FDA Approves Abbott's FreeStyle Navigator(R) Continuous Glucose Monitoring System
March 13, 2008
New Tool Uniquely Provides Minute-by-Minute and Trend Information That Can Lead to Proactive Diabetes Management
March 13, 208 (PRNewswire-FirstCall) -- The Food and Drug Administration (FDA) has approved the FreeStyle Navigator(R) Continuous Glucose Monitoring System (http://www.continuousmonitor.com/) in the United States for people with diabetes.
Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.
The FreeStyle Navigator system will be available in the second quarter of 2008 by prescription only. It received CE Mark (http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0478 .htm) in June 2007 and has been available outside the United States since September 2007.
"Understanding glucose trends, with the goal of minimizing fluctuations, is an important part of improving the management of diabetes," said endocrinologist and Director of the International Diabetes Center Richard Bergenstal, M.D. "We are always looking for new tools like these to enable people with diabetes to continuously monitor their glucose levels, putting them on the offense, not defense, so they can take action before a high or low glucose level occurs."
For people with diabetes, less time spent with low (hypoglycemia) or high (hyperglycemia) blood sugar has been correlated with less risk for a number of serious short- and long-term diabetes-related complications.(1) By measuring glucose levels continuously, the FreeStyle Navigator system is designed to provide more and better information than traditional fingerstick glucose measurements, which can lead to improved diabetes management.
Abbott's FreeStyle Navigator system offers a number of key advances for people with diabetes who require insulin and want to tightly manage their disease. The system monitors glucose levels by measuring and transmitting glucose information once per minute to the pager-sized receiver, which can be clipped to a belt or carried in a pocket or purse. It also provides audible or vibrating alarms before glucose levels become too high or too low, displays five directional trend arrows to help people understand if glucose is rising or falling, and stores historical data and glucose trend information for up to 60 days. Additionally, the sensor and transmitter are designed to accommodate showering, swimming and a range of normal physical activities.
Clinical Trial Results
The accuracy, safety and efficacy of the FreeStyle Navigator system have been demonstrated in two separate pivotal clinical trials, including a five-day, in-clinic study and a study of people with type 1 and type 2 diabetes at home.
Five-Day In-Clinic Study(2): Abbott conducted a study to test the accuracy of its FreeStyle Navigator system in 58 subjects ranging in age from 18 to 64. This study met its primary endpoint of demonstrating accuracy over five days of wear. Using the Clarke Error Grid (CEG), comparing readings from a lab reference to a reading from the FreeStyle Navigator Continuous Glucose Monitoring System at a specific point in time, a combined 98.4 percent of the measurements were in the most accurate zones, A (81.7 percent) and B (16.7 percent), which means that measurements allowed patients to make either correct and safe treatment decisions, benign treatment decisions, or no treatment decision at all.
Home Use Study(3): In a study on the safety and efficacy of the FreeStyle Navigator system, 123 people with type 1 and type 2 diabetes used it in their homes for 40 days, wearing the sensor on the back of their upper arm or abdomen. Continuous glucose values were not visible to the user during the first half of the study, but were visible to the user during the second half of the study. A Clarke Error Grid (CEG) analysis demonstrated that 96.8 percent of the values were in the most accurate zones (zones A and B). Using a FreeStyle Navigator system, study participants with type 1 diabetes spent significantly less time in a hypoglycemic state (i.e., low blood sugar) -- a serious condition for this population -- during the phase of the trial when values were visible to the user. In addition, participants using a FreeStyle Navigator system who had type 2 diabetes spent significantly less time in a hyperglycemic state. Hyperglycemia (i.e., high blood sugar) is a serious problem, particularly for people with type 2 diabetes.
About the FreeStyle Navigator System
The FreeStyle Navigator system is composed of three parts: a sensor, a transmitter and a receiver. The sensor, worn for up to five days and then replaced, is placed just under the skin and is attached to a plastic sensor mount with adhesive to adhere to the skin, like a patch. The transmitter snaps into the sensor mount and sends glucose information wirelessly to the pager- sized receiver. The system discreetly measures glucose levels once per minute; provides high/low glucose alarms based on customizable, physician- and patient-determined levels; and delivers early-warning alarms that indicate if glucose levels are likely to be too high or too low 10, 20 or 30 minutes in advance. The system also stores up to 60 days worth of glucose information that can be analyzed by the user or a health care professional.
Indicated for people ages 18 and older, the FreeStyle Navigator system is designed to continually record interstitial fluid glucose levels for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator system are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.
Additional information about the FreeStyle Navigator system is available at http://www.continuousmonitor.com.
About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, Calif., is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help patients better manage their diabetes. Abbott Diabetes Care is committed to developing products to reduce the discomfort and inconvenience of blood glucose monitoring and introducing systems that are easier to use, require smaller blood samples and provide faster results.
Abbott Diabetes Care markets several leading-edge glucose monitoring systems and test strips in the United States for use in both home and hospital settings; leading brands include FreeStyle(R) Lite, FreeStyle Freedom(TM), FreeStyle Flash(R) and Precision Xtra.(TM) Additional information about Abbott Diabetes Care may be found at http://www.abbottdiabetescare.com.
Posted by dlife at 01:03 PM | Comments (6)
FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products
February 15, 2008
February 15, 2008 (FDA) - The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."
Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.
The FDA's "Good Reprint Practices" draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.
Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.
In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.
The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act.
The FDA welcomes public comments on the draft guidance. Typed comments should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.
Posted by dlife at 09:10 AM | Comments (0)
SYMLIN Pen-injector Devices Now Available
January 07, 2008
SymlinPen Offers SYMLIN Administration for Enhanced Glucose Control with Potential Weight Loss
January 7, 2008 (Press Release) – Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today the availability of the SymlinPen™ 120 and the SymlinPen™ 60 pen-injector devices for administering SYMLIN® (pramlintide acetate) injection. These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control.
“SYMLIN offers enhanced blood glucose control with potential weight loss for patients with diabetes using mealtime insulin, enabling them to do more to manage their diabetes,” said Daniel M. Bradbury, President and CEO, Amylin Pharmaceuticals. “The convenience of the new SymlinPen™ with simple, fixed dosing will make it easier for these patients using multiple daily injections to start and stay with SYMLIN.”
SymlinPen™ 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. SymlinPen™ 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose. Both pen-injector devices can be conveniently stored at room temperature not to exceed 86 degrees F (30 degrees C) after first use.
Posted by dlifenews at 04:44 PM | Comments (0)
FDA Approves SYMLIN Pen-Injector Devices Offering Convenience and Accuracy for SYMLIN Use
October 01, 2007
October 1, 2007 (PRNewswire-FirstCall) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that the U.S. Food and Drug Administration (FDA) has approved the SymlinPen(TM) 120 and the SymlinPen(TM) 60 pen-injector devices for administering SYMLIN(R) (pramlintide acetate) injection. These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control.
"SymlinPen 120 and SymlinPen 60 offer patients improved convenience and accuracy," said Daniel M. Bradbury, President and CEO, Amylin Pharmaceuticals. "For people with diabetes using mealtime insulin, the addition of SYMLIN can enhance glucose control with the potential for weight loss."
SymlinPen(TM) 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms per dose. SymlinPen(TM) 120 features fixed dosing to deliver 60 or 120 micrograms per dose. Both pen-injector devices can be conveniently stored at room temperature not to exceed 86 degrees F (30 degrees C) after first use. The pens are expected to be available to patients by December 2007.
"Not Approvable" Letter Received for SYMLIN Use with Basal Insulin Alone
Amylin also announced today that the FDA has issued a "Not Approvable" letter for SYMLIN use with basal insulin (without mealtime insulin) in patients with type 2 diabetes who have not achieved desired glucose control. SYMLIN is currently approved in the U.S. for patients with type 2 or type 1 diabetes who use mealtime insulin and need improved glucose control.
"SYMLIN remains an important therapeutic option for people with diabetes who use mealtime insulin therapy," Bradbury added. "We will initiate discussions with the FDA to clarify their response for its use with basal insulin alone."
About SYMLIN
SYMLIN is the first and only amylin mimetic for use in patients with diabetes treated with mealtime insulin. SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of SYMLIN contributes to glucose control after meals.
Healthcare professionals and people with diabetes may obtain more information, including the complete Prescribing Information and the Medication Guide, at http://www.SYMLIN.com.
Important Safety Information
SYMLIN is not intended for all patients with diabetes. SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within three hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high- risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk. This information is highlighted in a boxed warning in the SYMLIN Prescribing Information for healthcare professionals and in a Medication Guide for patients, which will be distributed by pharmacists.
Other adverse events commonly observed with SYMLIN when co-administered with insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported. The incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually increased to the recommended doses.
Posted by dlifenews at 09:00 AM | Comments (1)
New Technique to 'See' and Protect Transplants Successful in Diabetic Animal Model
July 30, 2007
July 30, 2007 (EurekAlert) - Researchers at Johns Hopkins have found a way to overcome a major stumbling block to developing successful insulin-cell transplants for people with type I diabetes.
Traditional transplant of the cells, accompanied by necessary immune-suppressing drugs, has had highly variable results, from well- to poorly tolerated. Part of the problem, the Hopkins researchers say, is an inability to track the cells—so-called pancreatic beta cells—once they’re inside the body.
Now a new technique encapsulates the insulin-producing cells in magnetic capsules, using an FDA-approved iron compound with an off-label use, which can be tracked by magnetic resonance imaging (MRI). The product, tested in swine and diabetic mice, also simultaneously avoids rejection by the immune system, likely a major reason for transplant failure. The work will be published online next week in Nature Medicine.
“We’re really excited because we can track where we put the cells and make sure their protective housing stays intact and that the cells don’t move. This could solve the mystery of why current transplantation techniques work only for so long,” says one of the study’s authors, Aravind Arepally, M.D., assistant professor of radiology and surgery at Hopkins.
Type I diabetes—the most common childhood sort—causes a person’s immune system to destroy the pancreatic beta cells that make insulin. Without insulin, blood sugar levels can become dangerously high and lead to complications that include blindness or kidney failure. Careful monitoring of blood sugar levels paired with insulin injections can manage the condition, but transplanting healthy beta cells holds more promise for the moment-to-moment fine-tuning of insulin levels, says Arepally.
Current experimental cell transplantation techniques are done “naked and blind,” only lasting a short period of time, according to co-author Jeff Bulte, Ph.D., a professor of radiology and chemical and biomolecular engineering at Hopkins. The unprotected transplanted cells are vulnerable to attack by the recipient’s immune system, and researchers cannot see the cells to figure out why they stop making insulin after a while.
To address both of these challenges, the research team captured beta cells in tiny porous capsules made from a mixture of alginate, a gooey material made from seaweed, and Feridex, a magnetic iron-containing material visible under MRI. They then used a machine that oozes droplets of this mixture to surround and encapsulate individual islet clusters each containing about 500 to 1,000 insulin-producing beta cells. Once the cells are encapsulated, the shell hardens, creating a “magnetocapsule” that measures less than 1/128 of an inch across.
“They’re tiny spheres with nano-scale pores just big enough too let the good stuff out but keep the bad from getting in,” says lead author Brad Barnett, medical student and Howard Hughes fellow at Hopkins. The openings in the magnetocapsule are so small that the body’s immune system sentinels cannot reach and attack the transplanted cells.
The team first transplanted magnetocapsules into the abdomens of mice engineered to develop diabetes. Blood sugar levels in the animals returned to normal within a week and stayed that way for more than two months. In contrast, more than half of untransplanted diabetic mice died, and the rest had very high blood sugar levels.
To mimic human transplantation, the researchers then implanted magnetocapsules into the livers of swine with the help of MRI fluoroscopy, special reflective screens and a computer monitor that provide real-time imaging. The liver was chosen, rather than the usual pancreatic home of beta cells, because it contains many blood vessels that can deliver insulin quickly to the rest of the body.
“Getting the magnetocapsules into the right place requires hand-eye coordination normally required when playing video games,” says Arepally. The team threaded a long needle-like tube into a large vein near the upper thigh and guided the tube upward, across and into a neighboring blood vessel, ending in the body of the liver.
The pigs underwent MRI and blood tests three weeks after magnetocapsule transplantation. MRI showed that the magnetocapsules remained intact in the liver, and blood tests revealed that the cells were still secreting insulin at levels considered functional in people.
“We hope that our magnetocapsules will make tissue-type matching and immunosuppressive drugs problems of the past when it comes to cell-based therapies for type 1 diabetes,” says Bulte.
Posted by dlifenews at 09:29 AM | Comments (0)
FDA Approves Continuous 7-Day Glucose Monitoring System
June 04, 2007
June 4, 2007 (FDA) - The U.S. Food and Drug Administration today approved a device that measures glucose levels continuously for up to seven days in people with diabetes.
While a standard fingerstick test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.
“The STS-7 System supplements standard fingerstick meters and test strips, providing diabetics ages 18 and older with a way to see trends and track patterns,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “It can help detect when glucose levels drop during the overnight hours, show when glucose levels rise between meals and suggest how exercise and diet might affect glucose levels.”
The STS-7 System, manufactured by DexCom Inc. of San Diego, Calif., uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body’s tissues (interstitial fluid). Sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs.
Diabetes is caused by the body’s inability to produce or use insulin, a hormone that unlocks the cells of the body, allowing glucose (sugar) to enter and fuel them.
An estimated 20.8 million people in the United States—7 percent of the population—have diabetes. Most have type 2 diabetes, a condition in which the body does not properly use insulin. An estimated 5 percent to 10 percent of people with this chronic disease have type 1 diabetes, which results from the body's failure to produce insulin. People with type 1 diabetes must take insulin every day.
Diabetes can lead to wide fluctuations in blood sugar levels. Over time, abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease.
While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have lower incidences of complications associated with the disease.
FDA’s approval of the STS-7 System was based on results of a study conducted by DexCom of 72 patients with diabetes at five clinical sites in the United States. The study demonstrated that the STS-7 System was safe and effective for detecting trends and tracking patterns in glucose levels in adults.
A three-day version of the device, the STS Continuous Glucose Monitoring System, was approved in March 2006.
Posted by dlifenews at 02:18 PM | Comments (6)
"Virus Sponge" Could Improve Flu Treatments, Diabetes Care, Vaccine Development
May 11, 2007
May 11, 2007 (Newswise) — Influenza virus H5N1, which caused the recent outbreak of avian flu, may have a new enemy.
Researchers at the University of Maryland's A. James Clark School of Engineering have created a "virus sponge" that could filter a patient's blood in a process similar to kidney dialysis, removing the virus from the patient's body. The concept could also be used to make vaccine production more efficient and in a pill to reduce glucose levels in diabetics, among other applications.
The virus sponge is based on a technology called molecular imprinting. In molecular imprinting, researchers stamp a molecule's shape into a substance (in this case, a hydrogel—a sponge-like material). When the specific molecule filters through the hydrogel, it fits in the imprint hole and is trapped.
The research group of Peter Kofinas, a professor in the Clark School's Fischell Department of Bioengineering, is the first to apply molecular imprinting to the capture of viruses, and to show that this approach is possible using an inexpensive hydrogel.
Kofinas' team has so far used this technique on plant viruses and Human Parvovirus B19, which causes "fifth disease" in babies, and has now begun work on the H5N1 influenza virus.
"This new technology could be integrated into hospitals and healthcare centers at minimal cost," according to Kofinas. Modifying existing dialysis machines to include the virus sponge technology would be relatively simple, he said.
"This virus removal device can be used the same way as a kidney dialysis machine," Kofinas continued. "If you have a viral infection, you can go to the hospital and have your blood cleaned of that virus."
While a new vaccine must be developed each year for the strain of influenza that is expected to be the most potent, a hydrogel can be imprinted as a universal filter for all flu strains. However, to achieve better performance, a hydrogel filter can also be produced to catch a particular strain of the virus.
The molecular imprinting process has many applications beyond trapping viruses.
"Applying the technology to a drug or food additive could contribute to the dietary freedom of those who suffer from type II diabetes," Kofinas said.
A pill containing the hydrogels could be developed to remove excess sugars when taken with food, thus helping diabetics regulate their diet, Kofinas explained. The hydrogels would work within the small intestine to remove glucose prior to absorption into the blood stream.
Drug manufacturers could use the hydrogel filters in vaccine production. Pharmaceutical companies use viruses to create the vaccines that fight them. Hydrogels could be used to strip the virus out of the finished medication—a process that is currently very time-consuming and expensive.
Another potential application is to use the material as a filter in masks for those needing protection in case of biological warfare or other harmful biological agent exposure.
Kofinas has filed a patent on this technology. Currently, he is collaborating with researchers at the National Institutes of Health on how to use the hydrogels to clean human viruses out of blood. Advances in this area could help ensure a safer blood supply by allowing for the low-cost removal of viruses like hepatitis and HIV from donor blood.
Kofinas is also associate chair and director of graduate studies in the Fischell Department of Bioengineering. His graduate students, Linden Bolisay, Brendan Casey, Angela Fu and Daniel Janiak, continue to contribute to this research.
Posted by dlifenews at 10:03 AM | Comments (0)
Disposable Insulin Nanopump From Debiotech and STMicroelectronics Marks Major Breakthrough in Diabetes Treatment
April 19, 2007
April 19, 2007 (PRNewswire-FirstCall) - Debiotech and STMicroelectronics (NYSE: STM) today announced a strategic cooperation agreement aimed at manufacturing and delivering to the market a unique miniaturized insulin-delivery pump. 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 will 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.
Insulin pump therapy, or Continuous Subcutaneous Insulin Infusion (CSII), is an increasingly attractive 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 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 leading-edge technology will also find applications in many other biomedical applications.
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 insulin Nanopump, developed by Debiotech and industrialized by ST, represents the first use of microfluidic MEMS technology in diabetes treatment. Functional samples have already been produced and the two partners expect that a fully industrialized product, in the form of a disposable cartridge, will be available in selected markets in 2008. Debiotech will remain responsible for the commercialization of the product through its licenses with major players in the medical device market.
The industrialization efforts will leverage STMicroelectronics' 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.
"ST's increasing focus on applying its semiconductor manufacturing processes and growing experience in microfluidic biotech applications affords us the potential to improve lives for millions of people around the world," said Anton Hofmeister, Group Vice President and General Manager of ST's Microfluidic Division. "Working with Debiotech, a leading developer of innovative biomedical applications, we are committed to the industrialization of the insulin Nanopump that aspires to push the boundaries of diabetes treatment."
"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 SA.
Posted by dlifenews at 10:53 AM | Comments (6)