Breakthrough Pulmonary Hypertension Treatment To Enter Pivotal Trial Before Year End
IDE trial of SoniVie’s catheter device will be the first for a denervation treatment for PAH.
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The FDA granted its breakthrough designation to SoniVie’s TIVUS and ReCor's Paradise ultrasound renal denervation systems for treating hypertension.
The UK-based company is seeking to raise a further $100m in 2021 following the recent US clearance of its first product, a daytime-use neurostimulation device for snoring and mild obstructive sleep apnea.
The deal combines two of the largest providers of sterilization and infection-prevention products to create a $4bn-plus-revenue business.