The Food & Drug Administration recently sent a “major deficiency letter” to Sanuwave. Federal regulators said the company’s application for a noninvasive foot therapy to treat diabetic foot ulcers lacked important product safety information.
The letter calls on the firm to amend its application by responding to the cited deficiencies and provide additional information. Sanuwave is currently seeking approval for its dermaPACE diabetic foot ulcer treatment.
The FDA letter specifically cited a previous dermaPACE study that failed to meet a 100% wound closure goal. The feds called for the company to conduct another study.
“We will continue to work toward our goal of a positive approval decision from the FDA so we can bring this novel, promising treatment to the millions of patients who suffer from these debilitating, recalcitrant wounds,” said Christopher M. Cashman, the firm’s president and CEO.
Diabetic foot ulcers are open sores or wounds that appear on the bottom of a foot. They occur in approximately 15% of diabetes patients. Nursing home residents with limited mobility face a higher risk for developing such ulcers.
From the February 01, 2012 Issue of McKnight's Long-Term Care News
