News

December 19, 2011

Ultradian Diagnostics completes successful human pilot study, partners with UAlbany NanoCollege to ramp up research and pilot prototyping

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Flexible, band aid-like patch for continuous glucose monitoring demonstrates great promise to enable pain-free treatment of people with diabetes

Read the Times Union article, "Making good ideas better" 

Rensselaer, NY – Ultradian Diagnostics LLC (Ultradian), an early-stage medical device company based in Rensselaer, New York, today announced the successful completion of a human pilot study for its minimally invasive, continuous glucose monitor (CGM), as well as the launch of advanced research and pilot prototyping in partnership with the College of Nanoscale Science and Engineering (CNSE) of the University at Albany – critical steps toward commercializing its innovative technology to deliver improved, pain-free treatment to individuals with diabetes.

The human pilot study conducted at the State University of New York (SUNY) Upstate Medical University in Syracuse showed that Ultradian’s Biologue CGM© – a flexible, band aid-like patch for real-time monitoring of blood glucose levels that would eliminate the need for painful pinpricks – exhibited a high degree of accuracy as compared to CGM devices now on the market.

The Biologue CGM© includes a skin-adhered sensor module that works in tandem with a small intradermal sensor, which measures glucose in interstitial fluid. The sensor module sends data up to 10 feet to a proprietary hand-held monitor or personal computer for display and analysis. The device is painless during use and no adverse skin reactions were observed.

Concurrently, Ultradian is now working with CNSE to accelerate the commercialization of its innovative health care technology. That collaboration, which integrates research at CNSE’s Albany NanoTech Complex with access to pilot prototyping capabilities at CNSE’s Smart System Technology and Commercialization Center of Excellence (STC) in Canandaigua, will enable top-quality, cost-effective scale-up for high-volume manufacturing.

“This is a major milestone on Ultradian’s path toward commercialization that demonstrates our CGM is competitive in the marketplace for continuous glucose monitoring products,” said Ultradian Diagnostics CEO John P. Willis, Ph.D. “Innovations in our CGM design that allow for real-time, automatic correction of signal drift due to bio-fouling, redundant glucose measurements and a single-point calibration method were successfully demonstrated in this study. The ability to partner with CNSE, including its Smart System Technology and Commercialization Center, is a critically important step forward in providing access to state-of-the-art capabilities that will accelerate commercialization at a fraction of the cost compared to similar companies at this stage of development.”

“The partnership between Ultradian Diagnostics and CNSE’s Smart System Technology and Commercialization Center of Excellence showcases CNSE’s unique ability to provide a ‘one-stop shop’ for advanced research and pilot prototyping that is critical to assisting small companies in commercializing their innovative products and creating high-tech jobs in New York,” said Paul Tolley, CNSE Vice President for Disruptive Technologies and Director of CNSE’s STC. “It also demonstrates the powerful potential of nanotechnology to drive 21st century health care technologies that offer improved performance at a reduced cost.”

Ruth Weinstock, MD, Ph.D., Principal Investigator and Chief of Endocrinology, Diabetes and Metabolism at SUNY Upstate Medical University, said, “We are impressed with Ultradian’s CGM and very excited by the results of this pilot study and believe this new technology could greatly benefit patients with diabetes, and move us forward in the development of the artificial pancreas.”

Simultaneous with CGM measurements, two reference methods were utilized which included the YSI 2300 Stat Plus Glucose Analyzer for the analysis of venous blood samples and a One Touch Ultra Mini personal blood glucose meter for the analysis of fingerstick blood glucose samples and calibration. A total of 1023 paired data points were obtained. Using a standard accuracy metric known as the Clarke Error Grid, 87 percent of data fell within the clinically accurate “A” zone and 13 percent within the clinically acceptable “B” zone (100 percent). The mean absolute relative difference (MARD) was 11.4 percent, while the mean absolute residual (MAR) was 17.7 mg/dL.

Longer-term studies are planned with extended wear periods prior to FDA pre-market approval. Ultradian is actively pursuing strategic partnerships with established medical device companies to bring its technology to market and to close the loop to form an artificial pancreas.

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About Ultradian Diagnostics LLC. Ultradian is an early stage medical device company and a pioneer in the development of highly accurate minimally and non-invasive medical devices with applications in home health monitoring, intensive care and sports medicine.

About CNSE. The UAlbany CNSE is the first college in the world dedicated to education, research, development and deployment in the emerging disciplines of nanoscience, nanoengineering, nanobioscience and nanoeconomics. With more than $12 billon in high-tech investments, CNSE represents the world’s most advanced university-driven research enterprise, offering students a one-of-a-kind academic experience and providing over 300 corporate partners with access to an unmatched ecosystem for leading-edge R&D and commercialization of nanoelectronics and nanotechnology innovations. CNSE’s footprint spans upstate New York, including its Albany NanoTech Complex, an 800,000-square-foot megaplex with the only fully-integrated, 300mm wafer, computer chip pilot prototyping and demonstration line within 85,000 square feet of Class 1 capable cleanrooms. More than 2,600 scientists, researchers, engineers, students and faculty work here, from companies including IBM, Intel, GlobalFoundries, SEMATECH, Samsung, TSMC, Toshiba, Applied Materials, Tokyo Electron, ASML and Novellus Systems. An expansion now underway, part of which will house the world’s first Global 450mm Consortium, will add nearly 500,000 square feet of next-generation infrastructure, an additional 50,000 square feet of Class 1 capable cleanrooms, and more than 1,000 scientists, researchers and engineers from CNSE and global corporations. In addition, CNSE’s Solar Energy Development Center in Halfmoon provides a prototyping and demonstration line for next-generation CIGS thin-film solar cells. CNSE’s Smart Systems Technology and Commercialization Center of Excellence (STC) in Rochester offers state-of-the-art capabilities for MEMS fabrication and packaging. CNSE also co-founded and manages operations at the Computer Chip Commercialization Center at SUNYIT in Utica and is a co-founder of the Nanotechnology Innovation and Commercialization Excelerator in Syracuse. For information, visit www.cnse.albany.edu.

Ultradian Diagnostics Contact:
John Willis, Chairman and CEO, Ultradian Diagnostics
(phone) 518-618-0046
(email) jwillis@ultradian.com

CNSE Contact:
Steve Janack, CNSE Vice President for Marketing and Communications
(phone) 518-956-7322 (cell) 518-312-5009
(e-mail) sjanack@uamail.albany.edu