Lumaegis has closed a pre-seed funding round worth $200,000 to advance its RadBox sterilisation device, which uses a new type of technology not currently on the US medtech market.
Utilising a combination of germicidal and thermal radiation emitted by light-emitting diodes (LEDs) to achieve medical instrument sterility, the device has already received FDA De Novo classification status.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Lumaegis will use the funds obtained from this round to build production units and conduct UL/CE, longevity and FDA-required testing, which the company hopes to initiate later this year.
In a 26 August statement, Lumaegis’ CEO John Morreale noted that the company anticipates the first sales of RadBox to come in 2026, with commercial production beginning in the same year.
Morreale said: “Many dental professionals who collaborated with us during the RadBox design phase will be among our first users, providing essential clinical feedback.”
Lumaegis has designed its sterilisation platform for use in dental clinics, surgical centres, and labs. The company has already secured its first large customer, namely an investor in the sterilisation sector that will initially purchase more than 2,000 units.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIf RadBox is to be granted FDA clearance, it would be the first sterilisation technology of its kind to arrive on the US market – differing from traditional ultraviolet (UV) methods due to its dual-pronged germicidal and thermal approach.
The technology could also overcome some of the issues associated with gas sterilisation by ethylene oxide (EtO), which requires a lengthy degassing period of up to 48 hours.
Furthermore, it could prevent the potential exposure of healthcare professionals to EtO, which has been associated with haematologic changes, various cancers and spontaneous abortion during occupational exposure, according to the US Centers for Disease Control and Prevention (CDC).
RadBox would also be suitable for more use cases than steam sterilisation, which cannot be used on any heat-sensitive materials that are prone to corrosion, warping or melting.
The device has also been proven to trigger a six-log reduction in bio-indicator Bacillus pumilus in less than three minutes, which could reduce the sterilisation timeline in surgical settings compared with EtO, which takes several hours to achieve.
If approved, RadBox would enter a market worth $3.7bn in 2024 – joining five FDA-approved UV sterilisers for surfaces in the space, according to GlobalData. The UV offshoot of this sector accounted for $310m of the market’s value this year.
