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Old 03-28-2019, 10:52 AM   Nav to Top  #1
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Default NAOV = MC $27 M / 2 US-approved Products / NEXT approval in Q3

(NAOV) MC $27 Million /Shares Out 6.4 M / Float 1 M / 2 Products approved in US / 1 Potential Blockbuster expected to be approved in Q3 = 1000%+ UPSIDE on this unknown GEM...

NanoVibronix (NAOV)

Market Cap $27 Million
Shares Out 6.4Million
Price $4.10

i24 News Reports on the Effects of the PainShield (APPROVED IN US)


PainShield: for the treatment of pain, muscle spasms and tendon diseases. The product has U.S. 510(k) clearance, CE Marking and Health Canada regulatory approval.At-home use for trigeminal neuralgia (TN), a neurological condition characterized by extreme pain along the trigeminal nerve in the face, is the main focused market for PainShield. First-line treatment oftrigeminal neuralgia, which causes such severe pain thatit has been called the suicide disease, are anticonvulsants. Surgery and opioids may also be used. While medications can be initially effective, their ability to control the disease usually wanes over time. Estimated U.S. incidence of TN isbetween ~40k and 140k. General soft tissue pain represents a less-defined but relatively enormous market and potent opportunity for PainShield, as does the recent crackdown on opioid overprescribing.

UroShield: for the prevention of bacterial colonization and biofilm in urinary catheters.Currently CE Marked, an FDA De Novofiling for UroShield is anticipated in 1H 2019. If all goes to plan, the device could make its U.S. introduction later this year. The target market is big(24M indwelling catheters sold in the U.S. each year) and largely underserved (antibiotics are first-line treatment yet often prove to be ineffective)1. Indwelling catheter induced urinary tract infections are commonplaceand, given that they cost the healthcare system billions of dollars each year, hospitals have an economic interest to adopt novel technologies (potentially such as UroShield) that can prevent them.

WoundShield: to speed the healing of hard-to-treat wounds.
WoundShield is CE Marked and has Health Canada approval. The chronic wound market is large and encompassesdiabetic foot ulcers (U.S. prevalence is ~5.5M with recurrence rate of 66%), venous leg ulcers (U.S. prevalence is ~600k with one-third recurring four or more times) and pressure ulcers (U.S. incidence of ~2.5M). An estimated $25B or more is spent each year on treating chronic wounds. While there are several modalities of advanced wound therapies available with varying degrees of effectiveness, almost all require operation by a trained clinician and a trip to the hospital. By contrast, WoundShield is designed for at-home use by an individual patient. Another potentially potent, and largely unique, advantage of WoundShield is the ability to use it as an adjunct, or complement, to existing advanced wound care modalities

LungShield: similar in form to UroShield but different in its application, LungShield is designed to reduce the risk of endotracheal infection in a hospital setting. It is currently being evaluated in a human pilot study in patients undergoing mechanical ventilation to determine its effect on development of bacterial colonies on endotracheal tubes

RenooSkin: to facilitate rejuvenationof facial skin.Unlike the NAOVs other products in which the transducer is enclosed in a patch or clip, RenooSkin consists of a head band-like applicator which houses two transducers near each ear. In vitro studies have indicated RenooSkin may be as effective as Retin-A (tretinoin, which generates ~$300M in annual sales)in its ability to rejuvenate skin. Target market is the non-prescription skincare space. Skin care is a very large market, generating ~$8B in annual sales in the U.S. Facial skin care is the fastest growing subcategory within skin care with sales of products such as facemasks, facial moisturizers and facial sprays increasing by as much as 39% annually

We recently met with the FDA and expect to file a 510(K) Class 2 filing in the first quarter of 2019. Towards this end, we have several smaller studies planned and underway we expect to include in our submission, which we believe will help support our application, including an animal model in sheep, a comparative study of leachables from a urinary catheter with and without UroShield attached, which is already underway, and a small study of patients with neurogenic bladder dysfunction. Given our past clinical data we are quite confident in our FDA submission and our goal is to receive marketing clearance in the U.S. by the third quarter of 2019, which we believe will be a major milestone for the Company. In the meantime, we are in active discussions with a number of potential partners in the U.S. and abroad, all of which should help drive value for shareholders.

● Pain Market. Our PainShield product is aimed at the pain treatment market. Pain-related complaints are one of the most common reasons patients seek treatment from physicians. According to Landro L, “New Ways to Treat Pain: Tricking the Brain, Blocking the Nerves in Patients When all Else Has Failed,” Wall Street Journal, May 11, 2010, approximately 26% of adult Americans, or approximately 76.5 million people, suffer from chronic pain. The National Center for Health Statistics has estimated that 54% of the adult population experiences musculoskeletal pain.

● Wound-Healing Devices Market. Our WoundShield product is aimed at the market for wound-healing devices. The global wound care device market totaled approximately $24 billion in 2015 and it is expected to grow at a CAGR of 6.7% during 2016-2022 (as reported by P&S Global Research in January 2017).

● Catheter Market. Our UroShield product is complementary to products in the catheter market. The global catheter market totaled approximately $26.6 billion in 2015 and it is expected to grow at a compound annual growth rate (“CAGR”) of 9.7% through 2021 (as reported by Zion Market Research). Approximately 25% of patients who are admitted to a hospital will have an indwelling catheter at some point during their stay and 7% of nursing home residents are managed by long term catheterization.
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