Stimwave Market Approval May Disrupt SCS Industry

by James Cavuoto, editor

December 2014 issue

The recently announced market approval of Stimwave Technology Inc.’s Freedom 4 injectable stimulation system could have a serious impact on the neuromodulation device industry in the years ahead. The announcement created a buzz among attendees at the recent North American Neuromodulation Society meeting.

Stimwave, based in Miami Beach, FL, announced FDA 510(k) clearance to market the company’s wireless, injectable spinal cord stimulation device for relief of chronic back and leg pain. The device is already on the market in Europe in four- and eight-contact configurations and the four-contact Freedom device is expected to be commercially available in the U.S. next month.

The device differs from existing SCS systems in that it contains no leads or implanted pulse generator, relying instead on power and telemetry provided by an external RF transmitter. Stimwave is touting the device’s simplicity and cost savings for payers and patients. While traditional SCS systems can cost upwards of $20,000, the Stimwave Freedom system will be available in configurations costing as low as $10,000. Also, unlike existing SCS therapy, which requires a trial period with percutaneous leads, the microstimulator serves as its own trial device, enabling more clinicians to maintain care of their chronic pain patients.

Despite FDA clearance, not everyone in the industry is convinced that the product will be successful in the market. Some neural engineers we spoke to questioned whether the external RF device would be able to deliver energy to the device in a consistent and effective manner. Others complained about the relative paucity of clinical data and technical details. Some competitors expressed doubt that patients would be willing to accept the inconvenience of an externally worn transmitter when fully implanted alternatives exist.

Stimwave claims that the RF transmitter, operating at 915 MHz, can comfortable deliver energy to depths of 13 cm. The company is conducting a consumer-oriented campaign to market the body-worn transmitters in a number of configurations, including devices outfitted in a bandage, a brassiere, a T-shirt, and a fanny pack. A room-based transmitter capable of communicating with the microstimulator from a distance of up to 3 feet is in development, as is a wireless bed antenna a patient can use while sleeping.

In an interview with NBR, Stimwave CEO Laura Tyler Perryman touted a number of competitive advantages of the Freedom device, including MRI compatibility at 1.5T and 3T, the ability to inject the device with a 14G needle and anchor it with a simple office procedure, and the elimination of complications that might otherwise arise from tunneling, lead migration, and percutaneous trial leads. She also said the device would be programmable to deliver stimulation in a number of different waveforms and frequencies up to 1.5 MHz. She said the company has developed burst stimulation paradigms and the device is also capable of operating in the dorsal root ganglion.

Even the naysayers acknowledged that if Stimwave’s claims about RF delivery are true that the device would exert competitive pressure on existing SCS vendors. The system would be attractive in emerging markets like parts of Asia because of its lower price point and simplicity of implantation. In the U.S. and Europe, the device would almost certainly exert downward price pressure on existing SCS systems and could even make Stimwave an attractive acquisition target if for no other reason than to exert some degree of control on product pricing.

At the NANS meeting, Stimwave announced initiation of a multi-center, randomized, double-blind, placebo-controlled clinical study of its wireless high frequency stimulator for the treatment of chronic, non-specific origin low back pain, the Tsunami study. The study is designed to compare a sham device to stimulation of spinal nerves at settings that are not perceived by the patient, thus allowing for a true, blinded patient experience. The study un-blinds the patients after 90 days, after which time the sham group devices are enabled to allow the sham participants to benefit from the therapy long-term.