SME of the Week: Cibiltech

Access to transplantation and preservation of functional allograft are the major global medical challenges in the field of nephrology identified by regulatory agencies (FDA and EMA), established transplant societies, such as the European Society of Organ Transplantation, (ESOT), the Haute Autorité de Santé and the NHS. Here, Stéphane Tholander, Co-Founder and CEO of Cibiltech, summarises how Cibiltech was created and how the team aim to help reduce NHS spending by extending the lifespan of renal allografts.

The creation of Cibiltech

We founded Cibiltech in 2019 with the help of four seasoned tech entrepreneurs and four distinguished researchers. Our vision is to become a pioneer in the development of artificial intelligence (AI)-based software medical devices to prevent organ failure. In the same year, we signed two contracts: one with an exclusive distribution partner in the US and another with a global pharmaceutical company. These contracts have allowed Cibiltech to grow with:

• The development of Predigraft and Apilife applications (API, Saas platform)
• Obtaining CE marking (MDR)
• Deployment and early reimbursement in France from January 2021
• The start of an international multicentre randomized controlled trial in 17 centres and seven countries

The origin of the project

Prof. Alexandre Loupy’s team at the Paris Transplant Group (INSERM U970) focused their research on answering the problem of long-term follow-up of renal transplantation as well as the current limited renal function monitoring options.

The team developed and validated, in external cohorts, the iBox (integrative Box) algorithm to predict long-term graft survival and address this medical need. This composite score (functional, immunological, and histological parameters) based on AI demonstrates >80% performance, outperforms clinicians in assessing long-term predictions of graft failure and has been validated in over 30 centres worldwide.

To date, the iBox is the only tool available to improve a clinician’s prognostic judgment in clinical practice and informed medical decision-making. We hope that this tool could prolong long-term allograft survival, reduce return to dialysis and therefore improve patient quality of life. The iBox was patented in 2019 (EP3712898A1) and is protected by a license held by INSERM Transfert, for which Cibiltech has full marketing exclusivity for the next 20 years.

Reducing NHS spending by extending the lifespan of renal allografts

The NHS spends 3% of its budget on kidney failure services, this includes dialysis, renal transplantation and associated costs (around £1.4 billion). An NHS study from 2009 showed that kidney transplants could save £241,000 over 10 years per patient compared to dialysis. The NHS could hence save about £50.3M per year in dialysis for every year if every transplanted kidney is functional.

Our technology efficiently predicts the survival of the kidney graft over seven years and thus enables clinicians and patients to find an appropriate treatment strategy to maintain the allograft for as long as possible. Our goal is to:

• Identify early signs of functional graft decline in order to anticipate a change in treatment and increase its success rate
• Significantly prolong kidney allografts lifespan from resulting successful therapy changes

According to our estimates, our solution could save 20% of hospitalization costs and 6% of biopsies and DSA avoided for patients with a low risk of kidney graft loss (60% of patients).

For more information visit: www.cibiltech.com

For Market Access information, contact: victoria.hemzacek@cibiltech.com and for communications-related information, contact: charles.brioix@cibiltech.com.

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Cibiltech is part of the sixth cohort of the DigitalHealth.London Accelerator programme.

The DigitalHealth.London Accelerator is a collaborative programme funded by two of London’s Academic Health Science Networks – UCL Partners and the Health Innovation Network, MedCity, CW+ and receives match funding from the European Regional Development Fund.