Faster, easier, fertility preservation: Gameto opens first U.S clinical site for pivotal Fertilo study
Aims to provide women with a new, less invasive option for preserving their fertility
Female-led biotech company Gameto has announced the opening of its first U.S. clinical site for enrolment in its pivotal Fertilo study - its technology that matures eggs outside the body and is therefore a less invasive and easier way for women to preserve their fertility.
The Fertilo study is designed to evaluate the efficacy and safety of the proprietary fertility preservation technology and will take place across multiple U.S. sites, with the first clinical site now open for patient enrollment.
"We are excited to mark this milestone in our efforts to advance fertility preservation," said Dr. Beryl I. Walker, CEO of Gameto.
"Opening our first U.S. clinical site is a critical step in expanding access to our innovative technology and gathering the data needed to transform the future of fertility care."
Traditional fertility preservation (egg freezing for example) can take an incredible emotional and physical toll. It relies on nearly two weeks’ worth of injections to help stimulate hormones and mature eggs. Instead, Fertilo recreates the egg maturation process in a lab setting using engineered ovarian support cells (OSCs). This replaces many of the hormone injections required and reduces fertility preservation cycles. The result is a more comfortable and less invasive experience for patients.
Dr. Walker continued, “We believe that Fertilo has the potential to change how women think about fertility preservation. By offering an innovative, non-invasive solution, we hope to make fertility preservation more accessible to those who need it, and ultimately improve the outcomes for women who wish to preserve their fertility for the future.”
The Fertilo study is expected to enroll a diverse group of participants across various stages of fertility, providing critical insights into the potential of Gameto’s technology to offer a more effective, less invasive option compared to existing methods. As the company expands its clinical trials, the hope is to gather significant data to support the broad application of this groundbreaking treatment.
The Fertilo study is part of a broader effort by Gameto to address the growing demand for fertility preservation as women delay childbearing for personal, educational, and professional reasons. The company’s technology could offer new hope for women looking to preserve their reproductive options without the need for the invasive, costly procedures typically associated with egg freezing.
Promise for IVF outcomes
Earlier this year, Gameto also announced a world-first as a baby was born from eggs matured outside of the body using its technology. The delivery was conducted at Santa Isabel Clinic, in Lima, Peru and highlighted another major application of the Fertilo technology.
Gameto is rapidly expanding the availability of Fertilo and has secured regulatory clearance in key markets such as Australia, Japan, Argentina, Paraguay, Mexico, and Peru.
Recently, the company announced a strategic partnership with IVFAustralia, a leading IVF clinic chain and part of the Virtus Health group, one of the top five global providers of assisted reproductive services.