Healthcare Industry News:  liver failure 

Devices FDA

 News Release - January 4, 2006

Vital Therapies Receives FDA Guidance Allowing for the Shipment of ELAD(R) Liver Assist System Cartridges to China

SAN DIEGO, Jan. 4 (HSMN NewsFeed) -- Vital Therapies, Inc. (VTI) announced today that it has received guidance from the United States Food and Drug Administration (FDA) that will allow the Company to begin shipment of its ELADŽ (Extracorporeal Liver Assist Device) cartridges to China. Allowance to ship the cartridges was the final step required for pivotal clinical trials of the ELAD to begin in China in early 2006. VTI plans to confirm ELAD's safety and efficacy in these trials, which will serve as the basis for China approval and launch.

Liver disease is endemic in China and causes more than 400,000 deaths annually. If approved, the ELAD system will be the first ever human cell-based support therapy for liver failure.

"Liver disease is a major medical problem in China, and there's an overwhelming and unmet need for new therapies," said Duan Zhong-Ping, M.D., professor, Beijing Artificial Liver Treatment & Training Center and vice president, Beijing YouAn Hospital. "I see many patients in our hospital every month whose lives are threatened by liver disease, and a good percentage of these patients die even with the mechanical artificial liver treatment available here today. We desperately need a new option that will provide metabolic function and allow time for patients' livers to recover or regenerate."

The ELAD system provides important metabolic support for patients with severe liver failure, thereby enabling a bridge to recovery or transplant depending on the type and severity of liver failure. The system is made up of four cartridges containing cells that function like a normal human liver by metabolizing toxins and removing waste products while delivering essential proteins back into the plasma. These cartridges are incorporated into a blood-pumping system at the patient's bedside and enable continuous patient treatment for up to 12 days. The key to the performance of ELAD is its utilization of a proprietary human hepatocyte cell line, C3A, an immortalized cell line that can be grown, stored and shipped worldwide.

According to the World Health Organization (WHO), liver failure affects approximately 12 million patients worldwide. In China, hepatitis is the third most prevalent disease and 20 million people have active viral liver disease. Official estimates suggest that China's yearly medical expenses for liver disease total more than $12 billion.

"FDA allowance to export the cartridges made at our San Diego plant was the final regulatory hurdle we needed to overcome in order to start treating patients in our pivotal clinical trial in China," said Terry Winters, Ph.D., chairman and CEO of VTI. "Personnel are now being trained and cartridges manufactured so we can begin patient treatment early in 2006."

The Company also announced the appointment of Kent Lam as CEO of VTI, China, Vital Therapies' China subsidiary in Beijing. "We are delighted to have Kent in place to run VTI's China operation," said Dr. Winters. "He has been associated with the ELAD project for many years and is well known to us as an astute businessman with excellent experience in the medical field. He is well suited to the challenge of building VTI's business in China after we obtain regulatory approval from the SFDA."

VTI recently completed private equity financing in the United States, raising $9 million to fund further clinical studies. The Company has already conducted Phase 1 and 2 clinical trials with ELAD in the United States and the United Kingdom.

About Vital Therapies, Inc.

Vital Therapies, Inc. (VTI) is a San Diego-based liver therapy company. VTI is developing the first human-liver cell-based system, ELADŽ (Extracorporeal Liver Assist Device), which provides important metabolic support for patients with severe liver failure. For more information, please visit: www.vitaltherapies.com.


Source: Vital Therapies

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