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Serpex Medical Announces Second FDA 510(k) Clearance of Its Steerable Endobronchial Instrument Platform - The Compass Steerable Needle

Thursday, September 08, 2022

Serpex Medical has announced that its Compass Steerable Needles, innovative steerable biopsy needles designed to provide precise access to lung nodules in the intrapulmonary region, have received clearance from the U.S. FDA through the 510(k) pathway. Serpex Medical aims to leverage the capabilities of steerable instruments to enhance precision and access, thereby improving the diagnosis and treatment of lung cancer. This clearance of the Compass Steerable Needles follows the recent clearance of Serpex's Recon Steerable Sheath.

Dr. George Cheng, an interventional pulmonologist, expressed the need for such innovation, stating, "The Compass steerable needle is a much-needed innovation. It provides exceptional maneuverability that will enable us to more precisely target and access lesions, at a nominal cost. It's also agnostic in design, so it can be paired with any navigation platform. It is just what we needed."

Lung cancer is the leading cause of cancer-related deaths worldwide. Detecting and diagnosing lung cancer can be challenging due to small and difficult-to-access lesions. Serpex's slim articulating Compass Steerable Needles offer precise three-dimensional positioning, facilitating improved reach to all 18 segments of the lung and enabling access to small lesions outside of the airways. The device's design allows for a controlled approach to target locations and the sampling of multiple aspects of the tumor without unwanted tip deflection, addressing the challenges associated with lung biopsy.

Sasha Schrode, President and CEO of Serpex Medical, emphasized the importance of precision in diagnosing lung cancer, particularly in peripheral areas of the lung. Schrode stated, "We are excited to deliver another innovative product that empowers clinicians to more successfully diagnose lung cancer at an earlier stage."

Duke Rohlen, Executive Chairman of Serpex Medical and CEO of Ajax Health & Zeus Health, hailed this achievement as a significant milestone in the pursuit of practical and intuitive innovation by the Serpex team. With two sets of clearances now obtained, Serpex is poised to make a significant impact on the standard of care for patients with lung cancer.

Serpex Medical is backed by prominent investors including Ajax Health, Zeus Health, Aperture Venture Partners, and Western Technology Investment.

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