Somanetics obtains exclusive sublicense to new cerebral autoregulation technology

Oct 15 2009

Somanetics Corporation (Nasdaq: SMTS) today announced that it has signed an Exclusive Sublicense Agreement with Raba Equity Partners II, LLC ("Raba coreFoundry"). Under terms of the agreement, Somanetics has obtained exclusive rights, subject to specified rights of the U.S. Government and rights retained by The Johns Hopkins University, to new cerebral autoregulation technology developed at The Johns Hopkins University. Integration of this technology into Somanetics' INVOS(®) Cerebral/Somatic Oximeter would yield the first noninvasive monitor providing cerebral autoregulation data for routine clinical use. The cerebral autoregulation technology is associated with two pending patents. Somanetics has provided Raba coreFoundry an up-front, non-refundable payment of $1.8 million and will pay a royalty on future revenue associated with the technology. The up-front payment will be accounted for as a research and development expense in the fourth quarter of fiscal 2009.

Somanetics plans to utilize this patent-pending method of combining blood pressure measurements and signals from the INVOS System to continuously monitor and display cerebral autoregulatory function information. Somanetics plans to file a new 510(k) pre-market notification with the FDA to support marketing the new module in the U.S. by late 2010 and initiate product shipments for sale early in 2011.

Cerebral autoregulation refers to the body's ability to maintain constant blood flow to the brain despite changes in blood pressure. In many critical care situations, the brain's autoregulation can become impaired, making it vulnerable to changes in blood pressure and to potential brain injury due to loss of this critical protective mechanism. For example, blood pressure below the patient's autoregulation threshold can result in cerebral ischemia, while blood pressure above the patient's upper limit of autoregulation can result in cerebral bleeding.

Patients at highest risk of impaired cerebral autoregulation include those undergoing certain surgical procedures, such as cardiovascular, neurological and major orthopedic procedures, and liver transplants. Others at risk include patients with traumatic brain injury, those who have suffered a stroke, infants on ventilators and premature babies.

"Adding the ability to noninvasively assess the state of cerebral autoregulation to the INVOS System's existing measurement of brain oxygen saturation should enhance the value proposition for the INVOS System, increase our market potential by supporting entry into new clinical applications and strengthen our leadership position in the growing oximetry market," said Bruce Barrett, Somanetics' president and chief executive officer. "We believe the noninvasive approach of assessing cerebral autoregulation with the INVOS System may make the measurement simple enough to support routine clinical use and potentially prevent neurologic injury to patients."