Trailblazing biotech Memphasys Ltd has achieved a crucial step in the rollout of its IVF sperm separation technology after winning a draft certificate by the International Organisation for Standardisation, or “ISO” for its quality management system, or “QMS” for manufacturing medical devices.
The ISO 13485 certificate is the global benchmark for QMS within the medical industry established by the ISO. Having the certification is proof the company meets the comprehensive medical device requirements set out by the standard.
Crucially, Memphasys said the certificate assists with selling medical devices in high regulatory markets such as Australia, Europe and China and it is an important step for product accreditation and acceptance by customers in other regions.
The ASX-listed company is developing commercial applications in biological separations and reproductive biotechnologies led by its patented bio-separation device known as “Felix”.
Felix combines an electrical separation technique known as “electrophoresis” with proprietary size exclusion membranes to isolate the most viable sperm cells for human artificial insemination.
Essentially, Felix is a medical device that “cleans up” sperm during the IVF process and only allows the better-quality specimens to be harvested. Memphasys is aiming to create the first automated, non-DNA damaging lab instrument for sperm separation with Felix and the company is looking to make Felix the “gold standard” method for preparing sperm samples in human IVF clinics.
The audit was conducted by international regulatory accreditation body BSI.
Memphasys Executive Chairman, Alison Coutts said:
“The ISO 13485 certification is extremely important as it provides international accreditation for our QMS. Its achievement not only supports product regulatory filings in high regulatory markets but will also assist with market access in low regulatory markets.”
The company said its quality management system is implemented using the specialist Greenlight Guru software system, enabling Memphasys to manage development, production, distribution, sales, and post market surveillance and support.
Coutts said she expects the final certification will be awarded by BSI in a couple of months.
Clinical trials of Felix are set to commence in March on patients at four Monash IVF Australian clinics. 104 couples are anticipated to participate in the trials with results due by December 2022 which are expected to support regulatory filings and international commercial sales.
Results from the study will be filed in a formal regulatory submission to the Therapeutic Goods Administration, or “TGA” of Australia to support Memphasys’ application to have the Felix system approved for sale in Australia and other international markets.
Should the TGA approve the Felix device, commercial sales may be fast tracked in various countries through Asia and the Middle East.
In December last year Memphasys landed the first sale of the Felix bio-separation technology to a women’s centre in Coimbatore, India. The centre is using the system for clinical IVF with the order including a Felix console plus an initial supply of single-use cartridges. The Felix business model is based on recurring sales of the cartridges so the initial sale may be followed up with further orders.
An internationally recognised ISO certification is a vital step for Memphasys’ aim of making Felix a globally successful technology in the expanding world markets for invitro fertilisation and with clinical trials on the horizon, 2022 may hold some interesting developments for the company.
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