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2015

GlySens Incorporated Secures FDA Approval to Extend Second Generation Fully-Implanted CGM Sensor Evaluation from 6 to 12 Months

Ongoing Clinical Trial Extension

SAN DIEGO, CA – November 21, 2015 /PRNewswire/ – GlySens Incorporated announced today that it has been awarded a two-year, two million dollar grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the National Institutes of Health (NIH). The grant is intended to support human clinical evaluation of the GlySens second generation ICGM long term implantable glucose monitoring system. Final preparations for launch of the trial are underway, and enrollment is expected to begin before the end of 2014.

“We are extremely pleased and grateful to have the support of NIDDK and the NIH as we take these next steps in the development of the GlySens ICGM system,” said Joseph Lucisano, PhD, GlySens President and CEO. “As appreciation continues to grow for the potential of continuous glucose monitoring to make a real difference in the lives of people with diabetes, the need to provide an effective, widely acceptable, patient-friendly product has never been greater. We believe that our long term system approach, with its fully implantable sensor intended to operate continuously for one year without need for replacement, will provide the convenience and ease of use that patients desire and foster widespread application of continuous glucose monitoring in diabetes care. The long-standing engagement of the NIH with our research program has provided tremendous value in helping us ensure that our approach aims to serve a broad range of patient needs while we also maintain the highest level of scientific rigor in our efforts. As with our other previous NIH sponsored projects, including the completed human clinical evaluation of the first generation ICGM system, we look forward to conducting this upcoming clinical trial with NIH support.”

About GlySens Incorporated
GlySens Incorporated is a privately held corporation devoted to developing the world’s first truly long term continuous glucose monitoring system, intended to dramatically improve the lives of people with diabetes. The GlySens fully implanted sensor—demonstrated up to 18-month lifetime in preclinical testing—wirelessly links to a convenient external receiver, designed to provide continuous, at-a-glance glucose measurement, recording, and alerts regarding hypo- and hyperglycemic glucose excursions. In contrast with other approaches that may require calibration multiple-times-per-day, system calibration checks of the GlySens sensor are designed to be required only infrequently, freeing users from the need for burdensome care and maintenance. For people living with diabetes, the GlySens implantable continuous glucose monitoring system (the GlySens ICGM system) is intended to provide a means for easy, unobtrusive, worry-free glucose monitoring, and empower users by providing the information they need, while freeing them to live life on their own terms.
ICGM is a trademark of GlySens Incorporated.

Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
Research reported in this release was supported by National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under grant number R44DK077254. The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
GlySens Incorporated Names William Markle Chief Executive Officer

Leadership Change to Drive Organizational Development

SAN DIEGO, CA – April 2, 2015 /PRNewswire/ – GlySens Incorporated announced today that William H. Markle has been selected to join the Company as President and Chief Executive Officer. Mr. Markle succeeds founder and current CEO Joseph Lucisano, PhD, who will continue to lead the Company’s development efforts as Chief Technology Officer.

Mr. Markle has distinguished himself in a successful 25-year career in the medical device field and was formerly founder, President, and CEO of GluMetrics, Inc. At GluMetrics, he directed the successful development of continuous real-time sensing technology for intravascular glucose monitoring in the intensive care and operating room environment. Previously, he held senior executive positions in marketing and business development at Tensys Medical and Masimo Corporation, and related positions at Baxter Edwards Critical Care and American Hospital Supply. Mr. Markle is an MBA graduate of Pepperdine University and an engineering graduate of Duke University.

“Along with our entire Board of Directors, I am happy to welcome Bill to the GlySens team. Bill is exceptionally well qualified to lead GlySens as we advance toward a commercial phase of operations, and I am very pleased that he will be joining us at this important juncture. I look forward to working together with Bill to complete the final system refinements, expand our ongoing clinical evaluations, and prepare the GlySens ICGMTM system for commercial launch,” said Dr. Lucisano. “It would be hard for me to be much more excited about the core GlySens technology, the proven capabilities of the development team, and the impressive, uncompromised feature set embodied in the GlySens ICGMTM device,” commented Mr. Markle. “The ability of the fully implanted sensor to reliably function for an extended period, shown to be up to 18 months in pre-clinical testing, with minimal required recalibrations, all while allowing the user to maintain an essentially normal body image, is a significant step forward in the CGM space. I am very confident we can deliver this remarkable technology platform in a user-preferred system architecture supporting a rapid expansion of the already proven benefits of continuous glucose monitoring,” continued Mr. Markle.

About GlySens Incorporated
GlySens Incorporated is a privately held corporation devoted to developing the world’s first unobtrusive, truly long term continuous glucose monitoring system, intended to dramatically improve and simplify the lives of people with diabetes. The GlySens fully implanted sensor—demonstrated up to 18-month lifetime in preclinical testing—wirelessly links to a convenient external receiver, designed to provide continuous, at-a-glance glucose measurement, recording, and alerts regarding hypo- and hyperglycemic glucose excursions. In contrast with other approaches that may require calibration multiple-times-per-day and also demand continuous wearing of through-the-skin or skin-attached components, system calibration checks of the fully-implanted, unobtrusive, wirelessly-linked GlySens sensor are designed to be required only infrequently, freeing users from burdensome care and maintenance requirements. For people living with diabetes, the GlySens implantable continuous glucose monitoring system (the GlySens ICGM™ system) is intended to provide a means for easy, unobtrusive, worry-free glucose monitoring, and empower users by providing the information they need, while freeing them to live life on their own terms. Additional information is available at www.glysens.com

ICGM is a trademark of GlySens Incorporated.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
SOURCE GlySens Incorporated
GlySens Incorporated Secures $12M Series C Investment Proceeds dedicated to advanced product commercialization steps

Capital Secured to Explore Commercial Opportunities

SAN DIEGO, CA – January 5, 2018 /PRNewswire/– GlySens Incorporated announced today that it has closed a $12 million dollar Series C investment round, which included participation from several new investors as well as a group of returning investors that had previously participated in the Company’s Series B financing. The Company will utilize the proceeds from the new investment to advance the development of its ICGM continuous glucose monitoring system for people with diabetes. This system includes a fully implantable sensor, with an intended one-year life, that wirelessly transmits glucose levels continuously to an external receiver for display and logging. The system operates without need for any through-the-skin or skin-attached elements and is expected to offer significant advantages to users, as compared with other glucose monitoring approaches.
“The proceeds from this investment will enable us to address final product development tasks and bring the GlySens ICGM system to an advanced state of commercial readiness on the path to market introduction,” said Joseph Lucisano, PhD, GlySens President and CEO. “We are pleased to have continued support from our returning investors, and are especially happy to welcome the new investors who played a key role in closing this round and providing support at this important juncture. As we conduct the upcoming human clinical trial involving our second generation receiver and fully implantable continuous glucose sensor, this additional funding will enable us to address the remaining elements needed to bring all aspects of the ICGM system to a fully commercial configuration. Closing the round at this time will be especially valuable as we accelerate our efforts in the final development phases.”

About GlySens Incorporated
GlySens Incorporated is a privately held corporation devoted to developing the world’s first truly long term continuous glucose monitoring system, intended to dramatically improve the lives of people with diabetes. The GlySens fully implanted sensor—demonstrated up to 18-month lifetime in preclinical testing—wirelessly links to a convenient external receiver, designed to provide continuous, at-a-glance glucose measurement, recording, and alerts regarding hypo- and hyperglycemic glucose excursions. In contrast with other approaches that may require calibration multiple-times-per-day, system calibration checks of the GlySens sensor are designed to be required only infrequently, freeing users from the need for burdensome care and maintenance. For people living with diabetes, the GlySens implantable continuous glucose monitoring system (the GlySens ICGM system) is intended to provide a means for easy, unobtrusive, worry-free glucose monitoring, and empowers users by providing the information they need, while freeing them to live life on their own terms. Additional information is available at www.glysens.com.
ICGM is a trademark of GlySens Incorporated.

Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
SOURCE GlySens Incorporated

2014

GlySens Incorporated Awarded $2 Million Grant from the National Institutes of Health Funding provided to support human clinical evaluation of next generation diabetes monitoring system

Funding Grant for Human Clinical Trial

SAN DIEGO, CA – November 21, 2014 – /PRNewsire/ – GlySens Incorporated announced today that it has been awarded a two-year, two million dollar grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the National Institutes of Health (NIH). The grant is intended to support human clinical evaluation of the GlySens second generation ICGM long term implantable glucose monitoring system. Final preparations for launch of the trial are underway, and enrollment is expected to begin before the end of 2014.

“We are extremely pleased and grateful to have the support of NIDDK and the NIH as we take these next steps in the development of the GlySens ICGM system,” said Joseph Lucisano, PhD, GlySens President and CEO. “As appreciation continues to grow for the potential of continuous glucose monitoring to make a real difference in the lives of people with diabetes, the need to provide an effective, widely acceptable, patient-friendly product has never been greater. We believe that our long term system approach, with its fully implantable sensor intended to operate continuously for one year without need for replacement, will provide the convenience and ease of use that patients desire and foster widespread application of continuous glucose monitoring in diabetes care. The long-standing engagement of the NIH with our research program has provided tremendous value in helping us ensure that our approach aims to serve a broad range of patient needs while we also maintain the highest level of scientific rigor in our efforts. As with our other previous NIH sponsored projects, including the completed human clinical evaluation of the first generation ICGM system, we look forward to conducting this upcoming clinical trial with NIH support.”

About GlySens Incorporated
GlySens Incorporated is a privately held corporation devoted to developing the world’s first truly long term continuous glucose monitoring system, intended to dramatically improve the lives of people with diabetes. The GlySens fully implanted sensor—demonstrated up to 18-month lifetime in preclinical testing—wirelessly links to a convenient external receiver, designed to provide continuous, at-a-glance glucose measurement, recording, and alerts regarding hypo- and hyperglycemic glucose excursions. In contrast with other approaches that may require calibration multiple-times-per-day, system calibration checks of the GlySens sensor are designed to be required only infrequently, freeing users from the need for burdensome care and maintenance. For people living with diabetes, the GlySens implantable continuous glucose monitoring system (the GlySens ICGM system) is intended to provide a means for easy, unobtrusive, worry-free glucose monitoring, and empower users by providing the information they need, while freeing them to live life on their own terms.
ICGM is a trademark of GlySens Incorporated.

Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
Research reported in this release was supported by National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under grant number R44DK077254. The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
GlySens-UCSD Collaborative Research Leads to Key Findings Regarding the Viability of Long-Term Implanted Devices

RESEARCH ARTICLE | LS Kumosa et al. "Permeability of Subcutaneous Tissues Surrounding Long-Term Implants to Oxygen," Biomaterials. September 2014

SAN DIEGO, CA – July 4, 2014 – RESEARCH ARTICLE - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4527688/pdf/nihms611284.pdf

Important research findings were published today regarding GLYSENS INCORPORATED’s collaborative efforts with Professor David Gough’s Biosensor Research Lab at the University of California, San Diego. The publication, in the journal Biomaterials, is entitled “Permeability of subcutaneous tissues surrounding long-term implants to oxygen” and was released today on the journal’s website.

The research project represented a joint effort between GlySens and Dr. Gough’s UCSD group, and examined important factors that influence the rate of oxygen transport to implanted devices, including the influence of the body’s normal and expected “foreign body response.” An adequate supply of oxygen from the tissue environment is of vital importance for the viability of many types of long term implants, including long term implanted sensors.
The results of this research confirm, that with proper device design, adequate oxygen delivery can be sustained over the long term and that oxygen supply need not be a limiting factor in long term implant viability.
GlySens Incorporated Featured in MedCity News

Advancing a Long-Term Glucose Sensor

SAN DIEGO, CA  – April 2, 2014https://medcitynews.com/2014/04/sensor-startup-building-implant-can-measure-blood-sugar-year/

GLYSENS INCORPORATED is profiled in a feature article in today”s edition of MedCity News by author Karen Heyman, entitled, “No more needles: Startup tests implant that can measure blood sugar for up to a year.”
Several times every day, many of the nearly 19 million Americans diagnosed with diabetes have to check their glucose levels. Even though this task can be life-saving, patients are often reluctant to do it regularly. Existing methods are either painful (pricking a finger for a blood sample) or cumbersome (implanted sensors that require frequent replacement). Joseph Y. Lucisano and David A. Gough believe they have a better way. They are the co-founders of GlySens Incorporated, and hold 18 monitoring and related technology patents. They have developed an implanted glucose monitoring system that can work for over a year before requiring a change. If successful, it will join a market projected to reach $568.5 million globally by 2020, according to Allied Market Research.

“What we hope to deliver to people with diabetes is freedom. To give them some time in their day when they can hopefully be free from remembering they have diabetes,” Lucisano said. “The more people that use our product and forget that they’re using it — that’s what we’ll count as success.”

2013

GlySens Incorporated’s Recent Developments are Discussed in a Feature Story in the San Diego Union-Tribune

Center Stage in Diabetes Battle

SAN DIEGO, CA  – August 28, 2013 – GLYSENS INCORPORATED’S recent developments are discussed in a feature story in today’s San Diego Union-Tribune by Staff Writer Bradley Fikes, entitled, “Center Stage in Diabetes Battle.”

San Diego biomedical companies have made big strides and continue to play major role in development of treatments.
Privately held GlySens is developing an implanted glucose sensor meant to last for at least a year, said Chief Executive Joseph Lucisano. An animal trial completed in 2010 gave encouraging results. More recently, GlySens completed a feasibility trial of the sensor on six people for six months.

The main advantage of long-term sensor implants is ease of use, which will encourage patient adoption, said Joseph M. Smith, chief medical and scientific officer for West Health Institute. The La Jolla-based not-for-profit funds development of technology to reduce the cost of health care. “That’s just the kind of technology we’re going to need to reduce the footprint of this disease on those who struggle with it,” Smith said.
GlySens named as Finalist in the 2013 San Diego Business Journal Innovation Awards

San Diego Business Journal Innovation Awards

SAN DIEGO, CA  – June 18, 2013 - http://www.cbjonline.com/a3sdbj/resources/PDFs/2013/Innovation_062413.pdf

GLYSENS INCORPORATED joined a handful of companies in the Medical Device category honored as finalists in the 2013 San Diego Business Journal Innovation Awards. The awards program was created by the San Diego Business Journal to recognize breakthrough technologies and unique new products developed by San Diego companies in a broad spectrum of industries from medical research to aviation safety and social media to mobile senior care. The finalists in ten categories were honored at a reception held today at the Scripps Institute of Oceanography’s Seaside Pavilion in La Jolla.
GlySens Discusses its Long Term Fully Implantable Glucose Monitoring System at NIH Artificial Pancreas Conference

Investigation of Long-Term Feasibility with New Sensor Insertion within Same Pocket 

BETHESDA, MD  – April 10, 2013 –  GLYSENS INCORPORATED’S presentation entitled “Long Term, Fully-Implanted, Self-Contained Subcutaneous Glucose Sensor: Results from Clinical Evaluation and Applicability for Closed Loop Systems” was delivered today by Dr. Joseph Lucisano, the Company’s president and CEO, at the “Workshop on Innovation towards an Artificial Pancreas,” held at the National Institutes of Health (NIH). The April 9-10 workshop, co-sponsored by the NIH, the U.S. Food and Drug Administration (FDA), and the Juvenile Diabetes Research Foundation (JDRF), is bringing together over 175 scientists and clinicians from around the world to discuss the latest developments related to glucose sensors, insulin pumps, algorithms, and medications in the quest to develop an “artificial pancreas” closed-loop automatic glucose control system for people with diabetes. In this context, Dr. Lucisano discussed the GlySens implantable continuous glucose monitoring (ICGM) system, and its potential for eventual application in an artificial pancreas.

From the GlySens presentation abstract: In addition to meeting objective engineering utility specifications as dictated by particular control system requirements, components comprising a closed loop artificial pancreas system must also meet minimum user acceptability requirements to ensure widespread appeal and eventual widespread application of such systems. For the glucose monitoring element in such systems, key characteristics affecting user acceptability include human factors related to the intrusiveness of the device such as: (1) comfort and level of associated “device awareness;” (2) associated demands for maintenance of any externally attached elements; and (3) associated demands for user interaction/maintenance (including especially calibration frequency). Long term, fully-implanted, self-contained sensor approaches with radio telemetry signal transmission have the potential to deliver superior performance with respect to such human factor considerations, and we have developed a long term fully-implanted subcutaneous sensor system specifically intended to address these needs.

2012

GlySens Presents Results of Human Feasibility Study at the Annual Diabetes Technology Meeting

New Funding to Fuel Technology Development

BURLINGAME, CA  – November 8, 2012 –  GLYSENS INCORPORATED presented results today of the recently completed first human feasibility trial of its long term, fully implantable continuous glucose monitoring (ICGM) system. The trial evaluated the Company’s first generation fully-implanted sensors in six individuals with diabetes for periods of five to six months.

The presentation, entitled “Application of the Implantable Continuous Glucose Monitoring System in a Human Subject” was delivered by GlySens’s President and CEO Dr. Joseph Lucisano at a morning session of the twelfth annual meeting of the Diabetes Technology Society. The annual meeting, held this year November 8-10 at the Bethesda North Marriott Hotel & Conference Center, is a premier scientific venue for discussion of diabetes care technology. Last year’s meeting brought together over 500 clinicians and scientists from 24 countries to focus on applying science and technology to improve the lives of people with diabetes.
West Health Investment Fund invests in GlySens

Startups Demonstrate Innovative Technologies to Lower the Cost of Health Care in the Treatment of Diabetes and Medication Adherence

SAN DIEGO, CA  – August 12 , 2012 –  The West Health Investment Fund, West Health’s fund focused on lowering health care costs, has announced it participated in the recent venture financings of GlySens, Inc. and RxAnte, Inc., two startup technology companies with innovative technologies that could lower the cost of health care. Financial terms of the investments were not disclosed.

“Through targeted external investments in companies focused in advancing cost-effective and cost-saving models of care, West Health can impact the cost of health care in the country,” said Nicholas J. Valeriani, chief executive of West Health. “These two innovative companies highlight the kinds of new approaches to diabetes treatment and medication adherence that have great potential to disrupt the current delivery model and lower the cost of health care.”
GlySens Incorporated featured in Scientific American

Tomorrows Medicine

SAN DIEGO  – May 1, 2012https://www.scientificamerican.com/article/tomorrows-medicine/

GLYSENS INCORPORATED is featured in the May 2012 issue of Scientific American, in an article entitled “Smart Implantable Devices”. In the article, author Katherine Harmon reports: “A new implantable glucose sensor made by GlySens in San Diego might someday offer millions of diabetics a wireless monitoring system of their own. The device takes near-continuous readings under the skin of a patient’s glucose level- which is then correlated to the level in the blood. The result: far more accurate and more complete information for guiding insulin dosing and timing than can be achieved by testing blood from finger pricks. And because the sensor is implanted, it requires less upkeep than current external monitors.”

2010 & older

GlySens Incorporated profiled by the San Diego Union-Tribune

The Next Step in Diabetes Care

SAN DIEGO, CA  – July 29, 2010https://www.sandiegouniontribune.com/sdut-sd-company-hopes-monitor-will-revolutionize-2010jul28-htmlstory.html

GLYSENS INCORPORATED is profiled in a front-page story in today’s San Diego Union-Tribune by Staff Writer Keith Darcé, entitled, “SD company hopes monitor will revolutionize diabetes care.”

A small San Diego medical device company and a UCSD scientist believe they’ve come up with the solution to a problem that has long vexed people with diabetes: a device that constantly monitors blood-sugar levels without painful finger pricks or frequent maintenance.

GlySens is seeking permission from the Food and Drug Administration to launch a pilot study testing its implanted wireless sensor in about a dozen people with diabetes. The request came after researchers completed trials of the device on animals.

On Wednesday, University of California San Diego bioengineering professor David Gough and several GlySens researchers published results from the final study on a pair of pigs in the journal Science Translational Medicine.
GlySens-UCSD Collaborative Research Leads to Key Findings Regarding the Viability of Long-Term Implanted Devices

RESEARCH ARTICLE | DA Gough et al. "Function of an Implanted Tissue Glucose Sensor for More than 1 Year in Animals," Science Translational Medicine. July 2010

SAN DIEGO, CA – July 28, 2010 – RESEARCH ARTICLE - https://stm.sciencemag.org/content/2/42/42ra53

An implantable sensor capable of long-term monitoring of tissue glucose concentrations by wireless telemetry has been developed for eventual application in people with diabetes. The sensor telemetry system functioned continuously while implanted in subcutaneous tissues of two pigs for a total of 222 and 520 days, respectively, with each animal in both nondiabetic and diabetic states. The sensor detects glucose via an enzyme electrode that is based on differential electrochemical oxygen detection, which reduces the sensitivity of the sensor to encapsulation by the body, variations in local microvascular perfusion, limited availability of tissue oxygen, and inactivation of the enzymes. After an initial 2-week stabilization period, the implanted sensors maintained stability of calibration for extended periods. The lag between blood and tissue glucose concentrations was 11.8 ± 5.7 and 6.5 ± 13.3 minutes (mean ± standard deviation), respectively, for rising and falling blood glucose challenges. The lag resulted mainly from glucose mass transfer in the tissues, rather than the intrinsic response of the sensor, and showed no systematic change over implant test periods. These results represent a milestone in the translation of the sensor system to human applications.
GlySens Incorporated First-Generation Sensor Progress reported in Popular Science

First Generation Glucose Sensor Development

SAN DIEGO  – July 28, 2010https://www.sandiegouniontribune.com/sdut-sd-company-hopes-monitor-will-revolutionize-2010jul28-htmlstory.html

Results achieved with the GLYSENS INCORPORATED first-generation implantable glucose monitoring system are reported by author Lauren Gravitz in an article entitled “Wireless, Implantable Glucose Sensor Could Revolutionize Diabetes Treatment,” in this week’s online edition of Popular Science.
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GlySens Incorporated is recognized as a New California 100 Business Innovator by Golden Capital Network & Hamilton Lane

Medical Device Innovator

SAN DIEGO, CA  – September 1 , 2009 – GLYSENS INCORPORATED has been recognized as a New California 100 Innovative Business by Golden Capital Network and Hamilton Lane. New California 100 businesses are some of the most innovative companies in the state representing California’s commitment to innovation, entrepreneurship, and workforce competitiveness. Endorsed by the California Business, Transportation and Housing Agency, New California 100 companies are recognized for their important contributions to the state economy.

Approximately 100 companies throughout the State of California received this recognition from over 400 nominations. New California 100 Businesses will be recognized during a luncheon awards ceremony at 11:45am-1:15 pm on September 22, 2009 at the New California 100 Conference in Sacramento’s Sheraton Grand Hotel.

New California 100 Businesses are market leading technology companies who have been selected based on the uniqueness of their innovation, competitive advantages, and job and economic impact on California’s economy now and into the future. “These innovators are powerful job-creating machines,” said Jon Gregory, CEO/President of Golden Capital Network. “We believe innovation and entrepreneurship are the drivers of economic growth in California and these Innovation All-Stars are models for our state.”
GlySens Presentation Voted Best Submission at the Eighth Annual Diabetes Technology Meeting

Innovation Leader

BETHESDA, MD  – November 14 , 2008 – GLYSENS INCORPORATED’S presentation entitled “Long-term Results of a Subcutaneous Glucose Sensor in Animals” was selected as the Best Submission at the eighth annual meeting of the Diabetes Technology Society. The annual meeting, held this year November 13-15 at the Bethesda North Marriott Hotel & Conference Center, is a premier scientific venue for discussion of new technology developments related to the care of diabetes. More than 600 scientists and clinicians from 24 countries are in attendance.

GlySens’s presentation was selected by the Society’s review committee as the best submission from all submitted abstracts and presentations, announced Dr. David Klonoff, the Society’s President and Chair of the meeting’s Planning Committee, at today’s morning session. A total of 182 abstracts are published in this year’s meeting proceedings.
In his presentation today, Dr. Joseph Lucisano, president and CEO of GlySens, reviewed the Company’s progress developing a long term, fully-implanted glucose sensor system intended to function effectively as a subcutaneous implant for one or more years. Discussed were recent long term studies in which devices were implanted subcutaneously in pigs and operated for periods of four to twelve months as determined by experiment protocol. Telemetry signals were broadcast and received every ten seconds to twenty minutes and regular glucose response testing was performed. Devices were explanted at varying time intervals, tested extensively in vitro, and showed insignificant glucose and oxygen sensitivity changes. The tissue-implanted sensors showed response lags to rapid rate blood glucose challenges that averaged nine minutes and “A+B” error-grid performance was maintained at 96% or higher over one year of continuous operation. No systematic changes in response lag or other performance measures were seen over the implant period.

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CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.
GlySens®, Eclipse®, and ICGM® are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
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