Case Study 3

GT Urological - Reimbursement

At GT Urological, a Minnesota-based start-up focused on new technology to treat patients with stress urinary incontinence, the regulatory team had made significant progress in developing the protocol for a clinical trial to assess the safety and efficacy of a new product.  But just before the protocol was to be submitted to the Food and Drug Administration, GT Urological recognized the need to make sure adequate reimbursement considerations had been incorporated into a key element of the protocol – a questionnaire. 

Lacking in-house reimbursement expertise and needing it quickly, GT Urological turned to Vallon LifeScience.  Soon, an interim reimbursement specialist was on the case.

“Vallon LifeScience saved us the time of interviewing and qualifying a consultant,” said Dave Anderson, vice president of Research and Development for GT Urological.  “They provided initial screening and sent us one candidate who had the qualifications we needed. “

The reimbursement expert provided GT Urological a detailed review of its clinical trial protocol and recommended changes to the questionnaire, the answers to which would be critical in securing reimbursement for the new product.  In addition, she provided an overview of the company’s reimbursement strategy.

With the assistance of Vallon LifeScience, GT Urological quickly and easily gained the highly qualified and specialized talent it needed.  As a result, the company was able to submit a clinical trial protocol designed to demonstrate both the clinical and economic value of its new product. 

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