Belluscura Regulatory News (BELL)

Belluscura PLC

("Belluscura" or the "Company")

Commencement of Manufacturing and Fourth US Distribution Agreement

LONDON, U.K. AND PLANO, TX, U.S. (27 July 2021). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces it has started manufacturing and has signed its fourth distribution agreement.

The first X-PLO2R™ units are currently being manufactured in the US and the Company expects to meet its targeted commercial launch of X-PLO2R™, with the first units being distributed in Q3 2021.

The Company also recently signed its fourth distribution agreement with a US Service-Disabled Veteran-Owned Small Business dealing exclusively with the US federal government in areas such as Veterans Affairs and The Department of Defense. This is the next stage in establishing US-wide distribution coverage as part of the Company's commercialisation strategy.

As described in the Company's Admission Document, Belluscura's plan is to appoint distributors in the US to give US-wide coverage for the launch of the X-PLO2R™. Following launch in the US, the Company intends to pursue commercialisation globally.

About the X-PLO₂R™

The X-PLO₂R™ weighs less than 1.5kg (3.25lbs) and the Directors believe it is the world's first modular portable oxygen concentrator and that it will generate more oxygen by weight than any other US Food & Drug Administration ("FDA") cleared POC in its class. The X-PLO2R™ can deliver up to 95% pure oxygen to patients 24 hours a day, 7 days a week to help improve the quality of life for millions of people worldwide who suffer from chronic lung diseases, such as Chronic Obstructive Pulmonary Disease and respiratory distress caused by COVID-19. The X-PLO₂R™ is designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices.

In March 2021 Belluscura received 510(k) clearance from the FDA for the X-PLO2R™, which will be launched commercially in Q3 2021. Additional products within the range will be launched within the next 12 months.

Robert Rauker, CEO of Belluscura plc, said: "The Company has made great progress since X-PLO2R™ received FDA 510(k) clearance in March and the commencement of manufacturing is the next step before our targeted commercial launch this quarter. We have been pleased with the early interest from distributors based in the US, Europe, South America and Asia, wanting to supply the X-PLO2R™, which gives us great confidence for 2021 and beyond. Additionally, having the X-PLO2R™ portable oxygen concentrator available through a Service-Disabled Veteran-Owned Small Business is a tremendous opportunity and great honour for the Company."

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About Belluscura plc (www.belluscura.com)

Belluscura is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organisations.