NOI_FDA-SS-116549.pdf

NOTICE OF INTENT TO SOLE SOURCE

Date: February 27, 2023 Subject: Axion Biosystem Maestro Multi-Well Microelectrode Array (MEA) system

FDA ID: NOI_FDA-SS-116549

This is a notice that the U.S. Food & Drug Administration (FDA) intends to issue a purchase order to Axion BioSystems, located at 1819 Peachtree Road NE, Atlanta, GA 30309. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements.

The NAICS Code is: 334516- Analytical Laboratory Instrument Manufacturing.

TECHNICAL REQUIREMENTS:

1. Shall provide a newly manufactured unit, not used, and refurbished or previously used for demonstration.

2. Shall provide the following for the Axion Biosystem System, BRAND NAME or EQUAL:

A. Processing chip for compact integrated signal amplification, digitization, and stimulation for reduced analog noise and increased sensitivity of small cellular signals.

B. Hardware capable of measuring voltage and impedance.

C. Standalone system designed for a benchtop; no incubator required.

D. Small footprint: 11” x 18” x 9” (W x D x H).

E. Fully integrated environmental chamber for temperature (5° above ambient-45°C), CO2 (0-

100%), and humidity (in-plate feature) control. Enables stable short- or long-term recording with minimal perturbations to the culture.

F. Compatible with custom gas mixtures to generate special environments, such as hypoxia.

G. Dual-zone heating control (top and bottom) with multiple sensors for even plate heating, ensuring accurate temperature, reduced well-well variability, and eliminating condensation and noise as a result.

H. 360-degree CO2 shower for even gas exchange and reduced well-well variability.

I. Recycled chamber atmosphere for heat and humidity stability and reduced CO2 consumption and evaporation.

J. Electrically shielded recording chamber with anti-vibration engineering features to reduce noise.

K. Automated plate docking.

L. Barcode system for tracking plate ID.

M. Integrated and fully customizable electrical stimulation.

N. Stimulate any combination of electrodes or wells with simultaneous measurement.

O. Fully customizable stimulus design.

P. Constant current or constant voltage stimulation modes.

Q. Up to 768 simultaneously recorded channels.

R. 6-, 24-, 48- or 96-well plate formats with up to 786 electrodes/plate.

S. Ability to expand acquisition functionality with cardiac, neural, or impedance software modules T. Ability to induce and measure cardiac local extracellular action potentials (LEAP) on any, and every, electrode in a plate.

U. High-pass filter capable of adjusting down to 0.01 Hz for accurate measure of low frequency action and field potential features.

V. At least 8 and up to 64 electrodes/well for improved measurement of conduction velocity.

1. <6 μV noise (root mean square, RMS) when measuring cardiac signals for improved sensitivity and waveform feature detection.

2. <2 μV noise (RMS) when measuring neuronal activity for improved sensitivity to small signals.

W. Flexible high-pass filter settings: 1 Hz to measure low frequency neural oscillations or 200 Hz to cut off common 50/60 Hz environmental noise.

X. Capable of array-based impedance measurement of contractility with simultaneous voltage for excitation-contraction measurement and local contractility changes.

Y. Capable of array-based impedance measurement of cell coverage and viability on microelectrode array (MEA) plates.

Z. Capable of monitoring live cell function parameters in real time including cell proliferation, cytotoxicity, cell adhesion, receptor based functional assays, immune cell killing, ADCC, viral neutralizing antibody detection, cell migration, wound healing, and barrier function in a 96-well plate through impedance.

AA. Maestro Software shall include the following:

1. Axion Integrated Studio (AxIS) Navigator MEA acquisition and analysis software.

2. Activity map for real-time, plate-wide feedback of action potential activity.

3. Live continuous and averaged waveform information with conduction mapping (cardiac-only) and raster plots (neural-only).

4. Software-controlled temperature, CO2 and electrode stimulation.

5. Compatible with the Cardiac Analysis Tool, Neural Metric Tool, and AxIS Metric

Plotting Tool software for over 25 neural and 12 cardiac endpoint measurements and figures across electrodes, wells, and groups exported in text or image format.

6. MATLAB compatible data for customizable analysis.

7. Axion Integrated Studio (AxIS) Z impedance acquisition and analysis software.

This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Axion BioSystems, within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: March 9, 2023, by 9:00AM (EDT). Please email responses to Nicole Craig at nicole.craig@fda.hhs.gov. No phone calls will be accepted.

mailto:nicole.craig@fda.hhs.gov