Brisbane's Convergence Medical on fast-track to commercialisation with FDA ‘breakthrough’ listing

Brisbane-based medical technology startup Convergence Medical is targeting 2025 to achieve the quantum leap of commercialising its world-first arthroscopic surgical robot after the device secured a place in the US Food and Drug Administration’s (FDA) Breakthrough Devices Program.

Company founder Dr Chris Jeffery, a serial entrepreneur whose successes include a public listing of hearing technology company Audeara (ASX: AUA), says FDA recognition is a significant development for the company which was only incorporated in 2022.

“Breakthrough designation is only given to products and projects that are thought to be truly and significantly transformational,” Jeffery tells Business News Australia.

“We have demonstrated initial testing that has shown our robot can execute simulated arthroscopic procedures four times quicker with a 30-times increase in precision than manual operations.”

Jeffery says just over half of the more than 50 million arthroscopic procedures performed every year have complications, largely due to the use of outdated and manual equipment.

Convergence Medical’s V01 Arthroscopic Surgical Robot has the potential to reshape the future of repairing joint injuries such as the ACL in the knee and the rotator cuff in the shoulder.

The V01 is designed to decrease the physical and cognitive burden on surgeons while enhancing operative precision and dexterity. The VO1 is said to offer 21 degrees of freedom that the company says improves operative perception and precision.

Convergence Medical’s growth has been buoyed by two capital raisings totalling $3 million in the past year, including an angel round backed by Angelloop and a recent seed round that saw a three times valuation uplift for the company.

With qualifications in electronics, medicine and business, including a history of successful startups and medical device developments, Jeffery has drawn the attention of US venture capitalists and the medical industry.

The company’s technology was a finalist in this year’s global Surgical Robotics Industry Awards and Jeffery is also set to present to a JP Morgan RESI conference in San Francisco in January.

“The business is pretty young but it’s moving very quickly,” says Jeffery, who was a finalist in the 2023 Brisbane Young Entrepreneur Awards. 

The company’s rising profile has led to San Francisco-based surgeon Dr Nicholas Colyvas being appointed chief medical officer in a move that positions Convergence Medical to tackle the lucrative US market.

“Nick is one of the most active educators and publishers on social media in the field of arthroscopy and he has also previously grown companies like myself,” Jeffery says.

“Now we have money in the bank and a globally experienced team that can guide us to developing a working demonstratable robot.

“We couldn’t be better on paper and now we are walking the path to what we believe will be a pretty exciting outcome.”

Convergence Medical is aiming to complete the pre-clinical phase of development as early as next year which will lead to an FDA 510k submission towards the end of next year.

“We’re aiming to release our first robot for clinical use to be based at San Francisco initially in November 2025,” Jeffery says.

Apart from listing Audeara, a hearing health company, on the ASX in 2021, Jeffery also founded medical device company Field Orthopaedics which teamed up with Switzerland-based Medartis last year for an exclusive global distribution partnership.

Jeffery, who graduated from medicine in 2014 and worked as a principal house officer in the orthopaedic department of Brisbane’s Princess Alexandra Hospital, began his entrepreneurial journey in 2015 while also undertaking a PhD in bionics looking at the integration between humans and robots.

Jeffery successfully translated three aspects of his PhD into three different commercial entities with the technology over the years delivering novel innovations such as headphones that optimise the sound to be perfect for the listener; immersive cameras that operate like the human eye; medical devices to treat wrist arthritis; and micro anchors and implants to improve minimally invasive surgery.

Jeffery highlights the support received by Convergence Medical from the Brisbane Economic Development Agency (BEDA) and its MedTech Initiative: Global Accelerator program which is leading the mission to the JP Morgan RESI conference in the US next year.

“We’re delighted to see Chris and the Convergence Medical team reach such an important milestone,” says BEDA's CEO Anthony Ryan.

“We understand how important it is for startups to access global markets, but the journey from ideation to launch can be complex.

“Brisbane has a history of pioneering world firsts in health and is fast establishing itself as a medtech innovation hub. We have some of the brightest minds, leading health and research institutes, and world-class innovation emerging from home-grown global organisations headquartered in Brisbane and early-stage ventures alike.

“Brisbane is also one of the largest hospital and healthcare clusters in the southern hemisphere and home to Australia’s largest research facility, the Translational Research Institute, as well as MedTech pioneers like Vaxxas and Microba who are advancing a new frontier in healthcare.”