Mount Sinai BioDesign

Mount Sinai BioDesign’s mission is to empower physicians and researchers to bring their ideas to life by providing a multidisciplinary incubator for the invention and implementation of medical devices that meet patient needs.

As an innovation center embedded within the Mount Sinai Health System, we work side by side with clinical experts across a wide range of disciplines. Also, Mount Sinai BioDesign’s strong affiliations with industry facilitate testing, validation, and adoption of products in our portfolios.

Mount Sinai BioDesign enables physicians and surgeons to translate the medical needs of their patients into market-ready medical technologies. Through a structured process, we help clinicians by refining clinical needs, designing effective solutions, and rapidly prototyping devices, all while protecting intellectual property. The team specializes in minimally invasive surgical technologies and has developed devices for open and endovascular neurosurgery, otolaryngology, orthopedic surgery, cardiac surgery, and other disciplines. Successful technologies are licensed directly to industry and manufacturing partners or launched as new startups with partnering entrepreneurs.

In just a few years since its inception, Mount Sinai BioDesign has established several mature partnerships that have successfully designed and launched clinical trials, conducted user-feedback studies, assisted in submissions to the U.S. Food and Drug Administration, and facilitated the development of novel algorithms. Mount Sinai BioDesign is now actively seeking to expand its collaboration with a growing number of industry partners. 

This strategic focus has enabled our team to assist external entities in navigating the complexities of health system integrations and accelerating the development and implementation of new technologies. By partnering with major industry leaders, we’ve been able to extend our impact into broader specialties at various stages of the translational pipeline, while enhancing their ability to develop the next generation of tools to assist clinicians and improve patient treatment and care.

Elementa Labs

Mount Sinai BioDesign is engaging with startup companies via Elementa Labs, Mount Sinai’s virtual accelerator program that enables startups to explore ways to strategically align their efforts with Mount Sinai and the health care industry in general. This 12-week program gives entities access to subject-matter expertise in health care and science, allowing for a better understanding of their customers and the potential advancement of their core technology platforms. The program enables companies to work with a predetermined Mount Sinai champion on strategizing a comprehensive development plan to be executed after programming. 

Precision Neuroscience Laboratories

Precision Neuroscience was co-founded by Benjamin Rapoport, MD, PhD, Assistant Professor of Neurosurgery at the Icahn School of Medicine at Mount Sinai, a practicing neurosurgeon who has a PhD in electrical engineering and computer science. Dr. Rapoport also serves as the Scientific Director of Mount Sinai BioDesign.

Precision Neuroscience has developed a new brain-computer interface (BCI) that deciphers brain signals and maps 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. This new 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. The film is one-fifth the thickness of a human hair and was designed to be implanted and removed by neurosurgeons without damaging brain tissue.

Precision has been partnering with academic medical centers and health systems to perform a series of first-in-human clinical studies. The goal of each study varies, and the company announced its collaboration with Mount Sinai in March 2024. At Mount Sinai, Precision is exploring different applications for its array in clinical settings, for example, how it can be used to help monitor the brain during surgery. Accessing the level of detail the Layer 7 Cortical Interface provides could help doctors be more delicate with their surgeries and inspire other interventions in the future.

PharynVac Surgical Technology

PharynVac Surgical Technology was founded by Alfred Marc Iloreta, Jr. MD, Assistant Professor of Otolaryngology, Neurosurgery, and Artificial Intelligence and Human Health at the Icahn School of Medicine. PharynVac is a balloon aspiration catheter used during sinonasal surgery to minimize patient blood ingestion, exposure to pathogens and toxins by surgical staff, and obstructed endoscopic visualization. Currently, PharynVac is in phase I clinical trials.

MitralPrint

Following transcatheter mitral valve repair (t-MVR), up to 25 percent of patients with initial satisfactory results will develop recurrent regurgitation, suggesting the inadequacy of standard intraoperative transthoracic ultrasound assessment to anticipate mid- and long-term failure. This shortcoming sparked a strong interest among Mount Sinai cardiothoracic surgeons and interventional cardiologists for an intraoperative assessment tool to effectively guide the t-MVR procedure.

With the help of Mount Sinai BioDesign, Daniel Grinberg, MD, MS, and David H. Adams, MD, developed the MitralPrint guidewire to quantify MCF in real time during both open heart surgery for mitral valve repair and minimally invasive t-MVR. 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. The two tissues may be within the patient’s heart, e.g. a mitral valve, an aortic valve, or tricuspid valve. MitralPrint enables measurement of the coaptation force in vivo and allows real-time assessment of the success of surgical repair in the heart.

Mount Sinai Innovation Partners

Mount Sinai Innovation Partners (MISP) teams with innovators throughout the Health System to translate research projects into health care products that benefit patients and society. While Mount Sinai BioDesign focuses on devices, MISP’s innovations range from vaccine development to genomics—as well as medical devices. Where our interests coincide, we benefit from collaborations that draw upon our respective areas of expertise.

BioMedical Engineering and Imaging Institute

The BioMedical Engineering and Imaging Institute (BMEII) focuses on the use of multimodality imaging for brain, heart, and cancer research, along with research in nanomedicine for precision imaging and drug delivery. BMEII is composed of research groups in all aspects of imaging research.