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AirXpanders

Australia suspends sales of certain textured breast implants

October 3, 2019 By Nancy Crotti

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 […]

Filed Under: News Well, Oncology, Recalls, Regulatory/Compliance, Women's Health Tagged With: AirXpanders, Allergan, Australia Therapeutic Goods Administration

AirXpanders abruptly pulls the plug

July 17, 2019 By Brad Perriello

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 […]

Filed Under: Cosmetic/Aesthetic, Featured, Oncology, Wall Street Beat, Women's Health Tagged With: AirXpanders, Bankruptcy

AirXpanders wins FDA clearance for smooth AeroForm

July 15, 2019 By Nancy Crotti

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 […]

Filed Under: 510(k), Featured, News Well, Regulatory/Compliance, Women's Health Tagged With: AirXpanders, FDA

AirXpanders files special FDA 510(k) seeking nod for smooth AeroForm

May 14, 2019 By Fink Densford

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 […]

Filed Under: 510(k), Cosmetic/Aesthetic, Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: AirXpanders

AirXpanders to explore ‘strategic alternatives’

May 9, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News, Featured, Wall Street Beat Tagged With: AirXpanders

AirXpanders touts study results

April 8, 2019 By Nancy Crotti

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 […]

Filed Under: Clinical Trials, Featured, Hospital Care, Implants, News Well, Oncology, Surgical, Women's Health Tagged With: AirXpanders, Johns Hopkins University

AirXpanders closes $15m in mixed funding

September 11, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News, Funding Roundup, Wall Street Beat Tagged With: AirXpanders

Dr. Gawande tapped to lead Amazon-JPM-Berkshire health play | Personnel Moves – June 21, 2018

June 21, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: AirXpanders, Amazon, Avantis Medical Systems Inc., Berkshire Hathaway, Boston Scientific, CHF Solutions Inc., Corindus Vascular Robotics, Haemonetics, Intuitive Surgical, IsoRay, JP Morgan Chase, medicen, Medtronic, Merz, MRI Interventions, Pivot Medical, Stimwave

AirXpanders raises $15m debt round

August 8, 2017 By Brad Perriello

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 […]

Filed Under: Funding Roundup, Oncology, Women's Health Tagged With: AirXpanders

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

April 4, 2017 By Fink Densford

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 […]

Filed Under: 510(k), Cosmetic/Aesthetic, Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: AirXpanders

AirXpanders lands $34m private placement

January 27, 2017 By Sarah Faulkner

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 […]

Filed Under: Funding Roundup, Implants, Surgical, Women's Health Tagged With: AirXpanders

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