AirXpanders wins FDA nod for next-gen AeroForm tissue expander components

AirXpanders (ASX:AXP) saw shares rise today after it won FDA 510(k) clearance for an enhanced film material used to contain carbon dioxide in its AeroForm Tissue Expander system

The Palo Alto, Calif.-based company’s AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to a permanent breast implant. The device administers small amounts of CO2 up to 3 times a day to gradually stretch tissue prior to a breast implant procedure.

“We are very excited about the FDA’s decision which is consistent with the CE Mark and the TGA approval that we have already received. Plastic surgeons and their patients in the United States are very excited to finally have access to this game changing product for breast reconstruction and we appreciate the FDA’s support in helping us continue to advance the state of the technology. The AirXpanders team have performed well against the aggressive goals we set for ourselves for the targeted market release of AeroForm in the U.S. The market response to AeroForm has been overwhelmingly positive and we are thrilled to be able to begin our broader U.S. commercial launch ahead of schedule. We look forward to working with our ‘first users’ to offer AeroForm as an option and elevate the standard of care for women undergoing reconstructive surgery,” prez & CEO Scott Dodson said in a prepared statement.

Shares have risen as much as 6.9% to 71¢ (AUD 94¢) today, the highest point for the company in over a month.

In January, AirXpanders said it received commitments from investors in a private placement to raise $34 million (AUD $45 million). The company said that its investors committed to subscribe for 16.3 million shares of common stock at ¢70 apiece.

The company plans to use the funds to bring its breast tissue expansion device to the U.S., including building inventory for the U.S. market and hiring a sales force.

AirXpanders also said it plans to complete its expansion of commercial manufacturing capacity in Costa Rica.

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