Memphasys scheduled to complete clinical trial “by the end of the calendar year”

Clinical trials of its Felix sperm separation device for IVF clinics are now 90 per cent complete, according to reproductive technology specialist Memphasys, with the company also sharing that it now anticipates “entering larger markets earlier than previously expected” following a decision to pursue CE mark registration.

In a statement on Thursday, the company told shareholders that the trial, conducted in collaboration with Monash IVF Group, now requires “fewer than 20” more patients to be complete. 

Nine sites across Australia are currently recruiting, and the Kiba Park Clinic in Japan “may also contribute to the clinical trial, further expediting timelines.” 

“From less than 50 [per cent] completion at the start of 2024 to 90 [per cent] today, we are well on track to wrap up the trial by the end of the calendar year,” said Managing Director and CEO Dr David Ali. 

“Only a handful of patients remain, and several have already consented and are pending treatment.”

The trial aims to demonstrate the superiority of Felix versus two established sperm preparation techniques, known as swim-up and density gradient centrifugation. 

According to the company, its system is “a simple easy-to-use console and cartridge” requiring only six to seven minutes versus between 45 and 60 for the more established methods, creating productivity gains for clinicians. 

Memphasys also shared an update that it will be seeking CE mark registration in Europe “as soon as practicable… following clinical trial completion”, citing strategic advice from new regulatory consultants.

It said registration process “could take less than one year after submission to the regulatory body, making it a faster route than the Australian Therapeutic Goods Administration (TGA) process. 

“In addition, the CE mark offers significant advantages, including a broader market access as well as the ability to register with the TGA shortly after obtaining the CE mark.” 

It is preparing its technical file for submission, targeting the second half of the 2025 financial year.

Picture: credit Memphasys

Further reading

Memphasys tech shows advantages in small-scale sperm preparation trial

Memphasys progresses freeze-free semen transporter

Memphasys receives first order from Vitrolife in Japan

Memphasys Felix device in clinic use

Medical opinion lines up behind Memphasys’ sperm sorting device

Memphasys to launch new device to boost IVF success