We’re excited to share that our Felix™ System is nearing the completion of its clinical trial in Australia, with 95% of patient recruitment already completed. If current recruitment rates are maintained, the study is expected to conclude by the end of this calendar year. This will provide us with essential data to support our regulatory submissions and market expansion efforts. As demand for innovative fertility solutions continues to rise, Memphasys is positioning itself at the forefront of the global assisted reproductive technology (ART) market.
Global Momentum: Proven Success in Japan and India
Our Felix™ System is already making an impact in Japan, and we’ve achieved similar success in India, where we’ve seen live births and positive clinical outcomes, further validating the system’s potential. Through our collaboration with Vitrolife Japan KK, we’ve secured a solid commercial foothold in Japan, which represents a key market with about 14.5% of global ART demand.
The success we’ve experienced in Japan demonstrates the Felix™ System’s clinical efficacy. With the upcoming publication of the Australian trial results, we anticipate even stronger adoption and demand. We’re excited to see growing interest from fertility clinics in Japan, and we’re confident that the trial results will further cement our system’s reputation as a game-changer in fertility treatments.
Accelerating Market Entry Through Europe
As we near the conclusion of the trial, we are actively pursuing CE mark approval, which will help accelerate our entry into the European market and unlock access to other high-demand regions, including India. Our CE mark application is expected to be submitted soon after the trial’s completion, with regulatory clearance possible within 12 months.
Dr. David Ali, CEO of Memphasys, commented on our global expansion strategy:
“We are thrilled to announce that 95% of our trial recruitment has been completed. This milestone reflects our commitment to fast-tracking the Felix™ System’s clinical validation and underscores our dedication to bringing this innovative solution to market as quickly as possible. The CE mark approval will allow us to tap into larger markets and accelerate our commercial growth trajectory.”
Why Felix™ Is Changing the Game
The Felix™ System uses patented bio-separation technology, combining electrophoresis with proprietary size exclusion membranes to isolate the most viable sperm cells. This method significantly improves clinical outcomes by enhancing sperm selection, offering fertility clinics a more efficient and effective tool for ART procedures.
Live births have already been achieved, and we’re confident that the Felix™ System’s proven performance will be further validated by the trial results. Its ability to improve patient outcomes while giving clinics a competitive edge positions it as a leading technology in the field of ART.
Commercial Opportunities on the Horizon
As the Felix™ System nears regulatory clearance, we are excited about the growing commercial opportunities ahead. We are positioned to:
• Expand our distributor networks and partnerships, particularly in high-demand regions like Europe, Japan, and India.
• Attract strategic investors to scale operations and meet the growing global demand for innovative ART technologies.
• Drive a surge in Japanese sales, leveraging clinical validation to further strengthen our market position.
Looking Ahead: Disrupting Fertility Technology Globally
The Felix™ System is on track to disrupt traditional sperm selection methods, with early commercial success in Japan and India already showing its potential. As we near regulatory approval in Europe and other key markets, we’re ready to capitalise on the growing demand for innovative fertility technologies.
Dr. David Ali expressed his confidence in the future:
“Positive trial results will solidify the Felix™ System’s position as a leading choice for fertility clinics worldwide. We’re excited to bring this transformative technology to market and drive significant growth for Memphasys.”
With the trial nearing completion, we’re confident that the Felix™ System will be a cornerstone of our growth strategy, positioning us as a leader in the global fertility tech market.