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Carmat

Carmat raises EUR 52.9m and extends cash runway

Update | Pharmaceutical & healthcare | 21 Dec 2017

Carmat raised EUR 52.9m through the sale of 2.645m shares at EUR 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 EUR 643m, up from EUR 627m previously. Due to increased share count, our per-share equity valuation has decreased to EUR 77.34 (from EUR 106.98, previously).

Carmat

Back on track as pivotal study resumes

Outlook | Pharmaceutical & healthcare | 31 Jul 2017

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 EUR 627m, down from EUR 747m previously.

Carmat

Executive Interview - Carmat

Edison TV: | Pharmaceutical & healthcare | 26 Jun 2017

Stéphane Piat, CEO of Carmat, discusses the limitations of human heart transplant availability that build the commercial case for the development of its biocompatible artificial heart implant. He also outlines the characteristics that differentiate the Carmat heart from the SynCardia artificial heart and from ventricular assistance devices, which can potentially lead to better tolerability, less thrombosis risk and improved patient outcomes. He then discusses the next steps needed to advance the Carmat heart project and summarises the company’s financial position and requirements.

Carmat

Carmat obtains clearance to resume pivotal study

Flash note | Pharmaceutical & healthcare | 05 May 2017

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. Our valuation (previous rNPV of €747m in our 15 July 2016 update note) is under review.

Carmat

Regulatory agency suspends Carmat implants

Flash note | Pharmaceutical & healthcare | 01 Dec 2016

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

Cleared to start pivotal study in France

Update | Pharmaceutical & healthcare | 15 Jul 2016

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 an estimated mid-2016 net cash position of €41.3m.

Carmat

Setting the stage for pivotal heart study

Update | Pharmaceutical & healthcare | 05 May 2016

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 of €651m (up from €611m), or €116.92 per share after including an estimated mid-2016 net cash position of €41.3m.

Carmat

Green light to conclude feasibility study

Update | Pharmaceutical & healthcare | 30 Nov 2015

Carmat has obtained regulatory authorisation to conclude the feasibility study of its artificial heart and to adopt a new clinical protocol enabling patients with less severe heart failure to participate. This should pave the way for a CE mark study in 2016 and could lead to a launch in CE mark regions in H217. Our valuation is raised from €591m to €611m (€129/share).

Carmat

Daily comment

Institutional Comment | Pharmaceutical & healthcare | 12 Feb 2015

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Carmat

A new lease of life and a cash injection

Update | Pharmaceutical & healthcare | 04 Feb 2015

The discharge of the second patient implanted with the Carmat heart last August satisfies the 30-day success criteria of the feasibility study. The patient returned home supported by a 3kg portable energy source newly approved for trials, which enhances the clinical and commercial utility of the bio-prosthesis. Carmat has secured a contingent equity line up to €50m, which could fund CE mark approval. We have raised our DCF valuation to €591m from €533m due to running the model forward a year and updating for estimated post-equity raise net cash of €24.8m.

Carmat

Daily comment

Institutional Comment | Pharmaceutical & healthcare | 21 Jan 2015

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Carmat

Daily comment

Institutional Comment | Pharmaceutical & healthcare | 05 Nov 2014

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