Otivio would like to apply for funding from the EU to carry out a Fast Track to Innovation. The key purpose of the project 1. Optimize the current device to allow for economic manufacturing of the system
a. Reduce manufacturing cost
b. Improve design to enhance usability and efficient distribution as well as evaluate device specific elements to allow for optimal commercial models
2. Develop clinical and health economic data to allow reimbursement
a. Perform a multi-center randomized controlled trial comparing clinical outcome and health economic data using the Otivio device with current standard of care.
3. Demonstrate market acceptance through early sale
a. Through close interaction with a leading distributor, develop and test commercial models and pricing in the market backed by the clinical and health economic data.
Challenges for the:
The PES-project will:
a. Identify a partner able to perform re-design and larger scale manufacturing of the FlowOx product.
b. Identify a clinical trial site with experience and interesting in testing new devices for treatment of chronic ulcers and peripheral arterial disease.
c. Engage a distributor to ensure proper design input to final device development and clinical health economic assessment.
Otivio AS would also like to obtain support to approach NICE (Medical Technologies Evaluation Programme) in the UK, obtain regulatory support and advice on how to obtain reimbursement. The company is planning to use UK as a test market before expanding into the US, the rest of Europe and other parts of the world through partners.
This is firmly implemented in the company?s overall strategy and business plan.
Otivio will organize, plan and coordinate the project. Otivio will have a supportive role in the manufacturing phase, a leading role in the clinical testing phase as well as the market planning acitivites.
The manufacturing partner will have a leading role in the commercial redesign.