Field:

Urology, UroGynecology, Gerontology

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Description:

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.

 

Need:

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.

 

Advantages:

• 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

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R&D status:

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.

 

IP status:

Several granted and pending patents.

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Business opportunity:

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