Houston-Based Endothelix Receives FDA Approval for New Cardiovascular Test

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VENDYS® technology uses fingertip temperature to measure vascular function.

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Endothelix has announced that its non-invasive VENDYS® technology, which utilizes a simple blood pressure cuff and fingertip probes to monitor vascular reactivity, has been approved for commercial use by the U.S. Food & Drug Administration (FDA).

Developed by Dr. Morteza Naghavi and researchers at the Texas Heart Institute and the University of Texas Health Science Center in Houston, the proprietary VENDYS® technology measures vascular function by monitoring changes in fingertip temperature in response to an arm-cuff occlusion, which serves as a vascular stress test.

The company’s FDA approval follows multiple clinical trials conducted in major cities and supported by a $1 million award from the Texas Emerging Technology Fund, an initiative from Governor Rick Perry’s economic reform committee. “This benchmark represents proven success by Endothelix and a rewarding investment for Texas,” Governor Rick Perry said. “The Emerging Technology Fund allows Texas to invest in innovative companies which are key to driving competition, advancement and diversification in our state’s robust economy and the global marketplace.”

According to well-known cardiovascular researchers (Dr. Craig Hartley from Baylor College of Medicine in Houston; Dr. Harvey Hecht from Lenox Hill Hospital in New York, and Dr. Matthew Budoff from Harbor UCLA Medical Center in Los Angeles), the clinical trials have consistently demonstrated the ability of the VENDYS® technology to measure vascular function with a non-invasive, non-imaging procedure that is simple, inexpensive and user friendly.

Automated cuff occlusion implemented by the VENDYS® device causes a significant drop in fingertip temperature followed by temperature rebound after cuff release. The speed and magnitude of temperature recovery is a measure of vascular reactivity. The greater the rebound, the more reactive and healthy is the artery.

Clinical studies have shown that individuals with lower fingertip thermal reactivity have increased cardiovascular risk factors and greater coronary plaque build-up than those with higher fingertip thermal reactivity.

“I am impressed by the data from the Endothelix clinical trials,” says Dr. Mathew Budoff, Professor of Medicine at UCLA and Director of Cardiovascular Imaging at the Los Angeles Biomed Institute. “VENDYS technology is indeed very promising.”

Cardiovascular disease (CVD) is not only America’s number one killer (more than one million deaths each year), but also the most expensive disease (more than $350 billion per year). According to the American Heart Association, three out of four heart attack victims are individuals with hidden atherosclerosis (plaque buildup), completely without symptoms (so called Vulnerable Patients) and thus unaware of their risk. Unfortunately, about half of these victims die within one hour of the onset of symptoms. This fact highlights the importance of preventive screening.

Current methods for CVD screening include traditional blood tests for measurement of risk factors (such as cholesterol) or advanced atherosclerosis imaging tests (such as CAT scans and MRIs). While traditional risk factors are statistical predictors of future CVD, they do not measure the state of an individual’s vascular health. In addition, advanced imaging modalities have significant cost or radiation barriers, and therefore cannot be used repeatedly (weekly or monthly).

“Endothelix is striving to bring a comprehensive non-invasive, non-imaging cardiovascular risk assessment solution to doctors’ offices that is simple, inexpensive, and operator independent,” says Dr. Naghavi, Founder and President of Endothelix.

By incorporating a comprehensive risk assessment platform into primary care, Endothelix intends to enable family physicians to practice as preventive cardiologists.

“Endothelix is creating a groundbreaking approach which will provide a revolutionary and innovative, low-cost way to address the cardiac market,” said Walter Ulrich, President and CEO of the Houston Technology Center (HTC).

Endothelix has been assisted by HTC since 2005. The company is also affiliated with BioHouston, a local organization that supports Houston-based life science companies.

“We are excited about the prospects of Endothelix as an emerging, leading cardiovascular company based in Houston,” said Jacqueline Northcut, President and CEO of BioHouston.

About Endothelix
Endothelix is a Delaware corporation based in Houston, Texas and formed in December 2003. The company is positioned as the first to incorporate non-invasive, non-imaging micro and macro vascular (endothelial -dependent and –independent) function monitoring technologies into the existing risk factor assessment to help physicians more accurately monitor their patients’ cardiovascular health, and to use appropriate therapies for the prevention and treatment heart of attack and stroke.

Endothelix has established research collaborations with University of Houston, Texas A&M University, University of Texas – Austin, Baylor College of Medicine, Lenox Hill Hospital, Columbia University, Harbor UCLA Medical Center, Cedars-Sinai Medical Center and MD Anderson Cancer Center. Endothelix’s Scientific Advisory Board includes world-renowned cardiovascular specialists including Daniel Berman MD, Matthew Budoff MD, Erling Falk MD, PhD, Craig Hartley PhD, Harvey Hecht MD, Ioannis Kakadiaris PhD, Obdulia Ley PhD, Roxana Mehran MD, Ralph Metcalfe PhD, Khurram Nasir MD, Arshed Quyyumi MD, John Rumberger MD, PhD, and Hirofumi Tanaka PhD. Visit http://www.endothelix.com for more information.

Robin Owen, PhD. Chief Operating Officer
Robin.Owen @ endothelix.com

About Houston Technology Center
Houston Technology Center (HTC), a business accelerator and the largest technology business incubator in Texas, accelerates the commercialization of emerging technology companies in the Greater Houston area. A 501(C)(3) corporation, HTC assists Houston-based entrepreneurs within several key sectors: Energy, Information Technology, Life Sciences, Nanotechnology and NASA/Aerospace technologies, by providing in-depth business guidance, access to capital and service providers, and entrepreneurial education.

HTC serves as the Gulf Coast Regional Center for the Texas Emerging Technology Fund, helping small to mid-size companies expedite the commercialization of new technologies. To date, the Gulf Coast RCIC helped 10 Gulf Coast region companies raise nearly $10 million in grants.

About BioHouston
BioHouston, Inc., a non-profit corporation founded by Houston-region academic/research institutions. It is leading a broad effort to establish the Houston region as a vigorous global competitor in life science and biotechnology commercialization. Visit http://www.biohouston.org for more information.


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