Belluscura (BELL) 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.
The UK medical device firm, which is focused on developing oxygen enrichment technology spanning broad industries and therapies, said firstly, the CMS is proposing to remove its National Coverage Determinations (NCD) at section 240.2.2 of the Medicare NCD Manual.
If approved, the Company said this would end coverage with evidence development, thereby allowing the Medicare Administrative Contractors (MACs) to make coverage determinations regarding the use of home oxygen and oxygen equipment for Cluster Headaches (CH).
Meanwhile, Belluscura noted that CMS is also proposing to modify its NCD for Home Use of Oxygen at section 240.2 of the Medicare NCD Manual ‘in order to expand patient access to oxygen and oxygen equipment in the home, and to permit contractors to cover the use of home oxygen and oxygen equipment in order to treat CH and other acute conditions.’
Currently, Section 240.2 of the Medicare NCD Manual, which has been effective since 1993, provides for home oxygen therapy only if the patient is in the chronic stable state, it noted.
Speaking to shareholders, CMS highlighted, "We note that since the inception of the Public Health Emergency (PHE) due to the COVID 19 pandemic, CMS has begun to permit health care services to increase the capacity of the American healthcare system outside the setting of the traditional inpatient hospital, including the treatment of acute illnesses."
Robert Rauker, Belluscura CEO commented: "If approved, this gives another substantial opportunity for Belluscura, in particular with the launch of its X-PLO2R DX Model in the first half of 2022. Shareholders will be kept fully updated on developments from the CMS."
Earlier this week, Belluscura unveiled that it had signed its second US distribution deal for its X-PLO2R™ portable oxygen concentrator ("POC") portfolio, which it says marks the next stage in establishing US-wide distribution coverage as part of its commercialisation strategy.
The Group’s strategy is to appoint distributors in the US to give US-wide coverage for the launch of 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.
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.
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Belluscura 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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