Healing wounds with physics and shock waves

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(via COMTEX News Network)--

Diabetic foot ulcers are seen more and more as our aging population experience more problems with obesity, vascular diseases and diabetic damage to nerves, which results in loss of movement, sensation, or other functions.

A promising technology which utilizes high-energy acoustic pressure waves in the "shock wave" spectrum to elicit biological effects and induce tissue regeneration and healing is capturing attention.

Shares of the mostly undiscovered, emerging medical technology company, SANUWAVE Health SNWV have been lifting in anticipation of a significantly important approval from the U.S. Food and Drug Administration for the firm's dermaPACE device.

This year, the firm completed a pivotal Phase III trial involving over two hundred patients and some of the results have industry observers excited and speculators taking notice.

Patients with diabetic foot ulcers who were treated with dermaPACE, stabilized and physicians noticed that many of these ulcers quickly reduced in size and continued to full closure in a significantly greater proportion than ulcers in the study's control group.

One undesirable effect which has been seen in most previous and standard of care treatments which are currently available has been the recurrence of these types of foot ulcers. In the recent data submitted to the FDA, it appears doctors noticed that the ulcers closed with SANUWAVE's technology showed exceptionally low wound recurrence. That is important since chronic and complex wounds cost patients over $20 billion annually in the U.S. alone.

Physicians have noted that the Georgia based firm's treatment technology has the added benefits of being non-invasive and devoid of significant clinical side effects. That has industry insiders and Wall Street commentators reasoning that the FDA approval for the acoustic pressure wave treatment device could exponentially increase the value of the firm.

Leading competitors, like Kinetic Concepts KCI, are watching developments closely as the disruptive technology from SANUWAVE may carry broad implications for others in the sector who offer wound care solutions and therapies.

Since the approval process for this type of medical device is more involved and includes the detailed submission of clinical data to support claims, investors know that submissions to U.S. regulators leading to actual approval are critical. Last month, company officials submitted the third and final module of its Premarket Approval (PMA) application for the dermaPACE device.

Analysts who cover the stock feel the filings are in-line with expectations and that FDA approval should come sometime during the first half of 2012.

Unfortunately, the growing number of patients who may benefit from the new treatment option will have to wait as the dermaPACE device is currently available only to physicians and patients involved in the firm's clinical trials. Author Michael Deosdade covers market innovators for United Press Networks

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Posted In: Press ReleasesHealth CareHealth Care Equipment
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