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Spermosens AB ("Spermosens" or the "Company") is pleased to announce the first interim results from its ongoing clinical study aimed at validating the diagnostic value of the patented JUNO-Checked system. The study is progressing as planned, and the first results are now being presented according to schedule. The first interim results from the clinical study show a positive correlation between higher JUNO scores, which measure the sperm cells' binding capacity to the egg, and increased fertilization rates and pregnancy outcomes following IVF treatments. JUNO-Checked, the first-ever method to measure this binding capacity, represents a groundbreaking advancement in male fertility diagnostics. The results mark a significant step in demonstrating the potential of this innovative technology to enhance fertility care.
The study, conducted at the Reproductive Medicine Center (RMC) in Malmö, has successfully recruited 25 couples, with clinical data collected from 13 cases. The interim analysis reveals several key findings that support the clinical relevance of the JUNO-Checked system. Higher JUNO scores are associated with improved fertilization rates. Positive correlation was also observed between JUNO scores and pregnancy outcomes, with higher scores correlating with an increased likelihood of successful pregnancies following IVF treatments. These findings indicate that the JUNO-Checked technology could serve as a valuable predictive diagnostic tool for enhancing fertility treatment.
In addition to its correlation with fertilization and pregnancy outcomes, the JUNO score also appears to be linked to embryo quality. High JUNO binding affinity is associated with a greater rate of high-quality embryos, emphasizing the role of sperm-egg binding capacity in determining reproductive success.
The study explores the potential impact of age on fertility outcomes. For women, the interim results show that women under 35 years demonstrate a higher level of binding between IZUMO and JUNO proteins. This finding aligns with existing knowledge that women over 35 typically exhibit lower egg and embryo quality. The data suggest an age-related factor in women that impacts the binding efficiency of IZUMO on sperm to JUNO on the egg membrane. The age range for women in the study is 29-39 years. Preliminary data for male age does not show a direct correlation between male age and the sperm's ability to bind to eggs. However, the limited sample size (n=13) requires further investigation to draw definitive conclusions. The age range for men in the study is 26-50 years.
The findings support the hypothesis that sperm binding capacity plays a critical role in fertility outcomes. They further validate the potential of Spermosens' JUNO-Checked technology to improve fertility diagnostics in IVF clinics and enhance donor selection for sperm banks. This aligns with the Company's vision of addressing critical gaps in the global assisted reproductive technology (ART) market, which is estimated to be worth USD 25 billion and growing at an annual rate of 6%.
Tore Duvold, CEO of Spermosens, comments: "We are encouraged by these early findings, which underscore the diagnostic potential of the JUNO-Checked system. As the first technology of its kind, JUNO-Checked is uniquely positioned in a large and growing market. Improving fertility care by increasing treatment success rates and aiding in donor selection for sperm banks can help individuals and couples facing infertility challenges. These results validate our approach and bring us closer to offering a solution that could transform fertility diagnostics. We remain committed to advancing this study and leveraging its outcomes to attract strategic commercial partnerships."
Maria Liljander, CSO of Spermosens, adds: "The results from this first interim analysis are promising and provide early evidence supporting the hypothesis that sperm binding capacity is a critical determinant of reproductive success. By identifying trends between JUNO scores, fertilization rates and pregnancy outcomes, we are building a strong foundation for the clinical and commercial relevance of JUNO-Checked. I look forward to continuing this important study and further validating the technology's potential to improve fertility care globally."
The ongoing study will continue to recruit additional patients, with further interim analyses planned in 2025. These milestones are expected to strengthen Spermosens' position in discussions with potential partners in Europe, the United States and Japan, paving the way for broader adoption of JUNO-Checked technology.
For more information, please contact
Tore Duvold, CEO
info@spermosens.com
Spermosens AB is a pioneering biotechnology company dedicated to advancing fertility treatments through innovative diagnostic solutions. Based in Sweden, Spermosens specializes in developing cutting-edge technologies that improve fertility outcomes and simplify the treatment process for individuals and couples facing infertility challenges. The proprietary JUNO-Checked product aims to enhance the precision and effectiveness of fertility diagnostics, ultimately helping more people achieve their dream of parenthood. Committed to scientific excellence and patient care, Spermosens collaborates with leading research institutions and commercial partners to bring transformative solutions to the market. The company's shares are listed on the Spotlight Stock Market. The shares have ISIN code SE0015346424 and are traded under the short name SPERM. 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 19-12-2024 12:21 CET.