About 10% of patients who enter the emergency room undergo an examination to evaluate their hydration conditions, by means of an ultrasound study of the pulsatility of the inferior vena cava, in order to obtain a better diagnostic-therapeutic framework. To make this assessment more reliable and repeatable, an innovative ultrasound technique was developed

Patent Status

SUBMITTED

Priority Number

102017000006088

Priority Date

20/01/2017

License

ITALY-EUROPE

Market

The target market is that of ultrasound systems, which incorporates both hardware and software devices:

- Total Addressable Market: world market $6.12B

- Serviceable Addressable Market: Italian market for ultra-portable probes - $6.8M

- Serviceable Obtainable Market: approximately 1% of the SAM - $700k

Compound Annual Growth Rate: 2.2%

Problem

To better understand the patient's condition, ultrasound (US) of the inferior vena cava (IVC) gives a lot of important information for doctors, and it is used in several specialties, but the calculation of its parameters (specifically, the pulsatility) is complex and inaccurate, due to the following issues:

- Problems resulting from irregular geometry
- Continuous movements due to cardiac and respiratory activities
- Poor repeatability of inter- and intra-operator measurement

This makes it difficult for physicians to use this parameter when making decisions that have a strong impact on the patient's well-being (e.g., estimation of volemic status and central venous pressure).

Current Technology Limits

M-MODE
La visualizzazione M-Mode unisce in sequenza una sezione dei frame catturati durante l’ecografia. Questa modalità, applicata alla VCI, mostra come varia il diametro del vaso lungo una sezione fissa e permette di fare misure manuali.

LIMITI
- Non real-time;
- Misura manuale/soggettiva;
- Scarsa precisione;
- Richiede di cambiare modalità sull’ecografo;
- Richiede familiarità con apparecchio.

CONSEGUENZE
- L’uso dell’M-mode richiede tempo;
- Poca fiducia nel risultato puntuale;
- Se il medico ha poco tempo si limita a compiere una valutazione qualitativa della VCI usando il B-Mode.

Killer Application

January 2021 - Prototype: Experimental use aimed at scientific research, Specialized on VCI, Open source probe.

January 2022 - Minimum Valuable Product: In ward on critically ill patients, Applicable on VCI and other vessels, Device hardware + software designed with partners.

Our Technology and Solutions

Our proprietary software eliminates any measurement difficulties for the parameters inherent in the inferior vena cava:
It reduces the uncertainty of measurement
It increases the simplicity and speed of calculation.
The technology therefore allows to take full advantage of the information that can be obtained from the collapsibility of the VCI. Thus, it is a support tool for physicians in the diagnosis and monitoring of patients in critical conditions.
The patent makes possible the immediate calculation of vital parameters deductible from the pulsatility of the inferior vena cava, such as hydration and central venous pressure.

Advantages

Our software offers real-time values relating to the collapsibility of the vein, allowing to:

- Simplify the calculation process:
- No manual calculation
- There is no need to switch to M-Mode
- Have reliable measurements
- To be able to compare the results obtained in monitoring
- Identify precisely the alert threshold values
- Decrease the time taken to do the ultrasound evaluation

Roadmap

The loan of approximately € 50k from Compagnia di San Paolo and LiftT, received in mid-July, made it possible to accelerate the development of the prototype and give life to a medium-long term project aimed at creating a spin-off of the academic research. The main macro activities planned between 2020 and 2025 are presented below.

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