Paterna Biosciences, a Salt Lake City fertility biotechnology company specializing in male reproductive medicine, has announced that the company has grown functional human sperm entirely outside the body.
The company established viability by using those sperm to fertilize human eggs and form embryos. The company believes this is a worldwide first.
“Male infertility contributes to roughly half of all cases in which couples struggle to conceive, yet there is no FDA-approved drug treatment for the condition and the field lags an estimated 30 years behind female-focused interventions,” Paterna said in a release. The statement said scientists have attempted to produce human sperm outside the body, a process known as in vitro spermatogenesis, for nearly a century and, to date, have only been successful in animal models.
“As a clinician, I often quickly reach a point with these patients where I have to look them in the eye and say there is nothing more I can do. That’s what this technology is designed to change,” said Dr. Alexander Pastuszak, a reproductive urologist and co-founder and CEO of Paterna. “For the first time, we can offer men who’ve been told there are no options a path forward that starts with their own biology. That is not a small thing, and the science is groundbreaking.”
Pastuszak said Paterna’s breakthrough came from decoding the biological instructions that guide sperm development — signals and conditions the body naturally creates — entirely in the lab. Starting from a small testicular biopsy, the Paterna team coaxed stem cells through the maturation process, producing sperm that are structurally and genetically indistinguishable from those made in the body. Early embryos formed using the lab-grown sperm show results comparable to those produced through standard in vitro fertilization.
Paterna said it plans to enter international markets in 2029 and achieve initial FDA approval of its product soon after.
