Phase III data show significant reductions in blood glucose with investigational compound empagliflozin used as monotherapy in adults with Type 2 Diabetes

Data presented at the American Diabetes Association 73rd Scientific Sessions® also showed reduction in body weight and systolic blood pressure in treated study subjects

INGELHEIM, Germany & INDIANAPOLIS, US - Saturday, June 22nd 2013 [ME NewsWire]

(BUSINESS WIRE/ME NewsWire)-- For Non-US and Non-UK Media

Boehringer Ingelheim and Eli Lilly and Company today announced results of a 24-week Phase III clinical trial, which showed that treatment with the investigational compound empagliflozin* as monotherapy produced statistically significant reductions in HbA1c (average blood glucose) versus placebo, in patients with Type 2 Diabetes (T2D) who had not received any treatment for at least 12 weeks prior to randomisation.1

Empagliflozin is a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by reducing glucose reabsorption in the kidney.

Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®, the study in patients with T2D (n=899) investigated the safety and efficacy of two doses of empagliflozin (10mg and 25mg) for 24 weeks.1 Results of the primary endpoint showed placebo-adjusted reductions in HbA1c from baseline to week 24 of 0.74% (p<0.001) and 0.85% (p<0.001) for the empagliflozin 10mg and 25mg dose, respectively.1 Sitagliptin 100mg, which was used as an active comparator and not powered for a head-to-head comparison with empagliflozin, showed a placebo-adjusted reduction in HbA1c of 0.73% (p<0.001).1

Study findings at 24 weeks also showed significant improvements with empagliflozin in secondary endpoints:1

    After 24 weeks, patients treated with empagliflozin 10mg and 25mg showed significant placebo-adjusted decreases in body weight of 1.93kg (p<0.001) and 2.15kg (p<0.001), respectively.1 Sitagliptin 100mg showed a weight increase of 0.5kg versus placebo (p=0.036).1
    Statistically significant placebo-adjusted reductions in systolic blood pressure of 2.6mmHg (p=0.023) for empagliflozin 10mg and 3.4mmHg (p=0.003) for empagliflozin 25mg.1 Sitagliptin 100mg did not show a statistically significant change in systolic blood pressure versus placebo.1
    Changes in diastolic blood pressure were only statistically significant for the empagliflozin 25mg arm (1.9mmHg (p=0.030) reduction versus 0.5mmHg reduction for placebo).1

“It is encouraging that these results indicate empagliflozin as monotherapy provided improvements in reducing blood glucose without causing weight gain," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Controlling blood glucose and weight are ongoing challenges for people with Type 2 Diabetes and new treatment options are needed to better manage this progressive condition”.

The proportion of patients reporting adverse events from each study group was 54.9% and 60.5% for empagliflozin 10mg and 25mg, respectively, 61.1% for placebo and 53.4% for sitagliptin 100mg.1 Commonly reported adverse events included hypoglycaemia (plasma glucose ≤70mg/dL and/or requiring assistance – reported by 1 (0.4%) patient per randomised group, none required assistance), as well as adverse events consistent with urinary tract infection (reported in 6.7% and 5.4% of randomised patients on empagliflozin 10mg and 25mg respectively, 5.2% on placebo and 4.9% on sitagliptin 100mg) and genital infection (reported in 3.1% and 4.0% of patients on empagliflozin 10mg and 25mg, respectively, none on placebo and 0.9% on sitagliptin 100mg).1

Additionally, a subset of patients with baseline HbA1c greater than 10% (mean=11.5%, n=87), which was above the study inclusion criteria, were placed on open-label empagliflozin 25mg for 24 weeks and obtained a mean reduction of 3.7% from baseline HbA1c.1 Adverse events were reported by 64.4% of patients included in this subset.

About the study

The 24-week, randomised, double-blind, placebo-controlled trial investigated the safety and efficacy of empagliflozin in drug-naïve patients with T2D. Patients were randomised to receive empagliflozin 10mg (n=224) or 25mg per day (n=224), sitagliptin 100mg per day (n=223), or placebo (n=228) for 24 weeks. Patients with HbA1c more than 10% (n=87) received open-label empagliflozin 25mg per day for 24 weeks. The primary endpoint of the trial was change from baseline HbA1c at week 24. Secondary endpoints were change from baseline in body weight, systolic blood pressure and diastolic blood pressure at week 24.1

About the empagliflozin Phase III clinical trial programme

Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme that plans to enrol more than 14,500 patients. This programme comprises more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

* Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/22_june_2013_empagliflozin4.html

Contacts

Boehringer Ingelheim GmbH

Marco Winkler

Product Communication Manager

Email: press@boehringer-ingelheim.com

Phone: +49 (151) 689 46812



or

Lilly Diabetes

Tammy Hull

Communications Manager

Email: hullta@lilly.com

Phone: +1 (317) 651 9116

Permalink: http://me-newswire.net/news/7739/en

Quintiles Transforms Laboratory Management for Investigator Sites with Quintiles Infosario® Platform

New Functionality Streamlines Workflow, Speeds Results and Improves Patient Safety

RESEARCH TRIANGLE PARK, N.C. - Saturday, June 22nd 2013 [ME NewsWire]

DIA 2013

(BUSINESS WIRE)-- Quintiles today announced new functionality that improves laboratory management for investigator sites, delivered by its award-winning Quintiles Infosario® technology platform. Infosario seamlessly combines data, processes and Quintiles’ therapeutic expertise to enable faster, better-informed decisions across the drug development lifecycle. With Infosario, investigators and site personnel now have the ability to order tests, track samples and view results within one secure, online portal.

“The investigators working with Quintiles’ Global Laboratory network can now experience the benefits of streamlined communications, improved data accuracy and accelerated laboratory tests results,” said Thomas Wollman, Senior Vice President, Quintiles Global Laboratories and Cardiac Safety Services. “Our customers and investigators view the Infosario portal as a significant step forward in improving the speed and quality of laboratory management. This is another example of how we partner with our customers to improve their probability of success.”

The portal puts timely laboratory data at the fingertips of investigators, offering greater transparency and efficiency to tighten study timelines and improve patient safety through enhanced data quality. Investigators and site personnel can process electronic requisitions, review reports and respond to queries in an interactive format that cuts hours out of the process. The new functionality offers:

    Improved data quality through electronic requisitions and simplified medical reporting resolutions
    Improved sample tracking and traceability through electronic sample tracking
    Improved data consistency and fewer queries through the availability of online Standard Operating Procedures (SOPs) and training
    Reduced query resolution time through email alerts for unviewed medical reports or unanswered queries

More than a quarter of Quintiles’ investigators currently have access to the Infosario portal, and new functionality across Quintiles’ laboratory and clinical development services will be released in the near future to expand the platform to Quintiles’ entire network of more than 175,000 investigators. In an effort to continuously improve Infosario to meet customers’ needs, Quintiles is introducing enhancements in the coming months, including secure document exchange, investigator profile registrations and online training capabilities.

According to Michelle Kopfinger, an investigator site coordinator, “Quintiles is making proactive changes to help make lab management from a site perspective less burdensome. All of the lab reports are at the tip of your fingers and the data clarifications are resolved quicker through the system. It’s a great tool for managing lab reports.”

This announcement comes on the heels of Quintiles receiving the 2013 Informatica Innovation Award for “Enterprise Data Integration” for Infosario’s pioneering efforts to integrate clinical research and healthcare data across numerous institutions and at a scale never before accomplished in the biopharmaceutical industry. For more information, view the Infosario portal fact sheet and website. Demonstrations of Infosario will be available at the Drug Information Association (DIA) Annual Meeting on June 24-27 in Boston, Mass.

About Quintiles

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 27,000 employees conducting business in approximately 100 countries. We have helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.

Click here to subscribe to Mobile Alerts for Quintiles.

Contacts

Quintiles

Mari Mansfield, + 1-919-998-2639

Media Relations

mari.mansfield@quintiles.com

Mobile: +1-919-259-3298



Karl Deonanan, +1-919-998-2789

Investor Relations

InvestorRelations@quintiles.com

Phase III data show significant reduction in blood glucose with investigational compound empagliflozin added to metformin or metformin plus sulphonylurea in adults with Type 2 Diabetes

Data presented at the American Diabetes Association 73rd Scientific Sessions® also showed statistically significant reductions in mean daily glucose and body weight in treated study subjects

INGELHEIM, Germany and INDIANAPOLIS, US - Saturday, June 22nd 2013 [ME NewsWire]

(BUSINESS WIRE)-- For Non-US and Non-UK Media

Boehringer Ingelheim and Eli Lilly and Company today announced results of two Phase III 24-week clinical trials of the investigational compound empagliflozin* added to metformin with and without the addition of sulphonylurea, respectively, in people with Type 2 Diabetes (T2D). These results showed statistically significant reductions in blood glucose among people who received empagliflozin, as measured by reductions in HbA1c (average blood glucose) after 24 weeks.1,2

Empagliflozin is a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by reducing glucose reabsorption in the kidney.

The studies, presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®, also demonstrated statistically significant reductions in key secondary endpoints, including mean daily glucose and body weight.1,2 Overall adverse events were reported in a similar percentage of patients treated with empagliflozin 10mg, empagliflozin 25mg and placebo, respectively.

“Metformin is the foundation of treatment for Type 2 Diabetes in people without clinically relevant renal impairment. However, many people don’t meet their blood sugar target due to the progressive nature of the condition and have difficulties managing other risk factors such as weight and increased blood pressure,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The results from this study of empagliflozin as an add-on to metformin or metformin plus sulphonylurea therapies are promising for people with Type 2 Diabetes”.

24-week study with empagliflozin as an add-on to metformin

In this 24-week randomised, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin showed a placebo-adjusted reduction in HbA1c of 0.57% (p<0.001) and 0.64% (p<0.001) for empagliflozin 10mg (n=217) and 25mg (n=213), respectively, compared with placebo (n=207).1 The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose of 8mg/dL (p=0.006) with empagliflozin 10mg and 12mg/dL (p<0.001) with empagliflozin 25mg.1 Empagliflozin 10mg and 25mg also had a significant placebo-adjusted reduction in body weight of 1.63kg (p<0.001) and 2.01kg (p<0.001), respectively.1

Further analysis also showed reductions in systolic blood pressure by 4.5mmHg (p<0.001) with empagliflozin 10mg and 5.2mmHg (p<0.001) with empagliflozin 25mg versus placebo.1 Other analysis findings showed reductions in fasting plasma glucose by 20.04mg/dL (p<0.001) with empagliflozin 10mg and 22.28mg/dL (p<0.001) with empagliflozin 25mg versus placebo.1

Adverse events were reported by 57.1% and 49.5% of patients on empagliflozin 10mg and 25mg, respectively, and 58.7% of patients on placebo. Common adverse events included hypoglycaemia (plasma glucose ≤70mg/dL and/or requiring assistance – reported in 1.8% of patients on empagliflozin 10mg, 1.4% on empagliflozin 25mg and 0.5% on placebo, none required assistance), as well as adverse events consistent with urinary tract infection (reported in 5.1% of patients on empagliflozin 10mg, 5.6% on empagliflozin 25mg and 4.9% on placebo) and genital infection (reported in 3.7% of patients on empagliflozin 10mg, 4.7% on empagliflozin 25mg and none on placebo).

24-week study with empagliflozin as an add-on to metformin and sulphonylurea

In this 24-week randomised, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin plus sulphonylurea therapy showed a placebo-adjusted reduction in HbA1c of 0.64% (p<0.001) and 0.59% (p<0.001) for empagliflozin 10mg (n=225) and 25mg (n=216), respectively, compared with placebo (n=225).2 The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose of 10.02mg/dL (p<0.001) and 13.06mg/dL (p<0.001) with empagliflozin 10mg and 25mg, respectively. Loss of weight greater than 5% was achieved by 27.6% and 23.6% of patients treated with empagliflozin 10mg and 25mg (p<0.001; 1.75kg and 1.99kg), respectively, as add-on to metformin plus sulphonylurea, versus 5.8% on placebo.2

Adverse events were reported by 67.9%, 64.1% and 62.7% of patients on empagliflozin 10mg, 25mg and placebo, respectively. Common adverse events include hypoglycaemia (plasma glucose ≤70mg/dL and/or requiring assistance – reported in 16.1% of patients on empagliflozin 10mg, 11.5% on empagliflozin 25mg and 8.4% on placebo; none required assistance), as well as adverse events consistent with urinary tract infection (reported in 10.3% of patients on empagliflozin 10mg, 8.3% on empagliflozin 25mg and 8.0% on placebo) and genital infection (reported in 2.7% of patients on empagliflozin 10mg, 2.3% on empagliflozin 25mg and 0.9% on placebo).

About the empagliflozin phase III clinical trial programme

Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme that plans to enrol more than 14,500 patients. This programme comprises more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

*Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/22_june_2013_empagliflozin3.html

Contacts

Boehringer Ingelheim GmbH

Marco Winkler

Product Communication Manager

Email: press@boehringer-ingelheim.com

Phone: +49 (151) 689 46812



or

Lilly Diabetes

Tammy Hull

Communications Manager

Email: hullta@lilly.com

Phone: +1 (317) 651 9116







Permalink: http://www.me-newswire.net/news/7738/en

Trajenta® (linagliptin): New data on safety and efficacy in Type 2 Diabetes patients with moderate to severe renal impairment

Data presented at the American Diabetes Association (ADA) 73rd Scientific Sessions® provides insights for use of Trajenta® (linagliptin) in adults with Type 2 Diabetes (T2D) with moderate to severe renal impairment

INGELHEIM, Germany & INDIANAPOLIS, US - Saturday, June 22nd 2013 [ME NewsWire]

(BUSINESS WIRE)-- For Non-U.S. and Non-UK media

Boehringer Ingelheim and Eli Lilly and Company today announced results from a new study that demonstrated linagliptin showed statistically significant reduction in blood glucose levels (HbA1C) in adult patients with Type 2 Diabetes (T2D) with moderate to severe renal impairment (RI), compared with those receiving placebo (12 weeks). Most patients had T2D for more than ten years (76%) and were on insulin (86%). After 12 weeks, patients on placebo switched to glimepiride up to 52 weeks. The study found that patients treated with linagliptin had lower rates of hypoglycaemia and less weight gain than those who received glimepiride.1

“These are important findings for physicians managing patients with Type 2 Diabetes and renal impairment, which we are seeing more and more in today’s practice,” said Professor Markuu Laakso, Professor of Medicine at the Department of Medicine, University of Kuopio, Finland. “Approximately half of patients living with Type 2 Diabetes are also at risk of declining renal function, and treatment options for these patients can be limited. Ensuring that optimum blood glucose levels are achieved paired with the prevention of hypoglycaemic events is becoming more of a challenge.”

These new findings were derived from a double-blind trial including 235 T2D patients with moderate to severe RI (estimated glomerular filtration rate <60 mL/min/1.73m2). Patients received linagliptin, 5 mg qd (n=113) or placebo (n=122) for 12 weeks, then placebo patients were switched to glimepiride 1-4 mg qd and treatment continued to week 52.

The primary endpoint was the reduction in HbA1c levels from baseline at 12 weeks.

Key results from the study showed:

    Greater mean reduction in baseline HbA1c at 12 weeks for patients treated with linagliptin vs. placebo (-0.53±0.06% vs. -0.08±0.07%; p<0.0001)
    In the 40 week extension, HbA1c was lower with linagliptin vs. glimepiride (difference is not statistically significant)
    Less frequent hypoglycaemic events experienced with linagliptin vs. glimepiride (57.9% vs. 69.3%)
    Weight neutrality for linagliptin versus weight gain for patients treated with placebo followed by glimepiride (mean increase after 52 wks 0.06 kg linagliptin vs. 1.74 kg placebo/glimepiride)

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities worldwide approved linagliptin for the treatment of adult patients with T2D as monotherapy or in combination with metformin, with metformin and a sulphonylurea, and as add-on therapy to insulin. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.2,3

About Linagliptin

Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin), as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with Type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).2,3

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/22_june_2013_linagliptin2.html

Contacts

Dr. Ralph Warsinsky

Corporate Communications

Boehringer Ingelheim GmbH

Email: press@boehringer-ingelheim.com

Phone: +49 178 290 8561



or

Tammy Hull

Communications Manager

Lilly Diabetes

Email: hullta@lilly.com

Phone: +1 (317) 651 9116

NIKE Announces Strategic Leadership Changes

Brand President Charlie Denson to retire in 2014

BEAVERTON, Ore. - Friday, June 21st 2013 [ME NewsWire]

(BUSINESS WIRE)-- NIKE, Inc. (NYSE: NKE) announced today that Charlie Denson, NIKE Brand President since 2006 and a 34-year veteran of the brand, will retire in January 2014. In conjunction with Denson’s decision to retire, the Company also announced strategic changes in its executive management team as part of the Company’s long-term organizational strategy to align the business to continue to drive growth. The changes reflect the Company’s focus on the consumer by accelerating innovation, elevating design, aligning product and merchandising excellence, optimizing go-to-market strategies and sharpening focus on supply chain and manufacturing capabilities.

Effective July 1, 2013, Trevor Edwards, currently the EVP of Brand and Category Management, will become the new NIKE Brand President leading all category and geographic business units, the Jordan Brand, Action Sports which includes Hurley International LLC, Digital Sport and brand management throughout the world. The team reporting to Edwards will be organized to optimize an integrated marketplace and will now include NIKE’s wholesale, retail and e-commerce operations.

Eric Sprunk, currently the EVP of Merchandising and Product, will become NIKE, Inc.’s Chief Operating Officer leading all manufacturing, sourcing, IT and procurement for the company. In this role, Sprunk will also continue to oversee the company’s efforts to drive innovation in the supply chain. Hans van Alebeek will remain EVP of Global Operations & Technology reporting to Sprunk.

Jeanne Jackson, currently the President of Direct-to Consumer, will become President of Product and Merchandising, leading NIKE’s product engines and merchandising. Jackson will be responsible for driving the strategy for creating all footwear, apparel and equipment for the company and leading the merchandising of product to the global marketplace.

Dr. Thomas Clarke, currently the President of New Business Development, will become President of Innovation. He will lead NIKE’s Advanced Product Innovation Teams and the Sustainable Business & Innovation (SB&I) team. Hannah Jones will remain VP of SB&I reporting to Clarke and will continue to report to Parker on policy matters relating to sustainability and labor practices.

Edwards, Sprunk, Jackson and Clarke will report directly to Mark Parker, NIKE, Inc.’s President and CEO, along with Parker’s current direct reports including Hilary Krane who becomes EVP, Chief Administrative Officer and General Counsel, Don Blair, EVP and Chief Financial Officer, David Ayre, EVP of Global Human Resources, John Slusher, EVP of Global Sports Marketing, Jim Calhoun, President & CEO of Converse, John Hoke, VP of Global Design and Tinker Hatfield, VP of Creative Concepts.

“Charlie’s contributions to NIKE are deeply significant and he’s helped build the brand around the world. I’ve worked with him for more than 30 years and I will miss him,” said Parker. “We have a thoughtful succession strategy in place and have built a highly experienced, consumer-focused executive management team with the expertise, acumen, and brand knowledge required to continue to build sustainable growth for NIKE, Inc. for the long-term.”*

Prior to his retirement in January 2014, Denson will work closely with Parker to help manage the transition.

ADDITIONAL MANAGEMENT CHANGES

The company also announced a number of additional senior management changes.

Gary DeStefano, President of Global Operations, has decided to retire after 31 years with the company. His retirement is effective July 29, 2013. Effective July 1, Elliott Hill, VP & GM of North America, will become President of Geographies and Sales. Jayme Martin, the VP & GM of Global Running, will become VP & GM of Global Categories. NIKE Golf will now report to Martin. Christiana Shi, the VP of e-commerce, will become President of Direct to Consumer, leading NIKE’s retail and e-commerce organizations. Hill, Martin and Shi will report directly to Edwards.

“I would like to thank Gary for his leadership, particularly for the important role he played in building our geography structure around the world and his dedication to the company. We greatly value his contributions and his part in developing the next generation of leaders at NIKE,” said Parker.

As Hill moves into his new role, Joaquin Hidalgo, the VP & GM of Emerging Markets, will become the VP & GM of North America and Roland Wolfram, the VP & GM of NIKE Football, will become the VP & GM of Emerging Markets. Hidalgo and Wolfram will report to Hill.

As Martin moves into his new role, Patrick Seehafer, the VP of Global Footwear for Converse, will become the VP & GM of NIKE Running. Dermott Cleary, the VP & GM of NIKE Sportswear, will become the VP & GM of NIKE Football. Dirk-Jan van Hameren, the VP of NIKE Sportswear for Western Europe, will become the VP & GM of NIKE Sportswear. Seehafer, Cleary and van Hameren will report to Martin.

About NIKE

NIKE, Inc. based near Beaverton, Oregon, is the world’s leading designer, marketer and distributor of authentic athletic footwear, apparel, equipment and accessories for a wide variety of sports and fitness activities. Wholly-owned NIKE, Inc. subsidiaries include Converse Inc., which designs, markets and distributes athletic lifestyle footwear, apparel and accessories and Hurley International LLC, which designs, markets and distributes surf and youth lifestyle footwear, apparel and accessories. For more information, visit www.nikeinc.com and follow @Nike.

* The marked paragraphs contain forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties are detailed from time to time in reports filed by NIKE with the S.E.C., including Forms 8-K, 10-Q, and 10-K. Some forward-looking statements in this release concern changes in futures orders that are not necessarily indicative of changes in total revenues for subsequent periods due to the mix of futures and “at once” orders, exchange rate fluctuations, order cancellations, discounts and returns, which may vary significantly from quarter to quarter, and because a significant portion of the business does not report futures orders.

Contacts

NIKE, Inc.

Media:

Kellie Leonard, 503-671-6171



Investors:

Kelley Hall, 503-532-3793

KCI Initiates Negative Pressure Wound Therapy with Instillation Randomized, Controlled Prospective Study

Study to Compare Traditional Negative Pressure Wound Therapy to V.A.C. VeraFlo™ Instillation Therapy, using the V.A.C.Ulta™ Negative Pressure Wound Therapy System

SAN ANTONIO - Thursday, June 20th 2013 [ME NewsWire]

(BUSINESS WIRE)-- Kinetic Concepts, Inc. announced today the initiation of patient enrollment in a multi-center clinical study assessing the benefits of negative pressure wound therapy (NPWT) with intermittent instillation therapy with a topical wound cleanser. The randomized, controlled prospective study involves six investigative centers across the United States and compares traditional NPWT with V.A.C.® Negative Pressure Wound Therapy to adjunctive treatment with V.A.C. VeraFlo™ Instillation Therapy using the V.A.C.Ulta™ Negative Pressure Wound Therapy System for wounds that require hospital admission and serial surgical debridement.

This study follows an independent retrospective, historical cohort-controlled study recently presented at the 2013 Technology Innovations in Plastic Surgery meeting in San Francisco, California by physicians from MedStar Georgetown University Hospital, Center for Wound Healing, led by Christopher E. Attinger, M.D., Chief, Division of Wound Healing1. These results, involving 142 patients, assessed the effectiveness of NPWT with V.A.C.® Therapy compared to V.A.C. VeraFlo™ Instillation Therapy using the V.A.C.Ulta™ Negative Pressure Wound Therapy System in the adjunctive treatment of wounds that required hospital admission and serial surgical debridement.

The results suggested a significant decrease in operating room visits for study patients who received V.A.C. VeraFlo™ Instillation Therapy using the V.A.C.Ulta™ Negative Pressure Wound Therapy System. Further, the investigators reported a trend toward a two- to three-day reduction in hospital stay compared to traditional V.A.C.® Therapy in these patients.

“Because of the encouraging Georgetown University study results, we are excited to be initiating a study that will take a more careful look at the negative pressure wound therapy with intermittent dwelling of instillation,” said Ron Silverman, M.D., chief medical officer, KCI. “This study further demonstrates the KCI commitment to and investment in the new future of NPWT with instillation therapy and better treatment solutions for our customers and patients.”

About KCI

Kinetic Concepts, Inc. (KCI) is a leading global medical technology company devoted to understanding, developing and commercializing innovative, high-technology transformational healing solutions for customers and patients in more than 25 countries around the world. Headquartered in San Antonio, Texas, KCI is committed to advancing the science of healing and positively impacting patient care by developing customer-driven innovations to meet the evolving needs of healthcare professionals. Proprietary KCI negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 7 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.

1. Powers KA, Kim PJ, Attinger CE, et al. Early Experience with Negative Pressure Wound Therapy with Instillation in Acutely Infected Wounds. Presented at the 2013 Technology Innovations in Plastic Surgery Conference, May 31-June 2, 2013, San Francisco, CA.

Contacts

KCI Corporate Communications
Mike Barger, 210-255-6824
mike.barger@kci1.com

Another Step towards Olympic and Paralympic Games in Oslo

OSLO, Norway - Thursday, June 20th 2013 [ME NewsWire]

(BUSINESS WIRE)-- The City of Oslo and the Norwegian Olympic and Paralympic Committee and Confederation of Sports has presented the application for a Financial Shortfall Guarantee for a possible Norwegian bid for the 2022 Winter Olympic and Paralympic Games to the Ministry of Culture.

In a ceremony at the office of the Hon. Minister of Culture, Ms Hadia Tadjik, in Oslo today, the joint application for a Financial Shortfall Guarantee to the Norwegian Government from the City of Oslo and the Norwegian Olympic and Paralympic Committee (NOC), regarding a possible bid for the 2022 Winter Olympic and Paralympic Games in Oslo was presented.

– The hosting of Olympic and Paralympic Games in Oslo, will, if the plans pan out, have great implications for the whole country, stated the Minister of Culture.

The application is the result of more than a year of comprehensive evaluations and recommendations organised by the Municipality of Oslo in collaboration with the NOC. The choice of a total concept including analyses of various models and venues, economical impact for society, and a separate process of external quality evaluation, is the base of the joint application presented today.

– This is an important day for Norwegian sports and indeed for the City of Oslo and the whole country, concludes Mr Børre Rognlien, the President of the NOC. All Norwegian summer and winter sports federations – representing over 12000 local sports clubs - supports a possible bid, and we recognize the tremendous opportunities for the younger generations by linking Olympic and Paralympic Games in 2022 Norway with the Youth Olympic Games (YOG) in Lillehammer in 2016. By being the host for YOG 2016, we aim to further develop a modern and youth oriented content of Olympism and to underline the importance of a holistic approach to the development of a new generation of athletes. This approach will be an important component in the work leading up to possible Olympic and Paralympic Games in Norway in 2022. We are also proud to present a top class venue concept where half of the venues already exists, states Rognlien.

– This represents a unique opportunity to create and take part in something great, with implications way beyond our national boundaries and for a whole new generation. The Winter Games in Oslo will allow us a rare opportunity to present Norway as a destination for winter sport, as a modern knowledge based society, and as an attractive partner. These will be Olympic and Paralympic Games for the whole nation, states the Governing Mayor, Mr Stian Berger Røsland, Head of the Oslo City Government.

The Mayors of the co-operating municipalities of Lillehammer, Øyer, Ringebu, Lørenskog and Bærum, in addition to the host city itself and the NOC, were all present at todays ceremony.

If the inhabitants of Oslo approves the plans to go ahead with the application in the referendum on 9th September 2013, the Government will continue its work with the evaluation of the application. The Norwegian Parliament will make its decision on the Financial Shortfall Guarantee during the autumn of 2014.

Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20130619006239/en/

Contacts

For The City of Oslo and the Norwegian Olympic

and Paralympic Committee and Confederation of Sports

Geir Owe Fredheim

Phone : +47 472 359 57 / +47 21 02 90 83

E-mail : geir.o.fredheim@idrettsforbundet.no









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