Following the welcome announcement that Virtual Incision has received FDA marketing authorization for MIRA, we spoke to Fernando Pacheco, investment director at Endeavour Vision, and board director at Virtual Incision to understand what the breakthrough will mean for healthcare providers, surgeons and patients alike…

Let’s start with the FDA marketing authorization. Why is it such a big deal for Virtual Incision?

It’s a huge achievement – largely because the US regulatory pathway for new and novel robotic-assisted surgery (RAS) devices have never been more rigorous. In the past, RAS platforms relied mostly on pre-clinical, benchtop performance and animal data to demonstrate equivalence to existing predicates. In the past few years, the FDA changed the process, and novel RAS platforms must now seek market authorization via a de novo classification pathway, which is a risk-based classification process involving extensive non-clinical and clinical performance testing to demonstrate, along with special controls, a reasonable assurance of the safety and effectiveness of the device for its intended use. Essentially the bar has been raised for any new entrant – so we have an already very complex development process (RAS platforms are very complex, highly technological devices) that now also requires a much more rigorous regulatory process.

This caught most new robot development programmes off-guard and since the new pathway came into practice, to our knowledge only one other RAS system has obtained authorization via the De Novo pathway – but for other indications. Importantly, that first one was not substantiated with US clinical data.

Virtual Incision completed one of the first investigational device exemption (IDE) US clinical trials for an RAS device in bowel resection with their MIRA system in 2021-2023, with successful colectomy procedures in 30 patients over 3 sites and 4 console surgeons. This formed the basis for the de novo submission in April 2023. Note that a tremendous amount of work went into that submission, totalling around 30,000 pages!

And it paid off. Thanks to that painstaking work, Virtual Incision is one of the first companies to obtain marketing authorization with a new RAS device in adults undergoing colectomy procedures via the de novo classification pathway. It is also the first miniaturized RAS platform.

Our understanding is that other systems are either still enrolling their own IDE trials –or seeking to use OUS registry or prospective data to substantiate their approvals. Time will tell who is successful, and when.

What’s your perspective on the importance of robotic-assisted surgery in the future – is this a big growth area?

The RAS market is massive – and underpenetrated. The global soft tissue RAS market stood at USD ~5.8bn in 2021 and is expected to continue growing at 12-14% for the next 10 years (~$21bn in 2032E, based on Goldman Sachs estimates). This is because only <10% of addressable surgeries are performed robotically – just ~2 million of up to 50 million soft tissue surgeries are carried out every year. Though penetration for RAS is still relatively low, there’s broad consensus that the market is headed that way – a trend driven by surgeon, hospital and patient preference. The increased precision and control RAS offers democratises skillsets, so that minimally-invasive surgery (MIS) can be offered more often, by a broader pool of surgeons. Over time, it is expected the clinical benefit will be hard to deny, especially as technologies (incl. digital / AI) and techniques improve further. What makes this sector particularly unique, is that it is currently dominated by a single well-known player that has >99% of the market. Beyond this, most public device companies active in soft tissue surgery have also focused on the soft tissue robotics space, spending billions on M&A or on internal R&D projects. On the private company side, no new robot has reached the US market successfully.

Cost, efficiency, and size/utilisation remain limiting factors for RAS adoption, which has driven its selective use, and continued under penetration – today being used mostly for more complex, lower volume procedures (such as prostatectomy). Mainframe robots cost a few million USD up-front and a few thousand USD per case in direct costs to operate. They also bring scheduling and access challenges, with higher indirect costs due to the 30min+ set-up time for each patient, as well as the inability to efficiently move the robot to other operating rooms (limiting it to large operating rooms only). Unsurprisingly, only ~10% of US operating rooms have access to RAS today, and it remains exclusively for inpatient usage – even with the push to move procedures to lower acuity sites of care (outpatient and ambulatory surgery centres).

As one surgeon recently put it during a Wall Street analyst interview, “you don’t need a Lamborghini to run out for groceries” (TD Cowen). In other words, there’s a clear opportunity for an alternative form-factor, beyond ‘mainframe’ systems, to help expand the market and drive RAS penetration across more procedures and sites of service. And that’s where MIRA comes in.

In that context, how is MIRA positioned and why do you think it will be a winner?

It’s all in the compact design. MIRA is the world’s first miniaturized RAS system, enabling a ‘tray-to-table’ concept that makes any operating room RAS-capable in a matter of minutes. This is enabled from the use of unique IP and small motors in the robots’ arms, that work within body – versus driving them at a distance from outside the body.

This unique design has drawn significant attention from surgeons and hospital administrators alike, who see the value of increasing their capacity to perform surgery robotically. Moreover, the unique tech also means lower upfront and usage costs, not to mention the flexibility of using any operating theatre without the need for a dedicated ‘robotics’ team. Ultimately, it avoids the logistical inefficiencies of traditional mainframe robotics.

While the initial indication is in colectomy (bowel resection), the company is working on expanding into gynaecology, general surgery, urology and other soft tissue and solid organ surgery. It’s also working on making the system even smaller and tackling more general surgical procedures – particularly outside the inpatient operating room.

Although other companies have tried to target the RAS market with slight changes on the main-frame concept (e.g., modular, pedestal-based systems, or open consoles), MIRA is a game-changer in the space and streaking ahead of the competition. It’s an exciting time for Virtual Incision – and indeed surgery as a whole.