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Mercury Biomed Receives $1.5M NIH Grant for WarmSmart Surgical Warming Device

• Mercury Biomed was awarded a $1.5 million NIH grant to advance its WarmSmart device, a novel solution for managing core body temperature during surgery. • The WarmSmart device utilizes Selective Thermal Stimulation to noninvasively warm the body core, working with the body's thermoregulatory function. • Clinical trials at the Cleveland Clinic will assess WarmSmart's effectiveness in maintaining normothermia during surgery, addressing a $2.5 billion market. • The funding will support Phase II clinical trials and FDA clearance efforts for WarmSmart, offering a potentially safer alternative to current warming methods.

Mercury Biomed has been awarded a $1.5 million Phase II Small Business Technology Transfer (STTR) grant from the National Institute of General Medical Sciences (NIGMS) to further develop and commercialize its WarmSmart device. This device is designed to prevent life-threatening complications associated with rapid core body temperature reduction during surgery, a risk faced by 53 million patients annually in the US.

WarmSmart Technology

WarmSmart employs a novel Selective Thermal Stimulation approach, working in concert with the body’s intrinsic thermoregulatory function to noninvasively maintain normothermia. Unlike alternative methods, WarmSmart aims to provide a smarter and safer way to warm patients in the peri-operative environment.

Clinical Validation and Development

The NIH's decision to award these additional funds was based on the successful completion of Phase I milestones, including the development of commercial-grade prototypes and demonstration of the clinical effectiveness of Mercury’s approach. The technology originates from research at The University of Texas at Austin, under the direction of Professor Ken Diller, Mercury’s Chief Science Officer.
Clinical trials will be conducted at the Cleveland Clinic under the direction of doctors Daniel Sessler, Andrea Kurz, Kurt Ruetzler and Mehmet Turan. Dr. Sessler noted the importance of keeping surgical patients warm and the potential of this new method. This Phase II award will provide the funds necessary to conduct these trials and pursue FDA clearance.

Market Opportunity

The global market for patient temperature management solutions is estimated at $2.5 billion per year, highlighting the significant need for effective and innovative solutions like WarmSmart. Mercury Biomed's CEO, Brad Pulver, expressed appreciation for the NIH's support and the company's belief that WarmSmart will offer a vastly different and improved approach to maintaining normothermia in the operating room.
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Reference News

[1]
Mercury Biomed Awarded $1.5M National Institutes of Health Grant | AP News
apnews.com · Dec 27, 2021

Mercury Biomed received a $1.5 million Phase II STTR grant from NIGMS to advance WarmSmart, a device for peri-operative ...

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