Memphasys believes it has found a quicker, cheaper way to get its Felix sperm separation system cleared by US regulators. It could open a door to an IVF market worth about US$5.9 billion.
The company had expected Felix to go through the FDA's De Novo pathway. That slower, more complex route is for new devices with no equivalent already on the market. After reviewing its strategy with specialist advisers, the board has now found a legally marketed device it thinks could serve as a predicate. It has not named the device.
If the FDA accepts the predicate, Felix could use its more established 510(k) pathway. Under 510(k), a company only has to show its product is substantially equivalent to a cleared device.
Memphasys said it will ask the FDA for feedback on the predicate, testing requirements and supporting evidence through a preliminary consultation called a Q Submission. It is aiming to file formally in the first quarter of calendar 2027.
About 500 US clinics offer assisted reproduction. The latest national data from the Centers for Disease Control and Prevention recorded 435,426 treatment cycles in 2022. The US makes up about 20 per cent of global IVF revenue.
The company said the US program will be ringfenced so it does not pull attention away from sales in Europe, Australia and New Zealand, Asia and the Middle East. It also said the program is not expected to significantly affect short-term cash flow.
"The Board's reassessment of our US regulatory strategy has identified a potentially faster and more direct pathway for Felix into a US$5.9 billion IVF market representing around 20% of the global market," Executive Chairman David Tasker said.
"We will pursue this opportunity in a disciplined and ringfenced manner, while maintaining our immediate focus on driving Felix adoption and revenue across Europe, ANZ, Asia and MENA."
Memphasys also reported repeat orders from clinics and partners in Italy, the United Kingdom and the Middle East. Felix uses electrophoresis and membranes to pick out the most viable sperm. It is designed to replace centrifugation, which the company says can damage DNA.
