Medical International Technology Files for U.S. Food & Drug Administration Approval of Its Needle-Free Jet Injector for Human Mass Inoculation.Business Editors/Health/Medical Writers DENVER, Colo.--(BUSINESS WIRE)--Sept. 15, 2003 Medical International Technology, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : MDIR MDIR Medical Device Incident Report ), a developer and marketer of patented needle-free jet injectors for human and animal inoculation, today announced that its MIT MIT - Massachusetts Institute of Technology Canada subsidiary has filed a 510(k) application with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for regulatory clearance to market its MED-JET(R) needle-free injector for human mass inoculations. "The MED-JET delivers all types of medications from influenza vaccines to insulin and other types of injectables," stated Karim Menassa, President and Chief Executive Officer of MIT. "Its low-pressure technology offers a clear advantage to alternative high pressure injection systems that can cause blowback blow·back n. 1. The backpressure in an internal-combustion engine or a boiler. 2. Powder residue that is released upon automatic ejection of a spent cartridge or shell from a firearm. 3. and expose medical workers and patients alike to microscopic traces of blood." Although there are products on the market for injections by a single user, Mr. Menassa noted that the potential for cross contamination cross contamination Medical practice The passsage of pathogens indirectly from one Pt to another due to use of improper sterilization procedures, unclean instruments, or recycling of products has been a nagging problem for mass inoculations. "Our patented MED-JET is a safe, efficient and cost effective injection system that already has been approved for human inoculation in Canada," he stated. "Key advantages include its light weight (0.5 kg) and an excellent medication absorption rate. Most importantly, the system can inject easily up to 600 individuals an hour during a crisis such as an epidemic or bio-terrorism attack." Mr. Menassa said that FDA approval of the MED-JET is expected to open up potential markets in the U.S., in areas such as defense, the military and homeland security. Other uses include the vaccination of school children, pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. vaccinations for babies and the healthcare industry in clinics and hospitals, just to name a few. Jet injection utilizes a high-pressure stream of liquid powered by compressed air compressed air, air whose volume has been decreased by the application of pressure. Air is compressed by various devices, including the simple hand pump and the reciprocating, rotary, centrifugal, and axial-flow compressors. , carbon dioxide or a spring mechanism to penetrate the skin and deposit the medication in the subcutaneous tissue. Some jet injectors which operate at 600 pounds per square inch Noun 1. pounds per square inch - a unit of pressure psi pressure unit - a unit measuring force per unit area (psi) have been known to bruise the skin. At the same time, "blowback" from high pressure injections often causes the leakage of blood and other body fluids, creating the potential for contamination. Medical International Technology addressed this problem by developing patented technology which injects medication at a much lower pressure - 125 psi. MIT CANADA, with offices in Montreal, is a subsidiary of Denver, Colo.-based Medical International Technology, Inc. (MIT USA), which specializes in the development, production, marketing and sale of patented needle-free injectors both for humans and animals, for individual and mass vaccinations. MIT CANADA has just introduced several models of the AGRO-JET, a needle-free jet injector for different niches in animal applications, and the Med-Jet, for human mass vaccinations. This press release contains certain "forward-looking" statements, as defined in the U.S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 that involves a number of risks and uncertainties. Statements, which are not historical facts, are forward-looking statements. The Company, through its management, makes forward-looking public statements concerning its expected future operations, performance and other developments. Such forward-looking statements are necessarily estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. It is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , competition and other factors that may be identified from time to time in the Company's public announcements. |
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