SOURCE: NanoVibronix, Inc.

NanoVibronix, Inc.

March 30, 2016 09:00 ET

NanoVibronix Provides Business Update on Its Proprietary and Patented Low Intensity Surface Acoustic Wave Technology That Targets Wound Healing and Pain Therapy

ELMSFORD, NY--(Marketwired - March 30, 2016) - NanoVibronix, Inc, (OTCQB: NAOV), a medical device company, today has issued a business update on the company's patented low intensity surface acoustic wave technology for pain management, wound healing and other indications.

William Stern, PhD, Chief Executive Officer of NanoVibronix, stated, "We are pleased with the progress we have made with our technology in 2015. Our proprietary and patented low intensity surface acoustic wave technology targets wound healing, pain therapy and prevention of infection in urinary catheters administered at home. Our novel wearable technology allows us to treat wounds, and pain by implanting our transducers into a small, self-adhering acoustic patch, thereby eliminating the need for technicians and medical personnel to manually administer ultrasound therapy, which reduces the cost of therapy. Moreover, we believe that the delivery of ultrasound through our wearable devices is more effective than existing products, as our technology is better positioned to target the affected areas of the body.

"Our primary products consist of PainShield®, WoundShield™, and UroShield™. PainShield® has FDA clearance and CE Mark. Both UroShield® and WoundShield® have CE Mark. Each of our products employs a small, disposable transducer that transmits low frequency, low intensity ultrasound acoustic waves that repair and regenerate tissue, and increase antibiotic efficacy. Through their size, effectiveness and ease of use, our wearable ultrasound devices eliminate the need for technicians and medical personnel to manually administer ultrasound treatment with large, office based machines, thereby promoting patient independence and enabling more cost-effective home-based care.

"In February, we announced that we had an overwhelmingly positive response to our PainShield® device, at the American Academy of Pain Medicine (AAPM) 32nd annual meeting at the Palm Springs Convention Center in Palm Springs, CA. PainShield® utilizes our patented, wearable ultrasound platform, and is the first wearable hands-free, patch-based device that delivers localized surface acoustic wave energy, creating a therapeutic effect to relieve localized pain and induce soft tissue healing. PainShield® is intended for chronic and acute pain and is especially effective for sports injuries such as ankle pain, tendonitis, knee pain, shoulder pain, and muscle pain, as well as injuries to other areas of the body. Other applications include treatment for trigeminal neuralgia, and female and male pelvic pain. We are currently ramping up our marketing efforts in North America for PainShield®. We anticipate that these efforts will include recruiting indirect sales personnel and representatives, making in-office calls to physicians and attending trade shows and conferences. We have also identified a niche market for PainShield® which is in the sports arena where in many cases reimbursement is either available from sports organizations or by self-pay.

"We are also currently conducting a double blinded clinical trial for UroShield™ in the U.S. in order to obtain 510(k) clearance from the U.S. Food and Drug Administration. UroShield™ is intended to prevent biofilm, increase antibiotic efficacy in the catheter lumen and decrease pain and discomfort associated with urinary catheter use. It is designed to be used with any type of indwelling urinary catheter regardless of the material or coating. We believe UroShield™ is the first ultrasound based medical device on the market that simultaneously addresses all of the aforementioned catheter-related issues.

"Our WoundShield™ product treats acute and chronic wounds with a disposable treatment patch that delivers localized therapeutic low frequency ultrasound. We are marketing WoundShield™ in Europe and will pursue the necessary approvals to commence marketing in the United States. Our strategy for selling WoundShield™ in the U.S. is to find a strong partner in the wound care market.

"Most recently, we have announced that the Israeli Patent Office has issued a notice of allowance for our system and method for surface acoustic wave treatment of skin. The patent will be granted following payment for patent issuance, which will be done this month. This patent has already been granted in China, and is in the final phase of being granted in the U.S. as well. The patent covers our surface acoustic wave technology as it relates to wound healing, reduction of pain, drug delivery, and cosmetic rejuvenation of skin. With the Israeli Notice of Allowance, soon to be followed by a U.S. patent, we will be able to add cosmetic skin rejuvenation to our list of medical and cosmetic applications for our technology. We are developing a device for the facial rejuvenation market called Renooskin. Previous in vitro clinical studies on human skin were done showing that the surface acoustic wave technology provided skin rejuvenation comparable to Retinol A, a well-accepted anti-aging cream. We are developing a head band like applicator for the surface acoustic wave treatment and have arranged for a pilot trial with a cosmetic dermatologist. We believe that pending proving efficacy of the Renooskin and receiving regulatory approval, the device can be sold in a non-reimbursement market since cosmetic devices are exclusively private pay. We expect first article testing to be completed by Q3 of 2016.

"The Company has sufficient cash reserves on hand to fund continued product development, clinical trials for additional 510-k clearances, and a robust marketing program, both here in the U.S. and in international markets until such time as we become cash flow positive. Overall, we are extremely pleased with our progress and look forward to announcing additional milestones in the near future."

About NanoVibronix 
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 healing and provide pain relief. The devices can also be administered at home, without the assistance of medical professionals. The company's products include PainShield® and WoundShield™, which both have CE Mark. The PainShield™ also has FDA clearance. NanoVibronix's catheter based products include the UroShield™ and NG-Shield™ that are both CE Marked. Additional information about the company is available at: www.nanovibronix.com.

SAFE HARBOR STATEMENT: This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as "expect," "believe," and "should." Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company's Form SEC filings.

Contact Information

  • Investor Relations Contacts:
    Rodd Leeds or Natalya Rudman
    Crescendo Communications, LLC
    Email: naov@crescendo-ir.com
    Tel: 212-671-1020