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Major unmet medical need in prevention of surgical site infection 

Surgical Site Infections (“SSI”) remain a serious concern for hospitals, surgeons, and patients due to significantly longer postoperative hospital stays, higher readmittance rates and repeated surgery in 73% of spine surgery patients with SSI. Clinicians and researchers have tested a wide range of factors to isolate a reason for SSI in an attempt to mitigate this risk, including examining typical risk factors such as age, weight, disease state, and even a possible correlation between surgical interns and the academic year, but no singular event points to a solution. 

Depending on a number of variable factors, the rate of SSI cited in the literature ranges from 0.7% to 11.9%. Specifically, in procedures involving long operating times and significant amounts of hardware, such as posterior spinal instrumentation procedures, the rate averages 7.2%. With approximately 500,000 instrumented spine fusion surgeries performed in 2005, and with surgical volume growing at a rate of over 15% annually, we believe that the economic impact on the health care system as a whole from SSI following instrumented spine surgery now runs over $2 billion per year. 

Current anti-infective treatments

Utilization of systemic IV antibiotics (e.g. gentamicin) and anti-microbial irrigation of the surgical site are the current standard of care treatments to reduce the incidence of SSI in instrumented spine surgeries. In addition, direct application of antibiotics to the surgical site and the use of antibiotic coating on various orthopedic surgical implants have also been tried with varying levels of success in certain surgical procedures. Each of these treatments, including the current standard of care practice, have their limitations and disadvantages, including the inability to deliver a controlled dosage of antibiotic in the desired therapeutic range with little or no systemic absorption.  

Flow Pharma’s solution: hybrid manufacturing/drug delivery technology

Flow Pharma proposes to address the market need for reducing the rate of SSI by utilizing its proprietary technology for manufacturing microspheres to produce a controlled dosage delivery of antibiotics. The Company’s initial product, named Edura™ gentamicin, will be manufactured using the Flow Focusing micro fabrication process, developed by Dr. Alfonso Ganan-Calvo at the University of Seville in Spain. This process allows microspheres to be made to produce a consistent controlled release profile for the selected antibiotic. The Company has obtained a license, subject to certain restrictions, to use the Flow Focusing micro fabrication process for implantable drug delivery applications.  

The Company intends to conduct controlled clinical studies to demonstrate that Edura™ gentamicin, when used in conjunction with IV antibiotic prophylaxis, can significantly decrease the rate of surgical site infections. Flow Pharma anticipates that it will position and price the product as a new standard of care treatment along with IV antibiotic for routine use in all in instrumented spine surgeries.

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