Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical System

First use in gastric bypass at Memorial Hermann-Texas Medical Center 

Trial will support submission for multiple procedures

NEW BRUNSWICK, N.J., April 14, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced completion of the first cases in the clinical trial for the OTTAVA™ Robotic Surgical System. The cases mark the first clinical experience with the OTTAVA System.

Dr. Erik Wilson*, Chief of Minimally Invasive and Elective General Surgery UT Health Houston and the lead investigator for the clinical study, performed Roux-en-Y gastric bypass surgery using the OTTAVA Robotic Surgical System at Memorial Hermann-Texas Medical Center.

"Surgical robotics is at the forefront of innovation in minimally invasive surgery," Dr. Wilson said. "I am proud to have performed the first clinical study cases with OTTAVA and potentially help advance the standard in surgical robotics."

OTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach.

Data from this investigation aims to support the system's ability to perform a variety of procedures. Upon completion of the study, the company plans to submit the OTTAVA system for De Novo authorization in the United States, targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.

"We are proud to reach this important milestone in our robotic surgery program," said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. "OTTAVA is a key innovation in our portfolio of advanced surgical technologies – all of which are designed to transform the surgical experiences across all surgery. Our people work side-by-side with surgical teams in ORs around the world every day to raise the standard of care for patients and deliver what's next in surgery."

Johnson & Johnson MedTech's OTTAVA system received investigational device exemption (IDE) approval from the U.S. FDA in late 2024.  The system is designed to advance clinical innovation in general surgery, a stronghold for Johnson & Johnson MedTech's broader surgery business. OTTAVA is designed to address unmet needs that persist in robotic surgery today and support complex procedures. The system's unique unified architecture, surgical instrumentation powered by Ethicon expertise, and future connection to the Polyphonic™ digital ecosystem are designed to meet the needs of each patient's care and each surgeon's clinical approach.

"As a company operating at the intersection of biology and technology, clinical evidence generation is the core of our innovation programs to advance surgical technology for patients," said Peter Schulam M.D., PhD, Chief Scientific Officer, Johnson & Johnson MedTech. "Through this clinical study, we are proud to be partnering with surgeons to gather evidence and support the ongoing pursuit of scientific study for the advancement of robotic-assisted minimally invasive surgery."

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.

Surgical Solutions from Johnson & Johnson MedTech

Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. For over 100 years, we have helped advance surgical care through our innovative portfolio across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts around the world we are progressing what's next in surgery to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Auris Health, Inc. is part of 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 the OTTAVA™ Robotic Surgical System. 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 Johnson & Johnson. Risks and uncertainties include, but are not limited to 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; 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; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

© Johnson & Johnson and its affiliates 2025. US_SRG_RADS_399335

Media contact:
Lindsey Diaz-MacInnis
ldiazmac@its.jnj.com 

Investor Relations:
Tracy Menkowski
[email protected]

SOURCE Johnson & Johnson MedTech