Earlier than the pandemic hit in full pressure, Johnson & Johnson’s bid to realize floor in digital surgical procedure was a key speaking level, with CEO Alex Gorsky in January touting the potential for many years of progress to stem from the fruits of Auris Well being, Verb Surgical and associated initiatives.
J&J initially deliberate to host a medical units investor day May 13 to element these efforts, however rescheduled as a result of pandemic. Over six months later, J&J on Thursday up to date traders on the broader units enterprise, which has confronted gross sales declines amid COVID-19, however particularly highlighted its robotics plans to service operations from joint reconstruction to tissue biopsies to urological procedures.
Though Intuitive Surgical dominated robotic surgical procedure for common surgical procedure functions the previous 20 years, wider-scale medtechs, significantly J&J and Medtronic, have appeared to get a slice of the increasing market.
J&J cited information, later echoed by analysts, suggesting robots account for two% of procedures worldwide. Within the common surgical procedure realm, roughly 10% of procedures within the U.S. leverage robotics in comparison with lower than 1% exterior the nation — which J&J, its friends and analysts imagine suggests vital room for additional penetration.
However J&J is intentional in describing its new choices not simply as robotic surgical procedure however digital surgical procedure. Whereas robotics are an essential part, it additionally contains imaging, analytics, devices — a variety of merchandise that J&J can co-market to prospects.
Though J&J has talked up its Velys orthopaedics and Monarch bronchoscopy platforms, the corporate had but to disclose many particulars on its common surgical procedure platform. J&J partially labored on common surgical procedure robotics with Alphabet’s life sciences analysis group Verily by way of its joint initiative Verb Surgical, earlier than opting to purchase out Verily’s stake to regulate Verb solely final December.
J&J plans to compete with Intuitive’s da Vinci and Medtronic’s forthcoming modular gentle tissue robotic, dubbed Hugo, below the model identify Ottava. J&J mentioned it’s pursuing U.S. market clearance through FDA’s De Novo pathway, reserved for lower-risk units that lack a legally marketed predicate.
That affirmation follows an replace from the corporate in July that its plan to easily submit for a 510(okay) had shifted, and that it aimed to enter first-in-human trials within the second half of 2022. That timeline stays, with validation actions slated for subsequent yr.
The system will characteristic six arms, versus the three or 4 traditionally current in robotic programs, that will probably be built-in into the working desk. That design differs from da Vinci’s boom-mounted nature and Hugo’s modular format.
Morgan Stanley analyst David Lewis requested what number of procedures really necessitate using six arms. J&J Medical Gadgets Chief Growth Officer Fred Moll, who based Intuitive Surgical, famous that whereas three, 4 or 5 arms are ample for a lot of surgical procedures, the imaginative and prescient is to have the ability to assist a wider vary of process varieties with out necessitating shopping for a brand new sort of robotic, significantly as the corporate targets an growing variety of surgical and interventional specialties.
J&J didn’t define when precisely it plans to launch Ottava. Requested by an analyst whether or not 2024 was a practical estimate, J&J didn’t commit. SVB Leerink wrote in a word they assume it will be late 2023 “at greatest.” Fortunately for J&J, Medtronic’s personal in-development common surgical procedure robotic has additionally confronted disruptions as COVID-19 restricted some in-person work on Hugo.
Velys to problem Mako, Rosa; Monarch expands
J&J is awaiting FDA’s completion of 510(okay) overview of Velys whereas waiting for first-in-human use later this month. It is prepping for a business launch in 2021 with a knee utility, which might drive use of its Attune knee programs. The presentation prompt J&J will probably be seeking to price the system affordably sufficient to focus on adoption in ambulatory surgical procedure facilities.
That will additionally imply new competitors subsequent yr for Stryker and Zimmer Biomet. Already available on the market are greater than 1,000 Mako robots from Stryker, as Zimmer Biomet goals to have 300 Rosa robots positioned by yr’s finish.
Though J&J’s preliminary focus has been joint reconstruction, administration mentioned the corporate is seeking to backbone and trauma as different process areas to create robotic arms.
In contrast to the multi-competitor orthopaedics areas, J&J is extra forward of the sport with the Monarch robotic and its early-stage lung most cancers targets.
Since closing its $3.Four billion buyout of Monarch creator Auris Well being final April, J&J has carried out greater than 4,000 bronchoscopy circumstances with the Monarch robotic, cleared by FDA in 2018.
J&J touted the benefits of its wider healthcare breadth than smaller, extra specialised opponents all through Thursday’s presentation, with Monarch maybe being the most effective instance. One potential situation that Moll highlighted was with the ability to biopsy and diagnose a cancerous lung tumor in a affected person and “in the identical day” transfer ahead with remedy, both performing a process utilizing an energy-based ablation device from Ethicon or localized drug supply with a Janssen remedy.