Publication of the AVERT System Pilot Clinical Trial in Leading Peer-Reviewed Journal
Minnesota, United States and Melbourne, Australia – January 2, 2014 – Osprey Medical Inc. (ASX: OSP) today
announced publication of results from the pilot clinical trial of the AVERT system (Contrast Conservation
System/CCS). The study which was conducted in late 2012 at the Alfred Hospital in Melbourne Australia by Dr David
Kaye and Dr Stephen Duffy, was titled “Reducing iodinated contrast volume by manipulating injection pressure
during coronary angiography” and was published ahead of press on-line in the December 2013 edition of leading
industry peer-reviewed journal “Catheterization and Cardiovascular Interventions”.
The 21-patient pilot clinical trial, demonstrated that the use of the AVERT System was associated with a highly
significant 40% reduction in dye injection compared with standard imaging techniques, whilst maintaining image
quality. Study investigator, Dr David Kaye Head, Cardiology Division Baker IDI Heart and Diabetes Institute stated:
“We are very encouraged by the effectiveness of the AVERT System in reducing the amount of contrast dye used in
interventional cardiology procedures while maintaining acceptable visualization of the coronary anatomy. The
AVERT System offers physicians the opportunity to lower contrast dye usage which may ultimately protect the
kidneys of the many patients who are at risk for CIN”.
Mike McCormick, President and CEO of Osprey Medical, commented: “Successfully driving physician awareness via
leading industry peer reviewed scientific publications by key opinion leading physicians such as Dr Kaye and Dr Duffy,
is expected to be of great assistance to the commercialisation of AVERT System. We look forward to publication of
additional tier one scientific data of the AVERT System in the future.
We are currently underway with a randomized, multi-center, IDE trial of the AVERT System, with first patient
enrolment imminent. In addition to evaluating the effectiveness of the AVERT System for CIN reduction, the trial will
also measure economics savings with use of the AVERT System.”
Further information:
About the AVERT™ System
The Avert System consists of a re-usable contrast modulator with easy to adjust settings. A disposable modulation reservoir
easily loads into the contrast modulator unit and attaches to commonly used manual injection systems used by interventional
cardiologists during heart procedures.
About the AVERT Trial
The aim of the trial is to support expansion of the AVERT System’s marketing claim to include “reduction of contrast induced
nephropathy (CIN)”. Patients who are at-risk for CIN with pre-existing stage 3-4 chronic kidney disease undergoing a heart
procedure such as angioplasty and stenting may be eligible to participate in the trial. The trial will enroll approximately 700
patients at up to 45 sites in the U.S., Europe, Canada, Australia, and New Zealand. The Company is aiming to complete
enrollment, submit for and obtain FDA clearance for the expanded claim in the first half of 2015. Further information is
available at www.ospreymed.com on the “Clinical” page.
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 mergers-acquisitions. Osprey Medical’s
advisory board comprises world-recognised experts in heart and kidney diseases