A03_Justification_and_Approval_(J A)_for_Other__Than_Full_and_Open_Competition_-_RevMedX_Spiral.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), 1 Kansas Street, 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: 2014-2015

Name of Proposed Contractor(s): RevMedX Street Address: 25999 SW Canyon Creek Road, Suite C City, State, Zip: Wilsonville, OR 97070 Phone: (503)-297-3339

3. Description of Services or Supplies:

The total estimated value of the proposed action is $ 2,135,000.00

This proposed effort is for a single, three (3) year Firm Fixed Price Research, Development, Technology and Engineering (RDT&E) contract with a total value of $2,135,000.00, including a base effort of $1,375,000.00 and optional tasks totaling $760,000.00. The purpose of this effort is for the proposed contractor to provide research and development to improve the design, performance, and manufacturability of Revmedx’s XSTAT-30 and XSTAT-12 devices. It is also the goal of this effort that the proposed improvements to the design will reduce the cost of this item.

XSTAT-30 is a proprietary, Food and Drug Administration (FDA) approved hemorrhage control device that is 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. The device accomplishes this by applying a group of small, rapidly-expanding sponges into a wound cavity, creating a barrier to blood flow. The XSTAT product line also includes the XSTAT-12 device, for small caliber wounds, which operates on the same principles.

Under this effort, the contractor will conduct research and development into the following: change the design of the large applicator to allow for more compressible sponges per device, thereby improving performance by increasing the effectiveness of the internal pressure applied by a single device and reducing the number of devices required on a single wound; research the effectiveness of changing the application of the radiopaque marker to the individual sponges from gluing to lamination in order to improve manufacturability and reduce costs; explore the implications of removing the chitosan clotting factor from the sponges; designing and developing an XSTAT pouch for rapid sponge removal in the operating theater; and developing an XSTAT training system.

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-30 (Regulatory Number K130218, Produce Code PGZ) is manufactured by exclusively by RevMedX, who is the patent holder for all XSTAT devices.

The XSTAT-30 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-30 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-30 device has 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 device was 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-30 is a proprietary technology owned by RevMedX which prohibits the Government from obtaining this capability from any other source. While significant investment has already been made into this product by the Government, including approximately $6 million in RDT&E which 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 United States Air Force is interested in further development of this device to include refinement of the design and removal of the chitosan in order to gain additional fielding approvals for conventional forces. The design improvements included within this effort will benefit USSOCOM though increased capability, manufacturability and reduced cost as well as broaden the applicability of the product for other conventional services.

6. Actions to Increase Competition: This effort furthers the development of the XSTAT devices. The original effort 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. Since that time, market research has been on-going. Market research for medical device systems such as this is mainly accomplished though trade shows that focus on tactical medical devices, and which are attended by users in the USSOCOM community and vendors that make tactical medical devices that may be suitable for USSOCOM operations, with or without modification. Additionally, any new devices which receive FDA approval are monitored for potential application to meet this requirement. Marketing events attended in this manner resulted in the original identification of one other vendor who could potentially meet these requirements. Both systems were evaluated during a USSOCOM evaluation to determine their ability to meet the capability requirements. It was determined that RevMedX device met the user requirements by providing a more 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. Medical committee meetings, symposiums and conferences are attended on an ongoing basis if personnel are available and allowed to travel. Additional market research is done though marketing outreach by vendors and a review of catalogs and other product literature. Recent marketing events attended include the Military Health System Research Symposium (MHSRS) from 18-21 August 2014, Special Operations Medical Association Scientific Assembly (SOMSA) from 14-15 December 2014 and the Biomedical Research Advisory Group (BRAG) from 11-12 March 2015.

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: W911NF-11-C-0038 Was action competed? Yes No

9. Additional Information to support the justification. Approval to field the XSTAT-30 has been provided in accordance with USSOCOM Directive 70-1, Appendix C and Appendix D. All other XSTAT devices will be approved following FDA approval. The technical, schedule, and cost risk for these improvements items are considered to be low.

APPROVAL

Based on the foregoing justification, I hereby approve this acquisition for X-STAT Spiral Development by RevMedX, Inc in the estimated dollar amount of $2,135,000.00 inclusive of all options, on an other than full and open competition basis, pursuant to the authority of 10 USC 2304(c)(1) “Only One Responsible Source and No Other Services Will Satisfy Agency Requirements”, as authorized by FAR 6.302-1, subject to availability of funds, and provided the services and property described herein have otherwise been authorized for acquisition.

SIGNATURE:_____________________________ DATE:_______________

CHERYL A. DeLUCA

DELUCA.CHERYL.A.1228573

2015.05.28 12:54:03 -04'00'