SPINAL FUSION PROCEDURES PERFORMED ANNUALLY

• iData Research's study in 2018 revealed that around 1.62 million spinal fusion procedures performed in the US yearly.
• Out of the annual spinal fusion procedures conducted in the United States, interbody fusions were the ones most commonly performed, with more than 352,000 performed yearly in the US, according to iData Research.
• Cervical fixation is another significant type of spinal fusion procedure in the US. As of 2017, 85.5% of this type of spinal procedure were anterior while 14.5% of them were posterior, as per the study by iData Research.
• However, the number of spinal fusion procedures performed in the United States jumped from 1.187 million in 2007 to over 1.391 million in 2011. Within these periods, the number of patients it was performed on went from 662,400 in 2007 to 741,700 in 2011, according to a 2014 report by Bone And Joint Burden.

FINDINGS RELEVANT TO THE NUMBER OF COFLEX PROCEDURES PERFORMED ANNUALLY

• Globally, the Coflex procedures have been performed on over 163,000 patients in more than 60 countries since its inception, as per information on Coflex's official directory. Unfortunately, the company did not provide data showing the number of procedures performed in the United States alone; neither is such information available for any country.
• According to the United State's National Library of Medicine, Coflex received its investigational device exemption (IDE) in 2006 before its approval by the FDA in October 2012.
• Based on the number of Coflex procedures performed global and the date it received its investigational device exemption in 2006, we took it that the Coflex procedures began in 2006 (which is 12 years as of 2018). Thus, we estimated the average number of Coflex procedures performed annually to be 13,583 globally, as there is no data in the public domain specific to the United States.

RESEARCH STRATEGY:

CALCULATION

• Coflex® Interlaminar Stabilization® device is Paradigm Spine’s signature product which is used in over 60 countries. The company was acquired by RTI Surgical last year.

• Coflex is covered nationally by Medicare and Paradigm Spine. The North American Spine Society (NASS) has already issued a coverage policy recommendations for Coflex procedure which will provide evidence to private insurance companies to allow their patients access to this procedure.

•  82% of the Michigan population is covered by insurance companies for Coflex procedure; 4.1 million people were covered by Medicare, Medicaid, and ACA; while 4.5 million people were covered by Blue Cross Blue Shield.

•  10.5 million lives throughout the states of Pennsylvania, West Virigina, and Delaware were covered for Coflex procedures; 5.5 million were covered by Medicare, Medicaid, and the Affordable Care Act; and 5 million were covered by Highmark, Inc. and affiliates.

•  Blue Cross Blue Shield also covers Coflex procedures in North Dakota. It is the largest commercial payer in North Dakota.

• Coflex is one of the popular types of Interspinous Devices (ID) implants together with X-STOP, Wallis, and DIAM. According to the National Inpatient Sample (NIS) database, 66.7% who have undergone ID procedures was paid by Medicare while 23.1% was paid by private insurance patients last 2014.

• Paradigm Spine’s 2018 revenue was $422.2 million.

• Medicare national average payment for coflex is $17,253 for hospital inpatient, $14,698 for hospital outpatient, and $10,542 for Ambulatory Surgical Center (ASC).

Research Strategy: