Investigator-initiated study grants

Cyberonics, Inc., is committed to supporting research endeavors that are consistent with the Company’s mission to advance device-based solutions that improve the lives of people with epilepsy and their families—all in compliance with applicable laws and regulations, as well as our Business Practice Standards and policies. The criteria governing the award of Cyberonics’ grants and research are intended to ensure that support for activities is never tied to the past or future use of our VNS Therapy.

Cyberonics provides investigator-initiated study grants for three general categories of research: 

  1. Clinical trials
  2. Animal trials
  3. Device-only requests

Examples of financial support that Cyberonics cannot make and of prohibited uses of Company support are as follows: 

  1. Grants to support activities that occurred prior to receipt of the grant request packet
  2. Grants to support promotional activities
  3. Grants made to, at the request of, or for the benefit of any specific individual, whether a potential or actual medical professional, or medical professional-in-training
  4. Grants to support an individual practice
  5. Grants that are incorrectly categorized as investigator-initiated study grants and would be rejected if properly categorized
  6. Grants made, in whole or in part, as an inducement for, conditioned upon, or in any way dependent upon the prescription, purchase, lease, recommendation, use, or implantation of VNS Therapy
  7. Overhead- or infrastructure-related expenses not directly attributable to the research request
  8. Any use of grant funding that is inconsistent with the use approved by the Company during the grant request process

To request an investigator-initiated study grant from the Company, submit the following information via email at iis.committee@cyberonics.com, by facsimile to 281.853.2730, or by mail to Cyberonics, Inc., 100 Cyberonics Blvd., Houston, TX 77058, Attention: Investigator-Initiated Study Review Committee:

  1. A completed Letter of Intent (DOC- 113K)
  2. A detailed budget and/or requested support (e.g., number of devices, leads, etc.)
  3. A copy of the investigator(s) CV(s)
  4. Relevant supporting literature or previous publications on the topic to be studied (optional, but helpful for the Investigator-Initiated Study Review Committee during the grant review process)

Background on the IIS Committee

The IIS Committee is made up of representatives from Quality/Clinical/Regulatory (Vice President), Marketing (Sr. Director), Research & Development (Sr. Director), Legal (Director), and Global Medical Affairs (Sr. Director). The committee has more than 80 combined years of experience in business and more than 50 years with Cyberonics. Each member of the committee has one vote, so no one person can over-influence the outcome. Studies are either “accepted,” “not accepted,” or “accepted pending suggested modifications/classifications.”  Research projects are evaluated twice a month at regularly scheduled IIS Committee meetings. Criteria for proposal approval are based on, but not limited to, the following: strategic focus of the company, potential outcome/output, PI and his/her track record with the research in question, cost/resources requested, and the funds/resources available.

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