Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.
Medtronic plc revealed data at the EuroPCR conference which showed there was a significant, safe and sustained blood pressure reduction in patients treated with its Spyral renal denervation system who meet European recommended guidelines criteria over a three-year period.
Aktiia SA raised $42 million in an oversubscribed series B funding round and rebranded to Hilo. The funds will be used for product innovation, expansion into new markets and to build out its blood pressure monitoring platform to support enterprise use cases.
Rona Therapeutics Co. Ltd. has obtained IND clearance from China′s National Medical Products Administration (NMPA) for RN-1871, a small interfering RNA (siRNA) drug targeting angiotensinogen (AGT) for hypertension.
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
Positive top-line data from phase II and III studies of lorundrostat for treating uncontrolled or resistant hypertension propelled Mineralys Therapeutics Inc.’s stock sharply upward on March 10. The phase III Launch-HTN study hit its primary endpoint in reducing systolic blood pressure and the phase II Advance-HTN study also met its primary endpoint of a clinically meaningful reduction in blood pressure. Oral lorundrostat targets dysregulated mineralcorticoid aldosterone as a selective aldosterone synthase inhibitor. Mineralys estimated there to be about 15- to 20-million patients with uncontrolled hypertension in the U.S. On March 10, the Radnor, Pa.-based company’s shares (NASDAQ:MLYS) closed 42% upward at $14.96 each.
Boston Scientific Corp. agreed to acquire Sonivie Ltd., developer of a therapeutic intravascular ultrasound system for denervation to treat resistant hypertension, pulmonary hypertension and chronic obstructive pulmonary disease. On a 100% basis, the deal is valued at $600 million with $400 million up front and $200 million upon achievement of a regulatory milestone.
As Wall Street looks ahead to phase III data due soon with Mineralys Therapeutics Inc.’s lorundrostat for uncontrolled or resistant hypertension, analysts are also weighing the odds of the firm in phase II with the same compound for obstructive sleep apnea.
With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination.
