ThruFlo Endovascular announced the completion of a seed financing round led by Atlas MedInnovation to accelerate development of its bifurcated flow diverter platform designed specifically for bifurcation aneurysms. The funding will support the establishment of formal research and development operations, completion of device design, additional pre-clinical studies, and submission of an Investigational Device Exemption application to the U.S. Food and Drug Administration.
The Irvine, California-based neuro-endovascular medical device company is developing what it describes as the first purpose-built flow diverter for bifurcation aneurysms. Cerebral aneurysms affect an estimated 16.5 million Americans, and approximately 60% of intracranial aneurysms occur at major vessel branch points, where conventional flow diverters were not originally designed to function.
ThruFlo’s technology features a dual-limb Y-shaped design that deploys as a single device. The company said the platform eliminates the need for coiling and may reduce procedural complexity, treatment time, and risk.
Pre-clinical studies demonstrated successful deployment and two-month device patency. The company is continuing to build clinical evidence to support future regulatory and commercialization efforts.
ThruFlo said it has established a strong intellectual property portfolio that includes multiple issued patents, international patents, and additional pending patent applications in the U.S. and abroad.
The company is supported by a Scientific Advisory Board comprising neurological surgeons and interventional neuroradiologists from USC Keck School of Medicine.
According to the company, the global neurovascular device market is expected to reach $3.8 billion by 2026, attracting acquisition activity from major industry players including Johnson & Johnson, Medtronic, and Stryker.
KEY QUOTES:
“Today’s interventionalists are using sidewall off-label devices such as stents with multiple detachable coils or intrasaccular devices for treatment of bifurcation aneurysms, because there is simply nothing better available. Our device was designed from the ground up for this indication. Pre-clinical studies confirmed successful deployment and two-month device patency, and we are focused on building the evidence that translates into better outcomes for patients.”
Samuel M. Shaolian, CEO, ThruFlo Endovascular
“ThruFlo is addressing a significant unmet need in neurovascular intervention with an innovative technology platform, strong intellectual property, and an experienced leadership team. Bifurcation aneurysms remain a challenging area for physicians, and ThruFlo’s purpose-built approach has the potential to improve treatment options for patients. We are excited to support the company as it advances toward key development, regulatory, and commercialization milestones.”
Shuo Qi, Director, PEEZNN & COMPANY
