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Strong Scientific Foundations Combined with Rigorous Engineering

Designed for a long life with reduced burden
The GlySens continuous glucose sensor has been uniquely designed to function reliably as a long term implant in subcutaneous tissues. The implant contains two independent detectors: the first measures glucose through a specific chemical reaction involving glucose and oxygen, which is monitored by an electrochemical “main” detector; the second is a “reference” detector that monitors background tissue oxygen levels. The system’s electronic circuitry automatically determines glucose levels by computing the difference between the signals from these two detectors. This approach is employed to reduce effects of secondary factors such as temperature and blood flow in the surrounding tissues and effects due to the body’s normal mild encapsulation response to the implant. Utilization of this “differential” approach played a key role in designing the glucose measurement to be robust and remarkably free from many common artifacts.
The implant’s differential measurement technology is designed to help ensure accurate sensor operation at all times including periods following meals and during activity and sleep. By monitoring the difference between the signals from a main detector and reference detector, the Eclipse ICGM system is designed to enhance fidelity and reliability of continuous glucose monitoring under a wide range of conditions.

GlySens has engineered novel methods for extending the lifetime of the implantable sensor. For example, GlySens’s unique sensor design allows a dramatic increase in the sensor’s usable life expectancy through “co-immobilization” of the primary enzyme used to catalyze the chemical reaction with a secondary enzyme. This combination enhances enzymatic stability and reduces tissue response to the implant.

“The GlySens device represents a potentially major technological leap…(SD Union Tribune, 7/28/10)”

Eric Topol, MD. Professor of Translational Genomics, The Scripps Research Institute; Director, Scripps Translational Science Institute; Founding Dean, Scripps School of Medicine; Chief Academic Officer, Scripps Health; Co-founder, West Health Institute

Five Key Scientific advantages

1
Sophisticated Measurement Engine

Designed to directly overcome key disadvantages in other sensor types by employing two enzymes; glucose oxidase and catalase. A unique differential oxygen detector arrangement.

Minimize Interference

The “potentiostatic” oxygen detectors are designed to resist interference by endogenous species present in the body as well as exogenous substances (like acetaminophen). The inherent detector lifetime can be exceedingly long, unlike hydrogen peroxide detectors and optical detectors used in other glucose sensor approaches.

Long Term Stability

Engineered to continue to be used long after the wound healing response subsides and the tissue stabilizes, which is expected to enhance stablility and long-term performance, unlike other hydrogen peroxide-based sensors which must be used immediately after implantation and need daily calibration.

Fully Implantable

The sensor is designed to be fully implanted, eliminating many of the issues associated with maintaining through-the-skin and skin-adhered components, which present significant burden and requirements for ongoing maintenance.

Intended for Minimal Interaction

The sensor is designed to allow automated measurements without user interaction and without the inherent variability associated with changing sensor sites every few days.

Key Publications and Presentations 

GlySens was founded on a rigorous experimental research approach and believes in maintaining a solid scientific basis for research and development. The following brief selections of publications and presentations by the company founders are illustrative of the scientific underpinnings of the company’s approach.

Select Publications

Lucisano, JY, TL Routh, JT Lin, and DA Gough.
“Glucose Monitoring in Individuals with Diabetes using a Long-Term Implanted Sensor/Telemetry System and Model.” IEEE Transactions on Biomedical Engineering, 10.1109/TBME.2016.2619333 (2016).
Kumosa, LS, TL Routh, JT Lin, JY Lucisano, and DA Gough.
“Permeability of subcutaneous tissues surrounding long-term implants to oxygen.” Biomaterials 35 (2014) 8287-8296. 
Rahaghi, FN and DA Gough.
“Blood Glucose Dynamics.” Diabetes Technology and Therapeutics 10, (2008) 81-94.
Rahaghi, FN and DA Gough.
“Prediction of Blood Glucose from Previous Values: An Update.” Commentaries on Perspectives in Diabetes, vol. 3, R. Paul Robertson, ed., (2007), 128-135.
Gough, DA.
“Development of the Implantable Glucose Sensor: An Update.” (Invited). Commentaries on Perspectives in Diabetes, vol. 2, R. Paul Robertson, ed., (2006), 195-202.
Rahaghi, FN and DA Gough.
“Glucose Sensors.” Encyclopedia of Medical Devices and Instrumentation. Ed. John G. Webster. 2nd ed. 6 vols. New York: Wiley, 2006.
Makale, MT, PC Chen, and DA Gough.
“Variants of the Tissue-sensor Array Window Chamber.” American Journal of Physiology – Heart and Circulatory Physiology 289 (2005): H57-65.
Makale, MT, MC Jablecki, and DA Gough.
“Mass Transfer and Gas-Phase Calibration of Implanted Oxygen Sensors.” Analytical Chemistry 76 (2004): 1773-77.
Gough, DA, K Kreutz-Delgado, and TM Bremer.
“Frequency Characterization of Blood Glucose Dynamics.” Annals of Biomedical Engineering 31 (2003): 91-97.
Makale, MT, JT Lin, RE Calou, AG Tsai, PC Chen, and DA Gough.
“Tissue Window Chamber System for Validation of Implanted Oxygen Sensors.” American Journal of Physiology – Heart and Circulatory Physiology 284 (2003): H2288-94.
Gough, DA and TM Bremer.
“Immobilized Glucose Oxidase in Implantable Glucose Sensor Technology.” Diabetes Technology and Therapeutics 2.3 (2000): 377-80
Jablecki, M and DA Gough.
“Simulations of the Frequency Response of Implantable Glucose Sensors.” Analytical Chemistry 72 (2000): 1853-59.

Select Presentations

 Lucisano, J, L Kurbanyan, S Martha, and T Routh.
“Clinical Update with a Long Term, Unobtrusive, Fully-Implanted Continuous Glucose Monitoring System,” 10th International Conference on Advanced Technologies & Treatments for Diabetes, Paris France, 2017.
Lucisano, JY and DA Gough.
“Continuous, Long-term, Fully Implanted Glucose Sensor.” NIH Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies, Bethesda, MD, 2016. 
Lucisano, JY               
“Update of Clinical Experience with a Long Term Fully-Implanted Continuous Glucose Monitoring System.” Sixteenth Annual Diabetes Technology Meeting, Milan, Italy, 2016.
Lucisano, JY, TL Routh, JE Lucisano, and E Watkins. 
“Late-Breaking Human Clinical Results from a Second-Generation Long Term Fully-Implanted Continuous Glucose Monitoring System.” Fifteenth Annual Diabetes Technology Meeting, Bethesda, MD, 2015.
Gough, David A., Lucas S. Kumosa, Melinda M. Tong, Timothy L. Routh, Joe T. Lin, and Joseph Y. Lucisano. 
“Fully Implanted Sensors: Demise of the ‘Impermeable Tissue’ Hypothesis.”  The Tissue Response to Implanted Active Medical Devices Meeting, Herndon, Virginia, May 9-10, 2014.
 Lucsiano, JY, TL Routh, and RL Engler
“Patient Preference Assessment of a Long Term Fully-Implantable Continuous Glucose Monitoring System,” Fourteenth Annual Diabetes Technology Meeting, Bethesda, MD, 2014, (A69).
Lucisano, Joseph Y., David A. Gough, Timothy L. Routh, Jennifer E. Lucisano, and Joe T. Lin.
“Long Term, Fully-Implanted, Self-Contained Subcutaneous Glucose Sensor: Results from Clinical Evaluation and Applicability for Closed Loop Systems.” NIH Workshop on Innovation towards an Artificial Pancreas, 2013.
Lucisano, Joseph Y., Timothy L. Routh, Marcus Hompesch, and Jennifer E. Lucisano
“Application of the Long Term Implantable Continuous Glucose Monitoring System in a Human Subject.” Twelfth Annual Diabetes Technology Meeting, Bethesda, MD, 2012, (S37).
Gough, David A., Joe T. Lin, Timothy L. Routh, and Joseph Y. Lucisano.
“Time Lag Stability of Long Term Subcutaneous Glucose Sensors in Animals.” American Diabetes Association 69th Scientific Sessions, New Orleans, LA, June 6-8, 2009.
Lucisano, Joseph Y., Joe T. Lin, Timothy L. Routh, and David A. Gough.
“Long Term Results of a Subcutaneous Glucose Sensor in Animals.” Eighth Annual Diabetes Technology Meeting, Bethesda, MD, November 13-15, 2008.
Lucisano, Joseph Y., Joe T. Lin, Timothy L. Routh, Thomas G. Wallner, and David A. Gough.
“Glucose Permeability in Tissues for Long Term Glucose Sensor.” Sixth Annual Diabetes Technology Meeting, Atlanta, GA, November 2-4, 2006.
Rahaghi, Farbod N., and David A. Gough.
“Defining Normal Blood Glucose Dynamics. “Fifth Annual Diabetes Technology Meeting, San Francisco, CA, November 10-12, 2005.
Gough, David A., Peter C. Chen, Milan T. Makale, Jared B. Goor, Farbod N. Rahaghi, Joe T. Lin, and Joseph Y. Lucisano.
“Detailed Validation of a Glucose Sensor Implanted in Tissue.” Fourth Annual Diabetes Technology Meeting, Philadelphia, PA, October 28-30, 2004.
Gough, David A.
“Validation of Implantable Glucose Sensors.” Third La Jolla Conference on Glucose Monitoring and Control, La Jolla, CA, February 12-14, 2004.
Gough, David A.
“Tissue Metabolite Sensors: Factors that Determine Their Signals.” Third Annual Diabetes Technology Meeting, San Francisco, CA, November 6-8, 2003.
Gough, David A.
“Long Term Implanted Sensors for Glucose, Oxygen, and Lactate.” The Future of Metabolic Monitoring of Glucose (sponsored by NIH, NASA, DoD, JDRF), Alexandria, VA, May 21-22, 2002.
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