Intravesical Drug Delivery
Urology, UroGynecology, Gerontology
The PharmaSphere is an intra-cavitary device for delivering drugs in a sustained manner into the target organ. The PharmaSphere is a floating intravesical device loaded with the indicated drug that may stay in the bladder from 1 to 12 weeks or even more, according the indication and the pre-determined length of the treatment period.
Since the majority of the patients suffering from OAB, IC/PBS and chronic bladder infections are female, first the elements for inserting and retrieving the PharmaSphere device from the bladder in female patients have been developed and even studied in animals and tried for the insertion and retrieval of another device for urine incontinence (somehow similar) developed by Innoventions in human subjects.
Bladder dysfunctions necessitating chronic treatments are Overactive Bladder (OAB), Interstitial Cystitis (IC)/Painful Bladder Syndrome(PBS), chronic bladder infections (CBI) resistant to systemic antibiotics.
Because of the side effects, in OAB patients there is a large amount of treatment drop-outs (40-70%) with the available medications.
IC and CBI necessitate repeated catheter insertions to the patient, apart of being inconvenient to the patient and adding to the cost of the treatment, they increase the risk of complications.
There is a need for long-term local delivery of medications in these patients.
Single insertion for Local, targeted, short or long-term, high or low-dose drug delivery
Allows combination of different drugs
Possible different release profile
High drug loading
Flexibility for different release profiles
No systemic side effects
Long-term presence of the pharmaceutical agent
Ambulatory, not disturbing patients’ routine daily activities
No repeated urethral catheterizations
Reduced risk from urethral manipulations inducing UTI
The ability to deliver several drugs using 2 versions of the PharmaSphere have been proved repeatedly in the laboratory.
The necessary insertion and retrieval elements for use in male patients for the PharmaSphere is being developed.
Several granted and pending patents.
Addressable Market (U.S.): Approximately 25% of the OAB + IC population of 5 M need of a solution. Expected to grow with population aging
Target ASP: $300 (per treatment) – 3 months x 4 = $1,200 - year
Product Market Value (U.S.): $1.5 billion