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Saturday, November 26, 2022

The Inside Story on SANUWAVE Health, Inc. (OTCBB:SNWV)

SANUWAVE Health, Inc. (OTCBB:SNWV) volume has dried up in recent weeks as the stock drifts near its 52 week lows of $0.041. SNVW is a stock with a history of highly explosive moves running from pennies to well over $1.50 a share in early 2013.

SNWV was originally incorporated as Rub Mucis Enterprises, Inc., in Nevada on May 6, 2004 and was focused on becoming a music library business that established a catalogue of copyrighted songs that they intended to license. In November 2009 they changed their name to SANUWAVE Health, Inc.,

SANUWAVE Health, Inc. (OTCBB:SNWV) is a shock wave technology company focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures.

SNWV initial focus is regenerative medicine – utilizing noninvasive, acoustic shockwaves to produce a biological response resulting in the body healing itself through the repair and regeneration of tissue, musculoskeletal and vascular structures.

The Company’s lead regenerative product in the United States is the demaPACE ® device, which is in a supplemental Phase III clinical study for treating diabetic foot ulcers with possible FDA approval in 2016, subject to submission of satisfactory clinical study results. dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand.

SANUWAVE has a number of partnership opportunities as well for their shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Co-CEO Kevin A. Richardson, II said on dermaPACE® PMA Submission: We had a great meeting with the FDA in June to determine a clear path to approval for our dermaPACE device for treatment of diabetic foot ulcers. At the meeting, the FDA agreed with our plan to analyze additional secondary endpoints in conjunction with the previously approved statistical analysis plan. FDA stated that they will look at the totality of the trial results, taking into account primary and secondary endpoints, safety, and benefit/risk assessments while reviewing a subsequent approval submission. Based on our meeting with the FDA, we are very encouraged that should the results of this trial mirror that of the previous trial, we can provide a clinically significant set of results in a PMA for the FDA’s approval consideration.

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The DMC will perform an analysis on the entire 130 patient population once the patients have completed the twelve week efficacy analysis period. This is expected to be completed in the first quarter of 2015. After their review of the 130 patients, the DMC may recommend: 1) stopping enrollment because the dermaPACE has met the minimum success criteria as compared to sham-control, 2) increasing enrollment to 170 patients which is the next predefined patient analysis point, or 3) stopping the trial due to poor results.

Kevin Richardson, II, Chairman of the board of directors of SANUWAVE, stated, “We are very pleased to have reached this enrollment milestone in the supplemental clinical trial of dermaPACE to treat diabetic foot ulcers. We anticipate having the feedback from the Data Monitoring Committee regarding the 130 patients in the first quarter of 2015 and look forward to updating shareholders at that time.”

In October SNWV announced top line and preliminary data analysis from the Company’s pivotal Phase III, Investigational Device Exemption (IDE) supplemental clinical trial comparing the rates of 100% wound closure at 12 weeks between dermaPACE® and Sham control (non-active treatment), when both are combined with the current standard of care for the treatment of diabetic foot ulcers (DFUs).

This study supplemented the Company’s earlier 206 patient Phase III trial of identical endpoints which demonstrated the exceptional safety profile and clinical benefit of the dermaPACE device for the treatment of diabetic foot ulcers; an area of significant unmet medical need and represents a $2 billion market in the United States alone.

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Currently trading at an $6 million market valuation SNWV does have a strong cash position of $1.6 million in the treasury, manageable debt and small but fast growing revenues. SNWV traded as high as $5 shortly after hitting the bb’s with many seed shareholders paying well over $2 a share. SNWV is an exciting story developing in small caps (especially from current price levels) they are in the midst of top line data analysis for their treatment of foot ulcers; dermaPACE and expect to have preliminary results for the public in early October. We will be updating on SNWV when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with SNWV.

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Disclosure: we hold no position in SNWV either long or short and we have not been compensated for this article.

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