AVERT™ with Contrast Monitoring Technology Receives FDA Clearance

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Posted: 2014-12-16 in Press Releases

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AVERT™ with Contrast Monitoring Technology Receives FDA Clearance

 

Minnesota, United States and Melbourne, Australia – December 16, 2014 – Osprey Medical Inc. (ASX: OSP) today announced that it has received US FDA 510(k) clearance for its AVERT™ System with Contrast Monitoring Technology (called the AVERT™ Plus). This enhanced system features a disposable smart syringe and reusable LCD monitor. The proprietary system offers several key benefits:

·        monitors and displays a physician inputted threshold volume which is based on the patient’s kidney function and compares it to contrast volumes   injected throughout the procedure;

·        automatically keeps real-time track of the amount of dye being used and the amount diverted by the AVERTTM System upon injection; and

·        allows for a more accurate method of recording the amount of dye delivered to the patient.

Osprey’s President and CEO, Mike McCormick commented: “We are delighted to receive FDA clearance for this addition of our contrast monitoring technology to our AVERT product platform, which enables us to commercialise our full AVERT Plus system in the US. We believe the enhanced AVERT Plus will be highly sought after for its benefits and value to physicians, patients and hospitals once we initiate our full US launch following receipt of our expanded market claim for CIN reduction targeted for 4Q 2015.”

“We are in the process of incorporating the AVERT Plus into our current

commercialisation efforts by first upgrading our existing customers during early QI 2015 followed by expansion to additional hospital accounts in Texas.”

The AVERTTM Plus provides a simple way for doctors and hospitals to readily comply with new dye volume recording guidelines that were recently issued by the US cardiology community to improve the quality of care following coronary procedures such as stenting or angioplasty.

 

Further information:

 

About the AVERT™ Plus System

The AVERT™ Plus System consists of a single use disposable convenience kit that includes the AVERT contrast modulation reservoir and a smart syringe with contrast monitoring technology. The disposable components attach to the reusable AVERT control system and monitor display unit.

 

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™ Plus System, is designed to reduce the amount of dye (contrast) injected during commonly performed coronary and peripheral angiographic procedures, thus protecting kidneys from damage 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:

 

Media

Investors

Company

Gavin Lower

Rebecca Wilson

Doug Schoenberg

Buchan Consulting

Buchan Consulting

VP of Marketing

T: (613) 8866 1215

M: (61) 417 382 391

T: (952) 955 8230

glower@buchanwe.com.au

rwilson@buchanwe.co.au

dschoenberg@ospreymed.com