The specific objectives of the feasibility study and results achieved are summarised in the table below:
Objectives:
- Performing a voice of customer survey to validate commercialisation and go-to-market strategy;
- Securing additional patent applications to cover and protect the specific detection methodology;
- Validating regulatory pathways (Belgium, Luxembourg, France, Germany and Italy);
- Developing a clinical support validation plan in concertation with consultants and regulators;
- Evaluating impact of new regulations (ISO 13485:2016 and CE-IVD);
- Updating and finalising business plan
Results:
- 10 interviews were conducted with experts in France, Belgium, the UK and the United States
- Our patent portfolio was analysed by a new patent lawyer and we filed a continuation of our awarded (USA) base diagnostic patent, protecting the HoloCyt application we also expanded the claims of the European patent application
- We held regulatory sessions with experienced consultants in Europe with Gert Bos (Partner at QServe) and in the US with Mark J Sarno (Vison Clinical research LLC) and defined the regulatory pathway for these regions
- We made a draft clinical validation plan and defined the number of clinical tests to be performed based on discussions and research
- We evaluated the new European regulations and their impact and decided to prepare for filing in compliance with these new regulations
- We finalized and updated our business plan
The SME phase 1 grant has enabled the company to identify a methodology to overcome market barriers and to solidify the business plan and financial needs in anticipation of a funding round.
Ovizio’s management has decided to spin-out the diagnostics unit in 2018. The new company will take over all active diagnostics projects within Ovizio and recruit additional staff. The main decision criteria for spinning of this entity are the different natures of business when compared to Ovizio’s already operational business within the bioprocess industry, the different profile of potential investors in the diagnostics field and the experience and skill set of staff members required to bring the products to the market. The spin-off will recruit additional scientific and managerial staff with experience in a similar environment.
Ovizio’s spin-out will sell a solution that comprises a device (holographic microscope) and related software, a consumable prefilled with a fixation and preservation liquid and a range of extended warranty services on a pay per test basis.
The device will be positioned as a better alternative to existing solutions as it performs a cytological test, an HPV test and a pre-cancerous cell detection test in a single device in minutes rather than hours and with better specificity and sensitivity.
The company will reach end users comprising
- in the first phase of commercialization:
- Clinical diagnostic laboratories
- Physicians' office laboratories
- Hospital laboratories
- In the second phase: gynecologists and practitioners directly for point of care testing.
Ovizio’s spin-out will rely on a carefully selected network of dealers throughout the world to support it’s commercialization process.
The initial focus of the company will be a roll out in Europe, more specifically in Belgium and France (2019), followed by the other main European countries in 2020 (Germany, United Kingdom, Italy and Spain), the rest of Europe in 2021 and a full roll out in the US as from 2022. In the first year of commercialization Belgium and France have been selected because of the already existing relations with labs and key opinion leaders (KOLs), relations with authorities and a favorable climate for co-testing.
The main goal- of Ovizio is to promote its technology through government sponsored screenings programs. The company will therefore participate in exhibitions and trade shows such as Eurogen in France. Publications by Key Opinion Leaders in the field are essential for the promotion of the technology and the adoption by scientific organizations. The main focus will be to created interest from key end-users.
Ovizio estimates that product development and clinical validations will cost about 30 M€ over the initial 3 years.
Prior to the submission of an SME phase II proposal, Ovizio will first further perform preliminary clinical test. Ovizio plans to roll out its full validation and comercialisation programme as of mid 2017, submitting it’s SME phase II proposal in early 2018.
