CARMAT announces a delay in the resumption of production of prostheses for the PIVOTAL study

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CARMAT: the Shareholders’ Meeting approves all of the resolutions supported by the Board of Directors

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CARMAT to present the positive interim results of the first part of the PIVOTAL study at the 39th ISHLT annual meeting in Orlando, Florida

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CARMAT reports its 2018 annual results and confirms its 2019 development prospects

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2019 Financial Calendar

Paris, January 21, 2019 – 6 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces its indicative financial calendar for 2019.

This preliminary agenda may be modified. Each publication will be released before market opening.

 

Event

Date

2018 Full-Year Results

Wednesday, February 13, 2019

Shareholders’ Meeting

Thursday, March 28, 2019

2019 Half-Year Results

Wednesday, September 25, 2019

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CARMAT presents positive interim results of the first part of its PIVOTAL study

Paris, January 15, 2019 – 8.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced an update on its clinical progress and recent developments, as well as its cash position at December 31, 2018.

 

Stéphane Piat, Chief Executive Officer of CARMAT, says: “Ten years after the creation of the Company, we are pleased to present today the results of the first cohort of 10 patients included in the PIVOTAL study. This is the tangible realization of Professor Carpentier’s vision that, at the time, was a challenge that seemed almost impossible to meet. Thanks to the work and tenacity of a group of men and women with unlimited commitment, we have successfully achieved the primary endpoint of the study for 70% of patients with 6 months of support provided by our bioprosthesis or the successful progress towards heart transplant. These interim data confirm that our bioprosthetic heart respects the physiology of the human body, and thus enables to avoid the complications typically observed with other technologies. This is a unique scientific and technological breakthrough that could help cope with the problem of end-stage heart failure, a major pathology that is becoming increasingly prevalent. We can assert that CARMAT has today reached a major milestone in its development enabling us to address the future with renewed confidence.”

  • Positive interim results of the first part of the PIVOTAL study

The interim analysis concerned the 10 patients of the first cohort of the PIVOTAL study, the first of whom was enrolled in August 2016 and the last in July 2018. Altogether, the study foresees the enrollment of 20 patients suffering from end-stage biventricular heart failure.

 

70% of the patients in this first cohort reached the study’s primary endpoint, corresponding to six-month survival with the bioprosthesis or a successful heart transplant within 6 months after device implant. By comparison, this rate was only of 50% for the feasibility study and 54-62% for the only total artificial heart currently on the market[1].

 

The data collected from the patients having achieved the study’s primary endpoint again confirm the biocompatibility of the CARMAT prosthesis, already proved during the feasibility study, and notably its positive safety profile, never before achieved by other technologies, with the absence of cerebrovascular accidents, gastrointestinal bleeding or infections due to the percutaneous cable. Furthermore, these patients only required light anticoagulant therapy.

 

The device has moreover proven its ability to respond to changes in the patient’s physical effort by modifying the flow, confirming that the self-regulation system works correctly.

  • Ongoing enrollment of the second cohort of patients

Patient enrollment for the second part of the PIVOTAL study began in accordance with the protocol in September 2018 in international medical centers, under the guidance of Principal Investigator Prof. Ivan Netuka (Chair of the Department of Cardiovascular Surgery at the IKEM institute in Prague, Czech Republic) and Co-Principal Investigator Prof. Finn Gustafsson (Rigshospitalet, Copenhagen, Denmark).

 

To date, the cumulative support time of the CARMAT heart within the framework of the PIVOTAL study has reached 5 years in the 11 implanted patients. This accumulated experience shows the ability of the CARMAT technology to provide a long-term solution for patients suffering from end-stage biventricular heart failure, along with a substantial improvement in their quality of life.

 

The analysis of the collected data, representing over 20 years of cumulative operating between the clinical study and the reliability tests benches, has made it possible to identify aspects in which the manufacturing process could be improved, essentially concerning the control of the integrity of the prosthesis and the cleanliness of its technical compartment.

 

The implementation of these corrective actions required the production – and therefore implants – to be suspended in the fourth quarter of 2018. Production has recently resumed and the new prostheses will be available from April.

 

The Company is currently validating additional clinical centers in two more countries in order to rapidly complete the enrollment of the second patient cohort and submit the CE marking dossier in early 2020. The PIVOTAL clinical data represents the final element needing to be added to the CE marking dossier prior to its submission to the DEKRA notified body.

  • Progress in the clinical development strategy in the United States

Since the submission of an Investigational Device Exemption (IDE) application for an Early Feasibility Study (EFS) in 2018, CARMAT has been holding constructive talks with the FDA (Food & Drug Administration, the United States health authority). Significant progress has been made, and the file should be supplemented with biocompatibility tests on a certain number of prostheses currently in production. This enables CARMAT to envision – assuming the FDA validates our application – the launch of implants in American patients by the end of 2019. The selection of clinical centers and the formation of scientific committees are ongoing.

  • Solid financial structure

CARMAT had cash and marketable cash instruments of €25.2 million at December 31, 2018, versus
€44.0 million at June 30, 2018, reflecting:

  • cash burn of €19.7 million over the period;
  • drawdowns on the contingent equity lines subscribed to with Kepler Cheuvreux for a gross total of €0.9 million. Within the framework of this contract, CARMAT has access to an additional €24.2 million of financing that could be exercised depending on its requirements and on market conditions over the coming 36 months[2].

 

Given the recent non-dilutive financing in the form of a €30 million loan granted by the European Investment Bank (EIB), CARMAT has the necessary financial resources to support its clinical and industrial developments and prepare the commercial phase.

 

[1] Kirklin JK et al, J Heart Lung Transplant 2018;37:685-691. Arabia F et al, J Heart Lung Transplant, 2018;37:1304–1312

[2] Assuming full drawdown of this equity financing line, a shareholder with a 1.00% stake in CARMAT prior to its implementation would see their stake reduced to 0.91% on a non-diluted basis

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The European Investment Bank supports CARMAT with €30m for the marketing process of its total artificial heart

Paris, December 17, 2018 – 6.00 pm CET
 
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, and the European Investment Bank (EIB), which is the bank of the European Union (EU), today announce the signing of a €30 million loan agreement supported by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe – more commonly known as the Juncker Plan.
 
This loan will support the strategic transformation of CARMAT into an industrial and commercial company via the completion of clinical trials and an increase in its production capacity. The agreement was signed by Ambroise Fayolle, Vice-President of the EIB, and Stéphane Piat, CEO of CARMAT, during a visit of the new automated manufacturing site in Bois-d’Arcy, near Paris.
 
The aim of this type of non-dilutive financing, granted by the EIB with the European guarantee within the framework of the Juncker plan, is to support research and innovation projects developed by companies with substantial growth potential. The CARMAT project meets these criteria as, assuming clinical trials are successful, its bioprosthesis could become a credible alternative to a heart transplant for tens of thousands of patients facing the well-known shortfall in available organs.
 
After having provided the proof of concept of its device in a feasibility study, CARMAT is currently evaluating its bioprosthesis within the framework of an international PIVOTAL study that foresees the inclusion of approximately 20 patients, the second part of this study having begun during the second half of 2018. In Europe, the study is conducted in various countries within cardiac centers of excellence and helps, with this unique medical device, to enhance surgeons’ know-how in caring for patients suffering from heart failure. This project will also have a positive impact on skilled employment. Indeed, CARMAT, which currently employs 180 permanent staff, is planning to double this number by 2025, principally in R&D.
 
This financing will support the clinical evaluation of the CARMAT bioprosthetic heart through to the granting of CE marking, which is expected in 2019, as well as industrial developments and preparations for the commercial phase.
 
“This European financing will support the marketing process of the world’s most advanced total artificial heart while helping increase the production capacities of CARMAT. By accompanying the transformation of this highly-innovative Med Tech into an industrial and commercial company, we are providing CARMAT with the means to develop and potentially become a global champion in the field of artificial hearts,” says Ambroise Fayolle, Vice-President of the EIB, and adds “Med Techs are a key vehicle for innovation that requires substantial investments during the clinical development phase. This is why we provide them with bespoke financing adapted to their specific requirements and their clinical phases. That is the added value of the Juncker plan!”
 
Pierre Moscovici, Head of Economic and Financial Affairs for the European Commission adds: “I am delighted about this new loan to French company CARMAT within the Juncker Plan. Artificial hearts developed by this company raise immense hope. This is concrete evidence that the Juncker Plan fosters innovation in health for the benefit of European citizens and gives French innovation excellence the opportunity to shine.”
 
Stéphane Piat, CEO of CARMAT, concludes: “We are very pleased about this financing agreement with the EIB, and I would like to thank all of the stakeholders who contributed to its realization. This operation allows us to diversify our sources of financing and will contribute to the gradual transformation of CARMAT into a European industrial and commercial company. We now have the necessary resources to complete the CE marking process, and remain confident in our ability to offer an innovative therapy to patients suffering from end-stage heart failure.”

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CARMAT announces the appointment of Pascale d’Arbonneau as Chief Financial Officer

Paris, December 12, 2018 – 6.00 pm CET
 
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the appointment of Pascale d’Arbonneau as Chief Financial Officer.
 
A graduate of the ESCP Europe business school, Pascale d’Arbonneau is a member of the Association nationale des directeurs financiers et de contrôle de gestion, (DFCG, the French association of financial and management control managers) and a lecturer at Paris Diderot University. Before joining CARMAT, Pascale d’Arbonneau was Executive Director of the Econocom International B.V. (EIBV) family office.
 
She began her career in 1989 as an auditor at Coopers & Lybrand (now PWC) before entering the pharmaceutical industry as Head of Finance & IT France at Johnson & Johnson – MSD (1995-1999). She spent most of her career (1999-2016) at GlaxoSmithKline (GSK). She joined as Director, Head of Controlling & Finance Partnering, France at GlaxoWellcome, just before its merger with SmithKline Beecham, managing a team of 20 people working on the combination of the two companies. She then held a number of senior positions within the Group (Vice President & Finance Controller, Pharma Europe from 2006 to 2010, Vice President & Area Finance Director, Western Europe from 2010 to 2014) before becoming Vice President Compliance and Control Integration for all business units worldwide.
 
“I am delighted to join CARMAT at a time when the Company is preparing to reach major milestones in its development, to continue the excellent work accomplished thus far on both the financing front and the industrialization front. I look forward to working in collaboration with the team to put in place a detailed financial roadmap and accompany the Company’s growth”, says Pascale d’Arbonneau.
 
Stéphane Piat, Chief Executive Officer of CARMAT, adds: “It is a great pleasure to welcome Pascale d’Arbonneau to our management team. Her arrival marks the completion of the structuring of our Management Committee in view of the challenges ahead, and notably the finalization of the key stages in the CE marking process. Her unique expertise in finance and management control within major global healthcare groups will be essential to secure the ramping up of our project.”

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