Special Notice Special Notice Page 2 of 2 Special Notice *= Required Field Special Notice Page 1 of 2 Regional Procurement Office (RPO) - East intends to negotiate on a sole source basis with Scintica, Inc., to purchase an iNSiGHT Small Animal Dual Energy X-Ray Absorptiometry (DXA) System for the Ralph H. Johnson VA Medical Center (Charleston). This system will allow for simultaneous high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis in preclinical research. The new system will operate as part of the VA Small Animal Imaging Core, providing a much-needed resource for animal models of bone disease, cardiovascular disease, and metabolic disease in both mice and rats. The following equipment will be purchased: ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT 0001 SHARED RESOURCE - EQUIPMENT iNSiGHT Small Animal Dual Energy X-Ray Absorptiometry (DXA) System The iNSiGHT is a small animal DXA system used to study body composition in a wide variety of animal models and tissues. Includes a 1-year warranty and a preventative maintenance visit in year 2. LOCAL STOCK NUMBER: OsInDXA-Sys 1.00 EA 0002 iNSiGHT Digital Radiography (DR) Mode Digital radiography (DR) is an available mode on the iNsIGHT system, different from the dual-energy x-ray absorptiometry (DXA) mode. This mode takes advantage of the digital x-ray detector within the system to provide an x-ray image from a single energy source. Settings can range from energies of 40\R\80 KeV, currents of 0.1\R\0.8 mA, and acquisition times of 5\R\60 seconds. LOCAL STOCK NUMBER: OsInDXA-DR mode 1.00 EA 0003 iNSiGHT Offline Analysis Viewing and analysis for data acquired on the iNsIGHT system. LOCAL STOCK NUMBER: OsInDXA-Offline 2.00 EA 0004 iNSiGHT Installation Installation on the purchased iNSiGHT system with basic safety requirements discussed, and system operation. LOCAL STOCK NUMBER: OsInDXA-Inst 1.00 EA 0005 iNSiGHT Training Training and on the purchased iNSiGHT system. LOCAL STOCK NUMBER: OsInDXA-Trn 1.00 EA 0006 Free Shipping and Handling iNSiGHT DXA LOCAL STOCK NUMBER: Shipping iNSiGHT STATEMENT OF NEED BACKGROUND A severe limitation in current in vivo imaging is the inability to image a single animal over multiple time points through disease progression, due in part to the toxicology associated with the delivery of radiation in the form of x-rays, to the subject. The VA Small Animal Imaging Core currently operates a Skyscan 1176 Micro-CT, which provides x-ray imaging and the ability to construct 3-D models of specific hard tissues/regions of interest. However, traditional micro-CT imaging is limited by a number of factors, including long imaging sessions (>45 minutes per animal/session) to attain resolution of <10 micrometers, restricted ability/inability to image and analyze soft tissues such as adipose (fat) content, time-intensive analysis to obtain basic density measurement of bone tissues, and delivery of high-dose radiation to the animal. Delivery of high-dose radiation for the purpose of imaging, particularly over long imaging sessions and multiple time points for a single animal, can significantly impact biological processes and can ultimately interfere with disease monitoring, discovery of novel disease markers, and measurements of treatment efficacy. Furthermore, analyses of micro-CT images, particularly for density readouts, requires a significant investment of time and resources on the part of the core/laboratory user and are inherently biased due to the multi-step, subjective process. There currently exists a need in our Research Program for a system capable of time-efficient, high-resolution imaging in concert with rapid, automated measurements of bone mineral density (BMD), bone mineral content (BMC) and body composition in small animal models of disease (mice and rats). The iNSiGHT DXA system by Scintica provides high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis simultaneously. The addition of this system to the VA Small Animal Imaging Core would provide the option for in vivo imaging of whole animal or regions of interest at 100 micrometers pixel size at 1.2x magnification with simultaneous, automatic DXA analysis, providing readouts of bone mineral density (BMD), bone mineral content (BMC), and body composition (adipose), in about 25 seconds per session. This is a significant time and cost advantage over traditional micro-CT imaging, and moreover, allows for multiple imaging sessions/density measurements in a single animal over time, delivering significantly less radiation to the animal in a single imaging session (10 seconds for X-ray imaging and 25 seconds for imaging with automated density measurement readouts) compared to traditional micro-CT imaging (>45 minutes). Using this technology, we will be able to accurately and reproducibly detect changes in both hard and soft tissue density, to include bone and adipose tissue in organs and tissues impacted by disease states, including osteoporosis, fracture, heart disease, liver disease, and obesity, among others. This system will make possible objective monitoring of both hard and soft tissues, including adipose (fat), which is not currently possible with the tools at hand, and will enhance the capabilities of our imaging core. Further, this system will make possible imaging with hard/soft tissue density readouts over time, as animals (both mice and rats) can be scanned multiple times over the course of disease/treatment progression with much lower risk of radiation toxicology, due to significantly shorter scan times. Lastly, with integrated, automatic DXA analysis through Insight analysis software, as well as automatic calibration, this system will allow for objective examination of hard and soft tissue density, with greatly reduced user bias and significantly reduced investment of user/core time dedicated to analysis. This system will greatly strengthen the research capabilities of our station, facilitating basic scientific discovery of mechanisms underlying physiological and pathological processes and translation of these findings to support the rapid implementation of cutting-edge personalized medical treatments. OBJECTIVES The iNSiGHT DXA system, manufactured by OsteoSys, will make possible simultaneous high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis in preclinical research. This system enables x-ray imaging of whole body and regions of interest (mice, rats), with a 100 micrometers pixel size at 1.2x magnification and 31 micrometers pixel size at 4x magnification, in conjunction with automated readouts of bone mineral density (BMD), bone mineral content (BMC) and body composition (to include adipose tissue). Maps of bone, lean and fat tissue are generated automatically for each subject, with an average imaging session of 25 seconds. Furthermore, the iNSiGHT DXA automatically calibrates daily, making obtained density measurements highly objective and reproducible, both critical elements in research studies in general and particularly those involving animal subjects. Not only will this system increase our ability to perform high-resolution imaging at significantly faster speeds in both mice and rats, but it will overcome several of the drawbacks of traditional x-ray imaging, such as micro-CT, which include higher radiation delivery to the animal, significantly longer scan times (>45 minutes), and inability to detect and analyze soft tissues including adipose due to limitations of the technology, including x ray source, voltage, and available filter sets. DXA analysis, as provided by the iNSiGHT DXA, will allow us to track changes in bone and adipose tissue in several disease states, that cannot be done with our current instrumentation. The new system will operate as part of the VA Small Animal Imaging Core, providing a much-needed resource for animal models of bone disease, cardiovascular disease, and metabolic disease in both mice and rats. OsteoSys has also developed software that accelerates the discovery process, with the ability to quickly and automatically calibrate and generate readouts of BMD, BMC, and body composition. This highly specialized system will allow researchers the opportunity to dissect how changes in bone and soft tissue density correspond with the pathobiology of many diseases, including cancer, heart disease, metabolic disease, liver disease, and osteoporosis, among others. SALIENT CHARACTERISTICS High resolution imaging and DXA system shall meet or exceed the following specifications and salient characteristics: Capability to perform high-resolution imaging and dual-energy x-ray absorptiometry (DXA) analysis simultaneously Compact frame with wheels Imaging area: 16.5 cm by 25.5 cm Cone beam scan method Ability to scan live animals, including both mice and rats: whole body or region of interest Capability to integrate with isoflurane-based anesthesia system for delivery to animal via nose cone during imaging/analysis Ability to scan ex vivo samples (excised bone, etc.) Ability to draw specific regions of interest for DXA analysis Ability to perform automatic calibration on a daily basis Ability to provide imaging with automatic DXA analysis, including automatic calculation of bone mineral density (BMD), bone mineral content (BMC), and body composition in 25 seconds, for both mice and rats, region of interest or whole body Ability to select both whole body and regions of interest for imaging and analyses Ability to generate separate x-ray attenuation image, bone, and colorimetric tissue map for fat and lean mass automatically Fully shielded unit that meets or exceeds FDA radiation safety standards, with no additional x ray shielding required Lead shielded glass viewing window for animal subjects 4 additional magnification levels for digital radioautography mode Radiation dose per DXA scan is 0.66 mGy Spatial resolution: 31 µm at 4X geometric magnification Measurement precision of: In vitro Reproducibility: 0.7%; BMD Reproducibility: 1.0%; and Fat Reproducibility: 1.0%; CV <1% and R² > 0.9 Energy range: 10 100 kV, configurable in digital radioautography mode Max energy for DXA Scan: 60/80 KV at 0.8mA Exposure range: 0.1 s 20.0 s, configurable in digital radioautography mode Stainless steel inner chamber for easy cleaning Access port for safe and efficient delivery of anesthesia into the chamber Dimensions equal or near to 26 in W x 24 in D x 44.5 in H Exposure control: fixed or pre-programmed in DXA mode, with option for fully automatic or manual voltage, amps, time, and stage height in digital radioautography mode Standard image acquisition time: average 10 seconds DXA image acquisition and analysis time: average 25 seconds Automated calibration for DXA analysis on daily basis Input power: 110/240 VAC + 10%, 50/60 Hz, 200 VA Line connection: standard line cord and plug medical grade Integrated high-power Workstation for high-resolution imaging and DXA analyses with the following features: Processor: Intel Core i5-9500 3.0 2666 USB 2.0 Ability to display imaging and measurement results on an integrated monitor Ability to record and process data for both mice and rats Capability to switch observations methods (high-resolution imaging, DXA mode) with a single touch Integrated software with the following characteristics: Insight software for analyses of both high-resolution imaging and DXA analyses, generating DXA tissue composition statistics, as well as bone, lean and fat tissue maps of whole body automatically and/or regions of interest of animal subject or scanned ex vivo material Ability to obtain measurements from an image and annotate acquired images Ability to save data and export both images and statistical data Offline Analysis Keys/Dongles to allow analysis on computers that are on directly connected to the iNSiGHT DXA Installation of system and comprehensive training to include intensive overview of the system in both imaging and DXA analysis modes, as well as data analysis, experimental design, and maintenance Warranty coverage to include (1) year of the following: Telephone and remote diagnostic repair support, Monday Friday, 8 am 7 pm All replacement parts Travel time and labor for onsite assistance during standard hours (Monday Friday, 8 am 5 pm local time, exclusive of observed holidays) All software updates and enhancements made commercially available All safety and quality updates Warranty coverage to include (1) preventative maintenance visit in year two This notice of intent is not a request for competitive proposals. Any responsible sources who wish to identify their interest and capability to provide this equipment or equipment that is compatible must notify this Contracting Officer at [email protected] NLT Thursday, March 30, 2023, by 11:59 AM EST. Telephone responses will not be accepted. Upon receipt of the interested parties' notification, the Contracting Officer will determine whether to conduct a competitive procurement or proceed with sole source negotiations.

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