Regis Assists Innovative Product in Obtaining Market Approval

Today, an implantable sacral nerve stimulation system was approved for market launch. We are highly honored to have participated in the registration process of this product and assisted the enterprise in obtaining medical device approval.

The working principle of this type of product is to continuously apply specific electrical pulses to specific sacral nerves to excite or inhibit neural pathways, regulate abnormal sacral nerve reflex arcs, and thereby influence and regulate the functions of target organs innervated by sacral nerves, such as the bladder, urethral/anal sphincter, and pelvic floor.

Relevant literature indicates that the prevalence of OAB (Refractory Overactive Bladder) among adults over 40 in China has reached as high as 21.4% in men and 26.4% in women. The impact of OAB on patients' quality of life is unimaginable, both physically and psychologically. The "Chinese Expert Consensus on the Clinical Application of Sacral Neuromodulation (2018 Edition)" points out that sacral neuromodulation (SNM) is an effective method for treating various lower urinary tract dysfunctions and is becoming increasingly popular in China.

As of today, there are only two sacral nerve stimulation products approved by NMPA. The launch of this product can further meet the clinical needs in the field of device therapy for lower urinary tract dysfunction in China, benefit more clinical patients, and have significant social benefits.

We are highly honored to participate in the registration process of this product. We believe this product will benefit more patients, and we wish the client company great long-term development.