Ann: Felix Data lock complete and regulatory submission commenced, page-20

Memphasys (ASX: MEM) has reached a key milestone in its push to commercialise the Felix™ System, announcing the completion of the data lock for its pivotal clinical trial. This final data validation ensures trial integrity and keeps the company on schedule for preliminary results in March 2025.

With the data locked in, the next major step is the CE Mark submission planned for June 2025, a crucial regulatory hurdle that would open the door to European market entry, followed swiftly by launches in Australia and India.

Felix™ System Progresses Towards Market Entry

The Felix™ System, Memphasys’ leading sperm separation technology, is designed to improve assisted reproductive treatments by selecting the most viable sperm cells. The completion of the clinical trial marks a significant validation step, reinforcing the potential of the technology.

Dr David Ali, Memphasys’ Managing Director & CEO, welcomed the progress:

"We are extremely pleased with the progress made in completing the data lock for the Felix™ clinical trial. This milestone ensures that we are on track to meet our timelines for releasing preliminary trial results and advancing towards the CE Mark submission."

International Expansion Strategy in Full Swing

Memphasys has been making decisive moves to establish Felix™ in key global markets.

• Japan: Memphasys’ exclusive distributor, Vitrolife Group, has already placed significant orders, supplying nine IVF clinics with Felix™ consoles and 500 single-use cartridges. Sales are expected to accelerate once preliminary clinical trial results are released, with Vitrolife actively working to position Felix™ for public health insurance coverage in Japan.
• Brazil: The company recently engaged Laboratorio Androscience, a leading Brazilian andrology clinic, to conduct clinical utility testing. This three-month study aims to benchmark Felix™ against existing sperm preparation methods, with discussions on a potential licensing deal in the pipeline.
• China: Memphasys has partnered with Heranova Lifesciences to conduct in vitro testing at Sichuan Jinxin Xinan Women & Children Hospital. The testing will assess Felix™ in both routine and challenging IVF cases, positioning the company for regulatory approvals in one of the world’s largest fertility markets.
• Middle East: An order has been secured for a demonstration unit and 30 cartridges of the Felix™ System in the UAE, underscoring strong regional interest in the technology.

The Road Ahead

With preliminary clinical trial results expected in March and the CE Mark submission slated for June, Memphasys is entering a defining period. If approvals fall into place as planned, the company will be well-positioned to bring Felix™ to market in multiple jurisdictions, potentially unlocking a significant commercial opportunity.