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 (ALCAR:EPA)Carmat SA (ALCAR:PAR)
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
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).
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TMT Acquisition (TMTA.L) has joined the Main Market (Standard) pursue opportunities to acquire businesses in the technology, media and telecom sector. Raised £5m, mkt cap £5.5m.
NMCN Plc has left the Main Market (Premium) following the appointment of administrators.
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Harmony Energy Income Trust to join the Specialist Fund Segment of the Main Market raising up to £230m. The Company's investment objective is to provide investors with an attractive
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Cambria Autos has left the AIM following a takeover.
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Light Science Tech Holdings, the controlled environment agriculture technology and contract electronics manufacturing Group to join AIM. Raising £5m. Expected mkt cap £17.4m. Due 15 Oct.
Harmony Energy Income Trust to join the Specialist Fund Segment of the Main Market raising up to £230m. The Company's investment objective is to provide investors with an attractive and susta
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Conditional dealings begin in W.A.G. payment solutions (Eurowag: WPS.L) on the Main Market (Premium). Eurowag is a leading pan-European integrated payments & mobility platform focused on the commercial road transportation industry. It makes life simpler for commercial drivers and operators across Europe through its unique combination of payments solutions, seamless technology, a data-driven digital eco-system and high-quality customer service. The Offer Price has been set at 150 pence pe
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Exactly one year ago, the FTSE 100 closed at 5,862, having fallen 100 points on the day, the lowest point since mid-May 2020, due in part, to the strength of sterling vs US$ at $1.34. One year on, the FTSE 100 has risen to 7,119, a rise of 21%, it remains 7% below the peak in January 2020. From an international viewpoint, US and European markets continue to trade at record highs. The US Federal Reserve is close to withdrawing some of its economic support this year as inflation picks up and the e
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Bens Creek Group to join Aim. Bens Creek, together with its subsidiaries, will, on Admission, own and operate a metallurgical coal mine located on 10,000 acres in the southern part of the state of West Virginia and eastern edge of the Commonwealth of Kentucky, in the central Appalachian Basin of the eastern United States of America. The Mine's operations are located primarily in Mingo County, West Virginia. The
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SEAL Advisors working in partnership with Oberon Capital is pleased to announce the publication of a briefing note on the MyHealthChecked plc.
The Future of Personal Health Care
Agile and responsive leadership has delivered a competitive array of MyHealthChecked branded COVID-19 testing products in a very short period of time
Over the past 12 months the company has been transformed from loss making and cash consumptive, to a high-growth, cash generative business
On the basis of repo
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What a difference a year makes - 12 months ago, the focus, quite understandably, was on the course of the pandemic and the lifting of the Lockdown (1) measures. For investors, it was the sustainability of the rally in markets seen since March 2020. Today, while we are still thinking about the lifting of lockdown measures, we are also concerned about two “old favourites” from previous decades. Inflation and the parlous state of public finances. The BoE has said that although CPI inflation rose to
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Danakali has left the main market (Standard).
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Press reports that Law firm Mishcon de Reya has agreed a merger with life sciences specialist Taylor Vinters after recently confirming its plans to go public on the London Stock Exchange (LSE).
Eurowag confirms its intention to undertake an initial public offering on the Main Market (Premium). The Offer would be expected to comprise both (i) new Ordinary Shares to be issued by the C
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Petershill Partners (PHLL.L), has joined the Main Market (Premium), a leading investment group providing bespoke capital and strategic solutions to some of the world's best performing alternative asset management firms. Petershill Partners today comprises minority investments in 19 high-quality Partner-firms, previously held in private funds managed by Goldman Sachs Asset Management (GSAM). The Partner-firms have US$187 bn of aggregated assets under management. The Offer would comprise (
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ANGLE reported an adjusted net loss of £7.2m (+58% vs. -£3.2m), with establishment revenues increasing 26% to £0.3m and costs rising 48% to £8.9m, reflecting the costs of opening its pharma services business and clinical laboratories in the US and UK. Net cash at 30 June was £21.0m, with a further £18.9m (net) placing proceeds after period-end. Evidence of momentum building within pharma services, backed by confirmation of three contract wins and multiple ongoing discussions (some of which are w
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ReNeuron has announced that the nine-patient Phase IIa (2m cell dose) extension study (halted in June after a presumed eye infection case) has fully restarted with five patients left to treat. Two patients are scheduled for treatment in October. The company expects to report some data by March 2022, which could potentially open the way to a crucial partnering deal. Full efficacy data at six months post-treatment should be available around the middle of 2022. Our valuation remains £190m.
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The current situation in the CDMO arena looks a bit like an arms race and Lonza seems to have firm plans to be part of it. The recently updated mid-term guidance is the explanation to do so, in our view. Management is strongly dedicated to staying with the extraordinary high EBITDA margin for the coming years.
Lonza’s hybrid investors day was well attended in Zurich, in which we participated.
Companies: Lonza Group (LONN:VTX)Lonza Group AG (LONN:SWX)
The positive market research results for Eroxon®, released this morning, provides further support for the company’s ongoing partnering efforts. We continue to believe that MED2002 is a differentiated product with significant potential in both prescription and OTC markets, and look forward to further PK data followed by Phase III start in H1 2018.
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ImmuPharma recently announced an update on the FDA meeting with Avion, ImmuPharma’s partner for Lupuzor™, on 4 December 2020 (Type ‘A’ meeting request). Based on the positive guidance and feedback from FDA, there is now a clear regulatory pathway to commence the Phase III trial in H2 2021, fully funded by Avion. As part of this feedback, Avion and ImmuPharma will develop and validate a bioanalytical assay in order to confirm the unique pharmacokinetic profile of Lupuzor™. This will be presente
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Today’s prelims are in line with management’s expectations with losses before tax in the period of £30.3m (vs. £29.4m prior year). Post-merger, 4D pharma is clearly a different beast with access to the largest global capital market for Pharma/Biotech, and supported by £25.2m (net) proceeds from corporate activity. The company has cash runway until Q2 2022 and is well placed to successfully execute its clinical development strategy with multiple shots on goal. Primary focus is on MRx0518 with two
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