Serpex Medical Announces FDA Clearance of Steerable Sheath for Transbronchial Access

Tuesday, August 30, 2022

Serpex Medical announced today U.S. FDA 510(k) clearance of its Recon Steerable Sheath – a steerable endobronchial tool that offers articulation at the distal tip to enable physicians to access difficult-to-reach areas of the lung anatomy. Serpex Medical seeks to leverage the power of steerable instruments to enable greater precision and access to improve the diagnosis and treatment of lung cancer.  The Recon Steerable Sheath is the first device cleared in Serpex Medical's product portfolio of steerable instruments.

"I've had the opportunity to trial this device.  The ability to make adjustments and reposition, particularly at the target location, is phenomenal," says Michael Machuzak, MD, Interventional Pulmonologist at The Cleveland Clinic who participated in the preclinical testing.  "This is an exciting and novel device that holds enormous potential for the future of bronchoscopy."

Lung cancer is the leading cause of cancer deaths worldwide.  It has the lowest 5-year survival rate (18%) when compared to other common cancers, in part because most cases are diagnosed late-stage.1 Approximately 70% of cancerous lung nodules are found in the outer third of the lung2 and diagnosing these cases early is challenging.

"Serpex Medical is committed to bringing much needed innovation to clinicians' toolset to enhance early lung cancer detection," says Sasha Schrode, President and Chief Executive Officer of Serpex Medical. "The intuitive articulation of the Recon Steerable Sheath gives clinicians a new level of control and precision, particularly in the lung periphery."

"Serpex is developing an innovative suite of steerable instruments to improve the accuracy of lung cancer diagnosis and treatment," says Duke Rohlen, Executive Chairman of Serpex Medical and Chief Executive Officer of Ajax Health & Zeus Health. "This technology is a meaningful contribution both to the field and to patients with lung cancer."

Serpex Medical is backed by Ajax Health, Zeus Health, Aperture Venture Partners and Western Technology Investment. The company's R&D pipeline includes a steerable needle among other devices leveraging its proprietary steerable device technology.

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