HEADWAY #6 Ee 30 4k Corporate Culture uth Corporate Spirit HAIR. aOR M Planting hopes and harvesting health EMBS Corporate Philosophy RAK, WHET. WEBER. HORS Technology Innovation, Lean Production Credibility-Cored Management, Knight Service tek BR Enterprise Target ‘ROE iS OB Me 9 EB A, A aM Me A, AB A A A ORE A Leading the breath testing industry Industrializing more valuable breath test projects Making the pursuit of health easierCompany Profile Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd. is the founder of breath testing industry in China and will continue to play a leading role in this field. We have always been committed to innovative research on the development of non-invasive diagnostic breath test products since our establishment. Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd. was founded in 1996. We are the only High-Tech enterprise in China that owns the intellectual property rights to engage exclusively in the development and production of breath test kit and analysis ‘equipment. Our headquarter is located in National High-Tech Industrial Park in Shenzhen with a GMP certified workshop covering an area of over 2000m’, With a number of branches spreading over 33 provinces and municipalities in China, we have built up a comprehensive and efficient service network serving over 8000 hospitals across China. Our ability to rapidly develop in our own large domestic market enables us to introduce the safe and effective breath test products to a world-wide market. Our ultimate goal is to promote the clinical efficiency and value for thousands of hospital clients and patients all over the world with a wide range of patient-friendly non- intrusive breath test products.HEADWAY #+6 Headway Milestones yy In August 1996, Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd. was established. ve In March 1997, Headway successfully developed the first Helicobacter pylori cost-effective and reliable testing method/for the diagnosis of Helicobacter pylori detector, thereby realizing the clinical rot of “C-Urea Breath Test, a simple, infection, vy In 1997, Headway adopted a niga of 0.75Ci “C-Urea which is shown to be the minimum dose applied in rea Br Test industry. vy In May 2002, the ie Environmental Protection of P. R. China capsule passed the survey by Ministry of 1d was granted the exemption from regulation for the usage of radioactive material. A re In December 2003, Headway Management Systems" standar certified to the "ISO9001:2000 Quality | sy In January 2004, Headway was authorized the GMP certificate by State Food and Drug Administration of P. R. China. > © 1b a00m Ye InJune 2005, "C-Urea Breath Test Kit was jointly identified as a National Key and New Product by Ministry of Seience and Technology of P. R. China, Ministry of Commerce of f R. China, GesiralldrsiiWfiN@OnToP Quality Supervision, Inspection and Quarantine of P. R. China and Ministry of Environmental Protection of P. R. China. etme vy In December 2008, Headway was entitled as a National High-Tech Enterprise. sy Headway is a firm with a history of intellectual innovation in the breath testing field and our excellence is recognized by the granting of two invention patents, nine utility model patents and two design patents in this field.Helicobacter Pylori The Nobel Prize in Physiology or Medicine for 2005 was awarded jointly'to Barry J. Marshall and J. Robin Warren for their discovery of "the bacterium Helicobacter pylori and its role in gastritis and peptic ulcer disease”. Helicobacter pylori (H. pylori) is the primary cause of gastritis and peptic ulcer disease and has been linked to the onset of gastric cancer in some individuals. This bacterium has been shown to infect more than 50% of the world's population with an incidence up to 80% in developing countries. cians Gastric fundus Lower esophageal sphincter Pylorus Helicobacter pylori Pyloric antrum Helicobacter pylori is a causative factor in: vy Chronic active gastritis vy Peptic ulcer diseases xy Gastric MALT lymphoma vy Gastric carcinomaHEADWAY #) “C-Urea Breath Test Helicobacter pylori has been identified by invasive methods such as culture, histological examination or rapid urease test on biopsy specimens as well as non- invasive methods like serological test, stool antigen test and urea breath test, Common Testing Methods for Helicobacter Pylori Infection yes No. Tests the entire easric mucosa for ee ‘Tests for. pylori | Tests small areas of active 1. pylori = antigens in stool the stomach infection — ves No ves ves The need for a simple, non-invasive and accurate diagnostic technology for the detection of H. pylori infection was met by the development of urea breath test, which allows infection status to be evaluated without the need for costly and invasive endoscopies. It is a method of choice for diagnosing active H. pylori infection and for monitoring the therapeutic effect of H. Pylori eradication.“C-Urea Breath Test The principle of “C-Urea Breath Test ‘The “C-Urea Breath Test is based on the detection of the enzyme urease, produced by H. pylori. Since urease is not present in normal human tissues, and since other urease-producing bacteria do not colonize the stomach, the presence of urease in the stomach can be equated with H. pylori infection. “CO,in breath, In the presence of urease, orally administered “C-Urea will be hydrolyzed into ammonia and “CO,. “CO, is absorbed into the blood circulation and exhaled by the lung. The presence of a significant amount of “CO, in the exhaled breath indicates active H. pylori infection. The “C-Urea Breath Test offers a range of ad © Accurate Sensitivity 95%, specificity 95%-100 © Comfortable ie Non-invasive, no endoscopic tube i rated by patients. © Convenient ; ‘Near-patient testing, analysis made on si onvenience for patients. © Safe Negligible radiation exposure, exempted from regulation of radioactive materials in USA and China. 7 © Simple 3 ¥ Easy operation, no special handling requit © Swift The entire test is finished within 30 minutes.HEADWAY eo Products ® Helicobacter Pylori Detector HUBT-20 Helicobacter Pylori Detector HUBT-20 is designed for a:simple and accurate “C-Urea Breath Test for the in vitro diagnosis of Helicobacter pylori infection. HUBT-20 uses an ionization counter to measure “Cin exhaled breath and requires no scintillation solution or special darkroom. Its compactness maximizes convenience both in operation and maintenance. Product Highlights: © Lightweight and compact for easy portability and hiandling; © Simple one-touch operation, user-friendly; © Well-designed on-screen menu, clear and sin © Analysis available on site © Automatic printing of results; © Real-time trouble shooting guide; Specifications: 1, Background Count Rate 2. "C Detection Efficiency. 150-1000 seconds <20w 275mm*210mm* 195mm OKg 3. Measuring Time: .® Helicobacter Pylori Detector HUBT-20A1 ‘The Helicobacter Pylori Detector HUBT-20AI developed from the culmination of a long and extensive development process on HUBT-20, is designed to provide the user with a reliable and advanced intelligent device that is easy to use and meets the strict clinical demands for Helicobacter pylori diagnosis. Product Highlights: © Dual channel, simultaneous measurements, high patient throughput; © High accuracy with DPM results: © Streamlined design, elegant appearance; © PC connection, professional software; © Automatic measurement and patient data storage; y Specifications: 1, Background Count Rate <0 CPM 2. “C Detection Efficiency... 215% 3. Measuring Time. ....... -- canes yenesonatenes ...250 seconds 4. Power. S20W --400mm%260mm*200mm 10Kg 5, Dimension... 6, Weight..HEADWAY ### Products e"C-Urea Breath Test Kit Undications) For use in the detection of gastric urease as an aid in the diagnosis of Helicobacter pylori (H. pylori) infection in the stomach. [Specification] 1. "C-Urea capsule: 27.8kBq(0.754Ci)/grain * 40 grains / package 2. Collection card: 40 pes/package 3. Package insert © The procedure of “C-Urea Breath Test 2. e& ‘Take a"C-Uren capsule 4 swith water. e Blow into a collection card for 3-5 minutes, ‘Test the collection card with a Helicobacter Pylori Detector and get the result.©"C Breath Test Analyzer Product Highlights: © High efficiency Fast operation, 2-3 minutes for one set of samples 12 channels, automatic batch testing © Simple One-touch operation, automatic control system © Accurate Good repeatability, standatd error<0,3%e Specifications: 1. Power Supply 2. Power. 3. Range of CO, Concentri 4, Sample Volumn... 5. Dimension... 6. Weight.. $40mm*404mm*345mm 18KgHEADWAY #++ Products e’C-Urea Breath Test Kit Applicable for all ages and types of subjects, including pregnant women and young children. -Urea Breath Test Kit ees 1.Blow up the first collection bag 2.Take one "C-Urea capsule 3.Wait for 30 minutes 4.Blow up the second collection bag 5.Test two bags of breath samples with an analyzerQualification woken ‘Shenzhen Headquarters Front Desk Workshop.Seca ae eee eee) Pe ULC er Mend Tee eer) reer rete) Broa export@headwaychina.com Cet eed Tsuna