Mar 23 2018
Redwood City, Calif. – March 23, 2018 – Auris Health, Inc. ("Auris Health"), formerly known as Auris Surgical Robotics, Inc., today announced U.S. Food and Drug Administration (FDA) clearance of the company’s Monarch™ Platform, ushering in a new era of medical intervention.
With the introduction of the Monarch Platform, Auris seeks to transform endoscopy, the use of small cameras and tools to enter the body through its natural openings. The Monarch Platform integrates the latest advancements in robotics, software, data science, and endoscope innovation, with the goal of dramatically improving patient outcomes, enhancing physician capabilities, and lowering costs to the healthcare system. Auris’ first targeted disease state is lung cancer. The FDA cleared the platform for diagnostic and therapeutic bronchoscopic procedures. The goal of the technology is to enable more-accurate diagnosis, and eventually treatment, of small and hard-to-reach nodules in the periphery of the lung.
Founded and led by surgical robotics pioneer Frederic Moll, M.D., Auris Health has raised more than $500 million in equity capital from leading technology investors including Mithril Capital Management, Lux Capital, Coatue Management, and Highland Capital.
“Technology has advanced significantly since the development of the earliest robotics platforms used in medicine,” said Dr. Moll, CEO, Auris Health. “The Monarch Platform is designed to address the limitations of current technology with the introduction of a new era of flexible robotics. With this FDA clearance, we intend to deliver on the promise of improving patient care, starting with earlier and more accurate diagnosis of pulmonary nodules. We envision additional uses for the technology across future endoscopic clinical indications.”
Lung cancer is the leading cause of cancer deaths worldwide. More patients die every year from the disease than from prostate, breast, and colon cancer combined. More than 90 percent of people diagnosed with lung cancer do not survive, in part because it is often found at an advanced stage. There are a variety of diagnostic options currently available for lung cancer, but all have limitations in accuracy, safety, or invasiveness. These limitations can lead to false positives, false negatives, or side effects such as pneumothorax (collapsed lung) and hemorrhage, which may increase health care costs and extend hospital stays.
“Four hundred fifty people die every day in the United States due to lung cancer. It is the number one cancer killer of both men and women in the world. Lung cancer screening has given us an opportunity to save some of these people by diagnosing the cancer early, while we have a chance to cure it. Despite the benefit, we still are limited by the current technology in making a diagnosis," said Michael Simoff, M.D., Director of Interventional Pulmonology at Henry Ford Health System in Detroit, Mich. "The development of new advanced technology, like the Monarch Platform, could allow us the opportunity to make the diagnosis early, which translates directly to saving lives.”
The Monarch Platform is a revolutionary flexible endoscopic technology that holds promise to fight lung cancer by allowing physicians to diagnose, and eventually treat, hard-to-reach, small peripheral nodules with greater precision than ever before. The Monarch Platform utilizes a familiar controller-like interface that physicians use to navigate the flexible robotic endoscope to the periphery of the lung with improved reach, vision, and control. Combining traditional endoscopic views into the lung with computer-assisted navigation based on 3-D models of the patient’s own lung anatomy, the Monarch Platform provides physicians with continuous bronchoscope vision throughout the entire procedure.
About Auris Health, Inc.
Based in Silicon Valley, Auris Health is pioneering the next era of medical intervention by developing platforms that enhance physician capabilities, evolve minimally invasive techniques, and create new categories of care that redefine optimal patient outcomes. The company is committed to transforming medical intervention by integrating robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform. Every element of our technology is driven by patient-specific design aimed at maintaining the integrity of the human body. The company is backed by leading technology investors including Mithril Capital Management, Lux Capital, Coatue Management, and Highland Capital.
Important Safety Statement: Complications from bronchoscopy are rare and most often minor, but if they occur, 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. It is uncommon for patients to experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).
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Complications from bronchoscopy are rare and most often minor, but if they occur, 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. Only rarely do patients experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).
Adverse effects from both Mini-PCNL and Ureteroscopy include pain, urinary tract infection, fever, hematuria (presence of blood in urine), exposure to low levels of radiation, retained or residual stones.
Adverse effects from ureteroscopy may include pain, perforation or injury to the ureter, resulting in extravasation of fluid and urine (urinoma), stricture of the ureter with risk of subsequent obstruction (hydronephrosis needing further repair), rare avulsion of the ureter, urinary blood clots, residual stones.
PCNL access may result in minor and major adverse effects. Minor effects include fever and nephrostomy leak. Major adverse effects may include injuries to pleura, liver, spleen, large vessels with related bleeding, gallbladder, duodenum, jejunum, colon with related cutaneous fistula, fever, pain, ileus, elevated counts.
Major adverse effects related to stone removal may include infection and urosepsis, intravascular fluid overload, extravasation of fluid, and post percutaneous nephrolithotomy bleeding.