RARITAN, NJ, April 4, 2023 – Ethicon*, a Johnson & Johnson MedTech Company**, announced today the treatment of the first patient in North America in its Investigational Device Exemption (IDE) clinical trial, the POWER1 study. This prospective, multicenter, single-arm study is intended to demonstrate the safety and effectiveness of transbronchial microwave ablation using the NEUWAVE™ FLEX Microwave Ablation System guided by the MONARCH® Platform. The study involves leading global thoracic oncology centers and is intended to enroll patients with oligometastatic (OML) tumors in the lung.
"We are extremely proud to have treated the first patients in North America in this exciting trial, which can be an important part of the future armamentarium for doctors treating lung cancer all over the world,” says Dr. Moishe Liberman, Thoracic Surgeon and Director of the Endoscopic Tracheobronchial and Esophageal Center at the CHUM Hospital in Montreal, Canada.i “The entire robotics, thoracic, radiology, anesthesia and research teams at the CHUM worked conjointly to make these first few cases a success for our patients. We are looking forward to treating more patients with this innovative technology in the near future."
About OML disease to the lung
The lung is a common site for metastatic spread of solid organ cancers such as colorectal, kidney and sarcoma and impacts thousands of patients across North America. Systemic therapies are continuing to become more effective in treating patients with metastatic cancers. A subgroup of patients; however, have residual tumors in the lung and other organs that do not resolve despite those systemic treatments. This subgroup of patients is determined to have an intermediate state of advanced malignancy in the lung called OML disease for which managing physicians continue to seek additional minimally invasive and lung-sparing therapies.
"We are excited to now be able to perform this minimally invasive treatment for OML cancer patients in North America in the POWER study, which is the first of its kind to use precision robotic-assisted bronchoscopy to deliver targeted transbronchial microwave ablation for the treatment of metastatic tumors in the periphery of the lung,” explains Avrum Spira, MD, MSc, Global Head, Lung Cancer Initiative at Johnson & Johnson.*** “The treatment of the first patient in North America in the study by Dr. Liberman and the team at CHUM is another exciting step in our mission to bring novel treatment approaches to cancer patients and potentially change the trajectory of the leading causes of cancer mortality worldwide.”
Ethicon announced the grant of the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for transbronchial microwave ablation technology using robotic-assisted bronchoscopy in July 2020. The Breakthrough Devices Program is a voluntary program for certain medical devices that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of this program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for Premarket Approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
Ethicon is a global leader in soft tissue microwave ablation with the NEUWAVE™ System and in flexible endoluminal robotics with the MONARCH® Platform. The NEUWAVE™ microwave ablation technology provides a minimally invasive option for soft tissue lesions. The MONARCH® Platform provides improved reach into the periphery of the lung with continuous real-time vision, precision and control, and was the first robotic-assisted bronchoscopy system introduced in the United States. The NEUWAVE™ FLEX Microwave Ablation System incorporates the established core NEUWAVE™ microwave ablation technology into a long flexible probe combined with the continuous real-time vision, precision and control provided by the MONARCH® Platform.
About Ethicon
At Ethicon, a Johnson & Johnson MedTech company, putting humanity at the core of care is our passion and our purpose. In collaboration with clinicians and health care experts around the world, we develop clinically differentiated surgical technologies and solutions to help address some of the most pressing health challenges of our time such as metabolic disease, cardiovascular disease and cancer. Through our efforts and ingenuity, we aspire to elevate standards of care and create a healthier future for the patients of today and tomorrow. Visit ethicon.com to learn more about us.
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.
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Cautions Concerning Forward-Looking Statements
Notice 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 NEUWAVE™ FLEX Microwave Ablation System and the MONARCH® Platform. 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., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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 the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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. None of the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
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- POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy); ClinicalTrials.gov Identifier: NCT05299606
- Dr. Liberman has been a consultant to Ethicon affiliates and has received support for clinical research from Ethicon affiliates in the past.
*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.
**Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson.
*** The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation Inc.