Fairtility Ltd.’s artificial intelligence (AI)-trained embryo classification system offers patients struggling with infertility and their physicians a better way to maximize the likelihood of implantation following in vitro fertilization (IVF) without the risk of a multiple pregnancy, a study in the Nature portfolio journal Scientific Reports found.
Valuations in the med-tech space lately call into question the old medical adage: “If you hear hoofbeats, think horses.” These days, you would be wise to consider unicorns in the differential diagnosis. Two new companies achieved the formerly rare status just this week. Viz.ai Inc.’s closing today of a $100 million series D financing propelled it into the stratosphere with a $1.2 billion valuation, joining Bostongene LLC which completed its own $150 million round Wednesday.
Bostongene LLC topped up its coffers with $150 million series B round, pushing its valuation over $1 billion and into unicorn territory. The med-tech industry’s latest mystical equine can whinny all the way to the bank with two other newcomers to the elite corral: Mindmaze SA and Freenome Inc., which jumped the $1 billion valuation hurdle in March and February, respectively.
Bioventus LLC continues to strengthen its portfolio through acquisitions and investments with a move to exercise its option to purchase Cartiheal Ltd. for $315 million up front and a potential payment of $135 million contingent on achievement of $100 million in trailing 12-month sales. The Cartiheal transaction follows the acquisition of Bioness Inc. and Misonix Inc. last year. Cartiheal developed the Agili-C implant, which received FDA breakthrough device designation in 2020 and premarket approval last week.
Ascensia Diabetes Care Holdings AG aims to reduce the pain associated with continuous glucose monitoring (CGM) just a bit with a new cost structure for Senseonics Holdings Inc.’ Eversense E3 CGM. The system, which lasts a ground-breaking six months without replacement, received FDA clearance in February.
T2 Biosystems Inc. is accelerating development of its T2biothreat and T2resistance panels, direct-from-blood panels that detect the six pathogens most likely to be weaponized and 13 common antibiotic resistance genes, respectively. A $4.4 million Biomedical Advanced Research and Development Authority (BARDA) cost-sharing contract will be used to advance clinical trials for the tests. The total potential funding from BARDA under the contract is $69 million.
Just nine months after a $55 million series B fundraising round, Billiontoone Inc. delivered an oversubscribed series C of $125 million. Demand for the company’s Unity prenatal test, which can assess fetal risk for common recessive conditions and aneuploidies using one maternal blood sample, tripled over the last year.
Vivosense Inc. aims to improve clinical trial recruitment and outcomes by developing new digital biomarkers and clinical outcome assessments (COAs) that use data from wearable devices, a goal made a touch easier by its successful completion of a $25 million series A financing round. The company’s platform is designed to detect and rigorously interpret subtle shifts in physiology using body-worn sensors.
After more than 10 years on the market in Europe, Staar Surgical Co. can finally see a brighter future for its newest lenses in the U.S. This week, the company received FDA premarket supplement approval of its Evo/Evo+ Visian implantable lens for the correction of myopia and myopia with astigmatism in patients aged 21 to 45. Made of a proprietary poly(2-hydroxyethyl methacrylate)-based collagen co-polymer the company calls Collamer, the lens is inserted behind the iris in a quick procedure and can be removed, if needed. Unlike laser-assisted in situ keratomileusis (LASIK), the Evo procedure does not remove corneal tissue.
Medtronic plc reported its tibial neuromodulation device was implanted in the first patient with overactive bladder as part of its Titan 2 pivotal study. The device stimulates the posterior tibial nerve near the ankle to assist in regulation of bladder function. Medtronic expects to enroll 130 patients in the study.