ELMSFORD, NY--(Marketwired - December 22, 2016) - NanoVibronix, Inc., (OTCQB: NAOV), a medical device company, today provided an update on three significant clinical trials for its PainShield™, UroShield™ and TrachShield™ devices. Studies are underway in the U.S. and in Israel in order to clinically validate the known benefits of its proprietary and patented low intensity surface acoustic wave technology.
Currently, NanoVibronix is conducting a double blinded crossover study of PainShield™ for Trigeminal Neuralgia in the U.S. The in-home study is being led by Dr. J. Rosenblum. 26 patients are currently enrolled with complete enrollment in the study expected within the next month for a total of 60 patients. The study is expected to be concluded during the first half of 2017.
PainShield™ is a wearable ultrasound device which has demonstrated over 70 percent effectiveness based on earlier clinical studies for reducing or curing severe facial pain due to Trigeminal Neuralgia. Although used by a large number of patients during the last eight years with validation by small clinical trials, this is the first double blinded clinical trial in the U.S. intended to further validate its effectiveness so that it can be widely prescribed for this disease. Current treatments for Trigeminal Neuralgia include prescription drugs, neurosurgical intervention and gamma knife x-ray. Drugs often do not work for pain relief, and the other medical procedures are minimally effective. Hundreds of thousands of patients suffer with the disease without any realistic options other than PainShield™.
Concurrently, NanoVibronix is conducting a 60 patient double blinded clinical trial for UroShield™ in the U.S. in various nursing homes. The study will measure the efficacy of reducing bacteriuria on both the outside and inside of the catheter, as well as reducing pain. The clinical trial is underway and is expected to be concluded within five months.
UroShield™ is an ultrasound device that clips on to any urinary catheter to prevent bacteriuria and biofilm formation in and on the catheter. Bacteriuria and biofilm formation often lead to urinary tract infection, which if not treated can lead to sepsis and death. Urinary tract infection is often difficult and expensive to treat and is nearly universal for indwelling urinary catheters that are implanted for more than several weeks. UroShield™ has been shown to prevent certain types of bacteriuria and it can be effective in preventing urinary tract infection and the pain associated with urinary catheters. Small prior clinical trials have shown UroShield™ can reduce the incidence of Pseudomonas by more than 90 percent.
Lastly, a TrachShield™ study is being conducted at the Shaare Zedek hospital in Jerusalem, Israel. It is a double blinded clinical trial with Dr. Reuven Friedman as the principal investigator. The goal of this study is to prevent bacterial growth on the endotracheal tube. TrachShield™ is a new product that NanoVibronix is in the process of launching. Following completion of the clinical trials, the Company plans to submit its 510(k) to the FDA.
The TrachShield™ device is similar to UroShield™ and clips onto endotracheal tubes. Endotracheal tubes typically get infected after intubation and can lead to serious infections and death. As of today, there are 38 patients enrolled in the study with another 30 patients to be studied. The clinical trial is expected to be completed in five months.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc. commented, "We are pleased with the progress we have made with our clinical trials. Our PainShield™ trigeminal neuralgia study is enrolling rapidly. Based on previous clinical trials and customer feedback, we believe PainShield™ represents the most viable solution to Trigeminal Neuralgia, a very painful and debilitating disease. We believe this trial will help validate and reinforce our earlier studies as we target key opinion leaders and seek reimbursement for the device."
"Upon completion of our clinical trials for UroShield™ and TrachShield™ we will submit to the FDA for 510(k) marketing clearance in the U.S. In advance of FDA marketing clearance, we are accelerating our efforts to enter into domestic and international distribution agreements with potential partners. We believe our patented low intensity surface acoustic wave technology will ultimately transform the pain management, hospital acquired infection, and wound healing markets and we are moving forward aggressively with the full commercial launch our medical devices to the global marketplace."
NanoVibronix Inc. is a medical device company headquartered in Elmsford, NY with research and development in Nesher, Israel, that is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave technology. The company's groundbreaking technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications. The devices accelerate wound and soft tissue healing, disrupt biofilms and bacteria colonization, while providing pain relief. The devices can also be administered at home, without the assistance of medical professionals. The company's products include PainShield® UroShield™ NG-Shield™ and WoundShield™. Additional information about the company is available at: www.nanovibronix.com.
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