MONARCH Platform for Bronchoscopy Receives Regulatory License for China
The MONARCH™ Platform is the first minimally invasive, robotic-assisted technology approved for bronchoscopy in a country with significant burden of lung cancer.
REDWOOD CITY, CALIF. – November 13, 2023 – Johnson & Johnson MedTech* today announced that the MONARCH Platform and MONARCH Bronchoscope have obtained regulatory approval in China. The platform is the first minimally invasive, robotic-assisted technology approved for peripheral lung procedures in China and the first J&J MedTech robotic-assisted technology approved in China. This also marks the first regulatory approval of the MONARCH Platform outside of the United States
The MONARCH Platform, used with the MONARCH Bronchoscope, is intended to provide bronchoscopic visualization of and access to adult patient airways for diagnostic and therapeutic procedures. The device enables physicians to use minimally invasive, robotic-assisted technology for peripheral lung procedures.
The ability to reach small, hard-to-reach peripheral lung nodules at an earlier stage and with greater precision is helping to transform the future of interventional care for patients because nodules from lung cancer are typically small, deep in the lungs and difficult to reach, making early-stage diagnosis and treatment difficult. Lung cancer is the leading cause of cancer deaths worldwide, and early detection has been shown to increase survival rates if the disease is caught at a stage when it is more likely to be treated successfullyi.
“There are more than two million patients diagnosed with lung cancer each year around the world, and nearly 40% of them are in Chinaii,” said Will Song, President, Johnson & Johnson MedTech China. “With this approval, MONARCH is poised to aid physicians in China as they work with patients to fight one of the most prevalent and deadly diseases in the country.”
“The MONARCH team is committed to driving meaningful innovation that changes the way patients experience healthcare,” said Adrian Whitford, President, MONARCH. “Expanding the reach of flexible robotic-assisted devices for lung procedures to countries around the world is part of our vision to deliver breakthrough technology that improves clinical outcomes for patients fighting diseases like lung cancer.”
To date, The MONARCH platform has been used in more than 35,000 cases in the United States.
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. To learn more, visit https://thenext.jnjmedtech.com/
* Comprising the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
Indications for Use (United States)
The MONARCH™ Bronchoscope and the MONARCH™ Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Important Safety Information
Complications from bronchoscopy may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. More serious complications from bronchoscopy may include collapsed lung, respiratory failure, hemorrhage, burns, heart attack, or cardiac arrhythmia.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding Johnson & Johnson MedTech, the MONARCH Platform and MONARCH Bronchoscope. 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 Auris Health, Inc., Johnson & Johnson Medical (Shanghai) Ltd. 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 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. None of Auris Health, Inc., Johnson & Johnson Medical (Shanghai) Ltd. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.