Biowave Corporation Announces 510(k) Clearance of Its DEEPWAVE(R) Percutaneous Neuromodulation Pain Therapy System.

NORWALK, Conn. -- Biowave Corporation announces that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its DEEPWAVE(R) Percutaneous Neuromodulation Pain Therapy system. The DEEPWAVE(R) system uses a patented percutaneous electrode array (PEA) to facilitate delivery of electronic signals through the skin and into deep tissue encompassing the pain site, thereby blocking the transmission of chronic, acute or post-operative musculoskeletal pain. The PEA is a single-use disposable device comprised of 1014 microneedles in a 2.5-inch diameter patch that is applied to the patient for a 30-minute treatment. PEAs are comfortable for the patient and feel similar to placing sandpaper or Velcro on the skin. Treatment using the DEEPWAVE(R) system may replace traditional first courses of action such as prescribing opiates, NSAIDs and physical therapy and is used prior to more invasive courses of action including injection therapies and surgery. Biowave will distribute its DEEPWAVE(R) professional device first to specialty physicians, including pain management specialists, spine surgeons and sports medicine surgeons for treating patients with chronic, acute or post-operative pain conditions. The HOMEWAVE(TM) system, which uses the same neuromodulation technology but employs non-invasive electrodes rather than the PEA, will be prescribed for home use by these physicians following 4 - 6 successful DEEPWAVE(R) treatments in the office, clinic or hospital.

"The clearance of the percutaneous DEEPWAVE(R) 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(R) 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(R) 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(R) is a registered trademark of Biowave Corporation. HOMEWAVE(TM) is a trademark of Biowave Corporation. For more information visit www.biowave.com.