Jane Metcalf of Interventional Spine

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