Spinal Balance: Surgical Sterilization Done Right

Written by Kevin Volz.

According to the American Chiropractic Association, 31 million Americans experience lower back pain at any given time. While most cases are treated without surgery, many patients are forced to go under the knife when other treatment methods fail. The most common type of back pain surgery is a spinal fusion, where vertebrae in the back are joined with a series of screws to reduce painful movements and nerve stretching. Infections after spinal fusions are common, however, because there are no standard sterilization methods to clean screws after they are removed from their packaging, but before they are put in the body.

“Up to 90 screws can be brought into an operating room for use in spinal surgery, but the surgeon may only use 4 of those 90 screws at a time,” said Dr. Anand Agarwal, president and CEO of Spinal Balance, Inc. “That leaves a lot of screws that are handled by a doctor or nurse and then left exposed on the operating table for a long period, gathering bacteria.”

Spinal Balance has developed a spinal fusion device that employs a no-touch screw system with each screw individually packaged. The packaging has an easy-to-remove lid, enabling doctors to maintain their efficiency during surgery. Once the lid is removed, surgical instruments are able to remove the screws from the packaging, with no one touching them before they are implanted into a patient’s body. This reduces the possibility of infection and eliminates the need for multiple sterilizations, which has been shown to cause corrosion of the implant.

“Our system could not only save someone’s life, but also reduces a hospital’s healthcare costs because they no longer have to pay for repeat sterilization during spinal fusion surgeries,” said Dr. Agarwal.

Dr. Agarwal spent years as a spine surgeon before starting Spinal Balance with Dr. Vijay Goel and, later, Arthur Karas. He frequently had to re-sanitize screws before implanting them into a patient, simply because they had been sitting for too long on the operating table. This increased the time needed to complete surgery and the number of required steps during the process. His mission with Spinal Balance was to build a technology that would enhance the surgeon’s experience, improve patient outcomes and reduce procedural costs.

Spinal Balance received a $600,000 Ohio Third Frontier Innovation Platform Program (IPP) award in 2013, which was used for product and technology development, and to hire additional employees. The company’s facilities are located in the University of Toledo’s LaunchPad Incubator, a northwest Ohio partner of Ohio Third Frontier.

The screws recently received 510(k) clearance from the FDA, allowing sales and marketing of the product in the United States. The company has received interest in using the technology from surgeons in Ohio, Florida, Japan and Europe.

Agarwal says that without the support from the state of Ohio, Spinal Balance would not be entering the medical device marketplace.

“We owe a great deal to Ohio Third Frontier,” said Agarwal. “Many of our technological innovations have been funded by the state, everything from prototyping to research studies. Their assistance has made this product possible.”

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