Spermosens passes an important milestone receiving approval for significant clinical study.

Spermosens AB announces that the Swedish Ethical Review Authority has given approval for the company’s application to start a clinical study at Reproductive Medicine Center (RMC) in Malmö with JUNO-Checked to evaluate sperm quality for couples undergoing fertility treatment. This means that the company now takes the next step in validating diagnostic use of JUNO-Checked.

Spermosens recently announced a revised strategy to accelerate the development and commercialisation of the unique JUNO-Checked product designed to address male infertility, with a clinical study conducted at RMC as a cornerstone. The purpose of the study is to investigate the male fertility related to a molecular recognition between sperm cells and oocyte via binding of two important proteins. The focus will be on the JUNO-binding, which measures the binding between the IZUMO1 and the JUNO proteins. A strong correlation between the binding of these key proteins and successful fertilization of the egg, will enable clinicians to assess the fertilization potential of sperm cells more accurately, leading to a personalized and more efficient IVF treatment. A positive outcome from this study can enhance IVF treatments, become a valuable diagnostic tool for sperm banks and as well to help couples experiencing fertility challenges prior to IVF treatment. Interim results will be validated and communicated throughout the study.

CEO Tore Duvold comments: "We are very pleased to announce that we have received the necessary approval to start our clinical study passing a significant milestone on our way to commercialize JUNO-Checked.”

About Spermosens AB. Spermosens 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.

About Reproductive Medicine Center (RMC) in Malmö. RMC is a leading fertility clinic located in Malmö, Sweden, renowned for its comprehensive and advanced reproductive healthcare services. The center specializes in offering a wide range of fertility treatments, including in vitro fertilization (IVF), Intra Cytoplasmic Sperm Injection (ICSI) and other assisted reproductive technologies. With a dedicated team of experienced medical professionals, state-of-the-art facilities, and a patient-centered approach, RMC is committed to providing personalized care and achieving the best possible outcomes for individuals and couples seeking to overcome infertility. The center also actively engages in cutting-edge research to continually improve and innovate in the field of reproductive medicine.

About JUNO-Checked.  Spermosens’ product, JUNO-Checked, is an innovative diagnostic technology designed to enhance fertility treatment outcomes. This unique product focuses on evaluating sperm quality by providing precise diagnostic information, which can potentially aid in personalized fertility treatments. JUNO-Checked aims to increase fertility rates and streamline treatment processes, offering hope to individuals and couples struggling with infertility. By leveraging advanced scientific research and cutting-edge technology, Spermosens AB is committed to making a meaningful impact in the field of reproductive medicine through JUNO-Checked.

About the ART market. Globally, 3-4 million IVF treatments are performed annually, with fewer than 1 in 5 being successful. According to the latest data from 2019, more than 1 million treatment cycles were reported in Europe. Japan, one of the largest markets with a 10 percent growth rate, reported over 498,000 treatment cycles in 2021. In the USA, over 413,776 cycles of assisted reproductive technology (ART) were conducted at 453 reporting clinics in 2021. The global market for IVF is estimated to be worth approximately USD 25 billion in 2023, with an annual growth rate of about 6% projected until 2030. Spermosens estimates the sales potential for JUNO-Checked to be approximately USD 600 million, based on 3 million annual IVF treatments and an assumed average price of USD 200 per cassette. The primary market for the Company's assisted reproductive technology (ART) is the world's IVF clinics, which collectively perform over 3 million IVF treatments each year. Additionally, Spermosens is exploring adjacent market opportunities beyond IVF clinics, including sperm banks, assessing sperm quality prior to IVF treatment, and for veterinary applications.

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 26-08-2024 11:39 CET.