Calyxo Inc. is releasing positive study results for its kidney stone removal technology, lauding evidence showing its steerable ureteroscopic renal evacuation (SURE) system is better at removing stones than standard treatment.

Calyxo Inc.发布了其肾结石清除技术的积极研究结果，称赞有证据表明其可操纵输尿管镜肾排空（SURE）系统在清除结石方面优于标准治疗。

The prospective, randomized, multi-center ASPIRE trial examined the safety and efficacy of Calyxo's CVAC System vs. ureteroscopy (URS) with basketing. The ASPIRE study's 30-day results indicate SURE is statistically superior to standard ureteroscopy (URS) at clearing stones and leaves significantly lower residual stone volume.

前瞻性，随机，多中心ASPIRE试验检查了Calyxo的CVAC系统与输尿管镜检查（URS）的安全性和有效性。。

Unlike standard URS, the CVAC System achieved these results independent of baseline stone burden. Safety was comparable between groups. An analysis of one-year data also showed a dramatically lower number of emergency department visits, hospitalization, and/or retreatment events for SURE patients compared to URS patients..

与标准URS不同，CVAC系统实现了这些结果，而与基线石材负荷无关。各组之间的安全性相当。对一年数据的分析还显示，与URS患者相比，SURE患者的急诊就诊，住院和/或再治疗事件数量显着减少。。

“Based on our study results, the SURE procedure was determined to be a safe kidney stone treatment that delivers consistently higher stone clearance and lower residual stone volume when compared with URS,” reported urologist Thomas Chi, M.D., of the University of California, San Francisco. “This efficacy and safety data, coupled with patient outcomes through the first year of follow-up indicates significant promise for SURE procedure using the CVAC System as a potential new gold standard of treatment.” .

“根据我们的研究结果，SURE手术被确定为一种安全的肾结石治疗方法，与URS相比，其结石清除率始终更高，残留结石量更低，”加州大学旧金山分校的泌尿科医生Thomas Chi医学博士报道。“这一疗效和安全性数据，再加上随访第一年的患者结果，表明使用CVAC系统作为潜在的新治疗黄金标准的可靠程序具有重大前景。”。

Calyxo recently introduced the redesigned CVAC System, an all-in-one, complete stone clearance device integrating ureteroscopy, laser lithotripsy, irrigation, and aspiration. In the early user evaluation, 47 urologists performed 152 cases with the CVAC System and reported a 99% median stone clearance, assessed visually at the end of the procedure.

Calyxo最近推出了重新设计的CVAC系统，这是一种集输尿管镜检查，激光碎石术，冲洗和抽吸于一体的完整结石清除装置。在早期的用户评估中，47名泌尿科医生使用CVAC系统进行了152例患者，并报告了99%的中位结石清除率，并在手术结束时进行了视觉评估。

Further, the performance of the CVAC System was judged to be “better than a ureteroscope” in 98% of cases. Finally, in the 70 patients expected to require more than one ureteroscopic procedure, physicians believed that CVAC helped avoid the second procedure 77% of the time. These results were collected through physician surveys after the procedure; clinical studies are planned to confirm these findings..

此外，在98%的病例中，CVAC系统的性能被判断为“优于输尿管镜”。最后，在预计需要不止一次输尿管镜手术的70名患者中，医生认为CVAC有助于77%的时间避免第二次手术。这些结果是在手术后通过医生调查收集的；计划进行临床研究以证实这些发现。。

“Urologist feedback on the new CVAC System and the associated clinical evidence was overwhelmingly positive,' Calyxo President/CEO Joe Catanese, Ph.D., said. 'We look forward to making the technology more widely available to help more patients in the coming months.”

“泌尿科医生对新的CVAC系统和相关临床证据的反馈绝大多数是积极的，”Calyxo总裁/首席执行官JoeCatanese博士说。“我们期待着在未来几个月内更广泛地使用该技术，以帮助更多患者。”

Approximately 10% of people in the United States will have a kidney stone at some point in their lives, according to the American Urological Association. Kidney stone disease is a painful condition that brings with it significant healthcare costs (Current Urology Reports estimates $4.1 billion in annual direct treatment costs by 2030)..

根据美国泌尿外科协会的数据，大约10%的美国人在一生中的某个时候会患肾结石。肾结石病是一种痛苦的疾病，它带来了巨大的医疗保健费用（目前的泌尿科报告估计，到2030年，每年的直接治疗费用将达到41亿美元）。。

Calyxo, Inc. is a medical device company focused on improving kidney stone treatment and care by delivering solutions that enable urologists to safely, effectively and efficiently achieve positive clinical outcomes. The company is based in Pleasanton, Calif.

Calyxo，Inc.是一家医疗器械公司，专注于通过提供解决方案来改善肾结石的治疗和护理，使泌尿科医生能够安全，有效和高效地实现积极的临床结果。该公司总部位于加利福尼亚州普莱森顿。