SonoMotion Advances Noninvasive Kidney Stone Treatment with Key Clinical Trial and NIH Grant
SonoMotion, a pioneering company in the healthcare technology field, has made headlines by successfully completing enrollment in their SOUND Break Wave pivotal clinical trial aimed at revolutionizing kidney stone treatment. This clinical trial, which focuses on the efficacy and safety of the Break Wave system, involves 64 patients across multiple centers and aims to submit clinical findings for FDA 510(k) approval in the near future.
The Break Wave system is a noninvasive method designed to fragment kidney stones using ultrasound waves. Remarkably, it offers a treatment that can be performed in outpatient settings without the need for anesthesia, contrasting sharply with traditional methods that typically require conscious sedation or general anesthesia. Dr. James Johannes, Director at the Center of Endourology and Stone Disease, emphasized the innovative nature of Break Wave: "This technology provides patients with a noninvasive, anesthesia-free treatment option that can be implemented in various healthcare environments."
SonoMotion recently secured a $2.2 million Fastrack SBIR grant from the NIH to further enhance the development of their Break Wave technology. This funding not only validates their mission but also strengthens their capability to expedite kidney stone treatment, potentially reducing recovery times and overall costs for patients. With one in ten individuals in the United States suffering from kidney stones—resulting in costs that soar to $10 billion annually—there is significant demand for more efficient and patient-friendly solutions.
The SOUND trial will provide crucial data that will serve as the foundation for a future submission to the FDA. Positive outcomes from this study could establish the Break Wave system as a leading noninvasive treatment modality for kidney stones, addressing a critical need in outpatient care.
Previously, in October 2024, SonoMotion received FDA de novo clearance for its Stone Clear™ device, which aids in removing residual stone fragments after lithotripsy. This device shares a technological platform with the Break Wave, presenting a comprehensive solution for treating kidney stones noninvasively. As these devices work in tandem, patients stand to benefit from a holistic approach to kidney stone management.
The implications of this breakthrough extend beyond mere technological advancement; they promise to alter the lives of countless kidney stone sufferers who wish to avoid the inconveniences and risks often associated with surgical interventions. In a healthcare landscape looking for innovative, cost-effective solutions, SonoMotion is poised as a frontrunner, positioning their technology as a potential first-line treatment for kidney stones.
Dr. Oren Levy, Co-Founder and CEO of SonoMotion, remarked on the significance of the NIH grant and clinical trial: "This recognition from the NIH is a testament to our commitment to transforming kidney stone treatment. We believe the Break Wave system offers an essential alternative for patients who wish to forgo anesthesia and the complexities of traditional surgical procedures. We appreciate the hard work of our investigators and research teams who made trial enrollment possible."
To showcase their advancements, SonoMotion will participate in the upcoming American Urological Association (AUA) meeting scheduled from April 26 to 29 in Las Vegas, where they will demonstrate the Break Wave technology at booth #1807.
As we witness the development of these cutting-edge medical devices, it's clear that SonoMotion is not just improving treatment options; they are also enhancing the quality of life for patients grappling with kidney stones. With ongoing innovations, the medical community watches closely, hoping for a future without the constraints of current treatment techniques.
The Break Wave system is a noninvasive method designed to fragment kidney stones using ultrasound waves. Remarkably, it offers a treatment that can be performed in outpatient settings without the need for anesthesia, contrasting sharply with traditional methods that typically require conscious sedation or general anesthesia. Dr. James Johannes, Director at the Center of Endourology and Stone Disease, emphasized the innovative nature of Break Wave: "This technology provides patients with a noninvasive, anesthesia-free treatment option that can be implemented in various healthcare environments."
SonoMotion recently secured a $2.2 million Fastrack SBIR grant from the NIH to further enhance the development of their Break Wave technology. This funding not only validates their mission but also strengthens their capability to expedite kidney stone treatment, potentially reducing recovery times and overall costs for patients. With one in ten individuals in the United States suffering from kidney stones—resulting in costs that soar to $10 billion annually—there is significant demand for more efficient and patient-friendly solutions.
The SOUND trial will provide crucial data that will serve as the foundation for a future submission to the FDA. Positive outcomes from this study could establish the Break Wave system as a leading noninvasive treatment modality for kidney stones, addressing a critical need in outpatient care.
Previously, in October 2024, SonoMotion received FDA de novo clearance for its Stone Clear™ device, which aids in removing residual stone fragments after lithotripsy. This device shares a technological platform with the Break Wave, presenting a comprehensive solution for treating kidney stones noninvasively. As these devices work in tandem, patients stand to benefit from a holistic approach to kidney stone management.
The implications of this breakthrough extend beyond mere technological advancement; they promise to alter the lives of countless kidney stone sufferers who wish to avoid the inconveniences and risks often associated with surgical interventions. In a healthcare landscape looking for innovative, cost-effective solutions, SonoMotion is poised as a frontrunner, positioning their technology as a potential first-line treatment for kidney stones.
Dr. Oren Levy, Co-Founder and CEO of SonoMotion, remarked on the significance of the NIH grant and clinical trial: "This recognition from the NIH is a testament to our commitment to transforming kidney stone treatment. We believe the Break Wave system offers an essential alternative for patients who wish to forgo anesthesia and the complexities of traditional surgical procedures. We appreciate the hard work of our investigators and research teams who made trial enrollment possible."
To showcase their advancements, SonoMotion will participate in the upcoming American Urological Association (AUA) meeting scheduled from April 26 to 29 in Las Vegas, where they will demonstrate the Break Wave technology at booth #1807.
As we witness the development of these cutting-edge medical devices, it's clear that SonoMotion is not just improving treatment options; they are also enhancing the quality of life for patients grappling with kidney stones. With ongoing innovations, the medical community watches closely, hoping for a future without the constraints of current treatment techniques.
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