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Dynasphere
24-48 hours Urodynamic Holter

Field:

Urology,  Uro-Gyn.

Description:

A totally intra-vesical Urodynamic Holter System based on a “Lab-on-a-Chip” loaded on Innoventions proprietary intra-vesical balloon technology. The device is intended to stay in the bladder for 24-48 hours and take pre-programmed periodic measurements of bladder volume, intravesical pressure etc. in a completely physiological environment. In addition, periodic measurements of pH, intravesical temperatures and urine chemistry (which are not measured with current urodynamic examinations) and their effect to the bladder activity will be observed.

 

Need:

Current urodynamic examinations (UD) only provide spot values about bladder functions in simulated environment, but do not reflect the changes occurring during daily activities of the patient. Currently performed UD examination is similar to a standard ECG compared with an ECG Holter. By being a completely intravesical system the DynaSphere will be able to measure and document the bladder functions like a Holter taking measurements of bladder functions in real life conditions for long periods (24-48 hours).This is a unique approach and there is no similar device in the Market.

 

Advantages:

The UD study will be performed during patient’s usual daily activities,

Bladder filling will be physiological and not through a catheter

No catheters or lines will extend from the urethra during the examination

Completely ambulatory

As such the underlying bladder dysfunction will be accurately reflected.

Will be affordable even to physicians with a low patient load – less initial capital investment

Will have an interface to Smart-Phone Devices.

R&D status:

Periodic  bladder volume measurement technology (developed)  

Integrating the additional sensors to the basic balloon – going on

Production of prototypes for bench testing, animal and human studies (after proper funding)

Time to market :± 36 months (pending appropriate funding)

 

IP status:

Multi- Granted and pending patents for the carrier balloon + additional new patent applications

Business opportunity:

An estimated 770,000 urodynamic procedures were performed in the U.S. in 2000, over 1 million in 2005 and 1.25 million in 2010, representing an annual growth rate of over 5%.The growth of treatments for incontinence and the treatment of other lower urinary tract diseases is driving urodynamic procedure growth.

The parameters which will be measured simultaneously by the DynaSphere will be able to provide an excellent functional picture of the bladder during the patients’ regular daily routine. Such a complete information cannot be obtained with none of the currently available urodynamic systems.