IRVINE, Calif., Sept. 29, 2016 /PRNewswire/ — Phygen, LLC, a company focused on the development of devices used in the stabilization and repair of spinal disease and trauma, today announced that it has received a Notice of Allowance for its latest pedicle screw assembly utilizing the AutoLok technology. The unique design and its inherent resistance to back-out will provide a decided advantage to the Leucadia product line as the company continues to implement physician driven innovations in spinal health.
“We are pleased to receive this Notice of Allowance and plan to move forward rapidly on the regulatory and operational fronts with the Leucadia AutoLok system,” said Phygen CEO Thomas W. Gardner. “The clear advantages of this revolutionary feature will provide our clinical users with innovation developed through our clinical advisory members. We plan to quickly ramp up our regulatory and manufacturing efforts to get AutoLok technology back into the hands of clinicians as soon as possible. Our clinical advisory board considers this the most significant innovation in pedicle screws since pedicle screws became the gold standard in fusion.
AutoLok was initially introduced in 2011, and over 400 levels were implanted in spinal fusion cases, with no instances of backout and no revisions or field complaints of any kind. AutoLok was taken off the market after Phygen’s asset sale in 2012, and Phygen has now re-acquired full ownership of the technology.
About Phygen
Spinal disease is the leading cause of lost productivity and surgical intervention in the United States with an annual cost of more than $150 billion.
Phygen LLC is a medical device company focused on the development of surgeon-designed orthopedic spinal implants and instrumentation to address the stabilization and repair of spinal trauma and disease. Laguna, Lucadia, Coronado, La Costa, Del Mar and Cabo all represent Phygen products designed by spine surgeons for spine surgeons.
For more information, please visit www.Phygenspine.com.
Forward-Looking Statements
This news release includes “forward-looking statements”. These statements are based upon the current beliefs and expectations of Phygen’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; significant fluctuations in expenses associated with product development, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the medical device industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Phygen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Phygen’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
