-New oxygen therapy technology provides treatment for range of conditions including COVID-19-
ST. LOUIS – Dynaris is pleased to announce that the Food and Drug Administration (FDA) has granted 510(K) Clearance to the Apogee, a new technology that doctors say lowers costs and may improve quality of life for the growing number of people on oxygen therapy, including those with COVID-19. The FDA Clearance will allow St. Louis-based Dynaris, the developer of Apogee, to begin manufacturing and distribution this year.
Apogee works dynamically with the nasal cycle intended to deliver oxygen to the patient’s lungs more effectively than other options. “Receiving FDA clearance is a huge step for Dynaris. Our team is incredibly excited because the Apogee could positively impact the lives of millions of people on oxygen therapy,” said Lon Aylsworth, CEO of Dynaris and primary inventor of the Apogee. “The Apogee is the world’s only dynamic patient oxygen conserver. Because it may deliver oxygen so much more efficiently than existing technology, the newly-approved Apogee may reduce resupply needs and dramatically lower the cost of oxygen therapy.”
Prior to the full FDA 510(K) Clearance, the Apogee also received FDA Emergency Use Authorization because of the device’s potential safety benefits to treating patients with COVID-19. As Dr. Shannon Sullivan, a pulmonologist shared in a letter to the FDA, “this innovation has the potential to have a meaningful impact for patients and systems affected by the current COVID-19 pandemic.”
Dynaris estimates Apogee will cost one-half of traditional oxygen therapy. Apogee’s more efficient delivery also means more freedom for patients. Patients will now be able to receive their prescribed levels of oxygen for far longer on the same sized tank. This could mean a higher quality of life for the 19 million Americans that are on oxygen and require oxygen therapy for conditions such as COPD (chronic obstructive pulmonary disease), pulmonary fibrosis, pneumonia, cystic fibrosis, sleep apnea and COVID.
Dynaris is located at the St. Louis Economic Development Partnership (STL Partnership) business incubator in Chesterfield, Missouri.
“The impact of the Apogee technology shows the power of these business incubators in making the St. Louis region such a renowned and impactful startup scene,” said Rodney Crim, CEO and President, St. Louis Economic Development Partnership.
About Dynaris
Founded in 2014, Dynaris has developed a new standard in oxygen delivery devices. Its patented and FDA Cleared Apogee is the first in a line of products designed to improve patient health, eliminate oxygen waste, reduce prescription costs, and provide a more comfortable therapeutic experience. Dynaris is a developer and manufacturer of oxygen therapy technologies. The company operates out of its ISO-13485 compliant facility in Chesterfield, MO.
To learn more about Dynaris, visit: www.dynaris.com