CMR Surgical achieves a major breakthrough with FDA approval for its Versius robotic system.
- This approval allows the company to enter the expansive US healthcare market, initially focusing on gallbladder surgeries.
- The Versius system enhances surgical precision by mimicking human arm movements and is the second-most utilised robotic surgical system worldwide.
- CMR, backed by influential investors, has raised about $1 billion and employs over 500 staff, primarily in the UK.
- Regulatory approvals in other countries, such as Japan and China, are being pursued, with IPO plans under consideration for future expansion.
CMR Surgical, headquartered in Cambridge, has made a significant stride in its global expansion efforts following the FDA’s approval of its Versius robotic system. This authorisation is a critical development, enabling the company to penetrate the US healthcare market, which is considered the largest in the world. Initially, the focus will be on offering robotic-assisted gallbladder removal surgeries for patients aged 22 and above.
The design of the Versius system, which replicates the movements of a human arm, aims to increase surgeon precision and has already gained substantial traction globally. Notably, it is the second most widely used robotic surgical system, with more than 26,000 procedures completed across multiple countries, including the UK. This FDA approval further cements its burgeoning presence in the field of medical robotics.
Founded in 2014, CMR Surgical has quickly established itself as a formidable force in the medtech sector, bolstered by significant investments from international entities such as SoftBank and Tencent. The company has secured approximately $1 billion in funding, with a notable $600 million round in 2021, marking the largest private investment ever in the global medical technology industry.
The workforce at CMR comprises over 500 employees, with 400 based in the UK. This substantial talent pool supports the company’s ambitious growth strategies. As co-founder and Chief Medical Officer Mark Slack points out, obtaining FDA marketing authorisation represents a pivotal milestone for hospitals and patients, facilitating greater access to advanced surgical technologies.
CMR’s ambitions extend beyond the US, as the company seeks similar regulatory endorsements in major markets like Japan and China. Although an initial public offering was considered, CMR has yet to make formal plans. However, such a move remains a possibility, aligning with its global expansion narrative and efforts to advance robotic-assisted surgery’s accessibility and efficiency.
The FDA’s approval is a pivotal achievement for CMR Surgical, solidifying its role as a key player in the global medtech arena.
