67 WALL STREET, New York - August 1, 2014 - The Wall Street Transcript has just published its Medical Devices Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Orthopedics and Cardiovascular Medical Devices - Medical Device Innovation and Consolidation Trends - Affordable Care Act - Aging U.S. Population - Medical Technology Innovation - Medical Equipment Growth Opportunities - Efficient Patient Treatment - Bifurcation in Medical Devices
Companies include: InVivo Therapeutics Corporation (NVIV) and many more.
In the following excerpt from the Medical Devices Report, the CEO of InVivo Therapeutics Corporation (NVIV) discusses company strategy and the outlook for this vital industry:
TWST: In other words, you don't have approval for broad use. You have approval for use in certain kinds of patients for whom other treatments are not available.
Mr. Perrin: Correct. We have approval to evaluate the Neuro-Spinal Scaffold in a defined set of spinal cord injury patients. In the device world, to obtain what's called the humanitarian use device, or HUD, designation the indicated population must be fewer than 4,000 patients per year in the U.S. So it is, in fact, much narrower than one would see in the orphan drug world.
When we applied for the HUD designation, we identified the group of patients who would be in our clinical trial as patients with acute spinal cord injury who have complete ASIA A injury with no motor or sensory function below the site of injury. Given the small patient population and the lack of any effective treatments, the approval process is quite unique. To obtain approval for a HUD, one must receive HUD designation and submit a humanitarian device exemption - HDE - application to the FDA.
An HDE is similar in both form and content to a premarket approval - PMA - application but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. Instead, the application needs to contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use. An approved HDE authorizes marketing of an HUD.
TWST: Are you worried that the scaffold might cause an immune reaction?
For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
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