Leland has been partners with NTG of Tokyo since the late 70's. They have always had a miniature oxygen filled cylinder that we have had in our program since 1984. Our product Sports Oxygen came out at that time and was received with tremendous acceptance throughout the consumer product community. However, the U.S. Food and Drug Administration put an action against the product claiming that due to its size and the fact that it did not conform to regularly accepted standards, i.e., size of the cylinder and the liters per minute of flow, that it was considered a new drug and we would be required to go through the requisite testing. Currently, the requisite testing on a new drug takes five to eight years and approximately $2 million to complete. We obviously are not in that category and, therefore, we withdrew the product. Today, a small portable 18 liter oxygen filled cylinder is still in great demand and we are actively pursuing the following areas:
- Aviation-Small aircraft are generally non pressurized in the cabin and when a pilot encounters a weather system, which may only be small in size, it is generally desirable to go up and over the weather system rather than going around it, as it saves time and fuel. The problem is that when the human body does not get enough oxygen at the higher altitudes of 10,000 feet, the pilot will lose his vision slightly and more so as it becomes darker thus his nighttime vision becomes impaired. When his vision becomes impaired, he cannot fly his aircraft properly and hypoxia will soon set in. We have found that pilots are willing to buy a small device that will provide them with some extra oxygen while they are flying at high altitudes.
- Prescription Use-Prescription oxygen is our ultimate goal, as we are actively working with consultants in the Food and Drug industry to obtain approval to proceed to sell prescription oxygen to consumers through authorized practitioners such as pharmacists and home respiratory care givers.
This exciting new project is moving forward. Aviation Oxygen is currently available while prescription O2 is in the first stage of regulatory application. We expect 2004 and 2005 will be a time frame to report significant new developments in this area