Mount Sinai BioDesign

A multidisciplinary team of neurosurgeons and neuroscientists from the Icahn School of Medicine at Mount Sinai are the first in New York to study a new brain-computer interface (BCI) that’s engineered to map a large area of the brain’s surface, in real time, at resolutions hundreds of times more detailed than typical arrays used in neurosurgical procedures.  The BCI, the Layer 7 Cortical Interface, contains 1,024 tiny electrodes spanning an area of 1.5 square centimeter, embedded in a flexible film that conforms to the brain’s surface.

As part of an open-label, single-arm feasibility study, Mount Sinai neurosurgeons are temporarily placing the investigational device on the surface of the study participants’ brains during intracranial procedures where surface mapping is routinely performed and correlated to evoked potentials (tests that measure the brain’s response to sensory stimulation) or standardized behavioral tasks that are routinely performed as part of these procedures. The device records high-resolution electrophysiological signals, and the data collected are compared to the data obtained using standard-of-care cortical surface arrays.

A team of Mount Sinai neuroscientists who have deep expertise in human electrophysiology will analyze and interpret the massive amount of data collected from the device. A secondary objective of the study is to assess the ability of the thin-film electrode to map electrophysiological correlates of awake behavioral tasks, including motor, speech, and cognitive tasks.

The MitralPrint device is composed of a sensor array, deployment device, and computer system and is used to objectively measure the coaptation, or closure force, between two tissues in a patient’s body, such as a mitral valve, an aortic valve, or tricuspid valve. MitralPrint enables the measurement of coaptation along an entire contact surface between at least two tissues and facilitates the two-dimensional, three-dimensional, or four-dimensional mapping for precise identification and visualization of the coaptation forces along the contact surface between the tissues.  Currently, four rounds of sensor prototyping and testing have been performed, as well as bench-top testing to verify that the sensor can measure biologically relevant forces in the heart. A successful biosimulator study in an isolated pig heart has been completed, as well as a successful study in ex-vivo gathered mitral valves. The next step will be an in vivo animal study.

Sinonasal surgery is extremely common. PharynVac is a balloon aspiration catheter that mitigates three issues at the same time: surgical staff pathogen and toxin exposure, patient blood ingestion, and periodic obstructed endoscopic visualization. Only blood ingestion has a current solution: packing the pharynx with absorbent materials with regular associated adverse events.

If successful, PharynVac will decrease surgical staff exposure, reduce post-procedure nausea, and minimize operative times, potentially becoming a standard sinonasal surgical tool. The current phase I application would allow for the implementation of Good Manufacturing Processes (SA1), demonstrated blood and particle aspiration in a bio-realistic oral/nasal model (SA2), and demonstrated device safety/feasibility in a large-animal sheep model (SA3). At that point, PharynVac will move into phase II: FDA engagement and first-in-human clinical trials.

The Vascular Malformations Research Center is dedicated to advancing the understanding, detection, and treatment of vascular malformations through comprehensive clinical and translational research. Key research initiatives include a comprehensive Arteriovenous Malformation Clinical Research Program, including research into the optimization, management, and outcomes of embolization procedures. Using a strategy devised by Mount Sinai BioDesign, surgeons can now assess and quantify the extent of embolization through an analysis of an additional MRI sequence following embolization and preceding surgical resection. For challenging neurosurgical procedures in which large, highly vascular tumors are fed by dedicated arteries, the procedure can be particularly useful.