Bio-separations company Memphasys, which is developing technology to improve IFV treatment, has executed an agreement for the manufacture and assembly of its revolutionary device and arranged a $4.2 million placement.
The biotech minnow has appointed W&S Plastics, which is one of the largest plastic injection moulding companies in Australia, to create its disposable cartridges – with the cartridge representing the key piece of the technology where the separation process occurs.
W&S has yielded immediate results for the Company, with the medical plastics specialist identifying an initial tooling strategy which could see the cartridges for the trial assessments with Key Opinion Leaders also prove acceptable for regulatory approval as well as commercial sales for the first 12-18 months. A more expensive tooling program is tipped to be introduced following this period.
The use of the initial tooling method improves the commercialisation process for the Felix device by the earlier introduction to market of a commercial-grade Felix device.
Commenting on the appointment, Memphasys Executive Chair Alison Coutts said:
“The appointment of W&S Plastics, who have a high level of experience in the design and manufacturing of intricate components of medical devices, is a key milestone for Memphasys as we look to realise our commercialisation goals in 2020.”
The manufacturing agreement signifies Memphasys’ imminent arrival at the commercialisation stage for its technology.
The company is only waiting for regulatory approvals with the European CE Mark targeted first, followed by TGA and FDA approval.
Memphasys plans to be in a position to launch its sales program for the Felix device in Q2 2020.
The company finds itself fully funded as it heads towards the launch of sales, following the concurrent arrangement of a $4.2 million placement.
Patersons Securities has been appointed Lead Manager the placement of approximately 180 million ordinary fully paid shares at an issue price of 2.3 cents per share.
Memphasys has received full support from current major shareholders with $850,000 from current director Andrew Goodall and $2 million from Peters Investments – the investment vehicle of prominent Australian horse owner-breeder Bob Peters.
“The completion of this placement is a strong endorsement from our shareholders in our ability to develop the Felix device to deliver improved IVF treatment results through our unique bio-separations technology,” Ms Coutts said.
“The Company is strongly focused on commercialising Felix and the support we have received allows us to enhance our focus and continue to surpass major milestones,” she said.