- Memphasys (MEM) reports the first live birth of a healthy baby boy in India using its Felix system at the Coimbatore Women’s Hospital Centre
- However, Memphasys has temporarily suspended sales of Felix into the country following changes introduced in August 2022 regulating all assisted reproductive therapy clinical processes and medical devices in India
- MEM has acted to address these changes by submitting a voluntary product registration and plans to manufacture its product in India to expedite the regulatory clearance of Felix
- Meanwhile, the company has completed the first commercial sale of its Felix system to a clinic in Japan
- Memphasys last traded at 1.6 cents on March 31
Reproductive biotechnology company Memphasys (MEM) has completed the first commercial sale of its Felix system to a clinic in Japan.
The Felix system is an automated, single-use cartridge that gently separates high-quality sperm from a semen sample within six minutes for use in human IVF procedures.
The sale involved 30 sterile, single-use Felix cartridges and consoles to the Kobe Assisted Reproductive Technology (ART) clinic in Japan.
The Felix system is currently available for sale across the country, where MEM has chosen to initially work with private clinics that treat self-funded patients, following the introduction of Japan’s new IVF reimbursement regime in 2022.
Meanwhile, Memphasys’ Indian key opinion leader partner, Coimbatore Women’s Hospital Centre, has reported the first live birth of a healthy baby using the Felix system.
The clinic uses Felix predominantly for males suffering from high sperm DNA fragmentation, which is common and correlated with infertility.
MEM said its key opinion leaders were “esteemed practitioners” of the global IVF sector and had traditionally been the first buyers of new products in their industry. The Coimbatore Women’s Hospital Centre has already made multiple orders for the Felix system.
However, while India represents one of the top five addressable markets globally for the Felix system, Memphasys has temporarily suspended sales of Felix into the country following changes introduced in August 2022 by the Central Drugs Standard Control Organisation (CDSCO) to regulate all ART clinical processes and devices sold in India.
MEM said it had already acted to address these changes by submitting a voluntary product registration with CDSCO and was actively planning to manufacture its product in India to expedite the regulatory clearance of Felix and reduce manufacturing costs.
Memphasys last traded at 1.6 cents on March 31.