Dr. Bruce Murphy

Summary

Bruce Murphy and consultant cardiologist Martin Quinn have devised an easy-to-use minimally invasive solution for treating patients with greater than moderate tricuspid regurgitation. This is a significant clinical need with up to 1.6m patients in the US eligible for this therapy. The tricuspid valve is often termed the forgotten heart valve, as surgical interventions are carried out on less than 1% (8,000) of the estimated 1.6m eligible patient population in the US. This is because patients with tricuspid valve disease often have significant co-morbidities and many patients are not candidates for surgery. Even in those who are fit for surgery the risks are high with an operative mortality of between 10% and 35%. Thus there is a significant clinical need for a minimally invasive solution. The technology that we propose to develop uses standard procedures and techniques that are used during pacemaker lead implantation. This approach will ensure safety, ease of use and a high physician adoption rate. The underlying technology relies on the development of an implant that can always be placed in the correct position to inhibit regurgitation of the tricuspid valve. The technology is currently the subject of an Irish patent filing (priority date Sep 2014) and a subsequent PCT filing in Sep 2015. The competitive landscape is reasonably limited. The Cleveland Clinic, Cardio Solutions and Edwards Lifesciences have initiated R&D programs that utilise a similar approach to the one proposed in this application. Galway based 4Tech have a unique solution. While the Mitralign system is a translation of their mitral system to the tricuspid position - this system has many intricacies and may have a low user adoption rate. In summary, the competitive products do not posses the desired user requirements of ease-of-use, adjustability and atraumatic properties that we are proposing. A considerable market opportunity exists in this field, for example: By 2020 there will be approximately 56 million US citizens over the age of 65, utilising a conservative figure of 1.5% of this population experiencing greater than moderate TR (estimated from the Framingham study) equates to 850,000 patients with greater than moderate TR. The cohort of this patient-set that could benefit immediately from treatment due to severe quality of life interfering disease can be determined from De Meester et al, whereby they observed that 10% of patients undergoing a diagnostic procedure had significant TR. Implying that 85,000 patients in the US would have immediate quality of life benefits from a tricuspid intervention. An estimated total US market of $1.7Bn exists. Potentially the OUS market would be another $1.7Bn, equating to a global market opportunity of approximately $3.4Bn. The overall objective of this proposal is to develop the CroiValve technology to the value add point that it has been verified in in vivo medium-term pre-clinical studies. Furthermore a robust regulatory, clinical, technical and business plan will be developed in parallel to assembling a rounded team to raise future finance and develop the device through a European regulatory submission and investigational device trials in Europe.

Funding Agency

Enterprise Ireland

Programme

Commercialisation Fund

Summary

This collaborative research project will focus on the design and development of a re-entry device for the treatment of chronic total occlusions due to peripheral arterial disease (PAD). Currently, the company uses glass and/or silicone models to iterate designs at an early concept stage and this helps to evaluate product performance and product deliverability to the site of the CTO. However, the proposed solution for this project will be dependent on its ability to exit the vessel wall after crossing a CTO in the sub-intimal (SI) space. This is a very delicate procedure which requires both dexterity and finesses by the end-user and will require a novel solution to achieve this technically challenging endpoint. As a result, both the penetration capability and the trackability of the device will have to be developed using more clinically relevant models earlier in the NPD lifecycle. Utilising Prof. Murphy research group's expertise, particularly their capability to successfully penetrate the vessel wall and track though the SI space and their extensive knowledge of the mechanical characterization of vascular tissue will provide the Clearstream with the additional capability they require to develop a next generation CTO device.

Funding Agency

Enterprise Ireland

Programme

Innovation partnership

Summary

AMCARE develops regenerative therapies which aim to circumvent some of the limitations of current treatments for MI patients. Our rationale is to use biomaterials to deliver cells or growth factors to the heart.Biomaterials are materials in which cells can be encapsulated or attached, can support delivered cell growth and which are tolerated by the body. In this way, delivered therapeutics are retained within the heart tissue for extended periods. In addition, biomaterials provide a protective environment for delivered stem cells and enhance stem cell survival in the harsh conditions of the infarct. By combining regenerative stem cells and growth factors within the same biomaterial, our aim is to maximise regeneration in the heart thanks to the synergistic effects of both therapeutics.

Funding Agency

European Commission

Programme

FP7

Summary

We have developed a minimally invasive mitral valve replacement device on a previous Enterprise Ireland commercialization fund. We have continued the development work on this medical device post the Enterprise Ireland funding to assess its safety and efficacy. The device's key attributes lie in the technical features that allow for safe and simple fixation of the prosthesis to the native mitral valve anatomy. The device is currently being tested in large animals and we are open to pursuing licensing agreements with structural heart medical device companies.

Summary

A ssignificant number of individuals in the developed world suffer from moderate to severe mitral valve disease, however 50-80% of the patients that present themselves at surgical centres are denied surgery due to the high risk of intraoperative death. One of the reasons for a high death rate is the trauma that is associated with open heart surgery. There is a clinical need to treat these patients with a less traumatic minimally invasive technology that will result in minimal post procedure mortality. To meet this need over the last 10 years there has been a drive to develop transcatheter technologies that are capable of repairing the mitral valve of these patients in a minimally invasive manner. These technologies have advanced mainly in two technology branches: (1) leaflet plication and (2) coronary sinus annuloplasty. However these two technologies have a number of drawbacks. Our "gap" or "angle" is that a safe effective technology that is low in profile and easy to deliver will be accepted by cardiologists and heart surgeons as the preferred device due to its user-friendliness. We are developing one of the most straightforward and easy to use devices in the arena of transcatheter mitral valve repair/replacement.

Funding Agency

Enterprise Ireland

Programme

Commercialisation Fund

Project Type

Applied collaborative project with NUIG