Michael Barbella, Managing Editor02.21.24
NanoVibronix Inc. has signed a research agreement with the University of Michigan Regents for a randomized control trial study of UroShield.
“We are partnering with a team of researchers at the University of Michigan to further advance clinical evidence of the efficacy of UroShield," NanoVibronix CEO Brian Murphy said. "UroShield is cleared under the U.S. Food and Drug Administration’s (FDA) Enforcement Discretion, and we hope positive outcomes from this independent study will support an application to the FDA for permanent clearance. RCTs are considered the ‘gold standard’ in clinical research, and we are pleased to be working with the team at the University of Michigan.”
UroShield generates ultrasonic waves to create an acoustic shield on the surfaces of a catheter to interfere with the attachment of bacteria, prevent bacterial biofilm formation, the development of infections, and may eliminate or reduce the need for antibiotics. It is designed to prevent biofilm formation, decrease bacteriuria/UTI, reduce catheter pain and discomfort and increase antibiotic efficacy.
“The research, which is being led by the Center for Research and Innovations in Special Populations (CRIISP), an experienced and highly accomplished research team, will be conducted primarily with nursing home residents and is aimed at studying the impact UroShield may have on reducing urinary tract infections, catheter blockages, and pain and improving the quality of life of the patients studied. The first phase of the study will include a validation pilot of 20 patients in advance of the full study. The full study is expected to include more than 300 patients. We look forward to receiving the researchers’ conclusions and hope for positive outcomes for patients in the study. The study is expected to commence in the first half of 2024.”
NanoVibronix Inc. is a medical device company headquartered in Elmsford, N.Y., with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety to medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The company’s primary products include PainShield and UroShield, which are portable devices suitable for administration at home without assistance of medical professionals.
“We are partnering with a team of researchers at the University of Michigan to further advance clinical evidence of the efficacy of UroShield," NanoVibronix CEO Brian Murphy said. "UroShield is cleared under the U.S. Food and Drug Administration’s (FDA) Enforcement Discretion, and we hope positive outcomes from this independent study will support an application to the FDA for permanent clearance. RCTs are considered the ‘gold standard’ in clinical research, and we are pleased to be working with the team at the University of Michigan.”
UroShield generates ultrasonic waves to create an acoustic shield on the surfaces of a catheter to interfere with the attachment of bacteria, prevent bacterial biofilm formation, the development of infections, and may eliminate or reduce the need for antibiotics. It is designed to prevent biofilm formation, decrease bacteriuria/UTI, reduce catheter pain and discomfort and increase antibiotic efficacy.
“The research, which is being led by the Center for Research and Innovations in Special Populations (CRIISP), an experienced and highly accomplished research team, will be conducted primarily with nursing home residents and is aimed at studying the impact UroShield may have on reducing urinary tract infections, catheter blockages, and pain and improving the quality of life of the patients studied. The first phase of the study will include a validation pilot of 20 patients in advance of the full study. The full study is expected to include more than 300 patients. We look forward to receiving the researchers’ conclusions and hope for positive outcomes for patients in the study. The study is expected to commence in the first half of 2024.”
NanoVibronix Inc. is a medical device company headquartered in Elmsford, N.Y., with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety to medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The company’s primary products include PainShield and UroShield, which are portable devices suitable for administration at home without assistance of medical professionals.