MINNEAPOLIS, MN--(Marketwire - July 22, 2009) -
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E-18 Corp. (OTCBB: ETEN) management today discussed federal regulations and the advantages of the Protectus Medical Hypodermic Safety Syringe, developed by its wholly owned subsidiary SquareOne Medical, Inc., doing business as Protectus Medical Devices (“Protectus Medical Devices”). The Protectus Medical Hypodermic Safety Syringe is the only safety syringe that currently meets the functional definition of “Self-Sheathing” mandated by the U.S. Federal Government. None of the manufacturers of other devices on the market can make this claim.
“The Protectus Medical Hypodermic Safety Syringe is the only fully automatic, self-sheathing safety syringe, which means that if a healthcare worker loses control of the device, it automatically sheaths and will protect healthcare workers and patients from needlestick injuries,” said Dr. John Salstrom, President and CEO of Protectus Medical Devices. “The healthcare worker using the syringe does not need to take any specific action to make it safe. The OSHA ‘Guideline’ was entered into the Federal Register as a mandate in 1991. In a subsequent Federal Register in 2001, OSHA specifically states this mandate again (see Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Injuries; Final Rule 66:5317-5325). The Final Rule amended the ‘Engineering Controls’ definition to: ‘Engineering Controls means controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.’”
This list of “Criteria for Acceptance” addresses the elements specifically intended by the definition of “Engineering Controls” stated by The Occupational Safety and Health Administration (OSHA):
-- “An engineering control is the use of available technology and devices to isolate or remove hazards from the worker.” -- “Examples of engineering controls include, but are not limited to, puncture resistant sharps containers, splash guards, mechanical pipetting, and self-sheathing needles.” -- “Engineering Controls shall be examined and maintained or replaced on a regular schedule to ensure their effectiveness.” (SOURCES: -- Compliance Assistance Guideline for February 27, 1990 OSHA Instruction CPL 2-2.44B Enforcement Procedures for Occupational Exposure to Hepatitis B Virus and Human Immunodeficiency Virus -- Federal Register/Vol. 56 No. 235/ Friday, December 6, 1991/Rules and Regulations -- OSHA 29 CFR Part 1910.1030 Bloodborne Pathogens)
“The Protectus Medical Hypodermic Safety Syringe fixed barrier (sheath) automatically covers the needle if intentional control of the device is lost at any time during its use, thus making the device truly self-sheathing,” Dr. Salstrom said. “We believe that the fact that we have the only device that truly meets the functional definition of ‘Self-Sheathing’ mandated by the Federal Government is a major competitive advantage for the Company.”
The Company’s lead product, the Protectus Medical Safety Syringe, is a patented, automatic, self-sheathing hypodermic safety syringe. The Protectus Medical Safety Syringe is designed to significantly reduce or eliminate accidental needlestick injuries that have plagued the healthcare workplace for decades. More information about Protectus Medical Devices may be found at the Company’s corporate website at www.protectusmedical.com.
About E-18 Corp.
E-18 Corp., through its wholly owned subsidiary, SquareOne Medical, Inc., doing business as Protectus Medical Devices, develops and markets innovative safety medical percutaneous devices that, collectively, have the potential to dramatically reduce needlestick injuries for medical professionals worldwide. In the nearly $5 billion global hypodermic syringe market, the Protectus Safety Syringe, the Company’s lead product, is the only fully automatic, self-sheathing hypodermic safety syringe that currently meets the functional definition of “Self-Sheathing” mandated by the U.S. Federal Government. None of the manufacturers of other devices on the market can make this claim. Protectus Medical Devices has successfully patented its automatic, self-sheathing hypodermic safety syringe product, and, based on the results of full comparison clinical trials, the Protectus Safety Syringe (formerly the SquareOne Safety Syringe) has received the required 510(k) permission from the U.S. FDA to manufacture and market the device in the U.S. More information about the Company may be found at www.protectusmedical.com.
Forward-Looking Statements
Under The Private Securities Litigation Reform Act of 1995: The statements in the press release that relate to the Company’s expectations with regard to the future impact on the Company’s results from new products in development are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties. Words such as “expects,” “intends,” “plans,” “may,” “could,” “should,” “anticipates,” “likely,” “believes” and words of similar import also identify forward-looking statements. 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. 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 E-18 Corp. can be found in the filings of E-18 Corp. with the U.S. Securities and Exchange Commission.
Contact Information
E-18 Corp.
John Salstrom
President and CEO
moreinfo@protectusmedical.com
Ph: 800-778-8438