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.
Pavmed Inc. implanted its Portio system in three patients in a first-in-human (FIH) study of its intraosseous infusion system and successfully infused fluids in all patients without complications. The Portio system allows long-term direct access to bone marrow for delivery of fluids, medications and other substances in individuals with poor venous access, kidney dialysis or adverse reactions to anticoagulants.
Investors kicked in $45 million in a series C financing round for Podimetrics Inc., the maker of a device that provides early indication of developing diabetic foot ulcers. D1 Capital Partners led the round with new investor Medtech Convergence Fund and an undisclosed strategic investor. Polaris Partners and Scientific Health Developed returned for the series C, which brought the total raised by Podimetrics to date to more than $73 million.
For patients with complex fractures, bone lost to cancer or trauma and those undergoing spine surgeries, the fear of incomplete or distorted bone growth remains an acute and well-founded concern.
Boston Scientific Corp. sent warning notices of the potential for embolisms arising from use of its Spaceoar and Spaceoar Vue systems because of “inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis.”
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics.
