San Francisco and Singapore, Nov. 17, 2022 (GLOBE NEWSWIRE) --
- Funds 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 has received FDA Breakthrough Device Designation for Break WaveTM
- Strategic investment in SonoMotion strengthens Advanced MedTech’s existing global portfolio in urology and kidney stone management
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. 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.
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. Break WaveTM uses low pressure ultrasound waves to target and fragment kidney stones non-invasively, in an outpatient setting with little to no anesthesia. 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.
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.
Dr Oren Levy, Chief Executive Officer of SonoMotion, added: “With support from Advanced MedTech and Lyndon Rive, SonoMotion is on an exciting trajectory to fundamentally change how kidney stones are managed. Break WaveTM, in combination with Stone ClearTM, has the potential to deliver a new first-line treatment of kidney stones which saves OR time, reduces patient treatment costs and allows patients to resume their lives earlier. We look forward to advancing our solutions to meet the needs of urologists and patients with our innovative ultrasound technology.”
Abel Ang, Group Chief Executive of Advanced MedTech, said: “As an Integrated Urology Platform company, Advanced MedTech is in a unique position to strategically invest and support disruptive startups like SonoMotion. We have led several rounds of investment into the company because of its potential to non-invasively treat kidney stones. We look forward to working with the team as they continue to develop Break WaveTM as a truly innovative kidney stone technology platform.”
Lyndon Rive, co-lead investor, said: “I’m proud to co-lead this investment in SonoMotion alongside Advanced MedTech. Break WaveTM has the potential to be an important solution in the management of kidney stones and I’m pleased to support Oren and the team as they advance its development towards commercialization.”
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About SonoMotion:
SonoMotion is a Silicon Valley based medical device start-up that is developing non-invasive solutions for the treatment of kidney stones.
For more information on SonoMotion, please visit http://www.Sonomotion.com/
About Advanced MedTech Holdings
Advanced MedTech Holdings is a global medical technology leader with a core focus in urology devices and contract manufacturing services. The Group serves millions of patients and physicians in 100 countries worldwide. Advanced MedTech Holdings makes strategic investments in disruptive medical technology companies, strengthening its portfolio of healthcare solutions for customers around the world. Advanced MedTech Holdings is a wholly owned subsidiary of Temasek.
For more information, visit https://www.advanced-medtech.com.
Oren Levy CEO, SonoMotion oren.levy@sonomotion.com
