Translational Partnerships and New Indications - Device Portal

Application ProcessSteps necessary for applying to New Market Indications funding opportunities
Application process for New Market Indications

 

The following table shows a list of companies that have signed a Memorandum of Understanding (MOU) with NIH to participate in the Translational Partnerships and New Indications component of the SPARC program. The table provides basic information on the devices and support that each company will make available for current and future applicants seeking NIH funding. Interested potential applicants can obtain further information on devices by contacting the Company Contact listed in the table below. Since we envision multiple funding opportunities, we will continue to partner with additional companies beyond the initial set of funding announcements. Companies that are potentially interested in participating should contact Siavash Vaziri

 

Please check this site in the future for additional devices being made available as new partnerships are formed. 

 

Devices Table
Company Product Application / Original Indication Regulatory Status Accessories Device information and company support Company Contact
Blackrock Microsystems Utah arrays (NeuroPortTM and slanted arrays) Stimulation/recording for cortical and peripheral applications 510(k) and IDE Pneumatic electrode inserter system, NeuroPort data acquisition system Device Information

 

Dr. Robert Franklin- Engineering Manager
Boston Scientific PrecisionTM stimulation systems Spinal cord stimulation PMA Various percutaneous and surgical paddle stimulation leads Device Information Dr. Juan Hincapie - Principal R&D
VerciseTM stimulation systems Deep brain stimulation IDE DBS Guide software, DBS standard or directional leads
CorTec Brain Interchange® and AirRay® Electrode Implantable system for chronic open and closed loop interaction In process Hermetic Encapsulation technology Device Information

 

Dr. Jörn Rickert - CEO
CVRx BAROSTIM NEOTM

 

Baroreflex activation therapy for resistant hypertension and heart failure IDE Electrical stimulation and data acquisition hardware and software Device Information

 

Dr. Seth Wilks - Principal Research Scientist
ImThera Medical aura6000TM

 

Obstructive sleep apnea IDE 6-contact cuff electrode, Clinical Manager software Device Information

 

Mr. Marcelo Lima - CEO
Medtronic Activa RC+S General purpose research system (similar in capability to Activa RC/PC used in DBS) IDE Nexus (-D and -E) Algorithm Development Toolkit, Vectris MRI leads, Reveal LINQ Cardiac Monitor Device Information

 

Dr. Jeff Kramer - Vice President, Research and Technology
Enterra II Gastric electrical stimulation HDE
InterStim II Sacral neuromodulation PMA
RestoreSensor Spinal cord neuromodulation PMA
Micro-Leads Various electrode technologies General purpose neural interface technology In process Conformal arrays, STIM-GRID high density arrays, Precision electrodes, Multi-contact cuffs Device Information

 

Dr. Bryan McLaughlin - President
NeuroNexus Conventional and high-definition thin-film electrodes General purpose neural interface technology In process External neural recording and stimulation systems Device Information

 

Dr. Daryl Kipke - President
Nexeon MedSystems SYNAPSETM

 

General purpose research system In process 3-contact helical cuff lead and 4-contact percutaneous lead Device Information

 

Mr. Will Rosellini - CEO
Ripple LinkTM and Link-STM

 

Stimulation/recording for neurophysiology and neuroprostheses research In process Grapevine Neural Interface System, 3D printing of flexible electrodes, software support Device Information

 

Dr. Daniel McDonnall - President and Vice President of Research
Stimwave Freedom Stimulator System Peripheral nerve or spinal cord wireless neurostimulators for pain management 510(k) External transmitter for power Device Information

 

Ms. Laura Tyler Perryman - Chairman and CEO

 

Template Agreements

The following template documents may be used to streamline creating partnerships between investigators and device companies. Investigators are strongly encouraged to consult early with their institutional technology transfer or sponsored research office in order to confirm that the terms and conditions of the CDA and CRA for the selected device are at or near acceptable to their institution.

       CDA - Confidential Disclosure Agreement
This template document can be signed by academic researchers to allow confidential discussions of proprietary details with a given company regarding the capabilities of a device prior to submitting SPARC funding announcement applications. In some cases the template language may be used “as is” whereas in other cases it may be a starting point for discussions.

       CRA - Collaborative Research Agreement
This is a template document to be used for agreements between device manufacturers and academic research institutions to form partnerships for submission of SPARC funding announcement applications. The goal of this document is to provide standardized terms covering essential components of such agreements (e.g., intellectual property, data and publications, reporting requirements, etc.). In some cases the template language may be used “as is” whereas in other cases it may be a starting point for discussions. 

       MOU - Memorandum of Understanding
The purpose of this document is to describe the nature of the signatory company's agreement to participate in the program. The document goes over the process under which Collaborative Research Agreements will be reached with academic researchers wishing to use the company's device(s) prior to receiving NIH funding through the SPARC program. Each signatory company has provided a description of the materials and support it is willing to make available for this purpose and has agreed to use the template Collaborative Research Agreement for partnering with research institutions for this program. 

This page last reviewed on December 5, 2019