AMF Medical announced that its Sigi™ Insulin Management System, for diabetes treatment, has been granted Breakthrough Device Designation by the US Food and Drug Administration. Sigi is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled pump cartridges.
Sigi can be programmed to deliver basal and bolus insulin at both set and variable rates. In addition, as an Alternate Controller Enabled-pump, it is able to receive, execute and confirm dosing commands by interacting with Bluetooth-compatible, continuous glucose monitors and alternate controller devices, like a smartphone or an iController, the company said in a press release.
Sigi is also smaller, lighter, and more convenient than current insulin delivery systems. This is made possible by its ergonomic design, which accommodates standard, insulin pre-filled pump cartridges.
AMF Medical Co-CEO and Co-Founder Mr. Antoine Barraud said: “We would like to thank the FDA for recognizing our team's proprietary, patient-focused technology, which provides users with enhanced clinical and convenience features. This Breakthrough Device Designation will expedite the development of Sigi and prioritize its review in future FDA regulatory submissions. It is a huge step forward in bringing Sigi to market to improve insulin management.”
“Clinical study data has shown that Sigi is delightfully easy to use. Study patients have expressed satisfaction as well as eagerness for this next-generation patch to be readily available. We are pleased that the FDA also sees its clear value and is moving the process forward,” said Professor A. Wojtusciszyn, MD, Ph.D. from Lausanne University Hospital (CHUV) and principal investigator of the first Sigi clinical study.
Originally founded in 2014 in the Swiss Medtech Valley, AMF Medical is developing a novel technology to address the unmet needs of people on insulin therapy. The company's flagship product, Sigi, is a next-generation, plug 'n go, semi-reusable, and rechargeable patch pump, designed to make life easier for people with diabetes. Sigi is intended for prescription use only and is not yet FDA Cleared nor CE-marked. AMF Medical is led by Co-CEOs Mr. Pim van Wesel and Mr. Antoine Barraud, Ph.D. who is also a Co-Founder. Diabetes industry experts John Timberlake and Peter Gerhardsson serve on the company's Board of Directors.