TGA review of breast implants has AirXpanders going flat
Health & Biotech
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One day after announcing nearly $1.9m in revenue for the June quarter, AirXpanders (ASX:AXP) is being forced to stop selling its AeroForm controlled tissue expander product.
Concerns breast implants are associated with anaplastic large cell lymphoma (ALCL) have led to the Therapeutic Goods Administration (TGA) suspending sales and distribution of all textured breast implants in Australia.
That has meant that AirXpanders, maker of breast implants, has received a notice from the TGA suspending the sales and distribution of its AeroForm products for at least six months.
A day earlier, the company was spruiking improved revenue, led by a 14 per cent growth in its US business.
Though AirXpanders is adamant its tissue expanding technology, which makes temporary devices used in patients undergoing two-stage breast reconstruction following mastectomy, is safe, the TGA says the potential risk of BIA-ALCL associated with the device outweighs any benefits of it remaining on the market.
If the TGA finds cause for concern in the products, which to date have produced zero reported cases of BIA-ALCL, it may recall and remove all remaining products.
It is the latest bit of bum news for the company, which in May was forced to slash its workforce by 45 per cent, following a 25 per cent reduction in April last year.
AXP shares have been in trading suspension since the end of March, having lost 94 per cent of their value since the start of 2018.
Frank Grillo, president and CEO, said his company was “very disappointed” in the news, though it would keep on keeping on, with US Food and Drug Administration (FDA) and European CE Mark approval expected before the year is out.
“There have been zero cases of BIA-ALCL associated with the AeroForm device, which is indicated for implantation for no more than six months,” he said.
“According to literature reviews, the median time of implantation of a breast implant and the onset of BIA-ALCL is eight years. Due to the limited history of AeroForm in Australia, TGA has preliminarily concluded that any link between the device and BIA-ALCL is yet to be seen in Australia.
“We believe the AeroForm tissue expander is safe, effective, and provides a level of convenience highly desired by patients and their surgeons. In addition, due to the much shorter implantation time, we do not believe a tissue expander should be evaluated in the same manner as a permanent breast implant.
“Regardless of the outcome of the notice, AirXpanders continues to work diligently to bring AeroForm Smooth Shell to the market as expeditiously as possible. This product will no longer have a textured shell.”