MiMARK Diagnostics, a company specializing in women’s health, has completed its first seed funding round, raising €4.22M. The funds are intended to advance their work in gynecological diagnostics, focusing on the use of gynecological fluids as a non-invasive source for biomarker detection. The company received €1.5M from EIT Health back in 2021. MiMARK is developing in vitro diagnostic solutions for managing gynecological…
Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, is pleased to announce that it has secured an incremental $42.5 million in financing (total of $67.2M inclusive of initial April 2023 financing). The round was led by existing Gynesonics investors Amzak Health, Endeavour Vision, Kaiser Permanente Ventures, Runway Growth Capital, and Bain Capital; with new…
Health Canada has granted approval to MYFEMBREE for the management of pain related to endometriosis and heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. The drug, a joint venture between Sumitomo Pharma Canada and Pfizer Canada, is an oral combination therapy meant to be taken once daily. Endometriosis and uterine fibroids are serious health issues affecting a significant portion of…
Gynae Health startup Daye and clinical trial company Lindus Health have launched a clinical trial for a Diagnostic Tampon designed to allow women and assigned female at birth (AFAB) individuals to conduct HPV and STI tests in their homes. Supporting Daye’s mission to close the gender health gap, its Diagnostic Tampon has the potential to transform women’s experience when being screened for…
Indian femtech company Nesa Medtech has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fibroid Mapping Reviewer Application (FMRA). The Software as a Medical Device (SaMD) creates a 3D model of the uterus from ultrasound images, helping physicians diagnose and plan treatments for patients with symptomatic uterine fibroids. Uterine fibroids, also known as leiomyomas, are non-cancerous growths…
In a stride towards the development of innovative treatments for cancer, the U.S. Food and Drug Administration (FDA) has granted approval for the Phase I/II clinical trials of LBL-033, an anti-MUC16/CD3 bispecific antibody developed by Leads Biolabs. The biotech company is set to investigate the safety, efficacy, and pharmacokinetics of LBL-033 in combating advanced solid tumors, including ovarian cancer. This bispecific antibody,…
Founded in 2018 by Fahti Khosrowshahi following her personal experiences with infertility treatments, Ceek Women’s Health aims to revolutionize gynecological care. Recognizing the need for more modern, patient-friendly tools in this sector, Khosrowshahi’s company is dedicated to developing innovative solutions that elevate the standard of care women receive. With the launch of the Nella Single-Use Vaginal Speculum the company is not taking…
Women’s health focused pharma company Organon has made a $8M strategic investment in Claria Medical, a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. The agreement also grants Organon the option to acquire Claria Medical in the future. “Hysterectomy is one of the most commonly performed surgeries for women, which is why it is critical…
