Alfred E Mann Foundation for Scientific Research

Filing Period

Apr 1, 2010 to Mar 31, 2011

Signed

Aug 12, 2011

Return Version

2010v3.4

Gross Receipts

$44,721,242

Mission

Major Activities

Activity 2

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 trail for pain management using infumorph. Three patients were implanted with pumps at two separate centers, the north carolina pain center and at uc san diego. In parallel, system component and accessaroy inventory was built to support the 75 patient human trial. On an ongoing basis, certain engineering projects were in development focusing on product improvement and additional functionality.

Activity 3

New projects: a) icpm: initial development work began on a new technology allowing the monitoring of intercranial pressure. The goal of this project is to couple a pressure sensor to the intra-ventricular catheter of a hydrocephalus shunt in order to monitor intracranial csf pressure in real time, to monitor the adequacy and effectiveness of individual patients' shunt operation, and to protect the health of shunt patients. The major area of focus during the intitial feasibility analysis is "drift" that results from various forces placed on the sensor. Over time the built in forces cause the output to drift and result in inaccurate readings.status:mutiple sensors have been evaluated by using a series of rigorous experiments and tests. One commercially available pressure sensor that meets the requirements has been identified. Packaging method to assemble the sensor into an implantable package has been developed and long term soaking tests with bare sensors and assembled packages have been conducted. Asics have been designed and tested for the potential use of such icpm system.b) ap: the artificial pancreas development path consists of several steps culminating in a fully implantable, closed-loop, autonomous artificial endocrine pancreas. Such a system will maintain blood glucose levels in diabetics to normal range without risk of hypoglycemia (low blood glucose). Four major components constitute the ap system: an implantable pump delivering insulin to the intraperitoneal space, insulin which is stable at body temperature, an implantable glucose sensor, and a control algorithm.status: a major effort at this time is acquisition of external funding for this ambitious project. One grant application has been submitted to nih, another is in preparation, and we are meeting with private funding agencies. An existing implantable pump developed by amf is under bench testing using two candidate insulins. Insulins are being tested for physical and chemical stability. We are in the process of evaluating several potential glucose sensor partners. We have evaluated control algorithm partners and are submitting a grant request for animal studies with one of these investigators.

Filer

EIN

95-4002032