Universitair Ziekenhuis Brussel

NEW YORK, April 9, 2024 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women's healthcare, today provided an update on its clinical program for their lead asset, Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSC-IVM) to mature eggs outside of the body, and recent additions to its management team and scientific and clinical advisors. Clinical highlights Following productive discussions with the U.S. Food and Drug Administration (FDA), Gameto received tentative approval to proceed to Phase 3 trials, subject to the completion of certain assay and manufacturing requirements. This Phase 3 trial is a critical step toward a Biologic License Application (BLA) approval, with pregnancy assessed at 12 weeks of gestation as the primary efficacy endpoint. "This is a significant milestone in our journey to bring innovative treatment options to patients, and we are fully committed to meeting the rigorous standards set by the FDA to advance our product through the final phases of clinical development," said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. "IVF is a relatively new field and navigating the regulatory pathways in this industry poses unique challenges. We are grateful to the agency for their guidance and excited to have a defined path towards a potential BLA approval and market authorization in the U.S." As part of its discussions with the FDA, Gameto submitted preclinical animal data showing use of Fertilo did not lead to abnormalities in live births of mice. Mice born from eggs matured with Fertilo showed no genetic, developmental, or behavioral abnormalities, and overall no significant differences between live births compared to traditional IVM. Gameto presented these initial results at the 2023 American Society for Reproductive Medicine Congress. The manuscript describing these data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2024.04.04.588122v1 and Gameto is submitting it for scientific peer-review for potential publication. Strengthened management team with appointment of Carlos Lejtik, M.D., as Medical Director Dr. Lejtik is a gynecologist and obstetrician, specializing in human reproduction, with over 20 years of experience. He leads the clinical adoption and medical teams at Gameto. Prior to Gameto, he had extensive experience in Medical Management at Pfizer. While at Pfizer, he planned and developed in-person and digital medical education programs for primary care physicians and specialists, collaborated with national and international key opinion leaders to develop diagnostic guidelines for various medical specialties (e.g., Women's Health, Contraception, Oncology, Central Nervous System, Dermatology, Infectious Diseases, Vaccination, and Rheumatology), successfully launched and positioned female health products such as "Duavive and Sayana," and established relationships with key associations, colleges, and medical boards. Welcoming leading reproductive medicine experts Pietro Bortoletto, M.D., M.Sc., and Michel de Vos, M.D., Ph.D., as scientific and clinical advisors Dr. Bortoletto is a board-certified reproductive endocrinologist. He is currently a Reproductive Medicine Specialist, Director of Reproductive Surgery, and Co-Director of Oncofertility Program at Boston IVF in Boston, Massachusetts. He is on staff at the Beth Israel Deaconess Medical Center Department of Obstetrics & Gynecology and a clinical instructor at the Harvard Medical School. In addition to his clinical role, Dr. Bortoletto currently serves as the Interactive Associate in Chief for Fertility & Sterility as well as Media Editor for F&S Reports. Dr. de Vos has worked as a gynecologist since 2006 and currently is a senior medical director at the Centre for Reproductive Medicine at Universitair Ziekenhuis Brussel, Belgium and an associate professor in reproductive medicine at Vrije Universiteit Brussel. In 2011, ESHRE and the European Board and College of Obstetrics and Gynaecology (EBCOG) recognized him as a subspecialist in reproductive medicine and surgery. He is a principal investigator of the FOTO (Freezing Ovarian Tissue and Oocytes) consortium, encompassing oncofertility research projects at three universities in Brussels: Vrije Universiteit Brussel (VUB), Université Libre de Bruxelles (ULB) and Université Catholique de Louvain (UCL) and he is a founding member of the Belgian Fertility Education Initiative (BFEI). "We are excited to welcome Carlos, Pietro, and Michel to the Gameto team," added Dr. Christian Kramme, Chief Scientific Officer of Gameto. "All three bring deep expertise in human reproduction, endocrinology, and women's health. They will be instrumental as Gameto enters commercial markets around the world, accelerates its growth and prepares to meet the FDA's conditions for Phase 3 trial initiation. Their experience is a great complement to our team and will help us realize our mission of filling the massive gaps in fertility medicine and improving the female reproductive journey." About Fertilo 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. Gameto's goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population. Fertilo has received different regulatory classifications in foreign jurisdictions, and after consultation with national regulators, has been cleared for commercialization in Australia and in large markets in Latin America. 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.

A medical researcher has identified a genetic cause for the increased risk of low birth weight in babies born following assisted reproductive technologies such as IVF. VUB professor Claudia Spits, of the Reproduction and Genetics research group, has identified a genetic cause for the increased risk of low birth weight in babies born following assisted reproductive technologies such as IVF. "Previous studies have identified treatment-related causes for low birth weight, but this is the first time we have been able to identify an underlying genetic factor," says Professor Spits. She organised a large-scale study with Brussels IVF (the centre for reproductive medicine at UZ Brussel), the centre for medical genetics (CMG) at UZ Brussel and Maastricht University Medical Centre (UMC). Initially, she studied the DNA of babies born both from spontaneous pregnancies and after fertility treatment. She found that in both groups, a greater risk of low birth weight was associated with certain mutations in mitochondrial DNA, and that these mutations were slightly more common in children born after fertility treatment. Mitochondria are the "energy factories" in the cell that are inherited through the mother. If they do not function properly, as they develop, they can cause a variety of health problems such as cardiovascular disease and diabetes. To determine whether these mutations are transmitted from mother to child, the researchers also studied the DNA of the mothers. Analysis showed that children born after fertility treatment have more new, non-transmitted mutations than babies conceived without assistance. As a final step, the group studied oocytes obtained through hormonal stimulation and through natural cycle, to determine whether hormonal stimulation was harmful. The mitochondrial mutations did not necessarily appear to be caused by hormonal stimulation. "In particular, a combination of age-related factors in conjunction with hormonal stimulation can lead to a higher risk of abnormal oocytes," says Spits. "The risk of mutations in the oocyte's mitochondrial DNA increases with age. During a normal cycle, mechanisms exist to remove mutated oocytes and select only healthy cells. However, with hormonal stimulation to boost oocyte production, this mechanism is switched off and mutated oocytes are released." Spits' team will conduct further studies, but these insights can be immediately implemented in assisted reproductive technology (ART) treatments to limit the risk of oocytes with mutagenic mitochondria. "It appears that the larger the number of oocytes obtained after hormonal stimulation, the higher the chance of mutations. In the future, we can pay more attention to achieving a proper balance between an adequate oocyte yield and minimizing the risk of mutations." Spits concludes.

Aidoc AI identifies suspected cases of acute pulmonary embolism, enabling rapid care coordination and treatment cross-functionally with their PE Response Team LONDON, Oct. 26, 2023 /PRNewswire/ -- Aidoc today announced a pioneering collaboration with the Pulmonary Embolism Response Team (PERT) at UZ Brussel (UZB), becoming the first European hospital to use AI for cross-departmental care coordination, expediting treatment for suspected pulmonary embolism (PE) patients. Aidoc automatically flags suspected positive cases of PE and sends an automatic alert to UZ Brussel's Pulmonary Embolism Response Team (PERT), allowing for fast multidisciplinary decision-making and rapid delivery of life-saving treatment. "The use of the new application is a step forward in expediting the treatment of pulmonary embolisms because the artificial intelligence allows the images to be evaluated in a systematic manner according to predefined criteria," shared Frans Van den Bergh, interventional radiologist at UZ Brussel. Pulmonary embolism is the third most common acute cardiovascular syndrome, resulting from a blood clot obstructing a lung artery, and can be swiftly fatal without prompt diagnosis and treatment. Early initiation of treatment is associated with better outcomes, but with hospital admissions on the rise and increased demand for CT scans from emergency departments, rapid communication of results to referring physicians is a constant challenge for radiologists1,2. AI-driven PERT solutions deployed in hospitals in the United States have shown great success, resulting in 40% reduction in time-to-treatment3 and 37% decrease in the length of hospital stays4. "We are thrilled about our ongoing collaboration with Aidoc," states Marc Noppen, CEO of UZ Brussel. "I'm delighted to witness Aidoc's AI platform expand beyond radiology, delivering value to other service lines, which promises to bring huge benefits to our patients." Aidoc's always on AI has already been running at UZB, assessing all chest CT exams for PE and prioritising suspected positive cases in the radiology workflow. Now, when a suspected acute PE case is identified by Aidoc's AI, PERT members – comprising an interventional radiologist, cardiologist, pulmonologist and intensivist – receive a notification via Aidoc's mobile app. The notification includes images and clinical data including the right ventricle-to-left ventricle ratio, an important predictor of adverse outcomes in acute PE. The app's chat feature allows for secure cross-departmental discussion and for rapid action to be taken. Every step in the imaging workflow — from acquisition and algorithm activation to care escalation – is automatically facilitated by Aidoc's industry-leading operating system, the Aidoc aiOS™. "As our first partner in Europe, UZ Brussel is no stranger to AI, they were the first to implement our entire suite of Radiology AI solutions and now they are the very first hospital in Europe to deploy AI across service lines to manage and treat acute PE patients," says Jeremy De Sy, RVP Sales and Innovation Europe at Aidoc. "This innovative approach not only enhances patient care but also sets the stage for a promising future of AI-driven healthcare across Europe." About Aidoc Aidoc is a pioneering force in clinical AI. We focus on aiding and empowering healthcare teams to optimize patient treatment, which results in improved economic value and clinical outcomes. Our clinically proven AI solutions eliminate silos, increase efficiencies, and improve outcomes by delivering critical information when and where care teams need it leading to immediate collective action. Built on Aidoc's proprietary aiOS™, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in more than 1,000 medical centers worldwide, Aidoc has the most CE-marked solutions (10) in clinical AI and its AI-based solutions cover 75 percent of patient populations, enabling physicians to make informed decisions based on real-time data. Aidoc AI is always on, running in the background to change the foreground. Visit Aidoc.com to see how we are connecting all points of care with always on AI. About UZ Brussel UZ Brussel (University Hospital Brussels) has a staff of more than 4,100 employees. It is attached to the Faculty of Medicine and Pharmacy of the Vrije Universiteit Brussel (Free University of Brussels) on the Brussels Health Campus in Jette. With 721 hospital beds, it accounts for 30,779 admissions of patients each year from Belgium and abroad, 412,246 consultations (emergencies not included) and 78,840 patients at the emergency care. Its philosophy is founded on three principles: Dutch-speaking, pluralist and social. As a university hospital, it also has a teaching mission and conducts scientific research. More information can be found at . Logo: References [1] Cheikh AB, Gorincour G, Nivet H, et al. How artificial intelligence improves radiological interpretation in suspected pulmonary embolism. Eur Radiol. 2022;32(9):5831-5842. doi:10.1007/s00330-022-08645-2 [2] Smith SB, Geske JB, Maguire JM, Zane NA, Carter RE, Morgenthaler TI. Early anticoagulation is associated with reduced mortality for acute pulmonary embolism. Chest. 2010;137(6):1382-1390. doi:10.1378/chest.09-0959 [3] Gupta et al. "Mechanical Thrombectomy, Artificial Intelligence and the Activation of a Pulmonary Embolism Response Team" PERT Consortium 2022 [4] Zaiden et al, "Enhancing Patient Outcomes with an AI-Based PERT Team in a Large Academic Health System." PERT Consortium 2023. SOURCE Aidoc