Intention to Float - AIM

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This announcement is an advertisement and not an admission document or a prospectus. This announcement is not and does not constitute or form part of, and should not be construed as, an offer of securities for subscription or sale in any jurisdiction nor a solicitation of any offer to buy or subscribe for, any securities in any jurisdiction, nor shall it or any part of it, or the fact of its distribution, form the basis of, or be relied on in connection with, any contract or commitment whatsoever. This announcement does not constitute a recommendation regarding any securities. Prospective investors should not subscribe for or purchase any securities referred to in this announcement except in compliance with applicable securities laws and regulation and on the basis of the information in the final admission document ("Admission Document") intended to be published by Belluscura plc ("Belluscura" or the "Company"), and any supplement thereto, in connection with the placing of ordinary shares of £0.01 each ("Ordinary Shares") and the proposed admission of the entire issued and to be issued ordinary share capital of the Company to trading on AIM, a market operated by the London Stock Exchange plc.

Belluscura PLC

("Belluscura" or the "Company")

Intention to Float on AIM

Designer and manufacturer of FDA cleared, lightweight and portable oxygen concentrators

to raise £15 million, with an expected pre-money market capitalisation of £35-40 million

LONDON, U.K. AND PLANO, TX, U.S. (7 May 2021).  Belluscura plc, a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces its intention to seek admission of the entire issued and to be issued ordinary share capital of the Company to the AIM market of the London Stock Exchange ("Admission").

Belluscura's first product, the X-PLO₂R^TM, is a lightweight FDA cleared portable oxygen concentrator ("POC") designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices. The 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 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 worldwide who suffer from chronic lung diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and respiratory distress caused by COVID-19. The X-PLO₂R will be launched shortly and additional products within the range will be launched within the next 12 months.

Belluscura either owns or exclusively licenses a total of 26 patents and applications relating to oxygen enrichment devices and treatments.

The Company is seeking to raise £15 million via a conditional placing of shares ("Placing") to support the commercial roll-out of the X-PLO₂R and to progress Belluscura's oxygen enrichment product portfolio. Following completion of the Placing and Admission to AIM, Belluscura is expected to be valued in the region of £50-55 million.

SPARK Advisory Partners is acting as Nominated Adviser, and Dowgate Capital is sole Broker and Bookrunner in relation to the proposed Placing.

Key highlights

·    £15 million to be raised (before expenses) through a conditional placing with institutional investors at between 42-48 pence per new Ordinary Share

·    The net proceeds of the Placing will be used by the Company:

-     To widen staffing resources within Engineering & Quality, Marketing, Sales & Customer Service, Compliance & Finance and appointing a key Manufacturing & Regulatory Executive

-     Marketing of the product ranges, including building the brand, improving the website functionality and SEO and social media presence

-     Funding towards the FDA Medical Device Compliance, IT & Data Compliance and CE Mark Clearance

-     Research & Development into new products and increasing testing capabilities

-     Funding for the overheads of the firm, such as running the offices, and;

-     Initial working capital funding

·    Expected market capitalisation on Admission in the region of of £50-55 million 

·    Admission and commencement of dealings on AIM expected to take place in late May

The Company will publish an Admission Document which will be available in due course on the Company's website: https://www.belluscura.com

Robert Rauker, CEO of Belluscura plc, said: "We are delighted to announce our intention to float on AIM. These additional funds will allow us to accelerate our sales effort and the commercial roll-out of the first of our portfolio of oxygen concentrators under development. Our patented oxygen enrichment technology is designed to positively impact millions of people across the globe suffering from serious respiratory diseases.

"Our debut on the AIM market will see us well-positioned for commercial growth and well-financed to support the launch of our FDA cleared X-PLO₂R portable oxygen concentrator as well as advancing the other products within our portfolio to commercial launch.

"We look forward to welcoming support from investors for our portable oxygen enrichment technology, which will make a huge difference to people who need supplemental oxygen to enjoy a more active lifestyle at a reduced cost."

For further information please contact:

About Belluscura plc (www.belluscura.com)

Belluscura is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organisations.

Background & history

Belluscura was established in the UK in December 2015 with the object of commercialising intellectual property in the medical device space. The Company is currently focused on devices and treatments involving enriched oxygen.

The Company has raised approximately $11.7 million since 2018 in a number of fundraising rounds in order to develop and commercialise the Company's product portfolio.

In February 2017, Belluscura entered into a co-exclusive license and development agreement with Separation Design Group LLC ("SDG") of Waynesburg, Pennsylvania, to jointly develop and commercialise the X-PLO₂R^TM portable oxygen concentrator, a device that weighs less than 1.5kg, yet can deliver up to 800ml per minute of pulse dose enriched oxygen to a patient prescribed long term oxygen therapy. This agreement was updated in March 2021 to be an exclusive licence and development agreement.

SDG owns patents and patent applications covering novel oxygen enrichment technologies and treatment devices and methods. Through joint development efforts with SDG and the licence, Belluscura now either owns or exclusively licenses a total of 26 patents and applications relating to oxygen enrichment devices and treatments.

The Belluscura and SDG development relationship also includes the development of additional products, the X-PLO₂R CX^TM and the X-PLO₂R DX^TM portable oxygen concentrators. The X-PLO₂R CX is expected to produce the equivalent of 4 litres pulse dose oxygen and 750ml continuous flow oxygen. The X-PLO₂R DX is being designed to produce the equivalent of 6-litres pulse dose oxygen and 2-litres of continuous flow oxygen.

On 2 March 2021 Belluscura received 510(k) clearance from the US Food &Drug Administration ("FDA") for the X-PLO₂R. The Directors do not anticipate requiring additional FDA 510(k) clearances to launch the X-PLO₂R CX and the X-PLO₂R DX portable oxygen concentrators, as it expects to be able to self certify under "substantially equivalent" protocols of the FDA.

Belluscura plans to launch the X-PLO₂R shortly and the X-PLO₂R CX and X-PLO₂R DX within the next 12 months. The Company has a manufacturing agreement to produce the products in the USA. Following a soft launch, the Company plans to appoint distributors in the US to give US-wide coverage; this is expected to occur in the second half of 2021 and into 2022. Belluscura will commence International Regulatory clearances during 2021 and 2022 before expanding distribution globally. Following launch in the US, the Company intends, in due course, to pursue commercialisation in the UK, EU, Japan, South Asia, Australia, South America and Latin America.

Belluscura has an experienced executive management team with significant expertise in the medical devices industry and UK public companies.

The Market

The global respiratory care devices market is estimated to be $23.4 billion in 2021 and expected to reach $28.6 billion by 2024, growing over $1.7 billion per year. (Source: Research&Markets.com - Global Respiratory Care Devices market)

Supplemental Oxygen Therapy Market 

Within the respiratory care devices market, the supplemental oxygen therapy devices market was forecast in 2018 to grow by 6 per cent. per year from $3.2 billion in 2021 to $4.2 billion by 2026.

The impact of the COVID-19 pandemic has led to an increase in this growth forecast to 11 per cent. per annum. The market is now forecast to reach $5.7 billion by 2026, an increase of 66 per cent. over the next 5 years. The World Health Organisation ("WHO") announced on 24 June 2020 that it would be purchasing 184,000 oxygen concentrators, valued at over $100 million, to address oxygen shortages in 120 countries. (Source: Reuters, 24 June 2020 https://www.reuters.com/article/us-health-coronavirus-who-milestone/who-warns-of-oxygen-shortage-ascovid-cases-set-to-top-10-million-idUSKBN23V2FG)

As of February 2021, the WHO and partners have distributed over 30,000 concentrators and 40,000 pulse oximeters and patient monitors, reaching 121 countries, including 37 countries that are classified as "fragile".

Respiratory Diseases

The principal respiratory disease that requires management through the prescription of supplemental oxygen is Chronic Obstructive Pulmonary Disease ("COPD"). In addition, other respiratory diseases where symptoms are alleviated through supplemental oxygen include Coronavirus, Pulmonary Fibrosis and Cystic Fibrosis.

Chronic Obstructive Pulmonary Disease ("COPD")

COPD is the name for a group of lung conditions that cause breathing difficulties. These conditions include Emphysema, Chronic Bronchitis and Asthma. COPD typically affects middle-aged or older adults who smoke. The World Health Organisation estimates that 328 million people globally have COPD, of whom 65 million have moderate (Stage 2) or Severe (Stage 3) symptoms.

Although originally more common in men, due to increased smoking among women the disease now affects men and women almost equally. COPD also affects non-smokers, though smoking is the cause of 90 per cent. of COPD cases.

Symptoms of COPD comprise breathlessness, a persistent chesty cough, frequent chest infections and persistent wheezing. COPD is progressive and incurable, and by 2030 it is forecast that it will be the third leading cause of death worldwide.

In the early stages of COPD, the progression of the disease can be slowed by inhalers, tablets and pulmonary rehabilitation. As symptoms become more severe, oxygen enrichment products are used to prevent the level of oxygen in the blood falling to a dangerously low level.

COVID-19

The use of oxygen concentrators is a cornerstone treatment for COVID-19, with the WHO indicating that it intends to purchase over 100,000 units to distribute globally. The NHS is recommending oxygen for COVID-19 patients that are breathless and have blood oxygen saturations less than 94 per cent.

Although most people recover from COVID-19 after a short period, for some people, the symptoms can last for considerably longer. According to the NHS, long Covid symptoms include shortness of breath which may require the use of oxygen concentration treatment.

Other Respiratory Diseases

Although COPD is the primary disease for which oxygen enrichment products are used, they are also used to alleviate the symptoms of Pulmonary Fibrosis, Cystic Fibrosis and other respiratory disorders. Currently, it is estimated that 1.5 million adults in the US and 3.5 million adults in Europe use supplemental oxygen for these respiratory disorders.