New CPT Category 1 Codes Granted for Profound Medical’s TULSA

Profound Medical Corp. announced that, with sponsorship and support from multiple physician specialty societies, the American Medical Association (AMA) has established three new Current Procedural Terminology (“CPT’) Category 1 codes for MRI-Monitored Transurethral Ultrasound Ablation (TULSA) of prostate tissue, performed using the company’s TULSA-PRO system.
 
The first CPT Code describes the complete TULSA procedure when furnished by a single physician, such as a urologist. The other two CPT codes each describe a part of the TULSA procedure when TULSA is furnished by two physicians, such as a urologist in collaboration with a radiologist.
 
“We are honored the TULSA application was approved by the AMA’s CPT Editorial Panel for Category I code status,” Profound’s CEO/Chairman, Arun Menawat said. “The establishment of these permanent codes specific to TULSA is a critical milestone for the broader adoption of the technology to treat prostate diseases in the United States. The application was independently sponsored and submitted without the direct involvement of Profound, which is a testament to the level of physician support for this new procedure. We would like to take this opportunity to thank the societies for their support, as well as the independent TULSA-PRO users who provided their invaluable feedback. Looking forward, as we continue to work toward realizing TULSA’s full potential for a broad spectrum of patients with prostate disease, we believe having multiple distinct CPT Category I codes for TULSA will give our physician users the flexibility to either do the entire procedure on their own, or collaborate and be reimbursed for their part of the service.”
 
The three new CPT Category 1 codes and their descriptors covering the TULSA procedure will be included in a future edition of the CPT Codebook and will be effective on Jan. 1, 2025. In the meantime, U.S. hospitals performing the TULSA procedure on Medicare patients may continue to utilize HCPCS C code, C9734, established by the U.S. Centers for Medicare and Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (“OPPS”). Effective Jan. 1, 2023, reimbursement to a hospital billing under C9734 was increased to $13,048.
 
Profound is commercializing TULSA-PRO, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia. TULSA-PRO®is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (FDA).
 
Profound is also commercializing Sonalleve, a therapeutic platform that is CE marked for treating uterine fibroids and palliative pain treatment of bone metastases. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for treating osteoid osteoma. The company is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.