Calyxo

What Calyxo does

Calyxo is a US-based commercial-stage medical device company that develops the FDA-cleared CVAC (Continuous Vacuum-Assisted Clearance) System for minimally invasive kidney stone removal. Founded in 2016 and headquartered in Pleasanton, California, the company employs 251-500 people and serves hospitals, ambulatory surgery centers, and endourologists performing kidney stone procedures. The SURE (Steerable Ureteroscopic Renal Evacuation) Procedure, performed exclusively with the CVAC System, uses laser lithotripsy combined with continuous irrigation and vacuum aspiration to achieve complete stone clearance. Adoption has grown sharply, with more than 40,000 patients treated cumulatively as of April 2026, up from roughly 20,000 six months earlier.

The CVAC System integrates five capabilities — direct visualization ureteroscopy, laser lithotripsy, microjet irrigation via four angled nozzles, dynamic aspiration, and stone collection — into a single device with proprietary dual-lumen continuous-flow channels that maintain stable intrarenal pressure, available in Standard and Reverse Deflection configurations. Calyxo operates a razor-and-blade commercial model, selling reusable console hardware to US hospitals and ASCs paired with single-use disposable ureteroscopes and catheters. Distribution is exclusively domestic through a direct enterprise sales force targeting high-volume stone centers and academic institutions, supported by a four-region reimbursement and market access team assisting with the dedicated HCPCS C9761 facility code ($9,672 hospital outpatient / $6,612 ASC for 2026 Medicare) and C1747 device code.

Commercial traction is anchored by an unusually deep clinical evidence base for a Series F-stage medtech: the ASPIRE randomized controlled trial (97% stone clearance vs 93% for standard ureteroscopy, p=0.036; residual stone volume 14.3 mm³ vs 70.2 mm³, p=0.012), 9 peer-reviewed publications, 45+ scientific abstracts, the CLEARANCE prospective study, and the 789-patient REASON real-world outcomes study, with authorship from KOLs at Mayo Clinic, Massachusetts General Hospital, Johns Hopkins, UC San Diego, UT Southwestern, Northwell, and Lenox Hill. The company has raised more than $122.7 million across a Series C ($32.7M, July 2022), Series D ($50M, December 2023), and Series F ($40M, April 2026), with lead investors including Questa Capital, CRG, Avidity Partners, Ally Bridge Group, and Janus Henderson Investors. The senior leadership team is largely drawn from NeoTract, the developer of the UroLift System acquired by Teleflex for $1.1 billion.

Name

Calyxo

Legal name

Calyxo, Inc.

Website

https://calyxoinc.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

251–500 employees

Short description

Calyxo is a US-based commercial-stage medical device company that develops the FDA-cleared CVAC System, an all-in-one device for kidney stone removal via continuous vacuum aspiration during ureteroscopy, sold to hospitals and ambulatory surgery centers.

Ownership category

akta.pro rank

Product category

Urology Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro industry

PRIMARYHLAHAKAI

Kidney Stone Management & Lithotripsy Devices

Healthcare & Life Sciences/Medical Devices & Diagnostics/Renal & Dialysis Devices

SECONDARYHLAHADAA

Open & Minimally Invasive Surgical Instruments (Handheld, Laparoscopic, MIS)

Healthcare & Life Sciences/Medical Devices & Diagnostics/Surgical Instruments, Endoscopy & OR Equipment

SECONDARYHLAKAOAG

Urolithiasis / Kidney Stone Centers

Healthcare & Life Sciences/Specialist Medical Practice/Urology

Keywords

• Kidney stone treatment
• Urology medical devices
• Aspiration lithotripsy systems
• Endourology devices
• Ureteroscopy equipment

Headquarters

HQ city

Pleasanton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations

Revenue model

1. CVAC System Device Sales: Calyxo generates revenue through the sale of its CVAC System, including the reusable device console/control unit and disposable components (single-use ureteroscope, steerable catheter). The system received FDA clearance and is commercially available to hospitals and ambulatory surgery centers.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Calyxo develops, manufactures, and commercializes the CVAC System, an FDA-cleared, all-in-one medical device for kidney stone treatment that integrates ureteroscopy, laser lithotripsy, microjet irrigation, dynamic vacuum aspiration, and stone collection into a single device. The CVAC System enables the SURE (Steerable Ureteroscopic Renal Evacuation) Procedure, a minimally invasive kidney stone treatment that uses continuous irrigation and vacuum aspiration to clear stone fragments during and after laser lithotripsy, achieving complete stone clearance. The company sells reusable device consoles and disposable single-use ureteroscope components to hospitals, ambulatory surgery centers, and urology practices in the United States.

Product overview

Calyxo offers a unified product portfolio centered on the CVAC System, an all-in-one FDA-cleared medical device for kidney stone treatment. The CVAC System integrates multiple capabilities—ureteroscopy, laser lithotripsy, microjet irrigation, dynamic aspiration, and stone collection—into a single device, used exclusively for the SURE (Steerable Ureteroscopic Renal Evacuation) Procedure. The company also provides CVAC Image Processor Software (v1.5) to enhance intraoperative visualization during procedures. Calyxo's products focus on achieving complete stone clearance through vacuum aspiration technology, supported by clinical evidence from randomized controlled trials and real-world studies.

Differentiator

Problem solved

Functional benefit

Brands

• SURE Procedure: Steerable Ureteroscopic Renal Evacuation (SURE) Procedure - a minimally invasive kidney stone treatment performed exclusively with the CVAC System that uses laser lithotripsy, irrigation, and vacuum aspiration to achieve complete stone clearance.

Products and services

• CVAC System An all-in-one FDA-cleared medical device for kidney stone clearance that integrates ureteroscopy, laser lithotripsy, microjet irrigation, dynamic aspiration, and stone collection into a single device. Uses irrigation and vacuum aspiration to continuously clear stone fragments during and after laser lithotripsy. Sold to hospitals and ambulatory surgery centers for use by urology departments.
• SURE Procedure The Steerable Ureteroscopic Renal Evacuation (SURE) Procedure is a minimally invasive kidney stone treatment performed exclusively with the CVAC System. It uses laser lithotripsy, irrigation, and vacuum aspiration to evacuate stone fragments during laser lithotripsy, achieving complete stone clearance. Performed by urologists for kidney stone patients.
• CVAC Image Processor Software Medical imaging software (version 1.5) that enhances intraoperative visualization during CVAC System procedures, improving image clarity and consistency throughout the kidney stone removal procedure. Bundled with the CVAC System hardware.

Quantifiable outcome

• 97% mean stone clearance (SURE) vs 93% (standard URS), p=0.036
• +6 more outcomes

Named customers8 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• EDGE Consortiumcore partnerStrategic or Co-development PartnerMulticenter research consortium conducting comparative studies of the CVAC System versus suction sheaths. Mayo Clinic Arizona and other institutions participate in EDGE research.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Boston Scientific: Diversified medtech giant with a substantial urology portfolio (including acquired Lumenis holmium lasers and LithoVue single-use ureteroscopes) that directly competes in stone-management OR equipment and could iterate integrated aspirator platforms to challenge CVAC.
• Olympus Corporation: Dominant flexible ureteroscope manufacturer and endourology incumbent; competes with Calyxo in kidney stone visualization and could pair its scopes with third-party suction sheaths to mirror a CVAC-like workflow.
• Karl Storz: Endoscopy and OR visualization leader whose flexible ureteroscopes and integrated towers serve the same endourology suite in hospitals and ASCs as the CVAC System.
• Teleflex: Acquired NeoTract/UroLift for $1.1B and now markets a major BPH device; competes indirectly for urology budget and OR time, and was the prior employer of multiple Calyxo executives.

Direct peers

• Cook Medical: Long-standing urology/stone-management supplier with ureteral access sheaths, baskets and laser fibers used in the same endourology procedures Calyxo targets with CVAC.
• Dornier MedTech: Focused lithotripsy device maker (shockwave and laser platforms) competing head-to-head with CVAC for kidney stone treatment volumes in hospitals and high-volume stone centers.
• EDAP TMS: Urology-focused device company with lithotripsy and HIFU technologies addressing the same kidney stone management indications as Calyxo's SURE procedure.
• Lumenis (Boston Scientific): Holmium laser franchise for laser lithotripsy that pairs with every flexible URS or aspiration platform — a complementary/competitive technology to the laser lithotripsy module inside the CVAC System.

Emerging players

• Shockwave Medical (Johnson & Johnson): Acquired by J&J in 2024; its intravascular lithotripsy platform demonstrates how quickly a urology-adjacent lithotripsy technology can be commercialized and absorbed — a model incumbent competitors could pursue for kidney stones.

Regional players

• Richard Wolf: European-headquartered endoscopy and urology device maker; offers ureteroscopes and stone-removal instruments serving the same endourology workflow and could be an acquisition route into European markets for CVAC.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/kalera-medical-inc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds6 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Calyxo