Hadasit’s and Ramot’s LuboCollar for Trauma Patients Demonstrates Positive Results in Safety Study
An Efficacy Study of the LuboCollar is Now in Progress at Hadassah Hospital
JERUSALEM & TEL AVIV, Israel--(BUSINESS WIRE)--Hadasit, the technology transfer company of Hadassah University Hospitals, and Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University, announced today that the Lubo Cervical Collar, designed for use in trauma situations, has demonstrated positive results in a two-part Phase I safety study. The IRB approved study was registered with the National Institute of Health (NIH) and operated under the guidelines of both the NIH and the Israeli Ministry of Health.
“LuboCollar is designed to protect the neck by restricting the movement of the head relative to the rest of the body and to maintain an open airway in a non-invasive, simple and quick to operate way. It does so by using a “jaw-thrust”
“The LuboCollar has the ability to save the lives of trauma patients in pre-hospital and emergency treatments. I demonstrated the LuboCollar to some ER colleagues during a recent trip to the U.S. The feedback was positive regarding the design of the device and its potential,” said Dr. Jacob Assaf, Head, Department of Emergency Medicine, Hadassah University Hospital, Ein Kerem.
Trauma is the number one killer of people between the ages of five and 40. All injured patients in trauma are at risk for cervical spine instability and air blockage. Though these patients are transported by pre-hospital teams with a cervical collar to protect the cervical spine, existing cervical collars ensure cervical spine stabilization but do not protect the airway of the patient, which is opened by invasive means in necessary situations.
“LuboCollar is designed to protect the neck by restricting the movement of the head relative to the rest of the body and to maintain an open airway in a non-invasive, simple and quick to operate way. It does so by using a “jaw-thrust”-like knob to maneuver the mandibles, pushing them forward in the direction of the chin,” explains Dr. Omri Lubovsky, developer of the LuboCollar and a physician in the Department of Orthopedic Surgery at Hadassah University Hospital.
The study included twenty people divided into two groups. The first group included healthy volunteers, seven men and three women between the ages of 28-36, who lied awake on a bed for 30 minutes with the collar attached to the neck. For the first 10 minutes the subjects remained still. The jaw thrust knob of the LuboCollar was then moved forward one centimeter and the patient remained in that state for the next 20 minutes. No adverse side effects (pressure sores, local irritation or damage) were reported.
The second group consisted of nine men and one woman between 20 and 52 years of age all with orthopedic surgeries already planned. The aim of this part of the trial was to study the LuboCollar on unconscious patients. Each patient wore the collar while under general anesthesia with a laryngeal mask or an endotracheal tube. The device engaged for five minutes without using the “jaw thrust knob”. The device then pulled the jaw forward one centimeter. The patient remained in that state for the following 20 minutes. No adverse side effects were reported.
The evaluations in both the first and second part of the study were conducted immediately after the collar was removed, again two hours later and for a final review 24 hours post.
Hadasit and Ramot also announced today that an IRB approved efficacy study is now underway at Hadassah Hospital of the LuboCollar on anesthetized patients. The study will begin with 10 patients and ultimately recruit a total of 20. The protocol in the efficacy study is exactly like that of the safety study with the exception that the anesthetized patients will not be intubated, meaning that they will breathe independently during the procedure.
Hadasit (www.hadasit.co.il) was established as a subsidiary of Hadassah Medical Organization (HMO) in Jerusalem, Israel to promote and commercialize its continuously generated intellectual property (IP), purposed to helping solve the problems of modern medicine. Hadasit guides technologies from innovation to commercial application. For additional information or to schedule an interview, please contact Marjie Hadad, Media Liaison, Hadasit, at +972-54-536-5220 or e-mail email@example.com
About Ramot at Tel Aviv University Ltd.
Ramot (www.ramot.org) is the technology transfer company of Tel Aviv University. Ramot fosters, initiates, leads and manages the transfer of new technologies from university laboratories to the marketplace by performing all activities relating to the protection and commercialization of inventions and discoveries made by faculty, students and other researchers. Ramot provides a dynamic interface connecting industry to leading-edge science and innovation, offering new business opportunities in a broad range of emerging markets. For more information, please contact Ramot at +972-3-640-6608 or e-mail: firstname.lastname@example.org