Osprey Medical Inc. announces enrolment of first patient in Diabetic Limb Clinical Study

Posted: 2012-12-04 in Press Releases

Download PDF

 

  • Osprey Medical has commenced its clinical study investigating the delivery of high dose antibioticsto patients with diabetes who present with life or limb threatening foot infections.
     
  • Osprey Medical’s Limb Recovery System, based on the company’s core CINCORTM technology, permits clinicians to use existing antibiotic therapies in a more targeted and aggressive manner.
     
  • The Diabetic Limb Clinical Study is expected to be completed in 2014



Minnesota, United States and Melbourne, Australia – December 4, 2012 – Osprey Medical Inc. (ASX: OSP) today announced the enrolment of the first patient in its Diabetic Limb Clinical Study in Australia, involving 25 patients with life or limb threatening foot infections as a complication of diabetes.

The Study will be conducted in two sequential parts commencing with a five patient single arm safety study to evaluate the safety and tolerability of the Limb Recovery System. The second part will be a randomised clinical outcomes study in 20 patients, comparing the effectiveness of the Limb Recovery System with standard dose intravenous delivery of antibiotic therapy, for the treatment of severe limb infections.


In July 2012, Osprey Medical received approval for a A$1.1 million grant from the Victorian Government’s Market Validation Program (MVP) to conduct a first-in-man clinical study on its percutaneous limb
perfusion technology, referred to as the Limb Recovery System. Osprey Medical will partner with the Royal Melbourne Hospitals’ Diabetic Foot Unit for the two year study.

Mike McCormick, President and CEO of Osprey Medical, said: “We are very pleased to be commencing the clinical trial of our innovative Limb Recovery System technology that has the potential to significantly
improve the quality of life outcomes for patients with diabetes who have lower limb infections.”

Osprey Medical’s Limb Recovery System is based on the company’s core CCINCOR™ technology and permits clinicians to use existing antibiotic therapies in a more targeted and aggressive manner. Osprey Medical’s Limb Recovery System was originally developed by Professor David Kaye and Dr. Melissa Byrne and their pre-clinical research team at the Baker IDI Heart and Diabetes Institute in Melbourne. This unique Limb Recovery System enables the circulation of the limb to be isolated and separated from the general circulatory system, which permits the delivery of antibiotic drugs at high doses that are otherwise
unachievable with standard care. This is achieved by creating an ‘artificial’ circuit by inserting catheters into the major artery and vein of the lower limb.

It is estimated that more than 360 million people worldwide have diabetes and this number is expected to increase by more than 50% by 2030. People with diabetes are particularly prone to diabetic limb and foot infections due to insufficient blood flow and impaired wound healing. Standard oral or intravenous delivery of antibiotics is often ineffective in these patients because dosage levels cannot be achieved at a
sufficient level at the site of the limb infection. Infections of the lower limb are the leading cause of amputations globally, leading to increased rates of hospitalisation and higher healthcare costs throughout
the developed world.

Head of the Diabetic Foot Unit at the Royal Melbourne Hospital, Associate Professor Paul Wraight, said: “The incidence of diabetes-related lower limb infections is increasing and the current treatment options
can narrow significantly if the infection becomes life threatening. We look forward to working with Osprey Medical’s Limb Recovery System to improve the range of treatment options for these high risk patients
with diabetes.”