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- AirXpanders will reduce its workforce significantly and plans to cease operations
- AirXpanders will immediately stop selling its AeroForm Tissue Expander System – used to improve breast reconstruction
- Just yesterday, the company received FDA approval for a smooth shell version of the product
- Last week AirXpanders advised the TGA it will suspend sales following review of all breast implant products
Medical technology company, AirXpanders has just announced it will no longer sell its products, effective immediately.
AirXpanders is best known for its key product, AeroForm. The AeroForm Tissue Expander System is used in patients undergoing two-stage breast reconstruction following a mastectomy. The device proved popular with patients as it was needle-free, simple to use and could be operated by patients in the comfort of their own homes.
The news comes unexpectedly as only yesterday the company announced receiving FDA approval to market a smooth shell version of its AeroForm product in the U.S.
Whilst the plastic surgery community supported the textured version of the tissue expander, CEO Frank Grillo expressed there has been a demand for a “smooth, untextured version of AeroForm.”
Last week, the company advised the Australian Therapeutic Goods Administration (TGA) it would be suspending sales of its products for six months. This followed a call for review of all registered breast implants and breast cancer.
There is a rare cancer called breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) that is often misunderstood. While it is not breast cancer, it is associated with breasts containing implants. The TGA concluded during its review, the potential risk of BIA-ALCL associated with the device outweighs any benefits of the device.
AirXpander’s AeroForm product initially experienced much success after being granted U.S. FDA de novo marketing authorisation in 2016. Company shares were trading as high as $1.18 in 2016. Shares are currently at just 3.5 cents.
In the midst of its declining success, AirXpanders plans to significantly reduce its workforce. The company plans to reduce its number of employees from 35 to eight. Further reductions are expected later in the year.
In addition, the company has notified customers it will not be providing customer service or sales support after July 18 2019. It plans to file a petition for relief this month.
