Business Wire01.03.19
Viz.ai Inc., an applied artificial intelligence company in healthcare, and NICO Corporation, a developer of modern minimally invasive interventional technologies for neurosurgery, have announced a collaboration to incorporate a new innovative clinical trial recruitment software from Viz.ai into the seminal ENRICH study, which is investigating the treatment of intracerebral hemorrhages (ICHs).
The current standard of care for ICH calls for medical management of the patient, or a “watch and see” protocol, which allows blood that is pooled from the ruptured vessel to remain in the brain. The ENRICH trial is evaluating the efficacy and safety of early surgical evacuation (less than 24 hours) using a parafascicular (parallel to the brain’s fiber tracts) and transsulcal (through natural openings and folds of the brain) surgical approach. The goal of surgical evacuation is to maximize clot removal, achieve durable hemostasis, and achieve functional improvement of the patient.
Viz RECRUIT utilizes advanced artificial intelligence to automatically identify potential subjects for clinical trials. In ENRICH (Early MiNimally-invasive Removal of ICH), Viz RECRUIT will notify investigators immediately when a patient meets the eligibility criteria for enrollment. Study investigators can coordinate subject enrollment easily and securely through a dynamic, mobile, HIPAA-compliant platform.
“Automated detection and notification of suspected ICH patients using artificial intelligence has the potential to significantly speed ENRICH trial enrollment,” said Gustavo Pradilla M.D., assistant professor of Neurosurgery at Emory University and chief of Neurosurgery at Grady Memorial Hospital. “Viz's AI technology allows investigators to identify more trial eligible candidates and therefore potentially shorten clinical trials.”
“With the added value that Viz.ai is bringing to ENRICH with its award-winning imaging and workflow software, the trial can potentially be shortened through faster enrollment and provide a reduced time to randomization,” said Jim Pearson, president and CEO of NICO. “All this translates into being able to more quickly offer patients validated clinical trial outcomes as we work toward new ICH treatment protocols for this most deadly and debilitating form of stroke.”
ENRICH is a multi-center trial sponsored by NICO and led by the Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital, both in Atlanta, Ga. Ideal trial subjects are spontaneous supratentorial intracerebral hemorrhage patients with a potential chance of benefiting from surgical treatment based on well-defined criteria for study enrollment.
“The ENRICH trial and NICO technologies can potentially transform the way that ICH is treated and change treatment guidelines,” said Chris Mansi, neurosurgeon and CEO of Viz.ai. “Dr. Pradilla and NICO are visionaries who are committed to significantly improving the lives of ICH patients.”
ENRICH opened patient enrollment in January 2017 for the 300-patient trial that includes multi-disciplinary teams of stroke neurology, neurosurgery and neuro-critical care physicians from 30 trial sites that include major medical and academic centers and large community hospitals.
Hemorrhagic stroke impacts more than 160,000 people in the United States and 3.4 million people worldwide. Caused from a weakened vessel that ruptures and bleeds into surrounding brain, previous studies suggest early removal of the hemorrhage can potentially mitigate brain injury; however, procedures in these studies did not offer automated, navigation-compatible, minimally-disruptive technologies and a standardized surgical approach.
Viz.ai's mission is to fundamentally improve how healthcare is delivered in the world, through intelligent software that promises to reduce time to treatment and improve access to care. Viz.ai’s flagship product, Viz LVO, leverages advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat.
In February 2018, the U.S. Food and Drug Administration (FDA) granted a De Novo clearance for Viz LVO, the first-ever computer-aided triage and notification software. Viz.ai announced its second FDA clearance for Viz CTP through the 510(k) pathway, offering healthcare providers an important tool for automated cerebral image analysis.
Viz.ai is located in San Francisco, Calif., and Tel Aviv, Israel, and backed by leading Silicon Valley investors, including Kleiner Perkins and Google Ventures.
NICO Corporation is an Indianapolis, Ind.-based medical device company developing modern interventional technologies used in a new way of performing less invasive brain surgery for subcortical and skull base lesions, intraventricular tumors and cysts, and hemorrhagic stroke. It is an outcomes-based company dedicated to revolutionizing minimally invasive neurosurgery through evidence-based, improved clinical and economic outcomes.
The current standard of care for ICH calls for medical management of the patient, or a “watch and see” protocol, which allows blood that is pooled from the ruptured vessel to remain in the brain. The ENRICH trial is evaluating the efficacy and safety of early surgical evacuation (less than 24 hours) using a parafascicular (parallel to the brain’s fiber tracts) and transsulcal (through natural openings and folds of the brain) surgical approach. The goal of surgical evacuation is to maximize clot removal, achieve durable hemostasis, and achieve functional improvement of the patient.
Viz RECRUIT utilizes advanced artificial intelligence to automatically identify potential subjects for clinical trials. In ENRICH (Early MiNimally-invasive Removal of ICH), Viz RECRUIT will notify investigators immediately when a patient meets the eligibility criteria for enrollment. Study investigators can coordinate subject enrollment easily and securely through a dynamic, mobile, HIPAA-compliant platform.
“Automated detection and notification of suspected ICH patients using artificial intelligence has the potential to significantly speed ENRICH trial enrollment,” said Gustavo Pradilla M.D., assistant professor of Neurosurgery at Emory University and chief of Neurosurgery at Grady Memorial Hospital. “Viz's AI technology allows investigators to identify more trial eligible candidates and therefore potentially shorten clinical trials.”
“With the added value that Viz.ai is bringing to ENRICH with its award-winning imaging and workflow software, the trial can potentially be shortened through faster enrollment and provide a reduced time to randomization,” said Jim Pearson, president and CEO of NICO. “All this translates into being able to more quickly offer patients validated clinical trial outcomes as we work toward new ICH treatment protocols for this most deadly and debilitating form of stroke.”
ENRICH is a multi-center trial sponsored by NICO and led by the Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital, both in Atlanta, Ga. Ideal trial subjects are spontaneous supratentorial intracerebral hemorrhage patients with a potential chance of benefiting from surgical treatment based on well-defined criteria for study enrollment.
“The ENRICH trial and NICO technologies can potentially transform the way that ICH is treated and change treatment guidelines,” said Chris Mansi, neurosurgeon and CEO of Viz.ai. “Dr. Pradilla and NICO are visionaries who are committed to significantly improving the lives of ICH patients.”
ENRICH opened patient enrollment in January 2017 for the 300-patient trial that includes multi-disciplinary teams of stroke neurology, neurosurgery and neuro-critical care physicians from 30 trial sites that include major medical and academic centers and large community hospitals.
Hemorrhagic stroke impacts more than 160,000 people in the United States and 3.4 million people worldwide. Caused from a weakened vessel that ruptures and bleeds into surrounding brain, previous studies suggest early removal of the hemorrhage can potentially mitigate brain injury; however, procedures in these studies did not offer automated, navigation-compatible, minimally-disruptive technologies and a standardized surgical approach.
Viz.ai's mission is to fundamentally improve how healthcare is delivered in the world, through intelligent software that promises to reduce time to treatment and improve access to care. Viz.ai’s flagship product, Viz LVO, leverages advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat.
In February 2018, the U.S. Food and Drug Administration (FDA) granted a De Novo clearance for Viz LVO, the first-ever computer-aided triage and notification software. Viz.ai announced its second FDA clearance for Viz CTP through the 510(k) pathway, offering healthcare providers an important tool for automated cerebral image analysis.
Viz.ai is located in San Francisco, Calif., and Tel Aviv, Israel, and backed by leading Silicon Valley investors, including Kleiner Perkins and Google Ventures.
NICO Corporation is an Indianapolis, Ind.-based medical device company developing modern interventional technologies used in a new way of performing less invasive brain surgery for subcortical and skull base lesions, intraventricular tumors and cysts, and hemorrhagic stroke. It is an outcomes-based company dedicated to revolutionizing minimally invasive neurosurgery through evidence-based, improved clinical and economic outcomes.
