Belluscura (BELL) has signed its fifth distribution agreement with an unnamed online partner, to distribute its FDA cleared portable oxygen concentrator, X-PLO₂R™ in the United States.
The Group, which develops medical devices focused on lightweight and portable oxygen enrichment technology, said the US client, which has already placed its first orders with Belluscura, is a ‘leading online distributor, located in Colorado, Arizona and Georgia’.
Belluscura also describes its online partner as being a ‘significant presence’ in the portable concentrated oxygen market which has cumulatively served over 100,000 customers.
Today’s distribution agreement is considered significant by Belluscura because it means the Company has now exceeded the initial commercial launch target for X-PLO₂R™ unit sales.
Belluscura said it demonstrates that its management team is successfully delivering on its commercialisation strategy while also highlighting ‘the evident market anticipation for X-PLO₂R™ and its ability to significantly improve the current standard-of-care,’ it noted.
In July, the Company said manufacturing had commenced in the United States for the first X-PLO2R™ units ahead of their planned distribution which had been on target for 3Q21.
Last month, Belluscura said initial demand for X-PLO₂R™, the world's first modular portable oxygen concentrator, had been “strong” since the first units were distributed to customers.
"Receiving FDA 510(k) Clearance for the X-PLO2R™ was pivotal for the Group, followed by an oversubscribed placing and successful listing in May. To have brought the product to market so quickly is a tremendous achievement,” commented Chairman, Adam Reynolds in the Company’s recently published half-year results for the six months to 30 June 2021.
Last month, Reynolds said the initial response from the market was “hugely positive” to date.
This morning, Robert Rauker, Chief Executive Officer of Belluscura, noted that initial demand for the X-PLO2R™ portable oxygen concentrator had been “excellent” and that the addition of a fifth distributor is expected to expand the Company’s coverage in the United States.
"With the Research and Markets updated Portable Oxygen Concentrator Market research report now forecasting a compound annual growth rate ("CAGR") of 14.0% from 2019 to 2026, this is a very exciting time for Belluscura,” commented Rauker of the current market.
"Within the past five months, Belluscura has been able to put in place distribution agreements that cover the majority of North America from the East to West coast. In addition, the Company is receiving interest from overseas distributors. We will update shareholders with expected unit deliveries for 2021 and 2022 in the near future,” Rauker added this morning.
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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.
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.
Belluscura said it has confidence for 2021 and beyond after receiving early interest from distributors in the US, Europe, South America and Asia, wanting to supply the X-PLO2R™.
Rauker has described having the group’s X-PLO2R™ portable oxygen concentrator available through a Service-Disabled Veteran-Owned Small Business is “a tremendous opportunity.”
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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