RECELL Autologous Cell Harvesting System/Kit

The Medical Readiness Contracting Office - West, JBSA - Fort Sam Houston, Texas intends to award a Firm-Fixed-Price sole source contract to Avita Medical Americas, LLC. under the authority of Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source, for the requirement for RECELL Autologous Cell Harvesting System/Kit. The RECELL System isolates the patient's own skin cells to produce a suspension of spray on skin cells (RECELL Spray-On SkinTM). The RECELL System heals burns using 97.5% less donor skin which reduces the donor site size. It also helps significantly lower donor site pain and increases patient satisfaction with donor site appearance. The RECELL System decreases the amount of allograft used during surgical produces by 32%. This enables a faster healing time and decreases the length of hospital stays.

The applicable NAICS code for this requirement is 339112 - Surgical and Medical Instrument Manufacturing; Small Business Size Standard: 1,000 employees. Award will be made on or after 01 October 2023.

The solicitation number is W81K0023Q0179 and is generated for the purposes of posting this notice. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. A determination by the Government not to compete the purchase order based upon responses to this notice is solely within the discretion of the Government. This notice is neither a request for quotes nor a solicitation of offers; however, interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. Questions will not be accepted after the due date. All responses must be received by 17 August 2023-10:00AM CST

Salient Characteristics for Avita Medical Americas, LLC Products

1. Must be Food and Drug Administration (FDA) approved, and The Joint Commission (TJC) compliant.
2. Must be able to meet standards set forth by the above governing agencies and conform to the rules and regulations set forth by Army Medical Command.
3. Must be able to provide the supplies/kits associated with surgery to prepare Spray-on-Skin.
4. May provide safe biologic and sterile products.
5. Shall also provide clinical solutions to wound management and care both pre and post operatively, but not limited to the items previous cited in the memorandum.

Contracting Office Address:

Medical Readiness Contracting Office - West

Attn: MCAA-RC, 3551 Roger Brooke Drive

JBSA-Fort Sam Houston, TX 78234-6200

Wayne V. Thompson

wayne.v.thompson3.civ@health.mil