A Quiet Revolution Inside the Brain

With a minimally invasive technology that enables medical teams to prevent brain hemorrhages simply and safely in real time, LuSeed Vascular is revolutionizing the neurovascular space with a novel treatment for brain aneurysms.

Hundreds of thousands of brain hemorrhages occur worldwide every year. Many of these are caused by aneurysms, which are estimated to affect about 1 in 20 people worldwide. Aneurysms can rupture without warning, leading to death or severe disability in roughly half of all cases, and even when patients reach the hospital in time, more than half face lengthy rehabilitation processes, significant risk of complications, and suboptimal long-term outcomes. Hundreds of these cases are recorded in Israel annually, and many patients don’t have time to wait for the right specialist to be available at the right moment.

Founded by Nitzan Hirsh and Amir Arthur, LuSeed Vascular is developing a solution specifically designed to address this complex challenge. Instead of relying on highly intricate brain surgery or implants, which are typically performed by only a handful of experts, the company offers a flexible nitinol-based implant delivered through a microcatheter that self-expands directly inside the aneurysm and prevents or stops bleeding. All of this is achieved through a minimally invasive procedure, enabling a quick, safe, and effective response that can be performed by any interventional or neurologist, thanks to the device’s built-in safety and short learning curve.

With ongoing support from the Israel Innovation Authority, the company aims to make a highly complex procedure accessible globally, bringing hope to both patients and physicians.

Seven years have passed since Hirsh and Arthur, then biomedical engineering master’s students, were first introduced to Biodesign, a structured approach to developing medical technologies that begins not with a product, but with a clearly defined clinical need. The method involves field observations, in-depth conversations with physicians, and a complete understanding of the clinical environment before attempting to design a solution.

An encounter with an interventional neurosurgeon towards the end of their studies exposed the two to the intricate world of brain aneurysms. Their curiosity evolved into a project, which eventually became a full-fledged startup. “We asked what the biggest challenge in the catheter lab was,” Hirsh recalls, “and discovered that life-saving interventions are often hindered by small operational obstacles, rather than theoretical problems. The challenges weren’t conceptual; they were practical and required simple, precise solutions, but ones that were technically sophisticated to execute.”

Their initial hypothesis led to a successful laboratory experiment and early backing from the Israel Innovation Authority, which provided the structure needed for continued development. The road ahead was long, but highly focused.

In late 2018, the two founders won first place in the medical device category of the Sanara Ventures competition. “That was more or less the moment we both resigned from our jobs and decided to devote all our time to advancing the project,” Hirsh says.

An Implant That Opens in Exactly the Right Place

The same scene is repeated in countless medical centers worldwide: a patient is diagnosed with a brain aneurysm and is indicated for treatment. However, the right specialist isn’t always on duty, the catheter lab isn’t always available, and in many cases, the optimal solution doesn’t fit the aneurysm’s shape or angle.

The options in such cases are limited: to either wait, transfer the patient to another hospital, or attempt a high-risk procedure. The system developed by Hirsh and Arthur is designed to overcome these limitations, enabling all skilled physicians, rather than just top-tier specialists, to act safely and flexibly without delay. “We’re developing equipment that’s intended for widespread use by interventional neuroradiologists, not just the top ten percent,” Hirsh explains, “it can be used by the on-call physician in the middle of the night, with a patient who’s hemorrhaging right in front of them.”

The device created by the two partners is inserted into the brain via blood vessels and is intended to prevent fatal hemorrhages caused by brain aneurysms. The technology is based on an endovascular implant deployed during a minimally invasive procedure, without the need to open the skull. The implant is made of nitinol – a soft, flexible alloy widely used in the medical device industry for its unique “shape memory” property. Once inserted into a catheter, it compresses into a thin strand, but as it is released, it immediately unfolds back into its designated shape.

The implant’s structure resembles a half-sphere made of a dense mesh that opens inside the aneurysm, gently adheres to its walls, and creates a controlled flow-diversion effect that stops the bleeding. The entire procedure is performed through the femoral artery via a small incision in the groin. “When it works, as it has until now in one hundred percent of the cases in our ongoing clinical trial across Europe, including long-term follow-up – the patient is released for observation that day,” Hirsh says.

The implant was designed to enable entry into the aneurysm from different angles, because cerebral blood vessel structures vary from one patient to another, and it is sometimes impossible to position an implant precisely. The device’s flexibility simplifies both the planning of the medical procedure and real-time decision-making. “It helps interventional surgeons understand how the implant will behave inside the aneurysm in real time and deliver a practical, meaningful solution,” Hirsh explains.

From Trial to Market

LuSeed Vascular is currently executing its clinical trials, completing a pilot study in Europe to demonstrate the implant’s safety and efficacy in dozens of patients. The next phase, which is a broad pivotal trial that constitutes a part of the regulatory approval process – is expected to take place in Europe and the United States, with the hope of Israeli participation.

“We’re preparing for it with determination,” says Hirsh. “This stage requires much more than financial resources, namely a support infrastructure, logistics, unified clinical protocols, and major partners with broad marketing and clinical networks.”

At the same time, the company is investing significant effort in manufacturing and operational aspects, recognizing that the transition from R&D to production is not just an engineering challenge but also a prerequisite for expansion. This transition is being carried out with the help of a grant received from the Innovation Authority.

“We have an ongoing ‘romance’ with the Innovation Authority,” says Hirsh. “We’ve graduated from nearly every available program, such as ‘Tnufa’, incubators, the R&D Program, and now the ‘Round A’ track. Every stage of the company’s growth was supported by the Authority, which enabled us to progress. And it’s not only about the investment itself, but rather, about the confidence, the backing, and the feeling that you have a partner accompanying you the whole way.”

Hirsh recalls one event in particular where he was invited to speak before senior physicians in the Negev: “I was asked to speak to the Department of Neurosurgery at Soroka Medical Center as part of an evening called ‘From the Entrepreneur’s Chair.’ I was asked for one piece of advice, and without hesitation, I replied that if you’re developing a Class III implant, you must work with the Israel Innovation Authority. It’s an institutional partner that has no substitute.”

The Vision: Building a New Gold Standard

Market trends continue to reinforce the need that LuSeed Vascular is addressing. The neurovascular field is growing steadily, driven by an aging population, earlier detection of aneurysms, and the expansion of available endovascular treatment options. At the same time, this growth highlights the global shortage of specialized physicians, alongside increased demand for solutions that enable precise procedures even in non-specialized medical centers.

For Hirsh and Arthur, the current implant is only the beginning. The company is not merely designing a product but also laying out the foundation for broad development. In the future, the principle of a sophisticated, easily delivered implant could also be applied to further areas of the brain, to a range of other critical indications, and possibly even become a new global standard.

“Our goal is to give physicians a simple and effective tool that works for them,” Hirsh summarizes. “Our first implant focuses on brain aneurysms, and that will remain the company’s primary focus for the next few years, but we’re already thinking ahead about expanding to other types of aneurysms, new anatomical regions, and perhaps even providing solutions for related conditions such as AVMs (arteriovenous malformations). Looking ahead, we see our technology not necessarily as a single product but as the basis for a clinical platform.”

And what about the broader vision? “A simpler, more effective solution for brain aneurysms. One that’s accessible and usable anywhere, at any time. This isn’t a revolution with posters and slogans. It’s practical medicine. And when it comes to the brain, nothing is more important.”

Alon Stopel, Chairman of the Israel Innovation Authority, said: “The various tracks of the Authority’s Startup Fund and Yozma Fund that provide support for outstanding entrepreneurs and innovative technologies, from the ideation stage through to Round A funding, are designed to propel and empower early-stage Israeli companies by facilitating an excellent financing environment in the coming years.”

This article is part of a new series examining how breakthrough technologies in Israel make the difficult journey from idea to market. The series explores the work of the Israel Innovation Authority’s Startup Fund, which partners with private investors to support deep-techcompanies at every critical stage, from pre-seed through Round A: https://innovationisrael.org.il/en/article/startup-fund-success-story/