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This French company has received regulatory approval to market its total artificial heart system in EU

Heart diseases such as chronic and acute heart failure are considered to be among the world’s leading causes of death. By designing and developing the world’s first-ever most advanced total artificial heart, Paris-based CARMAT aims to fulfil the unmet medical need to people suffering from end-stage biventricular heart failure.

In a recent development, CARMAT announced that it had received the CE marking for its artificial heart system. The CE marking was granted on December 22, 2020, to its total artificial heart system as a bridge to transplant in patients suffering from end-stage biventricular heart failure (Intermacs Classes 1-4) who are not amenable to maximal medical therapy or the LVAD1 and who are likely to undergo a heart transplant in the 180 days following implantation.

Eyes to ramp up production

The CE marking lets CARMAT market its total artificial heart system in all countries, including those from the European Union that recognise the certification. The company will accelerate the production of this artificial heart system and launch the same commercially in the second quarter of this year. Eventually, it will offer a solution to numerous patients waiting for a heart transplant.

Stéphane Piat, Chief Executive Officer of CARMAT, says, “The CE Marking is great news for patients and a major milestone for CARMAT. As early as January, we will accelerate the ramp-up of our manufacturing activities and intensify discussions with our core target customers in order to achieve a smooth commercial launch during the second quarter of 2021, and thus offer a solution to many patients waiting for a heart transplant.”

Shares soars

After the company obtained its CE marking, its shares posted their biggest gain in more than seven years, according to Bloomberg. In late December 2020, the stock climbed 34 per cent to €32.05 in Paris after rising as much as 50 per cent – its steepest intraday gain since May 2013. In 2020, the company’s shares advanced 66 per cent, providing the company with a market value of about €407M ($ 496M).

About CARMAT

With the artificial heart system, CARMAT intends to overcome the shortfall in heart transplants faced by tens of thousands of people suffering from irreversible end-stage heart failure. The company is run by the medical expertise of Alain Carpentier – known for inventing Carpentier-Edwards heart valves – and the technological expertise of the Airbus Group.

Last year, in October, the company was granted €13M in funding by the French Ministry of Health and Solidarity to conduct the EFICAS clinical study, already approved by the HAS (the French health authority) in April 2020.

Through the budget agreement with the French Ministry of Health and Solidarity, two-thirds of the total cost of the EFICAS study will be funded by the French state, which represents non-dilutive financing of €13M for CARMAT.

According to the company, it has been granted the largest subsidy ever given to an SME by Bpifrance; a total of €33m, with the backing of the European Commission.

CARMAT is backed by Matra Défense SAS (a subsidiary of the Airbus Group), Professor Alain Carpentier, the Centre Chirurgical Marie Lannelongue, Truffle Capital, a leading European venture capital firm, ALIAD (Air Liquide’s venture capital investor), CorNovum (an investment holding company held 50-50 by Bpifrance and the French State), the family offices of Pierre Bastid (Lohas), Dr Antonino Ligresti (Santé Holdings S.R.L.), the Gaspard family (Corely Belgium SPRL and Bratya SPRL) and M. Pierre-Edouard Stérin (BAD 21 SPRL), Groupe Therabel as well as the thousands of institutional and individual shareholders.

Startups – Silicon Canals

Manufacturer bulk orders wrong materials before approval?

After a long time with print-on-demand, I am finally graduating to a cut-and-sew manufacturer. I was disappointed with the images of the samples their representative sent me, seeing the fabric doesn't seem to match my reference photos or descriptions at all. I am extremely skeptical when he said they have already bulk ordered the fabric. As I am new to this, I'm not too familiar with the typical protocol. Is this normal? Was it up to me to specify NOT to bulk order until I approved samples? I understand certain things like hardware require bulk order and cannot necessarily be included in the sample–that's fine–but I at least expected to choose from example images as materials are sourced from various suppliers. Perhaps this is normal for fabrics?

I regret that I didn't specifically request to see or recieve a swatch of fabric before the samples were made, but I didn't think they were bulk ordering materials before approval. I'm now insisting on seeing what drawstring cords/hardware/ribbing they're sourcing before bulk ordering, worrying they aren't to my specifications either and hoping they haven't done so already. If it turns out it was up to me and this is normal, I'm alright with accepting the fabric issue as an expensive lesson. The longer I write, the more I wonder if I'm being naïve. Thank you for your input!

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