EDEN PRAIRIE, Minn. & SYDNEY--(BUSINESS WIRE)--Osprey Medical Inc, has today announced its plans to raise A$20 million through an underwritten Initial Public Offer (IPO) and has applied to list on the Australian Securities Exchange (ASX).
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.
Osprey Medical has applied for official quotation on the ASX through the offer of 50 million CHESS Depository Interests (CDIs). The offer price is A$0.40 per CDI. Based on the offer price the market capitalisation of Osprey Medical immediately following the Offer is expected to be approximately A$40.4 million.
Osprey Medical has principally been funded to date by Australian institutional funds including CM Capital Investments and Brandon Capital Partners. The Australian IPO is fully underwritten by Shaw Corporate Finance.
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.
“Current methods used for CIN prevention have had limited impact on reducing CIN risk and our initial data shows that the CINCORTM System can reduce the risk of CIN by 50%. Therefore we believe that our product can significantly improve patient quality of life and also lead to significant savings within the health system,” said Mr Mike McCormick, President and CEO of Osprey Medical.
“Funds raised from this offer will be used to conduct a pivotal clinical trial to gain US regulatory clearance targeted for 2014 and also to commence commercialisation of the CINCORTM System in Germany and the Netherlands.”
The offer of CDIs in Osprey Medical is made in a Prospectus lodged with the Australian Securities and Investments Commission (ASIC) on 7 March 2012. Copies of the Prospectus are available on the Company's website http://www.ospreymed.com/investors.php or from Shaw Corporate Finance. Applications by investors may only be made using the Application Form that will be in, or accompany, the Prospectus. The Offer is contained in the Prospectus and potential investors should consider the Prospectus in its entirety before making a decision whether to apply for CDIs. Investors will need to complete an Application Form in, or which accompanies, the Prospectus.
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.