Issue
Current in vitro fertilization (IVF) success rates yield only a 30% live birth rate per initiated cycle
The step of embryo transfer during IVF is the most critical phase in the process, and it is currently manual and operator-dependent. The process is limited by the inability to visualize the embryo’s positioning upon transfer, leading to failure when ensuring precise embryo placement and addressing uncertainties in its correct attachment
Video fragment © Schering-Plough (now Merck & Co.). Used for illustrative purposes only, with no commercial intent or ownership claim.
Particularly alarming in the USA and EU, where the average age will be 49 in 2050
Particularly alarming in the USA and EU, where the average age will be 49 in 2050
The field expects an increasing number of couples suffering from infertility and requiring assisted reproductive techniques (ART)
The field expects an increasing number of couples suffering from infertility and requiring assisted reproductive techniques (ART)
The combination of aging and a low birth rate have serious long-term implications
The combination of aging and a low birth rate have serious long-term implications
This project addresses a critical problem that represents an important barrier for millions of couples every year
This project addresses a critical problem that represents an important barrier for millions of couples every year
Premium Fertility introduces a disruptive solution: a semi-automated and controlled Transfer Direct System (TD System) that integrates optical, microfluidic, and automated components to allow operator-independent embryo placement.
The TD System disrupts the four-decade manual clinical paradigm by providing safe and consistent embryo transfer, expecting to elevate pregnancy success rates
To improve the embryo transfer procedure
Vision
To revolutionize IVF
Value proposition
• Research plans and protocols developed
• System design initiated, including the definition of specifications for critical components (e.g., external catheter, needle gauge, material type, and injection software)
• Optimization studies conducted for post-implantation monitoring
• Prospective, open-label, non-randomized, non-controlled (before-after study), single-center, intervention clinical trial
• The trial will be conducted in fifty patients under carefully controlled and intensely monitored clinical conditions
• We will evaluate and execute the necessary procedures to obtain regulatory approval in the EU (CE marking) and the USA (FDA approval) Transfer Direct System is classified as Class IIA under Rule 5 of Annex VIII of Regulation (EU) 2017/745 for medical devices
Clinical Study
Infertility is a public health issue affecting a significant number of couples, and In Vitro Fertilization (IVF) is one of the main therapeutic strategies in this field.
In this context, at Premium Fertility we are conducting a clinical study aimed at evaluating the safety and efficacy of a new embryo transfer system called the Transfer Direct System (TDS) in women of reproductive age undergoing IVF treatment.
The TDS is an investigational product designed to optimize the embryo transfer process through a controlled and automated system. As an investigational product, it has not yet been approved for commercial use by the health authorities. However, the study has been approved by a Research Ethics Committee and by the Spanish Agency of Medicines and Medical Devices (AEMPS), and is being conducted in accordance with applicable legislation.
The study, coordinated by Dr. Carlos Simón and Dr. Xavier Santamaria, is being conducted at different specialized assisted reproduction centers in Spain. Participation in the study is voluntary and takes place under medical supervision, following the principles of Good Clinical Practice.
For any enquiries, please contact us at recruitment@premiumfertility.com. This channel is for informational purposes only.
Our permanent staff includes highly qualified employees and comprises skilled personnel with a background in obstetrics and gynecology, reproductive medicine, and biomedical engineering. The Premium Fertility team also has several members with extensive experience (over twenty years) in business development and regulatory and quality affairs in the healthcare sector. Additionally, we have the support of experts in finance and accounting to guide us to market success
We are currently recruiting participants for our upcoming clinical trials. For further information on how to participate, please contact us at info@premiumfertility.com
Funded by the European Union (Grant Agreement No. 101218017). Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or the granting authority. Neither the European Union nor the granting authority can be held responsible for them
