Spermosens next-generation male fertility diagnostic product ready for clinical study
Spermosens AB ("Spermosens" or the "Company") is pleased to announce the development of the next-generation of its JUNO-Checked device, a groundbreaking product designed to assess male fertility potential. Developed in collaboration with Flex Medical Solutions (FMS), this next-generation JUNO-Checked device will play a pivotal role in the upcoming clinical study, which has recently received ethical approval to be conducted at Reproductive Medicine Center (RMC) in Malmö. The new product generation offers enhanced performance, including faster read-out times, strengthening its ability to provide valuable insights into male fertility diagnostics.
Earlier this year, Spermosens released a white paper showcasing the capabilities of the first-generation JUNO-Checked, a technology that measures the critical interaction between sperm and egg cells. This innovative solution is believed to deliver significant diagnostic value to fertility specialists, enabling more precise IVF treatment strategies.
With ethical approval in place for the clinical study at RMC in Malmö, Spermosens is fully prepared to initiate the trial. This study will gather essential data to validate the diagnostic value and clinical utility of the JUNO-Checked device, driving the Company towards commercialization and securing strategic partnerships.
Spermosens has taken decisive steps to optimize its operations and streamline resources. As part of this strategic focus on clinical evaluation and business development, the Company has reduced operational costs by over 50% as compared to 2023. These actions allow Spermosens to concentrate its resources efficiently on executing the clinical trial and scaling the production of sensors for JUNO-Checked.
The next-generation JUNO-Checked product not only offers superior performance but also underscores Spermosens’ commitment to addressing the global challenge of male infertility diagnostics. By advancing clinical validation and streamlining its operations, the Company is well-positioned to unlock significant value for both patients and shareholders alike.
CEO Tore Duvold comments: "We are fully committed to demonstrating the clinical and diagnostic value of JUNO-Checked. With ethical approval to conduct our clinical study at RMC in Malmö, this marks a crucial step forward. Our collaboration with Flex Medical Solutions has enhanced product performance, and with our leaner organization, we can now focus all efforts on the clinical trial and production. This is a defining moment for Spermosens as we move closer to market commercialization."
About Flex Medical Solutions (FMS). Flex Medical Solutions (FMS) is an industry-leading provider of medical device design, development, and manufacturing solutions. With a focus on delivering innovative, high-quality medical technologies, FMS collaborates with companies around the world to bring breakthrough medical products to market. By combining cutting-edge technology with expertise in regulatory compliance and production, FMS is committed to accelerating healthcare innovation. The collaboration with Spermosens underscores FMS’s mission to support life-changing diagnostics, especially in the field of reproductive health.
About Reproductive Medicine Center (RMC). 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 one 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 three 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.
* https://news.cision.com/se/spermosens/r/spermosens-siktar-mot-en-miljardmarknad,c3946354
For more information, please contact
Tore Duvold, CEO
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