Sanuwave (SNWV) stated that enrollment for the last part of their phase III study of ‘dermaPACE’ is set to begin before the end of Q2 – which is less than 30 days away. This is a huge catalyst for the company’s shares, which have traded completely under the radar thus far.
dermaPACE is a device that uses acoustic shock waves to “stress” cells which elicits a signal to begin repair, eg. within wounds. This technology has a long history of reliable safety data, which suggests the FDA would be comfortable approving the device for healing difficult-to-treat or non-healing wounds.
The company’s initial target is the $5 Billion diabetic foot ulcer market where standard of care is primarily bandages and topical ointments. Other therapies are limited in their efficacy, or effectiveness, which underscores the need for an efficacious and differentiated product. Non-healing wounds often lead to amputations which are costly procedures that continue to contribute to maintenance costs and loss of productivity costs throughout the life of an amputee.
MiMedx, a company offering an unregulated stem-cell bandage for non-healing wounds is seeing rapid growth and adoption of their product based purely on a longer shelf life. The company projects sales of ~$60M in 2013, and sports a valuation north of $700M.
Sanuwave would offer a product with (a)longer shelf-life, (b)non-invasive modality, (c)safe and well-established mechanism of action, and (d)a treatment with the lowest total cost for treating non-healing wounds in the market.
The company is literally a few data points away from a likely FDA approval. This is why enrollment of their first patient in this last stage study is a huge catalyst for SNWV. Just two years ago, Sanuwave completed their first Phase III study and traded over $4 per share. If MiMedx says anything about investor interest in these highly differentiated wound healing technologies, it’s this:
This time around, investors could bid SNWV up well over $4 a share. Zacks has already initiated the company with an outperform rating and says shares are headed over $1.60 near-term.
Today company released the following news:
SANUWAVE Enrolls First Diabetic Foot Ulcer Patient in the dermaPACE Clinical Trial
SANUWAVE Health, Inc. (OTCBB:SNWV) today reported that the first patient has been enrolled and begun treatment in the supplemental Phase III clinical trial of the Company’s dermaPACE device for treating diabetic foot ulcers. The clinical trial is designed to enroll a minimum of 90 patients at up to 20 U.S. sites.
Joseph Chiarelli , Chief Executive Officer of SANUWAVE, commented:
Enrolling and treating the first patient is an important milestone in our efforts to bring the CE Marked dermaPACE device to the U.S. market. We expect to show, through a successful trial, that the dermaPACE device can offer significant benefits over current therapies for diabetic foot ulcers. It is a simple, comfortable, and unobtrusive treatment option. As a result of our successful investigator meeting a few weeks ago, many of the 20 clinical sites currently have patients under-going the initial screening process required for enrollment in the dermaPACE study.
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