Animas® Vibe™ Insulin Pump and Continuous Glucose Monitoring System Receives FDA Approval

Integrated System Streamlines Diabetes Management for Patients

/ PR Newswire / — Animas Corporation today announced FDA approval of the Animas® Vibe™ insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. As the first and only integrated system featuring Dexcom G4® PLATINUM sensing technology with proven accuracy, Animas® Vibe™ allows patients to view glucose data and administer insulin right from the pump; simplifying and aiding their ability to make more informed decisions to fine tune insulin delivery and manage their diabetes.
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The Animas® Vibe™ system provides patients with their latest glucose readings on the pump screen1 and a complete view of glucose highs, lows, and rates of change over time. This information complements fingerstick testing results and can be used to help guide immediate and long-term insulin delivery therapy adjustments.2 CGM technology measures glucose levels every five minutes and provides real-time glucose values, as well as trend information. CGM has been shown to improve glycemic control in adult patients 25 years and older via lower HbA1c levels, less frequent hypoglycemia, and reduced glucose variability.3

“For many people who are insulin dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management. We are pleased to now offer people with diabetes in the U.S. a solution with CGM technology that provides the ability to make more informed decisions to manage their disease, which can ultimately improve blood glucose control,” said Dr. Brian Levy, Chief Medical Officer, Animas Corporation.

Animas® Vibe™ also offers precise insulin dosing with a low basal increment of 0.025 U/hr across all available ranges (0.025 U/hr to 25.00 U/hr) and a low bolus increment of 0.05 U across all available bolus ranges (0.05 U to 35.00 U). Animas® Vibe™ users can also personalize dosing by choosing individual insulin-to-carb ratios, insulin sensitivity factors, and blood glucose targets in 30-minute increments with up to 12 personal settings.

Additional key features of Animas® Vibe™ include:

  • Dexcom CGM sensor technology is approved for up to seven days of continuous wear with one of the smallest introducer needles on the market. With Mean ARD (Absolute Relative Difference) as the industry’s standard for measuring CGM accuracy, Dexcom’s 13% Mean ARD provides exceptional performance and accuracy for reliable results.
  • Waterproof up to 12 feet for up to 24 hours; Dexcom G4® PLATINUM transmitter is water resistant up to 8 feet for 24 hours.4
  • First and only CGM-enabled insulin pump with a high-contrast color screen, featuring color-coded graphs and arrows to indicate direction and rate of glucose change, revealing trends at a glance.
  • Customizable alarms to indicate high and low glucose levels.

“We are excited to bring Animas® Vibe™ to the U.S., which expands our insulin delivery portfolio and delivers on our promise to provide a range of solutions that help patients perform at their very best,” said Ty Lee, Vice President, Johnson & Johnson Diabetes Solutions.

Animas is now accepting orders for Animas® Vibe™ and anticipates shipment to patients to begin in January 2015. For more information, visit www.animas.com.

Expanding the global presence of Animas® Vibe™ has been a top priority for Animas, and today marks its introduction to the U.S. Animas® Vibe™ is also available in Europe, Australia, New Zealand, and Canada.

About Animas Corporation
With a shared vision of “creating a world without limits” for people with diabetes, Animas is a part of Johnson & Johnson Diabetes Solutions Companies, a cross-company collaboration that reflects an ongoing commitment to better serve the diabetes community with integrated solutions that meet the needs of people with diabetes across the continuum of care. Animas provides a wide range of insulin delivery products for people living with diabetes, including the OneTouch® Ping® Glucose Management System, Animas® Vibe™ insulin pump and CGM system and the Animas® 2020 insulin pump. Animas, from the Latin word meaning “true inner self or soul,” has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit http://www.animas.com/.

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(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, including expectations regarding the Animas® Vibe™. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Animas Corporation and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: manufacturing difficulties and delays, internally or within the supply chain; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Animas Corporation nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)

1Glucose values are not visible during the two-hour start-up period.
2*You must confirm your glucose reading with a fingerstick test before taking action. *CGM readings may not be displayed when in water.
3Tamborlane, W. Beck, R., Buckingham, B. New England Journal of Medicine. 2008; 359:1464-76. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. (Pg. 1470) 2. Garg S, Jovanovic L. Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained by using a 7-day continuous glucose sensor. Diabetes Care. 2006; 29 (12):2644-2649 pg. 2644, 2648.
4CGM readings may not be displayed when in water.

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