LSI Lifeline Sci. S

TIDMLSI

RNS Number : 4502B

Lifeline Scientific, Inc

17 April 2012

17 April 2012

Lifeline Scientific, Inc

("Lifeline" or "the Company")

LifePort(R) Kidney Transporter approved for launch in Brazil

Lifeline Scientific, the medical technology company, announces that it has received regulatory approval from the Brazilian regulatory agency, the Agencia Nacional de Vigilancia Sanitaria (ANVISA), to market its full line of clinical transplantation products, including the LifePort Kidney Transporter, in Brazil.

As previously announced, initial orders of approximately $0.95 million for the Company's LifePort Kidney Transporter and related consumables have already been facilitated by way of government grants within the states of Rio di Janeiro and Ceara and leading transplant programs in Rio and Fortaleza will be the first adopters. These initial orders are currently in process.

In 2011 Lifeline Scientific established a South American regional office in Sao Paolo with an experienced team which has been conducting technical training and market development efforts in key regions in anticipation of full market access.

Organ donation has been increasing in Brazil where the number of donors has been reported to now stand at greater than 10 donors per million population (pmp). In Rio the growth in the number of donors has been particularly dramatic, having increased from 4.4 to 14 pmp. in the last two years alone. Indeed, improved organ preservation and recovery is a key initiative within the health ministries of several Brazilian states and government-sponsored initiatives are under way in the major Brazilian transplant centres to improve the quality and availability of kidneys for transplant. Despite these efforts, Brazil's patient waiting list is still several times the annual supply of donor organs.

David Kravitz, Chief Executive of Lifeline Scientific, said:

"We are delighted to have received approval to launch our LifePort Kidney Transporter and full product line in the Brazilian market. The extensive market development and technical support efforts of our Sao Paulo team have been productive and reinforced our view that Brazil is an important transplant market with a high unmet need."

Eduardo Rocha, M.D., Coordinator General, State Transplant Program - Rio de Janeiro, Brazil, said:

"This may be the start of a new era in organ transplantation in Brazil. We expect that LifePort will enable us to offer our patients waiting for a kidney transplant better quality organs, decreasing the need for dialysis immediately following transplantation and keeping patients alive and well for a longer period of time without the need to return to dialysis. I am quite confident that most transplant centers in Brazil will soon demand this better quality organ preservation technique."

Enquiries:

Lifeline Scientific, Inc.

+1 847-294-0300

David Kravitz, CEO

Seymour Pierce

+44 (0)20 7107 8000

Sarah Jacobs / Mark Percy (Corporate Finance)

David Banks (Corporate Broking)

FTI Consulting

+44 (0)20 7831 3113

Simon Conway / John Dineen

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 provide improved kidney preservation, evaluation and transport prior to transplantation. Today, it is widely recognized as the world's leading machine preservation device for kidneys. Employed by surgeons in over 126 leading transplant programs in 23 countries worldwide, LifePorts have successfully preserved over 38,000 kidneys intended for clinical transplant. The product provides a sealed, sterile, protected environment where a solution is gently pumped through the kidney at cold temperatures to minimise damage while the organ is outside the body. LifePort is lightweight and portable, allowing organs to be perfused from the time of recovery until transplant. It is designed to travel unaccompanied by land or air, safely transporting the kidneys across town or between countries. While the kidney is being perfused, LifePort records data on temperature, flow rate, vascular resistance and pressure every 10 seconds providing surgeons with additional data prior to transplant. LifePort is the only system with clinical outcomes data produced from an independent, prospective, randomised, statistically powered, multi-centre clinical trial. Study results have been widely published in scientific journals, including the New England Journal of Medicine. Data indicates that patients receiving LifePort preserved kidneys experienced significant reduction in the incidence and duration of delayed graft function and increased graft survival at 1-year and 3-years post transplant. LifePort has also been recognized for its design and engineering. It has received prominent awards for design excellence from the medical device industry, has been selected for exhibition at the Smithsonian Cooper-Hewitt, National Design Museum and is part of the permanent Collection of The Museum of Modern Art (MoMA) in New York City.

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 is the FDA cleared, CE marked, and clinically validated, LifePort Kidney Transporter. Devices for preservation of the liver, pancreas, heart, and lung are in late stage pre-clinical development.

This information is provided by RNS

The company news service from the London Stock Exchange

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