Notice of Intent to SS _1253993.pdf

April 27, 2022

Notice of Intent to Sole Source

Axion Biosystem Maestro/Microelectrode Array System with trade-in

FDA_SS_1253993

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to Axion BioSystems, located at 1819 Peachtree Road, Suite 350 Atlanta, GA 30309.

In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required services as no other source has been identified who can provide the instruments to satisfy the agencies requirements.

The purpose of this notice is to inform the public that the FDA anticipates issuing an award to procure a Maestro Pro System with trade-in.

The associated North American Industrial Classification System (NAICS) Code is 334516:

Analytical Laboratory Instrument Manufacturing.

TECHNICAL REQUIREMENTS:

1. Ensure continuity with existing studies and with the data production collected with the current Axion Biosystem device (Maestro serial # 002.3067.591.00127). We presently use Axion hardware and software to acquire and process the data. Changing this format will affect the research that has been conducted by DBP scientists since 2015 with consequent repetition of some of the studies carried out for comparison with past results.

2. Be compatible with LUMOS-MEA device (serial # 005.763.0024) ensuring continuity with existing studies and with the data production. Changing this format will affect the research that has been conducted by DBP scientists since 2015 with consequent repetition of some of the studies carried out for comparison with past results.

3. Be compatible with MEA well plates, sizes 6, 24, 48, 96.

4. Allow real-time and label-free recording of cellular activity in every well of the multi-well plate, such as neural network activity, and cardiac functionality.

5. Provide plate circuit technology that allow cell visualization using transparent materials and simultaneous recordings from all the electrodes of the entire plate.

6. Provide measurements of fundamental functional parameters (e.g., activity, synchrony, and oscillation) of neural networks.

7. Provide measurements of fundamental functional cardiac performance, including contractility, action potential, field potential, and propagation.

8. Provide software capable of data collection and analysis of the cardiac and neural networks fundamental functional parameters such as:

9. Action Potential Duration, Field Potential Duration, Conduction Velocity, % Beats with

EAD’s, Number of Beats, Propagation Consistency, Total Active Electrodes, Beat Period, Spike Slope, Spike Amplitude, CiPA analysis tool.

10. Synchrony Index, Width at Half Height of Cross-Correlation, Mean Firing Rate, Number of Bursts, Burst Duration, Number of Spikes per Burst, Mean Inter-Spike Interval, Burst Frequency, Number of Network Bursts, Network Burst Duration.

11. Provide full control of the cellular environment, e.g., temperature (4 above ambient to 45C) and CO₂ (0-100%, increment step 1%) control.

12. Allow for temperature (4 above ambient to 45C) and CO₂ (0-100%, increment step 1%) levels to be automatically adjusted on the plate docking. MEA plates shall be labeled for scanning purposing and automatic record keeping.

13. Provide hundreds of simultaneous live cell recordings allowed by real-time measurements in multi well plates.

14. Be capable of measuring cell viability and coverage on MEA plates.

15. Provide a possible upgrade to measure general impedance from non-electrically active cells.

16. Have technical support and online knowledge base, hardware and software.

17. Provide 1-2 days for installation and virtual or on-site training.

18. Provide a quote must include all shipping and handling cost to the listed delivery location listed under delivery requirements.

19. Accept the current Axion Biosystem device (Maestro serial # 002.3067.591.00127) as trade in.

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: May 11, 2022, by 4:00PM (Eastern Time). Please email responses to Nicole Craig at nicole.craig@fda.hhs.gov. No phone calls will be accepted.

mailto:nicole.craig@fda.hhs.gov