![]() In September 2022, Break WaveTM was granted Breakthrough Device Designation by the FDA, which facilitates accelerated regulatory reviews and reduces the time needed to bring the device to market. The funds raised will be used to initiate a pivotal multicenter, international clinical study of Break WaveTM in the first half of 2023 that will support an application to the FDA for 510(k) regulatory clearance. Break WaveTM uses low pressure ultrasound waves to target and fragment kidney stones non-invasively, in an outpatient setting with little to no anesthesia. Kidney stones affect one in ten Americans at a cost of US$10 billion per yeari, placing a high burden of care and cost of treatment on healthcare systems. Funds will be used to advance the development of its novel Break WaveTM and Stone ClearTM ultrasound solutions that fragment, dislodge and expel kidney stones non-invasively. SonoMotion, a US-based medtech start-up specializing in non-invasive kidney stone management, today announces it has secured USD$12.4 million in Series C funding co-led by integrated global urology leader Advanced MedTech Holdings and SolarCity co-founder Lyndon Rive. Strategic investment in SonoMotion strengthens Advanced MedTech’s existing global portfolio in urology and kidney stone management SonoMotion has received FDA Breakthrough Device Designation for Break WaveTM 17, 2022 (GLOBE NEWSWIRE) -įunds raised will support SonoMotion’s upcoming pivotal, international, multicenter clinical trial of the Break WaveTM device and submission to the US Food & Drug Administration (FDA) for 510(k) clearance Sonomotion Raises USD$12.4 Million in Series C Funding to Advance Development of Break Wave
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