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Belluscura is focused on developing oxygen enrichment technologies. Its lead product, X-PLO₂R, is pitched as the world’s first modular portable oxygen concentrator (POC). It received FDA 510(k) clearance in March 2021 and came to the market in September 2021. Early uptake is encouraging, with the company signing five distribution agreements and exceeding its sales volume projections for the year. We expect recent reimbursement approval from the US Centers for Medicare & Medicaid Services (CMS) and expansion outside the US, to be the key growth catalysts for the company. Additional product launches (X-PLO₂R CX and X-PLO₂R DX) planned in the next 12 months should add further momentum.
Written by
Jacob Thrane
Belluscura |
Promising portable oxygen supplement device
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Medical devices |
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18 January 2022 |
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Belluscura is focused on developing oxygen enrichment technologies. Its lead product, X-PLO₂R, is pitched as the world’s first modular portable oxygen concentrator (POC). It received FDA 510(k) clearance in March 2021 and came to the market in September 2021. Early uptake is encouraging, with the company signing five distribution agreements and exceeding its sales volume projections for the year. We expect recent reimbursement approval from the US Centers for Medicare & Medicaid Services (CMS) and expansion outside the US, to be the key growth catalysts for the company. Additional product launches (X-PLO₂R CX and X-PLO₂R DX) planned in the next 12 months should add further momentum.
X-PLO2R: A ‘lighter’ alternative
X-PLO2R is a lightweight, pulse-based POC weighing less than 1.5kg (3.25lbs) designed to provide up to 95% pure oxygen 24/7. The company asserts that the device generates more oxygen by weight than any other FDA-cleared POC in its class, and is lighter and more convenient to carry than existing devices. The market response has been positive, with five distribution agreements already signed in North America and a sales volume for FY21 ahead of management estimates. Belluscura plans to launch two new products (X-PLO₂R CX and X-PLO₂R DX) in 2022 (higher capacity pulse-based POCs with continuous flow oxygen features; additional 510(k) approval not required) and apply for international regulatory clearances in 2022.
US reimbursement approval will be a key catalyst
In a positive development, the company received reimbursement approval from the CMS in November 2021. According to management, Medicare reimbursement covers c 50% of the oxygen concentrator market in the US and we see this approval as a major endorsement of the company’s X-PLO2R device and a key factor in advancing volume growth in the near term.
Market opportunity remains attractive
According to Grand View Research, the North American oxygen concentrator market was valued at $1.1bn in 2020 and is expected to grow at an annual rate of 10.7% from 2021 to 2028. An increasing number of chronic obstructive pulmonary disease (COPD) cases and the COVID-19 pandemic have been driving demand for respiratory products, particularly oxygen concentrators. Accounting for more than 50% of the market, POCs are expected to post the fastest growth rate in the forecast period, creating solid upside for the company. In this context, Belluscura benefits from a co-exclusive product licence and development agreement with Separation Design Group (SDG). However, we point out that if cumulative X-PLO2R sales do not reach $20m within 48 months of launch, the company is required to make a one-off payment of $3m (c 13% cash at end June 2021) to maintain this agreement.
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Research: Healthcare
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