Minnetronix Medical, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

ABSTRACT Aneurysmal subarachnoid hemorrhageSAHis a devastating neurological condition occurring as the result of a ruptured cerebral aneurysmThe mean incidence ispeople perpopulation and an estimatedcases annually in the USAfter securement of a ruptured aneurysmpatients are closely observed in the hospital fordays to monitor for cerebral vasospasmedemahydrocephalus and for the body to slowly clear any remaining blood from the subarachnoid spaceDue to the prevalence of these complicationsthere remains a significant unmet need to improve outcomes for these patientsEarly removal of blood and blood productse ghemoglobinoxyhemoglobinand downstream inflammatory proteinsfrom the cerebrospinal fluidCSFhas been shown to reduce the incidence of vasospasmstrokehydrocephalusthe need for permanent shunt placementand result in a shorter hospital courseCurrently available toolssuch as passive ventricular or lumbar drainshoweverare not sufficient for expedited blood removalOur central hypothesis is that blood and blood breakdown products from the CSF can be directly targeted and rapidly reducedusing a novelinterventional approachMinnetronixa medical device development and manufacturing companyhas developed an automated CSF treatment and filtration platformThe closed loop device extractscontaminatedCSF from the lumbar cistern and reintroducescleanedCSF back into the cervico thoracic subarachnoid spacea process termed Neurapheresisprocessing CSF at up toml minNeurapheresis therapy is an innovativenew therapeutic option that is intended to be complementaryand does not replace standard of care interventionsfor patients with SAHThe first in human trialPILLAR studypatient studypreliminary data in this applicationwas reviewed by the DSMB and had unanimous support for safety and an expanded clinical studyThe pilot study demonstrated a mean ofmL of CSF processed inhours of filtration and initially elevated mean CSF total protein and RBCs were reduced byandrespectivelyThe PILLAR Extension protocoltermed PILLAR XTproposed in this grantwas reviewed and approved by FDA and the central IRBThis study will directly measure performance of a CSF flow algorithm alongside continued evaluation of the device safetywith the addition of automation and longer therapy timeThe study will further explore continued reduction of blood in the cranial and spinal subarachnoid space with Neurapheresis therapyIn PILLAR XTthe larger sample sizepatientsand longer durationup tohours of pump time in Phase I and limited only by catheter indwelling time ofhours in Phase IIwill allow more efficacy data to power a future pivotal studyThis data will contribute to system optimizationrefinement of the protocol and selection of the appropriate endpoints for a future pivotal studyThe long term goal is to develop an automatedcosteffective platform with bedside catheter placement that rapidly removes blood from CSF and translates to reduced morbidity and mortality for aneurysmal SAH NARRATIVE In the USthere arecases of aneurysmal subarachnoid hemorrhageSAHannuallySAH patients can develop complications post aneurysm securementranging from vasospasm and stroke to shuntdependent hydrocephalusthe lasting effects of these episodes can be devastatingMinnetronix has developed an innovative therapeutic platform designed to rapidly filter and reduce blood and blood breakdown products from the cerebrospinal fluidCSFa process termed NeurapheresisA first in humanpatient clinical trialPILLARwas recently completed and found Neurapheresis to safely reduce blood in the cranial and spinal subarachnoid spaceIn an expanded FDA approved clinical studyPILLAR XTMinnetronix plans to further evaluate an automated Neurapheresis platform with increased therapy time to guide system improvements and design of an upcoming pivotal clinical study