Press release Limoges, 2024 November 7th




Professor Pascal Leprince, Head of the Cardiac Surgery Department at the
Pitié-Salpêtrière Hospital in Paris, has agreed to set up a pilot clinical
study to assess an antibiotic-loaded Porous Ceramic Sternal Stabilisation
Implant.

I.CERAM, specialist in innovative biocompatible ceramic implants, has announced an agreement to set up an
observational pilot clinical study in the department of Professor Pascal Leprince, Head of Cardiac Surgery at the
Pitié-Salpêtrière Hospital in Paris, to assess the benefits of using an antibiotic-loaded Porous Ceramic Sternal
Stabilisation Implant (ISS.C).

As part of its development work, I.Ceram has already initiated several technological breakthroughs, achieving two
world firsts with the implantation of the first ceramic sternal implant and the first antibiotic-loaded sternal
replacement implant.

The antibiotic-loaded Porous Ceramic Sternal Stabilisation Implant (ISS.C) has been designed to ensure optimal
stability of the chest wall by insertion between the two parts of the native sternum that have already undergone
sternotomy. This ISS.C implant was developed by I.Ceram as part of the S 2OP2CI, project, winner of the I.nov 9th wave
competition in January 2023. By integrating active antibiotic and antifungal molecules, this project aims to accelerate
the osseointegration of implants in an infected environment.
Post-operative instability of the chest wall jeopardises bone healing of the sternum, encourages infection and makes
post-operative management tricky. The expected objectives of using the antibiotic-loaded ISS.C sternal stabilisation
implant are to avoid bacterial contamination of the implant in the implantation environment while stabilising the chest
wall.

In the case of this pilot study, 10 implantations will be set up to assess the benefits of this system.

Professor Pascal Leprince's cardiac surgery department at the Pitié-Salpêtrière Hospital in Paris is a benchmark, both
nationally and internationally, for all adult cardiac and aortic operations, from the simplest to the most complex. His
active participation in this study is therefore a major asset in giving credibility to this new technological breakthrough.

Professor Pascal Leprince said: "Cardiac surgery is now widely practised in many countries. The excellence and
considerable progress made in their management have made them a benchmark procedure.
However, postoperative mediastinitis, linked to risk factors such as obesity, diabetes and respiratory insufficiency,
remains a potentially serious complication associated with a high mortality rate in all establishments.
I wanted to agree to this evaluation as part of a pilot study in view of the initial work already carried out by I.Ceram.
This pilot study will have three objectives: to measure the time taken to obtain negative bacteriological samples, their
medical follow-up and the non-recurrence of chest wall instability’.

More than one million sternotomies are performed worldwide every year. Patients with multiple risk factors that can
trigger infection of the sternal wound after sternotomy represent a risk for medical teams and health establishments,
with an increase in the number of steps in patient management that could result in a less-than-optimal discharge in
their care pathway. The associated management in the case of mediastinitis can lead to several repeat surgeries,


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Press release Limoges, 2024 November 7th

resulting in long weeks of hospitalization, sometimes in intensive care, with heavy demands on medical teams and
exponential financial costs.

Despite the surgical excellence practiced in aorto-coronary bypass cases, according to scientific publications and their
authors, the complication rate for mediastinitis varies from 0.3% to 2.5% or from 0.3 to 8%, depending on the
populations involved, geographical areas and surgical practices. The risk of mortality associated with the occurrence
of mediastinitis is between 5 and 20%, despite advances in its prevention, which remains an absolute priority.



For more information, please contact actionnaires@iceram.fr

About I.CERAM : Created in 2005 in Limoges, France, I.CERAM designs, manufactures and commercializes orthopedic implants and
ceramic implants offering a unique biocompatibility (10 international patents). Based on its know-how and the experience of more
than 30 years of its managers, the company has decided to strongly accelerate its development on bioceramics. I.CERAM is
labelled «innovative company», certified ISO 13485, ISO 14001 and has the EC marking. With its breakthrough
technology and state-of-the-art production facilities, I.CERAM has very strong growth potential. The company has been
listed on Euronext Growth since 2014. ISIN: FR0014005IU4- ALICR


Contacts :




Investor Relations Financial Communications
André Kérisit Solène Kennis
Tél : +33 (0)5 55 69 12 12 Tel : +33 (0)1 75 77 54 68
actionnaires@iceram.fr iceram@aelium.fr




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