Stimwave Receives FDA Clearance and Launches Commercialization for World’s Smallest Fully-Programmable, Eight-Electrode Wireless Pain Relief SCS System

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave Technologies, a leading innovator in wireless medical device
technology, a manufacturer and an independent research institute
headquartered in Fort Lauderdale, Florida, today announced that it has
received FDA clearance to market its eight-electrode wireless,
micro-technology neuromodulation device for relief of chronic back and
leg pain. The Stimwave Freedom-8A Spinal Cord Stimulation (SCS) System
is the world’s first wireless, fully-programmable SCS neuromodulation
device available and presents a potentially life-changing technological
breakthrough for the more than 90 million people in the United States
who endure daily chronic back and leg pain. Stimwave has also begun
commercialization of the device and began implanting in the first
patients earlier this quarter. Full nationwide commercialization is
planned for the first of the year.

Early marketing surveys conducted by the Company show that the majority
of candidate patients would prefer a wireless, miniature device to the
conventional, larger wired systems, which are typically 40 cc in volume
compared to the 0.4 cc volume of the Freedom Stimulator device.

“Patients utilizing the Stimwave Freedom-8A and Freedom-4A products not
only have the option of a wireless device, but the recent advancements
in this technology’s platform also provide the majority of the
programming and placement features available from wired systems that are
95 percent larger,” said Stimwave Chairman and CEO Laura Tyler Perryman.
“The safety and efficacy of even wider programmability options, or
high-frequency programming up to 10,000 Hz, is currently being
investigated with an FDA approved clinical trial.”

The wireless device’s form factor represents a major breakthrough in the
field of neuromodulation and eliminates the need for painful extensive
tunneling and placement of internal batteries within the body.
Stimwave’s Freedom-8A Stimulator is implanted in an outpatient procedure
through a standard needle with no need for general anesthesia or a large
surgical incision. The approach is expected to significantly reduce the
lifetime cost of care for chronic pain patients and offer a safe, viable
and effective alternative to pain medications.

“Patients’ needs in pain management are complex and unique. The
Freedom-8A SCS System is a first-of-its-kind product and offers a wide
variety of advanced programming features, polarity selection options for
up to eight separate electrodes per device, in the body in the least
invasive fashion ever offered,” said Dr. David Kloth, M.D., medical
director of the Connecticut Pain Care Center and author of Pain Wise.
“This advancement will provide clinicians with a multitude of options
and allow patients the most amount of freedom over their pain
management.”

The technology leverages a tiny, state-of-the-art device that delivers
small pulses of energy, in a fully-selectable manner, to eight
electrodes placed near surrounding nerves, triggering a reaction that
enables the brain to remap specific pain signals, thus providing pain
relief. The Stimwave Freedom Spinal Cord Stimulation (SCS) System
received FDA clearance for its four-electrode device last year, which
has also been upgraded to a fully-programmable model.

Please visit www.stimwave.com
for more information on the availability of the Stimwave Freedom-8A SCS
System. The Stimwave Freedom High Frequency (HF) SCS System is not
approved for sale or commercial distribution, and is limited to
investigational use only. For more information about the Stimwave High
Frequency (HF) clinical trial, please visit www.clinicaltrials.gov.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device
company engaged in the development, manufacture, and commercialization
of wirelessly powered, injectable, microtechnology neurostimulators,
providing patients with a convenient, safe, minimally invasive, and
highly cost-effective pain management solution that is easily
incorporated into their daily lives. Stimwave’s goal is to evolve its
patented, cutting-edge platform into the default for neuromodulation,
increasing the accessibility for patients worldwide while lowering the
economic impact of pain management. www.stimwave.com

Contacts

Glodow Nead Communications
Jenna Hudson, Sonia Sparks and Evan
Nicholson, 415-394-6500
StimwavePR@GlodowNead.com