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Nuevo dispositivo portátil de radiografía para descartar enfermedades cardíacas de forma rápida y precisa en pacientes con dolor torácico

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOUK20160810001
Publicado:
17/08/2016
Caducidad:
17/08/2017
Resumen:
Una empresa británica del sector de dispositivos médicos está desarrollando un dispositivo portátil para hacer radiografías a pacientes con dolor torácico en menos de 5 minutos. Este dispositivo permite descartar enfermedades cardíacas agudas mediante la producción de imágenes en 2D del corazón. El dispositivo identifica la actividad normal de las células cardíacas mediante una prueba no invasiva y totalmente pasiva. La empresa busca socios con el fin de lanzar al mercado y lograr la aceptación de la tecnología mediante acuerdos comerciales con asistencia técnica.



Details

Tittle:
New portable scanning device for rapid and accurate elimination of acute cardiac conditions for patients presenting with chest pain symptoms
Summary:
A UK based privately held medical device company is involved in the development of a portable device that can scan a patient presenting with chest pain in less than 5 minutes, helping to rule out acute cardiac conditions by producing highly accurate 2D imaging maps of the heart. The company is seeking a small number of geographic partners to help introduce and gain acceptance for this disruptive technology via commercial agreement with technical assistance.
Description:
Chest pain and related symptoms are the second most common cause of emergency department visits in the United States, accounting for approximately 7 million visits in 2010. The majority of patients with chest pain (around two thirds) ultimately have no cardiac basis for their presentation, but must follow the cardiac pathway and be treated as a fully blown heart attack until proven otherwise. Current practice recommended by both the European Society of Cardiology and the American Heart Association rely on a series of ´rule in´ tests, and include the measurement of serial blood diagnostics to detect the protein cardiac troponin released when heart tissue is damaged. Cardiac troponin can take up to 12 hours to be diagnostic after the onset of chest pain, so a negative troponin is not enough to rule out heart disease.

With a clear clinical need to ´rule out´ heart attacks and other acute cardiac events as early as possible and so improve patient care, the UK company has applied advanced quantum principles to create a unique device which has a ´rule out´ detection technology capable of identifying potentially life threatening conditions in acute medical settings.

Utilising new imaging technology, the device performs a simple and non-invasive scan at the patient´s bedside in around 3-5 minutes. The device produces a trace, numerical data and a 2D visual magnetic field map of the heart to aid healthcare professionals in the triage of patients presenting with chest pain. Cells in the heart that lack oxygen (ischaemic) or are necrotic distort the data points picked up by the device, and this can then clearly be seen in the resulting trace and map.

The first application of this technology will be to aid the rapid triage and identification of patients presenting to emergency departments with chest pain, but who ultimately have no cardiac related diagnosis. Identifying these patients early enables them to leave expensive cardiac diagnostic pathways so releasing resources to focus on other acute patients.

The company expect to have the product CE marked for sale in Europe in 2016 and a US 510(K) approval by the end of the year. Once European approval has been received the company will start a 1,000 patient international multicentre study to support the commercial launch.

The company wish to recruit a small number of geographic partners to work with them to introduce and gain acceptance for this disruptive technology. Commercial agreements with technical assistance are envisaged, and the company will:

- Provide full technical and clinical support to their partners;
- Provide in territory support to senior adoption stakeholders.
Advantages and Innovations:
Current projections would indicate that the new medical device can identify patients who do not have a cardiac related chest pain early at initial emergency triage. Currently no other deployable technology is available to quickly and reliably rule out ischemic heart disease in patients presenting with chest pain.

The new device can identify normal cardiac cellular activity in a simple 3 - 5 non-invasive and totally passive test at the patient´s bedside. Initial clinical studies would indicate that this can be achieved with a high specificity at near 100% negative predictive value. Identifying a non-cardiac patient early can save a hospital as much as US$2,000 per patient.

There is huge potential for significant financial savings to the healthcare institution and a short return on investment backed by strong economic evidence.
Stage of Development:
Available for demonstration
IPs:
Patent(s) applied for but not yet granted,Patents granted
CommeR Statunts Regarding IPR Status:
Patent granted in Japan and applications at a national stage in the following countries: China, Europe, USA, Korea, Ukraine, Russia.

Partner sought

Type and Role of Partner Sought:
The company is looking for partners that have experience in selling cardiology or emergency medicine capital equipment and that have gained sales based on promoting and educating clinicians using new and disruptive technology. Expected activities to be carried out by partners under commercial agreement with technical assistance include:

- Supporting local and national clinical trials to drive adoption;
- Promoting the device at ministry of health levels to gain appropriate reimbursement and establish as a standard of care;
- Engaging country key opinion leaders to raise the knowledge and acceptance of the new device;
- Promoting, selling and supporting throughout the territory in a manner appropriate to a best in class medical device company;
- Developing and executing a comprehensive outward facing communications plan to drive adoption of the device;
- Establishing a local education program to support the roll out and general awareness of this new device.

Partnerships with universities who would like access to the technology for research purposes will also be considered.

Client

Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English

Keywords

Technology Keywords:
06001005 Diagnósticos, diagnosis
06001011 Enfermedades circulatorias y del corazón
06001007 Medicina de urgencias
06001013 Tecnología médica / ingeniería biomédica