Brixton Biosciences Inc

Neural Ice Technology for Treatment of Pain - Project Summary Total Knee Arthroplasty (TKA) Is One of the Most Performed Orthopedic Surgeries to Relieve Joint Pain in Patients With End-stage Osteoarthritis (OA) or Rheumatic Arthritis (ra). in the Us, Over 700,000 Tka Procedures Are Performed Annually. to Manage Tka Pain Patients Are Commonly Prescribed Opioids, Contributing to a Spiraling Opioid Epidemic. the Misuse and Addiction to Opioids Is a National Public Health Crisis With an Estimated Economic Burden of $78.5 Billion Per Year. as Opioid Addiction Is Now a National Health Focus, Novel Non-opioid and Non-pharmacological Treatments for Postoperative Pain Are a Top Scientific Priority. There Is an Urgent Need for a Long-lasting, Drug-free Means of Relieving Post-tka Pain–which Is the Overall Goal of This Project. Cryoneurolysis Is an Opioid-sparing, Perioperative Intervention Used to Reduce Postoperative Pain. Current Cryoneurolysis Methods Apply Very Low-temperature Cryoprobes to Freeze Peripheral Nerves, Resulting in Reversible and Long-lasting Pain Relief. However, Due to Extremely Cold Temperatures (–88OC and Below) in Direct Contact With a Nerve and Surrounding Tissues, These Methods Are Not Nerve-selective nor Easy to Administer. They Also Are Not Injectable, Making the Treatments Time-consuming and Challenging to Adopt in Clinic. Our Initial Goal – an Easier to Use, Injectable Method of Cryoneurolysis to Reduce Postoperative Pain From Tka, Significantly Reducing or Eliminating the Use of Opioids. We Invented a Novel Injectable and Nerve-selective Cryoneurolysis Method That Overcomes the Limitations of Current Options. Neural Ice™ Can Be Injected Around Sensory Peripheral Nerves That Transmit Pain. We Have Shown in a Rat Model That Injection of Our Ice-slurry, Formulated to Bring Peri-nerve Temperatures to Around -5OC, Extracts Enough Thermal Energy to Reversibly Disrupt Nerve Structure and Reduce Pain Sensation for Up to 8 Weeks Without Damage to Surrounding Tissue. at the End of 2023, We Also Completed an Initial 16- Patient Feasibility Study Showing Significant Pain Reduction Response With No Serious Adverse Events (see Significance). in Response to These Findings (pre-clinical and Clinical) in October 2023 the Fda Granted Brixton Breakthrough Designation. in Phase Ii, We Seek to Optimize a Clinical Use Device That Produces an Injectable, Biocompatible, and Sterile Ice Slurry Which Meets the Fda Requirements for an Investigative Device Exemption (IDE) for a Pivotal Efficacy Trial. With Our Heal Phase I Grant We Generated Single-use, Terminally Sterilized Pre-filled Syringes That Contain On-demand Injectable Slurry for Use at Point-of-care Facilities. in Phase Ii We Seek to Optimize Our Design for Human Use (ease, Effectiveness, Cost, Etc.) and Test for In-vivo Biologic Response in Rat Model. We Will Also Establish Manufacturing of Human Use System & Prepare to Submit Pivotal Trial Ide Application to the Fda at the End of the Funding Period. If Successful, Our Study Will Lead to the Development of a Novel, Long-lasting and Non-opioid Treatment for Patients With Post-tka Pain.