First Patient Treated with Robotic-Assisted Transbronchial Microwave Ablation as part of global Ethicon POWER Study
RARITAN, NJ, December 5, 2022 – Ethicon*, a Johnson & Johnson MedTech Company**, announced today the treatment of the first patient in its latest 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 NEUWAVETM FLEX Microwave Ablation System guided by the MONARCH® Platform. The study, involving leading lung centers from around the world, is intended to enroll patients with oligometastatic tumors.
“The purpose of the POWER study is to demonstrate endobronchial microwave ablation as non-invasive and lung sparing with the latest advances in robotic bronchoscopy to help provide visualization and access to the airways,” explained Dr. Calvin Ng, Professor of Thoracic Surgery at Prince of Wales Hospital, The Chinese University of Hong Kong, and one of the lead study investigators.‡ “This approach may represent an important next-generation treatment option for lung tumors –minimizing the impact of surgery for patients and allowing for more rapid recovery. On behalf of the POWER study global investigators, we look forward to serving the patients who will participate in this trial and sharing the data and results in the future.”
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.
About oligometastatic disease to the lung
A large subgroup of patients with metastatic cancer has oligometastatic disease involving the lung (OML). This represents an intermediate state of advanced malignancy in which patients have only a limited number of tumors. The treatment approach for OML often involves systemic therapy and locally treating all sites of disease. Depending on the primary tumor type, location, and patient preferences, multiple approaches including surgery, radiation or percutaneous ablation may be used. Despite currently available options, there remains a need for alternative minimally invasive treatments.
“The POWER study is a critical step in further advancing our microwave ablation strategy via robotic-assisted bronchoscopy to help enable targeted, locally delivered cancer treatments to smaller nodules in the periphery of the lung,” explains Avrum Spira, MD, MSc, Global Head, Lung Cancer Initiative at Johnson & Johnson.*** “We are bringing together two innovative platforms with our expertise across J&J to help catalyze creative approaches aiming to improve patient outcomes – all of which could be transformational in changing the trajectory of the leading cause of cancer mortality worldwide.”
Ethicon is a global leader in soft tissue microwave ablation with the NEUWAVETM System and in flexible endoluminal robotics with the MONARCH® Platform. The NEUWAVETM 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 NEUWAVETM FLEX Microwave Ablation System incorporates the established core NEUWAVETM microwave ablation technology into a long flexible probe combined with the continuous real-time vision, precision and control provided by the MONARCH® Platform.
1 POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy); ClinicalTrials.gov Identifier: NCT05299606
‡ Dr. Ng is an active consultant to Johnson & Johnson and receives support for clinical research from 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 www.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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*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.
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 NEUWAVETM 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 2, 2022, 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.