Coapt Systems Launches FDA Cleared Novielle Voice (TM) For Restoration Of Voice Loss

Main Category: Ear, Nose and Throat
Also Included In: Regulatory Affairs / Drug Approvals;  Conferences
Article Date: 23 Sep 2008 - 1:00 PDT

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Coapt Systems Inc. announced the launch of its Novielle Voice family of injectable fillers at the 112th annual meeting of the American Academy of Otolaryngology -- Head and Neck Surgery (AAO-HNS) in Chicago, IL, September 21-24, 2008.

The U.S. Food and Drug Administration (FDA) cleared Novielle Voice Gel and Novielle Voice GelPlus earlier this year for restoration of voice loss. Novielle Voice is available in two formulations based on a proprietary, bioabsorbable Acrylomer(TM) Complex. Novielle Voice is injected into the vocal folds to repair defects that cause the voice to become faint and speaking to become difficult.

According to Dr. David Apfelberg, Medical Director for Coapt Systems, "Examples of patients who can be helped by Novielle Voice injections are patients who have experienced damage to nerves in the voice box, stroke, or surgery of the esophagus. We believe many other patient populations, such as those with Parkinson's disease or presbyphonia, age related loss of voice, can be helped with this simple procedure that can be performed under local anesthesia."

Dr. Edward Damrose is conducting a study on the longevity of Novielle Voice in Northern California, and is enthused. "Novielle Voice is a valuable addition to our armamentarium. I am impressed with our preliminary results and I trust that Novielle will prove useful in addressing the longer term needs of our patients."

"This is the first product line of a complete family of medical and aesthetic Novielle filler products that we plan to introduce. Novielle Voice works by replacing the lost volume in one or both of the vocal folds to restore voice volume and quality and reduce voice effort," said David Barella, Senior Vice President, Global Sales and Marketing. Barella added, "While this is not a permanent solution to voice loss, Novielle Voice will enable us to address the needs of patients who could benefit from intermediate duration injectable products."

Novielle Voice is available in the United States. To learn more, please visit http://www.NovielleVoice.com.

About Coapt Systems

Coapt Systems Inc. designs, develops and markets innovative facial rejuvenation products designed to provide natural, youthful results and reduce recovery time. The Company is privately-held and headquartered in Palo Alto, California. For information on Coapt Systems, please visit http://www.coaptsystems.com.

Coapt Systems Inc
http://www.coaptsystems.com