PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients with intravascular and peritoneal catheters, announced today that it has received 510(k) clearance for its FireFly™ Peritoneal Dialysis Connector Disinfecting System from the U.S. Food and Drug Administration (FDA). This regulatory determination by the FDA gives PuraCath clearance to market the FireFly device in the U.S. The device is intended for use by peritoneal dialysis (PD) patients as a method of controlling air and touch contamination while performing PD solution exchanges. In vitro testing demonstrated the effectiveness of the Firefly PD Connector Disinfecting System in achieving a 4-log reduction for several microorganisms which are known to cause peritonitis in PD patients.
“Receiving 510(k) clearance for the FireFly PD Connector Disinfecting System is a major accomplishment for PuraCath since it represents the initial regulatory approval for a device in our product portfolio pipeline,” said Julia Rasooly, PuraCath Medical’s CEO. “We believe our approach towards reducing microbial growth through the use of a novel UV light-based PD disinfection system will provide PD patients an easy-to-use, patient-friendly option for reducing bacterial and fungal contamination during PD dialysate exchanges.”
“We are pleased that PuraCath Medical has achieved this important regulatory milestone,” stated Bobby Yazdani, Founder and Managing Partner of Cota Capital, a current investor in PuraCath Medical. “This 510(k) clearance establishes a regulatory foundation for their innovative technology platform and will serve as a baseline for future regulatory approvals which expand the use and clinical application of their technology platform.”
PuraCath Medical is planning a limited U.S. market release of the FireFly PD Connector Disinfecting System while it continues R&D development initiatives to develop additional user-friendly technologies which are designed to reduce the risk of infectious complications associated with peritoneal dialysis and the use of catheters in other patient populations.
What is Peritoneal Dialysis?
Peritoneal dialysis is a home-based dialysis therapy that offers patients a more flexible and physiologically smoother dialysis option. Unlike hemodialysis, peritoneal dialysis uses a patient’s peritoneal membrane to remove toxins and excess fluid from the patient. Peritoneal dialysis therapy permits patients to have a more regular diet and more flexible treatment times, improving their quality of life. Currently there are over 45,000 peritoneal dialysis patients in the U.S. with the number of patients on this therapy increasing over the past several years. The most common complications from peritoneal dialysis include infection around the catheter site or infection of the lining of the abdominal wall (peritonitis).
About PuraCath Medical
PuraCath Medical, a San Francisco based-company, is dedicated to improving quality of life for patients by reducing the risk of infections. The Company is utilizing its technology platform, which was spun out of Stanford University, to develop novel, easy-to-use devices designed to reduce the risk of infections in patients with intravascular and peritoneal catheters in order to decrease infection-related hospitalizations and their associated costs.
For more information on PuraCath Medical, please visit www.puracath.com.