The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.
Hypertension is a frequent chronic condition commonly affecting the elderly, but its incidence is increasing among younger individuals. The estimates predict that 1.28 billion individuals aged 30-79 are currently living with hypertension worldwide. Despite the availability of effective treatments, monotherapy often leads to resistance and the management of adverse effects remains cumbersome.
Previous studies have shown that neuroinflammation within the brain significantly contributes to the development and progression of hypertension. Neurogenic hypertension is defined as chronically high blood pressure that is initiated and maintained through excessive activity of the sympathetic nervous system, and is associated with increased activation of the kinin B1 receptor (B1R). Moreover, the dysregulation of the kallikrein kinin system and its receptors, particularly B1R, is involved in cardiovascular diseases and other pathological conditions associated with inflammation.
Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
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.
