A novel double-point intravascular diagnostic probe with continuous monitoring of the biomarker panel, dual oxygen tension PcvO2 and PcsO2, for clinical assessment of heart failure

Información del proyecto

Sniff-Nose

Identificador del acuerdo de subvención: 697004

DOI

10.3030/697004

Proyecto cerrado

Fecha de la firma de la CE 14 Agosto 2015

Fecha de inicio 1 Septiembre 2015

Fecha de finalización 31 Octubre 2015

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

MI MEDICAL INNOVATION GMBH
Germany

Periodic Reporting for period 1 - Sniff-Nose (A novel double-point intravascular diagnostic probe with continuous monitoring of the biomarker panel, dual oxygen tension PcvO2 and PcsO2, for clinical assessment of heart failure)

Período documentado: 2015-09-01 hasta 2015-10-31

Resumen del contexto y de los objetivos generales del proyecto

The SME Instrument Phase 1 Sniff-Nose dual-oximetry measurement project led us to the identification of a very promising business opportunity in the field heart failure monitoring.

As a result we generated a business plan within the Phase 2 approach, supported together with an R&D report and an R&D plan for Phase 2.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

The work performed according to Task 1 to Task 15 of Phase-1 includes:
1. successful validation of the double-point oxygen measurement in the lab;
2. generation of an R&D plan for Phase 2;
3. clinical KOLs identified with opinion surveys conducted;
4. main risk assessment fulfilled ISO 14971 requirement;
5. regulatory strategy leading to CE marking created;
6. establishment of a clinical investigation strategy with highly-reputed Heidelberg University Hospital, in accordance with ISO-14155-rules for clinical investigation;
7. IPR management strategy planned with the assistance from the European project, Fit for Health 2.0 to ensure sustainable freedom-to-operate;
8. market research done containing a detailed competition analysis;
9. identification of health insurance reimbursement possibility (with established DRG figures achieved by a US competitor) leading to market viability;
10. marketing and sales strategy planned;
11. financial planning done with a budget fitting within Horizon 2020 also with assistance from Fit for Health 2.0;
12. strategic decision to add pressure measurement to the devices as it improves the value of the information collected on the patient;
13. successful search for a partner. emka TECKNOLOGIES (MKT), in Paris, a company with experience in implanted devices, was identified to join for Phase 2 as consortium coordinator;
14. a business plan for Phase 2 was established aiming at setting up a joint venture with MKT to market and sell the devices. Plan includes P&L and cash estimates covering Year 2017 to 2019.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

The Phase 1 results reached the following conclusions to be implemented in Phase-2:
1. Decision by MI and MKT to join their complementary strengths,
2. Decision to design a product family, named Cor/log, simultaneously measuring oxygen in 2 locations as well as central venous pressure;
3. All of the above leading to the key decision to set-up an ambitious joint venture to market and sell the devices to monitor heart failure patients.
4. This joint venture will be initially funded by MI and MKT with help of Phase-2 grant, with private investors expected to join as soon as clinical trials confirm the product viability.

sniff-nose-image-corlog-v2.jpg