Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness

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AUSTIN, Texas--(BUSINESS WIRE)--Aug 26, 2025--

Lumaegis, Inc., an emerging leader in medical device innovation, was recently honored as one of the 2024 RadLaunch Challenge Winners by the International Ultraviolet Association, recognizing its groundbreaking contributions to solid-state lighting-based sterilization technologies.

Lumaegis has also successfully closed a $200,000 pre-seed funding round, led by one of their global strategic partners. Lumaegis will use these funds to build the next set of production units and conduct FDA, UL/CE, and longevity testing.

At the heart of Lumaegis’ innovation is the RadBox, a patent-protected sterilization device designed as a fast, energy-efficient alternative to traditional sterilizers. The RadBox has received FDA De Novo classification, a designation reserved for breakthrough technologies with no existing, approved predicate device. This status highlights the RadBox’s significant advantages and its potential to improve patient outcomes, all the while saving the practitioners tens of thousands of dollars per year.

The company is set to begin FDA-required testing later this year. The RadBox utilizes dual-modality approach i.e., combination of germicidal and thermal radiation emitted by Light Emitting Diodes to achieve sterility. With key patent already granted and additional applications nearing completion, Lumaegis is preparing for commercial launch upon FDA De Novo approval.

“We anticipate our first sales in 2026,” said CEO John S. Morreale. “Production will begin that year, and we already have customers lined up. Many dental professionals who collaborated with us during the RadBox design phase will be among our first users, providing essential clinical feedback. Additionally, we’ve secured our first major customer — a global industry partner and investor in the disinfection and sterilization space — representing over 2,000 units in initial sales.”

Lumaegis is poised to redefine sterilization standards across dental and medical practices, offering a transformative solution that combines speed, efficiency, and safety, all the while reducing practitioners’ costs and improving their productivity.

About:

Lumaegis is headquartered in Austin, TX and is a member of University of Texas’ Austin Technology Incubator. Its mission is to support global health security and to reduce the environmental impact of sterilization processes globally. The founders are seasoned serial entrepreneurs with a proven track record of leveraging technology to address sustainability challenges.

View source version on businesswire.com:https://www.businesswire.com/news/home/20250826921360/en/

CONTACT: John S. Morreale

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: HARDWARE MEDICAL DEVICES TECHNOLOGY INFECTIOUS DISEASES HEALTH TECHNOLOGY DENTAL SURGERY BIOTECHNOLOGY MEDICAL SUPPLIES PRACTICE MANAGEMENT FDA HEALTH

SOURCE: Lumaegis, Inc.

Copyright Business Wire 2025.

PUB: 08/26/2025 10:37 AM/DISC: 08/26/2025 10:37 AM

http://www.businesswire.com/news/home/20250826921360/en

 

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