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This is a sole source procurement document from New Mexico for the CurvaFix IM System, a specialized orthopedic implant device used for pelvic fracture repairs. The CurvaFix IM System features a patented intramedullary implant design that allows surgeons to customize the implant to align with individual patient anatomy, addressing the complex surgical needs associated with pelvic fractures, which are among the most serious injuries treated by orthopedic surgeons. The procurement establishes CurvaFix as the sole source provider for this specialized medical device, eliminating competitive bidding requirements due to the unique nature and patent-protected status of the product.

The document justifies the sole source award based on the CurvaFix IM System's proprietary design and clinical advantages in treating pelvic fractures, which cannot be reasonably substituted by competing products. This procurement approach streamlines the acquisition process for New Mexico, enabling rapid access to this specialized orthopedic technology for patients requiring pelvic fracture treatment. The sole source designation reflects the product's unique capabilities and the medical necessity for access to this particular implant system within the state's healthcare procurement framework.

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UH

UHSS529-26

UNM Proposed Sole Source Form – Rev 04/07/2021

Proposed Sole Source Purchase Form Pursuant to New Mexico Procurement law, the UNM Purchasing Department will post your completed form on the UNM Sunshine Portal and the

State of New Mexico Procurement website for 30 days prior to purchase of the goods/services.

I. GENERAL INFORMATION. PLEASE PROVIDE THE FOLLOWING:

Date of Request 10/8/2026 Requisition Number (If Applicable) Request Submitted by: Dawn Boozer Title Director CCT Operating

Room Department Operating Room Email lealarcon@salud.unm.edu Phone 505.272.2575

Proposed Vendor CurvaFix, Inc. Amount 100K Vendor Address 10220 NE Points Dr, STte 300, Kirkland, WA 98007 Term of

Purchase 3 yrs w/ Renewals consistent W/NM Procurement Code

Buyer Team - See Commodity list at http://purchase.unm.edu/department-information/comm-code-listing.pdf

Provide a basic description of goods/services to be provided:

CurvaFix IM System for Pelvic fracture repairs. Pelvic fractures are among the most serious injuries treated by orthopedic surgeons. The CurvaFix IM Implant’s patented design enables the surgeon to customize the intramedullary implant to align with the patient’s bone curvature in a way not possible with conventional devices.

Why is this purchase needed?

Utilizing a familiar minimally invasive surgical technique, CurvaFix has the potential to improve patient outcomes and enable a less invasive approach to pelvic trauma surgery. CurvaFix is the first implant intentionally designed for use in poor bone found in patients with Fragility Fractures of the Pelvis (FFP).

Pelvic fractures are among the most serious injuries treated by orthopedic surgeons. The CurvaFix IM Implant’s patented design enables the surgeon to customize the intramedullary implant to align with the patient’s bone curvature in a way not possible with conventional devices.

II. BASIS FOR SOLE SOURCE PROCUREMENT. CHOOSE APPLICABLE BOX(ES) AND

PROVIDE ADDITIONAL INFORMATION, AS REQUESTED:

☒ Proprietary item, technology or service only available from the proposed vendor. (Check box and describe proprietary component) http://purchase.unm.edu/department-information/comm-code-listing.pdf http://purchase.unm.edu/department-information/comm-code-listing.pdf

UNM Proposed Sole Source Form – Rev 04/07/2021

The CurvaFix IM Implant is 510(k) cleared for the fixation of pelvic fractures. The CurvaFix IM Implant provides 3-dimensional multi-planar fixation for stability in length, rotation, and bending. In a subset of pelvic fractures patients, CurvaFix provides a better alternative to traditional hardware such as straight screws which can have a screw failure/backout rate of 14-20%. Bone plates are more invasive, requiring a lengthy surgery and require and open surgical procedure. In very curved bone corridors such as a dysmorphic sacrum, CurvaFix can follow the natural bone within the pelvis providing a longer, wider, curved implant which creates a more stable construct for healing. CurvaFix can also steer around existing patient hardware (spinal implants, hip replacements) allowing the ability to place a longer, wider, curved implant which creates a stable construct for healing and reduces the likelihood of implant backout and breakage.

☐ Compatibility requirement with existing item, technology or service. (Check box and describe compatibility requirement)

☐ Renewal of support/maintenance/subscription of software, technology or other intellectual property. (Check box and describe)

☒ Other Basis for Sole Source: Please describe below:

Only Available from this vendor/manufacture.

III. SUPPLEMENTAL DETAILS. PLEASE PROVIDE ADDITIONAL INFORMATION AS

REQUESTED BELOW:

UNM Proposed Sole Source Form – Rev 04/07/2021

Describe in detail the unique capabilities of the proposed vendor’s goods/service and/or personnel performing the work and why this constitutes the only source. Focus on what is unique about the goods/service and why no other vendor could meet your needs.

The CurvaFix IM Implant’s patented design enables the surgeon to customize the intramedullary implant to align with the patient’s bone curvature in a way not possible with conventional devices. Utilizing a familiar minimally invasive surgical technique, CurvaFix has the potential to improve patient outcomes and enable a less invasive approach to pelvic trauma surgery.

CurvaFix is the first implant intentionally designed for use in poor bone found in patients with Fragility Fractures of the Pelvis

(FFP).

Describe the due diligence made to locate other possible sources including communications with other universities, communications with similar providers, web searches, yellow page searches, review of advertisements and trade publications, etc.

Extensive web searches

List the other vendors who were contacted. Please describe the specs/qualifications/criteria that the other vendors were unable to satisfy.

UNM Proposed Sole Source Form – Rev 04/07/2021

N/A

Approved: _________________________________________________ Date: ___________________________ Jeffrey Gilmore (Oct 8, 2026 17:29:35 MDT) https://secure.na2.echosign.com/verifier?tx=CBJCHBCAABAAz2WuDDQw7kZs_YqUhEK9J5NCiqYcumnW

CurvaFix Sole Source UHSS529-26 Final Audit Report 2026-10-08

Created: 2026-10-08

By: Laura Alarcon (lealarcon@salud.unm.edu)

Status: Signed

Transaction ID: CBJCHBCAABAAz2WuDDQw7kZs_YqUhEK9J5NCiqYcumnW

"CurvaFix Sole Source UHSS529-26" History Document created by Laura Alarcon (lealarcon@salud.unm.edu) 2026-10-08 - 5:32:36 PM GMT- IP address: 206.192.168.18

Document emailed to Jeffrey Gilmore (jcgilmore@salud.unm.edu) for signature

2026-10-08 - 5:32:58 PM GMT

Document e-signed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) Signature Date: 2026-10-08 - 11:29:35 PM GMT - Time Source: server- IP address: 206.192.168.20 - Signature Appearance Selected:

DRAW

Agreement completed.

2026-10-08 - 11:29:35 PM GMT

2026-10-08T23:29:37+0000
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