Osprey Medical Names AVERT Trial Medical Leadership
November 18 2013 - 12:45PM
Business Wire
Osprey Medical Inc. (ASX: OSP) today announced that Dr. Roxana
Mehran will be the Principal Investigator (PI) of the AVERT Trial.
This trial will evaluate the Company’s AVERT™ System for a
marketing claim expansion to include “reduction of Contrast Induced
Nephropathy (CIN)” for patients undergoing angiogram or stenting
procedures.
The randomized, multi-center, IDE trial will be enrolling
approximately 700 patients at up to 45 sites in the U.S., Canada,
Europe, Australia, and New Zealand. Dr Mehran is a U.S.
interventional cardiologist with world-recognized expertise in the
area of CIN. She is Professor of Medicine and Director of
Interventional Cardiovascular Research at Mount Sinai Hospital in
New York. Dr. Mehran is internationally renowned for her work as a
clinical trial specialist within the field of interventional
cardiology and for her expertise in working with regulatory
agencies to conduct trials.
Dr. Mehran stated: “For years, the cardiology community has been
looking for potential solutions to prevent CIN in those patients at
risk for acute kidney injury, and I am excited to be leading the
AVERT clinical trial effort to evaluate this technology.”
Osprey Medical also announced that Dr. Gregg Stone will serve as
Chairman of the AVERT Trial’s Steering Committee, which provides
strategic direction and oversight of publications. Dr. Stone is
Professor of Medicine and the Director of Cardiovascular Research
and Education at New York-Presbyterian Hospital/Columbia University
Medical Center. He is also the Co-Director of Transcatheter
Cardiovascular Therapeutics (TCT), the world’s largest symposium on
interventional cardiology and vascular medicine.
In addition to evaluating the effectiveness of the AVERT System
for CIN reduction, the trial will include a health economics
sub-study to evaluate potential benefits for patients, hospitals,
and payers. The Primary Investigator for the health economic
sub-study will be Dr. James Tumlin, a practicing nephrologist and
Professor of Medicine at the University of Tennessee in
Chattanooga. Dr. Tumlin is widely acknowledged as a thought leader
in acute kidney injury, with over 20 years of clinical research and
numerous publications on kidney disease and contrast induced
nephropathy.
Mike McCormick, President and CEO of Osprey Medical, commented:
“We are pleased to have a world-recognized medical team leading our
AVERT clinical trial efforts. The AVERT System’s ability to reduce
the amount of dye used in commonly performed heart procedures may
provide a significant benefit in patients with at-risk kidneys.”
The trial will commence in Q4 CY 2013. 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.
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 trial will commence in Q4 CY 2013. The Company
is aiming to complete enrollment, submit for and obtain FDA
clearance for the expanded claim in the first half of 2015.
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.
MediaBuchan ConsultingHaley PriceT: (613) 9866 4722M:
(61) 423 139 163orInvestorsBuchan ConsultingRebecca WilsonM:
(61) 417 382 391orCompanyOsprey Medical Inc.Doug
SchoenbergVP of MarketingT: 952-955-8230
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