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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.

 

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 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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Does working in the Information industry cause COPD?

A recent Centers for Disease Control (CDC) study found that during 2013-2017, an estimated 2.4 million U.S. working adults 18 and older who never smoked had COPD. Research suggests that workplace exposures likely contribute to much of their disease.

According to the CDC report, among workers who never smoked, some of the highest COPD prevalences were in the information industry and administrative support occupations. The study also found that within the group of workers who never smoked, women had higher COPD prevalences than men.

See other statistics reported in the study, including COPD prevalences by sex, race and ethnicity, as well as public health implications, here

 

Oxygen and Wound Healing

Oxygen plays a vital role in our daily lives. We breathe because our bodies need oxygen to produce energy. However, in addition to enabling us to function, oxygen’s ability to produce energy plays an important role in wound healing.

Wounds that are infected and inflamed have poor blood flow. Exposure to high concentrations of oxygen (e.g. topical or hyperbaric oxygen therapy) helps accelerate healing by reducing inflammation, promoting collagen formation and stimulating the growth of new cells and blood vessels.

Although many factors affect the wound healing process, a study published in the Journal of Wound Care found that the use of topical oxygen therapy helped nearly half of the previously non-healing wounds close.

The Benefits of Oxygen Therapy

For people with chronic lung diseases, such as COPD, oxygen therapy is prescribed to increase the oxygen level in their blood. However, many patients do not comply with their prescribed treatment, with reasons ranging from self-consciousness to not understanding the benefits.

If you or your loved one has been prescribed oxygen therapy, here is a closer look at some of the benefits of long-term oxygen therapy:

  • Increased survival – by far, the most important benefit for people with COPD is that it prolongs your life if you have more severe resting hypoxemia (low levels of oxygen in your blood).
  • Reduced complications – supplemental oxygen helps reduce COPD complications by stabilizing pulmonary hypertension, reducing secondary polycythemia, and decreasing arrhythmias (irregular heart rhythms).
  • Lessened symptoms – supplemental oxygen can help relieve dyspnea (shortness of breath) and other symptoms related to COPD, including fatigue, dizziness, and depression.
  • Improved health-related quality of life – not only does supplemental oxygen improve your sleep and mood, it also increases your mental alertness and stamina, allowing you to get more done during the day.

These are just a few of the many benefits of oxygen therapy, so read more.

How does a portable oxygen concentrator work?

Portable oxygen concentrators are medical devices that help people with chronic lung conditions increase the oxygen level in their blood. Unlike the oxygen tanks and liquid oxygen systems that require replacement and refills, portable oxygen concentrators purify the oxygen from the air we breathe:

1. The concentrator draws in the air from the environment. The air that goes into the concentrator consists of about 20 percent oxygen, 78 percent nitrogen and 2 percent other gases.
2. The air is pulled into the cartridges filled with the material called Zeolite. Zeolite captures nitrogen through a process called pressure swing adsorption, thus concentrating the oxygen.
3. The concentrated oxygen is delivered to the patient via a nasal cannula.
4. Part of the oxygen is fed back through the cartridges to help clear out nitrogen and other gases that are then expelled back into the atmosphere.
5. The above process repeats.