JEM: The world safest subcutaneous, enclosed, biocompatible implantable device, attached directly to a AV fistula or graft or vein, for chronic disease patients in need of repetitive vascular access

Project Information

JEM Phase 1

Grant agreement ID: 728915

DOI

10.3030/728915

Project closed

EC signature date 15 June 2016

Start date 1 June 2016

End date 30 November 2016

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ACCESS FOR LIFE
Israel

Periodic Reporting for period 1 - JEM Phase 1 (JEM: The world safest subcutaneous, enclosed, biocompatible implantable device, attached directly to a AV fistula or graft or vein, for chronic disease patients in need of repetitive vascular access)

Reporting period: 2016-06-01 to 2016-11-30

Summary of the context and overall objectives of the project

➢ Millions of chronic disease patients worldwide depend on treatment that requires safe, repetitive access to the vascular system. The major markets are dialysis and oncology patients in need of chemotherapy. Other chronic disease patients, who require regular medications or blood transfusions, i.e. people with blood or digestive disorders, pediatrics, also need reliable venous access.
➢ There are approximately 21.4M cancer patients in Europe (http://www.eurocare.it/AboutUs/tabid/54/Default.aspx) with 4.5M on chemotherapy, and 20.1M cancer patients in the US with 4.2M on chemotherapy. Worldwide, there are 2.5M renal failure patients on dialysis, with close to 400K in Europe alone (2014 United States Renal Data System: USRDS. Page 29 vol 2).
➢ Current techniques to achieve repetitive venous access have frequent complications such as infection and blockage that cause a significant increase in patient morbidity and mortality, , and result in markedly increased costs of care.
➢ Damage to fistulas leads to an additional 150K operations/year to repair fistulas in the US alone, at a cost of $2.24 Billion dollars. Extrapolating to Europe shows similar costs.
➢ The desired outcomes for prolonged vascular access are well established: Avoid vessel perforation, prevent pseudo aneurysms, hematomas, thrombosis, and stenosis and empower a non-highly skilled clinician to achieve access.
➢ Those issues affect hemodialysis patients whose vessels are punctured three times a week during their entire treatment life; cancer patients who often require a small port under the chest wall skin for repetitive chemotherapy treatment; and chronic disease patients who often need sustained venous access to facilitate repetitive transfusion of blood and medications.

The market needs and demands a solution for repetitive vascular access, which avoids the above-mentioned complications and failures: clotted or infected catheters, vessel wall damage, and disrupted blood flow. The JEM medical devices have been designed to prevent these complications and allowing vessel access by lesser skilled nurse or patients in the home.

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

Based on results from the pre-clinical goat trials a year ago, and as an early achievement of the H2020 SME-Instrument Phase 1 program), Access for Life modified its device design to a cylindrical shape that allows easier and safer access of a needle into the device, located at the skin level. Efforts in the last six months focused on bench testing new device features in several configurations, culminating in our rodent trial to determine the most functional design and the most effective materials to accomplish our objectives.
Critical progress from the SME Instrument Phase 1 study was achieved in rodent trials designed to determine which cylinder architecture encourages device vascularized tissue encapsulation to avoid infection. Two histopathology reports from this trial (with a third report pending) have led to a refined model, enabling us to proceed to large animal trials in 2Q17 with a design to achieve our objective of safe, repetitive access to the vascular. This will lead to clinical trials and a market ready product in the next two years.
Access for Life was a Silver Award winner in the Mass Challenge accelerator program in Jerusalem, as a top 10 finalist out of 48 selected companies, who were accepted out of 532 applicants. http://tinyurl.com/hvafaos This prestigious program, along with winning the SME Grant, enabled us to greatly increase our company’s profile. Our clinical and business progress has resulted in marked increase in investor interest, as we raise funds for the upcoming GLP animal trials in April 2017 & the clinical trials scheduled for first quarter 2018.
Business activities and taking the product to market
We have greatly expanded our European contacts as we confirmed our business decision to apply first for the CE mark and explore which European markets to enter first. We met with relevant parties from Germany, Switzerland, Italy and the UK to focus these efforts. Our investigation includes understanding the relevant clinical ecosystems comprising leading healthcare providers who run dialysis clinics, major hospitals affiliated with an academic research center, plus leading researchers and clinicians in the fields of dialysis, nephrology, vascular access and interventional nephrology.
Intellectual property

Our PCT for our second patent was filed in May 2016 and we are now working on our next patents based on recent development efforts that have identified new avenues to make the device even more valuable for patients, providers, payers & physicians.

Besides the previous objectives, we also worked hard to gain visibility among potential investors and stakeholders, and we were accepted into the Mass Challenge Accelerator Program in Israel –as previous mentioned- we won a Silver Award. MassChallenge is the world’s largest accelerator program and the competition to get in is fierce. It is an intensive four-month program of lectures, mentorship, ideas and guidance to take a start-up to the next stage of development and to the market. http://masschallenge.org/

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)

Major accomplishments include improved product design, progress towards completion of the second stage of the animal trials, updating the business plan with a focus on European markets, exploring the various reimbursement options in several European countries, developing innovations to make the device even more valuable to all the relevant parties. Lessons learned from the first stage of the animal trials have resulted in an improved design, one which fits better under the skin and is easier to cannulate. These improvements were implemented in the second stage animal trials.

We have also confirmed as a strategic decision that the European market is our first target due to a well-organized dialysis market. We have calculated as per OECD statistics that there are approximately 419,832 patients on hemodialysis in Europe in 2016. (Source: Europe incidence of HD is 53% of US, calculated at Patients per million, pmp. EU-27 pop is 2.35 > than US. Sources: Fresenius Medical Care, OECD). And the market will continue growing. The opportunity for us is clear.

In the picture: at our table in the Startup Pavilion, Philip Libman, CEO, left, and Dr. Yehuda