Risks of blood loss in the operating room

One of the biggest concerns of patients when they enter the operating room is the loss of blood during surgery. This blood loss can lead to problems in many cases, as excessive loss can lead to a drop in blood pressure and even cause anemia.

A portable neurostimulation solution focused on reducing excessive blood loss could save precious time for surgical teams in the operating room.

A collaboration between Spark Biomedical, Inc. (Dallas, TX, USA) and the Feinstein Institutes for Medical Research at Northwell Health (Manhasset, NY, USA) will leverage the Feinstein Institutes’ years of research and proprietary solution concept in vagus nerve stimulation (VNS) for blood loss reduction and Administration-approved transcutaneous atrial neurostimulation (tAN) therapy device support Spark’s Food and Drug Administration (FDA), as well as its expertise in clinical trial management, FDA submission, market activation, and commercialization, to lead to this proprietary concept.

Los studies conducted by the team at the Feinstein Institutes over the past decade have shown that electrical activation of neural pathways to the spleen can prepare the body for coagulation (hemostasis) in the event of injury. A preclinical study demonstrated that ENV can effectively modulate coagulation, leading to a 50% reduction in bleeding time and volume. The reduction of blood loss through neuromodulation has anticipated clinical applications in a variety of possible settings, including operating rooms. Surgical teams could apply the device to reduce blood loss and save precious time in the operating room during the more than 50 million surgeries planned in the US each year. Additionally, at scenes of trauma, first responders could apply the device to trauma victims at accident scenes or in ambulances to decrease blood loss prior to hospitalization.

Studies over the past decade show that electrical activation of neural pathways to the spleen can prepare the body for clotting in the event of injury

“By leveraging Spark’s proprietary transcutaneous atrial neurostimulation (tAN) platform and our corporate infrastructure, Five Liters is perfectly positioned to immediately begin human trials and bring this solution to commercial application.” said Daniel Powell, CEO of Spark Biomedical. “We look forward to working with all the great scientists at the Feinstein Institutes to bring to life a life-saving vision that began more than a decade ago.”

“The basic scientific mechanisms of this approach have been extensively studied and this is a unique opportunity to translate the science into clinical trials for the treatment of life-threatening bleeds,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes. “If successful, these trials should represent an important milestone in the history of this long-unresolved clinical situation.”

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