Product wins Top Award at US Trade Show

X-PLO₂R™ wins gold award at Medtrade East 2021 in Atlanta

 

LONDON, U.K. AND PLANO, TX, U.S. (25 October 2021). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that its X-PLO₂R™  portable oxygen concentrator won the Providers’ Choice Gold, the highest accolade to be given at Medtrade East in Atlanta, the largest home medical equipment trade show and conference in the U.S.

 

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 generates 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 worldwide who suffer from chronic lung diseases, such as Chronic Obstructive Pulmonary Disease and respiratory distress caused by COVID-19. The X-PLO₂R™ is designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices.

 

Robert Rauker, CEO of Belluscura plc, said“It is fantastic news and a great achievement that our portable oxygen concentrator has received the highest accolade given by the largest home medical equipment trade show and conference in the U.S. This award solidifies the strong demand we are receiving for the product and we will update shareholders with expected unit deliveries for 2021 and 2022 in the near future.”

 

 

For further information please contact:

 

Belluscura plc www.belluscura.com
Robert Rauker, Chief Executive Officer via Walbrook PR
Anthony Dyer, Chief Financial Officer
 
SPARK Advisory Partners Limited (NOMAD) Tel: +44 (0)20 3368 3550
Neil Baldwin
 
Dowgate Capital Limited (Broker) Tel: +44 (0)20 3903 7715
James Serjeant / Nicholas Chambers
 
Walbrook PR Ltd (Media & Investor Relations) Tel: +44 (0)20 7933 8780 or belluscura@walbrookpr.com
Paul McManus / Sam Allen Mob: +44 (0)7980 541 893 / +44 (0)7502 558 258

 

 

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.

About Reach announcements

 

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Belluscura plc (UK)…Confirmation of Issue Price for Placing on the AIM market of the London Stock Exchange

24 May 2021
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM, THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE IT IS UNLAWFUL TO DISTRIBUTE THIS ANNOUNCEMENT.

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”)

Confirmation of Issue Price for Placing

Designer and manufacturer of FDA cleared, lightweight and portable oxygen concentrators
to raise £17.5 million, with an expected pre-money market capitalisation of £50.96 million

LONDON, U.K. AND PLANO, TX, U.S. (24 May 2021). Belluscura plc (AIM:BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that it has received very strong levels of support for the placing and subscription. First day of dealings will commence on Friday 28 May.

Key Fundraising Statistics:

Total Fundraising Size¹: £17.5 million
Issue Price per Belluscura Share: 45 pence
Number of Existing Belluscura Shares: 74,351,847
Number of VCT/EIS Placing Shares: 14,192,554
Number of General Placing Shares: 24,051,890
Number of Subscription Shares: 644,444
Enlarged issued share capital on Admission: 113,240,735
Market capitalisation at the Issue Price²: £50.96 million

Notes:

¹ Before estimated commissions, fees and expenses payable by the Company of approximately £1.4 million.
² The market capitalisation of the Company at any given time will depend on the market price of the Ordinary Shares at that time.
There can be no assurance that the market price of an Ordinary Share will equal or exceed the Issue Price.

Belluscura focuses on novel oxygen-based treatment platforms that can be adapted and applied in a wide range of
markets beyond those traditionally applicable to a single product or product line.Its range of portable products will
be lighter / more adaptable / have higher O₂ capacity by weight than existing oxygen enrichment products in their
respective class. Whilst potentially useful for recovering COVID patients, it has a wide range of use for sufferers of
pneumonia / COPD (i.e. asthma/ emphysema /chronic bronchitis) and other respiratory illnesses. It received 510(k)
clearance from the US Food & Drug Administration (FDA) in March 2021 for its X-PLO₂R range of oxygen
concentrators, which will be launched in 2021.

The Company has a registered office in the UK. Its subsidiary, Belluscura LLC, is based in Plano, Texas, USA. The USA
is the Company’s main country of operation.

Admission Document

The Admission Document (when published) will be made available on the Company’s website shortly, at
belluscura.com/investors.

Further announcements will be made as appropriate.

For further information please contact:

Belluscura plc

Robert Rauker, Chief Executive Officer                                                                                                           www.belluscura.com
Anthony Dyer, Chief Financial Officer                                                                                                               via Walbrook PR

SPARK Advisory Partners Ltd (NOMAD)   

Neil Baldwin                                                                                                                                                 Tel: +44 (0)20 3368 3550

Dowgate Capital Ltd (Broker & Bookrunner)

James Serjeant / Nicholas Chambers                                                                                                      Tel: +44 (0)20 3903 7715

Walbrook PR Ltd (Media & Investor Relations)                         Tel: +44 (0)20 7933 8780 or belluscura@walbrookpr.com

Paul McManus / Sam Allen                                                                             Mob: +44 (0)7980 541 893 / +44 (0)7748 651 727

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™
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™ and the X-PLO₂R DX™ portable oxygen concentrators. The X-PLO₂R CX is expected to produce theequivalent 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 XPLO₂R. 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 2021and 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-casesset-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

Belluscura Intends to Float on AIM

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-PLORTM, is a lightweight FDA cleared portable oxygen concentrator (“POC”) designed to replace larger, metal oxygen tanks and heavier portable oxygen concentrator devices. The X-PLOR 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-PLOR 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-PLOR 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.

 

Disclaimer:  This press release is for informational purposes only. Nothing in this press release should be construed as, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy or hold, an interest in any security or investment in Belluscura plc.

X-PLO₂R™ Portable Oxygen Concentrator Receives FDA Clearance

Belluscura is excited to announce that the X-PLO2R portable oxygen concentrator has been granted 510(K) clearance from the U.S. Food and Drug Administration (FDA). We are extremely proud to bring this technology to the market, in doing our part to help improve the quality of life for millions of people worldwide who suffer from chronic lung diseases, such as the Chronic Obstructive Pulmonary Disease (COPD), respiratory distress caused by COVID-19, and many other respiratory disorders.

View the full press release and continue to follow Belluscura for future updates.

 

Respiratory Therapist Spotlight: Ruthie Marker MSRC, RRT

Each year, Respiratory Therapists (RT) are celebrated during Respiratory Care Week, happening this year from October 25th to October 31st. RT’s play a vital role in the lives of various patient populations, and most notably this year, providing hands-on care for patients whose breathing has been compromised by the SARS-CoV-2 (COVID-19 Virus) pandemic.

Ruthie Marker MSRC, RRT, Manager of Clinical Affairs at Belluscura, has worked as a respiratory therapist for over ten years in various clinical settings and locations and, most recently, as manager of clinical affairs at Belluscura. We interviewed Ruthie recently to get her thoughts and feedback regarding her clinical and non-clinical medical device careers.

respiratory therapist

Ruthie Marker MSRC, RRT, Manager of Clinical Affairs at Belluscura, plc

Q: What was your first job as a respiratory therapist?

A: In my last year of undergraduate coursework I applied to University Medical Center at Brackenridge (UMBC) in Austin, TX as a respiratory care assistant. In that role, I helped with things such as disinfecting equipment and maintaining supplies stocked throughout the hospital. That summer, I completed two internships at UMCB in the Level I Trauma Intensive Care Unit (ICU). I enjoyed my internships so much that after receiving my degree and passing the required board exams, I started my respiratory career at UMCB and called it home fore the next four years.

Q:  What did you like most at UMCB?

A: What I liked the most about UMCB was working closely with the group of pulmonologists. The group consisted of about six highly experienced pulmonologists. What I enjoyed the most was assisting with bedside tracheostomies.  A procedure that once required the patient to go to the operating room can now be performed in a patients’ room which conserves cost, time, and most importantly, reduces infection risks.

Q: What was the most important lesson you learned working there?

A: The most important lesson I learned at UMCB was that life is very short. Trauma happens when you least expect it and I saw a lot of it there. It taught me to be thankful for every moment I have on this earth. I attribute much of who I am today as a respiratory therapist to the lessons learned while working with such amazing clinicians and the hands on experience I gained.

Q:  After Brackenridge, what did you do next?

A: The next two years were very fluid due to relocations, and in 2013 I started working at the Parkland Health & Hospital System in Dallas, TX, specifically the Medical ICU. In 2016, I began working in Parklands Level III Neonatal ICU (NICU). I fell in love with the NICU and learned so much, I was part of a resuscitation team that attended all high risk and preterm deliveries.

Q:  What was the most challenging and rewarding part of working at Parkland?

A: The NICU has by far been the most challenging, yet most rewarding area I have had the pleasure of working in. The resilience of these tiny humans is unbelievable! I have cared for babies that weigh less than a pound, 370 grams to be exact! With the amazing multidisciplinary team at Parkland NICU and the progressive treatment approaches, these babies thrive!

Q: As an RT, have you worked with COVID-19 patients?

A: Working in the NICU was a relatively ‘safe’ place to work since many of our patient interactions were with babies. While we did risk exposing ourselves in various other areas of the hospital, it remained my haven.

When I left Parkland, I took a crisis RT position in Baltimore, MD. The hospital I worked at in Baltimore was extremely understaffed and not equipped to handle the surge of patients now making their way to hospitals for treatment. I wanted to challenge myself, seeing if my skills for treating adult patients were still there. The transition was a bit bumpy, but I got back in the swing of things fast.

Q: What did you find was the most difficult part of dealing with patients during this pandemic?

A: As a respiratory therapist, treating both adult and preterm infants, I was used to treating patients with various chronic and acute conditions. COVID-19 is something no one was prepared for and forced us to adapt quickly. In the beginning, there were many unknowns, for example how best to manage patients requiring respiratory support.  I’ll admit I cried the first week I was there, feeling an overwhelming amount of emotions and experiencing the physical toll it took on me.

It was difficult to feel as if I was making a difference in patients’ lives and still see patients dying. My time in Baltimore was short, I applaud all my fellow RT heroes that are showing up, day after day, overcoming physical, emotional, and mental stress!

Q: When and why did you decide to leave the clinical practice of respiratory therapy and join a medical device company?

A: After graduating with my masters in December 2019, I wanted to explore the potential of my profession outside of clinical practice. As RTs, we depend on the technology developed by respiratory care and medical device companies to care for our patients, both in the acute care setting as well as outpatient care. I wanted to immerse myself in the industry responsible for helping make patients’ quality of lives better, currently through the development of a portable oxygen concentrator, and continue my passion for being a patient advocate.

I think it is essential for RTs to be at the heart of any products or therapy that will improve the lives of patients. After all, we help patients breathe easier! I still have a close relationship with many practicing RTs, and I read more clinical trials and articles now than ever before. This helps me stay current with treatment practices and enables me to continue growing my knowledge of patient care.

Q: As a respiratory therapist yourself, why is Respiratory Care Week important to you?

A: Have I mentioned one of the perks of Respiratory Care Week is all the delicious treats?! Ok, all kidding aside, the most important thing for me is for the world to know who we are. Breathing is a synonym for respiratory, and in my opinion, should be synonymous with a respiratory therapist. We are an integral part of patients’ lives, not only in the hospital setting but also in outpatient care, sleep medicine, asthma clinics, pulmonary rehabilitation centers, and soon will be involved in treating COVID-19‘long haulers.’

Takeaway

As healthcare continues to evolve rapidly, so will the various roles held by respiratory therapists. This Respiratory Care Week be sure to show your appreciation for the respiratory therapists in your community! They do so much behind the scenes with doctors and nurses and deserve recognition for what they do.

 

Ruthie has been a respiratory therapist for over ten years. She received her bachelor’s and master’s degrees from Texas State University in San Marcos, TX. She started her career working in a Level I Trauma center in Austin, TX, and most recently spent the last five years working at Parklands MICU and Level III NICU. Currently, she is the Manager of Clinical Affairs at Belluscura plc, a medical device company focused on developing innovative oxygen enrichment technologies designed to create improved health and economic outcomes for patients, healthcare providers, and insurance organizations.

New FDA Guidance Provides a Policy Designed to Expand the Availability of Respiratory Devices, Including Oxygen Concentrators, During the COVID-19 Pandemic

Today, the U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency.

WHITE OAK, MD  (Photo by Sarah Silbiger/Getty Images)

 
The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of devices that facilitate respiration, including ventilators and accessories. Learn more.

Belluscura and its research partner, Separation Design Group, announce the filing of a patent application on a modular portable oxygen enrichment ventilation system

LONDON, UK, PLANO, TX AND WAYNESBURG, PA, March 13, 2020.  Belluscura PLC, in conjunction with its exclusive research partner Separation Design Group, announced today the filing of a patent application covering novel modular portable oxygen enrichment ventilation systems for treating patients suffering from chronic obstructive pulmonary diseases (COPD) and acute respiratory distress syndrome (ARDS) brought on by such diseases as COVID-19.

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Belluscura announces filing of a patent application on an oxygen enrichment device and system for treating acute respiratory distress (ARDS), including ARDS caused by the recent Coronavirus

LONDON, UK AND PLANO, TX, February 6, 2020.  Belluscura PLC, in conjunction with its exclusive research partner Separation Design Group, announced today the filing of a patent application covering novel integrated portable extracorporeal oxygenation and carbon dioxide removal systems for treating patients suffering from acute respiratory distress syndrome (ARDS).

The latest patent application covers devices and systems for treating people suffering from ARDS including patients suffering from the recent coronavirus in Wuhan, China.  The primary cause of death from respiratory viruses like the coronavirus and influenza, are the result of the fluids accumulating inside the alveoli (the tiny air sacs of the lungs) which ultimately leads to the failure of the transfer of oxygen to and carbon dioxide out of the blood.  The current primary treatment for ARDS is oxygen therapy along with ventilator support.

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Belluscura PLC raises $2.7 million in latest financing round

LONDON, UK AND PLANO, TX, August 2, 2019.  Belluscura PLC announces the successful close of its latest fundraising round. Raising $2.7m, the private placing was priced at US$0.185 (15p) per share, giving Belluscura a post-money valuation of approximately US$9.0m.

Beginning with an over-subscribed UK crowdfunding campaign on CrowdCube earlier this year, 12 existing shareholders and 325 new shareholders invested in Belluscura during the latest raise.  The funds will be used by Belluscura to complete regulatory clearance and launch its innovative X-PLOR portable oxygen concentrator. 

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