First Patients Enroll in Clinical Trial in Brain Hematoma Detection
Handheld imaging device for early detection of brain bleeding in head trauma patients begins trials at two prestigi ous academic medical centers
Philadelphia, PA – July 26, 2006 – InfraScan, a medical device firm specializing in brain injury diagnostic products, announced today that more than 15 patients have been enrolled in its clinical trial for hematoma detection. The trials are taking place at Baylor College of Medicine in Houston and at the Hospital of the University of Pennsylvania in Philadelphia. InfraScan’s lead product, the Infrascanner handheld brain hematoma detector, is a portable imaging device using near infrared (NIR) technology for the detection of hematoma, or bleeding in the brain, in people experiencing head trauma.
While CAT Scans (CT) are currently the diagnostic standard for hematomas, many head trauma patients do not quickly receive a CT scan – either because of accident site or due to CT availability issues. For patients with brain hematomas, rapid identification of the bleeding can play a significant role in efforts to maximize preservation of life and brain function. The Infrascanner can facilitate rapid identification by prioritizing patients for CT scanning and triaging patients requiring transport to a facility with neurosurgery capability.
“The Infrascanner clinical trial is a critical step in our efforts to bring this technology to military paramedics and civilian doctors,” said Baruch Ben Dor, president and CEO of InfraScan. “Results of our prior research are very encouraging and we are confident that this next study will further demonstrate the utility of the Infrascanner. The next step in our development program will be an expected 510K application in early 2007.”
The Infrascanner unit is based on a PDA platform with a wireless detector sensor. It detects hematoma based on differential NIR light absorption of the bleeding versus non-bleeding part of the brain. A pilot study with an earlier Infrascanner prototype involving more than 300 patients demonstrated high sensitivity for detecting bleeding in the brain and for rapidly detecting the onset of late bleedings.
“Patients with blood clots in the brain from trauma must be evaluated and operated on as soon as possible to minimize the injury to the brain. The hematoma detector may be useful at the scene of an accident or on a battlefield in identifying patients who should be taken directly to a hospital with neurosurgical specialists.” said Claudia S. Robertson, MD, medical director of the Neurosurgical Intensive Care Unit at Ben Taub General Hospital and professor in the Neurosurgery Department of Baylor College of Medicine.
“We are looking forward to this study of a promising new device that we hope will facilitate rapid noninvasive detection of intracranial hematomas.” said Eric L. Zager, MD, professor in the Neurosurgery Department of the Hospital of the University of Pennsylvania. He added, “If it is found to be effective, the Infrascanner could si gnificantly improve the way our health system identifies patients who need emergent neurosurgical intervention. This device may be very useful in the field by paramedics in civilian or military settings, in emergency rooms, and intensive care units.”
An estimated 1.5 million inpiduals seek medical treatment for head trauma in the U.S. each year, and the worldwide incidence of head trauma is approximately 10 million inpiduals. In addition to the Infrascanner’s first application to brain hematoma, the company plans to pursue in the future a second application for the product in monitoring of stroke victims.
About InfraScan – InfraScan, Inc. is a medical device company that focuses on developing, commercializing and distributing hand-held diagnostic devices for head injuries and stroke. InfraScan’s flagship product, the Infrascanner handheld brain hematoma detector is a portable imaging device using near infrared (NIR) technologies for the detection of bleeding in the brain in head trauma patients. The company has received early-stage funding from BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, and from Ben Franklin Technology Partners of Southeastern Pennsylvania, and has received US Army and US Navy grants. For more information visit www.infrascanner.com
- Baruch Ben Dor, PhD
- President and CEO
- InfraScan, Inc.