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Small Biz Grants Fund Simpler Aneurysm Tests

Neurovascular Diagnostics founders

Founders of Neurovascular Diagnostics, from left, Jeff Harvey, Hui Meng, and Vincent Tutino. (Douglas Levere, University at Buffalo)

5 Nov. 2019. Two recent federal small business grants are supporting development of simple tests to screen for unruptured brain aneurysms in asymptomatic patients. The awards totaling nearly $1 million are made to Neurovascular Diagnostics Inc. in Buffalo, New York from set-aside programs for small businesses at National Science Foundation and National Institutes of Health.

An aneurysm is a weak or thinning spot in arteries caused by bulges that fill with blood. In the brain, aneurysms pose a threat of rupturing that can cause sudden and severe headaches, as well as other serious symptoms including seizures or loss of consciousness. National Institute of Neurological Disorders and Stroke, or NINDS — part of NIH — says some 30,000 people in the U.S. experience a rupturing brain aneurysm. The Brain Aneurysm Foundation says women, people over the age of 55, African Americans, and people of Hispanic origin are at higher risk. In addition, half of rupturing brain aneurysms result in death, while two-thirds (66%) of those who survive experience some permanent neurological deficit.

Neurovascular Diagnostics is a spin-off enterprise from engineering and medical school labs at University at Buffalo. The three year-old company’s founders include Buffalo engineering professor Hui Meng, neurosurgery professor Kenneth Snyder, and Vincent Tutino, a research professor in both the engineering and medical schools. A fourth founder is Jeffrey Harvey, a nuclear engineer and entrepreneur who lost is wife to an undiagnosed brain aneurysm that ruptured. Tutino is the company’s CEO and principal investigator on the NSF and NIH awards, while Meng is chief scientist, Snyder is chief medical officer, and Harvey is chief financial officer.

Since most brain aneurysms have no apparent systems, few people are diagnosed with the condition if no rupture occurs. To diagnose a brain aneurysm today requires a magnetic resonance angiogram, or MRA. Like an MRI, an MRA uses magnetic resonance imaging, and focuses on blood vessels. And while less invasive than some angiograms, it still requires a magnetic field, radio waves, and computer analysis, which makes it expensive and not suited for widespread screening.

“This can cost thousands of dollars, and insurance companies may not pay for it because patients often do not have any symptoms,” says Harvey in a university statement. “Because of what happened to my wife, one doctor said my children should be tested on a regular basis. To spend thousands of dollars every few years, that’s a lot of money.”

Neurovascular Diagnostics is developing a simple blood test that screens for certain characteristic RNA strands indicating the presence of an aneurysm. In December 2017, Neurovascular Diagnostics received an early stage grant from NSF’s Small Business Innovation Research, or SBIR, program to prove the technical and commercial feasibility of the technology. That effort identified 50 circulating RNAs in blood that predict the presence of unruptured brain aneurysms with more than 90 percent accuracy.

The new SBIR award of $750,000 funds a two-year, large-scale study to validate the technology. The Neurovascular Diagnostics team plans to take blood samples from 400 individuals both with and without brain aneurysms to verify the test’s accuracy, double-checked with high-throughput genomic sequencing.

The new NINDS award is an early-stage grant of $225,000 from the SBIR program at NIH to refine the company’s technology for further characterizing blood biomarkers of aneurysms to predict the risk of rupturing. That advance would enable the test to quickly identify individuals with biomarkers indicating a high risk of rupture.

Neurovascular Diagnostics is the second spin-off enterprise founded by Harvey based on University at Buffalo medical research and tied to a family member. As reported by Science & Enterprise in November 2010, Harvey and medical school professor Frederick Sachs founded Rose Pharmaceuticals, that later became Tonus Therapeutics. Harvey’s grandson was born with Duchenne’s muscular dystrophy, a rare genetic disorder, and the company is developing a treatment for the disease based on a protein found in tarantula venom.

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