OxySure (OXYS) Marks Seven Years and Thousands of Lives Saved - Safely
“If it wasn’t for this machine and what they did, our daughter may still be with us today but she wouldn’t be the Kylee we know.”
Mike Shea, father of Kylee Shea.
FRISCO, TX -- (MarketWired – October 26, 2015)
According to the reporting of Matt Lauer of the Today Show, what could have been a tragic situation actually turned into a happy ending for middle school student Kylee Shea. Added NBC’s Lilia Luciano: “What happened to 12-year old Kylee Shea is something most parents wouldn’t even think is possible. Walking the halls of her school she suddenly collapsed, and without the quick thinking of two teachers and a lifesaving device, she might not be here today.”
The story brings to life the incident, caught on the school’s security camera and published nationwide, where OxySure was used successfully and safely in saving Kylee’s life.
The Matt Lauer interview can be viewed here: https://www.youtube.com/watch?v=qGaTFFuRpDQ
Kylee Shea’s story mirrors that of thousands of lives saved over the past seven years with OxySure’s groundbreaking Model 615 emergency oxygen device.
Using a unique “oxygen from powder” technology this device allows anybody – a teacher, coach, friend, bystander, colleague or loved one – without training – to administer much needed oxygen in any medical emergency while waiting for first responders to arrive, creating outstanding medical outcomes and saving lives.
When asked about the lives saved and families OxySure has touched, Julian Ross, CEO of OxySure stated: “We are blessed to have the passionate support of thousands of families, nurses, caregivers, coaches, and many other OxySure users and survivors. We remain committed to our mission to continue to save lives and help our customers with our high quality, innovative, and safe medical products.”
In January 2010, Susan Greenwood wrote the following letter to Dr. Reedy, the then Superintendent of Frisco Independent School District:
“Dear Dr. Reedy, Words cannot express my gratitude for the OxySure machines that you purchased for the district. My daughter, Rylee Greenwood, was running sprints in athletics on Tuesday, January 5th at Scoggins Middle School when she experienced extreme respiratory distress. She was unable to breathe effectively and was severely oxygen deprived. Her life was saved by the school nurse, Ronda Figueroa, due to her prompt and proficient use of the OxySure and Epi pen. Rylee was transported to the hospital by ambulance and by the time she arrived she was breathing normally. Your decision to invest in the OxySure machines, and therefore in the reparatory health of our children, saved my child's life. Our family is very thankful for Scoggins and the district for making sure our children are safe!”
So what is the OxySure Model 615 exactly?
The OxySure Model 615 is an FDA-cleared breakthrough technology that is defining a new market with no direct competition. Protected by a patent portfolio and a variety of trade secrets, the OxySure Model 615 addresses the needs of enormous end markets that are at least as large as the install base for automated external defibrillators (AEDs), which exceeds two million units in the US, and potentially as large as the fire extinguisher base, which exceeds 100 million units in the U.S. and more than 500 million units globally. The OxySure Model 615 is also CE Marking approved.
A revolutionary portable emergency oxygen system using OxySure’s “oxygen from powder” technology, the Model 615 allows a parent, bystander, or victim to administer lifesaving oxygen in the event of a medical emergency, prior to the arrival of first responders.
Underscoring the need to bridge this gap and how critical it is, John B. Meyer, Director of Convention Center Operations, Corpus Christi Convention Center said this: “My passion for this product (OxySure) and its need comes from personal experience. Those precious minutes waiting for EMS to arrive were the longest minutes of my life. I wish I had OxySure available then – part of me feels strongly I might have been able to make a difference in the outcome for my colleague, and possibly even saved his life....”
Having OxySure’s Model 615 as a safety net creates improved medical outcomes; thousands of saves have already been reported in emergencies involving cardiac arrest (used post-resuscitation), heart attacks, stroke, asthma attacks (in conjunction with a bronchodilator, as applicable), COPD exacerbations, heat exhaustion, hypoxia/altitude sickness, migraine attacks, poisoning/overdose, diabetic emergencies, smoke inhalation, breathing difficulties, allergy emergencies, seizures, chest pain, fainting, dehydration, near drowning, hyperthermia, injuries with trauma, burn victims, and other medical, general or civil emergencies.
When asked by a reporter if he considered himself lucky, Brody Justice, a high school baseball player who collapsed during baseball practice and was saved using OxySure said this: “Not lucky that it happened (the collapse) but lucky to have had the oxygen.” The news story can be found here: https://www.youtube.com/watch?v=iSSlxngn7eg
Model 615 is also uniquely suited for homeland security applications (including emergency preparedness, mass casualty situations, etc.), civil emergencies, mining applications, and aviation applications.
Does OxySure Model 615 have any Regulatory Clearances or Approvals?
OxySure’s Model 615 has already received approvals and clearances from the following regulatory agencies:
• FDA cleared for over the counter sale, no prescription required (510(k), Class II device), December 2005;
• CE Marking clearance for over the counter sale, no prescription required (Directive 93/42/EEC, Annex II), February 2014;
• Agência Nacional de Vigilância Sanitária (ANVISA) approval in Brazil (ANVISA is the National Health Surveillance Agency for Brazil), June 2012;
• Israel Ministry of Health, (Approval number 4220403)
Innovative Products Can Be Confusing…
What about Safety?
In order to appreciate what the OxySure “oxygen from powder” process is about, one needs to understand what it is not.
OxySure is not a tank. An oxygen tank is an oxygen storage vessel for oxygen, which is held under pressure. According to the ESAB Group, “In an oxygen cylinder there is a precise relationship between cylinder pressure and cylinder contents. A standard oxygen cylinder that contains 244 cubic feet at 2,200 pounds per square inch (PSI) and 700 (6.5 m3 at 15200 kPa at 200C) will contain 122 cf (3.25 m3) when the pressure has dropped to 1,100 PSI at 700F (7600 kPa at 200C).”
Whether 2,200 PSI or 1,100 PSI this means a lot of pressure. Consequently, tanks are made of metal and require extreme care, training and maintenance to use. Failure to use oxygen tanks correctly can lead to major catastrophes, examples of which can be seen if a reader was to visit YouTube and search “oxygen tank explosion.”
OxySure is not a concentrator. An oxygen concentrator works much like a window air conditioning unit: it takes in ambient air, modifies it and delivers it in a new form. It works by:
• Taking in air from its surroundings
• Compressing the air, while the cooling mechanism keeps the concentrator from overheating
• Removing nitrogen from the air via a filter and (molecular) sieve beds
• Adjusting delivery settings with an electronic interface
• Delivering the purified oxygen via a nasal cannula or mask
Concentrators are typically used for long term oxygen therapy (LTOT), and are used under medical direction to provide low flow rates over long durations, usually in connection with serious respiratory illnesses such as bronchitis and emphysema. It is not suitable for emergency use (which is what OxySure is used for), which requires high flow rates for limited durations.
OxySure is not an “oxygen candle.” A chlorate candle, or an oxygen candle, is a cylindrical chemical oxygen generator that contains a mix of sodium chlorate and iron powder, which when ignited smolders at about 600 °C (1,112 °F), producing sodium chloride, iron oxide, and at a fixed rate about 6.5 man-hours of oxygen per kilogram of the mixture. Oxygen candles are normally used in commercial aircraft – if there is a decompression in an aircraft, the masks that are deployed will ordinarily carry oxygen from a chlorate candle source. What can be inferred is that these candles run extremely hot, and generally provide low flow rates not suitable for medical emergency use. Moreover, chlorate candles have to be handled by professionals only who are appropriately trained and transported in accordance with strict rules and guidelines provided by the Department of Transportation (DOT). If not, there can be serious consequences - readers need only search the ValueJet incident back in 1996 when 110 people perished over the Florida Everglades to appreciate this concern.
The OxySure oxygen creation process, demystified. So, then what is the Oxysure process for creating oxygen? The OxySure Model 615 includes the OxySure Powder and the OxySure Catalyst. The OxySure Powder is simply a salt which contains approximately 13% oxygen by weight. The Company uses the catalyst to release the oxygen molecule. The oxygen molecule is the only gaseous byproduct that is being released in the process. There are no other gases of any kind being released. Then, what is left in the cartridge is a simple wet mixture of salt.
The Southwest Research Institute (SWRI) conducted a study on the OxySure process to validate the fact that oxygen is the only gas being produced by OxySure. SWRI is a prestigious and highly respected leader among independent, nonprofit research and development organizations. SWRI has a staff of nearly 2,800 scientists, engineers, and support members and has clients that include NASA, Department of Defense and many others. In the study, SWRI not only validated that the purity of the oxygen, but it went one step further to test for and exclude the presence of undesirable gases such as carbon dioxide and carbon monoxide. A copy of the full report can be found here: http://www.oxysure.com/SWRI Final Report for OxySure_Confidential.pdf
In addition, the OxySure process was validated by the University of Texas at Austin (UTA). However, UTA went several steps further. In addition to testing for oxygen purity, UTA also tested the OxySure Powder, OxySure Catalyst and the remaining wet salt to validate their non-toxic nature and their environmentally friendly disposition. The report summary concludes, in part with the following Q&A:
What is the purity of the Oxygen being generated by the OxySureTM system?
The OxySureTM system produces 100% pure oxygen…
Are there any hazards associated with the powders?
The powders are not a fire hazard or an explosion hazard. In addition, the powders are non-toxic and environmentally friendly.
A copy of the full report can be found here:
After saving the life of a student at the College of Dental Medicine, Midwestern University Dr. Jay Morrow said this about OxySure: “Your product worked very well!”...
OxySure and USPTO / Smithsonian Innovation Expo
In November 2014 OxySure Systems, Inc. (OxySure) was honored to be selected by the United States Patent Office (USPTO) to be part of its inaugural Innovation Expo, conducted in collaboration with the Smithsonian Museum. The expo was held from November 1-2, 2014 at the National Air and Space Museum at the National Mall in Washington, D.C. OxySure joined ten (10) other patent holders which included Caterpillar, Ford Motor Company, Qualcomm, U.S. Department of Agriculture and the University of South Florida.
The USPTO has issued somewhere in excess of 9 million patents to date. Of those, OxySure was issued three utility patents and three design patents related to its groundbreaking OxySure Model 615 emergency oxygen device. The significance therefore, is that with so many millions of patents issued, and presumably held by millions of patent holders, why would the USPTO deem OxySure to be safe and groundbreaking enough to join such stellar companies as Caterpillar, Ford and Qualcomm at its inaugural Innovation Expo?
The Innovation Expo is collaboration between the USPTO and The Smithsonian designed to exhibit, showcase and celebrate American innovation and ingenuity. Candidates for the expo are selected from thousands of patent holders, including corporations, universities, the federal government and the inventor community that have commercialized innovation and new technological developments. Featured patented technologies will be breakthrough technologies and will have attained evident commercial success and influence and demonstrate significant contributions to both technological advancement and the standard of living in the United States. An example of an invention or product that fits this criteria is one that has established a new market or significantly reshaped an existing market. Additional details regarding the 2014 Innovation Expo can be found at the following links:
After seven years and thousands of lives saved, OxySure is well positioned and more determined to continue its quest to improve medical outcomes and save lives with its proven, safe and innovative products. These products positively impact the lives of children, families and people in the work place.
These positive outcomes were anticipated by Dr. James R. Winn, former CEO of the Federation of State Medical Boards and now a practicing physician: “Schools, churches, industry, airlines, and sports organizations are now able to have an emergency supply of life saving oxygen immediately available in a form that is both easy to use and to transport. Combined with the continued increase in availability of cardiac defibrillators, the OxySure system will prove invaluable in saving lives of individuals stricken with sudden collapse due to cardiac or respiratory problems...”
EVERY DAY, it is about people…
“We are equally grateful for the OxySure unit being available to ensure that Kylee’s quality of life is restored. Through this incident, we have become passionate advocates for the universal availability of AEDs and OxySure - wherever there are people! That means, in both public access areas and in private places....” Sheryl Shea, mom of 13-year old Kylee Shea, cardiac arrest survivor
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This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this release that are not historical facts, including, without limitation, statements that relate to the Company's expectations with regard to the future impact on the Company's results from new products in development, may be deemed to be forward-looking statements. Words such as "expects", "intends", "plans", "may", "could", "should", "anticipates", "likely", "believes" and words of similar import also identify forward-looking statements. These statements are subject to risks and uncertainties. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management. Readers are urged not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Except as may be required under applicable law, we assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release. Additional information on risks and other factors that may affect the business and financial results of OxySure Systems, Inc. can be found in the filings of OxySure Systems, Inc. with the U.S. Securities and Exchange Commission.