IONIQ Sciences announces its ProLung Test has been formally accepted for submission to China’s National Medical Products Administration
Salt Lake City, UT, September 17, 2020 – IONIQ Sciences, Inc. (“IONIQ” or the “Company”), is developing an advanced multi-cancer screen for early detection that has the potential to expand the therapeutic window, dramatically improve survivability and reduce the cost of healthcare. Today IONIQ announced that its IONIQ ProLung Test™ for lung cancer has been formally accepted for submission to China’s National Medical Products Administration (NMPA), which was formerly known as the Chinese Food and Drug Administration (CFDA). The regulatory submission package presented to the NMPA by IONIQ’s Chinese partner, ProLung Biotech Wuxi Co, is based on the exceptional PLW-216 clinical trial results of 84% sensitivity and 73% specificity that are superior to the clinical status quo of low-dose computed tomography (LDCT). The regulatory process to market the IONIQ ProLung Test is now underway in both China and the USA. In the USA, the FDA designated the ProLung Test a “Breakthrough Device.”
Mr. Jared Bauer, IONIQ Sciences CEO, stated, “We are excited about the continued progress with our long-time partner in China. It is a tremendous accomplishment for us to be in the regulatory process to market the IONIQ ProLung Test in both China and the USA.”
Mr. Jared Bauer, IONIQ Sciences CEO, further stated, “Utilizing our Electrical Impedance Analytics (EIA) technology that detects cancer in the earliest and most-treatable stage, we continue marching towards commercialization of the IONIQ ProLung Test. We are on-track to follow it with our IONIQ Breast Test, which has already entered an IRB-approved clinical feasibility trial, and ultimately a multi-cancer screen.”
Mr. Ning Zhou, ProLung Wuxi CEO, stated, “Lung cancer is a scourge around the globe. In China, lung cancer accounts for 24% of all cancers. Lung cancer kills almost as many people as the next two cancers combined in large part because it is most often diagnosed in the latest stages of the disease. However, the clinical evidence shows the five-year survival rate can be dramatically improved 5x to nearly 80% by shifting the diagnosis to the earliest, most treatable stages. The clinical trial results from PLW-216 clearly demonstrate the IONIQ ProLung Test can help accelerate a physician’s diagnosis of lung cancer and we stand ready to make a positive difference for those suffering from lung cancer.”
About IONIQ Sciences, Inc.
IONIQ Sciences, Inc. is developing an advanced multi-cancer screening technology for early detection that has the potential to expand the therapeutic window, dramatically improve survivability and reduce the cost of healthcare. IONIQ Sciences operates at the confluence of its Electrical Impedance Analytics (EIA) technology and Artificial Intelligence (AI). IONIQ Science’s first product utilizing its proprietary analytic platform, the IONIQ ProLung Test™ for lung cancer, has been designated a Breakthrough Device by the U.S. FDA. ProLung rebranded to IONIQ Sciences in May 2020.
Statements contained in this release that are not purely historical, including, without limitation statements regarding IONIQ Sciences’ future performance and goals, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in the IONIQ Sciences’ Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties include inherent risks and uncertainties relating to IONIQ Sciences’ ability to meet its funding requirements for its operations and other commitments and to obtain successful test results and regulatory approvals for its products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections.
For further information about IONIQ Sciences, Inc., please contact:
Andy Robertson | 1-801-503-9231| acr@IONIQsciences.com
IONIQ Sciences, Inc., Vice President of Business Development
IONIQ Sciences, Inc.
350 W. 800 N., Suite 214
Salt Lake City, Utah 84103