16th Feb 2015 07:00
Lifeline Scientific, Inc.
("Lifeline" or the "Company")
Regulatory approval in China
Lifeline Scientific (AIM: LSIC), the transplantation technology company, announces that the Chinese Food and Drug Administration (CFDA) have formally approved the Company's market leading clinical organ preservation and flush solutions, SPS-1® and KPS-1®, for commercial sale to hospitals within the People's Republic of China.
KPS-1 is a leading 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 leading 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.
LifePort Kidney Transporter is currently used in many of China's largest transplant hospitals under clinical observation research protocols funded by China Health Ministry grants. It is reported that more than an estimated 1,000 LifePort preserved kidneys have been successfully transplanted in China during these studies. The LifePort Kidney Transporter and a suite of complementary single-use consumable products are in the final phase of regulatory review with the CFDA. The Company is encouraged that the recent CFDA approvals of its preservation solutions bodes well for these additional product approvals coming soon.
China market development, including clinical training and technical support has been among Lifeline's key strategic initiatives in recent years. The Company's products are offered nationwide through LifePort certified distributors who are China market leading specialists in transplantation products and services.
Commenting David Kravitz, CEO of Lifeline Scientific, said: "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. The Chinese Health Ministry believe that based upon actual and anticipated demand, the number of renal transplant centres in China could grow from the 165 certified programmes today, to over 250 centres in the next five years. 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."
For further information:
Lifeline Scientific, Inc. | www.lifeline-scientific.com |
David Kravitz, CEO | Tel: +1 847 294 0300 |
Lisa Kieres, CFO | Tel: +1 847 294 0300 |
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Panmure Gordon (UK) Limited | Tel: +44 (0)20 7886 2500 |
Freddy Crossley (Corporate Finance) |
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Maisie Atkinson (Corporate Broking) |
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Walbrook | Tel: +44 (0)20 7933 8780 or [email protected] |
Paul McManus | Mob: +44 (0)7980 541 893 |
Mike Wort | Mob: +44 (0)7900 608 002 |
About Lifeline Scientific Inc.
Lifeline Scientific, Inc. is a Chicago-based global medical technology company with regional offices in Brussels and Sao Paulo. The Company's focus is the development of innovative products that improve transplant outcomes and lower the overall costs of transplantation. Its lead product, LifePort Kidney Transporter, is the global market-leading medical device for hypothermic machine preservation of donor kidneys. LifePorts and novel solutions designed for preservation of other organs are in development, with LifePort Liver Transporter next in line for commercial launch. For more information please visit www.lifeline-scientific.com
About LifePort Kidney Transporter
Created with the challenges of organ recovery and transport in mind, LifePort Kidney Transporter is a proprietary medical device designed to help improve kidney preservation, evaluation and transport prior to transplantation. It has been widely studied in clinical trials throughout the world and is the standard of care for machine preservation of kidneys. Employed by surgeons in over 165 leading transplant programmes in 27 countries, LifePorts have successfully preserved over 47,000 kidneys indicated for clinical transplant. For more information please visit www.organ-recovery.com
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