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Carmat recently announced that it has implanted nine of its physiologic heart replacement therapies (PHRT) since July, six of which were commercial implants (under the brand name Aeson in the EU) while three were part of the early feasibility study (EFS) in the United States. These nine implants are associated with approximately €2m in product revenue, which will be booked in H221. Importantly, due to the PHRT’s profile, which features autoregulation, pulsatility and hemocompatibility, additiona
Companies: Carmat SA (CKMTF:OTC)Carmat SA (ALCAR:PAR)
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Carmat announced that it has received a CE Mark for its physiologic heart replacement therapy (PHRT) and that the product will be launched in Q221 under the brand name Aeson. The approved indication is a bridge to transplantation therapy (BTT), although over time we expect approval for Aeson as a destination therapy (DT), which will enable commercialisation to a larger number of patients. The initial commercial focus will be on France and Germany, which Carmat estimates to account for 55% of the
Companies: Carmat SA
Carmat continues to make progress in the development of the total artificial heart (TAH). In February, the FDA granted full approval for the company to initiate an early feasibility study (EFS) in 10 patients at seven US centres. Additionally, the company has obtained reimbursement from the Centers for Medicare and Medicaid Services (CMS) for the device and routine care items and services related to the study. The company expects to implant the first TAH in Q121.
In January, Carmat announced data from the initial 10 patients included in the first leg of its EU pivotal study investigating the surgical implantation of the Carmat heart in patients suffering from end-stage biventricular heart failure (HF). In total, 70% of these patients achieved the primary endpoint, which is survival at six months post implant. Also, improvements to the device manufacturing process starting in Q418 slightly delayed timelines. The trial is expected to resume with the improv
In July, Carmat announced the enrolment of the 10th and final patient included in the first leg of its EU pivotal study investigating the surgical implantation of the Carmat total artificial heart (TAH) in patients suffering from end-stage biventricular heart failure (HF). Following the successful surgeries, the company expects to enrol an additional 10 patients in the second cohort by the year end. According to Carmat, data from all 20 patients should be sufficient to obtain CE marking for the
Carmat raised €52.9m through the sale of 2.645m shares at €20.0 per share. We estimate that this should increase the firm’s cash runway into Q219, or potentially through the completion of the ongoing EU pivotal study of the Carmat heart. Our rNPV valuation is €643m, up from €627m previously. Due to increased share count, our per-share equity valuation has decreased to €77.34 (from €106.98, previously).
Carmat resumed the EU pivotal trial of its artificial heart after addressing regulator concerns. We anticipate that the study could be completed in mid-2019, leading to a potential EU launch in 2020. The Carmat device could potentially fill a significant need among those waiting for human transplants and/or with terminal heart failure (HF) or acute myocardial infarction (MI). Our valuation is €627m, down from €747m previously.
Carmat announced on 2 May 2017 that it has obtained approval from the French regulatory agency (ANSM) to resume its pivotal trial for the Carmat heart. This follows a favourable review by ANSM of the actions and analyses taken by Carmat following the trial’s suspension after the death in October 2016 of this trial’s first patient six weeks after his implantation. Carmat maintained that the death was not due to a prosthesis malfunction, but due to poor handling of the batteries by the patient. Ou
On 30 November, Carmat announced that the first patient implanted with its bioprosthetic heart as part of its European pivotal trial has died. The implantation occurred in late August and press sources report that the death was in October. The company’s analyses do not suggest the prosthesis was responsible for the death, although the French regulatory agency (ANSM) is suspending future Carmat implantations. Our valuation (previous rNPV of €747m) is under review.
Carmat has received approval from the health regulatory authorities in France to start a CE mark enabling a pivotal trial for the Carmat bioprosthetic heart. We expect recruitment to start in the coming weeks, which could lead to commercialisation in Europe by H218. Following this clearance, we have raised our Carmat heart probability of success estimate for the EU market to 35% (from 30% previously). This raises our rNPV valuation to €747m (up from €651m), or €133.00 per share after including a
Carmat shareholders approved the terms of a €50m equity financing earlier this month. While the shares outstanding increased by 29.5%, we estimate funds on hand are sufficient to fund operations into H118, and likely through the completion of a pivotal study for the Carmat bioprosthetic heart. With the recent completion of the feasibility study, Carmat plans to start a CE mark enabling pivotal trial in H216, which could lead to commercialisation by H218. Our rNPV approach generates a valuation o
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