Alfred E Mann Foundation for Scientific Research

SLEEP APNEA AMF IS INVESTIGATING THE NEED FOR NEWER METHODS TO TREAT OSA (OBSTRUCTIVE SLEEP APNEA). OSA IS AN UNDER-DIAGNOSED AND UNDER-TREATED MEDICAL CONDITION THAT HAS BEEN LINKED TO SEVERAL SERIOUS CO-MORBIDITIES, INCLUDING HEART DISEASE. CURRENT TREATMENT OPTIONS ARE POORLY TOLERATED AND WHEN ADOPTED, HAVE LOW COMPLIANCE RATES. THE AIM OF THE AMF PROGRAM IS TO DEVELOP A NEUROSTIMULATION SYSTEM THAT WILL IMPROVE MEDICAL OUTCOMES AT A LOWER COST THAN CURRENTLY AVAILABLE TREATMENT OPTIONS, WHILE SOLVING THE PATIENT COMPLIANCE ISSUE. SUCH A PRODUCT SYSTEM WILL CONSIST OF A FULLY IMPLANTABLE NEURAL STIMULATOR SENSOR, CLOSED LOOP SYSTEM WITH SEAMLESS OPERATION REQUIRING MINIMAL INTERACTION FROM A PATIENT, THEREBY OFFERING A HIGHER LEVEL OF PATIENT SATISFACTION AND ADOPTION.STATUS:A NEW MECHANICAL DESIGN WAS DEVELOPED AND BUILT INTO DEMO UNITS; PROTOTYPE ELECTRONICS CIRCUITY FOR DEMONSTRATION PURPOSES HAS BEEN DEVELOPED AND BUILT INTO FORM FACTOR UNITS; DEMONSTRATION SOFTWARE WAS DEVELOPED TO DISPLAY RESPIRATION DATA ON A TABLET COMPUTER; ADDITIONAL DISCUSSIONS HELD WITH POTENTIAL COMMERCIAL PARTNERS IN AN EFFORT TO OBTAIN FUNDING

NEW PROJECT DEVELOPMENT AND PROTECTIONTHIS 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 FROM THE TIME THEY ARE ELEVATED TO DEVELOPMENT PROGRAMS AND CONTINUING SOMETIMES UNTIL LONG AFTER THESE PROJECTS HAVE BEEN LAUNCHED INTO SPINOUT COMPANIES OR LICENSED TO COMMERCIAL ENTITIES. 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 STRATEGISTS AND ANALYSTS. EXPENSES MAY INCLUDE ONGOING PARTICIPATION IN THE DEVELOPMENT EFFORT INCLUDING RESEARCH AND DEVELOPMENT SUPPORT, COLLABORATION MANAGEMENT, 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 PATENT PROSECUTION EXPENSES AND FEES, LEGAL FEES (FOR INTERNAL AND OUTSIDE LEGAL COUNSEL) FOR LITIGATION 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. DEPENDING ON FACTS AND CIRCUMSTANCES, 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:MAJOR EFFORTS WERE MADE IN THIS AREA RESULTING IN A NUMBER OF NEW POTENTIAL PROJECTS; OVER 40 POTENTIAL INDICATIONS WERE REVIEWED TO FOCUS IN ON A SMALL NUMBER OF KEY AREAS WITH DEVELOPMENT POTENTIAL; FURTHER ANALYSIS WAS PERFORMED ON THIS SUBSET AND PRIORITIES WERE SET FOR EACH OF THE FINALISTS; INCENTIVE COMPENSATION PAYMENTS WERE ISSUED TO PARTICIPANTS IN A LONG-TERM INCENTIVE PLAN RELATED TO A LIQUIDITY EVENT ASSOCIATED WITH A PROJECT LAUNCHED IN 2013; LEGAL EXPENSES CONTINUED TO BE ACCRUED IN CONNECTION WITH ONGOING PATENT INFRINGEMENT LITIGATION RELATING TO COCHLEAR IMPLANT INTELLECTUAL PROPERTY OWNED BY AMF