2017-08-11T17:00:31-05:00 2017-03-31 910189318 Moss Adams LLP 805 SW Broadway Ste 1200 Portland OR 97205 990 2016-04-01 954002032 Alfred E Mann Foundation for Scientific Research ALFR 6617026700 25134 Rye Canyon Loop Santa Clarita CA 91355 John Petrovich Chief Executive Officer (Acting) 6617026700 2017-08-11 1 Wendy Campos P00448102 5032421447 2017-08-10 23.243.54.222 2017-08-11 16:48:44 PD P DA39A3EE5E6B4B0D3255BFEF95601890AFD80709 7D0D6C7A6A5655B0595BBDB8C4257A6B648F0CEB 2016 2021-01-29 14:40:06Z John Petrovich 25134 Rye Canyon Loop Santa Clarita CA 91355 34851877 0 X www.aemf.org X 1985 CA CONDUCT MEDICAL AND SCIENTIFIC RESEARCH 3 3 80 0 76035 -75375 1124238 5865 926616 23845 2867141 953967 -377460 3000 4540535 986677 7000 8000 0 0 10867512 9596695 0 0 2044 6378698 5741212 17253210 15345907 -12712675 -14359230 82113434 63522432 8156995 1651881 73956439 61870551 X THE ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH IS A MEDICAL RESEARCH ORGANIZATION DEDICATED TO DEVELOPING AND COMMERCIALIZING INNOVATIVE SOLUTIONS FOR SIGNIFICANT UNMET MEDICAL CONDITIONS. 0 0 2171173 0 0 Advanced Technology Projects (New Projects)AMF has several early stage research and development efforts under way in this group that are directed at developing advanced technologies and concepts, including innovative uses for sensors, novel packaging and manufacturing processes for implantable devices including sensors, stimulators and pumps. The team is comprised of research scientists, engineers, legal and intellectual property experts, business strategists and analysts who monitor and evaluate new technologies and new project ideas and concepts before they are elevated to the status of full-fledged development programs. The group also provides business planning support for more mature AMF programs that are on their way to being commercialized. Status:As the projects are in initial feasibility or proof-of-concept stage for the most part, expenditures on any individual project are limited. Successful projects are screened for elevation to development program status, or to be financed in spinout companies by third parties. Unsuccessful efforts are terminated. During the previous period a number of new innovative projects have been evaluated by the team. Several new and promising areas were evaluated and one or more will become formal projects in FY2017. 3606022 3000 23845 Implantable Myoelectric Sensor (IMES I + Clinical)Initially, the "IMES" project was a consortium project with the following partners: Northwestern University, the Illinois Institute of Technology, and Sigenics (a closely held engineering company). The initial funding for the IMES program was coming from the National Institutes for Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of Child Health and Human Development (NICHD), as well as, the Defense Advanced Research Projects Agency (DARPA). In 2008, AMF assumed control of and responsibility for the entire project, performing mission critical engineering tasks, as well as preparing for and conducting a clinical trial. The IMES system implanted in the residual limb of a limb amputee would transmit muscle signals to the wearable prosthesis to permit control of the prosthesis in a more natural and intuitive manner. Status:AMF has qualified the first generation IMES system for a clinical trial with upper limb amputees. A clinical trial protocol was developed and FDA approval was obtained. Three patients have been implanted at Walter Reed National Military Medical Center ("Walter Reed") and have reported that the new equipment made available to them during the study improved their quality of life. AMF supports this clinical trial directly with frequent on-site visits by AMF personnel, who work in conjunction with physicians and other caregivers at Walter Reed. During 2016 AMF advanced its collaboration with Ossur, a maker of lower-limb prosthetics and other orthotic devices, where two lower limb amputee/patients were implanted with IMES devices. Additionally, AMF entered into a collaboration agreement with Ottobock, the world's largest maker of prosthetic devices (both upper and lower limb), to evaluate IMES devices in connection with a transhumeral (upper limb) amputee, where three patients were implanted with IMES. The Ossur study is being conducted in Iceland, and the Ottobock study is being conducted in Austria, at Europe's largest hospital, Vienna General Hospital, under the auspices of Dr. Oskar Aszmann of the Christian Doppler Laboratory for Restoration of Extremity Function, Medical University of Vienna. The two patients in Iceland and the three patients in Austria are successfully utilizing their devices in accordance with the clinical trial.AMF is in the process of seeking FDA approval of an HDE (Humanitarian Device Exemption) to enable the system to reach its intended patient population. Approval of the submission is anticipated in FY2017. 4338388 0 0 Implantable Myoelectric Sensor II (Infinity)The initial collaboration was re-vitalized to commence research and development work on a second generation of IMES, (partially supported by a grant from the National Institutes of Health) which will contain advanced features to improve medical outcomes at no additional cost to the patient or healthcare system. Initial design is complete with major focus being on final design and validation activities. Status:The final design of the product is complete and the system is being tested and verified. Peripheral devices that include a telemetry controller module that relays muscle signals to the prosthetic, and a clinician programmer have completed the design phase of the project and a final design review. Production test systems have been validated to prepare for final system verification and validation. Product qualification is in process with completion expected in FY2017. 2399400 5000 0 Sleep Apnea:AMF is investigating the need for newer methods to treat OSA (Obstructed 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 adopted and when adopted, have low compliance rates. The aim of the AMF program is to develop a neurostimulation product system that will improve medical outcomes at a lower cost than currently available treatment options while solving the 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 level of compliance and efficacy favorable to gold standard treatments. Status: A comprehensive product and economic analysis was performed this year demonstrating a need for a tolerable treatment. Several potential designs have been tested and reviewed, which required a number of engineering, animal and cadaver experiments. The process included obtaining input from key opinion leaders; ENT surgeons' implant approaches and pulmonologists treating obstructive sleep apnea. Further testing (both bench and animal) is in process and a final design is anticipated by the end of the fiscal year. Formal product development will begin in FY2017. 155263 0 0 Neural Respiratory Drive (NRD)Neural respiratory drive (NRD) can be derived from the amount of electrical activity occurring in certain muscles used for breathing. Analysis of electrical activity and other measurements (such as rate of breathing and heart rate) allows early detection of deteriorations in patients with breathing problems so their level of care can be appropriately increased. NRD can be monitored in COPD (Chronic Obstructive Pulmonary Disease) patients as a measure of their physiological effort to breathe. Additional potential applications include asthma and pneumonia sufferers. COPD exacerbations are associated with lung function decline, lower quality of life, and increased mortality. Patients with frequent AECOPD have 4.3 times greater risk of death. Currently used Early Warning Scores designed to identify patients at risk of deterioration are inaccurate and require considerable health care resources. NRD may be used to help patients recognize their symptoms, seek early treatment and prevent exacerbations reach a stage requiring hospitalization. Reduction of severity and prevention of new exacerbations is critical to the wellbeing of COPD sufferers.An NRD monitoring system using the IMES technology would be used to:- Provide an accurate measure of the Neural Respiratory Drive (NRD)- Allow usage in home/acute/office setting- Predict acute exacerbations to prevent hospitalizations- Determine readiness level for hospital discharge- Potentially extend life of COPD patients- Promote patient self-knowledge- Empower patient management of disease- Tie in with consumer devices/cloud storage- Resolve shortcomings of surface electrode EMG recordings- Signal amplitudes calibrated only once due to stability of implanted deviceStatus:The Implanted Myoelectric Sensor (IMES) (Infinity version) will be completed during FY2017. A flat coiled designed interface to the IMES sensor is under development that will power the sensor and provides a data connection for signal analysis and calculation of NRD index. A clinical research system will be developed in FY2017. 2554663 5000 0 12670246 1 0 0 0 0 0 0 0 0 0 1 1 0 0 0 1 0 1 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 1 34 0 1 80 1 1 1 0 0 0 0 0 0 0 0 0 X 3 3 0 0 0 0 1 1 0 1 1 0 0 1 1 1 1 1 1 1 1 1 1 CA X RENEE OLIVIERI 6617026883 25134 RYE CANYON LOOP SANTA CLARITA CA 91355 ROBERT GREENBERG CHAIRMAN 2.50 X X 0 0 0 RICHARD WAUGH BOARD MEMBER 2.50 X 0 0 0 Mari DANIHEL bOARD MEMBER 2.50 X 0 0 0 BRIAN MANN BOARD MEMBER 0.50 X 0 0 0 DAVID HANKIN CEO 65.00 X 469319 0 33531 FARAH BOROOMAND cfo 55.00 X 272416 0 29021 MARK CHAMBERLAIN coo 58.00 X 324149 0 27590 JOHN PETROVICH svp, bus. dev. & general counsel 54.00 X 333119 0 22547 MICHAEL PERRIN VP, QUALITY, regulatory, clinical 50.00 X 183575 0 21832 Desmond B Keenan CTO 40.00 X 179475 0 9225 James H Wolfe PRINCIPAL ASIC DESIGN ENGIneer 40.00 X 173144 0 27480 GLEN GRIFFITH Technical director 40.00 X 218762 0 21181 Edward Lee senior ASIC Design Engineer 40.00 X 175509 0 22190 Siegmar Schmidt Emerging technologies group mgr 40.00 X 171776 0 15963 Charles L Byers principal scientist 40.00 X 189406 0 15992 2690650 0 246552 36 0 1 0 Morgan Lewis & Bockius LLP 1701 Market Street Philadelphia PA 191032921 Legal Services 1026482 CDW Direct LLC PO Box 75723 Chicago IL 606755723 Hardware/Software 182294 Ronald C Allen 26637 Durham Way Hayward CA 94542 Regulatory services 149427 CMGRP Inc PO Box 74008263 Chicago IL 606748263 Marketing services 119889 computer packages inc 11 n washington street suite 300 rockville MD 20850 patent services 106206 10 5865 5865 research grant income 900099 23845 23845 23845 667648 76035 591613 34144919 6600 33862107 3093 282812 3507 286319 286319 other income 999999 3000 3000 3000 986677 23845 76035 880932 8000 8000 1918033 1409882 508151 6198223 5681271 516952 115767 105385 10382 789103 707631 81472 575569 500495 75074 1344948 879378 465570 85737 85737 229607 229607 939886 832399 107487 1172489 1089514 81497 1478 285432 237143 48289 855417 731014 124403 109065 86182 22883 23932 15914 8018 145588 145588 392399 264432 127401 566 95655 81707 13948 Education & Morale 40615 34619 5996 Miscellaneous 20442 5280 15162 15345907 12670246 2673617 2044 1430225 1392667 1335933 1342188 78448 68319 323181 397189 9014816 7480863 1474588 1533953 44957810 18340481 31674112 38540950 736306 694046 102831 1212639 82113434 63522432 1777475 1651881 6379520 0 8156995 1651881 X 73956439 61870551 73956439 61870551 82113434 63522432 -14359230 2273342 0 X 0 1 X 1 1 1 X WALTER REED NATIONAL MILITARY MEDICAL CENTER BETHESDA MD UCLA Foundation Los Angeles CA 1608883 665735 943148 5106633 4574955 531678 2299300 2240173 59127 1533953 limited partnerships 819298 F bioness inc. 2077000 F MEDALLION THERAPEUTICS, INC. 25968876 F MONOLYTHIX, inc. 4123416 F Axonics Modulation Technologies, Inc. 5552360 F 38540950 X Part X, Line 2: The Foundation, under the provisions of ASC 740, Income Taxes, had no uncertain tax positions requiring accrual as of March 31, 2017 and 2016. CENTRAL AMERICA AND THE CARIBBEAN 0 0 INVESTMENTS 6847602 cENTRAL AMERICA AND THE CARIBBEAN 0 0 INVESTMENT FEE EXPENDITURES 81375 0 0 0 0 0 0 6928977 0 6928977 1 0 1 1 1 0 Part I, line 3: THE ACCRUAL METHOD OF ACCOUNTING IS USED FOR BOTH AMOUNTS REPORTED AS INVESTMENTS AND EXPENDITURES. X X 0 0 0 0 0 0 0 1 0 DAVID HANKIN CEO 342319 0 115000 0 12000 0 5299 0 28232 0 502850 0 0 0 FARAH BOROOMAND cfo 217416 0 55000 0 0 0 4839 0 24182 0 301437 0 0 0 MARK CHAMBERLAIN coo 274149 0 50000 0 0 0 5299 0 22291 0 351739 0 0 0 JOHN PETROVICH svp, bus. dev. & general counsel 258119 0 75000 0 0 0 5299 0 17248 0 355666 0 0 0 MICHAEL PERRIN VP, QUALITY, regulatory, clinical 161075 0 22500 0 0 0 3415 0 18417 0 205407 0 0 0 Desmond B Keenan CTO 144475 0 35000 0 0 0 3200 0 6025 0 188700 0 0 0 James H Wolfe PRINCIPAL ASIC DESIGN ENGIneer 173144 0 0 0 0 0 3633 0 23847 0 200624 0 0 0 GLEN GRIFFITH Technical director 206262 0 12500 0 0 0 4390 0 16791 0 239943 0 0 0 Edward Lee senior ASIC Design Engineer 175509 0 0 0 0 0 3598 0 18592 0 197699 0 0 0 Siegmar Schmidt Emerging technologies group mgr 161776 0 10000 0 0 0 3448 0 12515 0 187739 0 0 0 Charles L Byers principal scientist 188406 0 1000 0 0 0 3530 0 12462 0 205398 0 0 0 Part I, Line 7 BONUS PAYMENTS WERE MADE, BUT ARE BASED ON ACHIEVEMENTS, GOALS, AND ARE APPROVED BY BOARD OF DIRECTORS. Form 990, Part VI, Section A, line 6 The foundation's articles of incorporation provide that the foundation is a membership corporation, with the members having the rights of membership as described in the foundation's bylaws. The bylaws provided for the foundation to have a lead member, designated by the bylaws to be Alfred E. Mann, who would possess all powers of membership conferred by law. The bylaws also provided that up to four additional members, appointed by the lead member, would have only those rights conferred upon them by the bylaws, which include only the right to name a successor lead member under certain described circumstances. Alfred E. Mann passed away on February 25, 2016, without having appointed any of the four authorized additional members; Mr. Mann's successor(s), if any, have not yet been finally determined. Form 990, Part VI, Section A, line 7a The foundation's bylaws provide that the foundation shall have one lead member who has the power to appoint, remove, and name successors for all members of the board of directors of the foundation. Alfred E. Mann passed away on February 25,2016; Mr. Mann's successor(s), if any, have not yet been finally determined. Board members appointed by Mr. Mann continue to serve. Form 990, Part VI, Section B, line 11b A DRAFT OF FORM 990 WAS PRESENTED BY MANAGEMENT TO THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS FOR THEIR REVIEW AND DISCUSSION. A FULL COPY OF THE FORM WAS PROVIDED TO ALL VOTING MEMBERS PRIOR TO FILING WITH THE IRS. Form 990, Part VI, Section B, line 12c CONFLICT OF INTEREST DISCLOSURES ARE UPDATED ANNUALLY AND POTENTIAL CONFLICTS ARE REVIEWED PRIOR TO PARTICIPATING IN TRANSACTIONS. IF A CONFLICT EXISTS, THE PERSON WITH A CONFLICT DOES NOT VOTE. Form 990, Part VI, Section B, line 15 THE BOARD OF DIRECTORS REVIEWS AND APPROVES THE COMPENSATION OF THE CEO AND HIS DIRECT REPORTS INCLUDING THE CFO. THEY ALSO REVIEW AND APPROVE THE OVERALL ANNUAL ADJUSTMENTS TO COMPENSATION OF OTHER EMPLOYEES. SPECIFIC ADJUSTMENTS FOR OTHER EMPLOYEES ARE HANDLED BY THE CEO AND HEAD OF HUMAN RESOURCES USING COMPARISONS TO SALARY SURVEYS FOR SIMILAR POSITIONS AND EXPERIENCE. THE BOARD OF DIRECTORS APPROVED COMPENSATION FOR THE CEO AND HIS DIRECT REPORTS INCLUDING THE CFO ON 06/07/17. THIS PROCESS WAS DOCUMENTED. Form 990, Part VI, Section C, line 19 MEMBERS OF THE PUBLIC OR INTERESTED PARTIES MAY REQUEST TO REVIEW OR RECIEVE A COPY OF THE GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS BY PHONE OR MAIL. Monolythix Inc 4720 calle carga camarillo CA 93012 464616473 Monolithic structure dvlpm for DNA purify, disease detection, blood analysis NV ALFRED E MANN FOUNDATION FOR SCIENTIFIC RESEARCH C -967789 64203 0.67250 1 Medallion Therapeutics Inc 28575 livingston avenue Valencia CA 91355 464651082 Development and commercialization of medical device (implantable drug pump) DE ALFRED E MANN FOUNDATION FOR SCIENTIFIC RESEARCH C -6157848 6752515 0.97630 1 1 0 0 1 0 0 0 0 0 1 0 0 0 1 1 0 1 0 0 medallion therapeutics inc D 7073683 Loan MEdallion therapeutics inc A 73674 INTEREST INCOME MONOlythix inc D 202361 Loan