TACKLING ANTIBIOTIC OVER-PRESCRIPTION

Project Information

OVER-AB

Grant agreement ID: 101113944

DOI

10.3030/101113944

Project closed

EC signature date 30 June 2023

Start date 1 September 2023

End date 31 August 2024

Funded under

• European innovation ecosystems

Total cost

No data

EU contribution

€ 75 000,00

Coordinated by

SHANX MEDTECH B.V.
Netherlands

Periodic Reporting for period 1 - OVER-AB (TACKLING ANTIBIOTIC OVER-PRESCRIPTION)

Reporting period: 2023-09-01 to 2024-08-31

Summary of the context and overall objectives of the project

Antibiotic resistance has emerged as one of the top ten global health challenges according to the World Health Organization (WHO). A significant contributor to this issue is the misuse and overuse of antibiotics. Traditional Antibiotic Susceptibility Testing (AST) methods, which facilitate evidence-based antibiotic selections, typically necessitate external microbiology labs and have a turnaround time exceeding two days. Consequently, healthcare providers often resort to prescribing broad-spectrum, first-line antibiotics, which are later adjusted based on laboratory results. This standard of care in managing bacterial infections is inadequate, adversely affecting patient outcomes and exacerbating antibiotic resistance.

ShanX Medtech BV (Netherlands), under the leadership of Dr. Sophia E. Shanko, is innovating a novel AST device that delivers results in as little as one hour and directly at the point of care. This groundbreaking system is set to transform clinical microbiology testing. As with any significant advancement, comprehensive studies involving various stakeholders are essential for successful market introduction and acceptance.

In this Women TechEU proposal, Dr. Shanko and the ShanX Medtech team have analyzed market dynamics, engaged Key Opinion Leaders, and identified purchasing drivers. The outcome of this project is a well-defined market position and a collection of term sheets resulting from successful fundraising efforts.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In this project, we identified key purchasing and non-purchasing drivers for our innovative system. Additionally, we engaged several Key Opinion Leaders to strengthen our approach. Concurrently, we focused on our fundraising efforts, refining our pitch deck and outreach strategy, resulting in a draft term sheet that is currently under negotiation.

As a direct outcome of this work, we secured pre-orders from a prominent Dutch player that holds 25% of the national AST market share, contingent upon obtaining CE IVDR certification. This achievement is particularly noteworthy for a diagnostic device that is three years away from market approval, highlighting its strong market potential and validation. We anticipate projected pre-orders of up to 300 base units of our system, which could generate sales ranging from €800.000 to €3.000.000 from this partner alone.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Several key features were identified by our Key Opinion Leaders (KOLs) as essential for successful uptake of our novel system. Notably, we are the only solution that can fully meet all customer and user requirements, which has led to obtaining conditional purchase pre-orders. These important features include:

- Direct-from-sample testing
- Point-of-care applicability
- Rapid turnaround time
- Broad applicability to a variety of pathogens
- Low cost of goods sold (COGS)
- Alignment with current reimbursement codes
- High sensitivity and specificity
- Minimal hands-on time required

Based on these insights, we have refined our pitch deck and narrative, resulting in securing an initial term sheet from a syndicate. The proposed terms include a €4 million equity fundraise and a €3 million governmental loan. These funds will enable us to advance our system toward regulatory approval and initial commercialization in the Netherlands, leveraging the pre-orders we have secured.

Additionally, we have successfully obtained a Dutch grant of €4.3 million in collaboration with a Dutch hospital and TU Eindhoven, which will allow us to conduct implementation studies of our instruments. We aim to finalize all the terms by Christmas 2024, bringing our total funding raised to €11.3 million.

Current methods and turnaround times for AST Vs the proposed solution