Vivonics Forms CranioSense Subsidiary

Vivonics Forms CranioSense Subsidiary

Vivonics, Inc. announced the formation of CranioSense, LLC as a wholly-owned subsidiary of Vivonics. CranioSense was formed to further develop and commercialize I-PASS (Intracranial Pressure Assessment and Screening System), a medical device that can monitor intracranial pressure completely non-invasively.  

Intracranial Pressure (ICP) is a key parameter in the management of TBI because damage to the small structures within a brain causes local swelling, and even mild swelling in the fixed volume of the skull results in increased pressure.  This elevated intracranial pressure can itself cause more damage, leading to a negative spiral that ends in dire health sequelae, including brain cell death and permanent brain injury or death. 

It is estimated that in one year, 1.74 million persons in the US alone sustain mild traumatic brain injury (TBI) requiring an office visit or temporary disability for at least 1 day.  This number does not include the many more injured, especially in an active population such as athletes or in the military, who try to shrug off the seemingly mild symptoms of headache, dizziness, and the like, but experience clinically significant elevated ICP. 

Current methods to measure ICP require drilling a hole through the skull to place a sensor or catheter.  The I-PASS device utilizes three small external sensors to calculate ICP.  The device can be applied quickly by a doctor, nurse, or medic on a patient with a potential brain injury.  The low cost and ease-of-use provided by I-PASS has the potential to provide accurate ICP measurement to practically all head trauma victims and is expected to enable better outcomes for these patients.

I-PASS was developed, prototyped, and tested by Vivonics under US government funding, including a $1.5M award under the Army Rapid Innovation Fund.  CranioSense was formed to further develop and commercialize the device and to allow outside equity investment independent of Vivonics.  Vivonics has provided seed capital to the new venture and licensed the I-PASS intellectual property to CranioSense. 

Vivonics was founded in 2012 and purchased the assets of the Biomedical Division of Infoscitex Corporation, which founder Gordon B. Hirschman previously ran as Executive VP.  Vivonics is focused on improving health and human performance by bringing premier products to life.  The formation of CranioSense is an important step in fulfilling this purpose.  Mr. Hirschman serves as CEO of CranioSense and I-PASS inventor Anna M Galea, PhD, serves as CTO.