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Oct 15 2018
REDWOOD CITY, Calif. & SAN ANTONIO--Auris Health, Inc., today announced the results of a study designed to test the ability of the Monarch™ Platform, the first FDA-cleared robotic platform for diagnostic and therapeutic bronchoscopic procedures, to successfully access nodules in the lung.
Results of the ACCESS study were presented last week at the CHEST 2018 Annual Meeting in San Antonio during a late breaking presentation by Alexander C. Chen, M.D., of St. Louis, Mo. Findings demonstrated the effectiveness of the Monarch Platform in biopsying implanted simulated tumor targets in cadaveric human lungs. In particular, the robotic platform demonstrated precision in performing peripheral lesion biopsies.
During the study, eight investigators performed robotic-assisted bronchoscopy procedures using the Monarch Platform on a cadaveric model designed to mimic a real-life bronchoscopy procedure. Sixty-seven simulated tumor targets one to three centimeters in size were prepared in eight human cadaveric lungs. The tissue acquired during the bronchoscopy was evaluated and correctly identified as the implanted target in 97% of cases.
"The ACCESS study showed that the Monarch Platform is able to successfully reach nodules in the lung in a cadaveric model and can biopsy the tissue with a high accuracy,” said Dr. Chen. “This study was the next step following the REACH study, which focused on the Monarch Platform’s ability to reach deeper into the lung periphery.”
The REACH study, published earlier this year in the Annals of Thoracic Surgery, found that the platform improved reach beyond a conventional thin bronchoscope into the periphery of human cadaveric lungs.
“Our mission is to enable diagnosis of lung cancer earlier in its progression, through the least-invasive approach – via the body’s natural openings,” said Frederic Moll, M.D., founder and CEO of Auris Health. “We are pleased with the performance the Monarch Platform demonstrated in the REACH and ACCESS studies, and look forward to further assessing the system’s benefits in prospective human clinical trials in the near future.”
Lung cancer is the leading cause of cancer deaths worldwide. More patients die every year from the disease than from prostate, breast, and colon cancers combined. Auris Health’s revolutionary Monarch Platform is designed to allow physicians to diagnose small, hard-to-reach peripheral lung nodules with greater precision than ever before.
About Auris Health, Inc.
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. Learn more at www.aurishealth.com.
AURIS and MONARCH are trademarks and/or registered trademarks of Auris Health, Inc. in the United States and in other countries. All other trademarks and product names used herein are the property of their respective owners.
See Business Wire Press ReleaseBronchoscopy:
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).
Urology:
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.