ADVanced Organ Support – Revolution in intensive care for treatment of multiple organ failure

Project Information

ADVOS

Grant agreement ID: 880349

DOI

10.3030/880349

Project closed

EC signature date 16 October 2019

Start date 1 December 2019

End date 30 April 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 275 055,00

EU contribution

€ 2 292 538,50

Coordinated by

ADVITOS GMBH
Germany

Periodic Reporting for period 2 - ADVOS (ADVanced Organ Support – Revolution in intensive care for treatment of multiple organ failure)

Reporting period: 2020-12-01 to 2022-04-30

Summary of the context and overall objectives of the project

Multiple organ failure (MOF) is a common condition on intensive care units (ICU) and is associated with very high mortality rates ranging up to 75%. About 10-15% of all ICU patients are affected by this life-threatening systemic disease. Major causes of MOF are sepsis, surgery, trauma, and rarely single organ failure. The severity of illness correlates with the number of impaired organs. Annually, nearly 450,000 people in West Europe and Northern America die because of MOF.
As severely ill COVID-19 patients die from MOF, the corona pandemic drastically increased the need for an effective and easy to use multi organ support device.

To treat MOF successfully, the vicious cycle of progressing organ failures and the increasing toxin accumulation in the body has to be stopped. ADVOS improves survival of patients with MOF from 10% upto 50%; these results have been confirmed also in severely ill COVID-19 patients treated with ADVOS. ADVOS has the potential to revolutionize the therapy of ICU patients worldwide, as it is the first, and only, ICU device for combined liver, lung, kidney support, and acidosis treatment in one device (technology leader in liver and acidosis support, with direct removal of acid). Our USP lies in enabling a scalable and thereby customizable multi organ support by eliminating protein-bound toxins (liver), water-soluble toxins (kidneys), the removal of CO2 (lungs), and additionally the regulation of the acid-base balance (acidosis/pH). The high and long-lasting efficacy of detoxification capacity is another important advantage. Considering the broad application spectrum of ADVOS, the demand in the target segment is barely served by any of the currently available therapies. ADVOS has the potential of creating a new therapeutic market by completely replacing conventional treatment options in specific patient groups. Currently, there is no other device in the market that supports all main detoxification organs as ADVOS does.

By improving MOF, the length of stay on the ICU will be reduced, thereby reducing cost and personnel expenses of the hospital. Preventing or shortening mechanical ventilation can also contribute to cost savings. It is imperative that cost containment for intensive care is a very important point for the society. ADVOS could contribute to this.
Therefore, cost containment for intensive care is a very important point for the society. ADVOS could be a substantial contributor to this effect.

Our unique ADVOS treatment system offers clinical teams a safe, easy to apply, well-tolerated, and effective therapy that can improve survival in MOF.
Our target segment is medium to high volume hospitals where clinical teams (physicians and nurses) treat patients with multi-organ failure on intensive care units on a regular basis. We target all medical disciplines where multi-organ failure usually can occur including hepatology, nephrology, intensive care medicine, internal medicine, general, and cardiovascular surgery.
Our unique ADVOS therapy meets exactly the pain-points and helps fighting the high mortality of patients suffering from multi-organ failure, while supporting the workflow of our customers.
Our economic buying reasons are that we have one extracorporeal device for patients with multi-organ failure instead of multiple standalone devices. Therefore, there will be reduced training effort for the clinical staff on ICUs, reduced costs, and reduced efforts for maintenance of several devices for the hospital technicians/biomedical teams. Another advantage is that we need less human albumin in the detoxification procedure because of the innovative albumin regeneration circuit. This saves costs for hospitals and payors. The ADVOS treatment is less cost intensive than multiple single-organ support systems at the same time.

The goal of the SME project ADVOS is faster market entry and penetration through improvement of device usability and ease of use (Integration of accessory components, state of the art turnable touch screen and smart user assistance), integration of IoT for remote access/maintenance in device, and increased marketing and communication measures.

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

The main technical objectives of the project aim to improve the usability and safety of ADVITOS’ modern clinical system for multi-organ support. This is to be achieved via the introduction of new capabilities (interfacing with other clinical equipment, both in terms of hardware and data connectivity) and the improvement of the existing system (in terms of ease-of-use). We have succeeded in identifying the main challenges for operators with respect to system setup, interaction, and handling, as well as defining approaches to improve the system accordingly. In particular, we have prepared the system for uninterrupted operation, automatic disposables and accessories identification; we have designed a more user-friendly exterior and interface to improve handling; and we have developed prototypes for “Internet of Things”-like connectivity that will streamline technical support and automatic system maintenance.

The introduction of a new therapy into new markets required ADVITOS to execute the following aspects:
- Conformity with local and regulatory standards
- Adaptation of user information and features
- Intense contact with supply chain channels
- Congress and trade fair participation
- Organization of workshops across clinics
- Market research and assessment regarding market potential
- Market access analysis regarding customer needs and reimbursement and commercial channels

ADVITOS succeeded in finalizing commercial contracts with clinics in Austria, and subsequently started treatment of patients abroad; with further clinics in France, Switzerland, and Italy in the pipeline.

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)

We expect to improve the clinical state of the art in multi-organ support by providing an integrated system that reduces the overhead associated with the large variety of auxiliary devices involved in these treatments. This will improve the standard of care by making systemic multi-organ failure treatment simple enough for wide adoption. In particular, we will drive the development of our current, commercial system to a stage where international distribution is possible, initially in a range of European countries.

The market introduction of new medical therapies requires significant investment and takes time. The new ADVOS therapy integrates four therapy options into one medical device and therefore ADVITOS invests in generating medical proof and product enhancement to increase use acceptance.
The ADVOS device provides a plethora of improvements beyond the current state of the art:
1.) Therapy benefit – improved outcomes for critically ill patients
2.) Cost benefit – three devices replaced by one, results in lesser material cost and improved workflow and labor efficiency
3.) Socio-economic benefit – in addition to improvement of patient survival, reduced length of stay and reduced invasiveness of therapy is known to reduce in-hospital cost and improve recovery of patients after ICU stay.

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