Reproductive biotechnology company Memphasys is working with key opinion leader companies in Japan and Canada to launch “in vivo” studies for its Felix System that aids IVF conception.
A key opinion leader is an expert or thought leader within the scientific community who has earned the trust of their peers for specific concepts.
In an update on its commercialisation activities, NSW-based Memphasys says the studies are precursors to potential commercial opportunities in Japan and Canada.
Management believes its regulatory approval processes in China and the USA are also proceeding according to plans, adding initial results from the company’s clinical trial with Monash IVF in Australia are encouraging.
Felix is an automated device that quickly separates high-quality sperm from semen for use in IVF procedures and is believed to be the first automated sperm separation method for preparing non-DNA damaged sperm samples for IVF clinics.
It can process semen samples in as little as six minutes, whilst other methods of sperm preparation can take up to an hour.
Memphasys believes no other sperm separation method available offers the same combination of speed and quality of isolated sperm as Felix and the company has already secured its breakthrough sales to the Women’s Center in Coimbatore in the south of India.
India recently changed the regulation of medical devices sold in India and to all assisted reproductive technology clinical processes undertaken in the country.
Memphasys’ CEO Alison Coutts said the changes to India’s regulatory regime may have a short-term bearing on Felix’s sales but would ultimately bring more certainty and greater clarity around market governance to one of the world’s largest and most rapidly growing IVF markets.
In November, Coutts will visit India to meet with Memphasys’ partners to determine which the best way forward for the company under the new regime.
China represents another potentially massive market for Felix and Memphasys is busy with its distribution partner preparing two applications to the country’s National Medical Products Administration.
The first requests a device classification for Felix; the second seeks eligibility for the fast-tracked “Green Channel” pathway for innovative medical products.
For the USA, Memphasys reports it has submitted a meeting request to the powerful Food and Drug Administration, or “FDA” and expects to receive feedback early next year.
25 Oct 2023
