Geared Power BioTech accepted into the FDA’s Safer Technologies Program for its BioGuard UVC™ device

BioGuard UVC™ is Positioned as Safer Technology to Prevent the Spread of Respiratory Disease by Inactivating Airborne Pathogens Present in Exhaled Breath

WAYNE, NJ, UNITED STATES, April 15, 2026 /EINPresswire.com/ -- Geared Power BioTech, a health technology startup, today announced that its flagship product, BioGuard UVC™, meets the eligibility factors for acceptance into the U.S. Food and Drug Administration’s (FDA) Safer Technologies Program (STeP), which includes a reasonable expectation of clinical success.

Devices included in STeP are anticipated to present technological or design innovations that may raise novel and/or complex scientific and/or regulatory issues. The FDA believes that STeP may enable patients to have more timely access to these devices than they would have had otherwise, due to earlier interaction between FDA and sponsors, dedication of additional resources, and application of program principles. The FDA intends to leverage many of the principles of the Breakthrough Devices Program for STeP in order to expedite the development and review of devices that have the potential to significantly improve safety, and will work collaboratively with the sponsor to define an efficient device development path towards obtaining an FDA marketing authorization.

BioGuard UVC is a first of its kind, personal, wearable pathogen inactivation device designed to prevent the spread of respiratory disease by inactivating airborne pathogens present in exhaled breath before they reach the surrounding environment by real time exposure to 254nm germicidal UVC within its enclosed UV Chambers. Its filter-less design offers no restriction to air flow, making it easy to breathe through.

"I want to thank the Division of Infection Control Devices at the FDA for their work with us, and their recommendation to apply for the Safer Technologies Program," said Gary Kellstrom, Jr., CEO & Founder of Geared Power BioTech. "Acceptance into the Safer Technologies Program is a major milestone in our journey to commercialize BioGuard UVC. The potential to reduce the spread of respiratory disease and associated healthcare costs for hospitals adopting BioGuard UVC is real. We are excited about the work ahead and look forward to continued engagement and collaboration as we develop the required evidence for FDA market clearance."

This builds on Geared Power BioTech’s recent announcement of Congressional support encouraging BARDA and the War Department to adopt UV Technology to eliminate pathogens in exhaled breath and thereby stop the spread of these infections, which was enacted in the 2026 Appropriations. Please refer to our News Room for this announcement as well as others about our 'Leader in Life Sciences' and 'Coolest Thing Made in New Jersey' awards from 2025.

About Geared Power BioTech - based in Wayne, NJ, Geared Power BioTech is a high potential startup working to commercialize its first product – BioGuard UVC, a medical device poised to transform respiratory infection control for healthcare facilities, emergency response, and public health applications. For more information, visit https://GP-Bio.com or contact info@gearedpower.com.

GARY KELLSTROM, JR.
Geared Power
+1 973-801-4127
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2025 Coolest Thing Made in New Jersey - BioGuard UVC

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