Johnson & Johnson MedTech has received a go-ahead from the FDA to begin human clinical trials of its Ottava surgical robot, with plans to explore its uses in laparoscopic, hybrid and open procedures.
The bed-based, soft-tissue system is designed to fit within nearly any operating room, with four robotic arms that are incorporated into the motorized operating table and can be folded underneath. The company said it is now focused on training study investigators on Ottava’s uses and its Ethicon instruments before they begin to enroll U.S. patients and prepare for surgical cases.
“We are bringing the best of J&J MedTech’s surgery expertise to the Ottava system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities in service of patients around the world,” Hani Abouhalka, J&J MedTech’s group chairman for surgery, said in a statement.
Ottava was first born out of the Verb Surgical joint venture in partnership with Google’s life-science-focused sister company, Verily. J&J took over that project in full in late 2019 and later merged its development with a robotic surgery program picked up through its multibillion-dollar acquisition of Auris Health that same year.
That combination recently culminated in a lawsuit that had been brought against J&J by Auris’ investors, Fortis Advisors, over unpaid milestone commitments from the deal. A Delaware state court in September awarded more than $1 billion in damages to Fortis as part of a ruling that J&J did not devote the resources necessary to advance the development of Auris' six-armed iPlatform robot.
Instead, the judge said that—after iPlatform and Verb’s robot were pitted against each other in an internal competition dubbed Project Manhattan—the iPlatform design was subsequently abandoned in favor of Verb’s bed-based approach, with the former effectively becoming “a parts shop” for the latter.
Ottava was previously slated to make its first-in-human debut in late 2022, but that timeline was pushed back amid technical challenges and disruptions due to the COVID-19 pandemic.
The system is designed to take on Intuitive Surgical’s mainstay da Vinci robot; compared to its towering, many-armed frame, J&J aims to offer a solution with a smaller and more flexible footprint. Other competitors aim to do the same, such as with modular, cart-based platforms being put forward by Medtronic and CMR Surgical.
Last month, CMR’s Versius received an FDA clearance for minimally invasive gallbladder removal procedures. The laparoscopic robot previously received a CE mark approval in Europe in 2019.
Meanwhile, Medtronic’s Hugo has collected regulatory green lights for use in Europe, Canada and Japan. Earlier this year, the company said it has launched additional clinical studies to expand its reach in hernia repair and gynecological procedures as it works toward an FDA submission.
Ottava will also connect with J&J’s Polyphonic digital ecosystem, something of a private social network for surgeons, where analytics and patient data can be translated into direct feedback.
The platform will allow healthcare providers to follow patients through pre-op tasks, observe remotely as they undergo the procedure and track their recovery through to discharge. Surgeons will also be able to create video clips from their operations and annotate, share and tag others within the health system for their input and review.