China approves Profound Medical’s Sonalleve

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The Chinese Food and Drug Administration (CFDA) has approved Profound Medical’s (TSXV:PRN; OTCQX:PRFMF) Sonalleve for the non-invasive treatment of uterine fibroids.

Sonalleve is a therapeutic platform that combines real-time MRI and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve can offer women with uterine fibroids a quick, non-invasive therapy option, allowing patients to usually go home the same day and return to their routines within two days.

“Obtaining CFDA approval for Sonalleve marks a major milestone for our company and provides important additional validation of this powerful, patient-friendly new approach to treating uterine fibroids,” CEO, Arun Menawat, said in a statement.

Profound’s distribution partner, Philips, has a strong brand position in China, having installed MR imaging systems in many of the country’s largest hospitals, he added.

“That, combined with the recent appointment of Ian Heynen to lead our global sales and marketing function, positions us very well to plan and execute the commercial launch of Sonalleve in this very large and attractive market,” Dr. Menawat said.

In a new report, analyst Prakash Gowd of CIBC World Markets said approval of Sonalleve in China is testament to the strong benefits of Sonalleve in the treatment of uterine fibroids, and to the partnership between Profound and Philips.

Mr. Gowd figures that Philips has MRI units in about 30% of the top hospitals in China, and these would be the prime targets for Sonalleve sales.

“We also view this approval as positive for the longer term since Profound will eventually look to get TULSA-PRO approved in China,” he added. “Having Sonalleve on the market should provide some benefits in market adoption.”

Uterine fibroids, or leiomyoma, are the most common non-cancerous tumors of the female reproductive tract in women. Affecting an estimated 20% to 50% of women over 30 years of age, the disease can cause painful symptoms and abnormal menstrual bleeding. 

The most common medical treatment for this disease now is hysterectomy. Involving invasive surgery, hospitalization and extensive recovery time, hysterectomy also results in a women’s permanent inability to have children.

Michelle Carr