SSJ - Nevro_Redacted.pdf

Single Source Justification (Simplified Acquisition)

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Section A: General Contract Information

Contracting Activity: 60th CONS

Project/Program Name: NEVRO HF10 Spinal Cord Simulator (SCS)

Purchase Request/Identification Number: FM442700800118

Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

NEVRO HF10 is a non-pharmacological neuromodulation device that has proven to be very effective in treating chronic back and leg pain. This spinal cord stimulator (SCS) works at a higher frequency than its competitors, and provides greater pain relief to a larger percentage of patients. Unlike traditional SCSs, NEVRO HF10 therapy does not cause paresthesia, which is that tingling or buzzing sensation commonly experienced with traditional SCSs.

Quantity: 5 EA

Section C: Justification for Soliciting from a Single Source or Brand Name

NEVRO is the only company that provides this product as they hold a patent on this item and no other vendor is authorized to sell this item. The NEVRO HF10 is cutting edge technology approved by the FDA and given the Superiority Label because it outperforms all its competitors. The NEVRO HF10 does what no other traditional SCS does. That is, it doesn't cause numbness and tingling. Instead, it provides more consistent and longer lasting pain relief. NEVRO operates at 10 times higher frequency than traditional generators. It is far more consistent in treating back and leg pain. Research data showed that the responder rate for back pain at 24 months was 79% for NEVRO vs 49% for its competitors. Paresthesia rate was 0% for NEVRO vs 44% for those with traditional SCS.

Section D: Efforts to Obtain Competition

Market research into traditional SCS was made by contacting sales representatives from both Abbott and Medtronics. Product information and specs were received, along with price quotes. After reading through research results, comparing product specs and cost, it was easy to see that NEVRO HF10 was not only more feasible, but also a far better product. The FDA supports research findings and have given NEVRO HF10 the superior label. It delivers better and longer lasting pain relief from chronic leg and back pain in comparison to traditional SCS. NEVRO HF10 is a great adjunct for people who have had surgery and tried other pain management therapies.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

Currently NEVRO is the only maker and supplier of the NEVRO HF10 SCS. NEVRO is currently working to get their products added to ECAT for future purchases. Market research will continue to be conducted to see if there are new products available to meet the governments need or if authorized dealers of this product become available.

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Brand Name Urgency Exclusive Licensing Agreement Industrial Mobilization Other Sole Source

Single Source Justification (Simplified Acquisition)

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Date

23-Mar-2020

Name and Rank/Grade of Requiring Activity Member

NICHOLAS L. WILSON, SSgt

Signature of Requiring Activity Member

Date

23-Mar-2020

Name and Rank/Grade of Contracting Officer

Gage Bergman, TSgt

Signature of Contracting Officer