News & Events

Home/ News Room

2020

GlySens Incorporated Announces Close of Series F Financing

Incremental Financing Supports On-Going Clinical Evaluations and First-in-Man Study of the Third Generation System

SAN DIEGO, CA – June 12, 2020 – GlySens Incorporated Closes Incremental $15 Million Financing Supporting On-Going Clinical Evaluations and First-in-Man Study of the Third Generation Eclipse® 3 ICGM® System. The round was led by previous lead investors, McNair Interests and The Sarofim Group.

Proceeds from the financing will support ongoing clinical trials and development programs supporting the Company’s fully implanted, long-term CGM systems and additionally, enable first-in-man studies of the third-generation system. The Eclipse 3 ICGM System is designed to provide long-term glucose monitoring with a targeted 2-year implant lifetime, a sensor that is 40% smaller than the previous sensor generation with no additional electronics or need for “on-body” adhesive components. The system communicates via Bluetooth® Low Energy (BLE5) directly with an iPhone®, thus eliminating any dedicated receiver and supporting an interoperable diabetes device ecosystem. First implants with the Eclipse 3 system are targeted for Q1 2021 with expanded trials to follow.
“We are most impressed and encouraged with the fundamental bio-engineering prowess and creative problem-solving displayed by the technical team at GlySens” commented Dr. Jake Kushner, Medical Director of McNair Interests. “Fully implanted, long-term sensors have long been plagued by a confounding foreign body response essentially limiting in-vivo sensor viability to weeks or, best case, months but certainly not years. The GlySens measurement engine brings real promise to the prospect of a multi-year, fully implanted CGM system. We believe the GlySens’ team is well positioned to deliver on this next-generation CGM solution” added Dr. Kushner.

“We are tremendously appreciative of this vote of confidence and continuing support from McNair Interests and The Sarofim Group” commented William Markle, President and CEO of GlySens Incorporated. “We have, by sheer necessity, evolved into a highly focused, biotechnology-driven company poised to deliver the first viable, long-term, fully implantable CGM solution which eliminates any body-worn components while delivering CGM performance in-line with today’s commercial standards” added Mr. Markle.

About GlySens Incorporated
GlySens Incorporated is a biotechnology based medical device company located in San Diego, California with a mission to dramatically simplify and improve the CGM user experience and ultimately the lives of insulin-dependent diabetic patients. Our mission is best summarized in our commitment to our customers and patients with diabetes to “Live more and worry less.” Additional information is available at www.glysens.com.
About McNair Interests
McNair Interests is a private investment and management company headquartered in Houston, Texas. We focus on transformative real estate projects, breakthrough medical discoveries and disciplined investments, considering every opportunity for its ability to drive innovation while generating value and creating a lasting, positive impact on the community. To learn more visit www.mcnair.com.
ICGM is a trademark of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
iPhone is a registered trademark of Apple.
Bluetooth is a registered trademark of the Bluetooth Special Interest Group (Bluetooth SIG).
Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
Media contact: William Markle at 858-638-7708
SOURCE GlySens Incorporated

2019

GlySens Furthers Partnership with University of Melbourne to Initiate the FIGS-HD Clinical Trial

Feasibility Trial of Advanced Implantable Glucose Sensor

SAN DIEGO, CA – April 10, 2019 – GlySens® Incorporated today announced that the first three participants have received an implantable glucose sensor as part of a long-term feasibility study at the University of Melbourne. This clinical trial investigates the safety and efficacy of the ICGM System, in Adult participants with Type 1 diabetes, for up to eight (8) months of home use. The FIGS-HD trial is scheduled to verify advancements of the ICGM System and demonstrate iterative enhancements.  It is a collaboration between leading researchers at the University of Melbourne to develop new technologies that advance patient care and enable the broad adoption of continuous glucose monitoring.

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 wirelessly communicates to an external receiver, designed to provide continuous, at-a-glance glucose reporting and alerts regarding hypo- and hyperglycemic glucose excursions. While other CGM approaches may require calibration multiple-times-per-day and demand continuous wearing of through-the-skin or skin-attached components, the calibration checks of the 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—“Live more, worry less.”
Eclipse, ICGM and GlySens are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

2018

GlySens Incorporated Announce Close of Series E Financing

Funds Will Fuel Next Generation Technology Development and Clinical Trials of Long-Term, Implantable Glucose Sensor for People with Diabetes.

SAN DIEGO, CA – November 13, 2018 – GlySens® Incorporated today announced that the company has completed a Series E equity financing led by existing investors, bringing the total amount of equity raised by the company to over $50 million. The series E round gives GlySens the financial assets to execute multiple human clinical trials with its Eclipse® ICGM® System and complete development of its Gen 3 next-generation system, intended to extend the in-vivo sensor lifetime to 2-years.
“With this round and existing investments, we have the capital and resources to execute our strategic roadmap and deploy multiple iterations of the technology, demonstrating continuous improvements in performance while simultaneously advancing the next generation Gen 3 platform” said Bill Markle, President & CEO.
Earlier in 2018, GlySens closed out clinical trials at two different sites, with US and OUS partners. These trials added to a robust device safety profile and confirmed feasibility of the long-term implantable glucose sensor for extended human use. On the near-term horizon is the next generation Eclipse 3 ICGM System, which is 40% smaller, designed for a 2-year life and communicates with Bluetooth Low Energy, direct to a smart phone (iOS) or compatible diabetes device(s). This system has the potential to significantly reduce the burden of glucose management and enable an interoperable future of diabetes care; providing high quality and long-term glucose data for integration with multiple devices that improve an individual’s health.

Eclipse, ICGM and GlySens are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
GlySens Incorporated President and CEO William H. Markle to Speak at Upcoming Healthcare Technology Conferences

A Long-Term Vision for Diabetes Technology 

SAN DIEGO, CA – November 5, 2018 – GlySens® Incorporated today announces it will participate in the 18th Annual Diabetes Technology Meeting as well as the 12th Annual Canaccord Genuity Medical Technologies & Diagnostics Forum. These speaking events will take place November 8th, in Bethesda, MD and November 15th, in New York, NY, respectively. The aim is to bring together esteemed healthcare faculty, regulatory officials along with capital investors and update GlySens’ latest innovations and growth opportunities. During these presentations William H. Markle, President & CEO of GlySens Incorporated, will explore how a novel Long-Term (1-year and next gen 2-year), Implantable Continuous Glucose Sensor can help individuals with diabetes and their care givers sustain the benefits of continuous glucose monitoring systems. The presentations will review current CGM system challenges and outline a long-term, unobtrusive, patient centric solution with benefits to all healthcare stakeholders (Patient, Clinician, Payor). The GlySens future of CGM is one that enables an ecosystem of interoperable diabetes devices that reduce burden and allow individuals to live more and worry less.

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 wirelessly communicates to an external display, designed to provide continuous, at-a-glance glucose reporting and alerts regarding hypo- and hyperglycemic glucose excursions. While other CGM approaches may require calibration multiple-times-per-day and demand continuous wearing of through-the-skin or skin-attached components, the calibration checks of the 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 Eclipse® 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. “Live more, worry less.”

Eclipse, ICGM and GlySens are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
GlySens Incorporated Granted New Patent, Expanding Portfolio for Glucose Sensor Technology

IP Expansion for Novel Diabetes technology

SAN DIEGO, CA – September 8, 2018 – GlySens® Incorporated today announced the United States Patent and Trademark Office has issued the company another new patent. GlySens has exclusive rights to the patented technology and adds it to its existing portfolio, bringing the company’s total to nine glucose sensor patents.

U.S. Patent 10,041,897 covers a foundational element of the sensor technology incorporated in the Long-Term, implantable, Eclipse® ICGM® System, which is intended to deliver the next generation of continuous glucose monitoring. The implantable sensor is designed to reside in the subcutaneous tissue, in a lower abdominal quadrant, for up to 1-year with no through the skin or on body components. This design will reduce the burden of diabetes devices by eliminating the stigma of externally worn components. “We know many people start CGM and want to use CGM but ultimately stop and don’t continue. We believe one reason for discontinuing is the need for adhesive patches and plastic components on your body, 24/7. We simply do not wish to compromise and believe CGM should be unobtrusive and easy to use and the ICGM System takes steps in that direction” said William H. Markle, President and CEO of GlySens Incorporated. The investigational device has been previously evaluated in multiple human trials and continues development with additional performance and feasibility studies forthcoming.

In the United States, more than 30 million adults and children have diabetes. The total economic cost of diabetes in 2017 was $327 billion. Diabetes devices are rapidly expanding the reach of technology to empower those individuals managing their disease. A fully implanted CGM sensor with minimal maintenance, could offer an unobtrusive tool for glucose management and integrate with additional technologies for improved health outcomes. The long-term, Eclipse® ICGM® System is designed to empower individuals by providing the information they need, while freeing them to live life on their own terms.

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 wirelessly communicates to an external receiver, designed to provide continuous, at-a-glance glucose reporting and alerts regarding hypo- and hyperglycemic glucose excursions. While other CGM approaches may require calibration multiple-times-per-day and demand continuous wearing of through-the-skin or skin-attached components, the calibration checks of the 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. “Live more, worry less.”

Eclipse, ICGM and GlySens are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.

Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
GlySens Incorporated to Discuss Latest Algorithm Advancements at the 11th International Conference on Advanced Technologies & Treatments for Diabetes

Continuous Algorithm Development for Improved CGM Accuracy 

SAN DIEGO, CA – February 6, 2018 – GlySens executives will share the latest signal processing advancements on Friday, February 16th, 2018 at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) meeting. These data will be presented in the exhibition hall, during an oral E-poster session at 10:15 am (CET) and likewise the data will be displayed in the viewing area throughout the scientific event. These data demonstrate significant advancements in the Eclipse® ICGM® System capabilities and further validate the scientific foundation of a long-term, implanted continuous glucose sensor.

Eclipse, ICGM and GlySens are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

2017

New Data Suggests Potential Reductions to Current Barriers in Continuous Glucose Monitoring Adoption

RESEARCH ARTICLE | RE Engler et al. “Adoption Barriers for Continuous Glucose Monitoring and Their Potential Reduction with a Fully Implanted System: Results from Patient Preference Surveys,” Clinical Diabetes 2017

SAN DIEGO, CA – December 12, 2017 – RESEARCH ARTICLE - https://doi.org/10.2337/cd17-0053
GlySens® Incorporated today announced the publication of new data in Clinical Diabetes from two recent patient preference studies, providing further support for a proposed 1-year, fully implanted CGM device, with no skin-attached components, currently in development.

According to the data, adult participants and parents of children with diabetes, most frequently sited four factors when deciding to employ CGM: 1) to improve glycemic control (83%), 2) lower A1C (54%), 3) to avoid hypoglycemia (53%) and 4) physician recommendation (42%). Among participants who had never used CGM, key impediments for not trying were 1) cost, 2) having a device attached to the body, and 3) expectations of discomfort when wearing. Interestingly, current and past Adult CGM users confirmed many of these expectations, reporting having problems sometimes or often with the appearance of CGM on the body, discomfort while wearing, insertion pain and skin irritation. Parents of children reported these same issues with greater frequency than adults. “These data suggest that certain people with diabetes are willing (at least initially) to tolerate obtrusive features because of their tremendous motivation to improve their health” said Robert Engler, MD. “It is clear, with our survey of over 1,000 individuals, that a CGM system which eliminates the obtrusiveness of on-body components would enjoy significant up-take among the general patient population.”

Glucose control is key to preventing both short-term and long-term complications of diabetes. A 1% reduction in A1C results in a reduction in the risk of long-term complications like stroke, heart disease, eye damage and kidney disease reduces by 40%.1 A fully implanted CGM sensor with minimal maintenance paired with an external display device, could offer an unobtrusive tool for uncompromised glucose management. The long-term, Eclipse® ICGM® is designed to empower individuals with diabetes by providing the information they need, while freeing them to live life on their own terms.

Eclipse, ICGM and GlySens are trademarks of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.

1 The post-trial monitoring results: 10 years follow up: Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW. 10-year follow-up of intensive glucose control in type 2 diabetes.   N Engl J Med. 2008; 359:1577-1589.
Clinical Trial to Evaluate GlySens Eclipse ICGM System

Successful Commencement of Feasibility Trial in Melbourne Australia

SAN DIEGO, CA – August 7, 2017 – GlySens® Incorporated today announced another series of successful insertions of the ICGM® sensor in the FAST Trial. This trial is a feasibility study designed to evaluate advanced sensor algorithms in a limited number of clinical participants. Individuals are enrolling at St. Vincent’s Hospital, in Melbourne Australia, with David O’Neal, MD.

According to the World Health Organization (WHO), an estimated 422M adults worldwide are living with diabetes, accounting for 8.5% of the global population.1 The staggering prevalence marks a significant public health problem with substantial economic burden as well as assorted health complications. The 2016 American Association of Clinical Endocrinologists (AACE) Consensus statement and the 2016 Endocrine Society Clinical Practice Guidelines both recommend CGM as a tool to benefit the health outcome of individuals whose A1C is ≥7%, for those with history of severe hypoglycemia, hypoglycemia unawareness and those willing and able to use the device. “CGM is a tremendous tool to reveal glycemic variability and aid in the daily management of diabetes” said Bill Markle, President and CEO of GlySens Incorporated. “However, it continues to be poorly adopted by clinicians and patients primarily due to modifiable device barriers, namely the discomfort, daily and weekly maintenance and burden of through the skin, adhesively applied, needle sensors. A broadly acceptable solution is greatly needed to enable all individuals to use the powerful tool and live their healthiest life.”

The GlySens Eclipse® ICGM system is a long-term, fully implantable Continuous Glucose Monitoring device that enables uncompromised and unobtrusive glucose management. This is intended to empower individuals with diabetes by providing the information they need, while freeing them to live life on their own terms.

The FAST trial is scheduled to capture data through early 2018. It is a collaboration between leading clinicians and researchers to develop and employ new technologies that advance patient care while enabling the broad adoption of continuous glucose monitoring amongst all individuals living with and managing diabetes.

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 wirelessly communicates to an external receiver, designed to provide continuous, at-a-glance glucose reporting and alerts regarding hypo- and hyperglycemic glucose excursions. While other CGM approaches may require calibration multiple-times-per-day and demand continuous wearing of through-the-skin or skin-attached components, the calibration checks of the 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—“Live more, worry less.”
GlySens to Present at the American Diabetes Association 77th Scientific Sessions

Interim Clinical Results

SAN DIEGO, CA – June 10, 2017 – GlySens® Incorporated, an early stage medical device company focused on the development and commercialization of the Eclipse® ICGM® System, a fully-implantable and long term, continuous glucose monitoring system, today announced that the company will share interim clinical results at the American Diabetes Association, 77th Scientific Sessions in San Diego, CA.
Joseph Lucisano, PhD., Founder and CTO of GlySens Incorporated, is scheduled to share interim clinical data on Saturday, June 10, 2017 at 11:30am (p.s.t.). Interested parties may also view the poster on Saturday, Sunday, and Monday of the meeting in the poster hall, during viewing hours.
NEW Published Data Shows Feasibility of GlySens ICGM System

RESEARCH ARTICLE | JY Lucisano et al. "Glucose Monitoring in Individuals With Diabetes Using a Long-Term Implanted Sensor/Telemetry System and Model", Transactions on Biomedical Engineering, September 2017

SAN DIEGO, CA – June 10, 2017 – RESEARCH ARTICLE - https://doi: 10.1109/TBME.2016. 2619333

GlySens® Incorporated today announced the publication of new data in Transactions on Biomedical Engineering, from the development of the ICGM® System; intended for long-term monitoring of subcutaneous tissue glucose in people with diabetes. The ICGM System data closely matched reference blood glucose and finger stick values from all participants. Statistical correlation indicated strong association between the sensor signals and reference glucose values. Therefore long-term glucose monitoring in individuals with diabetes is shown to be feasible with this system and further development continues.

2016

GlySens Incorporated Shares Recent Data and Market Insights of the Long Term, Fully Implantable Glucose Monitoring System

Executives to Share Recent Clinical Data and Market Validation

BETHESDA, MD  – November 10, 2016 – GlySens Incorporated executives, Bill Markle and Joseph Lucisano, PhD presented separate findings at the 16th annual Diabetes Technology Society meeting. This conference brings together leading scientific researchers and health care professionals from around the world to focus on applying science and new technologies to the fight against diabetes. The presentation entitled “Market Opportunities and Customer Preference Data for a Fully Implanted Long-Term CGM Solution” was given by Mr. Markle, the Company’s President and CEO, while an “Update of Clinical Experience with a Long-Term Fully Implanted CGM System” was presented by Dr. Lucisano, the Founder and CTO. The clinical update was accompanied with a scientific poster presentation.

From the GlySens Presentation Abstract:
Joseph Y. Lucisano, PhD
GlySens Incorporated

Objective:
Recent human experience with a second generation long term fully-implanted (no skin-attached elements) continuous glucose monitoring system (the GlySens Eclipse ICGM® System) includes the launch of same-pocket reimplantations of new sensors in six adult human subjects, following completion of a 12-month initial sensor implant period.

Method:
At the end of an initial 12-month subcutaneous implant period, the GlySens Model 100 ICGM Sensor in each of six human subjects was exchanged for a new replacement sensor in a minor outpatient surgical procedure utilizing local anesthesia. Following sensor replacement, subjects are to self-monitor blood glucose four times per day and meter-stored fingerstick values are to be downloaded during monthly clinic visits that also include meal-based glucose excursions with YSI plasma glucose measurements and, in some cases, Dexcom G4 CGM recordings. Monthly subject interviews including a standardized survey questionnaire are conducted to assess tolerance of the device.
Result:

There were no significant adverse events associated with the sensor replacements. All sensors were easily extracted, with no significant adherent capsular tissue. Early performance measurements of the replacement sensors suggest feasibility of the approach for sensor replacement/renewal as part of an extended long term monitoring regimen.

Conclusion:
Use of the fully implanted ICGM Sensor requires an annual user decision (whether to implant/reimplant or not) and an occasional decision to recalibrate; no maintenance of body-worn components or other regular user intervention is required to receive glucose readings. This combination of features offers minimal barriers for adherence to treatment modalities requiring continuous glucose monitoring.
Patient Enrollment and Implantation Procedures Complete for FIGS-2 Trial

FIGS-2, Multi-site Clinical Trial Completes Enrollment

SAN DIEGO, CA  – October 4, 2016 – GlySens Incorporated today announced the successful implantation of the twentieth human subject participating in the Function of Implanted Glucose Sensor 2 (FIGS-2) trial [Clinicaltrials.gov NCT02345967] for people with diabetes in the United States. The FIGS-2 study is a multi-center, long-term assessment of the Eclipse ICGM® Sensor. The twentieth participant is an important milestone for the company. “We believe the clinical data will further support our growing confidence in our positive safety profile while enabling our technical team to qualify the system software and complete product development” said Bill Markle, President and CEO of GlySens. The primary objective of the FIGS-2 trial is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.
GlySens Discusses its Long Term Fully Implantable Glucose Monitoring System at 4th Annual NIH Artificial Pancreas Workshop Patient Enrollment and Implantation Procedures Complete for FIGS-2 Trial

Thought Leadership Among Diabetes Industry Peers 

BETHESDA, MD  – July 6, 2016 –  GlySens Incorporated’s presentation entitled “Continuous, Long-term, Fully Implanted Glucose Sensor” was discussed today by Dr. Joseph Lucisano, the Company’s founder and CTO, at the “Fourth Artificial Pancreas Workshop.” This event, held at the National Institutes of Health (NIH) campus, is organized in coordination with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Diabetes Mellitus Interagency Coordinating Committee (DIMCC). The aim is to bring together a multi-disciplinary forum to discuss current and potential future challenges of bringing new artificial pancreas (AP) technologies to individuals with diabetes. Dr. Lucisano discussed the GlySens Eclipse ICGM® System and its potential for eventual application in an artificial pancreas.

From the GlySens Presentation Abstract:

Joseph Y. Lucisano, PhD1; David A. Gough, PhD2
1GlySens Incorporated; 2University of California, San Diego

A stable, user-acceptable glucose sensor is an essential component of any AP system. A long-term (>1 year), second generation, fully implanted sensor/telemeter device (Eclipse ICGM® Sensor), developed by GlySens in conjunction with an NIH-funded collaboration between GlySens and UCSD, is currently in clinical trials (ClinicalTrials.gov Identifier NCT02345967). The sensor is based on a reaction catalyzed by glucose oxidase and catalase coupled with electrochemical oxygen detection, which helps ensure immunity to interferents and stability of calibration. The device’s detectors are located on the face of a hermetically-sealed titanium housing containing a battery, potentiostats, logic circuitry, and a telemetry transmitter. The transmitter has a typical minimum range of 12 feet, sending glucose-dependent signals every 3 minutes to an external receiver/display, which handles calculations, alerts, calibration, information relay, etc. The sensor is implanted subcutaneously or exchanged yearly by a simple outpatient procedure using local anesthesia, requires no skin-attached elements, and may require recalibration by finger-stick at most only every few weeks to months.

The fully implanted sensor requires an annual user decision (whether to implant or not) and an occasional decision to recalibrate; no regular user intervention is required to receive glucose readings. This combination of features presents minimal barriers for adherence to continuous glucose monitoring as may be required for various treatment modalities, including AP systems. In contrast, the present percutaneous sensors require multiple daily decisions (to finger-stick or not) and weekly decisions (to insert and replace or not), as well as disadvantages related to percutaneous device management and skin irritation.
Successful Re-implantation of the Eclipse® ICGM® Sensor in Sixth Clinical Trial Participant

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

SAN DIEGO, CA  – March 14, 2016 –  GlySens Incorporated today completed the successful re-implantation of the Eclipse ICGM® Sensor in a sixth human subject participating in the Function of Implanted Glucose Sensor 2 (FIGS-2) trial [Clinicaltrials.gov NCT02345967] for people with diabetes in the United States. The FIGS-2 study is a multi-center, long- term assessment of the Eclipse ICGM Sensor. Re-implantation of the sixth participant is a crucial step in the sensor development as participants enroll in a second 12-month, in-vivo trial period. “These new data will support our ongoing signal processing assessments as well as an overall assessment of the long term use-case of our implantable technology,” said Joseph Lucisano, PhD, the Company’s founder and CTO. The primary objective of the FIGS-2 trial is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration. The Figs 2 trial is no longer enrolling participants but remains ongoing for data collection.
GlySens Incorporated Secures $20M Series D Investment to Advance its Fully Implanted, Long-Term Continuous Glucose Monitoring System

New Funding to Fuel Technology Development

SAN DIEGO, CA  – January 5, 2016 –  PRNewswire/ – GlySens Incorporated announced today that it has closed a $20M Series D financing led by prior investors from its Series C round, in addition to significant participation from new investors.

“The clinical performance of our fully implanted ICGM® system, now with multiple patients approaching 12 months of in-vivo use, was instrumental in our ability to secure incremental funding on terms highly supportive of the Company’s long term vision and viability,” commented William Markle, President and CEO of GlySens. “Our current clinical trial being conducted in San Diego, under an FDA-approved IDE, is continuing to emphatically demonstrate the viability of the GlySens Eclipse ICGM® system to continuously monitor interstitial glucose in subjects with diabetes for a minimum of 12 months, with essentially zero impact to body image, and with the intended requirement of finger stick calibration only once or twice per month. We are so fortunate to have such sophisticated and passionate investors who share our vision of an uncompromised, unobtrusive CGM solution; we take their endorsement and vote of confidence very seriously,” continued Mr. Markle.

“The proceeds from this Series D investment, in combination with the significant remaining balance from our prior Series C round, places us in an enviable position to further expand our clinical trials to support a CE-Marking application, hire additional staff, and complete the build-out of a new modern facility and optimized manufacturing plant,” commented Joseph Lucisano, PhD, the Company’s co-founder and Chief Technology Officer. “We are making rapid progress on both the optimization of the sensor itself and on its attendant signal processing algorithms, and are pleased also to be nearing completion of our first commercial-version receiver. Plans are additionally in process for pushing our sensor data directly to a smart phone,” continued Dr. Lucisano.

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—having demonstrated up to an 18-month lifetime in preclinical testing—wirelessly links to a convenient external receiver, designed to provide continuous, at-a-glance glucose reporting and alerts regarding hypo- and hyperglycemic glucose excursions. While other CGM approaches may require calibration multiple-times-per-day and demand continuous wearing of through-the-skin or skin-attached components, the 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—“Live more, worry less.” Additional information is available at www.glysens.com.

ICGM is a trademark of GlySens Incorporated registered in the U.S. Patent and Trademark Office.
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
Media contact: William Markle at 858-638-7708
SOURCE GlySens Incorporated
Archive

3931 Sorrento Valley Blvd
Suite 110
San Diego, CA 92121

Ph:  +1 (858) 638-7708
Fax: +1 (858) 638-7727

© 2020 GlySens Incorporated. All Rights Reserved.
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.
Terms of UsePrivacy Policy
map-markerphonenewspaper-o linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram