Attachment 1 Purchase Description.pdf

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: There is a great need to develop noninvasive biomarkers for pediatric neuromuscular disease that can be applied at all ages, without sedation. This need derives from the new development of gene directed therapeutics that are now entering clinical trials. One of the most significant of such biomarkers would be the ability to quantify collagen and fat accumulation in muscle as a result of the disease process. Multispectral Optoacoustic Tomograpy (MSOT) has the ability to measure this in a noninvasive nonsedated application.

2. Background Information and Objective: MSOT is a new imaging technology that combines tissue visualization via ultrasound with tissue composition analysis via near-and extended near-infrared laser pulse induced spectral analysis of endogenous absorbers. Ultrasonic detection and spectral unmixing then allows the identification and quantitation of individual molecular components of the tissue, including collagens, tissue oxygenation via (de-) oxygenated hemoglobin, lipid content and even glycogen. It is real-time and operated like a conventional ultrasound, hence noninvasive and child friendly while not requiring any sedation. This technology provides a unique opportunity as an analytical biomarker of muscle and nerve in a number of diseases of interest to the National Institute of Neurological Disorders and Stroke (NINDS). The same technology/instrumentation will be acquired for the animal imaging facility so this biomarker can be ported seamlessly from the preclinical models to human. The intended application in pediatric neuromuscular disease include quantifying collagen content as a marker of fibrosis in early onset muscular dystrophies. In our disease cohort of early onset neuromuscular disease including congenital muscular dystrophies and myopathies as well as infantile Pompe disease, optoacoustic imaging will be developed as a biomarker and correlated with other outcome measure. MSOT will be superior to MRI as the patients are young they would not be able to undergo repeated sedated muscle MRI scans. In addition, muscle collagen content, which is the most important biomarker of fibrosis, cannot be directly quantified by muscle MRI.

3. Generic Name of Product: Multispectral Optoacoustic Tomograpy System

4. Purchase Description: [SYS- MSOTACUITYechoCE2] MSOT Acuity Echo (660- 1300nm)

5. Salient characteristics:

1. Handheld Optoacoustic Imaging System for Clinical Research

• Closed system on wheels

• Fully integrated cart system with 19'' rack architecture

• Fast-tunable high-energy 25 Hz OPO laser system

• Laser wavelength spectrum: 660nm-1300nm

• Maximum pulse energy @ 750 nm: 30 mJ

• 2D Handheld ultrasound 125° curved array with 256 elements operating at 4 MHz Frequency

• Active ultrasound imaging capability with synthetic aperture beamforming, spatial compounding

• System Power: 16A/230VAC

Items Included with System:

• High-performance workstation: Intel Core i7, 4 TByte HDD, RAID, 32 GByte RAM

• ViewMSOT acquisition and data processing software:

o Data management: Study data administration, creation of reports, data export o Data acquisition: single images, image sequences, multispectral data sets o Data processing: Image reconstruction, spectral unmixing, signal quantification o Data analysis: Measurements, spectral analysis, color maps, image filters

• Durable phantom for system self-test

• 2 laser safety goggles (one each for user & patient)

2. Laptop for MSOT Data Processing

• Intel i7 Dual Core - 8GB RAM - 500GB HDD

• high-end graphics card (NVIDIA GeForce or similar)

• 15,6'' FHD screen (1920x1080)

• Windows 10

3. Laser Safety Glasses, NIR, for Operators; fits eyeglasses Safety classification: ≥LB4 @ 660-1400 nm, ≥LB5 @ 675-1360 nm; fits eyeglasses

4. Laser Safety Glasses, NIR, for Operators; does not fit eyeglasses Safety classification: ≥LB4 @ 660-1400 nm, ≥LB5 @ 675-1360 nm; does not fit eyeglasses

5. Laser Safety Glasses, NIR, for Patients Safety classification: ≥LB4 @ 660-1400 nm, ≥LB5 @ 675-1360 nm; does not fit eyeglasses

6. Quantity: 1 Unit

7. Delivery, Installation and Training: The Contractor shall deliver the equipment to:

National Institute of Neurological Disorders and Stroke/NIH

35 Convent Drive, Bldg 35, Room 2A-116 Bethesda, Maryland 20892 within 60 days after receipt of order. The equipment shall be delivered and installed between the hours of 8:00am and 5:00pm EST, Monday through Friday. Delivery must be Freight on Board (FOB) Destination and include inside delivery. The equipment shall be delivered and installed in coordination with the Contracting Officer’s Representative (COR) at the time the equipment is ready to be shipped.

The Contractor shall provide on-site training within 30 days after equipment installation.

In total, the Contractor shall deliver, install, and provide training on the system within 120 days after receipt of order.

8. Other Requirements: The Contractor shall provide an Original Equipment Manufacturer

(OEM) certified technician to perform the setup and installation of the equipment.

Warranty – Upon receipt of equipment, a one year warranty will be provided. The Contractor will provide an Original Equipment Manufacturer (OEM) certified technician to repair any defects during warranty period. Warranty service shall include either onsite or remote trouble-shooting capabilities based on complete knowledge of the entire system.

Warranty shall not include routine or periodic maintenance services.