FDA Approves Trial for Capillary Biomedical’s SteadiFlow Tech

Capillary Biomedical Inc. (CapBio) has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study of its SteadiFlow seven-day-wear infusion set technology.
 
Infusion sets enable people on insulin pump therapy to deliver insulin under the skin for the maintenance of healthy blood glucose levels. Market research among people with diabetes who pump insulin shows that poor reliability is the most prevalent problem pump users face today and extending wear duration beyond three days is the most commonly requested improvement.
 
Capillary’s new infusion sets are designed to significantly extend patient wear time to seven days and maintain insulin stability. “Current infusion sets are designed to be changed every two to three days, and often fail sooner,” said Roy Beck, MD, PhD, director of the Jaeb Center for Health Research. “To have a reliable infusion set that extends wear to a week or beyond would likely improve quality of life for patients on insulin pumps.”
 
For the new 15-site study, investigators will recruit at least 240 subjects between 18 and 80 years old with type 1 diabetes. The subjects will be on insulin pump therapy in the non-randomized and prospective single arm study, and each participant will undergo 12 one-week wear periods. The study will test Novolog and Humalog insulin. Jaeb Center for Health Research in Tampa, Fla., will serve as the CRO.
 
CapBio’s SteadiSet infusion set, powered by its SteadiFlow technology platform, is designed to increase the wear time of insulin infusion sets by addressing the common causes of infusion site failure. The SteadiSet also features an integrated inserter designed for easy, painless, hidden needle, one-handed insertion. The entire set has been made with materials selected to reduce preservative loss for improved insulin stability and reduced aggregate formation. CapBio’s cannula was designed to filter particulates and aggregates before they are delivered to the tissue, which helps to ensure that any aggregates that form in the tubing are removed before reaching the tissue. Reduced aggregates are believed to reduce tissue inflammation and may help to improve infusion set reliability. The SteadiSet adhesive has also been optimized for extended-wear. The combined features of the SteadiSet infusion set are designed to work together to reduce site failures and increase wear time.
 
SteadiFlow cannula technology features a soft and flexible cannula designed to move with the body tissue during physical activity, increasing comfort while greatly decreasing tissue damage and inflammation.
 
“With this pivotal trial we are pleased to be taking a significant next step in the evolution of our SteadiFlow infusion set,” said CapBio CEO Paul Strasma. “Based on the strength of previous clinical data, we’re optimistic about the results of this forthcoming trial and we’re excited to play a leadership role in what might be possible with insulin pump technology.”
 
Based in Irvine, Calif., Capillary Biomedical is focused on simplifying insulin pump therapy. The Company’s first product, the SteadiSet infusion set featuring SteadiFlow technology, is designed to improve the comfort, reliability and predictability of insulin pump therapy.