Bacterin and RyMed Collaborate and Receive FDA Consent to Commercialize Antimicrobial Needleless Connector
BELGRADE, Mont., Aug. 10 /PRNewswire-FirstCall/ -- Bacterin International Holdings, Inc. ("Bacterin" or the "Company") (OTC Bulletin Board: BIHI), a developer of antimicrobial coatings for medical applications and revolutionary bone graft material, today announced that the U.S. Food and Drug Administration (FDA) has cleared RyMed Technologies' InVision-Plus® CS™ needleless IV connector for commercialization.
In a joint development project between RyMed and Bacterin, the InVision-Plus CS is treated with Bacterin's patented antimicrobial technology. The InVision-Plus CS is the only needleless IV connector to offer the combined antibacterial protection of chlorhexidine and silver. The device is designed to reduce potentially deadly, catheter-related bloodstream infections.
Bacterin has received an initial order for the InVision-Plus CS with full production expected by the fourth quarter of 2010. Bacterin will receive a royalty on all devices treated for RyMed.
Commenting on the FDA clearance, Mr. Dana W. Ryan, RyMed's president and CEO, said, "Our companies have put in a tremendous effort over several years to develop the InVision-Plus CS connector, combining RyMed's InVision-Plus technology with Bacterin's chlorhexidine/silver ion engineering. This product has the potential to take over the market and give clinicians a clear choice to protect their patients worldwide."
RyMed's InVision-Plus and InVision-Plus CS are needleless IV connectors designed to address intraluminal thrombotic catheter occlusion and catheter-related bloodstream infections. This proprietary needleless connector design is combined with Bacterin's unique patent-pending antimicrobial septa treatment that is effective for the life of the connector against the following microorganisms: Acinetobacter baumannii, Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis.
According to the Institute of Medicine in Washington, DC, preventable adverse events in the U.S., including hospital-originated infections, are responsible for 44,000 - 98,000 deaths annually. Hospital-developed infections involve 5% - 15% of patients, and more than 85% of primary bacteremias (the presence of bacteria in the bloodstream) are catheter related.
Last week, the FDA stated it is requiring makers of most IV needleless connectors to examine and report potential risks associated with the devices. One of the companies not mentioned in the FDA notice was RyMed Technologies.
As of October 2008, Medicare and Medicaid do not reimburse hospitals for the treatment of catheter-related bloodstream infection, which are estimated to cost approximately $40,000 per incident to treat. Hospitals within 28 states are now required to report their infection rates, and this practice is expected to be applied nationwide.
Mr. Guy Cook, Bacterin's President & CEO, added, "The FDA is addressing a serious issue in the industry. It has been estimated that as many as 30,000 patients die annually from catheter-related infections. Our two companies have created and are now at the point of commercializing a solution to a deadly problem. In 2001, as a result of a revision in the Bloodborne Pathogen Standard, the use of needleless systems was adopted by most healthcare facilities. In 2009, the U.S. market for vascular access devices and accessories was valued over $3 billion, a 5.4% increase over 2008; however, antimicrobial needleless connectors, a new addition to the market, represented only 0.02% of all needleless connectors in 2009. Today, with FDA support and the reimbursement changes by Medicare and Medicaid, we anticipate a tremendous need for our products."
About Bacterin International Holdings, Inc.
BACTERIN INTERNATIONAL HOLDINGS, INC. ("the "Company" or "Bacterin") develops, manufactures and markets biologics products to domestic and international markets. Bacterin's proprietary methods optimize the growth factors in human allografts to create the ideal stem cell scaffold and promote bone and other tissue growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain with a facet joint stabilization, promotion of bone growth in foot and ankle surgery, promotion of skull healing following neurosurgery and cartilage regeneration in knee and other joint surgeries.
Bacterin’s Medical Device division develops anti-microbial coatings based upon proprietary coating technologies. Bacterin develops, employs, and licenses bioactive coatings for various medical device applications. Bacterin’s strategic coating initiatives include antimicrobial coatings designed to inhibit biofilm formation and microbial contamination on medical devices drug delivery, local (as opposed to systemic) pain management, and anti-thrombotic factors for medical device applications. Headquartered in Belgrade, Montana, Bacterin operates a 32,000 sq. ft., state-of-the-art, fully compliant and FDA registered facility, equipped with five "Class 100" clean rooms. For further information please call (406) 388-0480 or visit www.bacterin.com
About RyMed Technologies, Inc.
RyMed Technologies, Inc., founded in 1994, specializes in the development and marketing of innovative safety products in the field of intravenous catheter care management. The company's products are designed to help reduce catheter-related infections associated with vascular access. More than 10 years of research and development have gone into its unique needleless connector, InVision-Plus with Neutral Advantage technology, and related products. The company is headquartered in Franklin, Tennessee. For more information, call (615) 790-8093 or access www.rymedtech.com.
This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof. These forward-looking statements are based on current expectations or beliefs and include, but are not limited to, statements about the Company's use of proceeds from the private placement offering and its earnings release. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the company's ability to meet its obligations under existing and anticipated contractual obligations; the company's ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability and willingness of third-party manufacturers to timely and cost-effectively fulfill orders from the company; the ability of the company's customers to pay and the timeliness of such payments, particularly during recessionary periods; the company's ability to obtain financing as and when needed; changes in consumer demands and preferences; the company's ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. The company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.
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SOURCE Bacterin International Holdings, Inc.
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