Johnson & Johnson MedTech Provides Details and Timeline for General Surgery Robot

Nov. 7, 2023 – New Brunswick, New Jersey – Johnson & Johnson MedTech* today announced plans to submit the OTTAVA robotic surgical system for an investigational device exemption (IDE) application to the U.S. Food & Drug Administration (FDA) in the second half of 2024 to initiate clinical trials.

Drawing on Johnson & Johnson MedTech’s more than 135-year legacy of leadership in surgery, OTTAVA reimagines the surgical experience. The system is designed to create space in the operating room (OR), simplify complex workflows, enable flexibility for clinical approaches, and deliver the trusted performance of Ethicon** instrumentation.

“Johnson & Johnson was born in surgery with the advent of sterile sutures, and we have since helped surgeons improve care for patients by offering transformative technologies across all types of surgery,” said Hani Abouhalka, Company Group Chairman, Robotics & Digital, Johnson & Johnson MedTech. “We believe the future of surgery is personal. Starting with the human impact – the connection between the patient, surgeon, and OR staff – we are unlocking what science and technology can do to improve the surgical experience and health outcomes for everyone involved. OTTAVA is designed to consistently deliver this experience in any OR globally.”

Designed to seamlessly integrate into the OR for new clinical experiences

OTTAVA incorporates four robotic arms into a standard size surgical table. This unified architecture allows for an invisible design, with the robotic arms available when needed or stowed under the surgical table when not. The design removes barriers to movement and collaboration in robotic operating rooms and offers surgical teams the freedom and flexibility to adapt to clinical workflows and individualized patient needs.

The system’s “twin motion” feature – unified movement of the table and the robotic arms – is designed to allow surgical teams to address important clinical needs during surgery, such as the ability to reposition a patient without interrupting the procedure.

“Today, the majority of ORs are not robotic because they were not built with a robot in mind,” said Dr. Eduardo Parra-Davila, *** a Colorectal and General Surgeon at the Palm Beach Digital Institute. “The industry needs a system that is adaptable, easy to use in any OR in the world, and maintains space in the OR. As surgeons, we need space to improve the workflow in the OR, increase safety, and enable 360-degree patient access so we can perform at the capacity that we would like to. That’s where OTTAVA comes in. OTTAVA offers a unique design that incorporates into any OR and allows surgeons to do what they would like to do and know how to do, which is focus on the patient.”

Drawing on Johnson & Johnson’s experience in surgery

OTTAVA exclusively features trusted Ethicon instrumentation, designed for performance and precision, and offers surgeons a more consistent experience between traditional laparoscopic and robotic procedures. Ethicon instruments on OTTAVA are backed by decades of innovation and market leadership in minimally invasive surgery, providing leading device-to-tissue and user-to-device interactions.

“I want consistency and reliability across the instruments I use,” said Dr. Erik Wilson****, Chief of Minimally Invasive and Elective General Surgery at the University of Texas Health Science Center in Houston. “Often today, I am required to use instruments with variable utility and functionality between traditional laparoscopic procedures and robotic-assisted procedures. Access to the reliable Ethicon laparoscopic instruments on a robotic platform would be useful to operate with less variability regardless of surgical modality.”

When authorized for commercial launch, OTTAVA will join Johnson & Johnson MedTech’s portfolio of commercially available robotic systems, including the MONARCH™ Platform and the VELYS™ Robotic-Assisted Solution, and will be backed by the company’s global team of specialists in surgical education and clinical training.

The OTTAVA robotic system is under development and is not authorized to be marketed or sold in any market. For more information, visit: http://thenext.jnjmedtech.com/surgical-robotics.

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more information, visit https://thenext.jnjmedtech.com/.

* Comprising the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment, including Ethicon, Inc. and Auris Health, Inc.

** Ethicon represents the products and services of Ethicon, Inc., and certain of their affiliates. All other trademarks are the property of their respective owners.

*** Dr. Parra-Davila is a paid consultant for Johnson & Johnson MedTech.

**** Dr. Wilson is a paid consultant for Johnson & Johnson MedTech.

NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS:

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Auris Health, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; the Company’s ability to realize the anticipated benefits from the separation of the Company’s Consumer Health business; and the New Consumer Health Company’s ability to succeed as a standalone publicly traded company. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. None of Ethicon, Inc., Auris Health, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.