“Custom Spine announces FDA clearance of the
ISSYS LP Polyaxial Screw System”

June 20, 2007 - Parsippany, New Jersey

Custom Spine Inc., a privately held spinal implant company, is pleased to announce that it has received FDA clearance for the commercial launch of the ISSYS LP Low Profile Polyaxial Screw System. Mahmoud Abdelgany, CEO of Custom Spine is quoted as saying: “The release of ISSYS LP compliments our comprehensive ISSYS family of instruments and implants allowing us to strategically increase sales and expand our market presence.”

The ISSYS LP was designed utilizing the original ISSYS platform. The system’s features and benefits represent an evolution by developing the most innovative titanium rod fixation system to be launched in the spinal implant industry.

The primary feature of ISSYS LP, a low profile screw, is to provide better force distribution and resistance to screw failure at the bone-screw interface. It is simplistic, versatile and easy to use. ISSYS LP will provide the surgeon a low profile polyaxial screw that is designed with a double lead buttress thread which allows for ease of insertion and exceptional purchase strength. The unique saddle design accommodates 6.0mm and 6.35mm titanium rods with 6.4mm medial-lateral head translation providing the added flexibility for screw placement.

The ISSYS LP Polyaxial Screw System is designed with “best-in-class” instrumentation, including the patented one-step toggle free screwdriver, a one handed rod reducer and block inserter which simplifies the surgical procedure. The ISSYS LP was designed as a Minimally Invasive Surgical compatible system based on the future development of Custom Spine’s intellectual property.

“The goal at Custom Spine is to turn the pedicle screw market upside down!”