Belluscura (BELL ) has highlighted a recent statement issued by the American College of Chest Physicians (CHEST) which advocates for the expanding demand for home oxygen.
The London-listed medical device developer, which is focused on lightweight and portable oxygen enrichment technology, informed investors that this recent statement from CHEST was issued on the rationale for home use of oxygen coverage beyond cluster headaches.
In response to the US Centers for Medicare & Medicaid Services (CMS) proposed decision on the appropriate use of oxygen for cluster headaches and expanding coverage for the home use of oxygen, CHEST, a worldwide community of over 19,000 clinicians advancing patient care in chest medicine, submitted rationale to CMS to expand the home use of oxygen.
Belluscura told investors that this rationale was joined by several other major healthcare organizations including, amongst others, the American Association for Respiratory Care, American Lung Association, COPD Foundation and the American Thoracic Society.
It outlined that a key rationale for expanding the ability of practitioner is to allow: "… maximum flexibility of the treating practitioner to determine clinically appropriate oxygen use based on medical need, without the patient having to first try and fail other therapeutic alternatives, is an important change and one that can help improve overall patient care."
Robert Rauker, Belluscura’s Chief Executive, commented: "This CHEST rationale, following on so closely from the CMS proposals, highlights the expanding demand for home Oxygen, and the increasing opportunity for Belluscura's novel oxygen concentrator technology. Shareholders will be kept fully updated on developments from CHEST and CMS."
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Last month, Belluscura said manufacturing had commenced in the United States for the first X-PLO2R™ units ahead of their planned distribution which is currently on target for 3Q21.
The Company also highlighted that it has 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.
Addressing shareholders, the Company said this marked the next stage in establishing US-wide distribution coverage as part of the Company's commercialisation strategy.
The Group signed its first US distribution deal for its X-PLO2R™ portable oxygen concentrator portfolio in June 2021, its second in early July, and its third in mid-July.
Belluscura was admitted to trading on the AIM market of the LSE in May 2021, 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.
In recent weeks, the Group said new proposals from the US Centers for Medicare & Medicaid Services (CMS) could expand US health care services beyond the traditional inpatient hospital setting.
The CMS is proposing changes to two separate, but medically related, National Coverage Determinations relating to home oxygen therapy which, if approved, could grant Belluscura ‘another substantial market opportunity’ ahead of its X-PLO2R DX Model launch in 1H22.
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