Key results

A total of 83 couples were recruited, and 66 semen samples were analyzed. Of these, 53 cases met all inclusion criteria and were included in the final statistical analysis. All participating couples were undergoing standard IVF due to unexplained infertility, with semen samples classified as “nothing abnormal detected” (NAD) in standard testing. The median age was 34 years for both women (max 40) and men (max 50), representing a typical IVF population.

The study’s primary finding is a statistically significant positive correlation between the JUNO Score and fertilization rate, defined as the percentage of mature oocytes (MII) that developed into two-pronuclear (2PN) zygotes. This means that samples with higher JUNO Scores - reflecting stronger sperm binding to the JUNO receptor - were associated with higher fertilization rates. In contrast, fertilization rates were low in cases with low or undetectable JUNO binding.

The results demonstrate that JUNO-Checked offers a unique diagnostic value by functionally assessing sperm binding capacity – a critical step in fertilization that current methods cannot detect.

Clinical and strategic implications

Currently, there is no diagnostic tool available in clinical practice to assess the functional ability of sperm to bind to the egg. For couples where standard tests yield normal results but fertilization still fails, JUNO-Checked may offer a long-awaited explanation, enabling more individualized treatment strategies and potentially improving IVF outcomes.  

With the clinical study now successfully completed, Spermosens will focus on optimizing the JUNO-Checked system to meet commercial requirements. A bridging study is planned using the next-generation, commercially adapted version of the system to support regulatory approval and market entry. Preparation of a peer-reviewed article will begin, presenting the full analysis of the clinical study.

In parallel, Spermosens is engaged in active discussions with potential commercial partners in Europe, the US, and Japan. The positive clinical findings significantly enhance the Company’s position in these ongoing dialogues. The newly formed partnership with Scalania AG is expected to strengthen regulatory and market activities in Europe, while the collaboration with ScanMed Partners drives business development in the US. In Japan, discussions are advancing with a leading company that holds a strategic interest in assisted reproductive technologies.

Dr. Tore Duvold, CEO of Spermosens, comments: “This is the most important milestone in Spermosens’ history. For the first time, we have demonstrated a statistically significant correlation between the JUNO Score and fertilization outcomes in IVF, providing robust evidence of JUNO-Checked’s diagnostic value. These results establish a strong scientific basis for our technology and underscore the clinical relevance of assessing sperm function in cases of unexplained infertility. The technology provides insights into sperm function that are simply not accessible with current methods. These results not only validate our scientific foundation, but also highlight the clinical need for this type of diagnostic tool – especially for couples facing unexplained infertility. With this evidence in place, we will now accelerate efforts to prepare JUNO-Checked for commercial use and work with partners to bring it to IVF clinics and sperm banks worldwide.”

Dr. Ingela Soltic Liljeqvist, Principal Investigator and Embryologist at RMC, comments: “Many couples we see at the clinic suffer from unexplained infertility, where standard tests show no abnormalities, yet fertilization repeatedly fails. This can be extremely frustrating for patients and clinicians alike. What makes JUNO-Checked so important is that it gives us a new window into the fertilization process, helping us detect sperm-related issues that routine semen analysis simply cannot identify. The test has the potential to guide better treatment decisions and provide patients with more answers and, ultimately, better outcomes.”

About JUNO-Checked

JUNO-Checked is a patented diagnostic technology developed by Spermosens to assess the ability of sperm cells to bind to the JUNO receptor on the egg – a critical step in the fertilization process. This essential interaction   cannot be evaluated through conventional semen analysis. JUNO-Checked replicates this biological process by exposing sperm cells to recombinant JUNO protein and measuring their binding capacity. The result is a direct functional assessment of fertilization potential, offering a novel diagnostic parameter that enhances current fertility evaluations

The technology is designed for use   in IVF clinics and sperm banks and is particularly valuable in cases of unexplained infertility. In sperm banks, JUNO-Checked may contribute to improved donor selection and more robust quality control.

Unmet need and market potential

Male infertility is a contributing factor in approximately 50% of all infertility cases. Yet conventional semen analysis often fails to identify the cause, leaving many couples without answers, particular when IVF treatments fail despite normal test results. This diagnostic gap contributes to patient frustration, emotional distress and escalating healthcare costs.

With millions of IVF cycles performed globally each year, JUNO-Checked technology holds significant potential to improve treatment outcomes and reduce the burden of unexplained infertility.

For further information, please contact:

Tore Duvold, CEO
Email: info@spermosens.com

Spermosens AB is a pioneering biotechnology company based in Sweden, focused on advancing fertility diagnostics through science driven solutions. The company develops cutting-edge technologies designed to improve fertility outcomes and streamline treatment pathways for individuals and couples facing infertility. The proprietary product, JUNO-Checked, provides a novel diagnostic approach that enhances precision and evaluations by measuring the sperm-egg binding capacity. JUNO-Checked supports more informed clinical decisions and individualized treatments strategies. Driven by a strong commitment to scientific excellence and patient care, Spermosens collaborates with leading research institutions to deliver transformative fertility diagnostics to the global market. The company's shares are listed on the Spotlight Stock Market under the name SPERM (ISIN code SE0015346424). For more information, see www.spermosens.com

This disclosure contains information that Spermosens is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 11-06-2025 12:49 CET.