Osprey Medical Receives US FDA Clearance for the AVERT™ System

Posted: 2014-06-17 in Press Releases

Download PDF

Osprey Medical Receives US FDA Clearance for the AVERT™ System

 

Key points:

  • Opsrey receives FDA clearance for the 2nd generation AVERT System
  • AVERT product sales to commence imminently in Texas, US
  • Texas sales effort to demostrate uptake and usage patterns for full US launch 2015


Minnesota, United States and Melbourne, Australia - June 17, 2014 - Osprey Medical Inc. (ASX: OSP) today announced that it has received US FDA 510(k) clearnace for its 2nd generation AVERTSystem for the controlled infusion of dye.

The Company expects to be immindently selling the system in Texas, where a number of hospitals have been routinely using the 1st  generation system.

Osprey President & CEO, Mike McCormick, stated: "We are extremely pleased to achieve US clearance of our 2nd generation AVERT™ System.  It is an excellent milestone for our Company.  This system has a number of ease-of-use features that allow hospitals to use the AVERT™ without the need for Osprey support staff at each case.  As a number of Texas hospitals have been routinely using the 1st generation system, we expect these easy to use features will drive broad adoption throughout Texas.

"We are also currently enrolling patients at several sites for our randomised, multi-site post market IDE clinical trial for an expanded marketing claim of "reduction of Contrast Induced Nephropathy" (CIN). Our initial sales efforts in Texas is to successfully show the commercial potential, uptake and usage patterns of our AVERT™ System in a single US State in preparation for a full US commercialisation following FDA clearnace of an expanded CIN reduction marketing claim which is expected in the second hafl of 2015." Mr McCormick concluded.

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.

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.Contact details:


Contact details:

Media Investors Company
Kelly Hanrick Rebecca Wilson Doug Schoenberg
Buchan Consulting Buchan Consulting VP of Marketing
T: (613) 9866 4722 M: (61) 417 382 391 T: (952) 955 8230
khanrick@buchanwe.com.au rwilson@buchanwe.co.au dschoenberg@ospreymed.com