Belluscura Receives FDA Clearance for XPLO2R POC

LONDON, U.K. & PLANO, Texas (March 9, 2021)—Belluscura PLC, a medical device developer, has been granted 510(k) clearance and marketing authorization by the U.S. Food and Drug Administration (FDA) for the XPLO2R portable oxygen concentrator (POC). Belluscura developed the X-PLO2R POC with their research partner, Separation Design Group, an award-winning oxygen enrichment research laboratory.

The X-PLO2R POC has patented technology that can deliver up to 95% pure oxygen to patients 24/7. Weighing less than 3.25 lbs. (1.5 kg), the lightweight X-PLO2R POC is designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices to help improve the quality of life for millions of people worldwide who suffer from chronic lung diseases, such as chronic obstructive pulmonary disease (COPD) and respiratory distress caused by COVID-19. The X-PLO2R is expected to be commercially launched in 2021.

“Belluscura researched the portable oxygen market and concluded that new technology could improve the quality and efficiency of oxygen concentrators while also reducing the cost to the patient and caregiver,” said Robert Rauker, CEO of Belluscura. “Belluscura has exclusively licensed, acquired or jointly invented 18 patents and applications in the field of concentrated oxygen generation.”

Belluscura also confirms that it is considering the feasibility and timing of an initial public offering (IPO), and the potential admission to trading on the AIM Market of the London Stock Exchange (or other recognized stock exchange) and expects investments should qualify for Enterprise Investment Scheme (EIS) relief.

For more information visit belluscura.com.