A03_JA-18-72_Arsenal_Medical_WSS_Redacted.pdf

DEPARTMENT OF THE ARMY

US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21702-5014

Control No: JA-18-72

For Official Use Only

Justification Review Document for Other Than Full and Open Competition

Program/Equipment: Intracavitary Noncompressible Hemorrhage Control Agent (Wound Stasis System)

Authority: 10 U.S.C. 2304(c) (1). The Federal Acquisition Regulation (FAR) citation is 6.302-1(a) (2) (ii), when the supplies or services required by the agency are available from only one responsible source.

Amount:

Prepared by:

Typed Name: DSN:

Title: Product Manager Date: 14 December 2017 E-mail:

Contracting Officer:

Typed Name: Ms. Kelly Green DSN:

E-Mail: Date Reviewed: 04 February 2018

Technical Representative:

Typed Name: DSN:

Title: Product Manager Date Reviewed: 14 December 2017

Requirements Representative & Project Manager

Typed Name: DSN:

Title: Project Manager Date Review: 14 December 2017

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Project Manager:

Typed Name: DSN:

Signature: __ Date Review: 14 December 2017

Control No: JA-18-72

For Official Use Only

Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA) on behalf of the U.S. Army Medical Material Agency (USAMMA).

2. Description of Action: This approval is being sought for the issuance of an out of scope modification to contract W81XWH-15-C-0147 to Arsenal Medical, Incorporated.

This is a Cost-Plus-Fixed-Fee (CPFF) contract with an approved fee of . The modification is incrementally funded and will utilize Fiscal Year (FY) funds.

3. Description of Services: The objective of this contract is to execute clinical trials, manufacture and provide the Wound Stasis System (WSS) medical device, applications training support to the WSS product development effort sufficient for Food and Drug Administration (FDA) submission and clearance of the device as a pre-hospital hemorrhage control agent. This includes providing Subject Matter Expertise (SME) in the development of the clinical protocols, Quality System Regulation (QSR) - compliant representative test articles for the study and training material for users on the WSS medical device.

The additional human factors study is estimated to cost . This will increase the total value of the contract from to include all options.

The period of performance for this contract will remain at sixty (60) months for the base period and thirty-six (36) months for the option period for a total of eight (8) years or ninety-six (96) months.

Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c) (1). The FAR citation is 6.302-1(a) (2) (ii), Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development of highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition and unacceptable delays in fulfilling the agency’s requirements.

5. Reason for Authority Cited: Arsenal Medical owns the proprietary rights and is the only developer and manufacturer of the WSS medical device. The WSS medical device was assessed by the Department of Defense (DoD) Hemorrhage and Resuscitation Steering Committee as the only solution to meet DoD’s medical capability gap for the treatment of intracavitary, noncompressible hemorrhage. There are no other commercially available FDA approved devices that meet DoD’s medical capability gap.

All other efforts are at a significantly lower Technology Readiness Level (TRL) than the WSS device. Introduction of a new contractor to duplicate Arsenal Medical’s efforts and reach the same progress in developing and obtaining FDA approval for a treatment for intracavitary, noncompressible hemorrhage would cost the Government an additional and delay the WSS medical device for an additional four years.

The requiring office derived their estimate from the previous DARPA contracts awarded to Arsenal Medical to demonstrate biocompatibility, proof of concept, and efficacy in preclinical trials. The additional time would place the program at risk and prevent the WSS medical device from obtaining FDA approval in FY22, thus delaying the device for use for the warfighter.

6. Efforts to Obtain Competition: A sources sought notice was posted to FedBizOpps on 22 December 2017. No responses were received in response to the sources sought notice. No additional effort will be made to solicit offers from as many potential sources as is practicable as there is only one source capable of rendering the required services to ensure the consistency and scientific merit of the tests to be performed. Arsenal Medical will follow the statutory requirements as defined in FAR 19.702, when soliciting subcontractors under this requirement. Arsenal Medical is the only developer, manufacturer and owner of the intellectual property for the WSS medical device. The WSS medical device was assessed and determined to be the only device that fulfills the current capability for point-of-injury therapies to treat intracavitary hemorrhage. No other solutions were determined feasible at this time.

7. Actions to Increase Competition: The USAMMA Project Manager (PM) and the Integrated Product Team (IPT) will continue to see competitors for future requirements for the same or similar services for point-of-injury therapies to treat intracavitary hemorrhage. As the device becomes commercially available, the market will be tested for the same or similar devises through market research or full and open competition.

8. Market Research: Market research was conducted to identify all qualified sources for point-of-injury therapy to treat intracavitary hemorrhage. The methods used include an independent Analysis of Alternatives (AoA), Request for Information (RFI), and a broad internet search. The independent AoA was commissioned by the IPT, “Intracavitary Noncompressible Truncal Hemorrhage AoA” on 11 September 2014 to compare potentially relevant products based on their ability to address the capability gap. The AoA identified Arsenal Medical’s WSS medical device as the only solution to meet DoD’s medical capability gap to effectively minimize, mitigate and prevent injury and personal impact to the service member, as required by the Military Operational

Medicine Research Program (MOMRP) and the Combat Casualty Care Research Program (CCCRP). The IPT evaluated the technology readiness level status and concluded that it is a necessity that the services be provided by the same contractor for validity of results purposes. The RFI encouraged interested parties to provide information on technological solutions for intracavitary noncompressible (abdominal) hemorrhage for field use in a battlefield setting. The RFI was posted to FedBizOpps.gov for fifteen (15) days and only one (1) response was received, which was from Arsenal Medical. The broad internet search produced three results for point-of-injury therapies to treat intracavitary hemorrhage. All three results were for Arsenal Medical’s efforts in obtaining FDA approval for their WSS medical device. The broad internet search did not reveal any new articles for point-of-injury therapies to treat intracavitary hemorrhage. The articles below were used for this market research and provide background information for Arsenal Medical’s WSS device.

a. The Defense Advanced Research Projects Agency (DARPA) (2012). DARPA Foam Could Increase Survival Rate For Victims Of Internal Hemorrhaging. The official homepage of DARPA, http://www.darpa.mil/NewsEvents/Releases/2012/12/10.aspx

b. Kyle Maxey (2012). Injectable Foam Stops the Bleeding.

www.Engineering.Com, http://www.engineering.com/DesignerEdge/DesignerEdgeArticles/ArticleID/5067/Injecta ble-Foam-Stops-the-Bleeding.aspx

c. Mathew M. Burke (2013). Stasis foam for battlefield wounds shows promise.

Stars and Stripes, http://www.stripes.com/stasis-foam-for-battlefield-wounds-shows-promise-1.216687

The Integrated Product Team (IPT) continuously performs market research by attending conferences and vendor days, reviewing research articles, and conduct broad internet searches similar products. Market research conducted by the IPT concluded that Arsenal Medical’s WSS device is the most technologically mature device being evaluated by the FDA. The IPT is working with USAMRAA to award a new contract to perform additional market research for hemorrhage control.

9. Interested Sources: To date, no other sources have written to express an interest.

In accordance with FAR 5.201, a notice of the proposed contract action was made available through the Government Point of Entry (GPE) and no bids or proposals were received.

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of the last several awards:

(a) Defense Advanced Research Projects Agency (DARPA) Contract No.

(b) Defense Advanced Research Projects Agency (DARPA) Contract No.

(2) Competitive status of these actions: These actions were awarded on a competitive basis.

(3) Authority previously cited if less than full and open competition was used.

Not Applicable

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

Not Applicable

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

The previous contracts were competed by DARPA for similar services, but it was specific to the initial formulation and development of the device prototype.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

No unusual patterns have been found.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

Not Applicable

For Official Use Only

11. Technical Certification:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Title: Product Manager Signature: _

12. Requirements Certification:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Title: Project Manager Signatu ___

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

The price established for the required services will be determined to be fair and reasonable based on price comparison for the same or similar study/services. In accordance with FAR 15.403, certified cost or pricing data will be required.

Typed Name: Ms. Kelly Green Title: Contracting Officer Signat _

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Ms. Kelly Green Title: Contracting Officer Signat _

Approval Contracting Officer

Based on the foregoing justification, I hereby approve the procurement of an additional human factors study on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c) using FAR citation 6.302-1(a) (2) (ii), Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development of highly specialized equipment, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: _________________________ Signature: 28 Feb 2018