Osprey Medical Inc. Commences Diabetic Limb Efficacy Study
Minnesota, United States and Melbourne, Australia – October 22, 2013 – Osprey Medical Inc. (ASX:
OSP) today announced the first patient enrolment in its Limb Recovery™ System efficacy study. This
technology allows clinicians to use existing antibiotic therapy in a more targeted and aggressive way in
patients with diabetes who present with life or limb threatening foot infections. The patient was
enroled at the Royal Melbourne Hospital in Melbourne, Australia.
Osprey’s efficacy study will involve a 20 patient randomized clinical trial comparing the effectiveness of
Osprey’s percutaneous perfusion Limb Recovery System with standard intravenous delivery of antibiotic
therapy for treatment of severe limb infections. The system enables the circulation of the limb to be
isolated and separated from the general circulatory system, permitting the delivery of antibiotic drugs at
higher and sustained doses that are otherwise unachievable with standard intravenous care. This is
achieved by creating an “artificial” circuit by inserting catheters into the major artery and vein of the
lower limb.
In July 2013, the Company announced completion of a five patient pilot safety study for the technology.
The primary investigator, Associate Professor Paul Wraight, said: “After successfully completing the pilot
safety study, we are excited to begin the efficacy study which will help us to determine how effective
this technology is at managing high risk foot infections in patients with diabetes. The potential to offer a
treatment option for patients who are at significant risk of requiring major limb amputation may benefit
people that have no alternatives.”
It is estimated that more than 360 million people worldwide have diabetes, a number expected to
increase by more than 50% by 2030.i People with diabetes are particularly prone to diabetic limb and
foot infections due to insufficient blood flow and impaired wound healing. Standard oral or intravenous
delivery of antibiotics is often ineffective in these patients because dosage levels cannot be achieved at
a sufficient level at the site of the limb infection. Infections of the lower limb are the leading cause of
amputations globally, leading to increased rates of hospitalisation and higher healthcare costs
throughout the developed world.
About Diabetic Limb Infections
Diabetes is a growing national epidemic in many developed countries. Research shows that approximately 8% of
the US and Australian populations have diabetes.ii,iii Diabetes related foot pathology is the most frequent cause of
hospitalisations, with at least 15% of all hospital admissions iv and includes conditions such as foot ulcers, infections,
and gangrene. The combination of difficult to treat infection with poor wound healing and poor blood supply can
lead to significant patient complications including lower limb amputations. It is estimated that there are more
than 100,000 lower limb amputations annually in the US and Australia.v,vi
About the Victorian Government’s Market Validation Program (Australia)
Osprey Medical’s clinical study for its Limb Recovery System, conducted at the Royal Melbourne Hospital, has
received funding through the Victorian Government’s Market Validation Program, which seeks to engage with
both government and business to promote innovation.
About the Royal Melbourne Hospital
The Royal Melbourne Hospital is one of Australia’s pre-eminent hospitals. It provides world-leading clinical care,
extensive surgical and medical expertise and outstanding research, built on its foundation as a university teaching
hospital. The Royal Melbourne Hospital provides the full range of tertiary/quaternary level medical and surgical
services including cardiac, neuroscience, oncology and trauma services as well as sub-acute care, aged care,
rehabilitation, ambulatory care, and residential and community services. The Royal Melbourne Hospital is a
privileged member of Melbourne’s world-leading Parkville Precinct, and enjoys strong relationships with many of
the city’s major universities and research institutes. Through these partnerships, The Royal Melbourne Hospital is
committed to improving patient care through translating research outcomes into clinical practice.
About Osprey Medical
Osprey Medical’s core technologies originated from research conducted by Dr David Kaye at Melbourne’s Baker IDI
Heart and Diabetes Institute. Osprey is focused on improving patients’ quality of life by protecting those with
chronic kidney disease from contrast induced nephropathy (CIN) and preventing limb amputation in diabetic
patients with advanced foot infections. The Company’s primary product, the AVERT™ System, is designed to
reduce the amount of dye (contrast) injected during commonly performed heart procedures, thus protecting
kidneys from damaged known as contrast induced nephropathy (CIN). Osprey Medical’s Limb Recovery™ System is
a percutaneous technology that allows physicians to deliver targeted doses of antibiotics to the lower limb in
patients with diabetes suffering from advanced foot infections.
Osprey Medical’s Board and Management are comprised of experienced and successful personnel with established
track records covering medical device development, regulatory approvals, sales and marketing, and mergersacquisitions.
Osprey Medical’s advisory board comprises world-recognised experts in heart and kidney diseases.
For further information, please contact:
Haley Price
Buchan Consulting
T: (613) 9866 4722
M: (613) 423 139 163
Doug Schoenberg
VP of Marketing, Education & Reimbursement
T: (952) 955 8234
M: (763) 258 7537
iInternational Working Group on the Diabetic Foot. (www.iwgdf.org)
iiCenters for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United
States, 2011. Centers for Disease Control and Prevention.
iiiDunstan DW, et al. The rising prevalence of diabetes and impaired glucose tolerance: The Australian Diabetes, Obesity and Lifestyle Study. Diabetes Care. 2002
May;25(5):829-34.
ivHill SL, et al. The effects of peripheral vascular disease with osteomyelitis in diabetic foot. American Journal of Surgery. 1999. 177:282-6.
vMichael J McCarthy, Lower-Leg Amputations are Increasing. Wall Street Journal