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May 2014

Cardiola has entered into advanced stage partnering discussions with a number of leading healthcare companies.

April 2014

Cardiola has filed a new global umbrella patent which, if granted, will prove intellectual property protection to April 2034.

This follows significant recent progress made by Cardiola in understanding of how and on what physiological systems the m.pulse® device works, which has resulted in substantial changes to the m.pulse® device and how it is applied to patients.

These biomarker-assisted discoveries, besides forming the basis for a new 20-year patent, have demonstrated improvements in patient efficacy, number of responders and patient comfort. They have also led to the identification of a number of cardiovascular and non-cardiovascular conditions that would benefit from m.pulse® treatment.

March 2014

Investigating the use of Cardiola’s m.pulse® device in emergency vehicles (e.g. ambulance), intensive care units, recovery and rehabilitation centres and in the home environment, a wide range of diagnostic and treatment devices (both implanted and non-implanted) have been identified as being suitable for use together with the m.pulse®.

January 2014

Cardiola has completed a series of investigative meetings with leading medical device and related companies, in order to determine (i) level of partnering interest, (ii) how well Cardiola’s m.pulse® device range, together with its comprehensive clinical trial portfolio, meets their needs and (iii) what additions and changes to the device and its clinical trial package would increase level of interest.

December 2013

Working together with a number of leading, internationally-respected cardiologists, over a period of 12-months, Cardiola has identified a significant number of high unmet medical need cardiovascular and non-cardiovascular conditions (beyond heart failure) that could benefit substantially from the addition of Cardiola’s m.pulse® device to treatment. Discussions regarding study design are now underway with clinical experts and partners.

September 2013

With the help of a major European heart centre, Cardiola has completed the design of and validation of an m.pulse® ‘acute decompensated heart failure study’.

May 2013

With the assistance of a number of experts in the field, Cardiola has completed the design and validation of a controlled, multicentre, ‘acute-plus-post-acute/chronic heart failure study’, the results of which are needed to secure FDA 510(k) approval and reimbursement in the USA.

March 2013

Cardiola has used data from recently conducted, biomarker-assisted clinical work (reported in January 2013), to further optimize the performance of its m.pulse® device. Clinical data suggests that such modifications will lead to improvements in patient efficacy, number of responders and patient comfort.

January 2013

Cardiola has successfully completed, analysed and documented 6-months of biomarker-assisted clinical work, the results of which confirm the mode of action of Cardiola’s m.pulse® device.

December 2012

Cardiola has received extremely positive results from a 6-month stable heart failure study, which was conducted in Europe in late-stage heart failure patients (NYHA Class 3 and 4).

November 2012

Cardiola has received very positive results from an acute, decompensated heart failure (ADHF) study conducted in several specialized cardiology treatment centres across Germany, in which Cardiola’s m.pulse® device was added to standard ADHF therapy.

July 2012

Cardiola has identified the mode of action of its m.pulse® device. Such mode of action is supported by existing clinical evidence. Additionally, Cardiola has identified a useful surrogate marker which is a well recognized predictor of future cardiovascular events, patient outcomes and treatment efficacy. Cardiola will use this surrogate marker in a study to further support the mode of action of the m.pulse® device.

March 2012

Cardiola has generated, validated and presented to its Board a significantly revised, ‘exit-focused’ business strategy. Such strategy has been recorded in a comprehensive business plan.