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FDA Clears Way for Innovative Acne Treatment Device

Therative today announced it has received clearance from the Food & Drug Administration (FDA) to begin marketing ThermaClear, its innovative hand-held consumer medical device for the treatment of acne. The company also announced it has closed an additional round of expansion financing, bringing total capital raised to over $5 million. Therative will use the funds to help launch ThermaClear into the marketplace. Leading the round were Foundation Capital, RWI Ventures and Band of Angels.

"FDA clearance and the additional funding are two important milestones in our development," said Peter Scocimara, CEO of Therative. "Acne is a pervasive condition that has been without an effective solution. The FDA has cleared the way for us to bring our device to market and we intend to change the way people treat acne with our unique approach and ground-breaking technology."

"We are very pleased with the confidence our financial partners have expressed in ThermaClear and the Therative team," added Scocimara.

Panel: No failure limits on birth control pills

The government shouldn't set failure limits on birth control pills because that could put less-effective but still beneficial contraceptives off limits to women, federal health advisers recommended Wednesday.

The FDA scheduled meetings both Tuesday and Wednesday with its outside experts to gather advice on future guidelines that drug makers could follow in seeking approval for new hormonal contraceptives.

The FDA is looking at how well studies done prior to approval of new birth control pills reflected their "real-world" use. Typically, that use is less consistent and reliable than it is in clinical studies.

Also, newer versions of the pill aren't being tested on women who reflect the broader population. The women in clinical trials are younger, skinnier and healthier than are U.S.

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