Memphasys receives early Thai FDA Felix approval

• Thai FDA approval received for the Felix system
• Enables earlier than planned commercial sales and distribution across Thailand
• Activates exclusive three-year distribution agreement with IVF Envimed
• Strong client response to Felix drives IVF Envimed to place an additional 100-unit order

Reproductive biotechnology company Memphasys’ (ASX: MEM) Felix system has received earlier than anticipated approval from the Thai Food and Drug Administration.

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The approval removes the final regulatory condition required to commence commercial sales under the company’s exclusive three-year distribution agreement with IVF Envimed.

Following Thai FDA approval, IVF Envimed has leveraged its well-established relationships with IVF clinics in Thailand to build early market interest in Felix.

Positive clinic response has been driven by the potential clinical benefits of Felix, including improved embryo utilisation and reduced sperm DNA fragmentation, together with its six-minute, simple and standardised sperm preparation process. In response to this positive feedback and anticipated demand, IVF Envimed has placed an additional order for 100 FelixTM cartridges and three paid consoles. This is in addition to the initial order of 100 cartridges and three consoles placed when the agreement was signed.

IVF Envimed has exclusive rights to sell and distribute the Felix system in Thailand and has a minimum contracted value of approximately $430,500 over three years.

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Marjan Mikel, NED and chair of the commercialisation committee, said that given the strong early interest generated by Envimed among Thai IVF clinics, Memphasys believes there is potential for Year 1 revenue to exceed the contracted minimum of $75,000, subject to the timing and level of customer demand.

“The early response to FelixTM from Thai IVF clinics has been extremely positive, and Envimed has responded by promptly ordering more Felix cartridges and consoles. That is exactly the commercial validation we want to see,” Mr Mikel said.

“We believe this is the start of a strong partnership with Envimed and, based on this early demand, we are confident of exceeding our Year 1 minimum contracted revenue.”

Thailand is one of South-East Asia’s largest assisted reproductive technology (ART) markets, conducting an estimated 20,000 to 30,000 IVF cycles annually across 110 registered IVF clinics nationwide. More than 95% of those cycles involve ICSI (intracytoplasmic sperm injection), underpinning strong structural demand for advanced sperm selection devices such as Felix.

The Thai approval follows the company’s recent Vietnamese regulatory approval and advances Memphasys’ South-East Asian commercialisation strategy. The Thailand agreement and the Company’s two-year agreement with TMSC Viet Nam Medical Technology Company Limited have a combined minimum contracted value of approximately A$1.0 million.

The commencement of the Thai agreement expands the Company’s growing international commercial network and provides a further pathway for converting contracted commitments into product supply and recurring cartridge sales.

MEM was down 9.09% to 0.5¢. Mkt cap $16.97M.

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