Debiotech (Lausanne, Switzerland) and STMicroelectronics (Geneva), which focuses on developing and delivering semiconductor solutions across the spectrum of microelectronics applications, reported a strategic cooperation agreement aimed at manufacturing and delivering to the market a miniaturized insulin-delivery pump for diabetics.
The Nanopump, which relies on microfluidic MEMS (Micro-Electro-Mechanical System) technology, is a breakthrough concept that allows a tiny pump to be mounted on a disposable skin patch to provide continuous insulin infusion.
The Nanopump is expected to enable "substantial" advancements in the availability, treatment efficiency and the quality of life of diabetes patients. The original technology was awarded the Swiss Technology Award in 2006, and this agreement brings it closer to the market.
The insulin Nanopump, developed by Debiotech and industrialized by ST, represents the first use of microfluidic MEMS technology in diabetes treatment, according to the companies. Functional samples have already been produced and the two partners expect that a fully industrialized product, in the form of a disposable cartridge.
Laurent-Dominique Piveteau, PhD, business development manager of Debiotech, told Medical Device Daily that the Nanopump is expected to be available in certain markets by late 2008, but he could not disclose when the entities would be seeking approval for the device from the FDA.
Piveteau said the Nanopump would be the smallest device of its kind. Debiotech will remain responsible for the commercialization of the product through its licenses with what it called "major players" in the medical device market.
Insulin pump therapy, or continuous subcutaneous insulin infusion (CSII), is an alternative to individual insulin injections that must be administered several times a day. With CSII, the patient is connected to a programmable pump attached to a storage reservoir, from which insulin is infused into the tissue under the skin.
"Continuous delivery throughout the day more closely mimics the natural secretion of insulin from the pancreas," the companies said.
The highly miniaturized disposable insulin pump combines Debiotech's expertise in insulin delivery with ST's strengths in manufacturing high-volume silicon-based microfluidic devices. Microfluidic technology allows the flow of very small amounts of fluids to be electronically controlled. This pump represents a "significant step" in the development and adoption of CSII therapy and the technology will also find applications in many other biomedical applications, the companies said.
Today, existing insulin pumps are about the size of a pager. The new ST-enabled Debiotech miniaturized MEMS device is about one quarter the size of these existing pumps and can be worn as a nearly invisible patch on the skin. The small size frees the patient from concerns with holding the pump in place and concealing it under clothing.
The MEMS-based Nanopump also provides better control of the administered insulin doses. Dosing precision is a critical factor in treatment efficacy and contributes to reducing adverse long-term consequences. The Nanopump is able to control delivery at the nanoliter level, very close to the physiological delivery of insulin. The device prevents over-dosing and detects under-delivery, occlusion, air bubbles and other potential malfunctions in the pump to further protect patients. As a disposable device, manufactured using high-volume semiconductor processing technologies, the MEMS-based Nanopump will also be much more affordable, allowing the patient or the health system to avoid the typical up-front investment associated with current pump solutions.
The industrialization efforts will leverage ST Microelectronics' growing experience in the biomedical market. Other bio-tech programs within ST's Microfluidic Division include the In-Check lab-on-chip platform, currently being applied to the detection of sepsis and Avian flu.
"This collaboration with ST represents a major step in manufacturing of the Nanopump to make it available to a broad market at a cost compatible with a unique disposable use. ST is a world leader in MEMS manufacturing and we are very excited to be working together to bring a real innovation to diabetic patients, offering a new way to treat one of the most severe diseases of our century," said Frederic Neftel, MD, president/CEO of Debiotech.
The companies said there are almost 250 million people affected by diabetes worldwide and the number is expected to grow over the next decade due to population growth, aging and lifestyle. Without proper treatment, diabetes can lead to cardiovascular disease, kidney failure, blindness, nerve damage, and ultimately death. Diabetes is a leading cause of death in most developed countries.
Debiotech specializes in the research and development of medical devices in the field of implantable and external drug delivery systems, using micromechanics, nanotechnologies and MEMS, for the treatment of severe diseases (such as diabetes, renal failure, cardiovascular diseases and cancer) as well as technologies for the delivery of vaccines, diagnostic and imaging devices.
Debiotech has numerous exclusive license agreements with companies in the medical device and pharmaceutical fields and holds more than 500 patents worldwide.