SSJ 36C244-25-AP-4689 TRANSMEDICS-POST_Redacted.pdf

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C244-25-AP-4595 provide authorization to Transmedics within the organ recovery window will be extremely restricted, and may result in this patient missing the transplant opportunity due to procurement delay if the offer is received outside of regular weekday business hours.

Transmedics represents its proprietary OCS device as the only fully-portable, FDA-approved perfusion technology for Donation after Brain Death (DBD) and DCD lung, heart, and liver transplant indications. Deceased donor organ transportation typically occurs in cold static storage that cools the organ to approximately 4 degrees Celsius to decrease metabolic demand, but this method ultimately generates cold ischimic injury to the organ. By contrast, Transmedics’ ex-vivo normothermic (normal body temperature) perfusion limits cold ischemia and prolongs organ viability during transport. Transmedics has indicated capability to provide a physician to surgically recover the organ from a potential donor in the indicated regions, and also to provide support staff to maintain the perfusion equipment and organ during transportation to the VAPHS transplant team.

Having confirmed Transmedics’ capability to commence services within the highly restrictive timeframe that authorization will be required upon identifying an acceptable donor organ for this patient, the contracting officer has authorized a sole source procurement using the unusual and compelling urgency authority in accordance with FAR 13.106-1(b).

4. Description of market research conducted and results or statement why it was not conducted:

Given the highly restrictive timeframe in which authorization to provide services was required, the contracting officer limited market research to confirming the contractor’s registration and responsibility qualifications in System for Award Management, and reviewing the VAPHS transplant team’s clinical determination of the contractor’s capability to satisfy the requirement. The contracting officer also reviewed the price quote in relation to a previous contract award for similar services (36C24423C0035) to determine price reasonableness.

5. Contracting Officer's Certification: Purchase is approved in accordance with

FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Benjamin Grogg Deputy Director of Contracting NCO4

BENJAMIN GROGG

Digitally signed by BENJAMIN

GROGG

Date: 2025.09.25 14:24:24 -04'00'