At TysonBio, we are taking a different approach to the diagnostic of diseases—one focused on developing, acquiring, and commercializing devices to detect and monitor the disease without compromising patient quality of life.

We target development and registration strategies in the United States, Europe, and the rest of the world to facilitate and to obtain regulatory approval in order to assist our partners on accelerating and meeting their health and medical device registration requirements in their perspective countries.

We plan to devote a substantial portion of our efforts to develop glucose monitoring system, and to advance its functions and features to make it more user friendly and meeting the exact needs of diabetics.

We have development capabilities to expand our portfolio of improved versions of currently marketed glucose monitoring system and immunodiagnostic test. In addition, we are actively researching novel medical monitoring devices to compliment our current portfolio within the domain of diabetes management.

History
Founded in 1999, Tyson Bioresearch Inc. is an innovative medical diagnostic manufacturing company dedicated to providing products and services to accelerate the development and commercialization of diagnostics. The Company supplies its products and services worldwide to research organizations, biomedical and medical device distribution companies.

Milestone

Year	Events
01/2009	‧ ‧ EZ Take Lancing Device receives Class I Ministry of Health issued Medical Device Certificate 　(No.000620) ß this second line should be after the bullet point “Ÿ”, perpendicular to the first letter “E” Received Taiwan Patent announcement on Integrated Blood Medical Diagnostic Device
08/2008	‧ TysonBio Link Health Management System (EZ Smart, Diachex, and Diachex+ model series) receive FDA approval (510K# K081726)
07/2008	‧ Perfect Mini Blood Glucose Monitoring System receives FDA approval (510K# K052818A006)
06/2008	‧ ‧ ‧ Receive approval of initial public offering form Securities and Futures Bureau EZ Plus Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002586) Diachex Basic, Diachex Superb, and Diachex Vigor Glucose Monitoring System receive FDA approval (510K# K072854)
04/2008	‧ ‧ ‧ ‧ Received Taiwan Patent (M334703) on " Integrated Blood Medical Diagnostic Device " T514, T513, T512 Glucose Monitoring System receives People's Republic of China SDA approval (No.2008_2400022) Smartchex Control Glucose Monitoring System receives People's Republic of China SDA approval (No.2008_2400026) Diachex+ Determine and Diachex+ Infinity Blood Glucose Monitoring System receives FDA approval (510K# K073492)
03/2008	‧ ‧ Clarity Blood Glucose Monitoring System receives FDA approval (510K# K062829/A003) EZ Scan Plus Blood Glucose Monitoring System receives FDA approval (510K# K072441)
02/2008	‧ ‧ Obtained People's Republic of China patent on "Multi-functions Portable Diagnostic Device & Display Method" (No.381064) T502 Glucose Monitoring System receives People's Republic of China SDA approval (No.2008_2400010)
11/2007	‧ Merge and acquire Mihorng Technology Ltd
10/2007	‧ Ultimate EZ Smart Plus Blood Glucose Monitoring System receives FDA approval (510K# K052818/A005)
08/2007	‧ ‧ Diachex Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002460) Smartchex Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002461)
06/2007	‧ ‧ EZtake Lancing Device receives Ministry of Health issued Medical Device Certificate (No.001901) EZ Smart 608 Blood Glucose Monitoring System receives FDA approval (510K# K062829A002)
04/2007	‧ Received Taiwan Patent (I 279222) on "Multi-functions Portable Diagnostic Device & Display Method"
03/2007	‧ Smartchex Blood Glucose Monitoring System receives FDA approval (510K# K052818A004)
01/2007	‧ EZ Scan Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002309)
12/2006	‧ ‧ HIV One Step Rapid Test & Glucose Monitoring System received Quality Product Silver Medal from Taiwan Biotechnology & Medical Committee. Taiwan National Health Research Institute & regional Health Department receives a donation of 10,000 HIV One Step Rapid Tests for nation-wide HIV screening campaign
11/2006	‧ Received Taiwan Patent (I 274876) on "Multi-detection Biosensor Strip"
10/2006	‧ Diachex Blood Glucose Monitoring System receives FDA approval (510K# K062829)
09/2006	‧ EZ Smart 608 Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002178)
08/2006	‧ ‧ HIV One Step Rapid Test & Glucose Monitoring System received Quality Product SNQ Certification from Taiwan Biotechnology & Medical Committee. EZ Smart 606 Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002170)
06/2006	‧ ‧ EZ Smart 168 Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002161) EZ Smart 168 Blood Glucose Monitoring System receives FDA approval (510K# K052818)
04/2006	‧ Joint research and development with National Taiwan University on novel diagnostic method for Tuberculosis.
03/2006	‧ ‧ ‧ Disposal lancet receives Ministry of Health issued Medical Device Certificate (No.000144) In compliance to new medical guidance, Hepatitis C (HCV) receives Ministry of Health newly issued Medical Device Certificate (No.002003); old Certificate (No.000118 void) In compliance to new medical guidance, HIV receives Ministry of Health newly issued Medical Device Certificate (No.002013); old Certificate (No.000119 void)
01/2006	‧ Sponsor and support Taiwan AIDS Foundation and Taiwan Homesexual Foundation on HIV screening event
12/2005	‧ ‧ ‧ EZ Smart Glucometer receives Ministry of Health issued Medical Device Certificate (No.001954) Obtained People's Republic of China patent on "Revisable Biosensor" (No.239238) Obtained People's Republic of China patent on "Biosensor Test Strip Structure" (No.ZL200420116622.2)
11/2005	‧ ‧ EZ Smart control solution receives Ministry of Health issued Medical Device Certificate (No.000771) EZ Smart test strip receives Ministry of Health issued Medical Device Certificate (No.001929)
06/2005	‧ ‧ ‧ GMP auditing approval on EZ Smart lactometer HIV One Step Rapid Test requested by Kaohsiung City Government Tender Received Taiwan Patent (M268579) on "Biosensor Test Strip"
03/2005	‧ ‧ GMP auditing approval on HIV, HCV One Step Rapid Test, EZ Smart Test Strip and control solution EZ Smart Glucose product winning Turkey tender
01/2005	‧ Tyson Bioresearch, Inc. USA office incorporated
10/2004	‧ ‧ Received Innovative Product Recommendation Certificate from Ministry of Economics HIV One Step Rapid Test receives People's Republic of China SDA approval (No.CS20040001)
09/2003	‧ ‧ Awarded (1) Outstanding Company, (2) Outstanding Leadership, and (3) Outstanding Product award by Taiwan Management Association. Selected by Ministry of Health in supporting Iraq Medical Initiative Program
07/2003	‧ ‧ Received grant from Ministry of Economics on development of SARS One Step Rapid Test in amount of $300,000 Received validation approval by WHO appointed laboratory on HIV One Step Rapid Test
05/2003	‧ Relocated Headquarters and manufacturing facility to HsinChu Science Based Industrial Park, ChuNan, Taiwan
04/2003	‧ Obtained Certificate of Free Sales (domestic & international) from Ministry of Health on EZ Smart Glucose product
10/2002	‧ Obtained CE Certification (TU01073-161)
09/2002	‧ Obtained Manufacturing License from Ministry of Health on HIV One Step Rapid Test (No.000119)
08/2002	‧ Obtained Manufacturing License from Ministry of Health on HIV One Step Rapid Test (No.000118)
01/2002	‧ Received grant on development of Tuberculosis One Step Rapid Test in amount of $300,000
12/2001	‧ ‧ Received Ministry of Health issued HIV One Step Rapid Test Exportation License (No.000112) Received Ministry of Health issued HIV One Step Rapid Test Exportation License (No.000114)
08/2001	‧ Obtained Company and Product trademark and Copyright
05/2001	‧ Receive cGMP approval
02/2001	‧ HIV One Step Rapid Test receives Brazil independent laboratory validation
12/2000	‧ ‧ Received ISO 9001, EN 46001, and ISO 13485 certification and approval Raised capital to $ 9.0 millions
10/2000	‧ ‧ Completes HIV One Step Rapid Test technology transfer Received validation approval by WHO appointed laboratory on HIV One Step Rapid Test
05/2000	‧ ‧ Initiate pre-clinical study on glucose test strip Raised capital to $ 6.5 millions
03/2000	‧ ‧ Headquarters relocated to HsinChu Science Based Industrial Park, HsinChu, Taiwan Raised capital to $ 4.5 millions
11/1999	‧ ‧ Tyson Bioresearch, Inc. incorporated in Taipei, Taiwan with capital of $ 2.5 millions

Using a multidisciplinary approach to product development, TysonBio facilitates new product introduction through cross-enterprise collaboration and concurrent efforts. Within this process, guidelines can be tailored to specific program requirements.

With many years of engineering and biochemical research experience & process development, more than 40 engineers and researchers working concurrently on development and commercialization of electromedical and biochemical diagnostic devices, TysonBio provides the extensive capabilities to further improve the performance, throughput, yield, and drive to the most competitive manufacturing solutions:

Internal Vertical Supply Chain Enabling Competitive Cost
TysonBio manufactures and supplies the comprehensive BOM materials from the internal and local supply chains, and share with customers the significant advantages of material cost down.
Scalable and High Volume Capability & Capacity
With abundant skillful labor force and strong engineering and research team, TysonBio has proven the production scalability and established reputation for fast and smooth production ramp-up.
Successful Tracking Records on Biosensor Manufacturing
TysonBio has been serving electromedical and biosensor product contract manufacturing for leading industrial companies for years, which are great success for our customers and TysonBio.
Flexible Cooperation Model
Joint Production Line
Co-Invested by Customer and TysonBio
Exclusive Manufacturing Projects and Dedicated Production Lines

From the conception of a product idea to the regulatory approved product delivery, TysonBio’s vertically and horizontal integrated electro and biomedical manufacturing facility fulfills both the development and manufacturing needs of our partner.