Profound Medical Announces FDA Approval of TULSA-PRO for Prostate Ablation Therapy

On August 20, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that medical device company Profound Medical (Profound) announced that its TULSA-PRO system for transurethral ultrasound ablation of the prostate had received FDA approval for market launch.

TULSA-PRO combines real-time magnetic resonance imaging (MRI), robotically directed focused ultrasound, and closed-loop temperature control software to help clinicians develop reliable treatment plans. The system is designed to perform personalized, predictable, incision-free, and radiation-free intraprostatic ablation procedures while protecting the patient’s urethra and rectum. TULSA-PRO has previously received CE marking in the European Union.

Intraprostatic Field Ablation SurgeryIntraprostatic field ablation surgery, which originated in Germany, is currently one of the most advanced clinical treatments for prostatic diseases both domestically and internationally. The intraprostatic ablation system leverages the powerful energy of a high-energy focused electric field to utilize electrothermal protein coagulation, cellular ionization sterilization, and bioelectric field correction effects. These mechanisms facilitate the expulsion of pathogenic toxins and purulent obstructions via a catheter, thereby improving the internal environment of the prostatic ducts and alleviating various symptoms caused by prostatitis and benign prostatic hyperplasia (BPH), ultimately achieving a cure. This treatment is non-invasive and painless, causes no damage to normal prostatic tissue, and is suitable for patients of all age groups.

Profound conducted the TULSA-PRO Chelation Therapy Assessment Trial (TACT) to evaluate the safety and efficacy of the system. The trial involved 115 prostate cancer patients from the United States, Canada, and Europe who underwent intraprostatic ablation with preservation of the urethra and urethral sphincter. The results demonstrated that patients treated with TULSA-PRO experienced fewer postoperative adverse events, reduced prostate volume, significant decreases in prostate-specific antigen (PSA) levels, and low rates of disease recurrence.

TULSA-PRO enables surgeons to ablate benign and malignant tumor tissues, primarily for the treatment of intermediate- to high-risk prostate cancer, locally recurrent prostate cancer, and benign prostatic hyperplasia (BPH). Compared with radical prostatectomy and radiation therapy, this system offers a superior safety profile and effectively prevents postoperative adverse effects such as urinary incontinence and bowel dysfunction.

Profound, founded in 2008 and headquartered in Ontario, Canada, is a leading medical device company. The company is dedicated to developing incision-free therapies to improve treatment outcomes for patients with prostate cancer, uterine fibroids, and bone metastases. Profound boasts robust platforms in robotics, magnetic resonance imaging (MRI), and ultrasound imaging, providing clinicians with advanced tissue ablation treatment systems. The company went public on the Toronto Stock Exchange in June 2015 under the ticker symbol PRN.

Profound has also developed the innovative Sonalleve therapeutic platform, which is used to treat uterine fibroids and bone metastases to alleviate patients’ pain symptoms. The platform has obtained EU CE marking and has been approved for market launch by China’s National Medical Products Administration (NMPA). Furthermore, Profound is exploring the efficacy of Sonalleve in treating other cancers, such as abdominal cancers.

Arun Menawat, CEO of Profound, stated, “We are delighted that TULSA-PRO has received FDA approval, and we believe this treatment system will bring significant benefits to more patients.”

(Compiled by Xu Xiaoxue)