Value Proposition:
· 3-dimensional maneuverability of implants enables alignment with patient-specific anatomy.
· Supports breakthrough combined monitoring/treatment device, with potential for adaptation to additional implants.
Technology Description
· Researchers at Johns Hopkins have developed a combined SCI monitoring and treatment device, called MUSIC, that received FDA Breakthrough Device Designation (see HEPIUS). Here, they have also developed an apparatus for surgical placement and securement of the MUSIC device. This apparatus, unlike existing ones in the field, is capable of adjusting an implant in all three dimensions along the spinal cord, enabling device placement to match patient-specific anatomy. Although developed for use with MUSIC, the apparatus could potentially be used with additional spinal implants.
Unmet Need
· There are nearly 18,000 new cases of traumatic spinal cord injury (SCI) in the United States every year (see NSCISC). Currently, there are few methods to monitor the injury site and either provide damage information or aid in the healing process. A CT scan or MRI can be performed, but these give indirect readouts and can take a long time to complete. Additionally, there are currently no therapies approved by the FDA to enhance patient outcomes following SCI (see Hwang, 2021). SCI is generally treated in a prioritized manner, focusing on life-threatening symptoms like breathing and bleeding before addressing the neurological injury (see UptoDate), which can lead to more extensive damage. Therefore, there remains a severe need for SCI interventions to both monitor and treat the injury. This unmet need demands the use of novel solutions, such as the MUSIC neural implant, which needs to be placed, fixated and taken off manually and without damage to the surrounding tissues.
Stage of Development
· The device has been validated in large animal and human cadaver models.
· Looking for partners in commercialization and human trials to gain full FDA approval.
Data Availability
· Data available upon request.
Publication
N/A
