New ENRICH-PLUS Study Builds on World’s First Positive Clinical Trial for Hemorr… – Press Release

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NICO awards University of Maryland $200,000 for first-of-its-kind study 
combining MIPS with neuroprotectant for basal ganglia ICH

INDIANAPOLIS, June 22, 2023 /PRNewswire/ — Just two months after announcing the world’s first positive surgical trial for the deadliest type of stroke, NICO Corporation is awarding a $200,000 Investigator Initiated Study grant with the goal of building on ENRICH (Early MiNimally-invasive Removal of ICH) conclusions to further improve patient outcomes following hemorrhagic stroke. ENRICH-PLUS, a sub-study of ENRICH, will examine the safety and suitability of supplementing early Minimally Invasive Parafascicular Surgery (MIPS) for clot evacuation of basal ganglia intracerebral hemorrhage (ICH) using NICO technologies with the Takeda Pharmaceutical Company drug Pioglitazone, an FDA-approved diabetes drug. Several preclinical studies showed that Pioglitazone reduced blood toxicity and accelerated removal of blood; it has never been evaluated for use in combination with surgical evacuation of stroke during neurosurgery.

New ENRICH-PLUS study uses neuroprotectant with MIPS to build on world’s first positive clinical trial for ICH.

“Initial evidence from preclinical studies has led us to believe that patients who undergo early MIPS to remove a blood clot and then receive Pioglitazone may have more rapid resolution of any residual blood in the brain, less inflammation and less cell death, which together may lead to improved patient outcomes. The goal of our study is to evaluate that hypothesis,” said Marc Simard, MD, PhD, who will lead the non-randomized controlled study and is a neurosurgeon and professor of Neurosurgery, Pathology and Physiology at the University of Maryland School of Medicine.

The results of the recently completed ENRICH trial sponsored by NICO are revolutionary and the market is positively responding to the level 1 evidence. The evidence was produced using NICO technologies and showed the MIPS patient group achieved a…

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