Movano Inc., dba Movano Health, expects to launch its medical-grade smart ring, Evie, on a one-time cost basis in 2023. The digital wearable, which is designed specifically for women, collects a range of health and wellness metrics, and translates them into personalized, actionable insights for wearers and their doctors.
Women’s health startup May Health SAS has completed treatment of the first five participants in a U.S. feasibility study of its investigational Ovarian Rebalancing technique, a one-time, ultrasound-guided, transvaginal ablation procedure for women with polycystic ovary syndrome (PCOS). The novel treatment is designed to jumpstart the ovaries into releasing mature eggs in normal monthly cycles in women with PCOS-associated infertility.
Women with endometriosis may soon be able to take a simple blood test to determine if they have the condition thanks to a new test being developed by Proteomics International Pty Ltd. that detects up to 78% of women with endometriosis.
Endometriosis affects one in 10 women, but diagnosis of this fertility impairing, and often painful condition often takes a decade. A growing number of companies hope to put women with the condition on the path to treatment much sooner with new diagnostics and investors, investigators and regulators see bright opportunities in the field.
Dartmouth College spinoff Nanopath Inc. closed a $10 million series A funding round to commercialize a point-of-care biosensing platform with ultrasensitive optical detection. The startup is developing a rapid test that provides genetic information in less than 15 minutes without the need for nucleic amplification. To date, the company has generated preliminary data in two clinical indications focused on women’s health: human papillomavirus genotyping and urinary tract infection characterization.
Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
The U.S. FDA has granted 510(k) clearance to a blood-based biomarker assay for disease monitoring of patients with metastatic breast cancer (MBC). The Divitum Tka assay, developed by Uppsala, Sweden-based Biovica International AB, measures the activity of the enzyme thymidine kinase-1 (TK1) which is highly associated with cell proliferation and a predictive marker of tumor aggressiveness. It is the first liquid cancer cell proliferation biomarker assay to be approved by the FDA for use in monitoring metastatic breast cancer.
If timing is everything, Femasys Inc.’s Fembloc has everything on its side. While the company’s dual tracks addressing infertility and providing permanent contraception may appear at odds, they both serve to put greater control of reproductive decisions and treatment in the hands of women. A permanent contraceptive, Fembloc offers an alternative to surgical tubal ligation by encouraging scar tissue growth in the fallopian tubes in an office-based procedure.
Proving that reproduction remains a fecund market for investment, Israeli startup Fairtility Ltd. closed a $15 million series A funding round. Led by Boston-based Gurnet Point Capital with support from Nacre Capital and others, the round boosted Fairtility’s funding to date up to $18.5 million.