Azienda Ospedaliero-Universitaria Careggi

Endometriosis afflicts one in ten women and girls of reproductive age, meaning there's around 190 people with the condition, says the World Health Organisation. Researchers find endometriosis link to heart attacks and strokes, and urge clinicians to include the condition in cardiovascular disease risk assessment Women with endometriosis have a 20% increased risk of heart attack and a 35% higher risk of stroke, leading researchers have found. Researchers in Denmark compared 60,508 women with a diagnosis of endometriosis with 242,032 women of the same ages without the condition, in which endometrial tissue grows outside the uterus. During follow-up over a period of 45 years, researchers found that 17.5% of women with endometriosis had experienced either a heart attack or a stroke due to a clogged artery, compared with 15.3% of women without endometriosis. They were also found to be at higher risk for heart rhythm problems and heart failure. The researchers will present their findings at an upcoming meeting of the European Society of Cardiology in London. Although significant, the study does not prove that endometriosis was the cause of these additional health issues. “However, the findings add to a growing body of evidence that female-specific risk factors – such as endometriosis, gestational diabetes and pre-eclampsia – should be rolled into cardiovascular risk prediction models,” said study leader Dr Eva Havers-Borgersen, from Rigshospitalet Copenhagen University Hospital. Tenth of world's women suffer with endometriosis She added: “We suggest that women with endometriosis undergo cardiovascular disease risk assessment.” Endometriosis is a common, chronic and extremely painful disorder involving the tissue that lines the uterus. The disease causes tissue similar to the uterus lining to grow outside it, potentially causing severe pain in the pelvis or making it harder to get pregnant. It afflicts one in ten women and girls of reproductive age around the world, meaning there are around 190 women with the condition, according to the World Health Organization. It is not known what causes endometriosis, and currently there are no treatments to cure it – only pain-relief medicines and hormone treatments, such as the combined contraceptive pill. However, in March Israeli biotech startup Gynica launched a clinical trial for a treatment for endometriosis, raising hopes for a cure for the disease which The first-of-its-kind clinical study would evaluate the safety, tolerability, and interaction of its intra-vaginal drug delivery platform and two proprietary drug candidates, and is being conducted at Careggi University Hospital in Florence, Italy. Endometriosis drug 'an unmet need' Gynica CEO Yotam Hod said at the time of the announcement that the company was engaged in pre-clinical research and development for the past four years towards "this enormous unmet need". He added: "This trial represents a significant step forward in our mission to revolutionise care and provide a better quality of life for the millions of women worldwide suffering from endometriosis.” Pending positive Phase 1 results, the company will then begin Phase 2 efficacy trials. Gynica aims to register its solutions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Phase 1 Study Led by World-Renowned Expert Prof. Felice Petraglia to Evaluate Gynica's Non-Hormonal, Intra-Vaginal Drug Candidates In perfect timing with Endometriosis Awareness Month, the announcement of the study is one step forward for the well-being and quality of life of over 200 million women in the world FLORENCE, Italy, March 14, 2024 /PRNewswire/ -- Gynica, a clinical-stage women's health biotech startup developing a novel Endometriosis treatment, announces today the submission of a first-in-human Phase 1 trial. The global first-of-its-kind clinical study will take place at Careggi University Hospital in Florence, Italy. It will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag© intra-vaginal drug delivery platform and two proprietary drug candidates, S-301 and S-302. Gynica, which was founded in 2019, set a goal to develop a solution for one of the most common but untreated diseases in the world - Endometriosis; a debilitating disease characterised by abnormal growth of uterine-like tissue outside the uterus, has a devastating impact on the lives of over 200 million women globally - around 1 in 10 of reproductive age. The physical and emotional tolls are immense, disrupting careers, relationships, and overall quality of life for these women. Despite its widespread prevalence representing an estimated $180 billion annual market according to the World Economic Forum and Mckinsey's Health Institute, Endometriosis continues to be an underserved and underfunded area lacking truly effective treatment solutions. As awareness of this condition continues rising, there is an urgent need to develop innovative therapies that can finally provide relief and restore quality of life for the hundreds of millions profoundly impacted by endometriosis worldwide. This global-first clinical study will evaluate Gynica's proprietary pharmaceutical-standard cannabinoids-based formulations intravaginally. Through these first-of-their-kind studies, the company is leveraging the promising potential of cannabinoids as therapeutic agents in women's health. The trial will be led by world-renowned Endometriosis expert Prof. Felice Petraglia, Past President and founding member of the Society for Endometriosis and Uterine Disorders (SEUD). It will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag platform and drug candidates. During the study, the team will examine the promising potential of cannabinoids as they engage with the endocannabinoid system (ECS), which is extensively distributed in women's reproductive organs, such as the uterus and ovaries. This positioning makes the ECS a crucial target for addressing conditions like Endometriosis. In this context, cannabinoids may possess the capability to alleviate various types of Endometriosis-associated pain. Further, it can mitigate the inflammatory microenvironment associated with Endometriosis. Gynica's proprietary IntraVag technology enables controlled release and direct delivery of APIs to target organs. Gynica aims to pursue registration of its novel solutions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Pending positive Phase 1 results, the company plans to advance into Phase 2 efficacy trials rapidly. "After four years of rigorous pre-clinical research and development efforts, we are thrilled to announce this upcoming milestone during Endometriosis Awareness Month. This trial represents a significant step forward in our mission to revolutionise care and provide a better quality of life for the millions of women worldwide suffering from endometriosis. In this enormous unmet need, patients urgently seek efficient solutions," stated Yotam Hod, CEO of Gynica. "Endometriosis is now recognized as a chronic disease, and to have a non-hormonal treatment for Endometriosis-associated pain has an absolute priority for many patients who require long-term management and for the gynecologist in order to have new therapeutic options with multiple mechanisms of action, says Prof. Petraglia. SOURCE Gynica

MARLBOROUGH, Mass.--( BUSINESS WIRE )--Hologic, Inc. (Nasdaq: HOLX) continues to deliver on its commitment to advancing women’s health by unveiling new research in artificial intelligence (AI) and offering innovative educational opportunities at the annual European Congress of Radiology (ECR) in Vienna, Austria from February 28 to March 2. The pioneer behind 3D mammography, Hologic will present new data that showcase how next-generation deep-learning solutions can assist with breast cancer detection and improve workflow for radiologists. Presented by esteemed breast imaging specialist and study author Dr. Sarah M. Friedewald, Associate Professor of Radiology and Chief of Breast Imaging at Northwestern Memorial Hospital, the research shows that Hologic’s Genius AI® Detection solution has an exceptional ability to correctly match pairs of Regions of Interest (ROIs) in different views. 1 “These data reveal how AI can help us correlate ROIs in a way that we have never seen before, which underscores that deep-learning technology can supplement our workflow as radiologists and help us provide better patient care,” said Dr. Friedewald. “Beyond its impact on our daily practices, these data emphasize the transformative potential AI has to drive improvements across the breast health spectrum. I’m looking forward to sharing this information with my colleagues from around the globe at ECR.” In addition, Dr. Friedewald will also present research highlighting how the Genius AI Detection algorithm can help radiologists identify potential cancers on mammograms previously interpreted as normal. 2 In a third study, research will be presented that demonstrates Hologic’s deep learning-based AI algorithm can help significantly enhance performance, surpassing traditional machine learning Computer-Aided Detection (CAD) algorithms in specificity and overall effectiveness. 3 “Research and education are central tenets of Hologic’s innovation, to support radiologists in achieving better patient outcomes,” said Tanja Brycker, Vice President, Strategic Development, Breast & Skeletal Health and Gynecological Surgical Solutions at Hologic. “We’re excited to present groundbreaking research at ECR and to continue our collaboration with Bayer on contrast-enhanced mammography. By offering our customers the opportunity to engage with world-renowned experts and explore our latest technology, we are ensuring they feel confident in their patient care procedures and decisions.” Hologic and Bayer will co-sponsor a contrast-enhanced mammography (CEM) symposium, facilitated by globally recognized breast imaging radiologists Dr. Jacopo Nori, Chief of Breast Imaging at Careggi University Hospital in Florence, Italy, and Dr. Marc Lobbes, Chairperson of the Board, Department of Medical Imaging at Zuyderland Medical Center in Sittard-Geleen, the Netherlands. The symposium, which will take place on Thursday, February 29 at 11 a.m. CET, is designed to provide radiologists with an understanding of how CEM can be effectively implemented into their daily practice. Hologic’s Genius AI® Detection technology is a cutting-edge solution now commercially available in the U.S., with plans for rollout in Europe, Canada and Asia by the end of 2024. About Hologic, Inc. Hologic, Inc. is a global medical technology innovator focused on improving the health and well-being of women, their families and communities through early detection and treatment. Its advancements include invention of the world’s first commercial 3D mammography system to find breast cancer earlier; leadership in testing for cervical cancer, sexually transmitted infections and respiratory illnesses; and minimally invasive surgical technologies for uterine fibroids and abnormal uterine bleeding. The company also champions women through the Hologic Global Women’s Health Index , which provides a science-backed data framework for improving women’s well-being. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com . Hologic, The Science of Sure and Genius AI are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. Views and opinions expressed herein by third parties are theirs alone and do not necessarily reflect those of Hologic. Dr. Sarah M. Friedewald is a paid Hologic consultant. Source: Hologic, Inc. ____________________ 1 Correlating breast lesions in tomosynthesis CC and MLO views using artificial intelligence (AI). Authors: Sarah Friedewald (Northwestern), Chirag Phargi (Solis). Accepted as podium presentation. 2 Evaluating performance of an artificial intelligence (AI) detection system on prior screening tomosynthesis studies of breast cancer patients. Authors: Sarah Friedewald (Northwestern), Chirag Phargi (Solis). Accepted as podium presentation. 3 Performance of a traditional machine learning computer-aided detection (CADe) algorithm versus a deep learning artificial intelligence (AI) algorithm on digital breast tomosynthesis (DBT) studies. Authors: Manisha Bahl (MGH), Constance Lehman (MGH). Accepted as electronic poster.