MedTech Outlook Magazine: Specials Magazine

A neurosurgeon can begin an operation with an image that precisely captures the patient’s anatomy. As surgery progresses, however, the brain can deform, shift and change shape, creating a gap between the original image and the anatomy in front of the surgeon. When the map no longer matches the brain, navigation becomes less useful. “So that’s what we’re doing in surgery. We’re updating the map,” says Keith D. Paulsen, PhD, co-founder, board director, president & Chief Executive Officer. InSight Surgical Technologies is developing surgical guidance around that problem. Its lead I²UPDATE system is designed to account for brain deformation during surgery, while its quantitative fluorescence technology addresses signals that may not be visible to the human eye.

Clot extraction (thrombectomy) is a critical procedure for stroke patients, achieving technical success rates above 90 percent. However, while thrombectomy effectively removes the clot, it does not address the underlying damage to the brain tissue caused by one, the disrupted blood flow to the brain (ischemia) from the blockage of the brain artery by the clot and two, the secondary damage caused by reperfusion injury. Reperfusion injury is caused by the sudden inflow of blood following the reopening of a clogged brain artery and is largely an inflammatory response accompanied by oxidative stress that exacerbates brain damage. As a result, less than 20 percent of patients experience a full recovery. Therapeutic hypothermia is a well-known neuroprotective strategy that slows metabolism and reduces cell death through multiple protective mechanisms. Yet, systemic (whole body) cooling in stroke patients is often too slow and carries risks such as shivering, cardiovascular instability, infection, and immune suppression. In fact, it typically takes many hours to reduce body and brain temperatures by a few degrees Celsius—a complex undertaking which is often unsuccessful. These limitations make it impractical as a neuroprotective treatment for stroke. In contrast, selective endovascular brain cooling offers a promising alternative by delivering rapid, targeted hypothermia directly to the affected brain tissue. This method achieves protective brain tissue temperatures within minutes without compromising overall body function or introducing widespread systemic complications. Hybernia Medical is positioning itself at the forefront of this innovative approach. The company has developed a catheter-based system designed to provide localized brain cooling immediately following thrombectomy. This solution works within minutes, cooling the targeted brain tissue directly through a catheter introduced via the same arterial pathway used during clot extraction. “We developed a device that cools the brain directly through a catheter system in a highly selective, precise, and fast manner,” says Jae Choi, co-founder and CEO. The approach is built on years of rigorous research and development, evolving through extensive tests and large-animal studies and building on numerous preclinical stroke experiments that have validated both its safety and feasibility. Early clinical signals suggest that when combined with thrombectomy, localized cooling could lead to significantly improved outcomes. Beyond the cooling mechanism itself, Hybernia Medical’s system is engineered with advanced technology to ensure optimal performance. Embedded sensors provide real-time feedback that allows the device to adjust dynamically to the patient’s anatomical and physiological environment. This intelligent design ensures that the cooling process is not only effective but also consistent and safe. The infusion system that drives the cooling process has been optimized for maximum efficiency by using minimal fluid volumes—down to a fraction of a milliliter—which enhances heat transfer at the tissue level without jeopardizing patient safety or causing systemic instability.