Exalenz Bioscience Receives Approval for Commercial Marketing in China for Its BreathID® Hp Lab System
MODI'IN, Israel and MANASQUAN, New Jersey, Feb. 25, 2019 /PRNewswire/ -- Exalenz Bioscience Ltd. (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that the China Food and Drug Administration (CFDA) has given Exalenz authorization to begin marketing and selling its BreathID® Hp Lab System for detection of H. pylori bacteria.
According to the World Health Organization, more than half of the world's population carries H. pylori, a major cause of stomach ulcers and the primary identified cause of gastric cancer, which is the third leading cause of cancer-related deaths globally. The prevalence of this bacteria in China is among the highest in the world, underscoring the need for a highly accurate and easy to administer test. The BreathID® Hp Lab System offers laboratories and hospitals several key benefits compared with other H. pylori tests, including:
- A non-invasive, non-radioactive approach to detecting H. pylori and confirming eradication after treatment.
- Requires only 15 minutes of a patient's time and only one hour fasting.
- Sample processing allows up to 30 tests to be processed each hour.
- Unsurpassed accuracy compared with other breath-based tests, with 100% sensitivity and 98% specificity.
- System is fully automated and integrated into the hospital information management system eliminating the need for manual data entry and potential errors.
"There is a high prevalence of H. pylori infection in China and effective detection and monitoring of this bacteria is essential for enabling early treatment and minimizing the risk of gastric ulcers and stomach cancer," said Prof. Song Hanming, Director of GI Section, Maanshan People's Hospital and Chief Director of Maanshan Municipal GI Association, Anhui Province, China. "Having used the BreathID® Hp point-of-care device, I am aware of the benefits that the BreathID technology provides and I believe that the Lab System is ideally suited to bringing those benefits to the Chinese hospital-based healthcare system."
"In line with Company strategy to focus on our H. pylori business, we are very excited to have the opportunity to broaden our product offering to the world's largest H. pylori testing market. Exalenz BreathID® Hp Lab System will be the first US FDA approved system to be offered in China and will bring China a product with unmatched quality and performance," said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. "The approval of the BreathID® Hp Lab System in China will expand our ability to meet the high volume testing needs within China. The vast majority of medical care in China is provided through hospitals that need a high-throughput option to conduct large numbers of tests in their facilities as rapidly as possible. The BreathID® Hp Lab System requires minimal patient and technician time, is easy to operate and provides unsurpassed accuracy compared with other breath tests for H. pylori. We believe these attributes will facilitate adoption of the BreathID® Hp Lab System at Chinese hospitals."
Exalenz is currently establishing sales channels and distribution infrastructure, and expects to commence sales of the BreathID® Hp Lab System in China in the fourth quarter of 2019.
About Exalenz Bioscience
Exalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company's flagship BreathID® Hp Systems offer the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. Exalenz holds regulatory approvals in the United States, Europe, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform. Additional information is available at www.exalenz.com.
SOURCE Exalenz Biosciences Ltd