JA_-_Microvention_final_Redactedx.pdf

Control Number: NCD-16-55

JUSTIFICATION REVIEW DOCUMENT

FOR OTHER THAN FULL AND OPEN COMPETITION

Program/Equipment: Non-fluoroscopic endovascular aortic balloon occlusion device to stop massive hemorrhage.

Authority: 10 U.S.C2304(c)(1) and FAR 6.302-1 Amount: $449,150

Prepared by: 24 May 2016 Department Head, DSN:

Regenerative Medicine, Naval Medical Research Center

Contracting Officer: 24 May 2016

Contracting Officer DSN:

Technical/Requirements Representative 24 May 2016

Department Head, DSN:

Regenerative Medicine, Naval Medical Research Center

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Agency/Contracting Activity: ACC-APG-Ft Detrick

2. Description of Action: Product development of a non-fluoroscopic endovascular aortic balloon occlusion device to stop massive hemorrhage.

Nature: New Requirement Follow-on Requirement

Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price Time & Materials Cost

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

Fiscal Year of Funds: 2016

Name of Proposed Contractor(s):

Microvention, Inc.

Street Address:

1311 Valencia Avenue City, State, Zip:

Tustin, CA 92780 Phone:

3. Description of Services or Supplies:

The total estimated value of the proposed action is $449,150.

Approval is requested to solicit on the basis of other than full and open competition for a new contract award to Microvention to support the product development and delivery of a non-fluoroscopic endovascular aortic balloon occlusion device to stop massive hemorrhage. The product development will be conducted through a protocol supported by the Advanced Medical Development (AMD) office at the Naval Medical Research Center (NMRC). This technology is proprietary to Microvention. This is an experimental device seeking FDA 501(k) premarketing clearance approval with this study, with resulting one device delivered at the end of twenty-four (24) months.

The device is based upon balloon or elastomer-mesh designs to control device over-inflation with anatomical localization provided by a separate deployable locator mesh.

For the successful placement of an occlusion balloon the device must possess several key capabilities to be an effective tool that aids patient stabilization while minimizing development of complications secondary to the utilization of the approach. These include: (i) use of a low‐profile aortic occlusion balloon to minimize the size of the arteriotomy required for insertion of this device, (ii) use of active, non‐fluoroscopic guidance to ensure precise positioning above the iliac bifurcation but below the renal and mesenteric vessels, (iii) utilization of balloon and/or elastomer mesh material that minimizes the potential for development of aortic wall injury in the setting of potential overinflation. The Advanced Medical Development (AMD) Program Office manages and coordinates the business and scientific research of advanced medical devices and its development through the project life cycle. Its mission is to promote, protect and maintain the health of personnel in Navy Medicine as well as support medical readiness through advanced biomedical research. "The AMD Program Office does not procure items for the services, but rather manages and coordinates research of the devices that as a result of peer reviewed proposals provides promising solutions to ultimately benefit the NAVY/Marines, Army, and AF. AMD is funding TOBAC because it appears that it will be a safer device in several aspects and easier to use than any current commercial solutions.

4. Authority:

Actions other than simplified acquisition procedures (select one):

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

FAR 6.302-2: Unusual and compelling urgency, 10 USC 2304(c)(2)

FAR 6.302-5: Authorized or Required by Statute, 10 USC 2304(c)(5)

Other: insert appropriate authority here

5. Reasons for Authority Cited:

In accordance with FAR 6.302-1(a)(2) only one responsible source exists for the acquisition. The Microvention temporary occlusion balloon catheter (TOBAC) device for stabilization of massive torso hemorrhage in the field is a unique device that has no equivalent when considered against other current designs. There is currently an unmet need of endovascular stabilization of incompressible hemorrhage while patients are being transported to a hospital for further management. This device addresses key issues with other devices, which chiefly include, the capability for use in a fluoroscopy free environment, provision of direct feedback concerning internal anatomic landmarks, and protection against aortic injury that may result from over inflation of standard devices in the field. This device has emerged through joint planning and invention between Microvention, Inc and the

Microvention, Inc possesses unique engineering and production capabilities which are critical to the design of this device.

Microvention is the proprietary owner of the technology and endovascular device, thus, the only company that can produce and further develop the TOBAC. Microvention, Inc., Tustin, California, was founded in 1997 to develop and manufacture unique therapeutic devices for the neurovascular embolization market. Utilizing unique materials and innovative processes, Microvention’s products are intended for the treatment of a wide spectrum of vascular diseases that, because of their morphology, location, or patients general medical condition, are considered high risk for management by traditional operative techniques.

Microvention has developed and utilizes a number of unique proprietary processes for catheter construction and microbraiding that will facilitate the development and manufacturing of the proposed

Temporary Occlusion Balloon Catheter (TOBAC) system. These techniques cannot be replicated at other manufacturing facilities and are critical to the production of the aortic balloon occlusion system.

Proprietary techniques include:

• Microfabrication assemble techniques and methods

• Microbraiding techniques and equipment

• Catheter fabrication techniques and equipment

• Coil winding techniques and equipment

• Overmolding capabilities and equipment

• Laser welding techniques and equipment

• Balloon fabrication techniques and equipment

• Nitinol fixturing and heat treating capabilities

• Centerless grinding capabilities and equipment

• Electropolishing techniques and equipment

Extensive Market research (see below) was conducted by the NHRC Program Manager to identify sources of aortic occlusion balloon device developers. While there are several commercially available aortic occlusion balloons that are FDA approved, not one of them can be placed without fluoroscopic guidance and are so large in size that they require a surgical cut down or advanced methods of percutaneous arterial closure in order to seal the vessel after device removal. Market research could only identify one source that has developed a medical device that will allow for placement of temporary occlusion balloons into the aorta without fluoroscopic guidance to meet the Government’s requirement.

50% of deaths on the battlefield are from non-compressible torso trauma. The purpose of this contract is to provide the military services a commercial alternative that has the potential to be safer and more effective thereby significantly reducing the loss of life of our warfighters.

6. Efforts to Obtain Competition:

While extensive Market research was conducted, see paragraph 8, and concluded that there are no other sources that can provide this unique device. IAW FAR 5.202, the contracting officer shall issue a notice of intent to award a sole source contract on Federal Business Opportunities at least 15 days prior to award of the contract, and any bids or proposals received shall be considered.

7. Actions to Increase Competition:

At this time, it is not the expectation of the Government to have any further follow-on requirements to this acquisition. Upon conclusion of this effort, any subsequent acquisition for this product will be competed to the maximum extent possible.

The TOBAC product has been developed by the company exclusively with private funding. The Government's intent is that after obtaining the 510k clearance by FDA, the company would commercially market their product and would be available to the Services to procure. The AMD Program Office has found that the subject TOBAC device promises to result in a safer and easier to use than any current commercial solutions. If FDA approval is achieved and market research at that time has the same outcome as the market research leading to this J&A, then a sole source contract to Microvention for procurement will be sought.

As this product has been developed to this point exclusively at private expense, while the contractor will not be required to relinquish any of its rights to the proprietary rights in technical data that they have developed, it is anticipated that at a minimum the Government will retain limited rights for data that was developed previously but may have Government purpose rights for anything that was developed with mixed funding. All applicable DFARS data rights provisions and clauses will be included in the resulting contract: DFARS provision 252.227-7017 Identification and Assertion of Use, Release, or Disclosure Restriction; DFARS clauses 252.227-7013 Rights in Technical Data-- Noncommercial Items, 252.227-7016 Rights in Bid or Proposal Information, 252.227-7030 Technical Data--Withholding of Payment, 252.227-7037 Validation of Restrictive Markings on Technical Data.

8. Market Research:

Based on market research conducted by , Department Head, Regenerative Medicine, Naval Medical Research Center, in April of 2016, there are several commercially available aortic occlusion balloons that are FDA approved. However, these balloons cannot be placed without fluoroscopic guidance and due to the large size of these devices, they require a surgical cut down or advanced methods of percutaneous arterial closure into order to seal the vessel after device removal.

They cannot be safely used in a prehospital setting and are unable to address the current unmet need of endovascular stabilization of incompressible hemorrhage while patients are being transported to a hospital for further management. Several of these hospital based fluoroscopy required balloons include:

1. Cook Medical Coda balloon - a 32 - 46 mm diameter balloon which requires a 12F sheath for placement.

2. Medtronic Reliant balloon - a 10 - 46 mm diameter balloon which requires a 12F sheath for placement.

3. Gore Q50 balloon - a 10 - 50 mm diameter balloon which requires a 12F sheath for placement.

4. Prytime Medical (formerly Pryor Medical) has invented a device that is designed to be used in emergency departments of hospitals for the management of massive pelvic hemorrhage. This device can be used with a 7F sheath, utilizes a compliant balloon, includes arterial line monitoring, and allows for therapy delivery above the balloon. This device is not indicated for use outside of an emergency department setting and, as such, cannot be used to address field-based stabilization of massive torso hemorrhage.

A second device is presently being developed by Pryor Medical and is the subject of US Patent US 2013/0102926 A1. This patent describes a device which has been developed for use in the field. The design involves a leading nitinol cage combined with an inflatable balloon.

Positioning of the device is based upon external anatomic landmarks and measuring marks on the balloon catheter itself.

This second device has significant flaws which may limit its use in the field. First, external anatomic landmarks for device positioning may be inadequate to determine placement. There can be significant variability in the location of the aortic bifurcation. Any aortic occlusion device must take into account internal anatomic landmarks to avoid the complications that may occur from inflating the device within the iliac system rather than the aorta proper. The second design flaw with the fluoroscopy-free Pryor device is the lack of consideration related to the potential for aortic wall injury that may occur with overinflation of aortic occlusion balloons.

The device uses standard polyurethane materials for construction of the balloon. Although this material is semi compliant under conditions of inflation, overinflation can result in significant tension on the wall of the aorta, resulting in aortic dissection or rupture. This complication may be difficult to immediately recognize in the population the device is targeted for given the likelihood these patients will be hemodynamically unstable at baseline. Semi-compliant balloons may be used safely in a hospital setting using fluoroscopic feedback to determine whether sufficient fluid/contrast has been delivered into the balloon to achieve occlusion without aortic wall injury. In the field no such visual feedback is available. The 2013/01012926 device does not address this issue and provides for no special accommodations to limit aortic wall injury from overinflation. The device that is the subject of the current proposal provides both direct feedback on internal anatomic landmarks and utilizes two separate designs which each address the overinflation-aortic wall injury issues that may arise from the use of standard semi-compliant balloons without fluoroscopic guidance.

A SBA “Dynamic Small Business Search” was conducted on 4 April 2016 under NAICS code 541711 Research and Development in Biotechnology, using key words “endovascular device” and “aortic balloon”, yielding no results. A SAM search was also conducted on 4 April 2016 using relevant key words “endovascular device” and “aortic device”, yielding no results.

Market research has determined that Microvention, Inc. of Tustin, CA is the only company that has developed a novel pre-hospital aortic occlusion device for controlling torso hemorrhage in a swine iliac junction model that will subsequently be used to treat combat casualties in far forward locations.

9. Interested Sources:

IAW FAR 5.202, the contracting officer shall issue a notice of intent to award a sole source contract on Federal Business Opportunities at least 15 days prior to award of the contract, and any bids or proposals received shall be considered

10. Other Facts.

a. Procurement History: No previous Government Purchase Orders or Contracts have been awarded to this company for this product/effort.

b. Acquisition data availability. The Government does not have the Technical data packages suitable for full and open competition, as the TOBAC product has been developed exclusively at private expense, and Microvention holds all rights to the proprietary data that exists. At this time it is not anticipated that the Government will acquire all of the rights to the data that would be necessary for use in any future full and open competition.

c. Subcontracting competition. The resulting contract shall include FAR clause 52.244-5, Competition in Subcontracting, the prime contractor obtains as much competition as possible in its subcontracting.

Signature:

11. 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:

Position Title: Department Head, Regenerative Medicine, Naval Medical Research Center Email address:

Date: 6/23/2016

12. 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.

Fair and reasonable determination shall be based on cost analysis of the proposed efforts, and cost realism analysis.

SIGNATURE DATE:

NAME:

TITLE: Procuring Contracting Officer

23 Jun 2016

13. 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.

SIGNATURE: DATE:

NAME:

TITLE: Procuring Contracting Officer

23 Jun 2016