12/2/2010 7:30:34 AM
LEXINGTON, Ky.--(BUSINESS WIRE)-- MedPro Safety Products, Inc. (OTCBB:MPSP.ob - News), a leading developer of transformational technologies that enable safer medication delivery and blood collection, announced today that its passive safety winged blood collection set, has received 510(k) market clearance from the U.S. Food and Drug Administration.
The passive safety winged blood collection set, commonly referred to as a ‘butterfly’ collection and infusion device, is the first collection set with a passive safety feature that activates through normal occupational use and without an extra procedural step. The needle becomes fully encapsulated as it is removed from the patient, thus reducing the risk of a needlestick injury. It can also be used as a single patient infusion set, allowing for venous access for blood collection in addition to infusion procedures. It features a familiar look and feel for the healthcare worker.
The product will be manufactured and distributed globally under an exclusive distribution agreement by an international manufacturer and supplier of medical devices and pre-analytic products.
“This clearance marks an important milestone toward MedPro’s objective to meet market demand for safer blood collection and infusion products,” said Craig Turner, Chairman and CEO of MedPro. “We expect our passive butterfly device to meet regulatory requirements set out by the Federal Needlestick Safety & Prevention Act, and help reduce the healthcare costs associated with needle stick injuries. According to the American Hospital Association, a single serious infection by a bloodborne pathogen caused by a needlestick injury can exceed $1 million in expenditures for testing, follow-up, lost time, treatment, and disability payments.”
About MedPro Safety Products, Inc.
Headquartered in Lexington, Kentucky, MedPro Safety Products, Inc. is a leading developer of safer medication delivery and blood collection systems. The Company licenses, develops and manufactures transformational technologies marketed through its global medical device partners. MedPro’s products address multiple product categories within the medical delivery (injection and infusion) and blood collection (blood collection sets and blood tube holders) markets. These products are considered the most passively available on the market as they require little or no clinician training as compared to competitive products. The total global market opportunity currently addressed by the Company is believed to be in excess of $6 billion. For additional information, please refer to the ‘Investor Relations’ link on the Company’s website (http://www.medprosafety.com).
Safe Harbor Statement
This release includes forward-looking statements based upon current expectations of the management of MedPro Safety Products, Inc. that involve risks and uncertainties, such as plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward- looking statements as a result of a number of factors, including our ability to identify and acquire medical safety device safety technologies with product development potential; our ability to successfully develop and bring products to market, including obtaining regulatory approvals; our ability to successfully increase sales of our products; our ability to obtain additional financing on satisfactory terms; our ability to attract and retain qualified employees; and governmental regulation associated with the medical safety products industry. Words such as "anticipate," "estimate," "plan," "continuing," "ongoing," "expect," "believe," "intend," "may," "will," "should," "could," and similar expressions are used to identify forward-looking statements. We refer you to the more detailed discussion of risks and uncertainties under "Risk Factors" in our Annual Report on Form 10-K and our other reports on file with the Securities and Exchange Commission.
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