Kallistem has successfully produced fully formed human spermatozoa in-vitro, using patient testicular biopsies containing only immature germ cells, also called spermatogonia.

Spermatogenesis is a complex physiological process covering production of spermatozoa from male primordial germ cells through mitosis and meiosis and takes 72 days in-vivo.

Leveraging two innovative, patented technologies that can meet current regulatory standards, the company completed the process, which a number of teams worldwide have been trying to achieve for more than 15 years.

Kallistem CEO Isabelle Cuoc said: “This is a major scientific outcome that enhances both our credibility and our development potential.

“Spermatogenesis is a complex physiological process covering production of spermatozoa from male primordial germ cells through mitosis and meiosis and takes 72 days in-vivo.”

“We are targeting a global market worth several billion euros in which there are currently no players.

“This should convince future financial partners to participate in Series A funding, which we expect to take place before the end of 2015.”

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To date, the company funded its development on its own and intends to raise funds this year to streamline its plans for growth, and is also looking for partners for its expansion into the US.

Kallistem is currently undertaking a therapeutic development project for patients whose fertility is at risk. Preclinical trials are expected to last until 2016 and will be followed by clinical trials in 2017.

The company’s five-year objective is to market its technologies under license to suppliers in the assisted reproductive technology market, and also sell them directly to public and private fertility clinics.

According to the company’s estimates, male infertility treatment could provide a market worth more than €2.3bn, with more than 50,000 new patients every year.

Prime focus would be on the needs of patients with non-obstructive azoospermia, associated with very low levels of fertility or even sterility, which affects 1% of the male population.