In accordance with §11-35-1560(A) of the South Carolina Consolidated Procurement Code, it is the intent of the Medical University of South Carolina (MUSC) to award without competition a sole source contract in accordance with Regulation 19-445.2105(B)(2) to BrainsWay Inc. for the purchase of a Refurbished Deep TMS System, Model 104 with H1 Coil, a Second Arm with H7 Coil Kit, and a Third Coil Stand with H4 Coil for use in an active research study conducted by the Department of Psychiatry and Behavioral Sciences.
Purpose and Objectives: The Medical University of South Carolina Department of Psychiatry and Behavioral Sciences requires replacement Deep Transcranial Magnetic Stimulation (Deep TMS™) equipment to support an ongoing research study involving the administration of TMS treatments within a mobile van environment. Researchers have demonstrated the feasibility of safely administering TMS treatments to patients in rural and community clinic settings using a specially configured van. The originally deployed BrainsWay system has failed and must be replaced to allow the continuation of the FDA-cleared and MUSC IRB-approved research protocol. The requested equipment includes a Refurbished Deep TMS System, Model 104 with H1 Coil, a Second Arm with H7 Coil Kit, and a Third Coil Stand with H4 Coil.
Sole Source Justification: BrainsWay Inc. is the sole provider of the proprietary Deep TMS™ technology and associated H1, H7, and H4 coils. BrainsWay has confirmed that Deep TMS technology was developed by BrainsWay and is protected by patents for which BrainsWay holds exclusive commercialization rights. No other company or entity is legally permitted to offer this technology.
The BrainsWay Deep TMS system is uniquely suited to the mobile treatment environment because its helmet-based design allows treatment administration in the confined space of a research van without requiring sophisticated neuronavigation systems or external coil-holding equipment. To maintain continuity of the active research study, the replacement equipment must be consistent with the system previously used in the study. The study protocol, associated equipment, and treatment methodology have already received FDA clearance and MUSC IRB approval. Use of an alternative system would require significant modifications to the research protocol and could jeopardize study continuity. Furthermore, no other manufacturers offer TMS coils, coolant systems, or electrode cables that are compatible with the BrainsWay platform. As a result, BrainsWay is the only source capable of providing equipment that meets the University's operational and research requirements.
QUESTIONS/ADDITIONAL INFORMATION: Shall be addressed to the email address of the Procurement Officer indicated below.
PROTESTS (MAY 2019): If you are aggrieved in connection with the intended award of this contract, you may be entitled to protest, but only as provided in §11-35-4210. To protest an intended award of a contract pursuant to §11-35-1560, you shall (i) notify the chief procurement officer in writing of your intent to protest within five (5) business days of the date this intent to award is posted, and (ii) if the appropriate chief procurement officer has been timely notified of your intent to protest, you may submit your actual protest within fifteen days of the date this notice of intent to award is posted. Days are calculated as provided in §11-35-310(13). Both protests and notices of intent to protest must be in writing and must be received by the appropriate Chief Procurement Officer within the time provided. The grounds of the protest and the relief requested must be set forth with enough particularity to give notice of the issues to be decided.
Any protest or notice of intent to protest must be addressed to the Chief Procurement Officer, Materials Management Office, and submitted in writing (a) by email to: protest-mmo@mmo.sc.gov or (b) by post or delivery to: 1201 Main Street, Suite 600, Columbia, SC 29201.
This notice of intent is not a request for competitive proposals. Any responsible sources who wish to identify their interest and capability to provide these products must notify this Contracting Specialist at gileno@musc.edu prior to the contact deadline: July 24, at 12:00 AM EST. Telephone responses will not be accepted. Upon receipt of interested parties’ notification, the Contracting Officer will determine whether to conduct a competitive procurement or proceed with sole source negotiations.
Any actual or prospective bidder, offeror, contractor, or subcontractor aggrieved in connection with the intended award or award of this sole source contract, shall notify the appropriate chief Procurement officer in writing of its intent to protest within five (5) business days of the date this notice is posted. Any actual or prospective bidder, offeror, contractor, or subcontractor who is aggrieved in connection with the intended award or award of this sole source contract and has timely notified the appropriate chief procurement officer of its intent to protest, may protest to the appropriate chief procurement officer in the manner set forth below within fifteen days of the date this notice is posted; except that a matter that could have been raised as a protest of the solicitation may not be raised as a protest of the award or intended award of a contract.
A protest must be in writing, filed with the appropriate chief procurement officer, and set forth the grounds of the protest and the relief requested with enough particularity to give notice of the issues to be decided. The protest must be received by the appropriate chief procurement officer within the time provided above. Days are calculated as provided in S.C. Code Ann. § 11-35-310(13).
Any Notice Of Intent To Protest And Protest Must Be Addressed To: Materials Management Officer
803-737-0600 • scbo@mmo.sc.gov • https://scbo.sc.gov • https://procurement.sc.gov
