SOUTH JORDAN, UTAH, December 28, 2023 – Purgo Scientific has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its local drug delivery device, the Purgo Pouch.  

Purgo Pouch is a refillable drug delivery device that sustains local high dose antibiotic therapy in a surgical or traumatic injury site; delivering the right therapy, to the right place, for the right length of time. It can be used in conjunction with drugs delivered systemically, or for stand-alone local tobramycin therapy. The device’s rate-controlling membrane is connected to a catheter and refilling port that is accessible from the outside and can be used to drain and refill the device for up to 30 days.  

Traumatic injury wounds and accompanying infection are far more common in Service Members than the average population. Yet recognizing Purgo Pouch’s potential to address these persistent problems in civilian and military healthcare, the Department of Defense via the Congressionally Directed Medical Research Programs is supporting Purgo Pouch development with over $10.3M in contract funds. 

Dustin Williams, PhD is the original Purgo Pouch inventor and attributes its current innovative state to Nicholas Ashton, PhD, and a remarkable team of engineers. Dr. Williams shared that the team “Envisions a world without surgical site or traumatic wound infections. That vision drives our development process, which has taken place for nearly 8 years now. Rates of surgical site infection have gone essentially unchanged over the past 40 years, especially for compound fractures in orthopedic surgery where the likelihood of infection is as high as 50%. We’re humbled, honored, and grateful that the FDA provided Breakthrough status to the Purgo Pouch. It’s a validation of just how desperately surgeons and patients need a solution.” 

“An estimated 300,000 people in the US develop surgical site infections each year. These infections are the number one reason for hospital readmittance, resulting in billions of dollars in additional cost to the health care system annually. We aim to reduce that number significantly,” stated Mike Benjamin, CEO of Purgo Scientific. 

About Purgo Scientific 

Founded in 2016, Purgo Scientific is dedicated to improving local drug delivery and reducing surgical site infections, particularly those that develop in compound fractures. The technology development is being led by Dustin Williams PhD, Director of the Bone and Biofilm Research Lab at the University of Utah, and Nicholas Ashton, PhD. 

About FDA Breakthrough Device Designation 

An FDA initiative that expedites the review of innovative medical devices addressing life-threatening or irreversibly debilitating conditions, requiring enhanced effectiveness and significant advantages over existing cleared or approved alternatives. 

CONTACT: 
Mike Benjamin 
Executive Board Chair & CEO
mike@purgoscientific.com