FloSpine Revolutionizes the Treatment of Spinal Stenosis with FDA Approval of the KeyLift™ System

KeyLift is the fifth FDA-approved product developed by FloSpine, all invented at Florida Atlantic University® Research Park

BOCA RATON, FLORIDA, USA, November 1, 2023 / EINPresswire.com / — Together with FloSpine, Florida Atlantic University’s Research Park^® is pleased to announce that FloSpine has received 510(k) clearance for its KeyLift™ Expandable Interlaminar Stabilization System from the FDA, and has expanded from the Global Ventures entrepreneurial support center into a new, larger office to support growth.

The newly approved device addresses spinal stenosis, a common and debilitating condition that affects more than 100 million people worldwide, resulting in approximately 600,000 surgeries annually in the United States alone. It occurs when the spinal canal narrows, putting pressure on the nerves and causing severe back and leg pain, weakness and numbness. Traditional treatment options for spinal stenosis often involve invasive surgical procedures with long recovery times. The KeyLift System introduces a less invasive alternative, allowing spine and interventional pain physicians to implement this revolutionary treatment in an outpatient surgery center.

The KeyLift Expandable Interlaminar Stabilization System features an innovative, expandable design that enables precise, patient-specific surgical procedures. KeyLift unlocks the biomechanics of the spine and provides three key benefits:
1. Support – KeyLift provides support on the strongest part of the spine, the lamina. This distinguishes it from existing devices that only support the spinous process, which is difficult in patients with osteoporosis.
2. Lift – With the ability to expand up to 4mm in height, KeyLift effectively distracts and relieves nerves, relieving pain caused by spinal stenosis.
3. Stabilize – Positioned closer to the instantaneous axis of rotation of the spine, KeyLift promotes intervertebral disc health by balancing the discs.

This breakthrough technology not only reduces patient discomfort and pain, but also significantly shortens recovery times by being performed in an outpatient surgery center, allowing patients to return to their daily lives more quickly.

The expandable design of the KeyLift system is the result of years of research, development and rigorous testing by the FloSpine team, supported by Luis Escobar, chief design engineer.

“KeyLift offers a more mechanically stable design in a minimally invasive package,” says Dr. Cheng-Lun Soo, MD, orthopedic spine surgeon and co-inventor of the KeyLift. “As a spine surgeon with more than 25 years of experience, I believe this technology will reach more patients by allowing more interventional physicians to treat mild to moderate spinal stenosis without the fear of major surgery.”

Like the four other products invented by FloSpine and approved by the FDA, KeyLift has a Florida-inspired name. FloSpine is committed to advancing spine health care, and to support its continued growth, the company recently expanded its headquarters to a 5,000-square-foot facility in Florida Atlantic University’s Research Park, after completing its scale-up at Global Ventures. The majority of FloSpine’s hiring comes from Florida Atlantic University’s College of Engineering, and over the next two years it plans to expand from 8 to 18 employees.

“This is the culmination of years of research and development to deliver a medical device that helps improve the lives of patients suffering from spinal stenosis. Our recent move to larger premises in the Research Park at FAU will allow us to train our surgical and distribution partners to become increasingly competitive in the spinal implant market,” said Peter Harris, Founder and CEO of FloSpine. “This marks two significant achievements for our company as we grow in supporting our spine equipment for both interventional pain physicians and spine surgeons. We are confident that KeyLift will become the standard in the treatment of this condition, improving the quality of life for patients overall.”

Andrew Duffell, president of the Research Park at FAU, added, “FloSpine’s growth and expansion of Global Ventures into the Research Park is an inspiration to healthcare entrepreneurs and Florida Atlantic students who see their classmates excel in an exciting, growing industry. We very much look forward to supporting the team as it continues to innovate and contribute to the region’s economy.”

In loving memory of Luis Escobar, Senior Design Engineer and friend.

Andreas Duffel
Research Park at FAU
+1 561-416-6092
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