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IST Receives FDA Clearance of Paramount(TM) IBF System for Minimally Invasive Spine Surgery

Innovative Spinal Technologies, Inc. (IST), a leading developer of the world's most advanced motion preservation and minimally invasive treatments for spinal disorders, announced the 510(k) clearance of its Paramount(TM) IBF System for minimally invasive spine (MIS) surgery by the United States Food and Drug Administration. The Paramount IBF System is now available nationwide through IST's network of sales representatives.

Based on a minimally invasive transforaminal implant delivery, the Paramount IBF System is a significant step forward in less invasive interbody fusion. The system's innovative inserter design offers an unprecedented level of control and maneuverability for precise implant placement. The comprehensive instrumentation system, combined with a broad selection of bulleted, anatomically correct PEEK-OPTIMA® implants, is indicated for use in patients with Degenerative Disc Disease (DDD) and may be implanted in either a direct posterior or transforaminal approach.

"We are excited to be one of the first medical device companies to receive FDA clearance for interbody fusion. With the expanded indications for DDD and T-LIF approach, the Paramount IBF system further reinforces the benefits of our minimally invasive Paramount Lumbar Fusion System and provides the ideal solution for MIS fusion," said Scott Schorer, President and CEO of IST.

Dr. Larry Khoo of ULCA Medical Center describes the innovative implant insertion technique and instrumentation as a major breakthrough in implant delivery. "The steerable implant delivery instrument allows me to place the Paramount implant more consistently with increased accuracy into the optimal interbody location," Dr. Khoo commented.

Paramount IBF expands the Paramount Lumbar Fusion family of products significantly, providing surgeons with a complete suite of products required for highly specialized minimally invasive spinal procedures. With MIS, the potential patient benefits include faster procedures, reduced blood loss, less tissue trauma and scarring, less postoperative pain, and a shorter hospital stay.

The company will be demonstrating Paramount IBF along with full suite of IST products at the North American Spine Society annual meeting.

About IST: Innovative Spinal Technologies, Inc.

Headquartered in Mansfield, MA, and founded in 2002, IST is a privately held spine technology company committed to advancing patient treatment by developing the world's most advanced motion preservation and minimally invasive products. IST maintains its highly ethical approach to distribution and an unwavering focus on ethics and integrity. For information regarding the Paramount(TM) IBF System, please contact Rob Brown, Vice President of Product Marketing, (508) 452-3500 or rbrown@ISTspine.com. More information about IST can be found at www.istspine.com.