PuraCath Medical News

PuraCath Medical Receives 510(k) Clearance of its Needleless Connector IT for Vascular Access

Wed, 22 Apr 2026 04:29:53 GMT

Device is intended for use primarily by ICU nurses during infusions in patients in a critical care setting.

February 12, 2026

2026 Introduction & FDA Clearance Announcement

PuraCath Medical™, a venture-backed startup company focusing on the development of technologies to reduce infections in patients with intravascular catheters, announced today that it has received 510(k) clearance for its FireFly™ Needleless Connector IT from the U.S. Food and Drug Administration (FDA). The Firefly™ Needleless Connector IT is a sterile single patient use connector for needleless access to the IV line and IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration. This regulatory determination by the FDA gives PuraCath clearance to market the FireFly™ Needleless Connector IT in the U.S.

Leadership Commentary & Industry Perspective

“Receiving 510(k) clearance for the FireFly™ Needleless Connector IT is a major accomplishment for PuraCath™ since it represents adding on to our vascular access product line portfolio,” said Julia Rasooly, PuraCath Medical’s CEO. “We believe our novel approach to disinfect IV and PICC catheters in hospitals or in outpatient care will provide nurses a safe and easy-to-use disinfection tool for reducing CLABSIs for infusion therapies.”

“Growing the vascular access portfolio is a major accomplishment toward eliminating needleless connector asepsis,” stated Dr. Gregory Schears, anesthesiologist at Mayo Clinic, and Clinical Advisor to PuraCath™.

Product Rollout & Future Development

PuraCath Medical™ is planning a limited U.S. market release of the FireFly™ Needleless Connector IT while it continues its initiatives to develop and commercialize additional safe, and user-friendly technologies in this product pipeline which are designed to reduce the risk of infectious complications (CLABSIs) associated with vascular access.

What is a CLABSI
(Catheter-Line Associated Bloodstream Infection)?

Definition and Clinical Context

A CLABSI (Catheter-Line Associated Bloodstream Infection) is a laboratory confirmed bloodstream infection related to a central line such as a central venous catheter, PICC line, midline, etc.

Impact and Statistics

CLABSIs are associated with a high-cost burden, and can account for more than $100,000 per case, due to prolonged hospital stays and increased mortality. More than 400,000 CLABSIs are known to occur annually in the U.S.

Causes and Risk Factors

The most common cause of a CLABSI is due to improper aseptic techniques or lack of compliance to proper aseptic techniques, and improper management of the catheter lines during access.

About PuraCath Medical™

PuraCath Medical™, a Silicon Valley based-company, is dedicated to improving the quality of life of patients by reducing the risk of infections. The Company is utilizing its technology platform, which was spun out of Stanford University’s Biodesign program, to develop novel, easy-to-use devices designed to reduce the risk of infections in patients with catheters in order to decrease infection-related hospitalizations and their associated costs. PuraCath Medical™ has received a prestigious small business government grant from the National Institute of Health (NIH) NIAID division with grant ID Number 5SB1AI174371 to support these initiatives.

Learn More

For more information on PuraCath Medical™, please visit http://www.puracath.com

PuraCath Medical™ to Present UV Disinfection Breakthroughs at Four Major Clinical Conferences in 2025

Thu, 27 Mar 2025 03:01:58 GMT

PuraCath Medical ^TM , a venture-backed startup company focusing on the development of technologies to reduce infections in patients with intravascular catheters, announced today its participation in four prominent clinical conferences in 2025. The company will join healthcare professionals and industry experts to present its latest advancements in UV disinfection technology and its impact on reducing Catheter-Line Associated Bloodstream Infections (CLABSIs). PuraCath Medical will be attending the following clinical conferences:

ASPEN 2025 Nutrition Science & Practice Conference
ONS 2025 Congress (Oncology Nursing Society)
NHIA 2025 Annual Conference (National Home Infusion Association)
CVAA 2025 Conference (Canadian Vascular Access Association)

At each event, PuraCath Medical will present new data on the effectiveness of its UV disinfection technology, alongside findings from simulation studies conducted with device end users.

“PuraCath Medical is excited to share 99.99% or 4-log disinfection data on its latest Firefly Disinfection Device and believes that it can be the solution to CLABSI reduction in vascular access lines worldwide” said Julia Rasooly, PuraCath Medical’s CEO.

For more information on PuraCath Medical’s clinical initiatives and conference schedule, please visit www.puracath.com

What is a CLABSI (Catheter-Line Associated Bloodstream Infection)?

A CLABSI (Catheter-Line Associated Bloodstream Infection) is a laboratory confirmed bloodstream infection related to a central line such as a central venous catheter, PICC line, midline, etc. CLABSIs are associated with a high-cost burden, accounting for approximately $46,000 per case, due to prolonged hospital stays and increased mortality. More than 250,000 CLABSIs are known to occur annually in the U.S. The most common cause of a CLABSI is due to improper aseptic techniques or lack of compliance to proper aseptic techniques, and improper management of the catheter lines during access.

About PuraCath Medical ^TM

PuraCath Medical ^TM , a Silicon Valley based-company, is dedicated to improving the quality of life of patients by reducing the risk of infections. The Company is utilizing its technology platform, which was spun out of Stanford University’s Biodesign program, to develop novel, easy-to-use devices designed to reduce the risk of infections in patients with catheters in order to decrease infection-related hospitalizations and their associated costs. PuraCath Medical ^TM has received prestigious small business government grants from the National Institute of Health (NIH), National Institute of Allergy and Infectious Disease (NIAID) with grant ID Numbers R43AI134553 and SB1AI174371 to support these initiatives.

Julia Rasooly, PuraCath Medical ^TM , http://www.puracath.com , julia@puracath.com

How UV Disinfection is Transforming Infection Prevention in Medical Settings

Thu, 10 Oct 2024 16:52:18 GMT

In healthcare settings, preventing infections is crucial, especially in patients who rely on central venous catheters for treatment. Central line-associated bloodstream infections (CLABSIs) are a significant concern, posing risks to patient health and increasing healthcare costs. To address these challenges, innovative technologies are being developed to enhance infection control measures, with UV disinfection emerging as a promising solution.

A recent advancement in this area comes from PuraCath Medical, which has demonstrated a significant reduction in CLABSI-associated microorganisms in needleless connectors using a novel UV disinfection system. This system utilizes ultraviolet light to effectively disinfect the needleless connectors that are commonly used in medical settings, thereby reducing the potential for harmful microorganisms to cause infections.

The technology works by targeting the microorganisms that can accumulate on these connectors, including bacteria and fungi that are often associated with CLABSIs. Through a carefully engineered process, the UV disinfection system ensures thorough cleaning of the connectors, helping to maintain a safer environment for patients.

By integrating UV disinfection into routine medical protocols, healthcare providers can improve infection control practices, enhance patient safety, and potentially lower the overall incidence of CLABSIs. This approach not only benefits patient outcomes but also contributes to cost savings for healthcare facilities by reducing the need for extended treatments and hospital stays due to infections.

The results from PuraCath Medical's research indicate that incorporating such UV disinfection technology could become a new standard in preventing CLABSIs, providing a more effective barrier against infections in healthcare settings. For more detailed information about the study and findings, you can read the original blog post here .

Embracing innovative infection prevention strategies like this UV disinfection system will play a pivotal role in shaping the future of healthcare, focusing on patient safety and reducing the burden of hospital-acquired infections.

Disinfection of needleless connectors for catheters in one second using a hand-held UV device

Wed, 09 Oct 2024 16:53:00 GMT

Central Line-associated Bloodstream Infections (CLABSIs) are deadly bloodstream infections with high mortality and morbidity rates in patients with vascular catheters. In the United States, around 250,000 occur yearly. Of these, about 80,000 occur in intensive care units.

PuraCath Medical Receives 510(k) Clearance for its Needleless Connector for Vascular Access

Tue, 03 Aug 2021 09:04:00 GMT

Device is intended for use primarily by ICU nurses during infusions in patients in a critical care setting.

What is a CLABSI (Catheter-Line Associated Bloodstream Infection)?

Why We Aren’t Using UV to Disinfect Everything—Yet

Tue, 16 Jun 2020 18:14:00 GMT

Negative perception and costs pose obstacles to a promising technology

As the coronavirus pandemic continues, a technology that has existed for over 100 years is getting renewed attention as a promising disinfection tool. Ultraviolet germicidal radiation, which uses short-wavelength UV rays to kill bacteria and viruses, is already used to disinfect the air, water, and surfaces in limited settings. In May, a report by the Illuminating Engineering Society, an authority on lighting technology, showed that UV-C germicidal radiation can play a key role in inactivating the SARS-CoV-2 virus, which causes Covid-19. Now some companies whose products use this technology are seeing heightened interest.
“The manufacturers can’t keep up with the demand right now,” says Edward A. Nardell, a professor of medicine at Harvard Medical School. “You’re going to see UV widely used as we continue with this pandemic and have no treatment.” This technology has previously been used in health care settings and is a standard method of potable water treatment, but it hasn’t been widely embraced because of negative public perception and concerns about costs.

The technology’s roots date to 1877 when scientists observed that sunlight could prevent the growth of bacteria inside a test tube . Shortwave UV rays kill or inactivate microbes by damaging their DNA, rendering them incapable of replicating. The discovery helped to stop the spread of measles in schools in the ’40s and the transmission of tuberculosis, says Nardell, but the demand dissipated as vaccines for these diseases were developed.

Germicidal UV is now sometimes perceived negatively, he says, because people confuse it with the UV-A and UV-B rays that cause sun-related damage. Germicidal UV technology uses a shorter wavelength of radiation, called UV-C, which is also generated by the sun but gets absorbed in the atmosphere, so it doesn’t pose as much of a risk to people outdoors. But even though UV-C rays are far less dangerous than UV-A and UV-B, overexposure to it indoors is still risky, and it’s still not safe for humans to be present when UV-C technology is being used, says Peter Setlow, a professor of molecular biology and biophysics at UConn Health. The technology’s reputation recently suffered a further setback when President Trump suggested in a press briefing in April that shining heat and light into the human body might be an effective disinfectant. Doing so, says Setlow, “would kill the Covid but you would kill the person.” Trump later walked back that recommendation .

Convinced that technology can be an important tool against Covid-19, a number of companies are pushing ahead. One that reports its product can kill SARS-CoV-2 is Xenex Disinfection Services, Inc., which makes R2-D2-like germ-zapping robots that are primarily used in health care facilities. These robots use a xenon lamp to emit pulses of broad-spectrum, high-intensity UV light that disinfect a room. According to Xenex CEO Morris Miller, tests by the Texas Biomedical Research Institute, an independent research entity, showed the robot could deactivate SARS-CoV-2 in two minutes. He says the robots are currently in over 500 hospital facilities, including one in Bergamo, the epicenter of Italy’s epidemic. The robots are also being used in hotels and government buildings, he adds, and airlines have expressed interest. Each Xenex robot costs $125,000, with a life expectancy of five to seven years.

PuraCath Medical, Inc. is focused on reducing hospital-acquired infections with a handheld UV ray device that disinfects catheters. The device, called the Firefly, zaps the part of the catheter that connects to medication or other solutions. In February, PuraCath received a $3 million collaborative grant from the National Institutes of Health to test the Firefly on SARS-CoV-2 and other microbes. In a test that used a sample of Covid-19 from a patient in Washington state, the Firefly successfully killed the coronavirus within one second. The device hasn’t, however, been cleared by the U.S. Food and Drug Administration, so it isn’t yet commercially available. In the meantime, PuraCath is also working on a device to disinfect N95 or equivalent medical-grade masks, 12 at a time. “Given the encouraging data [on] disinfecting through lots of layers through a catheter, we are confident we can disinfect a mask,” says Julia Rasooly, the company’s CEO and president. That device is expected to be ready later this year.

On May 19th, the New York Metropolitan Transit Authority launched a $1 million pilot project to test the use of UV-C rays in disinfecting subways, buses, and other forms of transit. Mark Dowd, the MTA’s chief innovation officer, says he hopes disinfection will “provide reassurance for people to start using the subways and buses.” The project involves 150 mobile disinfecting units developed by Puro Lighting to disinfect vacant spaces. Brian Stern, Puro’s CEO, says that his company uses the same type of light as Xenex but overcomes the steep cost by using a miniaturized version. He says the lamp’s small size results in a lower-cost product that ranges from a few thousand dollars to $20,000, depending on the size of the system.

Nardell believes UV-C can be effective for disinfecting spaces in large institutions, though he cautions that the true test will be how it works outside the laboratory. The Illuminating Engineering Society report made clear that UV-C can’t disinfect some surfaces. “Anything that’s shadowed behind dirt or dust, doesn’t get hit by the photons and inactivated,” Nardell said. “It’s important to have the right intensity of light and lots of overlapping fields of light so you eliminate the possibility of shadows, and light comes from multiple directions.”

Stern argues that cost and availability have been major obstacles to widespread adoption of the technology. “The majority of the commercial-grade technology in the market prior to the pandemic was in the form of the UV pushcarts or ‘robots,’ which range in retail price from $55,000 to $145,000,” he says, noting that the health care industry was one of the few that could afford these prices.
Patti Costello, executive director of the Association of the Health Care Environment, an arm of the American Hospital Association, says research on UV-C for disinfection has shown some promising results, but more studies need to be conducted. Since the technology isn’t yet formally recognized as an antimicrobial agent, she adds, “widespread use will take time.” She agrees with Stern that high costs to purchase and maintain the devices are another barrier.

Safety remains another key obstacle. Exposure from the current UV-C ray technology, notes Setlow, can damage the skin and eyes when used indoors.

David Brenner, director of the Center for Radiological Research at Columbia University, is investigating a specific UV-C wavelength, 222 nanometers, that could address the issue of human safety. This wavelength is known as Far-UVC. Brenner says his research indicates that Far-UVC cannot reach the epidermis or the cornea. “It can’t reach any living cells in our body,” Brenner said in an email. Setlow says that Far-UVC technology “offers the potential to disinfect while people are there,” but he emphasizes that definitive safety data is required before this technology can take off.

Nardell, who was previously infected with Covid-19, is nevertheless optimistic that Far-UVC will make inroads to prevent others from suffering the same fate. His ideal application for this technology in the near future would be to aim it directly over a coffee bar or in a nail salon between the technician and the customer. “It’s going to be revolutionary,” he says. “You’re going to see it everywhere.”

PuraCath UV Device Displays a 99.9999% Disinfection of COVID-19 Virus in 1 Second

Mon, 27 Apr 2020 09:13:00 GMT

PuraCath has been partnered and working with a top tier BSL-3 National Laboratory, which has a premiere high containment infectious disease facilities to test its Firefly UV device for the ICU and hospitals with 2019-nCoV (the COVID-19 virus).

The preliminary results show that PuraCath’s device has achieved 99.9999% disinfection with SARS-CoV-2 (the virus that is known to cause COVID-19) in just one second. The Firefly UV device can help reduce nurse-to-patient, patient-to-patient, or patient-to-nurse viral transmission in the ICU settings in hospitals. Moreover, in a rapidly paced environment like the ICU, it is critical to be able to disinfect fast and efficiently, like with Firefly.

“We are very excited with this recent partnership with a prestigious National Laboratory and news on rapid disinfection of the COVID-19 virus on our device. We believe that the Firefly can bring substantial clinical benefits and reduced infection transmission in critically ill patients in ICUs and hospitals worldwide,” states Ms. Julia Rasooly, CEO and Founder of PuraCath Medical.

PuraCath FireflyTM Can Kill Deadly Microorganisms with UV Light, Like SARS CoV-2

Thu, 19 Mar 2020 12:16:00 GMT

President Trump has officially declared a national emergency. A novel coronavirus has been identified in Wuhan City, China and has spread worldwide. It has been named SARS CoV-2 (causing disease COVID-19) by WHO. SARS CoV-2 has officially become a global pandemic by WHO. There have already been over 170,000 confirmed cases to date with an average of a 3% death rate. Every U.S. state, other than West Virginia, has confirmed cases of COVID-19. This link ¹ has the most up to date information on total COVID-19 confirmed cases and deaths. One of the dangers is that the onset of symptoms can occur up to 14 days after exposure, which may vary with age and other underlying health conditions. The Center for Disease Control (CDC) says that one can acquire COVID-19 by being 6 feet away from an infected person if they do not have personal protective equipment.

PuraCath’s Firefly ^TM disinfection technology has been successfully tested on other resistant and deadly microorganisms like Methicillin Resistant Staphyloccus Aureus (MRSA) and Candida Auris and proven to reduce 99.99% of those microorganisms with only 1 second of Firefly ^TM UV light. Moreover, in a study published by Cheng et al ² , UV germicidal irradiation (UVGI) was shown to effectively inactivate encapsulated coronavirus (like SARS, MERS, SARS CoV-2) and H5N1 virus. The wavelengths of UV-C that prove germicidal effect are between 185 nm to 285 nm and the same to the wavelengths used in the Firefly ^TM disinfection technology. As such, PuraCath’s standard protocols should be sufficient to eliminate 99.99% of SARS CoV-2.

The PuraCath Firefly device can help utilize UV light to protect nurse-to-patient or patient-to-patient transmission of the SARS CoV-2 in patients with Midlines, PICC, CVC, or IV lines ($3.6B+ US market). These patients can be at home or in hospitals and typically in the ICU. Moreover, these are typically immunocompromised or immunosuppressed patients who are most susceptible to acquire SARS CoV-2 and experience higher fatality rates.

Besides the Firefly ^TM , PuraCath is also working on expanding its platform to other devices to help patients and consumers protect themselves from viruses like the SARS CoV-2.

PuraCath Medical Shows Greater Than 99.99% Reduction in ‘Superbug’ Candida Auris with One Second of UVC Exposure

Wed, 19 Jun 2019 09:52:00 GMT

JUNE 18, 2019

PuraCath Medical, a venture-backed medical device company based in Silicon Valley, announced today that it has achieved 99.99% disinfection on its vascular access Firefly disinfection technology system with Candida auris (‘superbug’), Staphylococcus aureus, and Candida albicans.

“Achieving greater than 4 log disinfection in these virulent microbes with only one second of UV exposure is an incredible breakthrough and will help with compliance and ease of disinfection whenever accessing vascular access devices (VAD) and infusion systems!” says Dr. Gregory Schears, Professor of Anesthesiology in Rochester, MN. “Inadequate disinfection of needleless connectors is a significant contributor to biofilm formation in VADs and hence the development of CRBSIs. These results suggest that the Firefly disinfection technology may have a huge impact in helping to reduce CRBSIs in hospitals. This is very exciting!”

In vitro testing of the Firefly disinfection technology demonstrated the effectiveness of the UV light-based vascular access catheter connection system in achieving a greater than 4 log reduction of several microorganisms known to cause a Catheter Line Associated Bloodstream Infection (CLABSI). The mean log reduction of these microorganisms was 4.44 +/- 0.22 for Candida auris, 5.06 +/- 0.62 for Candida albicans, and 5.70 +/- 0.62 for Staphylococcus aureus.

“Our team is thrilled to have achieved this big scientific breakthrough of achieving 99.99% reduction in just one second of UV-C light,” says PuraCath Medical Chief Executive Officer and Co-Founder, Ms. Julia Rasooly. “With a device that is now faster than any other disinfection platform out there and safer, we look forward to having Firefly be the standard of care for catheter line disinfection in all hospitals and outpatient units.”

What is vascular access?
Vascular access refers to a rapid, direct method of introducing or removing devices or medication into the bloodstream. The global vascular access device market is valued at $3.6B and expected to grow at a CAGR of 6.89% per year. The vascular access market is comprised of peripheral IV catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and implantable ports. Infections related to these catheters are named Catheter Related Bloodstream Infections (CRBSIs).

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

Tue, 07 Mar 2017 15:17:00 GMT

San Francisco, California (March 7, 2017) – PuraCath Medical has published the result of its recent research on its ultraviolet (UV) light-based peritoneal dialysis catheter connection system in Peritoneal Dialysis International (PDI), the official Journal of the International Society for Peritoneal Dialysis . PDI is a major source of knowledge in the field of peritoneal dialysis and aims to promote the advancement of peritoneal dialysis knowledge through scientific publications and international scientific meetings.

“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

Thu, 12 May 2016 09:00:00 GMT

“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

Thu, 28 Apr 2016 16:00:00 GMT

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.”

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

Mon, 29 Feb 2016 06:30:00 GMT

“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 2 ^nd 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?

About PuraCath Medical

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

Tue, 26 Jan 2016 06:30:00 GMT

“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?

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 .

The MedTech Strategist: PuraCath Medical, Anti-infection Device Enables Greater Access to Peritoneal Dialysis

Thu, 22 Oct 2015 15:18:00 GMT

We are excited to announce that PuraCath Medical is listed as a start-up to watch in the latest volume of the MedTech Strategist published on October 16th. Please read the full article here.

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

Tue, 02 Jun 2015 01:00:00 GMT

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

Fri, 27 Mar 2015 08:41:00 GMT

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

Fri, 14 Nov 2014 00:35:00 GMT

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

Fri, 27 Jun 2014 14:10:00 GMT

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.

PuraCath Medical presents with booth at BIO 2014 conference under SBIR Innovation Zone

Wed, 25 Jun 2014 13:20:00 GMT

The 2014 BIO International Convention is June 23-26 at the San Diego Convention Center in San Diego, California.

BIO 2014 conference under SBIR Innovation Zone

PuraCath Medical, Inc. Awarded NSF Grant

Sat, 14 Jan 2012 06:13:00 GMT

PuraCath Medical, Inc. Awarded NSF (National Science Foundation) SBIR Phase I Grant for Developing Innovative Catheter Design for PD Patients.

PuraCath Medical, Inc. Awarded NSF SBIR Phase II Grant

Tue, 28 Dec 2010 06:24:00 GMT

PuraCath Medical, Inc. Awarded NSF SBIR Phase II Grant for Novel Peritoneal Dialysis Catheter to Reduce Infections.