Protectus Medical Devices, Inc. (formerly SquareOne Medical, Inc.) has developed and patented innovative safety medical percutaneous devices that, collectively, have the potential to dramatically reduce needlestick injuries for medical professionals worldwide.
The Protectus Safety Syringe, the Company's lead product, is the only fully automatic, self-sheathing safety hypodermic syringe that currently meets the functional definition of "Self-Sheathing" mandated by the U.S. Federal Government.
The status of the Protectus Safety Syringe as the only fully automatic, self-sheathing syringe gives Protectus Medical the potential to gain a substantial share of the $6 Billion global hypodermic syringe market.
Protectus Medical Devices has successfully patented its automatic, self-sheathing hypodermic safety syringe, and, based on the results of full-comparison clinical trials, the Protectus device has received 510(k) permission from the U.S. FDA to market and sell the device in the U.S. With the new OSHA regulations requiring significantly safer needle devices, Protectus Medical Devices is well-positioned in the safety syringe marketplace.
Each year, there are nearly one million accidental needlestick injuries in the United States alone (grossly under-reported). These injuries lead to tens of thousands of cases of hepatitis, HIV, and other bloodborne diseases. Healthcare workers face the prospect of years of physical and psychological suffering, and even death, as a result of this common, but preventable problem. The yearly direct cost of healthcare supplies and services required to treat the victims of accidental needlesticks is estimated to be in excess of $3 Billion!
Cost projections for manufacturing the Protectus Safety Syringe are only modestly higher than that of conventional syringes on the market today. The price of the Protectus Safety Syringe will be comparable to or less than other safety syringes currently on the market.
In summary, Protectus Medical has developed a patented self-sheathing safety syringe that can be manufactured for a modest cost increase over existing syringes without safety features. Based on the results of full-comparison clinical trials, the Protectus device has received 510(k) permission from the U.S. FDA to market and sell the device in the U.S. The Protectus Safety Syringe provides a tremendous marketing advantage over competitive devices, especially since Federal legislation now requires the use of safety syringes in all applications, particularly those that are automatic and self-sheathing.