Alfred E Mann Foundation for Scientific Research

Filing Period

Apr 1, 2011 to Mar 31, 2012

Signed

Aug 10, 2012

Return Version

2011v1.2

Gross Receipts

$62,738,507

Mission

Major Activities

Activity 2

Implantable pain pump: in december 2009, amf purchased the assets of a company called infusion systems. The assets included, among other things, the intellectual property and hard assets/equipment necessary to build an implantable infusion pump that can be used to pump various pharmaceutical products into the human body safely and accurately. The initial application is for pain management using morphine. Status: the foundation submitted and the fda approved an ide application to start a human clinical trial for pain management using infumorph. Fourteen patients were implanted with pumps at five separate centers, the carolinas pain institute, uc san diego, spectrum care pain treatment center, millennium pain center, center for pain and supporting care. In parallel, system components and accessory inventory was built to support the 75 patient human trial. On an ongoing basis, various engineering projects were in development focusing on: a new tablet programing platform and two new pump designs, one with a small drug reservoir and one with a larger reservoir.

Activity 3

Febpm: the function electrical stimulation battery powered microstimulator (febpm) program (formerly the battery powered microstimulator (bpm) program) is the development of the next-generation microstimulator system. It is designed for a wide range of medical applications including localized individual muscle control and orchestrated muscle group control. The present microstimulator (rfm - see below) is powered and controlled through an external rf field and only a few microstimulators can be controlled at once using a control algorithm installed on a pc and utilizing limited activity sequences. By contrast, the febpm implant has its own power supply which can be recharged as needed and then can operate for periods of time. Numerous febpm's can be communicated with and controlled using one external controller. Future versions of the febpm system may also contain sensors capable of communicating back to the controller to deliver various types of information used for system operation.status: a major milestone was reached during 2011 when the fcc issued an order enabling the foundation to share a small range of radio frequency in harmony with the existing users. This approval in conjunction with effectively securing a couple of key component suppliers has allowed the program to once again move forward. The major challenges remaining focus on the devices final qualification testing and determination of the initial clinical trial application.

Filer

EIN

95-4002032