GBS Inc. Announces Application for FDA Breakthrough Device Designation to Fast Track Rapid Saliva Glucose Test
The purpose of the application for the FDA Devices Breakthrough Program is to provide LSBD with an expedited path toward regulatory approval for its non-invasive, real-time Saliva Glucose test.
GBS is the licensee from LSBD for the Biosensor Platform for the
“We believe that this technology will fill an important and urgent gap in improving the outcomes of the millions of people living with diabetes around the world. This gap is more evident in the midst of the COVID-19 pandemic as poor diabetes control increases morbidity and mortality from the infection,” Interim GBS CEO and Chairman of the Board, Dr. Steven Boyages said.
The FDA’s Breakthrough Devices Program allows expedited approval for medical devices and products that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, like diabetes. The Purpose of the Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review.
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, GBS Inc.’s ability to develop and commercialize its diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although
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Spiro Sakiris – Chief Financial Officer
Source: GBS, Inc.