LSIC.L Regulatory News (LSIC)

Lifeline Scientific, Inc.

("Lifeline" or the "Company")

Regulatory approval in China

& Trading update

Lifeline Scientific (AIM: LSIC), the transplantation technology company, announces that it has received long awaited regulatory approval for its LifePort Kidney Transporter (LifePort) for commercial sale in China and provides a trading update for the six months ended 30 June 2015.

Regulatory approval in China

The Chinese Food and Drug Administration (CFDA) have formally approved the Company's lead product, LifePort Kidney Transporter, and all related single use consumables for sale to clinical transplant hospitals within the People's Republic of China. The news follows on from the approval of the Company's market leading clinical organ preservation and flush solutions, SPS-1® and KPS-1®, earlier in the year.

While under regulatory review, LifePort has been adopted for limited use in 21 of China's major renal transplant centres under clinical observation research protocols. During these studies a reported 1,340 LifePort preserved kidneys were successfully transplanted with key results reported in Chinese medical journals and transplant symposia.

Lifeline recorded approximately $3.3MM in China product sales during LifePort's 3 year pre-launch phase, while investing significantly in market development as part of the Company's planned geographic expansion. Lifeline will now work closely with its China national distribution partner to help prepare for the commercial introduction of LifePort which is presently expected to launch in the final quarter of the year.

The Chinese health ministry presently reports having 169 hospitals with active renal transplant programmes and is in the process of building a nationwide infrastructure of federally licensed organ procurement organisations patterned after successful national donation and transplant programmes in the West. With China's estimated 1.6 Billion population, present trends in the escalation of end-stage renal disease and the government's commitment to upgrade its national donation and clinical transplant infrastructure, the China market for transplantation could grow to the size of the US and Europe combined within the next 5-7 years. Chinese health authorities have recently reported an official transplant waiting list of 30,000 patients and overall estimates of patients in need at over 300,000.

Trading update

Lifeline provides the following trading update for the six months ended 30 June 2015:

Lifeline continues to see growth in transplantation products and services with revenues up 1.3% to US$15.0m (H1 2014: US$14.8m).1

Total sales of proprietary higher margin consumables remained steady at US$8.5m (H1 2014: US$8.5m). Lifeline's historical pattern of breakeven at the operating level for the half-year reporting period is expected to continue.

The cash position of the Company remains strong, with cash balances as at 30 June 2015 of US$3.1m (31 December 2014: US$3.3m), benefitting from increased net cash generated from operations in the period.

The Company continues to drive its planned new product and territory expansion initiatives and expects to see further growth in 2015, supported by additional revenue contribution from new contract wins announced on 14 July 2015. This progress is anticipated to impact the second half and beyond and provide the Company with confidence of meeting market expectations for the full year.

Lifeline will announce its interim results for the six months ended 30 June 2015 on Monday 21 September 2015.

Commenting David Kravitz, CEO of Lifeline Scientific, said:

"At the half year mark, I'm pleased to report that trading is in line to meet market expectations for the full year, which anticipates further growth in both revenues and profits. Whilst our recently reported key account wins in North America, Europe and the Middle East are encouraging, we continue to see strong potential for progress in South America and Asia, particularly in China following the recent CFDA approvals for LifePort Kidney Transporter and solutions. Growth contribution from our LifePort Liver Transporter is also expected."

1 Revenues from grant funding, consolidated in the past, now flow to a 49% Company owned joint venture spun out of our Cell and Tissue Systems Business Unit as previously announced at year-end 2014.

For further information:

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 200 leading transplant programmes in 29 countries, LifePorts have successfully preserved more than 50,000 kidneys indicated for clinical transplant. For more information please visit www.organ-recovery.com

About LifePort Liver Transporter

LifePort Liver Transporter is modelled upon the clinically proven technology platform of LifePort Kidney Transporter and the Company's early HMP prototype successfully used in clinical transplant studies by surgeons at New York-Presbyterian Hospital/Columbia University Medical Center. LifePort Liver Transporter and the Company's proprietary machine preservation solution, Vasosol®, are in the process of US and international regulatory registrations. The system is designed to help improve outcomes in liver transplantation by enabling the clinical use of hypothermic machine perfusion, and has been developed in consultation with clinical and research teams specialising in liver transplantation at Columbia University Medical Center and the University of Chicago. The system employs a rugged, streamlined ergonomic design for ease of use and transportability from donor bedside to recipient operating room. For more information please visit: http://www.organ-recovery.com/pipeline.php