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.

Pharyvac Surgical Technologies originated within Mount Sinai BioDesign during the COVID-19 pandemic, when the suspension of rhinology and endonasal surgeries highlighted an urgent unmet need around aerosol exposure and workflow inefficiencies. The project was co-developed by Alfred Marc Iloreta, MD, and Turner S. Baker, PhD, and advanced from early invention through prototyping and clinical validation within the BioDesign ecosystem. Following a successful incubation period within Mount Sinai BioDesign, Pharyvac spun out as an independent company to translate its surgeon-originated innovation into a commercially scalable device and platform focused on improving operating room efficiency, patient outcomes, and clinician safety in endonasal surgery.

Since spinout, Pharyvac has raised an oversubscribed pre-seed financing round and secured a non-dilutive Phase I NIH STTR award to accelerate development and commercialization. Its flagship device, the Pharyvac Suction Catheter, is designed for placement in the posterior nasal cavity and aims to enable continuous evacuation of blood, smoke, and biological debris while reducing the need for manual suctioning and limiting blood migration and aerosol exposure. The company is advancing toward FDA registration and device listing, targeting U.S. market entry and initial commercial launch in Summer 2026.

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.