PuraCath Medical Shows Significant Reduction in Causes of Peritonitis in Peritoneal Dialysis International Journal

“Publishing the result of our new research on our UV light-based peritoneal dialysis catheter connection system in PDI is a significant accomplishment for PuraCath team since it signifies approval of the data extracted from our newly designed device by the elite scientific society of peritoneal dialysis,” said Julia Rasooly, PuraCath Medical’s CEO. “We believe our approach towards reducing microbial growth through the use of our inexpensive technology will provide patients on peritoneal dialysis a chemical-free, technique-independent method for reducing bacterial and fungal contamination during peritoneal dialysis exchanges.” In vitro testing demonstrated the effectiveness of the UV light-based peritoneal dialysis catheter connection system in achieving a 4-log reduction of several microorganisms which are known to cause peritonitis in patients on peritoneal dialysis therapy. The mean log reduction of these microorganisms was 4.03 for Candida albicans, 4.73 for Staphylococcus aureus, and 5.29 for Escherichia coli. Here is the link to PuraCath’s article in PDI: http://www.pdiconnect.com/content/37/1/109.short

In 2016, PuraCath received 510(k) clearance for its FireFly Peritoneal Dialysis Connector Disinfecting System which gave the company permission to market the FireFly device in the U.S. The device is intended for use by patients on peritoneal dialysis therapy as a method of controlling air and touch contamination while performing peritoneal dialysis exchanges.

PuraCath Medical to Present Data on FireFly™ Peritoneal Dialysis Connector Disinfecting System during 53rd ERA-EDTA Congress

San Francisco, California (May 12, 2016) – Data being presented will support planned introduction of PuraCath Medical’s technology in the European Union. PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients with intravascular and peritoneal catheters, announced today that it will present data on its next generation version of the FireFly™ Peritoneal Dialysis (PD) Connector Disinfecting System during the upcoming 53rd ERA-EDTA Congress (European Renal Association – European Dialysis and Transplantation Association) being held in Vienna, Austria from May 21-24, 2016. The study being presented, entitled Effectiveness of UV Light in the Disinfection of Peritoneal Dialysis Catheter Connectionsdemonstrated the ability of the 2nd generation of the company’s PD device to achieve a greater than 4-log reduction in microorganisms which are commonly associated with peritonitis in patients receiving peritoneal dialysis. The annual ERA-EDTA Congress represents Europe’s largest nephrology meeting attracting over 8,000 registrants from around the world.

“Peritonitis continues to be a significant risk for patients receiving PD and remains the leading cause of technique failure and transfer to hemodialysis,” stated Julia Rasooly, PuraCath Medical’s CEO. “The data we will be presenting at this year’s ERA-EDTA Congress demonstrates that the FireFly System is effective in reducing air and touch contamination while patients perform PD exchanges, reducing their infection risk. We are in the process of obtaining regulatory approval for the FireFly System in the European Union and anticipate the ability to market our technology for use by PD patients in the E.U. later this year.”

“The presentation of data on the FireFly System at the ERA-EDTA meeting is an important milestone for PuraCath Medical since it represents the initial introduction of PuraCath’s technology to the medical and scientific community in Europe,” stated Bobby Yazdani, Founder and Managing Partner at Cota Capital and a member of PuraCath Medical’s Board of Directors. “Since the utilization rate for PD therapy in many E.U. countries is much higher than in the U.S., the opportunity for the company’s technology to assist in improving outcomes for PD patients is significant.”

The FireFly PD Connector Disinfecting System recently received U.S. Food and Drug Administration 510(k) clearance and is intended for use by patients as a method of controlling air and touch contamination while performing PD exchanges. PuraCath Medical is currently offering the device for sale via a limited market release.

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 company based in San Francisco, CA, is dedicated to improving the quality of life of dialysis patients by reducing infections related to peritoneal dialysis (PD) and saving time through improved, simplified connections of PD catheters. The Company is utilizing their technology platform, which was spun out of Stanford University, to develop novel, easy-to-use technologies 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.

PuraCath Medical Presents Data at National Kidney Foundation 2016 Spring Clinical Meetings

Boston, Massachusetts (April 28, 2016) – PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients with intravascular and peritoneal catheters, announced today that it presented data on its next generation version of the FireFly™ Peritoneal Dialysis (PD) Connector Disinfecting System during the National Kidney Foundation’s 2016 Spring Clinical Meetings held in Boston, Massachusetts.  The data presented confirms the effectiveness of the 2nd generation version of the company’s ultraviolet (UV) system for disinfecting peritoneal dialysis (PD) connections achieving a greater than 4-log reduction in microorganisms which are commonly associated with peritonitis in patients receiving PD therapy. The National Kidney Foundation meeting is being attended by over 3,000 healthcare professionals involved in the management and care of patients with renal disease.

Peritonitis remains a serious complication for PD patients and represents the leading cause of technique failure,” said Julia Rasooly, PuraCath Medical’s CEO. “While there have been improvements in PD connectors and connection methods which reduce PD infection risk, air and touch contamination during PD exchanges continue to be significant cause of peritonitis. We believe our FireFly technology will provide PD patients with an easy-to-use, patient friendly option for reducing bacterial and fungal contamination during PD exchanges.”

The FireFly PD Connector Disinfecting System recently received U.S. Food and Drug Administration 510(k) clearance and is intended for use by patients as a method of controlling air and touch contamination while performing PD exchanges. PuraCath Medical is currently offering the device for sale via a limited market release.

PuraCath Medical Presents New Research Data during 36th Annual Dialysis Conference

Company presents study on the effectiveness of next-generation version of the FireFly™ Peritoneal Dialysis Connector Disinfecting System

Seattle, Washington (February 29, 2016) – PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients with intravascular and peritoneal catheters, announced today that it presented data on its next generation version of the FireFly™ Peritoneal Dialysis (PD) Connector Disinfecting System during the 36th Annual Dialysis Conference held in Seattle, Washington. The study, entitled “Effectiveness of UV Light in the Disinfection of Peritoneal Dialysis Catheter Connections” demonstrated the ability of the 2nd generation of the company’s PD device to achieve a greater than 4-log reduction in microorganisms which are commonly associated with peritonitis in patients receiving peritoneal dialysis. The Annual Dialysis Conference represents the world’s largest multidisciplinary meeting on dialysis attracting over 1,400 participants from 40 countries.

“Peritonitis remains a significant risk for patients receiving PD and is the leading cause of technique failure and transfer to hemodialysis,” stated Nasser Hebah, MD, FNKF, FASN, Senior Medical Advisor to PuraCath Medical and an expert in PD outcomes and quality improvement. “I am enthusiastic about PuraCath Medical’s efforts and believe their approach to reducing air and touch contamination will reduce infection risk in patients at the time of performing their PD exchanges.”

“The results of this study validate the effectiveness of the 2nd generation version of the FireFly PD Connector Disinfecting System, which represents an even more user friendly version of our technology,” said Julia Rasooly, PuraCath Medical’s CEO. “Since we recognize the value and the lifestyle convenience peritoneal dialysis therapy offers to patients, we continue to make incremental improvements to our technology in order to enhance PD patient’s quality of life and provide an easy-to-use, patient friendly option to reducing bacterial and fungal contamination during PD exchanges.”

“The FireFly PD Connector Disinfecting System recently received U.S. Food and Drug Administration 510(k) clearance and is intended for use by patients as a method of controlling air and touch contamination while performing PD exchanges. PuraCath Medical is currently offering the device for sale via a limited market release.

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 company based in San Francisco, CA, is dedicated to improving the quality of life of dialysis patients by reducing infections related to peritoneal dialysis (PD) and saving time through improved, simplified connections of PD catheters. The Company is utilizing their technology platform, which was spun out of Stanford University, to develop novel, easy-to-use technologies 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.

PuraCath Medical Receives 510(k) Clearance for the FireFly™ Peritoneal Dialysis Connector Disinfecting System

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.

PuraCath Medical Presents Data on the Company’s Proprietary Infection Reduction Technology during the National Science Foundation’s SBIR Phase II Grantee Conference

Atlanta, Georgia (June 2, 2015) – PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients on dialysis therapy, announced today that the company was a featured presenter during the National Science Foundation’s (NSF) Small Business Innovation Research (SBIR) 2015 Phase II Grantee Conference held in Atlanta, Georgia. PuraCath presented data from research funded by a NSF SBIR Phase II grant for the project “Novel Peritoneal Dialysis Catheter to Reduce Infections” which demonstrated the ability to reduce bacterial growth in a simulated peritoneal dialysis delivery system when combining ultraviolet (UV) light with a UV transmissible connection system.

“PuraCath is honored to be selected to present data summarizing the results of studies with our technology which was funded by a generous Phase II and IIB grant associated with the NSF’s SBIR Grant program,” said Julia Rasooly, PuraCath Medical’s CEO. “We are proud to have been a recipient and the primary investigator for Phase I, IB, II and IIB NSF SBIR Grants with a total cumulative grant amount of $1.3 million. This non-­‐ dilutive funding, which has supported research and development initiatives for our proprietary technology to date, is a testimony to the medical need to reduce infectious complications in patients on PD therapy.”

“The support PuraCath Medical has received via NSF SBIR grants has permitted the Company to further demonstrate the clinical potential its UV light-­‐based technology has to reduce infectious complications in patients on peritoneal dialysis, allowing further growth in the use of this patient-­‐friendly and higher quality of life, lifesaving therapy,” stated nephrologist Glenn Chertow, M.D. “The ability of PuraCath’s management team to successfully obtain sequential SBIR Grants and the subsequent development of the company’s technology is a testimony to their ability to deliver results and the validates the company’s approach to improve patient outcomes in patients on dialysis therapy.

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 a 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 nearly
40,000 peritoneal patients on dialysis therapy 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 is a company based in San Francisco, CA and is dedicated to improving the quality of life of patients on dialysis therapy by reducing infections related to peritoneal dialysis (PD) and saving time through improved, simplified connection of PD catheters. The Company utilizes technology that was spun out of Stanford University and is developing a novel easy-­‐to-­‐use technology designed to reduce infections and improve outcomes for patients on PD therapy. For more information on PuraCath Medical, please visit www.puracath.com.

PuraCath Medical Presents Study at National Kidney Foundation 2015 Spring Clinical Meetings

Company presents new data on the effectiveness of UV light to purify peritoneal dialysis catheter connections across a wider range of microorganisms that contribute to infections in PD patients

Dallas, Texas (March 27, 2015) – PuraCath Medical, an emerging company in the development of technologies to reduce infections in patients with intravascular and peritoneal catheters, announced today that it presented new scientific data on its proprietary ultraviolet light-based technology during the National Kidney Foundation’s (NKF) 2015 Spring Clinical Meetings. The study presented reported on the ability to reduce bacterial growth in a simulated peritoneal dialysis delivery system when combining ultraviolet (UV) light with a UV transmissible connection system. This data confirms the effectiveness of combining UV light with a UV transmissible connection system to reduce bacterial growth across a wider range of bacteria and a fungi (Candida albicans) which are known to contribute to infections and peritonitis in peritoneal dialysis patients. The current study builds on earlier research the company presented at the American Society of Nephrology meeting in 2014.

“PuraCath Medical’s technology is a revolutionary approach to reducing the risk of infections that could lead to a change in the way peritoneal dialysis is performed,” stated Alberto Sabucedo, M.D., Ph.D., from the Department of Nephrology and Hypertension at the University of Miami. “This is a promising technology that will enable a better quality of life for patients on peritoneal dialysis, and I look forward to utilizing in my practice when it is available for clinical use.”

“While there is increasing interest in the use of peritoneal dialysis therapy to manage patients with end-stage renal disease, patients still currently remain at risk of developing infections and peritonitis from low compliance with rigorous disinfection protocols, impacting their ability to remain on this therapy for the long term,” said Julia Rasooly, PuraCath Medical’s CEO. “The study we presented at the NKF meeting confirms that our approach to reduce bacterial growth through the use of a novel UV light-based PD purification system is effective across a wider range of microorganisms than we initially tested. Based on the results of this study and the rapid progress we have made with our product development efforts to date, we look to initiate the first clinical studies of our technology in PD patients in the near future. PuraCath believes in the value and the lifestyle convenience peritoneal dialysis therapy offers to patients and we are developing a PD disinfection system that enhances PD patient’s quality of life and also provides an easy-to-use, patient friendly option to reducing bacterial and fungal contamination during PD exchanges. We feel confident that this will allow a broader range of patients to benefit from the quality of life of treatment on PD.”

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 a 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 is a company based in San Francisco, CA and is dedicated to improving the quality of life for the dialysis patient by reducing infections related to peritoneal dialysis (PD) and saving time through improved, simplified connection of PD catheters. The Company utilizes technology that was spun out of Stanford University and is developing a novel, easy-to-use technology 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.

CONTACT
Julia Rasooly, M.S.
Founder and Chief Executive Officer
PuraCath Medical Inc.
+1.650.559.0388

PuraCath Medical Presents Data at 2014 Annual Meeting of the American Society of Nephrology

Company presents study on the effectiveness of UV light to purify peritoneal dialysis catheter connections

PuraCath Medical, an emerging company in the development of technologies to reduce infections in dialysis patients, announced today that it presented scientific data during Kidney Week 2014 demonstrating the ability to reduce bacterial growth in a simulated peritoneal dialysis delivery system when combining ultraviolet (UV) light with a UV transmissible connection system. The study represents early results with an initial version of the technology PuraCath Medical is developing which will be designed to reduce connectology-related bacterial contamination for PD patients.

“Infectious complications remain a major risk for patients receiving PD and represent a leading cause of technique failure and transition to hemodialysis,” stated study co-author and nephrologist Glenn Chertow, M.D. “Approaches that can reduce bacterial contamination during peritoneal exchanges should reduce the risk of peritonitis and allow patients to remain on home-based therapy. In order to allow patients to choose PD and to remain on PD long-term, we need to reduce peritonitis risk. I believe the approach PuraCath Medical is taking will help us get there.”

“We are encouraged by the study results we presented during the ASN meeting which support our planned development of a novel UV light-based PD purification system,” said Julia Rasooly, PuraCath Medical’s CEO. “Since PuraCath Medical recognizes the value and the lifestyle convenience peritoneal dialysis therapy offers to patients, we are developing a PD disinfection system that enhances their quality of life and provides an easy-to-use, patient friendly option to reducing bacterial and fungal contamination during PD exchanges.”

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 a 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 nearly 40,000 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 is a company based in Mountain View, CA and is dedicated to improving the quality of life for the dialysis patient by reducing infections related to peritoneal dialysis (PD) and saving time through improved, simplified connection of PD catheters. The Company utilizes technology that was spun out of Stanford University and is developing a novel easy-to-use technology designed to reduce infections and improve outcomes for patients on PD therapy. For more information on PuraCath Medical, please visit http://www.puracath.com.

CONTACT
Julia Rasooly, M.S.
President and Chief Executive Officer
+1.650.559.0388

KHI stakeholders conference 2014 – June 11-12, 2014

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To advance scientific understanding of the kidney health and patient safety implications of new and existing medical products and to foster development of therapies for diseases that affect the kidney by creating a collaborative environment in which FDA and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products.