Justification and Approval_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Agency/Contracting Activity: Army Contracting Command – Aberdeen Proving Ground (ACC-APG), Natick Contracting Division (NCD), 10 General Greene Avenue, Natick MA 01760.

2. Description of Action:

Nature: New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price Time & Materials Cost

For Hybrid Contracts, list percentage of each type of pricing:

Firm Fixed Price:

Time & Materials:

Cost:

Funds: Operations and Maintenance, Army (OMA) Other Funds: RDT&E

Fiscal Year of Funds: 2019

Name of Proposed Contractor(s): RevMedx Inc.

Street Address: 25999 SW Canyon Creek Road, Suite C City, State, Zip: Wilsonville, OR 97070 Phone:

3. Description of Services or Supplies:

The total estimated value of the proposed action is

This proposed effort is for a single, two (2) year Firm Fixed Price Research, Development, Technology and Engineering (RDT&E) contract with a total value of . The purpose of this effort is to establish a follow-on mechanism for the successful design and development work completed pursuant to Specifically, the current proposed deliverables correspond directly with the optional, unexercised CLINs (3000-3006) of the initial contract. This follow-on effort will focus primarily on the development of a “Sponge Pouch”. This improvement in design, performance, and manufacturability of RevMedx’s XSTAT® family of devices (XSTAT-12 & XSTAT 30) will ultimately improve the devices’ utility, especially as it pertains to post-application surgical removal upon echelons of definitive care. It is also the goal of this effort that the proposed improvements to the design will also reduce the cost of this item.

The XSTAT® family of devices are proprietary, Food and Drug Administration (FDA) approved hemorrhage control devices, used for treatment of non-compressible hemorrhaging, which is the leading cause of death on the battlefield, resulting from deep penetrating large caliber or blast wounds which cannot be treated using a tourniquet or traditional manual compression techniques.

Control Number: NCD 20-03 Reference Number: JA-20-NAT-040

The devices accomplishes this by applying a group of small, rapidly expanding sponges into a wound cavity, creating great internal pressure and a barrier to blood flow.

This effort will enable the contractor to conduct research and development (R&D) on their proprietary design. The R&D will include the following: Design and development of the “Sponge Pouch” to include product validation testing, biocompatibility and sterilization reporting, and conduct of associated FDA regulatory activities and compliance, thereby improving performance by increasing the effectiveness of XSTAT® as it pertains to efficient/complete removal of sponges in the operating theater and/or upon arrival at definitive care facilities.

4. Authority: FAR 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(1)

5. Reasons for Authority Cited: The XSTAT® (Regulatory Number K130218, Produce Code PGZ) is manufactured by exclusively by RevMedx, who is the patent holder for all XSTAT devices.

The XSTAT was originally designed to meet the specific requirements for medic field applications and fill a critical operational need for improved hemostatic control to life threatening non-compressible hemorrhage.

XSTAT® is the only FDA-approved device/capability that treats wounds of this type with significant improvements to the traditional treatment methods (e.g. combat gauze and tourniquets) which require extensive application time and external pressure. The XSTAT devices have proven statistically significant improvements in hemostasis and survival when compared to traditional treatment methods to include a large reduction in blood loss, resuscitation fluids requirements, medic treatment time and ultimately patient survivability. The devices were successfully evaluated through extensive FDA testing which included GLP studies, biocompatibility testing, sterilization testing, shelf life testing, tissue studies, training validation and human factors evaluations.

XSTAT® is a proprietary, FDA approved technology, owned and manufactured by RevMedx, which prohibits the Government from obtaining this capability from any other source. A significant investment has already been made into this product by the Government to include approximately in RDT&E that would be duplicative if required to complete a new development effort, the vendor asserts rights over XSTAT® specifications developed at partially private expense, which may not be released outside the Government without authorization.

This effort with RevMedx is required to develop design improvements to the XSTAT® hemostatic devices in order to improve device performance, improve manufacturability and reduce manufacturing cost. This is the only device of its kind currently approved for use by USSOCOM.

Furthermore, there is no equivalent commercial medical application for this use. The previous contract effort made significant improvements to XSTAT® performance. The design improvements included within this effort will benefit USSOCOM though increased capability as well as broaden the applicability of the product, which may gain additional fielding approvals for conventional forces.

6. Actions to Increase Competition: This effort furthers the manufacturing and production capability of the XSTAT® devices. The original contract for the development of XSTAT® was competed through a full and open competition. Since that time, no other vendors have proven to meet user requirements for this type of penetrating hemorrhage control. Additionally, the propriety nature of this product and the patents held by RevMedx limit any ability to increase competition at this time. Further competition for this action is not currently planned.

7. Market Research: In accordance with FAR 10.002, market research is conducted by PM-SOF SSES and the USSOCOM operators on a continual basis. The original development effort for this device was awarded in December 2010 through a full and open competition at which time RevMedx was selected as the best value for the Government, Additionally, in an effort to improve performance, manufacturability and cost effectiveness another contract was awarded to RevMedx in September 2015 ( mentioned previously) of XSTAT® devices. However, market research has continued throughout this time and is on-going. Market research for medical device systems such as this is mainly accomplished though trade shows that focus on tactical medical devices, which are attended by users in the USSOCOM community and vendors that focus on the manufacturing of tactical medical devices that may be suitable for USSOCOM operations, with or without modification. Additionally, all devices that receive FDA approval are monitored for potential application to meet this type of requirement.

Medical committee meetings, symposiums and conferences are attended on an ongoing basis.

Additional market research is done though marketing outreach by vendors and a review of catalogs and other product literature. Marketing events attended in this manner resulted in the original contenders that resulted in being awarded to RevMedx when it was determined that these devices best met the user requirements by providing a most effective, more-expandable cellulose pellet that would provide an increased capability to stop non-compressible arterial bleeding. The XSTAT® device has also undergone FDA testing and an independent Government test against other hemostatic products to determine its proven efficacy. Recent marketing events attended include the Military Health System Research Symposium (MHSRS) in August 2019, Special Operations Medical Association Scientific Assembly (SOMSA) in May 2019, the Biomedical Research Advisory Group (BRAG); held in conjunction with SOMSA), and the Special Operations Forces Industry Conference (SOFIC) also in May 2019.

8. Procurement History:

Previous Purchase Order(s) or Contract(s): Yes No

If "Yes", for each purchase order or contract provide:

Purchase order or contract number:

Was action competed? Yes No

Purchase order or contract number:

Was action competed? Yes No

Purchase order or contract number:

Was action competed? Yes No

9. Additional Information to support the justification. The XSTAT® family of devices was identified in the Assistant Secretary of Defense for Health Affairs (ASD(HA)) Memorandum for Record, dated 17APR 2018, as a Department of Defense (DoD) Joint Trauma Systems lifesaving materiel (LSM) which should be issued and trained on in accordance with DoD Instruction 1322.24. The technical, schedule, and cost risk for these improvements items are considered to be low.

10. Technical / Requirements Certification: I certify that the supporting data under my cognizance which is included in this abbreviated J&A is accurate and complete to the best of my knowledge and belief.

Submitted By:

SIGNATURE: DATE:

NAME:

TITLE: Assistant Program Manager (APM)-SOF-SSES

Approved By:

NAME:

TITLE: Program Manager (PM)-SOF-SSES

11. Fair and Reasonable Price Determination: As contracting officer, I hereby determine that the anticipated cost to the government for this contract action will be fair and reasonable.

Price analysis will be used in this determination.

TITLE: Procuring Contracting Officer

12. Contracting Officer’s Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing, I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

TITLE: Procuring Contracting Officer

Date: 2019.11.20 15:14:37 -05'00'

Date: 2019.11.20 16:43:03 -05'00'

Date: 2019.11.21 14:27:09 -05'00'

Date: 2019.11.21 14:27:42 -05'00'