For 40 years, plastic surgeons have used saline injections to expand tissue and prepare patients for breast implants following mastectomies. These tissue expanders consist of a silicone shell with a magnet and a self-sealing port; a doctor uses a different magnet above the skin to access the port and inject saline to stretch the skin. The […]
AirXpanders (ASX:AXP) said yesterday it won FDA de novo clearance for its AeroForm tissue expander system designed for breast reconstruction procedures, and announced it is preparing to launch the device in the U.S. 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 […]
AirXpanders (ASX:AXP) said today that it raised $14.9 million (A$20 million) for its AeroForm tissue expander and tapped medical device veteran Scott Murcray to be its CFO/COO. Palo Alto, Calif.-based AirXpanders said the over-subscribed private placement of nearly 8.8 million shares at 56.8¢ apiece (A76¢) included both new and existing institutional investors. The proceeds are earmarked […]
Avedro said CEO David Muller stepped down shortly after it closed a $32 million equity round last month, replaced on an interim basis by COO Brian Roberts, the former CFO at Insulet (NSDQ:PODD). Waltham-based Avedro said Muller left to “pursue other opportunities.” “On behalf of the board and all the Avedro employees, I want to thank […]
Scott Dodson didn’t worry when the FDA requested a call. Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device designed for post-mastectomy breast reconstructions that uses a gradual patient-controlled release of compressed gas to expand and stretch the skin/underlying muscle before […]
AirXpanders said today it will submit an application for de novo classification with the FDA for its AeroForm tissue expander. The shift comes based upon advice the Palo Alto, Calif.-based company received from the FDA regarding its 510(k) submission, AirXpanders said. The AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand […]
AirXpanders said the pivotal investigational device exemption trial of its AeroForm tissue expander met its primary endpoint. Results from the trial were presented at the American Society of Plastic Surgeon’s meeting in Boston. The AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to […]
Breast tissue expansion device maker AirXpanders said yesterday that it raised $28.3 million (A$36.5 million) in an oversubscribed initial public offering. Palo Alto, Calif.-based AirXpanders said it floated 73 million shares at 39¢ (A50¢) apiece, with an indicated full-diluted market capitalization of $87.7 million (A$113 million). “We are delighted with the strong response to this IPO. […]
Breast tissue expansion device maker AirXpanders said yesterday that it filed for an initial public offering in Australia, looking to raise $36.5 million Australian (about $28 million U.S.). Palo Alto, Calif.-based AirXpanders said it’s planning to float 73 million shares at A50¢ apiece. AirXpanders’ AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions […]
Breast tissue expansion device maker AirXpanders still has about $4.8 million to go to top off a hoped-for $9 million funding, which has attracted 6 unnamed investors so far.
The funding round consists of equity, options to acquire other securities, Series E preferred stock and common stock, according to an SEC filing.
Palo Alto, Calif.-based breast reconstruction company AirXpanders received European CE Mark approval for its AeroForm device, a needle-free and patient-controlled tissue expansion system.
The AeroForm system uses carbon dioxide, released by the patient using a wireless remote control unit, to stretch skin and muscles to create space for a permanent breast implant.