Heron Therapeutics, Inc. announced that ZYNRELEF®? (bupivacaine and meloxicam) is included in the proposed 2025 Non-Opioid Policy for Pain Relief under the Medicare hospital Outpatient Prospective Payment System ("OPPS") and the Medicare Ambulatory Surgical Center ("ASC") payment system (the "Proposed Rule") as a qualifying product effective April 1, 2025. This Proposed Rule for payment within hospital outpatient departments ("HOPDs") and ASCs was issued by the Centers for Medicare & Medicaid Services ("CMS").

Under the Proposed Rule, ZYNRELEF qualified based on its postoperative pain indication and potential to reduce or eliminate the need for opioids. ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELE F is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

ZYNRELEF was initially approved by the U.S. Food and Drug Administration ("FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extent total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.

Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.