2022 Market Breakers - Cardiovascular
Market Breakers for 2022 – Cardiovascular
Just passing the mid-point of 2022, there has been some fascinating developments in the world of Cardiovascular MedTech. I am going to explore what the future has in store for devices within the CRM, Vascular and Heart Failure space in a chronological manner, from Ceryx Medical at the Pre-Clinical stage, through to iVascular in their first in-human trials and a final crescendo of Abbott gaining FDA approval to market their CardioMEMS HF Device.
Those not in the Cardiovascular space might be interested to read that, as of 2019 (WHO), coronary heart disease?was the biggest cause of death globally (16%). Here is hoping that these devices could play a pivotal role in the up-and-coming future for patients suffering from this debilitating disease.
So, without further ado let us start are journey with the below:
Ceryx Medical – Redefining Cardiac Rhythm Management
Ceryx Medical, is a Welsh based Medical Device start-up focussing on the Cardiac Rhythm Management space, (Ceryx meaning Synchronisation in Welsh). They are currently developing a bioelectronic technology that can mimic nerve centres to control a range of autonomic or rhythmic processes in the human body.
Having recently gained ￡3.8MM in funding to push the development of their flagship product, they now have ambition to use this capital to begin their ‘first-in-human clinical trails’ across the UK and New Zealand at the back end of 2022.
So, what makes Ceryx product so exciting?
?As we all know, the CRM space is an incredibly competitive arena, with a collection of companies holding the lion share for the global market (Boston, Medtronic, Abbot & Biotronik). So, to take a swing in this space, you have to start revolutionising the product and from the outside this is what Ceryx seem to be doing.
Ceryx’s device, the Cysoni (sympathise – Welsh), is a bionic device that paces the heart with real-time respiratory modulation. In lay-man terms, this means the device aims to replicate the natural interaction between heart rate and breathing, different to traditional CRM products that work towards a strict metronomic beat. According to Dr Stuart Plant (CEO) – the benefits of this for ‘’cardiology patients are potentially life-changing and life-extending, because as well as enabling the heart to work more efficiently, Cysoni also repairs the structure of single heart cells. It’s a huge scientific breakthrough.’’
Furthermore, it is all well and good having a revolutionary idea, but the ability to successfully productise an idea can often be the downfall for many inventions. However, Ceryx have the preliminary data to prove that their product can make a difference in this space.
In 2020, using fully conscious sheep with chronic heart failure and applying their pace-making device to modulate heart rate on a breath-by-breath basis mimicking RSA for 4 weeks; it showed that for the first time, ‘’in a large animal translational animal model that reintroducing respiratory modulated pacing in heart failure results in a dramatic improvement in directly recorded cardiac output. In addition, RSA pacing reduces apnea incidence and re-models cardiomyocyte morphology. Taken together, [the] data supports the concept of reintroducing RSA as a pacing paradigm in pacemakers.’’[1]
?Professor Gianni Angelini, British Heart Foundation professor of cardiac surgery at the Bristol Heart Institute and the National Heart and Lung Institute, Imperial College London also said: "This is a very important result because current pacemakers never give us such a large improvement in cardiac pumping. If this translates across to humans it may define the way we pace hearts in the future."[2]
Now, whilst Ceryx Medical are in the very early stages of development and the notion of seeing this product on the market will no doubt be a few years away; this is without a doubt an exciting innovation for above all, the patients suffering from Heart Failure.
iVascular – First In-Human Trials for their Vascular Stent
Over to Spain now; iVascular, a Catalonian company that develop medical devices for the treatment of disorders of the vascular system. Their therapies cover two areas; coronary and peripheral; with 14 different products.
As of May 2022, iVascular announced the initiation of its first in-human trial with its stent, iCover. The iCover achieved CE mark approval in May of 2021; and with this launch iVascular now offers a complete portfolio to treat all type of peripheral lesions.
?One of iCover’s USP is to offer a unique balloon-expandable (BC) stent with radiopaque markers to facilitate the implantation and the post-expansion. The first in-human trial was performed in Germany, with a patient who had an occlusion in the right common and external ilac artery. ‘’Three iCovers were implanted successfully, achieving an excellent flow after the procedure’’.[3] ?This patient is the first participant in the iliCo Study, which will evaluate the efficacy and safety of the iVascular iCover stent for the treatment of de novo aorti-illac atherosclerotic lesions in 214 patients across Germany, France, Belgium and Spain.
iCover is the only BX covered stent with radiopaque markers on the ends of the stent that facilitates the implantation and the post expansion. Professor Vicente Riambau (Hospital Clinic Barcelona) added that the ‘’iCover stands out for its excellent navigability and flexibility, while the radiopaque tantalum markers on its ends provide better visibility under X-rays, which enhances precision during implantation.”[4]
So, not only does the BX Stent have much greater radial strength compared to the self-expanding stent, but the Radiopaque markers go further to increase the placement accuracy. This is a great breakthrough for iVascular, as the iCover could not only go to further expand their companies market presence, but benefit more patients in the long run with the improved accuracy and strength of their stents.
Abbot – The Rise of Telemedicine for Heart Failure
The rise of Telemedicine continues at a rate of knots, mainly due to globally wide improvements in tech over the past decade. Telemedicine itself refers broadly to electronic and telecommunications technologies and services used to provide remote clinical services at-a-distance.
The rise of Telemedicine, especially of the back of COVID-19 is fantastic news for health practitioners across the globe.?Not only does this it allow patients to get almost immediate care, but it also takes a workload off of physicians and reduces overall hospital waiting times which are still navigating large backlogs of patients due to COVID. In Seattle alone, in March 2022, UW Medicine identified at least 5000 – 6000 surgical cases in its backlog as a direct response to the virus.[5]
With this being said, Abbott have been granted by the FDA the ability to market their CardioMEMES HF System. The first and only remote monitoring platform clinically proven to aid physicians in worsening heart failure, thereby reducing heart failure hospitalisations; which ultimately improves the quality of life for patients. The market impact that this can have in the US alone is vast, the CDC states that about 6.2 million adults in the US have heart failure; and in 2018 it accounted for 13.4% of all deaths in the country.[6]
In order for this product to work to its optimal standard, it requires daily Pa Pressure readings taken at home by the patient whilst also having a patient fitted with a pressure sensor permanently implanted in the distal pulmonary artery via a right heart catheterisation procedure. The daily results then provide notifications to physicians if the metrics recorded fall outside the individually customised limits.
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Just from reviewing the data by the CDC, the opportunity created on a commercial front is vast for Abbott here. However, that is not the most important aspect; what really matters is the benefit that is can have on the patients that use this.
Dr Val Rakita goes on to say that some of the benefits with using this product include the ''early intervention strategy means that patients symptoms are less likely to progress, minimizing their need to be treated at the hospital.'' as well as it allows ''patients with heart failure to live longer, healthier lives. The reduced risk of hospitalization is a major benefit of the device, and one that my patients and their caregivers say is a game-changer.''
Closing Comments from Oliver
I hope you enjoyed this brief summary of three interesting products breaking into the Cardiovascular market, all at different stages in the product lifecycle. All three products mentioned are at different stages, but no doubt will have huge impacts on the market. Part of what makes working in the MedTech world so fascinating is witnessing products that are in the pipeline to changing and impacting peoples lives. I remember recently seeing a photo (below) that showed the change between CRM products from 1970s to 1990’s; the transition from Mercury batteries to Lithium Technology, the introduction of rate adaptive pacing and the evolutionary changes in size.
About the Author
?Oliver works for RW Search, a MedTech Executive Search firm who work globally. Oliver is a Director who is responsible for the Cardiovascular Market working on Leadership, Commercial and R&D Positions. Feel free to reach out if you are growing your team or are interested in a new position.
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[2] ?https://www.med-technews.com/news/latest-medtech-news/new-device-developed-to-help-treat-serious-heart-conditions/
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[5] ?https://www.beckershospitalreview.com/strategy/how-hospitals-are-tackling-a-backlog-of-delayed-surgeries.html
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[6] https://www.cdc.gov/heartdisease/heart_failure.htm#:~:text=About%206.2%20million%20adults%20in%20the%20United%20States%20have%20heart%20failure.