Everything that can be counted does not necessarily count, everything that counts cannot necessarily be counted.
Albert Einstein

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Expertise

TheraGenesis’ staff has broad experience in the successful management of clinical development programs and registration of medical devices in Europe and the United States.

Our clinical programs are consistently and reliably managed in accordance with the regulatory expectations of both the FDA and the European Union - thus maximizing the utility of registration applications on either continent. Our track record and satisfied customers provide the evidence.

Urinary Incontinence/Retention

It is estimated that 1 in 6 adults experience some form of bladder control problem.

Particularly challenging is the management of patients with detrusor instability associated with urge incontinence or frequency-urgency syndrome who have failed behavioral modification and pharmocologic therapies. Equally difficult to manage satisfactorily are patients suffering from non-obstructive urinary retention for whom few therapeutic options exist. Until the introduction of sacral neuromodulation, these patients, managed primarily with intermittent or indwelling catheterization, had little hope of regaining volitional voiding function.

The clinical development of the InterStim neurostimulation device represented the first evaluation of such therapy in these target patients

Cardiogenic Shock

Ischemic Heart Disease

Deaths: 7.198.257

Years of life lost (YLL): 54.352.960

Years lost due to disability (YLD): 8.233.912

Disability-adjusted life years (DALYS): 62.586.874

(WHO)

It is estimated that 7-10% of patients who survive an acute myocardial infarction progress to cardiogenic shock, a physiologic state in which inadequate tissue perfusion results from cardiac insufficiency. These patients require immediate and rapid left ventricular support. In the absence of a mechanism to provide ventricular support, mortality rates range from 60-85%.

Inotropic medication, SVR modulation and volume management are typically used to stabilize the patient. Interventional intra-aortic balloon pump systems are frequently of value to reduce downstream load.

TheraGenesis clinically developed a novel catheter with an impeller-pump system designed to provide temporary left ventricular and circulatory support for patients with acute left heart failure.