BeyondAir PH-iNO Delivery System

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE EQUIPMENT LEASE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division - West (HCD-W), intends to award a firm fixed price contract for BeyondAir PH-iNO Inhaled Nitric Oxide (iNO) Delivery Systems in support of the Neonatal Stabilization Unit (NSU), Naval Hospital Guam (NHG) in accordance with Federal Acquisition Regulation FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs to:

TrillaMed, LLC 30100 Telegraph Rd. Ste 366 Bingham Farms, MI. 48025 *TrillaMed is the only authorized distributor of these systems to the United States Government. Two (2) iNO delivery systems are required for the implementation of a Level III NSU located at NHG. iNO is a gas that's used to treat a variety of conditions, including: Persistent pulmonary hypertension of the newborn (PPHN): iNO is approved for treating PPHN in newborns.

Pulmonary arterial hypertension (PAH): iNO is used in adults for acute pulmonary vasoreactivity testing during right heart catheterization. It's also being considered as a long-term therapy for PAH. Acute respiratory distress syndrome (ARDS): iNO has been shown to improve oxygenation in adults with ARDS.

COVID-19: iNO has been used as a rescue therapy for patients with COVID-19 and severe ARDS. Acute bronchiolitis: iNO has been used off-label to treat acute bronchiolitis. iNO works by relaxing the smooth muscles in the lungs, which widens the blood vessels. It's inhaled through the nose or mouth and should only be given by or under the direct supervision of a doctor.

The two (2) iNO delivery systems, to be delivered must meet the following minimum requirements: Must provide gas delivery: 0.1-80 ppm NO, 0.5-100 L/min gas flow Include gas monitoring to measure NO, NO2, and O2 concentrations Must include 24/7 remote support Must provide on-site corrective maintenance support in Guam or have implemented loaner program for off-site corrective maintenance support Must have a cartridge shelf-life of 12 months Must be compatible with the following existing equipment: Bunnell LifePulse 204 High Frequency Jet Ventilator Draeger Babylog VN500 Ventilators Draeger Babylog VN800 Ventilators VapoTerm Precision Hi-VNI Systems Must be capable to deliver units to NHG no later than 1 October 2024 Lease Period of Performance Base:

01 October 2024 – 30 September 2025 OPT1: 01 October 2025 – 30 September 2026 OPT 2: 01 October 2026 – 30 September 2027 OPT 3: 01 October 2027 – 30 September 2028 OPT 4:

01 October 2028 – 30 September 2029 52.217-8: 1 October 2029 – 31 March 2030 There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325412. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement.

However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.

Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Cassi Jo Newman at cassi.j.newman.civ@health.mil Closing date for challenges is no later than 0800 PDT on 28 September 2024. No phone calls will be accepted.