Korean FDA Approves the Ambulo 2400 ABPM System

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July 30, 2009 – Portland, Oregon, USA & Seoul, Korea Tiba Medical announced today that it has received regulatory approvals from the Korean Food and Drug Administration (KFDA) for its Ambulo 2400 ambulatory blood pressure monitoring system. Tiba Medical also announced that it has signed an exclusive partnership agreement with Uthis International Co. for distribution and marketing of the Ambulo 2400 to customers in South Korea.

 

“We are thrilled that the Ambulo 2400 has been cleared by the KFDA. This is an important milestone in our entry to the Asian marketplace” said Merat Bagha, President and Chief Executive Officer of Tiba Medical. "Korea is one of the most innovative and medically advanced countries in Asia. We are confident that the Ambulo 2400 will improve the standard of care for patients. Our distribution partner, Uthis International, has an excellent reputation at the best medical institutions in South Korea and already distributes antihypertensive treatments from a number of major global pharmaceutical companies. We are pleased that they will be representing the Ambulo 2400."

 

“The Ambulo 2400 is an excellent addition to our product portfolio” said Mr. Cheol Wook Yoo, President of Uthis International. “With the innovation and flexibility of the Ambulo 2400, Korean cardiologists, nephrologists, and other hypertension specialists can now benefit by obtaining a true picture of their patient’s blood pressure in an efficient manner. It will also help us in improving the marketing efforts of our pharmaceutical offerings by proving to physicians that our antihypertensive treatments provide superior 24-hour control. For these reasons, the Ambulo 2400 will be a success in Korea." said Mr. Yoo.

 

Korea is an important Asian destination for foreign medical devices. Its total medical device market is about $3 billion with imported products accounting for more than 60% of the market. According to the World Health Organization, Korean’s health expenditure per capita in 2006 was $705 compared to China’s $61. This means a greater proportion of the population can afford high-end medical treatment.

 

The Ambulo 2400 allows physicians to obtain the blood pressure measurements over the 24-hour circadian pattern of patients. The device is configured using its Hypertension Diagnostics Suite Windows®-based software to take measurements on specific intervals during the procedure and automatically saves these as well as activity data which will help determine activity/rest cycles of the patient. Upon the completion of a 24-hour study, the software is used to download measurements and assist the physician in determining the nature and extent of hypertension for each patient. The ABPM procedure is an invaluable tool in diagnosing such conditions as white coat hypertension, nocturnal hypertension including non-dipping, resistant hypertension, postural hypotension, etc.

 

The Ambulo 2400 is available directly from Uthis International effective immediately to physicians, hospitals and other healthcare professionals throughout Korea.

 

 

About Tiba Medical

 

Based in Portland, Oregon, Tiba Medical offers innovative and affordable hypertension diagnostics solutions. Tiba Medical is a FDA-registered establishment and certified to be compliant with the ISO 13485:2003, acknowledging that Tiba Medical meets quality system requirements that are recognized across the world. For more information about Tiba Medical and its products please visit our web site at www.tibamedical.com.

 

About Uthis International

 

Based in Seoul, Korea, Uthis International (www.uthis.com) and its wholly owned subsidiary Juthis International provide contract sales and marketing services in the pharmaceutical, biotech and medical device industries. The company has offices in Seoul, Daejeon, Daeku, Busan, Kwangju and Wonju. Uthis’ portfolio includes products from Sanofi Aventis, Boehringer Ingelheim, and Dongsung Pharmaceutical.

 


 

 

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