The joint healthcare venture between Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan Chase said this week it named Brigham and Women’s Hospital surgeon, New Yorker magazine staff writer and bestselling author Dr. Atul Gawande as its CEO, effective July 9. The joint venture said that the newly formed company will be headquartered in Boston, and will operate […]
AirXpanders raises $15m debt round
AirXpanders (ASX:AXP) said yesterday that it raised $15 million in debt financing from Oxford Finance, sending share prices up today in Australia. The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small […]
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 […]
AirXpanders lands $34m private placement
AirXpanders (ASX:AXP) said today that it has commitments from investors in a private placement to raise A$45 million, or $34 million USD. The Palo Alto, Calif.-based 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 […]
AirXpander’s AeroForm tissue expander transforms decades-old procedure
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 wins de novo FDA clearance for AeroForm breast tissue expander
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 raises $15m, taps medtech vet Murcray for CFO-COO role
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 CEO Muller is out | Personnel Moves
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 […]
For AirXpanders, a switch from 510(k) to de novo was no big deal
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 seeks de novo FDA nod for AeroForm
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 pivotal IDE trial meets endpoint
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 […]
MassDevice Network
@MassDevice
LinkedIn
Google+