# John McCutcheon

> John McCutcheon is President, CEO, and Director of EBR Systems, Inc., the Sunnyvale-based medical device company behind the WiSE CRT system - the world's first FDA-approved leadless solution for left ventricular pacing. With over 40 years in medical device sales, marketing, and general management, McCutcheon has shepherded EBR through pivotal clinical trials, FDA Breakthrough Device Designation, and the landmark FDA approval in April 2025. Before EBR, he led Ceterix Orthopaedics to a $105 million acquisition by Smith & Nephew. He brings a track record of building and selling medical device companies, now steering EBR's commercial launch of a technology that could transform how heart failure patients receive cardiac resynchronization therapy.

- **Role:** President and CEO at EBR Systems, Inc.
- **Organizations:** EBR Systems, Inc., Ceterix Orthopaedics, Ventus Medical, Emphasys Medical, Perclose, DVI, American Hospital Supply
- **Nationality:** American
- **Education:** B.A. in Economics, UCLA, B.A. in Psychology, UCLA, M.B.A., UCLA Anderson Graduate School of Management
- **Known for:** Led EBR Systems through FDA Breakthrough Device Designation (September 2019) and FDA approval (April 2025) of the WiSE CRT system, Oversaw the successful SOLVE-CRT pivotal clinical trial, which was halted early for success with 16.4% improvement in heart function, Secured NTAP reimbursement of up to $41,145 per case from CMS for the WiSE system

## Career timeline

- **1980s** — Began career at American Hospital Supply (later acquired by Baxter International)
- **1990s** — Moved to DVI, a medical device company later acquired by Eli Lilly
- **Late 1990s** — Joined Perclose, a vascular closure device company later acquired by Abbott Laboratories
- **2000s** — Joined Emphasys Medical (pulmonary valve devices), which was later acquired by Pulmonx
- **2010s** — Led Ventus Medical as an executive
- **2013-2019** — President and CEO of Ceterix Orthopaedics, leading the company to a $105M acquisition by Smith & Nephew
- **2019-06** — Joined EBR Systems, Inc. as President, CEO, and Director
- **2019-08** — EBR Systems closes $30M funding round simultaneously with McCutcheon's announcement as CEO
- **2019-09** — FDA grants EBR Systems Breakthrough Device Designation for the WiSE CRT system
- **2023-05** — SOLVE-CRT pivotal trial halted early for success; 16.4% improvement in heart function (p=0.003)
- **2025-01** — SOLVE-CRT study results published in JAMA Cardiology
- **2025-04** — FDA approves the WiSE CRT system - world's first leadless solution for left ventricular pacing
- **2025-04** — EBR Systems breaks ground on new 51,136 sq ft Santa Clara headquarters
- **2025-06** — First commercial implants of WiSE system at St. David's Medical Center (Austin, TX) and Cleveland Clinic
- **2025-10** — Secured NTAP reimbursement ($41,145/case) and Transitional Pass-Through Payment from CMS
- **2025-10** — Signed major purchasing agreement with HCA Healthcare

## Achievements

- Led EBR Systems through FDA Breakthrough Device Designation (September 2019) and FDA approval (April 2025) of the WiSE CRT system
- Oversaw the successful SOLVE-CRT pivotal clinical trial, which was halted early for success with 16.4% improvement in heart function
- Secured NTAP reimbursement of up to $41,145 per case from CMS for the WiSE system
- Negotiated major purchasing agreement with HCA Healthcare, one of the largest U.S. healthcare systems
- Guided the first commercial implants of the WiSE system at top-tier institutions including Cleveland Clinic and St. David's Medical Center
- As CEO of Ceterix Orthopaedics, led the company to a $105 million acquisition by Smith & Nephew
- Over 40 years in medical device sales, marketing, and general management with multiple successful exits
- Served on numerous boards of private medical device companies
- Leased 51,136 square feet in Santa Clara for EBR's new manufacturing, distribution, and R&D headquarters

## Latest updates

- **2025-10** — EBR Systems secures NTAP and TPT reimbursement for WiSE system; signs major HCA Healthcare purchasing agreement
- **2025-10** — SOLVE-CRT pivotal study results published in JAMA Cardiology
- **2025-06** — First commercial implants of WiSE CRT system completed at St. David's Medical Center and Cleveland Clinic
- **2025-04** — FDA approves WiSE CRT system - world's first leadless solution for left ventricular pacing; company breaks ground on new Santa Clara HQ
- **2025-01** — SOLVE-CRT study published in JAMA Cardiology
- **2025-03** — EBR Systems leases 51,136 sq ft in Santa Clara for expanded HQ, manufacturing, and R&D

## Links

- Website: https://ebrsystemsinc.com
- LinkedIn: http://www.linkedin.com/in/johnmccutcheon
- Twitter/X: https://twitter.com/EBRSystemsInc
- YouTube: https://www.youtube.com/watch?v=oxQYKbnDjlA

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Profile page: https://yespress.io/john-mccutcheon
Published by YesPress — https://yespress.io
Last updated: 2026-05-16