Alfred E Mann Foundation For Scientific Research

CONDUCT MEDICAL AND SCIENTIFIC RESEARCH

IMPLANTABLE MYOELECTRIC SENSOR II (IMES INFINITY) + OSSURTHE TECHNOLOGY HAS BEEN LICENSED TO OSSUR AND IS IN DESIGN AND MANUFACTURING TRANSFER.STATUS: ADDITIONAL ANALYSIS AND DEVELOPMENT WORK WAS DONE TO PREDICT FEASIBILITY OF THE USE OF THE DEVICE ON LOWER LIMBS; THE PRODUCT WAS TRANSFERRED TO A COMMERCIAL PARTNER (OSSUR) INCLUDING DOCUMENTATION OF ALL ELEMENTS OF THE UPPER LIMB PRODUCT; BUILD OF INITIAL CLINICAL IMES INFINITY UNITS WAS COMPLETED AT AMF.

IMPLANTABLE NEUROMODULATION PROJECT TO TREAT CHRONIC DISEASE THE AIM OF THE AMF PROGRAM IS TO DEVELOP A NEUROSTIMULATION SYSTEM THAT WILL IMPROVE MEDICAL OUTCOMES AT A LOWER COST AND/OR HIGHER PATIENT SATISFACTION THAN CURRENTLY AVAILABLE TREATMENT OPTIONS.SUCH A SYSTEM WILL CONSIST OF A FULLY IMPLANTABLE NEURAL STIMULATOR FOR SEAMLESS OPERATION AND REQUIRING MINIMAL INTERACTION FROM A PATIENT, WITH THE GOAL OF OFFERING A HIGHER LEVEL OF PATIENT SATISFACTION, ADOPTION, AND COMPLIANCE.STATUS:PLANNING, DESIGN, AND DEVELOPMENT OF THE FIRST-IN-HUMAN IMPLANT AND EXTERNALS HAVE BEEN INITIATED AND ARE WELL UNDER WAY; SEVERAL NON-SIGNIFICANT RISK CLINICAL STUDIES ARE UNDERWAY OR COMPLETED, INCLUDING A STUDY AT UCLA, ONE CONDUCTED BY HARVEY MUDD COLLEGE, AND AN INTERNAL VOLUNTEER STUDY.

NEW PROJECT DEVELOPMENTTHIS PROGRAM COVERS (A) THE MONITORING AND EVALUATION OF SEVERAL EARLY STAGE ADVANCED RESEARCH AND DEVELOPMENT EFFORTS UNDERWAY THAT ARE DIRECTED AT DEVELOPING ADVANCED TECHNOLOGIES, PROJECT IDEAS AND CONCEPTS BEFORE THEY ARE ELEVATED TO THE STATUS OF FULL-FLEDGED DEVELOPMENT PROGRAMS, AND (B) ONGOING EFFORTS RELATED TO THE ADVANCEMENT OF COMMERCIAL DEVELOPMENT AND PROTECTION OF INTELLECTUAL PROPERTY OF THESE PROJECTS ACROSS THE DEVELOPMENT LIFECYCLE. THE TEAM COMPRISES THE FULL RANGE OF EXPERTISE AVAILABLE AT AMF, INCLUDING SENIOR EXECUTIVE MANAGEMENT, RESEARCH SCIENTISTS AND ENGINEERS, LEGAL AND INTELLECTUAL PROPERTY EXPERTS, BUSINESS DEVELOPMENT STRATEGISTS AND ANALYSTS.EXPENSES MAY INCLUDE ONGOING PARTICIPATION IN THE DEVELOPMENT EFFORT INCLUDING RESEARCH AND DEVELOPMENT SUPPORT, COLLABORATION MANAGEMENT, CONFERENCE AND PROFESSIONAL SOCIETY MEETING ATTENDANCE, SERVICE IN MANAGEMENT OR ON THE BOARD OF DIRECTORS OF SPINOUT ENTITIES, PATENT PROSECUTION AND THE PROSECUTION OF INFRINGEMENT ACTIONS TO PROTECT THE VALUE OF THE INTELLECTUAL PROPERTY WE CREATE. IN ADDITION TO PAYROLL EXPENSES AND DIRECT EXPENSES PAID TO OUTSIDE VENDORS FOR GOODS AND SERVICES RELATED TO PROJECTS, EXPENSES IN THIS PROGRAM MAY INCLUDE TRAVEL EXPENSES, PATENT PROSECUTION EXPENSES AND FEES, LEGAL FEES (FOR INTERNAL AND OUTSIDE LEGAL COUNSEL) FOR EXPENSES TO CREATE, PRESERVE AND PROTECT INTELLECTUAL PROPERTY FROM INFRINGEMENT AND REMEDY PAST INFRINGEMENT, AND INCENTIVE AND OTHER COMPENSATION PAYMENTS TO EMPLOYEES AND OTHERS RELATED TO THESE PROGRAMS AND ACTIONS. IN SOME CASES, CERTAIN OF THESE EXPENDITURES MIGHT BE INCURRED LONG AFTER THE PROJECTS HAVE BEEN LAUNCHED INTO SPINOUT COMPANIES OR LICENSED TO THIRD PARTIES.REVENUES ASSOCIATED WITH THESE PROJECTS (SOME OF WHICH MAY ACCRUE LONG AFTER THE PROJECT AND ANY RELATED PROGRAM HAVE BEEN OUT-LICENSED OR LAUNCHED INTO A SPINOUT COMPANY) MAY INCLUDE RECOVERIES OF JUDGMENTS OR SETTLEMENTS FROM PATENT INFRINGEMENT LITIGATION, ROYALTIES ON NET SALES OF LICENSED PRODUCTS, MILESTONE PAYMENTS, ONGOING CONTRACT R&D FROM PARTNERS, LICENSEES AND SPINOUT COMPANIES, INTEREST, AND PROCEEDS OF LIQUIDITY EVENTS (E.G., INITIAL PUBLIC OFFERINGS, ACQUISITIONS) INVOLVING RETAINED EQUITY INTERESTS IN PROJECTS THAT HAVE BEEN SPUN OUT INTO STARTUP COMPANIES.STATUS:PRELIMINARY DESIGN ACTIVITIES BEGAN FOR A NEW BIOELECTRONIC PROGRAM BASED ON THE BUSINESS CASE ANALYSIS CONDUCTED IN THE PRIOR YEAR. THESE ACTIVITIES INCLUDED GENERATION OF INITIAL SYSTEM REQUIREMENTS, ASSEMBLY OF A TEAM OF KEY OPINION LEADERS WITH DOMAIN EXPERTISE, AND THE INITITAION OF SOME FUNDAMENTAL APPLIED RESEARCH IN THE AREA OF NOVEL ELECTRODE DESIGN, INCLUDING POTENTIAL PRE-CLINICAL TESTING. ADDITIONALLY, THE BUSINESS DEVELOPMENT TEAM, ALONG WITH EXECUTIVE MANAGEMENT AND OTHER STAFF, PERFORMED PRELIMINARY DUE DILIGENCE ON A NUMBER OF ASSETS.