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Nanovibronix Inc. (NAOV)

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Last Post: 1/22/2021 5:08:59 PM - Followers: 13 - 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 

Current Price
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NAOV News: NanoVibronix UroShield Joins PainShield on Federal Supply Schedule, Expanding Access to VA Market 08:30 AM
NAOV News: Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) 02/19/2021 04:01:34 PM
NAOV News: Amended Statement of Ownership (sc 13g/a) 02/16/2021 03:50:08 PM
NAOV News: Amended Statement of Ownership (sc 13g/a) 02/10/2021 04:27:51 PM
NAOV News: NanoVibronix Reports Schedule Published by NICE for Review of UroShield® Device 02/10/2021 08:00:00 AM
News News Alert: NanoVibronix UroShield Joins PainShield on Federal Supply Schedule, Expanding Access to VA Market 03/02/2021 08:30:00 AM
#138   Well this one was a miss . Sheesh Kid-Gloves 01/22/21 05:08:59 PM
#137   * * $NAOV Video Chart 01-22-2021 * * ClayTrader 01/22/21 05:07:23 PM
#136   its ok. DPW took some time but nailed OCMillionaire 01/22/21 02:00:08 PM
#135   Freaking Fridays. Oh well. FreeBird 01/22/21 01:59:02 PM
#134   that is what shorts do, cause and create OCMillionaire 01/22/21 12:23:57 PM
#133   For a 15m float, it's trading like a FreeBird 01/22/21 12:08:43 PM
#132   2.50 easy guys OCMillionaire 01/22/21 10:12:18 AM
#131   Looking great for $2 break Kid-Gloves 01/22/21 10:07:05 AM
#130   1.90 premarket, gap fill, consolidate, bounce and run OCMillionaire 01/22/21 09:45:14 AM
#129   Good morning Kid-Gloves 01/22/21 09:42:38 AM
#128   $1.50 so far wesley_ 01/22/21 09:42:09 AM
#127   2.50++ comin boys OCMillionaire 01/21/21 04:11:22 PM
#126   $1.34 nice wesley_ 01/21/21 03:56:44 PM
#125   $$$!!! 420man 01/05/21 04:26:32 PM
#124   Got me 20k 1,03 europtiger 12/03/20 09:25:30 AM
#123   * * $NAOV Video Chart 12-02-2020 * * ClayTrader 12/02/20 04:21:11 PM
#122   They are scum BUFCARP 12/02/20 02:25:57 PM
#121   Thanks. I was wondering what was going on today. Pedro2004 12/02/20 01:33:52 PM
#120   private placement tigertiger88 12/02/20 01:32:18 PM
#119   NanoVibronix Announces $6.0 Million Private Placement Source: Business Wire Nan tigertiger88 12/02/20 01:31:13 PM
#118   offering at .70 tigertiger88 12/02/20 01:30:37 PM
#117   timber tigertiger88 12/02/20 01:30:16 PM
#116   I watched them pull this down today. I Pedro2004 12/02/20 01:28:45 PM
#115   Well done! Its just mm‘s trading wich makes the europtiger 12/02/20 01:26:55 PM
#114   Great job. I flipped a little today. Pedro2004 12/02/20 01:25:28 PM
#113   I am All out since 1,87 in average.... europtiger 12/02/20 01:20:59 PM
#112   8 trading halts as of 8:07 PST. Absolutely Pedro2004 12/02/20 11:08:15 AM
#111   After 104 million traded -- starting to move now. Pedro2004 12/02/20 11:01:54 AM
#110   They must have Series XXX Preferred Stock that Pedro2004 12/02/20 10:43:10 AM
#109   The trading is crazy Pedro2004 12/02/20 10:27:37 AM
#108   Oh yeah we got a Runner europtiger 12/02/20 09:36:53 AM
#107   Solf 1/3 my shares 1,84 europtiger 12/02/20 09:31:07 AM
#106   Thanks for the gains NAOV. S3lfMade 12/02/20 09:19:15 AM
#105   Volume is Crazy.... lets Hope no bullstrap europtiger 12/02/20 09:18:31 AM
#104   This is Looking sweet europtiger 12/02/20 09:17:40 AM
#103   Steady...steady..... davidsson10 12/02/20 08:41:09 AM
#102   14 mil O/S peterus 12/02/20 08:10:31 AM
#101   Wlooowzaaaa 1,40 europtiger 12/02/20 08:07:26 AM
#100   Yes!!! europtiger 12/02/20 08:06:58 AM
#99   go time is here peterus 12/02/20 08:05:45 AM
#98   Looks like Go time europtiger 10/23/20 09:59:21 AM
#97   tin up peterus 10/20/20 06:47:02 AM
#96   Keep on Klimbim... 1$ Test and more be europtiger 10/20/20 06:23:24 AM
#94   Fully loaded 0,69 average europtiger 10/16/20 11:30:27 AM
#93   Hopefully because their loading KMBSOUTH 09/29/20 07:24:06 PM
#92   Added .7.... time to close offering and move xray168 09/28/20 11:36:26 AM
#91   Bought more as well .74.... but my average xray168 09/28/20 01:55:29 AM
#90   bought more 72s peterus 09/27/20 04:35:15 PM
#89   I’m in 76s looks good, huge potential . FROZENFLAME 09/25/20 03:09:47 PM
#88   think we will see a another dip after offering peterus 09/25/20 02:45:58 PM
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