Our Story

Arkis BioSciences® is an FDA registered and ISO 13485 certified medical device company providing sophisticated surgical tools and advanced catheter technology.  The company’s offerings advance the neurosurgical treatments of intracranial hypertension arising from hydrocephalus, traumatic brain injury, and hemorrhagic stroke.  In 2016, Arkis introduced its Single Pass Tunneling GuidewireTM as well as its Subcutaneous GuidewireTM.  In 2017, Arkis introduced its next generation CerebroFlo®  EVD Catheter which exclusively incorporates Endexo® polymer technology.  Headquartered in Knoxville, Tennessee, Arkis began operations in 2013 to serve the neurosurgical market to improve intracranial hypertensive patient care while reducing overall healthcare costs.

The company’s ISO 13485:2016 certification is provided by TUV USA, Inc. (Member of TUV NORD Group) for its Medical Device Quality Management System.

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Address: 1 Momentum Way, Knoxville, TN 37920 | Tel: (844) 247-5383 (toll free)

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Arkis BioSciences is ISO 13485:2016 certified for its Medical Device Quality Management System by TUV USA, Inc. (Member of TUV NORD Group).

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