TEL AVIV, Israel, Apr 21, 2026 — BAIBYS™, an Israeli MedTech company that has developed an autonomous micro-robotic system for sperm selection in Assisted Reproductive Technology (ART), today announced a confirmed clinical pregnancy following the first successful use of its system to select and physically isolate sperm cells for Intracytoplasmic Sperm Injection (ICSI).

The First-In-Human (FIH) procedure was performed by Dr. Nino Guy Cassuto, a male fertility specialist and BAIBYS™ Co-Founder, at Laboratoire DROUOT in Paris, France, on December 10th, 2025. The system autonomously selected and physically isolated sperm cells for an ICSI procedure involving a 37-year-old patient. The pregnancy has now been confirmed following completion of the first trimester.

More than 96% of sperm cells in a typical sample are considered abnormal according to the World Health Organization (WHO). Research has suggested that sperm selection at high magnification can reduce structural birth defects by approximately 45% compared to standard ICSI (Dieamant et al., 2021), yet manual high-magnification selection has remained impractical for routine clinical use: it is subjective and inconsistent, requires extreme expertise, and takes up to three hours per procedure.

The patent-protected BAIBYS™ system classifies sperm cells based on fine morphology and motility at high microscopic magnification, according to all WHO criteria. In a validation study, the system demonstrated 95% Positive Percent of Agreement (PPA) in identifying morphologically normal sperm cells compared with human expert classifications.

Additionally, and serving as the primary differentiator, the system physically picks up and isolates the selected sperm cells into a separate droplet using robotic micro-manipulation. Existing solutions may identify and recommend cells, but require an embryologist to perform the physical pick-up manually. BAIBYS™ is the only system that performs both selection and isolation autonomously.

In practice, a clinician loads a disposable cartridge containing the sperm sample, selects the number of cells needed, and presses Start. The system then runs automatically, without any human involvement, until sufficient ideal cells are isolated into the target droplet. BAIBYS™ holds CE Mark certification (January 2025), ISO 13485:2016 certification, and US Patent No. US 2025/0266154 A1.

“This result validates the core premise behind BAIBYS™: that one of the most consequential decisions in an ART cycle, selecting which sperm cells will be used to create embryos, should not depend on subjective visual assessment. This pregnancy demonstrates that the approach works in a live clinical setting,” said Yaron Silberman, Co-CEO of BAIBYS™.

“We built BAIBYS™ to make high-magnification sperm selection accessible across all fertility clinics, enabling broader patient access to its clinical benefits,” said Gal Golov, Co-CEO and Co-Founder of BAIBYS™. “This milestone confirms that autonomous robotic sperm selection can deliver clinical results while addressing the growing shortage of skilled laboratory professionals and the global decline in sperm quantity and quality.”

The Israel Innovation Authority (IIA) awarded BAIBYS™ a grant of up to $4.3 million in December 2025, operating under a matching structure where the government contributes approximately 43 cents for every dollar of private investment raised through the end of 2026. This is the fourth IIA grant awarded to the company, bringing total IIA funding to $5.5 million. The company’s lead investor is ACP HealthTech venture capital firm from Germany.