GlySens Incorporated Secures FDA Approval to Extend Second Generation Fully-Implanted CGM Sensor Evaluation from 6 to 12 Months
SAN DIEGO, November 21, 2014 /PRNewswire/GlySens Incorporated announced today that it has secured FDA approval for extending the current human clinical evaluation of its fully implantable continuous glucose monitoring system (the ICGM® System) from the originally approved six-month duration to the system’s commercially-intended operational duration of twelve months. “We very much appreciate the timely review and approval by FDA of our request to extend the duration of this clinical evaluation, and are...
GlySens Incorporated Names William Markle Chief Executive Officer
SAN DIEGO, 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...
GlySens Incorporated Secures $12M Series C Investment Proceeds dedicated to advanced product commercialization steps
SAN DIEGO, January 5, 2015 /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...
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
SAN DIEGO, November 21, 2014 /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...
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, Vol. 35, Issue 29, DOI: 10.1016/j.biomaterials.2014.05.012
SAN DIEGO, CA – July 4, 2014 – 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.
SAN DIEGO, CA – April 2, 2014 – 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.”
GlySens Incorporated’s recent developments are discussed in a feature story in today’s San Diego Union-Tribune
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.