Background

The Need:

The urothelium, the inner layer of tight, compact cells that cover the urinary bladder, is considered to be the toughest barrier in the human body. While it protects the bladder from waste products found in normal urine, it also restricts the effective absorption of drugs into the urinary bladder tissue during intravesical treatment (instillation of drugs into the bladder using a catheter).

Ultrasound has known properties to increase tissue permeability and to improve the uptake of drugs. The Vensica platform leverages ultrasound technology to improve treatments for Overactive Bladder (OAB) – A medical condition causing sudden and frequent urge to urinate, leading to involuntary loss of urine (incontinence). Patient suffering from this condition may need to urinate up to 30 times a day, and often during the night. This condition is associated with poor quality of life.

Today, Botulinum Toxin A is injected into the bladder wall as a second line therapy after failure of oral meds. Botulinum Toxin A is injected into the bladder wall using cystoscopy. In order to get better spread of the toxin, the urologist injects the Botulinum Toxin A to 20 sites on the bladder wall. This is a painful, complex procedure that is mostly done under sedation. Needle injections involve risks like hematuria and bladder infections.

The solution is a needle-free Botulinum Toxin A delivery platform, which is pain-free and eliminates the risks that are associated with needle injections. In addition, the solution allows a uniform delivery of the toxin to all regions of the bladder wall, thereby it is expected to improve the clinical results of the treatment and eliminate the risk of retention. Lastly, our solution greatly simplifies the procedure.