Publicly listed IVF technology innovator Memphasys (ASX: MEM) plans to kick off first sales into strategic markets by mid to late 2020 of its breakthrough Felix device, a device for separating high quality sperm from a semen sample for use in human IVF procedures.
A review of international regulatory environments by the company and its regulatory advisor had identified five countries to be the focus to target initial commercial sales of the device.
The markets, which include Japan, India, Canada, Iran and New Zealand, have regulatory frameworks that align to the Company’s commercialisation objectives of seeking early commercial sales timeframes, Memphasys Executive Chair Alison Coutts said.
“The identification of these markets demonstrates the path to commercial sales is becoming clearer, with a series of regulatory factors being a determinant in identifying these early-access targets,” she said.
With the Felix KOL evaluation program underway and cartridges and consoles continuing to be produced, Memphasys is moving quickly to introduce the Felix device throughout the international IVF market.”
A recently released independent research report by Allied Market Research on global IVF services markets found that all the countries are expected to report significant +100% growth (and in Canada’s case +230% growth) in fresh IVF cycles by 2026.
Memphasys has Key Opinion Leader (KOL) agreements in place in four of the five early-access target markets namely Japan, India, Canada and Iran.
The Company is in discussions with New Zealand-based clinics and centres with regards to appointing another KOL, which will see Memphasys hold a presence in all these early-access target markets.
In other news, Memphasys in conjunction with UNSW Sydney and Newcastle University have been awarded a three-year A$549,452 ARC Linkage Grant.
Funding will go towards research into development of scaling and optimising an efficient cell separation technology that could add significant commercial value to the Australian biomanufacturing sector
The cell separation technology would be used for both humans and animals, including for a next generation Felix device and also a device for animal artificial insemination.