Revolutions Medical Corporation Files Pre Market 510K Application With The FDA For 3cc Rev Vac Safety Syringe

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Oct 2008 - 9:00 PDT

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Revolutions Medical Corporation (OTCBB: RMCP) today filed its 510k application with the Food and Drug Administration for its proprietary 3cc Rev Vac Safety Syringe. The Rev Vac safety syringe uses patented technology to draw the needle into the syringe chamber after use. This safety syringe should result in a major decrease in accidental needle stick injuries. Another safety feature is that it will disallow the reuse of the syringe. This may decrease the spread of HIV and other blood borne diseases. This safety syringe is used one handed, which is such an important feature for the health care practitioner or medical personnel. There are no clumsy clamps, sheaths or other complex safety features that require two handed use.

"Revolutions Medical has continued to move forward with all of its proprietary technologies. I am pleased to get our 510K application filed with the FDA today for our 3cc Rev Vac safety syringe. As we await the FDA approval process, we are going through manufacturing selections and putting together a distribution team. We also are working on our 1cc, 5cc, 10cc Rev Vac syringes and other similar technologies to complete our safety line of disposable medical products.

"As the company transitions from strictly Research and Development of a number of proprietary technologies into sales and marketing, we expect to release a series of products into the medical marketplace over the next two years. I think our Rev Vac safety syringe has significant advantages over our competitors and will get a warm reception from the medical industry, and our manufacturing costs will be very competitive," states Ron Wheet, CEO of Revolutions Medical Corporation.

Rich Theriault, President of Strategic Product Development (SPD) states, "This is a key milestone in preparation for the manufacture and sales of the RevVac product line. SON Medical has done an excellent job in preparing this submission, and we look forward to a timely approval."

According to Dave Rothkopf, chief of regulatory affairs for SPD, "SON Medical has put together an excellent application and looks forward to a positive response from the FDA."

About Strategic Product Development, Inc

SPD provides design, development and manufacturing management services to the high technology sector. It has resources in China and Taiwan, to assess and manage low cost, high quality manufacturing resources for its clients.

About Revolutions Medical Corporation

Revolutions Medical Corporation is committed to continually developing and distributing new products and tools to the medical industry, whether internally or through acquisitions. Its goals are to make health care safer and less expensive by reducing risks, cutting time, and expenses. Its products include the Rev Vac safety syringe, safety blood drawing device and safety IV catheter. The world market for safety-engineered medical devices (SEMDs) is projected to exceed 2 billion this year and is forecasted to maintain a 20% annual growth rate in the near term. Revolutions Medical also provides software solutions and proprietary tools that are compatible with standard MRIs and standard PACS. The software includes sorting of images, color, 3D, and automatic segmentation of images. These tools will enhance the physician's diagnostic confidence in an industry that is growing at 10% - 15% (more than 25 million procedures) per year with a worldwide market potential for these tools that exceeds $3.5 billion. http://www.revolutionsmedical.com

Safe Harbor

Forward-looking statements made in this release are made pursuant to the "safe-harbor" provision of the Private Securities Litigation Reform Act of 1995. Forward-looking statements made by Revolutions Medical Corporation are not a guarantee of future performance. This news release includes forward- looking statements, including with respect to the future level of business for the parties. These statements are necessarily subject to risk and uncertainty.

Actual results could differ materially from those projected in these forward-looking statements as a result of certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of Revolutions Medical Corporation, and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, properly price, retain and successfully complete projects, and changes in products and competition.

Revolutions Medical Corporation