Parking some news since the last post
>>ROCKVILLE, MD--(INTERNET WIRE)--Jul 22, 2002 -- Conceptus, Inc. (NASDAQ:CPTS - news) today announced that the Obstetrics and Gynecological Devices Advisory Committee of the United States Food and Drug Administration (FDA) recommended approval for Essure(TM), the first alternative to tubal ligation for women seeking permanent contraception. The committee, by a vote of 8-0 with one abstention, recommended that Essure be approved once certain conditions are met. These conditions include changes to the labeling and implementation of the company's pre-existing plan to conduct post-marketing surveillance. Although Advisory Committee recommendations are not binding on the FDA, typically FDA final determinations are consistent with their recommendations. In May, the Essure PMA (Pre-Market Approval Application) was granted expedited review status by the FDA. The Essure device is investigational in the United States and currently marketed in Australia, Europe, Singapore and Canada.
Currently, an estimated 700,000 American women undergo tubal ligation each year, making it the most common form of contraception in the United States. Unlike tubal ligation, which requires cutting into the abdominal cavity, and is typically done under general anesthesia with a four to six day recovery period, Essure requires no incisions, can be performed without general anesthesia and most patients are able to return to their regular physical activities within one day.
"After researchers have worked for more than three decades to develop an alternative to surgical tubal ligation, Conceptus is extremely proud to have developed Essure and be one step closer to bringing this breakthrough option to women seeking permanent birth control," said Steve Bacich, President and CEO of Conceptus. "We are pleased that the Advisory Committee has recommended Essure for approval. When all FDA questions are answered, and if approval is given, we will work to make the procedure available as quickly as possible to women in the United States."
"Alternatives to incisional permanent birth control procedures represent an unmet need in this country," said Jay M. Cooper, M.D., founder and medical director of Women's Health Research Center, Phoenix, Arizona, and the principal U.S. investigator of Essure. "By offering women a procedure without an incision, without general anesthesia and without significant disruption to their family or work life, Essure could ultimately change the face of permanent contraception."<<
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>>SAN CARLOS, Calif.--(BW HealthWire)--Aug. 15, 2002--Conceptus, Inc. (Nasdaq:CPTS - News), developer of the non-incisional permanent birth control procedure Essure(TM), today stated that a lawsuit alleging patent infringement filed against the company by Ovion, Inc. is without merit, and that the company intends to defend its position vigorously. The lawsuit was filed on August 13, 2002 in the U.S. District Court, Northern District of California (San Francisco Division), and alleges that Conceptus is infringing Ovion's U.S. patent 6,432,116 by making the Essure device. The lawsuit appears to have been filed in response to Conceptus' previously filed lawsuit against Ovion in the same court alleging that Ovion's U.S. patent 6,096,052 is invalid, not infringed and unenforceable, and that Ovion has engaged in trade libel and unfair competition. Ovion's U.S. patent 6,432,116 is a continuation of its U.S. patent 6,096,052. Ovion is a small development-stage, privately held company.
"Our intellectual property portfolio has been painstakingly developed over many years and we will vigorously defend it. We are confident that we do not infringe any valid patent claim rightfully belonging to Ovion and that their lawsuit is without merit," commented Steven Bacich, chief executive officer.<<
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