Award-Winning Clinical Research Presented at Infusion Nursing Society Conference Demonstrates MaxPlus Clear™ Helps Reduce Catheter Related Bloodstream Infections to Zero

Ontario, CA (June 25, 2009) – Maximus,a business unit ofleading infusion therapy firm Medegen, Inc., announced today that new clinical findings presented at the Infusion Nursing Society annual conference on May 19, 2009 identified the MaxPlus Clear™ needleless access device as a device that assists in the reduction of bloodstream infections. Tim Royer, BSN, CRNI completed prospective surveillance at the VA Puget Sound Healthcare System in Seattle, Washington and presented his findings as an Oral Abstract titled “Using Clear Valves and Flushing with 20ml in the Adult Population to Attain Zero Central Line Associated Bloodstream Infection (CLABSI) Rate: A Prospective Surveillance.” The data presented consisted of six years of surveillance data spanning from January 2003 to December 2008.The abstract presentation and research was awarded first place in its category by the Infusion Nursing Society.

“Since January 2007 the facility saw a steady reduction in CLABSIs after instituting clear valves and a vigorous maintenance education of CVCs that includes flushing with 20ml of normal saline. The facility achieved a ZERO CLABSI rate in 2008 (p<0.05). "This is clinically significant," reported Royer. “As of March 20, 2009 it has been 433 days without a bloodstream infection, 433 days with a CLABSI rate of zero.”

The team implemented many interventions to reduce infection including: changing to a  swabable positive displacement connector (MaxPlus®), maximal sterile barriers and CHG prep, chlorhexidine patch, vigorous connector care education, switching to the clear version of the same connector (MaxPlus Clear™) and flushing with 20ml of normal saline. “An impressive continued drop to zero CLABSIs was noted with the implementation of the use of a clear positive displacement valve as a cue to clean, flush, or change the valve,” reported Royer.

In July 2007, Royer reported an initial cost savings of over $241,000 in the ICU’s alone for a five-fold decrease in CLABSI’s and a 60 percent reduction in contaminated blood cultures from this initiative.   

“Blood and debris are a growth media for bacteria. The care of CVCs that includes changing the valve if blood, precipitate, or debris are evident, coupled with flushing the catheter with 20ml NS to clear the catheter are associated with reduced infection rates. This is a clear enhancement to the central line bundle. If the valve is opaque, it does not trigger or reinforce the clear process to keep blood and debris out of the catheter,” reported Royer.

“This facility’s successful implementation of best practices coupled with use of the MaxPlus Clear connector illustrates how the MaxPlus Clear device can significantly enhance clinical care. By providing a visual cue to caregivers to disinfect and flush more thoroughly, patient outcomes are improved,” said Jeff Goble, President of Medegen.

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.

MaxPlus Clear is the first and only clear positive displacement connector shown to enhance patient care by lowering bloodstream infection and occlusion rates.

To view the abstract visit http://maximusmedical.com/studies_whitepapers.htm.   

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/.

Medegen Receives FDA Clearance for MaxGuard™ Advanced Luer-Activated Device with Antimicrobial Technology
First Positive Displacement Needleless Connector with Antimicrobial Technology

Ontario, Calif. (January 8, 2009)—Medegen, a leading innovator in infusion therapy  products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MaxGuard™ Advanced Luer Activated Device featuring Agion® Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated this new antimicrobial device exhibits a kill rate of greater than 99.99 percent representing a 4+ log reduction on infection-causing organisms predominantly responsible for catheter related bloodstream infections.

Medegen routinely receives input from IV Therapy clinicians regarding unmet needs and new product concepts. In 2006 clinical end users requested that Medegen’s leading device, the MaxPlus® Positive Displacement Connector, be offered with a clear housing to facilitate visualization of the fluid path. In February 2008, Medegen released the MaxPlus Clear™ which quickly became a leading product for the company because of the consistent and dramatic bloodstream infection reduction results it has brought to hospitals nationwide. Last year, MaxPlus clinical users requested an antimicrobial version of the MaxPlus Clear device for use on immunocompromised patients. Today, Medegen is once again fulfilling the clinical users’ requests by announcing FDA clearance of the new MaxGuard Advanced Luer Activated Device with Antimicrobial Technology.

"This is a significant achievement in Medegen’s ongoing pursuit to develop programs and products that help clinicians prevent bloodstream infections,” said Jeffrey Goble, President of Medegen. “Our goal has always been to provide clinicians with products that will significantly improve their efforts to enhance patient care and positive outcomes, and MaxGuard with Antimicrobial Technology meets that goal.”

Many hospitalized patients receive medications and nutritional support intravenously. During the process of administering intravenous medication, environmental contaminants can be introduced into the bloodstream. This is of particular concern if proper infection prevention techniques are not followed. MaxGuard with Antimicrobial Technology helps prevent contamination and growth of microorganisms at the point of entry into the catheter and subsequently in the bloodstream. MaxGuard is new technology introduced to assist hospitals in reducing catheter related bloodstream infections.

The introduction of MaxGuard comes at a time when bloodstream infection rates continue to be a major concern among hospitals. With the new federal policy restricting reimbursement for healthcare-associated infections (HAIs), healthcare professionals are seeking techniques and technologies to assist in their bloodstream infection prevention efforts. 

With the addition of antimicrobial technology, MaxGuard is an enhancement of the MaxPlus Clear, Medegen’s leading positive displacement connector. 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 seal barrier to contamination and allows for true disinfection during pre-access swabbing. The translucent housing provides for visualization of the fluid path allowing for complete flushing of the device.

“Healthcare professionals and facilities are seeking new technologies and practices to assist in their efforts to reduce the occurrence of catheter related bloodstream infections (CRBSI),” said Goble. “In addition to the negative impact on the patient, the cost of treating a single CRBSI can reach $56,000 or more according to the CDC and with changes in healthcare reimbursement practices, hospitals are looking for assistance in meeting infection reduction goals. We are very pleased to see the clinicians’ fast rate of adoption of the MaxPlus Clear and more importantly to receive feedback from many hospitals regarding bloodstream infection rate reductions concomitant with use of the MaxPlus Clear device.”

“We are excited to introduce MaxGuard and offer hospital clinicians yet another product to help prevent bloodstream infections, improve patient outcomes and reduce costs,” said Goble.”
 
MaxGuard Advanced Luer Activated device will be available second quarter 2009. Visit www.medegen.com for more information.

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/.

Medegen Prevails on Appeal in ICU Medical Inc. Patent Infringement Case
Leader in infusion therapy medical products protects proprietary innovation

Ontario, CA (November 24, 2008) – Medegen, a leading innovator in infusion therapy medical products, announced today that it has won an important legal victory in the United States Court of Appeals for the Federal Circuit in Washington, D.C.  The appellate court's decision reverses a judgment issued by a district court judge in the Central District of California of patent non-infringement entered in favor of ICU Medical Inc. (NASDAQ: ICUI).
Medegen argued successfully that the decision below inappropriately narrowed the definition of key terms of one of its patents (U.S. Patent No. 5,730,418).  This patent covers a number of Medegen’s novel inventions in needleless connectors, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications.  The case is now returned to the lower court with the appellate court having interpreted key claim language as Medegen had requested. 
“Medegen’s intellectual property is valuable and we feel strongly about protecting our innovations.  We are encouraged by the successful outcome of our appeal," 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/.

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/.

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/.

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:

1. Provides for complete visualization of the fluid path during priming and flushing of the device
2. Promotes an “Occlusion, and Contaminate Free” Line
3. Promotes compliance with best practices and aseptic technique
4. Promotes the use of Saline Flush and Lock vs. Heparin
5. Promotes complete flushing  

This in turn helps reduce:

1. Bloodstream infections
2. Occlusions
3. Heparin usage
4. False positive blood cultures
5. Nursing time
6. 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/.

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/.