? Osprey Medical is a late stage medical device company with products designed to reduce kidney injury from x-ray dyes used during common heart procedures such as stenting and angioplasty.
? Osprey Medical’s lead product, the CINCORTM System, has received approval to conduct a registration directed pivotal trial from the US FDA which is planned to start in 2012.
? The CINCORTM System has CE Mark approval and sales in Europe are planned to start in 2012.
? Osprey Medical’s CINCOR™ System originated from technology developed at the Baker IDI Heart and Diabetes Institute in Melbourne.
Minnesota, United States and Sydney, Australia – April 17, 2012 – Osprey Medical Inc, has today announced that its Initial Public Offer (IPO) raising of A$20 million has closed.
Osprey Medical’s Offer was well supported by institutional and retail investors in Australia, including founding investors CM Capital and Brandon Capital. The Initial Public Offer was underwritten by Shaw Corporate Finance.
The funds have been raised through an initial public offering of 50 million CHESS Depositary Interests (CDIs) at $0.40 and the indicative market capitalisation of Osprey Medical upon commencement of trading (based on the offer price) is approximately A$40.4 million. Admission of Osprey Medical to the official list of the ASX (Official List) and quotation of the CDIs on the Official List remain subject to satisfaction of all the listing conditions prescribed by the ASX. Upon listing on the ASX, Osprey Medical’s CDIs will trade under the ticker “OSP”.
“We are very pleased that investors have recognised the excellent commercial prospects for our lead product, the CINCOR System,” said Mr Mike McCormick, President and CEO of Osprey Medical.
The funds raised in the Offer will be used to:
? Conduct a pivotal clinical trial and seek US FDA clearance;
? Undertake a controlled market launch of the CINCORTM System in Europe;
? Further develop the CINCORTM platform technologies for additional applications;
? Conduct a medico-economic study to assist in both market adoption and reimbursement coding for the CINCORTM System; and
? Provide ongoing working capital.
“The successful completion of this raise enables us to rapidly move forward with our pivotal clinical trial in the US and also to commence commercialisation of the CINCORTM System in Germany and the Netherlands,” said Mr McCormick. “Our investors can look forward to a busy year ahead with updates on our progress in Europe and the US in the coming months.”
Osprey Medical is a late stage medical device company and its lead product, the CINCORTM System is used in angioplasty and stenting procedures to remove dye from the heart before it reaches the kidneys. The technology was developed at the Baker IDI Heart and Diabetes Institute in Australia.
Dye is routinely used to x-ray the heart tissue during these heart procedures, but it can cause serious and irreversible damage to the kidneys in patients with pre-existing kidney disease. Approximately 25% of angioplasty and stenting patients are at high risk of contrast induced kidney damage, also known as contrast induced nephropathy (CIN), and approximately 1-in-5 high-risk patients end up with CIN. CIN may cause irreversible damage that can lead to increased heart and kidney complications including death, and there is currently no viable way of preventing dye from reaching the kidneys.
The CINCORTM System has CE Mark approval with a commercial rollout planned in the European market in 2012. Osprey Medical also plans to start a registration directed pivotal clinical trial in 2012 and is aiming for FDA approval and US launch of the CINCORTM System in 2014.
About Contrast Induced Nephropathy (CIN)
Contrast Induced Nephropathy (CIN) is a form of kidney damage caused by the toxic effects of dyes (contrast) used by cardiologists to x-ray the heart and blood vessels during commonly performed heart procedures such as angioplasty and stenting. The dye is toxic and can reduce the blood flow in kidneys, which can lead to kidney cell death and serious patient complications.
About CINCORTM System
The CINCOR™ Contrast Removal System is designed to provide cardiologists with an advanced level of CIN protection in high-risk patients undergoing heart procedures such as angioplasty and stenting.
The CINCOR™ System is a catheter and vacuum system that is designed to directly capture and remove a significant quantity of the dye as it leaves the coronary sinus (the heart’s main drainage vein) before it makes its way to the kidneys.
Key CINCOR™ System Objectives:
• Remove toxic dye used in heart procedures
• Save patients’ lives
• Improve patient outcomes
• Provide opportunity for best patient care
• Save money for hospitals and payers
• Become the accepted standard of care for CIN Prevention
About Osprey Medical Osprey Medical’s CINCOR™ System originated from technology developed at Melbourne’s Baker IDI Heart and Diabetes Institute. Osprey Medical has been funded to date by Australian institutional funds managed by CM Capital Investments, Brisbane and Brandon Capital Partners, Melbourne and other Australian sophisticated or professional investors.
Following successful clinical trials across 6 sites in Australia, New Zealand and Europe, Osprey Medical obtained CE Mark and plans to commence a controlled market launch of the CINCOR™ System in Europe in 2012.
Osprey Medical has also obtained approval from the FDA in the US to conduct a registration- directed pivotal trial which is planned in 2012 and aims to obtain FDA approval to enable a US market launch of the CINCOR™ System in 2014.
Osprey Medical’s Board and Management is 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 disease.
For further information, please contact: Rebecca Wilson Buchan Consulting T: (613) 9866 4722 M: (613) 417 382 391
Doug Schoenberg VP of Marketing, Education & Reimbursement T: (952) 955 8234 M: (763) 258 7537
