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Johnson & Johnson MedTech Launches the DUALTO™ Energy System for Use Across Surgical Treatment Approaches

The DUALTO™ electrosurgical generator is designed to offer a simplified user experience, access to Polyphonic™ Fleet digital device management, and flexible application of monopolar, bipolar, ultrasonic, and advanced bipolar energy devices for open and minimally invasive surgery

DUALTO will be showcased at the Association of periOperative Registered Nurses Global Surgical Conference & Expo on April 5-8, 2025

The DUALTO Energy System recently received 510(k) clearance by the U.S. Food & Drug Administration1

New Brunswick, NJ – March 25, 2025 – Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced the launch of the DUALTO™ Energy System, a surgical solution that combines multiple energy modalities into an integrated platform for use across open and minimally invasive surgery. The system can be paired with Service Solutions to support uptime and is designed to work with the Polyphonic™ Fleet software application for device management. DUALTO has also been designed for future use with the company’s OTTAVA™ Robotic Surgical System.

The company will showcase DUALTO alongside their comprehensive portfolio of surgical products and digital solutions at this year’s Association of periOperative Registered Nurses (AORN) Global Surgical Conference & Expo taking place in Boston, Massachusetts, April 5-8, 2025.

Every year in the United States, clinicians use surgical energy instruments to cut tissue or control bleeding with precision and control in more than five million surgical procedures.2,3 DUALTO is developed to offer clinical teams the choice of powering monopolar, bipolar, ultrasonic, and advanced bipolar instruments, including HARMONIC™ and ENSEAL™ devices, from a single, consolidated system. The modular design and flexible architecture allow for up to 46% less footprint versus separate generators.4I DUALTO is also the first and only surgical energy system that will be available in a double configuration, allowing two surgeons to work in a complex procedure and activate simultaneous energy from one electrosurgical unit.

“The DUALTO Energy System represents a significant advancement in human-centric design, delivering a fully connected solution that simplifies surgical energy and enhances efficiencies in the OR,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “Johnson & Johnson MedTech has been a trusted partner in surgery for over a century, and we are leveraging clinical insights to tailor the design of our technologies to meet the needs of surgeons and clinical teams. DUALTO supports a more flexible and digitally connected OR ecosystem for the future of surgical care.”

Adaptive technology for more precise energy delivery
DUALTO leverages proprietary Adaptive Tissue Technology, enhancing the performance of HARMONIC and ENSEAL advanced energy devices. Adaptive Tissue Technology responds intelligently to changing tissue conditions, regulates energy delivery for improved temperature management, and provides tone changes and user signals, to enable more precise energy delivery.5II When powered by DUALTO, HARMONIC 700 and HARMONIC FOCUS+ instruments demonstrate more efficiency, transecting thick tissue up to 18% and 25% faster, respectively.6III,7IV

A human-centric, simplified approach to surgical energy
Streamlined OR setup could help to minimize stress levels for surgeons and their clinical teams.8V The design of DUALTO prioritizes usability – the instinctive touchscreen interface offers guided setup and troubleshooting, features clear visual and auditory cues for real-time feedback, and streamlines workflows in the operating room. With the capability to store personalized profiles for different surgeons and procedures, DUALTO supports faster setup and adjustments through custom energy settings.

“The user-friendly touchscreen of the energy system simplifies setup, and it allows my team to configure the system to fit my preferences and the specific procedure,” said Maie St. John*, MD, PhD, Professor and Chair, Department of Head and Neck Surgery in Los Angeles. “The design not only helps to reduce setup time and saves space in the OR, but it also streamlines troubleshooting with on-screen prompts and ultimately can improve our surgical energy workflows.”

Introducing Polyphonic™ Fleet: Designed to enhance OR workflows through a connected ecosystem
The DUALTO Energy System is designed to work with Polyphonic Fleet – an easy-to-use software application that helps hospitals oversee capital equipment. Polyphonic Fleet can inform the status of DUALTO for software upgrades and routine maintenance needs and provide instructions remotely, helping biomedical managers, engineers, and other users ensure the system has the latest software without disrupting the operating room schedule.

Johnson & Johnson MedTech’s Polyphonic ecosystem will enable new experiences across our portfolio of medical devices, robotics, and software solutions,” said Shan Jegatheeswaran, Vice President, Digital, Johnson & Johnson MedTech. “DUALTO combines advanced energy technology with Polyphonic Fleet’s ecosystem to provide remote support. We are excited to empower healthcare teams with capabilities for more connected OR devices.”

The Polyphonic™ digital ecosystem, which includes Polyphonic Fleet, will connect data across world-class surgical technologies, robotics, and surgical software while leveraging the global scale of Johnson & Johnson.

Johnson & Johnson MedTech will host several presentations, panel discussions, hands-on training, and live demonstrations throughout the AORN Global Surgical Conference & Expo. Attendees can learn more at Booth #1308 or online.

The DUALTO™ Energy System and Polyphonic™ Fleet will soon be available to select hospital sites in select markets.

The OTTAVA™ Robotic System is under development and is not authorized to be marketed or sold in any market.

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, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Ethicon, Inc., Auris Health, Inc. and Verb Surgical Inc. are Johnson & Johnson MedTech companies.

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. 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., Verb Surgical Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. 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.jnj.com or on request from Johnson & Johnson. None of Ethicon, Inc., Auris Health, Inc., Verb Surgical Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Footnotes
*Dr. Maie St. John is a paid consultant for Johnson & Johnson MedTech.

I. In a R&D study measuring stacked volume of the DUALTO™ Energy System and current generator systems in the market. For any stacked generator measurements, the largest length and widths of one unit with the combined height of both units was measured. Measurements compare a Double DUALTO™ Energy System with two Energy Modules to four current systems stacked. A Single DUALTO™ Energy System with one energy module is up to 23% less footprint compared to two current systems stacked. Footprint defined as the volume of space, either potential floor or boom space, taken up by energy generators.
II. Vs. HARMONIC ACE™ without Adaptive Tissue Technology.
III. In a R&D study evaluating performance improvements of the HARMONIC™ 700 instrument family on the DUALTO™ Energy System compared to the GEN11 Generator on thick porcine mesentery (p <0.05).
IV. In a R&D study evaluating performance improvements of the Harmonic Focus+ instrument family on the DUALTO™ Energy System compared to the GEN11 Generator on a thick tissue model (p <0.05), with 30 comparison transections.
V. In a pre-clinical summative usability study, with surgeons (n=33) that went through an end-to-end procedure and afterward responded to a series of statements regarding the DUALTO™ Energy System (32/33 agree).

1The ETHICON™ Total Energy System is now referred to as DUALTO™ Energy System, with no changes to its intended use, design, performance, or regulatory status under FDA 510(k) K243067. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243067.pdf
2Meeuwsen FC, Guedon ACP, Arkenbout EA, et al. The Art of Electrosurgery: Trainees and Experts. Surg Innov. 2017 Apr 24;24(4):373–378. doi: 10.1177/1553350617705207.
3Mattingly AS, Rose L, Eddington HS, et al. Trends in US Surgical Procedures and Health Care System Response to Policies Curtailing Elective Surgical Operations During the COVID-19 Pandemic. JAMA Netw Open. 2021 Dec 8;4(12):e2138038. doi: 10.1001/jamanetworkopen.2021.38038.
4Ethicon, Mantle Space Claim Measurement Study. 10/17/2024. Windchill Document #502047373
5Ethicon, HAR36 DV- ROIN 6175- Blade Heat. 10/30/2013. Windchill Document #PRC053965. Ethicon, HARMONIC ACE 5mm Diameter Shears + Adaptive Tissue Technology Instructions For Use
6Ethicon, Mantle Harmonic Claims. 10/17/2024. Windchill Document #502071965
7Ethicon, Mantle Harmonic Claims. 11/19/2024. Windchill Document #502071965
8Ethicon, Emergo Mantle Marketing Claims Report. 05/08/2024. Windchill Document #501949635

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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