"The clearance of the percutaneous DEEPWAVE® system is significant in that it is only the second percutaneous system ever cleared by the FDA for pain management," said Bradford Siff, President and Chief Executive Officer of Biowave Corporation. The classification of the DEEPWAVE® system is described by the FDA as a "percutaneous electrical nerve stimulator (PENS) that is used for the treatment of pain. Unlike transcutaneous electrical nerve stimulators that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a PENS device uses electrodes that are placed percutaneously to deliver stimulation."
Biowave has completed multiple clinical studies, including blinded randomized controlled trials, which have shown that a single 20 - 30 minute treatment immediately provides patients with a 75% average reduction in pain and a significant increase in range of motion which lasts for up to 24 hours. Biowave products provide results similar to implantable neuromodulation devices without the risk and at a fraction of the cost.
About Biowave
Biowave Corporation is a neuromodulation pain therapy company whose major goal is to help physicians and surgeons manage their patients' pain and reduce or eliminate the use of opiates, NSAIDs and their associated side effects. The percutaneous DEEPWAVE® physician system and non-invasive HOMEWAVE(TM) home prescription device deliver a patented electronic signal into deep tissue in the body blocking the transmission of pain. DEEPWAVE® is a registered trademark of Biowave Corporation. HOMEWAVE(TM) is a trademark of Biowave Corporation. For more information visit www.biowave.com.
Contact: Biowave Corporation Bradford Siff, 203-855-8610 brad.siff@biowave.com
Source: Biowave Corporation