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Maximus Features MaxPlus Clear® and New Clinical Research at Association for Professionals in Infection Control and Epidemiology Annual Conference June 15-17 |
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Maximus Features MaxPlus Clear® and New Clinical Research at Association for Professionals in Infection Control and Epidemiology Annual Conference June 15-17 The first, an abstract authored by Victor Lange, ICP, CRC entitled “Needleless Valves/Connectors: Infection Prevention” is the first place winner of the Clinical Innovations/Practice Abstract Presentation awarded by the Infusion Nursing Society Conference held May 3-8, 2008 in Phoenix, Ariz. In this study, the latest FDA requirements for microbial ingress testing of a needleless access device were performed on three different devices. Results confirmed that the MaxPlus connector with Tru-Swab™ technology is clinically superior to the two additional products tested in terms of microbial barrier properties when using common disinfection protocol and worst case clinical simulation. Maximus is the only needleless access device manufacturer to test their needleless access device against these new, more rigorous FDA standards and publish the results. In 2007, Maximus received 510K clearance for the claim of “meets and exceeds latest FDA guidance for microbial ingress testing.” Maximus will also display the first place winner of the 2008 Infusion Nurses Society Scientific Poster Contest for Clinical Research, authored by Andre’ Schotte, RN, PhD, entitled “Luer Activated Device (LAD) Performance”. In this study, clinical data was collected to compare the MaxPlus positive displacement connector to an alternative “neutral” connector for number of catheter occlusions over a seven week period. During this period, the MaxPlus connector experienced only one withdrawal occlusion and no total occlusions, whereas the alternate device experienced 11 withdrawal occlusions and nine total occlusions. To determine why there was such a discrepancy, the author conducted independent laboratory testing and discovered that out of nine different connectors tested, only the MaxPlus connector exhibited positive displacement which reduces the occurrence of blood reflux into the catheter at disconnect. The eight other connectors all exhibited negative reflux, including the connectors that claim to be neutral. Negative displacement connectors permit reflux of blood into the catheter when the syringe or administration set is removed from the connector. As evidenced in the clinical research, this can lead to occlusions. “The results of these two meaningful research efforts illustrate the clinical impact of the MaxPlus device,” said Jeff Goble, President of Medegen. “The annual meeting is a great way for nurses and infection control practitioners to see how the MaxPlus Clear Connector promotes best practice by allowing for thorough disinfection and flushing.” MaxPlus Clear is the first and only clear positive displacement connector shown to enhance patient care by lowering bloodstream infection and occlusion rates. For more information on the conference, visit http://conference.apic.org//AM/Template.cfm?Section=Home3
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Medegen Appeals U.S. Federal Court Decision in ICU Medical Inc. Patent
Infringement Case Medegen continues to believe that ICU Medical’s valve product, CLC-2000™, infringes on the Company’s patent for its proprietary valve technology (U.S. Patent No. 5,730,418). This patent covers a number of Medegen’s novel inventions in luer-activated valves, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications. “Medegen’s intellectual property is valuable and we feel strongly about protecting our innovations and are confident we will prevail in the appeal process," said Jeffrey Goble, President of Medegen.
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Medegen Introduces MaxPlus® Clear, First and Only Clear Positive Displacement Connector for Use in Infusion Therapy Maximus is the only medical device manufacturer to offer a clear positive displacement connector. "MaxPlus Clear was developed based on the input from leading clinical institutions and practitioners. The MaxPlus' positive displacement feature, combined with a clear housing, offers complete visualization of the fluid path thereby enhancing catheter care," said Jeffrey Goble, President of Medegen. "Our goal is to significantly assist clinicians in their efforts to promote patient safety by providing them with products that assure clinical best practices will be effective, resulting in lower occurrences of catheter-related blood stream infection and occlusions." The MaxPlus Clear is an enhancement of the MaxPlus®, the company’s leading positive displacement connector, adding a clear housing. It features Medegen’s patented positive displacement technology, which provides a bolus of fluid to clear the catheter tip upon disconnection from the device. It also features Medegen’s patented Tru-Swab™ top which acts as a double sealed barrier to contamination and allows for true disinfection during pre-access swabbing. Medegen’s MaxPlus Clear provides features not previously available to clinicians, and is new technology for the industry. MaxPlus Clear answers the need of medical practitioners in a number of ways:
This in turn helps reduce:
Medegen specializes in developing technologies in infusion therapy centered on helping hospitals drive greater clinical performance and improved patient care. Medegen offers some of the most cost-effective, technologically advanced and clinically superior medical products and manufacturing services in the market. MaxPlus Clear is available in the U.S. beginning immediately. MaxPlus Clear will be sold and distributed through Maximus. For sales and product inquiries contact 909-390-9080 or www.maximusmedical.com.
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Medegen Expands, Opens New Facility in Mexico Contract manufacturing, whereby medical device companies outsource the manufacturing of their products to partners like Medegen, is expected to reach the $8 billion mark industry-wide by year end. “Expansion of our manufacturing facilities will provide medical device companies with high-quality and cost-effective outsourcing solutions,” said Jeff Goble, President of Medegen. “This marks a new milestone for Medegen as we focus on growing our medical manufacturing services business unit, while continuing to develop innovative Maximus brand technologies for the intravenous medication delivery market.” The new 42,000 square-foot facility will enhance contract manufacturing capabilities to the medical device and pharmaceutical industries significantly expanding the services of Medegen’s Manufacturing Services operating unit. The facility will also handle Medegen’s finished goods assembly for its Maximus brand of IV therapy products that feature Tru-Swab™ valve technology. “Coupling Ontario-based medical device development resources with the device assembly capabilities of the Tijuana operation allows Medegen to offer a comprehensive range of manufacturing services,” said Ross Magladry, Medegen’s Vice President of Business Development, Manufacturing Services. “This expansion provides the market a one-stop alternative encompassing a scope of services from product design through sterile device distribution.” The brand new, FDA-registered manufacturing plant features state-of-the-art clean rooms and is FDA QSR compliant and ISO 13485 certified. The facility is conveniently located within a mile of the Otay Mesa crossing in the Parque Industrial Chilpancingo in Tijuana, Mexico. For a view of available hi-res photos visit: http://www.flickr.com/photos/medegen. |
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| Medegen Files Patent Infringement Lawsuit Against Icu Medical Monday, July 10, 2006 Ontario, Calif., (July 10, 2006)--Medegen LLC, a leading provider of medical devices and components to the healthcare industry today announced that its Medical Manufacturing Services (MMS) division has filed suit in U.S. federal court in California against ICU Medical Inc. (NASDAQ: ICUI) for infringement on U.S. Patent No. 5,730,418. This covers a number of Medegen’s novel inventions in luer-activated valves, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications such as catheter occlusion. The complaint alleges that two of ICU Medical’s valve products, CLC-2000™ and TEGO™, infringe on Medegen’s patent for its proprietary valve technology. This technology is used by Medegen in its MaximusTM product line known on the market as both MaxPlus™ and NacPlus™. Medegen manufactures and distributes these products to the acute and alternate care provider markets and to its OEM medical device channels. The suit requests that ICU Medical pay damages for infringement to Medegen, and requests the court to issue a permanent injunction preventing the further sale of these products by ICU Medical. “Medegen was the pioneer in positive displacement valve technology and we are a company committed to innovation in research and development,” said Jeff Goble, President for Medegen MMS division. “Our patents are critical to the success of our company and protect our ability to continue to provide enhanced products to hospitals, and ultimately patients. As such we must aggressively enforce our patent portfolio and defend our intellectual property.” Medegen’s line of needle-free valves, including the MaxPlus™, features Medegen’s Tru-Swab™ technology which promotes aseptic technique and proper disinfection of the valve prior to access. Tru-Swab™ valves offer a flat smooth surface, free of nooks, crannies, gaps, or slits that typically harbor bacteria even after disinfection. Clinical papers recently presented at the annual meetings of the Society of Healthcare Epidemiology of America and the Association for Professionals in Infection Control reported an increase in blood stream infections with certain valve technology that cannot be adequately disinfected. Tru-Swab™ valves provide clean and safe needle free access to IV catheters and IV administration sets used throughout the hospital. Medegen MMS division is an emerging market leader in IV therapy components, such as luer locks, luer caps, needleless access ports, anesthesia manifolds and drip chambers which are sold to selected medical device companies under the KippMed™ brand name. Medegen MMS also markets its MaximusTM brand of IV therapy products, featuring the MaxPlusTM valve and a line of IV custom sets. In addition, Medegen MMS offers complete outsourced contract manufacturing solutions to medical device and pharmaceutical companies. Note to Editors: Examples that graphically depict the Medegen luer-activated valve technology patent are available upon request. About Medegen, Inc. Medegen is a leading innovator in infusion therapy, focused on helping hospitals drive greater clinical performance for improved patient care. The growing company provides clinically superior medical products and reliable, cost-effective manufacturing services to the medical community through its three operating units: Manufacturing Services, Maximus and KippMed. Manufacturing Services provides cost-effective contract manufacturing solutions to medical device and pharmaceutical companies. KippMed manufactures and markets IV therapy components for the OEM market, drawing from a 25-year history in IV component supply. Maximus develops, manufactures and markets needleless intravenous therapy products for the acute care market. The Maximus line of medical products features patent-protected technologies which improve patient outcomes and greatly reduce bloodstream infection rates. Medegen is headquartered in Ontario, Calif. and has operations in Tijuana, Mexico. For more visit http://www.medegen.com/. |
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| Medegen Acquires Maximus Medical Products, Inc. Thursday, April 08, 2004 Medegen Holdings, LLC has announced the acquisition of Maximus Medical Products, Inc. Maximus is a manufacturer and distributor of specialty Intravenous Therapy products and has been the exclusive distributor of Medegen's patented NAC Plus® needleless connector product line. Additionally, Maximus manufactures both proprietary and custom lines of I.V. sets and disposables that are sold into hospitals through a network of regional specialty distributors. Maximus is dedicated to providing devices that protect clinicians and patients from needle exposure with quality, cost-effective, easy to use products that prevent the transmission of blood borne pathogens. Terms of the transaction were not announced. Medegen Chief Executive Officer, Charles Stroupe, commented, "The Maximus acquisition will accelerate sales and product development of our KippMed line of branded I.V. therapy products by enabling us to be closer to the clinicians who use our products. Maximus also has a strong supply chain position that brings low-cost offshore manufacturing capability to Medegen that can improve the value we offer to our contract manufacturing customers." The Maximus facility in Costa Mesa, California will be immediately integrated into Medegen's Ontario, California operations. Maximus will become a brand of Medegen MMS, Inc. and the Maximus sales and management team will assume responsibility for expanding Medegen's sales and product line of I.V. therapy devices. More information on the Maximus product line can be found at www.maximusmedical.com Jeff Goble, Medegen MMS President, commented, "We are very pleased to welcome the Maximus team to Medegen. Their extensive experience and successful track record in developing new I.V. therapy products and markets will accelerate the growth of our KippMed products. As a result, we expect to increase the pace of our new product development efforts to take advantage of the new distribution channel that Maximus brings to us. Additionally, Maximus' low-cost assembly capabilities will improve the value we offer to existing and future contract manufacturing customers." Medegen improves patients' access to healthcare by manufacturing high quality medical products at the most competitive costs possible. Medegen is a leading manufacturer and marketer of medical products serving healthcare markets worldwide. The company's branded products are sold through national and international distributors for use in a variety of healthcare settings including hospitals, long-term care facilities, physician offices, home care and laboratories. Medegen is also a leading contract manufacturer serving the medical and drug delivery device markets. Nautic Partners led the recapitalization of Medegen Holdings, LLC in 2002 and holds a majority interest in the company. Nautic Partners is the independent successor to Fleet Equity Partners, a private equity affiliate of FleetBoston Financial since 1986, during which time capital under management has grown from $20 million to over $1.7 billion. Nautic is currently investing Nautic Partners V, LP, a $1.08 billion fund that closed July 31, 2001. Contact Information: Marketing Manager Medegen Medical Manufacturing Services 909-390-9080 |
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| Medegen Announces Closing Of Sale Of Its Medical Products Division To Medical Action Industries Inc Wednesday, October 18, 2006 Scottsdale, Ariz., (October 18, 2006)--Medegen LLC, (www.medegen.com) a leading provider of medical devices and components to the healthcare industry today announced that it has closed the sale of its Medical Products division to Medical Action Industries Inc. (NASDAQ GS: MDCI), a publicly-held supplier of medical and surgical disposable products. Medegen will retain its Medical Manufacturing Services (MMS) division and its factories in Ontario, Calif. and Tijuana, Mexico. The MMS division is a leading supplier of specialty I.V. therapy products and devices. "The sale of our Medical Products division enables us to increase our focus on and investment in Medegen's specialty I.V. therapy and contract manufacturing businesses," said Charles Stroupe, CEO of Medegen. About Medegen, Inc. Medegen is a leading innovator in infusion therapy, focused on helping hospitals drive greater clinical performance for improved patient care. The growing company provides clinically superior medical products and reliable, cost-effective manufacturing services to the medical community through its three operating units: Manufacturing Services, Maximus and KippMed. Manufacturing Services provides cost-effective contract manufacturing solutions to medical device and pharmaceutical companies. KippMed manufactures and markets IV therapy components for the OEM market, drawing from a 25-year history in IV component supply. Maximus develops, manufactures and markets needleless intravenous therapy products for the acute care market. The Maximus line of medical products features patent-protected technologies which improve patient outcomes and greatly reduce bloodstream infection rates. Medegen is headquartered in Ontario, Calif. and has operations in Tijuana, Mexico. For more visit http://www.medegen.com/. About Medical Action Industries Medical Action Industries is a diversified manufacturer of disposable medical devices. Its products are marketed primarily to acute care facilities in domestic and certain international markets. Medical Action is a leading manufacturer and distributor of many of its products in the markets it competes in. www.medical-action.com |
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