Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma. The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases […]
AirXpanders abruptly pulls the plug
AirXpanders (ASX:AXP) abruptly pulled the plug yesterday, saying it plans to lay off nearly all its employees and file for Chapter 7 bankruptcy by the end of the month. The Palo Alto, Calif.–based company makes the AeroForm device for post-mastectomy breast reconstruction. It’s designed to expand and stretch the skin and underlying muscle prior to […]
AirXpanders wins FDA clearance for smooth AeroForm
AirXpanders said today that it has received FDA clearance to market a smooth shell version of its AeroForm Tissue Expander. The Palo Alto, Calif.–based company makes the AeroForm device for post-mastectomy breast reconstruction. It is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of […]
AirXpanders files special FDA 510(k) seeking nod for smooth AeroForm
AirXpanders (ASX:AXP) said yesterday that it submitted a special 510(k) application with the FDA seeking approval for a smooth shell version of its AeroForm tissue expander system. The Palo Alto-based company’s AeroForm tissue expander is intended for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent […]
AirXpanders to explore ‘strategic alternatives’
AirXpanders (ASX:AXP) said yesterday that it has engaged an independent financial advisor as it begins to explore ‘strategic alternatives.’ 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 amounts of CO2 up […]
AirXpanders touts study results
AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems. The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and […]
AirXpanders closes $15m in mixed funding
AirXpanders (ASX:AXP) said today that it closed funding rounds worth approximately $15 million in total, including an approximately $11.2 million (AUD $15.7 million) rights offering and US-based private placement with approximately $3.4 million (AUD $4.6 million). The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch […]
Dr. Gawande tapped to lead Amazon-JPM-Berkshire health play | Personnel Moves – June 21, 2018
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 […]
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