ieCrowd announced the achievement of an important milestone in the commercial development of the company's supplemental oxygen delivery device, Smart Oxygen.
The Smart Oxygen device, being developed by ieCrowd’s subsidiary Smart Oxygen Solutions, automatically adjusts to a patient’s changing demand for oxygen based on level of activity.
The FDA agreed that the 510 (k) submission for the Smart Oxygen device would require a series of technical laboratory and bench performance tests, but that no further clinical study would be needed.
This streamlined submission, as compared to a submission that includes clinical trials, confirms what Smart Oxygen Solutions believes will be its timeline for making the product commercially available.
The Company anticipates having licensing agreements and being manufacture ready as early as 2016. The regulatory pathway was clarified during a technical review meeting, held in response to the company’s "pre-submission" application for the device.
Smart Oxygen is designed for use by patients who need supplemental oxygen such as those with advanced COPD (Chronic Obstructive Pulmonary Disease). COPD is the 3rd leading cause of death in the U.S. with an estimated 14.8 million diagnosed patients and another 12 million undiagnosed. COPD is the 2nd leading cause of death in China.
The Smart Oxygen device is designed to automatically adjust the level of supplemental oxygen delivered to a patient on a breath-to-breath basis.
The device uses a novel and patent-pending algorithm and conserving function in order to deliver a dose of oxygen in response to a patient respiratory pattern, thus enabling the device to be responsive to a patient’s changing metabolic demand for oxygen, during daily activities such as walking, or any other type of exertion.
By automating the dose of oxygen delivered based on a changing demand, it is expected that patients could maintain satisfactory blood oxygen levels without manually adjusting the oxygen flow rate. The result could be increased mobility and a more dynamic lifestyle for the patient that likely will benefit quality of life and exercise performance.
The underlying technology was licensed by Smart Oxygen Solutions from the University of California, San Diego, where the original version of the device was developed. Smart Oxygen Solutions has assembled a group of experts from UC San Diego on lung physiology, pulmonary medicine, and chronic advanced lung disease treatment to advise on the Smart Oxygen device.
"Pulmonary rehabilitation (PR) programs have been shown to improve exercise capacity, quality of life, and dyspnea in patients with pulmonary disorders, such as chronic obstructive pulmonary disease (COPD)," said Dr. Xavier Soler, MD, PhD, Associate Medical Director of the Pulmonary Rehabilitation Program at UC San Diego, Division of Pulmonary, Critical Care and Sleep medicine and Chief Medical Advisor to Smart Oxygen Solutions.