The innovative treatment for chronic lower back pain was shelved in the US due to unacceptable regulatory hurdles from the FDA. The FDA required a randomized controlled trial with fusion surgery as the control and the innovative treatment as the test, which increased costs and study duration significantly compared to expectations. Due to the high costs and long study time required by the FDA, the innovative treatment was ultimately not pursued in the US market.

1. Innovative Product Shelved in US
Due to Unacceptable Regulatory
Hurdles
One Example and Lessons Learned
February 10, 2014
Jane Metcalf
(949) 525 - 1493

2. Innovative Treatment for Chronic Lower Back
Pain Due to Degenerative Disc Disease (DDD)
30 million US citizens afflicted with lower
back pain and @ 3 million suffer from
debilitating chronic back pain.

3. Present Therapeutic Options

4. Present Therapeutic Options
Potential Area of Treatment
by Innovative Device

5. Innovative Treatment for Chronic Lower
Back Pain - Benefits and Risks
Benefits
• Relieves Pain
• Less invasive than
fusion surgery
• Lower cost
• Faster return to normal
activities
• Potential to delay further
degeneration
• Reversible
Risks
• Long term results not
studied
• Same as minimally
invasive facet screws

6. Obstacle in Pathway to US Market: FDA
Designated “Gold Standard” Control
IDE for Pivotal Trial (2 years in FDA negotiation)
• Multicenter, prospective, randomized control, 250+
patients, followed for 24 months
Control versus Test Arms of Study
• Control: Fusion surgery with interbody cage, several
days in hospital, general anesthesia, six week
recovery, cost @ $28K
• Test: Percutaneous out-patient surgery, local
anesthesia, 3 day recovery, cost @ $3K

7. Issues
• Patient enrollment rate much slower than
expected – increasing project study duration by
2 years
• Costs much higher (@ $15 million) than
expected
• Population for new device indication not
addressed

8. Lessons Learned
• Early understanding of FDA requirements for
determining safety and efficacy is key in
managing investor expectations