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Nanovibronix Inc. (NAOV)

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Last Post: 3/29/2019 1:14:28 PM - Followers: 1 - Board type: Free - Posts Today: 0

(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)

UroShield: for the prevention of bacterial colonization and biofilm in urinary catheters

#Trial results compiled and expected 510(K) Class 2 filing to FDA in 1Q 2019

#Target FDA approval of 510K in 3Q 2019

#Projected target US launch in 3-4Q 2019

Product Pipeline:

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.

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.

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.

Largest Shareholder:

AIGH Capital Management LLC 371,574    
Globis Capital LLC 326,902    
Kennedy Capital Management, Inc. 314,475    
Miriam Winder-Kelly 215,355
Sabby Capital LLC 199,776
IDT Corp. 155,838
AmTrust Financial Services, Inc. (Investment Portfolio) 146,148    
Harold Jacob, MD 89,840    
Jona Zumeris, PhD 68,879    
Brian M. Murphy 45,840 

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NAOV News: Current Report Filing (8-k) 06/26/2019 05:01:37 PM
NAOV News: NanoVibronix Announces Closing of $3.2 Million Private Placement 06/24/2019 05:42:02 PM
NAOV News: Additional Proxy Soliciting Materials (definitive) (defa14a) 06/14/2019 11:46:44 AM
NAOV News: Current Report Filing (8-k) 06/14/2019 11:44:08 AM
NAOV News: NanoVibronix Announces Planned Launch of CBD Patch and Cream for PainShield® Designed to Amplify Therapeutic Effect 06/05/2019 08:30:00 AM
#5   FDA approval expected in Q3 BioSpecialist 03/29/19 01:14:28 PM
#4   major news imminent BioSpecialist 03/29/19 01:13:41 PM
#3   strong buy BioSpecialist 03/29/19 01:13:30 PM
#2   i like it BioSpecialist 03/29/19 01:13:21 PM
#1   NAOV moved to the Nasdaq from the OTC: Renee 11/02/17 08:42:06 AM