announced that it has signed its first US distribution agreement for its X-PLO2R™ portable oxygen concentrator (“POC”) portfolio, marking the first stage in the Group establishing US-wide distribution coverage as part of its commercialisation strategy.
The medical device developer, which is focused on lightweight and portable oxygen enrichment technology, said the unnamed distributor is located on the East Coast of the United States and is ‘an established nationwide seller of supplemental oxygen equipment.’
It stated that the distributor has immediately issued its first purchase order with anticipated delivery of the first X-PLO2R portable oxygen concentrators expected in Q3 of this year.
As described in the Company’s original admission document, Belluscura’s strategy is to appoint distributors in the United States to give US-wide coverage for the launch of the X-PLO2R; and this is expected to occur in the second half of 2021 and into 2022.
As a result, today’s news that it has secured its first US distribution agreement marks the successful first stage of the group’s efforts to establish this US-wide distribution coverage.
Belluscura’S 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 who suffer from chronic lung diseases, such as Chronic Obstructive Pulmonary Disease and COVID-19 related respiratory distress.
In March 2021, Belluscura received 510(k) clearance from the FDA for the X-PLO₂R, which will be launched commercially in 3Q21. The X-PLO₂R is designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices and it is expected that additional products within the X-PLO₂R range will be launched within the next 12 months.
Robert Rauker, Chief Executive of Belluscura commented: “We are very pleased with the reception the X-PLO2R portable oxygen concentrator has received from distributors.”
He added, “We look forward to the commercial launch in Q3 of 2021 and we anticipate signing a number of additional distribution agreements in the very near future.”
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Bellascura was admitted to trading on the AIM market of the LSE last month, raising £17.5 million at 45p through an oversubscribed fundraising following ‘strong support’ from investors.
The Group, which develops medical devices focused on lightweight and portable oxygen enrichment technology, is focused on commercialising its product portfolio in this space.
Following a US launch the Company intends, in due course, to pursue commercialisation across the UK, EU, Japan, South Asia, Australia, South America and Latin America.
As part of its commercialisation strategy for X-PLO₂R portfolio, the Directors of Bellascura have adopted a five-phase process which will commence with its initial launch in July 2021.
The global respiratory care devices market is estimated to be $23.4 billion in 2021 with the market expected to reach $28.6 billion by 2024, growing over $1.7 billion per year.
Within this wider market, the supplemental oxygen therapy devices market was forecast in 2018 to grow by 6% per year from $3.2bn in 2021 to $4.2 bn by 2026 and the impact of the COVID-19 pandemic has led to an increase in this growth forecast to 11% per annum.
As a result, the market is now forecast to reach $5.7bn by 2026, an increase of 66% over the next 5 years. In fact, to give a scope of this market, the World Health Organisation (“WHO”) announced on 24 June 2020 that it would be purchasing 184,000 oxygen concentrators, valued at over $100 million, in order to address oxygen shortages across 120 countries.
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