and pulls it away," Vine explains. "We've succeeded in reaching the back of the clot and pulling it out from there. The assessment is that this achievement will raise the effectiveness of cerebral angiography by 40% over current levels."
Medical solutions on the Gaza perimeter border
Inretio has eight employees, including three engineers engaged in development and three technicians involved in development and production, alongside the company's medical staff: Dr. Gal Yaniv, Director of the Endovascular Neurosurgery Unit at Sheba Tel-Hashomer Medical Center, and Dr. Ziv Neeman, an interventional radiology expert and Director of the Diagnostic Imaging Institute at HaEmek Medical Center. The company's scientific director is Dr. David Elmaleh, a Harvard University researcher/professor and entrepreneur in the sphere of brain drug and medical device development.
Clinical trials and HR are managed by Naama, a physiotherapist with a Master's degree in human resources who has spent many years managing medical centers and staff in the healthcare system. Vine has extensive managerial and engineering experience, and was involved for two decades in the management of engineering projects in the semiconductor industry.
The company is based in the Sha'ar HaNegev Regional Council's SouthUp technology incubator, founded to promote employment in the Gaza Perimeter region. "Preserving human life and quality of life is a supreme value for us, and we are committed to doing whatever it takes to supply safe products meeting the highest standards of quality and to investing efforts to see constant improvement," Vine says.
He adds that the company has won recognition and funding from the Israel Innovation Authority, and has received a grant for the development of additional net-based products. "Now that our patent has been approved and we have a product in the process of validation from the FDA, we are at the start of a process to raise 2 million dollars, per the company's 20-million-dollar valuation."
Inretio also has an American company, Inretio USA, based in Cambridge, Massachusetts alongside global medical giants. "The goal of the American company is to manage the clinical trials and pave the way for marketing the product in the United States," Naama explains. "The company has identified the American market as its target market for regulation and penetration. With the aid of our regulatory advisors in the American market, and Dr. Elmaleh, who is in contact with leading hospitals, we are aiming to reach this target."
in cooperation with Inretio