Carmat’s (OTC:CKMTF) goal of obtaining a CE mark for its artificial heart by the beginning of 2018 already looked ambitious; now it looks impossible. The French regulator ANSM has ordered the group to suspend implants of the device in its pivotal European trial following the death of the first patient in the study.
While regulatory caution is of course to be applauded, this may be a little harsh on the French company. The patients the heart is designed to treat are gravely ill, with a life expectancy of around two weeks. In this case, implantation of Carmat’s product allowed the patient to live at least a month.
The company’s shares initially fell by 29%, but have partly recovered and are now trading down 13% on yesterday’s close.
One month later
Carmat’s chief executive Stéphane Piat – only in the job three months – said that analyses performed so far have not shown the prosthesis to be involved in the patient’s death. Students of rhetoric will note that this is not the same as the analyses showing the prosthesis not to have been involved in the patient’s death.
The exact dates of the procedure and the patient’s death have not been released, the company only saying that the implant occurred at the end of August and the death in October.
The primary endpoint in the pivotal Advance HF trial, which is intended to enroll around 20 patients, is survival at six months – essentially the product is intended to allow patients to live slightly longer in case a donor heart becomes available. So this is certainly an endpoint miss – but is it so bad as to justify a trial halt?
A patient death a month or so after implantation would not be unusual for Carmat’s device. This patient, though the first in the Advance HF trial, was the fifth recipient overall to receive the device and then die. Of the four patients in the separate feasibility study – which had a one-month survival endpoint – the longest post-implant survival was nine months and the shortest 20 days (Carmat’s heart approaches market as rival hits the buffers, August 2, 2016). This latest patient at least beats that short period.
In the case of the patient in the feasibility study who lived for 20 days, surgeons concluded that death was due to the underlying heart failure, with no flaw or malfunction with Carmat’s device being identified.
Better late than never
Now it is vital that Carmat prove the same for the Advance HF patient. If it can show that the heart worked as intended the study can be restarted, and if enough of the other patients enrolled meet the three month endpoint, the device could yet gain CE mark, albeit a little later than Carmat had hoped.
Conversely if the artificial heart is shown to be faulty Carmat will have to redesign it and quite possibly begin human trials from scratch.
But there is a middle case. If patients die within a month or two of implantation simply because they are very ill, and if the ANSM halts the trial for an investigation each time, Carmat could be in trouble. The company has previously said it has cash to last it until CE mark – but that was when it was expecting CE mark at the start of 2018.