KXL System for Corneal Cross-Linking and Comsumables

Notice of Intent to Sole Source The Naval Medical Center San Diego (NMCSD) intends to award a sole source purchase order under the authority of FAR 13.106-1(b) (1) (i), due to only one source being available to meet the Government's needs, to AVEDRO, Inc 230 3rd Ave Ste 27 Waltham, MA, 02451-7552 The requirement is for KXL System for Corneal cross-linking which will help decrease Keratoconus which is a progressive thinning and distortion of the cornea. Keratoconus causes the cornea to bulge from its normal symmetric domelike smooth optical shape. The following items are needed: Item # Description Qty 001 KXL Device 1 002 Photrexa viscous treatments 2 003 Photrexa treatments 1 Total The objective of this sole source award is to procure the KXL system and consumables. The KXL System for Corneal Cross-Linking for the treatment of progressive keratoconus is the first and only FDA approved Therapeutic treatment for Progressive Keratoconus. The KXL system is able to achieve the cross-linking procedure in a short amount of time decreasing the exposure the patient has to UVA. The Government requires: 1. UVA Irradiation: 30 minutes at 3mW/cm2 2. Laser alignment for patient positioning 3. Wireless control for beam alignment in the X,Y and Z axes 4. Fully-integrated stable delivery platform 5. Tough screen operation 6. Self-calibration of UVA irradiation intensity Delivery: September 30, 2016 The NAICS code for this requirement is 339115; the Small Business size standard is 1000. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 7 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. 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 or to proceed with a sole source purchase order. Capability statements are due by 10:00 AM Local Time, 19 September, 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: contact@example.gov. The email subject line shall state: "Naval Medical Center San Diego, Notice of Intent to KXL System and consumables" NO TELEPHONE REQUESTS WILL BE HONORED