Sonic Incytes

Client

Sonic Incytes

Year

2019-Present

Services

Forecasting, Reimbursement, Health Economics, Sales & Marketing, Negotiations with Payors, Regulatory Strategy, Regulatory Document Creation, Regulatory Leadership, Device Handling Assessment, 510(K)/510(K) de novo, Meetings with Regulatory Authorities

Field

Devices & Diagnostics

Challenge

To navigate the FDA pathway regulatory approval and Reimbursement for the company.

image

A small start up developing promising diagnostics for NASH and other deadly diseases

Sonic Incytes engaged Novateur’s experienced FDA device regulatory experts to prepare their pre-submission to the FDA as well as accompanying the team to the FDA meetings. 
Supporting Sonic Incytes all the way to FDA approval continues. 
Under a separate mandate, Sonic Incytes engaged Novateur’s reimbursement experts to assess commercial viability of their products as well as identifying the required reimbursement codes for the company. 

 

"I found working with Novateur an absolute pleasure. They were flexible and responsive to the unique needs of a startup, and ensured we met our timeline. I feel more confident in achieving our upcoming FDA clearance and launching in the US market." 

George Aliphtiras
CEO, Sonic Incytes

 

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