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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
Leader in Medical Devices To Showcase Newest Product, Research Findings
Ontario, CA (June 16, 2008) – Maximus,a business unit ofleading infusion therapy firm Medegen Inc., will exhibit at the Association for Professionals in Infection Control and Epidemiology (APIC) annual scientific conference, June 15-17 in Denver, Colorado. The exhibit will feature the new MaxPlus® Clear, the first and only clear positive displacement connector for use in patient care, as well as two award-winning clinical research posters.
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
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 Appeals U.S. Federal Court Decision in ICU Medical Inc. Patent
Infringement Case
Infusion Therapy Medical Products Leader Continues to Protect its Proprietary Innovations
Ontario, Calif. (March 14, 2008)-Medegen, a leading innovator in infusion therapy medical products, announced
today that it is pursuing an appeal in the United States Court of Appeals for the Federal Circuit in Washington, D.C.
of a judgment of patent non-infringement entered in favor of ICU Medical Inc. (NASDAQ: ICUI) by a district court
judge in the Central District of California.
Medegen continues to believe that ICU Medical's valve product, CLC-2000T, 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.
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 Introduces MaxPlus® Clear, First and Only Clear Positive Displacement Connector for Use in Infusion Therapy
Shown to Enhance Patient Care Leading to Lower Bloodstream Infection and Occlusion Rates
Ontario, Calif. (March 10, 2008)—Maximus, a business unit of leading infusion therapy firm Medegen Inc., today introduced its MaxPlus® Clear positive displacement connector for use in patient care. MaxPlus Clear provides complete visualization of the fluid path providing a visual reminder to completely perform clinical practices such as priming, disinfection, and flushing. This clarity enhances clinical practice which can ultimately reduce the occurrence of bloodstream infections and occlusions in patients receiving 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:
- Provides for complete visualization of the fluid path during priming and flushing of the device
- Promotes an “Occlusion, and Contaminate Free” Line
- Promotes compliance with best practices and aseptic technique
- Promotes the use of Saline Flush and Lock vs. Heparin
- Promotes complete flushing
This in turn helps reduce:
- Bloodstream infections
- Occlusions
- Heparin usage
- False positive blood cultures
- Nursing time
- And all the costs associated with the above
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.
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 Expands, Opens New Facility in Mexico
Increase in Capacity to Meet Heightened Demand for Medical Product Manufacturing Services for Pharmaceutical and Medical Device Companies
Ontario, Calif. (Jan. 14, 2008)—Medegen Inc., a leading provider of medical devices, components and manufacturing services to the healthcare industry today announced it has expanded its manufacturing capabilities into Tijuana, Mexico. The recently opened facility will enable Medegen, through its Manufacturing Services operating unit, to meet the heightened demand for outsourced contract manufacturing as the medical device market is forecasted to grow at an annual rate of 10%.
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.
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 Responds to U.S. Federal Court's Decision in ICU Medical Inc. Patent Infringement Case
Medegen intends to appeal decision; will continue to protect its innovation
Ontario, Calif. (Sept. 17, 2007)-In response to today's motion granted by the U.S. Federal Court for non-infringement in favor of ICU Medical Inc. (NASDAQ: ICUI), Medegen, Inc. announced it will appeal the decision.
Medegen continues to believe that ICU Medical's valve product, CLC-2000T, infringes on the company's patent for its proprietary valve technology. "We are very disappointed by and disagree with the Court's decision," said Jeff Goble, President of Medegen. "We intend to pursue an appeal, and are confident in our chances of prevailing on such appeal."
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 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
Founded in 2001, Medegen LLC is a market leader in providing
superior products and services to the medical community through
its two divisions. The Medegen Medical Products (MP) division
develops, manufactures and markets disposable medical-surgical
products focusing on patient care and laboratory products. The
Medegen Medical Manufacturing Services (MMS) division provides
branded and OEM specialty infusion therapy disposables as well
as cost-effective outsourcing strategies to medical device and
pharmaceutical OEM's. Medegen is headquartered in Scottsdale,
Ariz. and has operations in Ontario, Calif.; Northglenn, Colo.;
Gallaway, Tenn.; and Tijuana, Mexico. For more information, visit
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
Founded in 2001, Medegen LLC is a market leader in providing
superior products and services to the medical community through
its two divisions. The Medegen Medical Products division develops,
manufactures and markets disposable medical-surgical products
focusing on patient care and laboratory products. The Medegen
Medical Manufacturing Services division provides branded and
OEM specialty infusion therapy disposables as well as cost-effective
outsourcing strategies to medical device and pharmaceutical OEM's.
Medegen is headquartered in Scottsdale, Ariz. and has operations
in Ontario, Calif.; Northglenn, Colo.; Gallaway, Tenn.; and Tijuana,
Mexico. For more information, visit 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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