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

BlackrockMicrosystems

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. Brett Dowden - Senior Biomedical Engineer

Boston Scientific

PrecisionTMstimulation 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

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

Research Programmer system, compatible with various leads, Nexus Algorithm Toolkit, Vectris MRI leads

Device Information

Dr. Tim Denison - Senior Director, Core Technology

Enterra II

Gastric electrical stimulation

HDE

InterStim II

Sacral neuromodulation

PMA

RestoreSensor

Spinal cord stimulation

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-8A and 4A

General purpose wireless neurostimulators

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 March 3, 2017