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Stimwave Granted New FDA 510(k) Clearance for the SandShark Injectable Anchoring System, Fixating Stimulators without Surgery

The Only Interventional, Minimally-Invasive Outpatient Procedure to Manage Chronic Pain without Opioids Debuts First USA Patient

POMPANO BEACH, Fla.--(BUSINESS WIRE)-- Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced the SandShark Injectable Anchor System received the U. S. Food and Drug Administration’s 510(k) clearance. The clearance of the injectable anchor allows interventional pain management clinicians to insert Stimwave’s Wireless Pain Relief® technology devices through the most minimally-invasive outpatient procedure for Americans who suffer from chronic pain as a proven alternative method to opioids.

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Sandshark Introducer with Loader Anchor

“The SandShark Injectable Anchor System is a ground-breaking innovation that moves the neurostimulation industry forward after being stagnant for the last decade with bulky battery implants designed decades ago,” said Laura Tyler Perryman, founder and CEO of Stimwave. “It allows clinicians to place the electrode portion of the stimulator and anchor those electrodes through the same needle puncture, similar to a nerve block, opening the door for more clinicians to provide patients with our efficient cutting-edge stimulators without a cut down to the fascia layer or a laminectomy to fixate the electrodes.”

“As a clinician, it is my goal to deliver the best therapy outcomes to my patients. Stimwave’s wireless system has already proven extremely beneficial for my chronic pain patients,” said Cuneyt Ozaktay, MD, interventional pain physician at Anesthesia Pain Care Consultants in Tamarac, FL who implanted the first Sandshark anchor in the U.S. “The SandShark allows me to anchor my electrodes while having the least amount of tissue trauma possible. The SandShark anchor allows pain physicians who aren’t comfortable with the large surgery required for implanting bulky batteries to begin to treat their opioid-dependent patients with stimulation and begin to change lives.”

Once the electrodes are placed, the SandShark applicator is slid down over the tail of the device, progressing the un-deployed anchor into ligaments and strong connective tissues. Once the radiopaque anchor is in the desired location, the clinician squeezes the handle and injects the anchor, simultaneously deploying the wings of the anchor, pushing them laterally into the tissue. This patented injection process locks the anchor to the stimulator, and the wings secure the stimulator to the surrounding tissue to prevent migration throughout the lifetime of the implant. The injectable anchor keeps the electrodes near the targeted nerves, allowing for a freedom of implantation not available in other neuromodulation devices, which are burdened by a bulky battery that needs recharging and is highly inconvenient for patients.

Aiming to provide a non-opioid alternative in the treatment of chronic pain, Stimwave provides the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System for patients in the United States. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain, the Stimwave Freedom SCS System is the most versatile system available in the industry. Stimwave’s devices use Wireless Pain Relief® technology and are 95 percent smaller than any other neuromodulation device on the market. The devices deliver pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief.

For more information, visit www.stimwave.com.

About Stimwave LLC

Stimwave LLC is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, micro-technology 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

*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

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Glodow Nead Communications
Evan Nicholson, Kati Stadum, Sarah Rogers or Rosemary O’Brien, 415-394-6500
StimwavePR@GlodowNead.com

Source: Stimwave LLC