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Gameto

Gameto

, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical trial for an induced pluripotent stem cell (iPSC)-based therapy.

一家临床阶段的生物技术公司，开发基于iPSC的女性健康疗法，今天宣布，美国食品和药物管理局（FDA）已批准其对Fertilo的研究性新药（IND）申请，以启动第一个基于美国的基于诱导多能干细胞（iPSC）疗法的3期临床试验。

This groundbreaking milestone highlights the potential of iPSC technology to address critical unmet needs in reproductive medicine..

这一开创性的里程碑突出了iPSC技术在解决生殖医学关键未满足需求方面的潜力。。

Fertilo is Gameto’s ovarian support cell (OSC) technology, designed to mature eggs outside the body using iPSC-derived cells. Unlike traditional methods, which rely on 10-14 days of high-dose hormonal stimulation to mature eggs, Fertilo uses engineered, young ovarian support cells to recreate the natural egg maturation process in a dish.

。与传统方法不同，传统方法需要10-14天的高剂量激素刺激才能使卵子成熟，Fertilo使用工程化的年轻卵巢支持细胞在培养皿中重建卵子的自然成熟过程。

This process replaces 80% of hormone injections required with traditional in vitro fertilization (IVF), and reduces the duration of treatment cycles to just 2-3 days, offering patients a more comfortable and less invasive experience. This also significantly reduces risks such as ovarian hyperstimulation syndrome and alleviates side effects caused by high-dose hormone treatments..

这一过程取代了传统体外受精（IVF）所需的80%的激素注射，并将治疗周期的持续时间缩短至仅2-3天，为患者提供了更舒适，侵入性更小的体验。这也大大降低了卵巢过度刺激综合征等风险，并减轻了高剂量激素治疗引起的副作用。。

“FDA clearance to advance Fertilo into a Phase 3 trial is a significant milestone for Gameto, and a landmark moment in iPSC technology,” said Dr. Dina Radenkovic, CEO and Co-Founder, Gameto. “We are proud to be pioneers in this field, with technology that has the potential to transform reproductive medicine.

Gameto首席执行官兼联合创始人Dina Radenkovic博士表示：“FDA批准Fertilo进入第三阶段试验是Gameto的一个重要里程碑，也是iPSC技术的一个里程碑。”。“我们为成为这一领域的先驱感到骄傲，我们的技术有可能改变生殖医学。

I’d like to express my gratitude to our team, whose work is focused on empowering women by offering a solution that is less invasive and improves the IVF journey. Fertilo is a solution for both men and women from all walks of life, offering millions of people new possibilities for family building at a time when declining birth rates present a growing global challenge.”.

我要向我们的团队表示感谢，他们的工作重点是通过提供一种侵入性较小且改善IVF旅程的解决方案来赋予女性权力。Fertilo为各行各业的男性和女性提供了一个解决方案，在出生率下降带来日益严峻的全球挑战之际，为数百万人的家庭建设提供了新的可能性。”。

The Phase 3 trial will evaluate the efficacy and safety of Fertilo in maturing healthy eggs outside of the body, yielding embryos and improving pregnancy rate assessed at 12 weeks of pregnancy, the primary efficacy endpoint for women undergoing assisted reproductive technologies. The Phase 3 study clearance follows the .

第三阶段试验将评估Fertilo在体外成熟健康卵，产生胚胎和提高妊娠率方面的功效和安全性，这是妊娠12周时评估的妊娠率，这是接受辅助生殖技术的女性的主要疗效终点。第三阶段研究许可遵循。

world’s first live human birth

世界上第一个活的人类出生

conceived using Fertilo technology, achieved at Santa Isabel Clinic in Lima, Peru, in December 2024.

使用Fertilo技术构思，于2024年12月在秘鲁利马的圣伊莎贝尔诊所实现。

Gameto will launch its Phase 3 clinical trial across 15 sites in the United States. The study will assess key outcomes, including embryo development, pregnancy rates (as a measure of efficacy), and maternal health and live birth rates (as safety endpoints). The protocol involves up to two days of hormonal injections stimulation, with up to two embryo transfers, and is open to couples struggling with infertility for at least one year.

。该研究将评估关键结果，包括胚胎发育，妊娠率（作为疗效的衡量标准）以及孕产妇健康和活产率（作为安全终点）。该方案涉及最多两天的激素注射刺激，最多两次胚胎移植，并且对患有不孕症至少一年的夫妇开放。

Participants who do not achieve pregnancy during the trial will be offered a voucher for a second attempt. The Phase 3 study will be a double-blind, randomized controlled trial to ensure robust data collection and analysis..

在试验期间未怀孕的参与者将获得第二次尝试的凭证。第三阶段研究将是一项双盲随机对照试验，以确保可靠的数据收集和分析。。

“Fertility clinics have been hoping for a solution that makes the journey towards parenthood shorter, safer and more likely,” said Martin Varsavsky, Co-Founder and Chairman, Gameto and Founder, Prelude Fertility, the largest network of IVF and fertility clinics in the United States and Canada. “Fertilo’s three-day IVF and egg freezing is the answer.”.

“生育诊所一直希望找到一种解决方案，使为人父母的旅程更短，更安全，更有可能，”美国和加拿大最大的体外受精和生育诊所Prelude Fertility联合创始人兼主席Martin Varsavsky说。“费蒂洛的三天体外受精和卵子冷冻就是答案。”。

“Gameto’s technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation,” said Dr. Christian Kramme, Chief Scientific Officer, Gameto. “With Fertilo, we’ve demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level.

Gameto首席科学官Christian Kramme博士说：“Gameto的技术平台为通过细胞工程启发的创新来应对生殖健康挑战开辟了全新的可能性。”。“通过Fertilo，我们已经证明了基于iPSC的疗法通过在细胞水平上针对卵巢健康来重新定义生育护理的潜力。

This milestone also highlights the power of iPSCs in regenerative medicine and our computational and cell engineering platform where we have broader applications including menopause and ovarian cancer.”.

这一里程碑还突出了iPSC在再生医学中的力量，以及我们的计算和细胞工程平台，我们在其中有更广泛的应用，包括更年期和卵巢癌。”。

Gameto is pioneering the use of iPSC technology in fertility care, building on Shinya Yamanaka’s Nobel Prize-winning discovery of induced pluripotent stem cells, which revolutionized regenerative medicine. As the first company to apply this technology in a Phase 3 clinical trial, Fertilo enables new possibilities in improving patient outcomes to transform fertility treatment and advance the field of cell therapy..

Gameto开创了iPSC技术在生育护理中的应用，其基础是山中伸弥（ShinyaYamanaka）获得诺贝尔奖的诱导多能干细胞发现，该发现彻底改变了再生医学。作为第一家将该技术应用于3期临床试验的公司，Fertilo为改善患者预后提供了新的可能性，以改变生育治疗并推进细胞治疗领域。。

In December 2024, Fertilo made history with the

2024年12月，费蒂洛创造了历史

world’s first live human birth

世界上第一个活的人类出生

using its Fertilo technology. By co-culturing immature eggs with Fertilo’s proprietary ovarian support cells, Gameto recreated the natural egg maturation process in the laboratory, offering a faster, safer, and more accessible fertility solution.

使用其Fertilo技术。通过将未成熟卵与Fertilo专有的卵巢支持细胞共培养，Gameto在实验室中重建了天然卵成熟过程，提供了更快，更安全，更容易获得的生育解决方案。

Gameto is actively expanding the availability of Fertilo and has secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru. The company also recently

Gameto正在积极扩大Fertilo的可用性，并已在澳大利亚、日本、阿根廷、巴拉圭、墨西哥和秘鲁获得监管许可。该公司最近也

announced a strategic partnership with IVFAustralia

宣布与IVFAustralia建立战略伙伴关系

, part of the Virtus Health group, to bring Fertilo to broader patient populations.

是Virtus Health group的一部分，旨在将Fertilo带给更广泛的患者群体。

About Gameto

关于Gameto

Gameto is a biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body.

Gameto是一家为女性健康开发新型治疗方案的生物技术公司，从不孕症开始。Gameto汇集了一支经验丰富、富有远见和激情的科学管理团队，开发一套产品套件，为女性的整个生育过程提供支持。Gameto的主导项目Fertilo旨在通过减少体外成熟卵子的激素注射，使体外受精和卵子冷冻更短，更安全，更容易获得。

Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to .

Gameto由医生出身的企业家Dina Radenkovic领导，Dina Radenkovic担任首席执行官和连续企业家，也是北美最大的生育网络之一Prelude fertility的创始人，Martin Varsavsky担任主席。。

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