Startup raises $11M to get transdermal iron patch through CE mark, FDA approval

Fe3 Medical has raised an $11 million Series B round that's slated to get it through clinical testing and regulatory submissions that would be sufficient to gain CE mark and FDA approval for its transdermal iron patch to treat iron-deficiency anemia.

Fe3 CEO Mark Sieczkarek

The San Antonio-based startup is an InCube Labs company and was among the first to help the incubator establish its InCube Lab Texas in that city. In addition to participation from InCube Ventures, this latest round was led by China-based strategic investor Jianmin Pharmaceuticals, HG Capital and Chinese insurance company VC firm PingAn Ventures.

Fe3 has already brought on as CEO a serial med tech executive Mark Sieczkarek, who led aesthetic medical device company Solta Medical through its acquisition by Valeant ($VRX) in 2014 for about $250 million and the now-controversial permanent birth control device maker Conceptus in its purchase by Bayer for about $1.1 billion in 2013. Prior to that, he held executive spots at Bausch & Lomb and Bristol-Myers Squibb ($BMY).

"Our preclinical results and strong intellectual property position give us confidence that our therapy has the potential to disrupt the current iron supplement market," said Fe3's Sieczkarek in a statement. "This is a several billion dollar global market opportunity, and we are now focused on moving into the clinic and bringing this important innovation to patients."

The company is planning to start Phase I clinical trials next year. The disposable transdermal patch requires minimal preparation and is worn overnight once weekly. It's intended to bypass the constipation and other gastrointestinal tract side effects that can result from oral iron pills. Almost half of patients can't tolerate these side effects that include constipation, diarrhea, nausea and bloating, Fe3 said.

An estimated more than 25 million people in the U.S., most of them women, have iron deficiency anemia due to a variety of issues including blood loss from menstruation or the gastrointestinal tract, chronic illness such as kidney failure, cancer, Crohn's and GI disorders, as well as increased iron needs during pregnancy.

After trials, the startup plans to build out medical device manufacturing capacity in San Antonio.

"Fe3 was created to address a clear, unmet clinical need as nearly half of the patients suffering from iron-deficiency anemia cannot tolerate oral iron," said Mir Imran, chairman and CEO of InCube Labs. "Our therapy is a compelling alternative to millions of patients, giving them the iron they need without the undesirable side effects of oral iron."

- here is the announcement