Nitinol is a superelastic nickel and titanium alloy with unique properties that allow deformation and subsequent full recovery of the original shape upon exposure to body heat.
NSVascular will focus on developing and commercializing TFN-covered stents for endovascular applications, with its first two applications being flow-diverting stents for intracranial aneurysms (IA) and stents for treating peripheral artery disease (PAD).
A multidisciplinary team, comprised of researchers from the UCLA Henry Samueli School of Engineering and Applied Science in collaboration with physicians from the David Geffen School of Medicine at UCLA, has been engaged in the development and the in vitro/in vivo testing of TFN-covered IA and PAD stents. "For the past five years our engineering team has benefited from collaborating with a top-notch UCLA medical team, spearheaded by Dr. Dan Levi and Dr. Fernando Vinuela. I am looking forward to working closely with the experienced management team at NeuroSigma and NSVascular in commercializing this promising technology," said Greg Carman, Ph.D., UCLA Professor of Mechanical and Aerospace Engineering and a co-founder of NSVascular.
"We are very excited that NSVascular will be moving this technology through translational studies and hopefully ultimately to patients thereby benefitting both society and the economy at large," said Earl Weinstein, Associate Director of UCLA's Office of Intellectual Property.
"We are delighted to have signed our fourth license with UCLA's Office of Intellectual Property and look forward to working closely with a new team of engineers and physicians from UCLA," said Lodwrick M. Cook, Chairman of NeuroSigma.
"The successful convergence of engineering and medicine is exemplified by the accomplishments of this team. We would like to applaud these accomplishments and the dedication on the medical side of Drs. Fernando Vinuela, Dan Levi, David Rigberg and Colin Kealey and on the engineering side of Professors Greg Carman and Youngjae Chun and Dr. K.P. Mohanchandra, to transition TFN-covered stents from the laboratory to the clinic and welcome them as co-founders and scientific advisors of NSVascular," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma.
Intracranial Aneurysm (IA) Flow-Diverting Stent
Intracranial aneurysms result from weaknesses in cerebral blood vessels, which can rupture and lead to stroke and death. It is estimated that up to one in fifteen people in the United States develop a brain aneurysm during their lifetime. The traditional method of surgical clipping to treat brain aneurysms is very invasive requiring removal of a section of the skull. Since 1995, endovascular coils, have gained popularity, now accounting for the majority of current procedures.
"Pre-clinical in vivo testing has shown a remarkable 100% aneurysm occlusion rate within minutes of treatment, an achievement unmatched by competing flow-diverting technologies," said Fernando Vinuela, M.D., Director of UCLA's Division of Interventional Neuroradiology and a co-founder and scientific advisor to NSVascular. "Furthermore, our TFN-covered flow-diverting stent keeps the flexibility of the delivery system allowing safer distal intracranial navigation and stenting of a larger number of aneurysms," added Vinuela.
The company believes that flow-diverting stents represent one of the fastest growing segments of the neurovascular market and may supplant intracranial coiling as the preferred treatment for certain aneurysms. Last month, in support of continuing pre-clinical trials at UCLA, NeuroSigma entered into a contract with UCLA to fund the development of prototype TFN-covered stents for use in upcoming human trials.
Peripheral Artery Disease (PAD) Stent
Ten million Americans suffer from PAD, a common circulatory problem in which narrowing of arteries can lead to a reduction in blood flow to the limbs and a possible precursor to amputation or death from heart attack and stroke.
The license with UCLA also includes the use of TFN-covered stents for the treatment of PAD. Since 2009 under an NIH Challenge Grant, UCLA has been conducting in vivo pre-clinical trials to demonstrate that its TFN-covered stents may eventually be used for the treatment of PAD by remaining patent even in vessels as small as 3 millimeters. A unique surface treatment of UCLA's TFN film provides super-hydrophylic properties, which greatly reduces the adherence of platelets.
CAUTION: NSVascular's TFN-covered stents are investigational devices and at this time are limited by United States law for investigational pre-clinical use only.
NSVascular will focus on developing and commercializing TFN-covered stents for endovascular applications, with its first two applications being flow-diverting stents for intracranial aneurysms (IA) and stents for treating peripheral artery disease (PAD).
A multidisciplinary team, comprised of researchers from the UCLA Henry Samueli School of Engineering and Applied Science in collaboration with physicians from the David Geffen School of Medicine at UCLA, has been engaged in the development and the in vitro/in vivo testing of TFN-covered IA and PAD stents. "For the past five years our engineering team has benefited from collaborating with a top-notch UCLA medical team, spearheaded by Dr. Dan Levi and Dr. Fernando Vinuela. I am looking forward to working closely with the experienced management team at NeuroSigma and NSVascular in commercializing this promising technology," said Greg Carman, Ph.D., UCLA Professor of Mechanical and Aerospace Engineering and a co-founder of NSVascular.
"We are very excited that NSVascular will be moving this technology through translational studies and hopefully ultimately to patients thereby benefitting both society and the economy at large," said Earl Weinstein, Associate Director of UCLA's Office of Intellectual Property.
"We are delighted to have signed our fourth license with UCLA's Office of Intellectual Property and look forward to working closely with a new team of engineers and physicians from UCLA," said Lodwrick M. Cook, Chairman of NeuroSigma.
"The successful convergence of engineering and medicine is exemplified by the accomplishments of this team. We would like to applaud these accomplishments and the dedication on the medical side of Drs. Fernando Vinuela, Dan Levi, David Rigberg and Colin Kealey and on the engineering side of Professors Greg Carman and Youngjae Chun and Dr. K.P. Mohanchandra, to transition TFN-covered stents from the laboratory to the clinic and welcome them as co-founders and scientific advisors of NSVascular," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma.
Intracranial Aneurysm (IA) Flow-Diverting Stent
Intracranial aneurysms result from weaknesses in cerebral blood vessels, which can rupture and lead to stroke and death. It is estimated that up to one in fifteen people in the United States develop a brain aneurysm during their lifetime. The traditional method of surgical clipping to treat brain aneurysms is very invasive requiring removal of a section of the skull. Since 1995, endovascular coils, have gained popularity, now accounting for the majority of current procedures.
"Pre-clinical in vivo testing has shown a remarkable 100% aneurysm occlusion rate within minutes of treatment, an achievement unmatched by competing flow-diverting technologies," said Fernando Vinuela, M.D., Director of UCLA's Division of Interventional Neuroradiology and a co-founder and scientific advisor to NSVascular. "Furthermore, our TFN-covered flow-diverting stent keeps the flexibility of the delivery system allowing safer distal intracranial navigation and stenting of a larger number of aneurysms," added Vinuela.
The company believes that flow-diverting stents represent one of the fastest growing segments of the neurovascular market and may supplant intracranial coiling as the preferred treatment for certain aneurysms. Last month, in support of continuing pre-clinical trials at UCLA, NeuroSigma entered into a contract with UCLA to fund the development of prototype TFN-covered stents for use in upcoming human trials.
Peripheral Artery Disease (PAD) Stent
Ten million Americans suffer from PAD, a common circulatory problem in which narrowing of arteries can lead to a reduction in blood flow to the limbs and a possible precursor to amputation or death from heart attack and stroke.
The license with UCLA also includes the use of TFN-covered stents for the treatment of PAD. Since 2009 under an NIH Challenge Grant, UCLA has been conducting in vivo pre-clinical trials to demonstrate that its TFN-covered stents may eventually be used for the treatment of PAD by remaining patent even in vessels as small as 3 millimeters. A unique surface treatment of UCLA's TFN film provides super-hydrophylic properties, which greatly reduces the adherence of platelets.
CAUTION: NSVascular's TFN-covered stents are investigational devices and at this time are limited by United States law for investigational pre-clinical use only.
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