Ovarian Hyperstimulation Syndrome

NEW YORK, April 2, 2024 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women's healthcare, today announced encouraging new findings from a study evaluating how minimal controlled ovarian stimulation (COS) in combination with Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSC-IVM) to mature eggs outside of the body, affected patients' egg retrieval experiences when compared to conventional stimulation. The data analysis found that women undergoing minimal hormonal stimulation for OSC-IVM reported experiencing few side effects, lower levels of pain after retrieval, and higher satisfaction levels with the shortened stimulation procedure, compared to conventional stimulation for in vitro fertilization (IVF). "This study is significant because female patients' pain, morbidity, and inconvenience are frequently minimized and neglected in the healthcare setting, and often more so for women pursuing fertility treatments and egg or embryo freezing," said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. "We are encouraged by these and previously published efficacy data which demonstrate that combining minimal hormonal stimulation with our investigational in vitro maturation solution may help women navigating fertility treatments avoid many of the common side effects associated with the conventional IVF hormone protocol. We care about the efficacy but also about the experience." Fertilo, Gameto's lead investigational program, is a solution derived from induced pluripotent stem cells (iPSC) and designed to mature eggs outside of the body as part of minimal hormonal stimulation cycles for in vitro fertilization and egg freezing. Fertilo is cleared for commercialization in Australia and in large markets in Latin America. Gameto's goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population. In the retrospective survey study, the minimal stimulation OSC-IVM cycles were associated with significant reductions in reported side effects and levels of pain. The data analysis found that severe pain was reported by 38.46% of patients undergoing conventional COS compared to only 7.69% of participants in the minimal stimulation OSC-IVM cohort. The majority of women in the minimal stimulation OSC-IVM cohort did not experience common IVF side effects: 86% reported no breast swelling, 76% reported having no pelvic or abdominal pain, 96% reported having no nausea or vomiting, and 96% reported having no bleeding. Approximately one-third of patients undergoing conventional COS experience ovarian hyperstimulation syndrome (OHSS), a painful and potentially dangerous response to the conventional stimulation protocol, with one to five percent of cases requiring hospitalization.[1],[2] In contrast, the participants in this analysis who underwent minimal ovarian stimulation cycles followed by OSC-IVM yielded no incidence of OHSS. Furthermore, in patients who went through both cycles, 92% of patients expressed they would repeat the minimal stimulation followed by OSC-IVM cycle, relative to 77% in conventional stimulation with IVF. The retrospective survey analysis included a comparison between 110 patients who underwent minimal stimulation cycles followed by OSC-IVM, versus 48 patients who underwent conventional stimulation cycles, and a pairwise comparison with data from 13 patients who themselves underwent both cycles. The manuscript describing these data is available on a preprint server at https://www.medrxiv.org/content/10.1101/2024.03.28.24304995v1 and is concurrently undergoing scientific peer-review for potential publication. Gameto is currently engaged in rigorous preparations to meet the FDA's conditions for Phase 3 trial initiation. For more information about Gameto and how the company is redefining women's healthcare, visit gametogen.com. About 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 is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of North America's largest fertility network Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.

NEW YORK, Sept. 14, 2022 /PRNewswire/ -- Gameto, a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system, today announced that it has raised an additional $17 million in funding from global software investor Insight Partners, Future Ventures, Arcadia Investment Partners, Bold Capital Partners, Plum Alley, Myelin VC, TA Ventures, Gaingels, Korify Capital, and other existing investors. The new financing brings the total capital raised since inception to $40M. Gameto's underlying cell engineering platform was developed in stealth under a scientific research agreement with George Church's lab at Harvard Medical School. In January, Gameto announced plans for three sequenced programs. The first program, Fertilo, is a biologic for IVF and egg freezing, aiming to make the process shorter, safer, and more effective. The following programs include Deovo, an organoid of the female reproductive system, and Ameno, a cell-based therapeutic to ameliorate the health consequences of primary ovarian insufficiency and menopause. Fertilo is a biologic for egg maturation derived from engineered ovarian supporting cells to facilitate a lower hormonal burden during IVF and egg freezing. This will allow women to obtain eggs in a shorter, more natural process without the risk of ovarian hyperstimulation syndrome. Currently, egg maturation drugs are hormone-based and the process is long, and expensive, with potential side effects. Gameto aims to bring to market a new mechanism of action to both reduce the number of hormonal injections and improve the efficacy of the process. Fertilo has entered preclinical development in partnership with leading clinics in the US and in Spain, the largest ART [Assisted Reproductive Technology] market in Europe. Partner clinics include Extend Fertility, RMA, Pozitivf, Ovation Fertility, Clinica Tambre, and Hospital Ruber Internacional. Inception Fertility™ (Inception), the largest provider of comprehensive fertility services in North America, also recently launched a study with Gameto to identify new techniques to improve in-vitro maturation. Through its ancillary brands, Inception serves as a mechanism to draw participants from its ecosystem of companies to take part in this and other groundbreaking studies that will elevate sciences and advancements in ART. Inception's network of fertility clinics, The Prelude Network® (Prelude), is the largest network to partner with Gameto, as it has over 85 locations across North America. Prelude was also founded by Gameto co-founder and chairman Martin Varsavsky. "Gameto is developing novel treatments across fertility and women's health, leveraging its proprietary technology to create a robust pipeline of compelling products," said Dylan Morris, Managing Director at Insight Partners. "We are excited to partner with the Gameto team as they translate their transformational developments into therapies that will ultimately improve human lives." "We're thrilled to have Insight join us in our mission to create novel therapies that improve women's lives," said Dr. Dina Radenkovic, CEO of Gameto. "Infertility is one of the first manifestations of accelerated ovarian decline. I'm incredibly excited that Gameto's technology could enable much cheaper, safer, faster, and more effective egg freezing and IVF. Our program Fertilo could help give women the power to have families at our own pace, when and how we want to do so." In order to support preclinical testing, Gameto has significantly expanded its global footprint with a headquarters and laboratory in New York and a European office in Madrid. Simultaneously, Gameto has formed a Bioethics committee composed of Professor Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin–Madison and a leading American authority on bioethics; Leslie Schrock, author, entrepreneur, and angel investor working at the convergence of health and technology, primarily in women's and family health; and Andrew McLaughlin, former Deputy Chief Technology Officer of the United States, to ensure that Gameto's developments are used for positive change. About Gameto: Based in New York and Madrid, Gameto is a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system. Gameto brings together an experienced scientific management team with vision and passion to develop groundbreaking products for women's health. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and leader in the fertility space Martin Varsavsky as Chairman. For more information, go to gametogen.com or follow us on Twitter @gametogen. About Insight Partners: Insight Partners is a global software investor partnering with high-growth technology, software, and Internet startup and ScaleUp companies that are driving transformative change in their industries. As of June 30, 2022, the firm has over $80B in regulatory assets under management. Insight Partners has invested in more than 700 companies worldwide and has seen over 55 portfolio companies achieve an IPO. Headquartered in New York City, Insight has offices in London, Tel Aviv, and Palo Alto. Insight's mission is to find, fund, and work successfully with visionary executives, providing them with practical, hands-on software expertise to foster long-term success. Insight Partners meets great software leaders where they are in their growth journey, from their first investment to IPO. For more information on Insight and all its investments, visit insightpartners.com or follow us on Twitter @insightpartners.

Qualified study participants will receive free in vitro maturation treatment at CCRM Fertility DENVER, April 4, 2023 /PRNewswire/ -- CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication. "IVM works by minimal stimulation of the ovaries with injectable hormones and after a few days, the immature eggs are retrieved from the patient, and are then matured in our state-of-the-art IVF lab," said CCRM Fertility Research Director Ye Yuan, Ph.D. "Based on our published research, CCRM Fertility has developed a new maturation system that helps these eggs mature successfully. Once mature, the process is identical to a typical IVF cycle." No longer considered experimental by the American Society of Reproductive Medicine (ASRM), IVM requires significantly less hormonal stimulation than IVF, which dramatically reduces the number of injections patients must receive. It also reduces the side effects often present with hormone treatment, and virtually eliminates the risk of ovarian hyperstimulation syndrome (OHSS), which causes the ovaries to swell and can cause severe pain. IVM could be especially beneficial to individuals who are at greater risk of OHSS, such as those with polycystic ovary syndrome (PCOS). "While IVM is offered in other countries internationally, CCRM Fertility is paving the way to bring this treatment to the U.S., allowing alternative and less invasive options for individuals, particularly those with PCOS, looking to start, grow or complete their families," said Dr. Yuan. In two previous IVM studies conducted by CCRM Fertility, initial results found that 41% of PCOS patients who had received IVM treatment have had live births or an ongoing pregnancy. The patients in these studies had poorer prognosis (due to age and other complications) than CCRM Fertility's targeted patients for its upcoming clinical trial. CCRM Fertility expects at least comparable or even better outcomes for its current study. For inclusion in the IVM study, all of the following criteria must be fulfilled: Ages 18 – 38 years old Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve Antral follicle count (AFC) greater than 24 AMH greater than 3.5 ng/ml Body Mass Index less than 35 Accept to have embryos biopsied for PGT Intend to perform embryo transfer within 4 months after completing the IVM cycle Paternal (or donor) age <45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) >1%, motility > 20% and sperm count > 10 million per ml (so samples can be prepared through standard procedure) Patients may not have had more than two failed IVF cycles in the past. To learn more, please reach out to Rachel Makloski at [email protected]. To be considered for the IVM study, please fill out the following form. About CCRM Fertility CCRM Fertility is a global pioneer in fertility treatment, research and science. Founded by Dr. William Schoolcraft over 35 years ago, CCRM Fertility specializes in the most advanced fertility treatments, with deep expertise in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction and egg donation. CCRM Fertility leverages its own data and a dedicated team of in-house reproductive endocrinologists, embryologists and geneticists to deliver industry-leading outcomes. CCRM serves 13 major metropolitan areas with 36 locations across North American, including Atlanta, Boston, Dallas-Fort Worth, Delaware, Denver, Houston, New Jersey, New York, Northern Virginia/D.C., Minneapolis, Orange County, San Francisco Bay Area, and Toronto. CCRM Fertility is a proud strategic partner of Unified Women's Healthcare, the leading platform for women's health services. Together with our affiliated providers and businesses, we anticipate the greatest opportunities to impact every woman's health at every stage of her journey and are unparalleled in our scale and ability to adapt to address unmet and underserved needs. For more information, visit . SOURCE CCRM