TD System · A novel embryo transfer technology to improve pregnancy rates

Infertility affects 1 in 6 couples globally, impacting over 186 million people. Assisted reproductive treatments, such as In Vitro Fertilization (IVF), offer solutions, but success rates remain low, with fewer than 1 in 4 patients achieving a live birth. The primary cause of failure is unsuccessful embryo implantation, where embryo transfer procedure — a manual process used for over 40 years, guided by tactile sensation and the operator’s experience — plays a critical role. To address this challenge, Premium Fertility has developed the TD System, a medical device based on live imaging, automation, and robotics. This innovation allows operators to perform precise, safe, and highly controlled embryo placements into the endometrial tissue. With this groundbreaking device, we aim to achieve pregnancy rates of up to 90%, representing a leap into the future of IVF with global impact.The TD System has reached TRL 6, with a fully functional product validated as an MVP, confirming its functionality and safety for real-world use. We are now prepared to take the next steps to bring this innovation to market, focusing on (i) ensuring safety and efficacy through clinical trials in the EU and USA, and (ii) finalizing the design to meet regulatory requirements and ensure a smooth transition to mass production.With significant market potential, Premium Fertility targets IVF clinics and hospitals worldwide, offering a scalable business model through direct sales and distributor partnerships. The TD System includes consumables and maintenance services, with projected cumulative revenues of €69M by 2031. Key strategic milestones include obtaining regulatory approvals in the EU, US, and other regions, supported by clinical trials and early adopters. EIC Accelerator funding will facilitate the completion of development and clinical validation, stablishing the TD System as the gold standard in fertility clinics, enhancing patient outcomes and reducing healthcare costs.