JUNO-Checked is Spermosens' innovative and proprietary diagnostic product designed to assess male fertility. This solution is believed to deliver significant diagnostic value to fertility specialists, enabling more precise fertility treatment strategies.

Key areas of collaboration in the MoU include:

• Distribution and commercialization of JUNO-Checked in the Japanese market.
• Regulatory approvals required for the product in Japan.
• Marketing and promotional strategies within Japan.
• Potential joint ventures or licensing arrangements.
• Technical support and after-sales services related to the product.

Tore Duvold, CEO of Spermosens, comments: “This MoU is an important milestone. The partnership will allow us to effectively leverage of an experienced regional partner in medical equipment and accelerate commercialization into the significant Japanese market. We are excited by the potential of this partnership and look forward to advancing our discussions.”

Formal negotiations are expected to commence soon, with the goal of finalising a commercial agreement to accelerate JUNO-Checked’s entry into Japan’s rapidly growing fertility market. This collaboration aligns with Spermosens’ broader strategy of expanding its global reach through strong commercial partnerships and licensing agreements, helping advance fertility treatments worldwide.

Spermosens’ regulatory investigations, conducted in collaboration with the Japan External Trade Organization (JETRO), suggest that JUNO-Checked may not require specific approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Early market entry is being evaluated, with the product expected to comply with general safety regulations, electrical safety standards, and electromagnetic compatibility requirements.

About the Japanese company. The undisclosed company operates in the medical, healthcare, and research sectors, with comprehensive functions for regulatory actions, marketing, sales and service maintenance.

About Japan’s Fertility Market. Japan is a key market for Spermosens, not only because of its size but also due to its significant growth in fertility treatments. In 2021, more than 498,000 in vitro fertilization (IVF) cycles were performed, marking an 11% increase, while nearly 68,000 babies were born through IVF (+15%). Despite the high average age of IVF patients (38-39 years), Japan’s public health insurance has covered fertility treatments since 2022, contributing to improved accessibility. However, success rates remain relatively low, at around 14%.

Sources. Asahi Shimbun, 2023. 70,000 babies born via IVF in Japan in 2021, a record high.
JETRO (Japan External Trade Organization) is a government organization promoting mutual trade and investment between Japan and the rest of the world.

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