IRVINE, Calif., June 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 Issuance for its latest interspinous device as an additional device for use in the treatment of spinal disease and conditions. This is the first patent issued for the La Costa ISP line, which includes a number of patent-pending ISP designs. The design of our first entry, the La Costa SnaplokISP, features the "no screws" stackable design initially announced by Phygen in 2011, and displayed to the spine surgery community at the AAOS meeting in San Francisco in February of 2012. This patent issuance exemplifies the Company's plan to develop and commercialize a platform of products to address disease and trauma of the spine.
"This patent issuance is our announcement that Phygen has resumed development of innovative products through our clinical advisor members," said Tom Gardner, Phygen's CEO. "We intend to listen to surgeons to develop implants and devices that are good for patients, good for reimbursement, and easier for surgeons to use."
"In addition to the La Costa SnaplokISP and Phygen's other patent-pending ISP implants, Phygen owns a patent-pending anti-backout pedicle screw system that we are preparing for re-launch. Our associated surgeons have implanted over 300 clinical levels without a single incidence of backout in over five years of clinical experience, and we are excited to re-launch this innovative system."
Phygen has also designed a complete interbody system, a posterior cervical pedicle screw and rod fixation system featuring our patent-pending anti-backout screw design, and several other products in early development. "We are in the process of completing our filings with the FDA in order to re-commence clinical use of our products. The development of our product offerings is significantly advanced by this achievement," concluded CEO Gardner.
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, Leucadia, 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.
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.
Phygen undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Thomas Gardner, CEO
Tel: (949) 752-7885 x105
Mark Selawski, CFO
Tel: (949) 752-7885 x107
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SOURCE Phygen, LLC