Intrasaccular devices treat brain aneurysms from inside the aneurysm sac, but many current designs struggle with sidewall and sharply angled anatomy. LuSeed Vascular, led by co-founder and CEO Nitzan Hirsh, built its DOME device to close that gap. DOME is designed to stay out of the parent artery while reaching sidewall and angulated aneurysms that are difficult to treat today.
The Israel-based company has completed first-in-human studies, is running a multicenter clinical program ahead of a pivotal trial, and is raising capital for its next clinical and regulatory phase.
LuSeed’s path follows a familiar medtech arc: find a specific clinical limitation, engineer around it, then build the evidence needed for wider adoption.
Starting from the Clinical Need
Hirsh and co-founder Amir Arthur, now COO, started LuSeed while completing master’s degrees in biomedical engineering.
They used the Biodesign methodology, interviewing physicians about unmet needs before choosing a technology.
Those conversations pointed them to neurovascular medicine and, specifically, brain aneurysms.
Method Plus Instinct
Hirsh describes the process as a mix of structured problem-finding and recognizing the moment when a problem and a solution fit together.
Looking back, he credits both the systematic method and the gut-level “aha” moments that told the team it was on the right track.
For Hirsh, LuSeed was a chance to apply engineering directly to patient care and to spend his time building something that contributes to medicine.
Why Aneurysm Anatomy Is the Problem
Brain aneurysms vary widely in shape and location. Endovascular options such as coiling and flow diversion have expanded treatment, but each carries trade-offs in positioning, anatomical fit, and, for some devices, the need for prolonged antiplatelet therapy.
An intrasaccular device takes another route. It sits inside the aneurysm instead of in the parent vessel, disrupting blood flow into the sac to promote occlusion.
How DOME Is Designed
DOME is a minimally invasive intrasaccular implant intended for both bifurcation and sidewall aneurysms.
After deployment, it rests against the aneurysm wall and neck to redirect blood flow and encourage thrombosis.
Dual-Layer Nitinol Construction
The device uses two layers of nitinol mesh with the marker enclosed between them, which limits protrusion into the parent artery. The layers are not joined at the distal end, creating a soft, atraumatic tip and extra flexibility during deployment.
Hirsh says that the design lets DOME approach an aneurysm from a wider range of angles than other intrasaccular devices.
Wider Deployment Angles, Fewer Sizes
More deployment angles could extend intrasaccular treatment to anatomies physicians currently treat another way.
LuSeed also kept the size matrix small. DOME comes in seven sizes, far fewer than some competing devices.
Fewer sizes simplify inventory and device selection for hospitals and remove one more barrier to adoption.
Early Clinical Results
According to Hirsh, DOME has been used in nearly 30 patients, with complete long-term occlusion in more than 80% of cases so far, including anatomies that challenge existing intrasaccular devices.
With first-in-human work complete, LuSeed is advancing a multicenter pilot ahead of its pivotal study.
The next phase will generate the evidence for U.S. enrollment, CE Mark, and eventually FDA premarket approval (PMA).
The U.S. is LuSeed’s main long-term market, followed by Europe, with Japan and India identified as potential Asia-Pacific opportunities.
Raising for the Pivotal Trial
LuSeed is raising capital to fund its pivotal program and progress toward PMA. Hirsh wants to round out the syndicate with investors who have neurovascular experience and can contribute beyond capital.
The raise is a useful case study for medical device venture capital. Clinical-stage neurovascular companies combine large unmet need, complex regulatory paths, and meaningful commercial upside.
Investors must weigh more than technical feasibility: clinical evidence, anatomical coverage, procedural workflow, regulatory and reimbursement strategy, physician adoption, and the team’s ability to execute a pivotal trial.
The Bigger Opportunity
LuSeed’s goal is to widen an existing treatment category, not just add another device to it. If DOME performs consistently across bifurcation and sidewall aneurysms, intrasaccular treatment could take a larger role in neurovascular care.
What the Pivotal Study Must Prove
For investors, physicians, and strategics, the pivotal study will show whether DOME’s engineering advantages deliver real clinical and procedural benefits.
It is the stage where promising engineering becomes a clinically validated product, or does not. Investors evaluating neurovascular companies can book a Compass AI demo to compare LuSeed with peers in the category.
Key Takeaways
- LuSeed Vascular targets a gap in intrasaccular aneurysm treatment: sidewall and highly angulated aneurysms.
- DOME’s dual-layer nitinol mesh allows deployment from more angles with less protrusion into the parent artery.
- With first-in-human work complete, LuSeed is running a multicenter pilot ahead of a pivotal study.
- Pivotal data will support CE Mark and FDA PMA filings.
- LuSeed is raising capital for its pivotal program and seeks investors with neurovascular expertise.
LuSeed’s story is a practical model for how medical device startups can start from a defined clinical limitation, engineer a focused answer, and build the evidence that determines whether a new approach earns broad adoption.
