Calyxo

Executive Summary

Calyxo is a private medical device company developing the CVAC System, a novel all-in-one platform for the minimally invasive SURE Procedure aimed at complete kidney stone clearance. Kidney stones affect millions annually, yet current treatments like ureteroscopy and shockwave lithotripsy often leave residual fragments, leading to recurrence and additional procedures. Calyxo's technology addresses this gap by combining vision, fragmentation, and extraction in a single system, potentially enabling urologists to achieve stone-free rates approaching 100% in a single session. The company, founded in 2009 and based in Pleasanton, California, has not yet commercialized a product but has likely completed development and is pursuing regulatory clearance. If successful, the CVAC System could become a standard of care in urology, reducing repeat surgeries, healthcare costs, and patient morbidity. The market opportunity is significant, with over 2 million stone-related visits annually in the US alone. However, as a pre-commercial company, Calyxo faces risks common to early-stage medical device firms, including regulatory hurdles, competitive pressure from established players, and capital requirements for launch. Nonetheless, its innovative approach holds promise for disrupting a stagnant treatment paradigm.

Upcoming Catalysts (preview)

• Q2 2027FDA 510(k) Clearance for CVAC System60% success
• Q4 2026Pivotal Clinical Trial Results Publication70% success
• Q1 2027Strategic Partnership or Licensing Deal50% success