16th Feb 2015 08:14
LONDON (Alliance News) - Lifeline Scientific Inc Monday said that the Chinese Food and Drug Administration has formally approved its clinical organ preservation and flush products, SPS-1 and KPS-1, for commercial sale to hospitals within the People's Republic of China.
KPS-1 is a specialty hypothermic machine perfusion solution that is used with the company's proprietary LifePort kidney transporter for machine preservation of donor kidneys indicated for transplantation. SPS-1 is a specialty hypothermic static preservation and flush "solution" indicated for pre-transplant flushing and static cold storage of abdominal donor organs, including kidneys, liver, pancreas, and small bowel.
"China is undergoing transformational changes in its national transplant system and has the potential to be among the three largest national market opportunities in the world for LifePort and our family of transplantation products," David Kravitz, Chief Executive, said in a statement.
"We believe these recent CFDA product approvals are a pre-cursor to the final regulatory clearance of our LifePort Kidney Transporter and related products. Upon these approvals our Chinese distributors have plans in place for a full commercial launch of our complete suite of CFDA approved products," the transplantation technology company's chief executive added.
Shares in Lifeline were untraded at the open on Monday, having last traded at 112.5 pence.
By Samuel Agini; [email protected]; @samuelagini
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