Entrepreneur with Research Background, developing class II & III medical devices to restore organ function using Neuromodulation.SUMMARYSuccessful in using Neural pathways to increase or decrease Organ Activity with new devices via Neural Stimulation or Selective Nerve Block. Patented these solutions. Proved clinical impact. Former RESPONSIBILITIES• Program Manager Neuromodulation.• Program Manager Mechanisms of Action (MOA).• Former head of Pre-Cinical R&D at Oculeve Inc. for class II and III medical devices.• Primary Scientist for Nasal Implant, Orbital Implant & Nasal Non-Implantable device lines.Ran Clinical Translation of pre-clinical results in 4 US Clinical Studies in 2016. Responsibilities in 2014 - 2016 ranged from Design and Execution to Evaluation in more than 10 Clinical Studies across 5 countries (pilot, FDA-pivotal and commercial/development).RESULTS• Prototyped new class II & III devices and treatment paradigms; provided neural path MoA.• Quadrupled clinical device efficacy and reliability with new stimulation waveforms.• 130+ patent applications, 20 granted patents for neuromod technology: electrodes & stimulators, filters & waveforms (!) for Neuro-Stim and non-destructive Neuro-Block.

Mechanism of Action MoA Studies, 50+patent applications, 10+publicationsRan Clinical Translation of pre-clinical results in US studies. Responsibilities ranged from Design and Execution to Evaluation in more than 10 Clinical Studies across 5 countries (pilot, FDA-pivotal and commercial/development). Functions:• Project lead for 4 Mechanisms of Action studies via neural stimulation driving tear glands.• Scientist work: Study design, protocol write-up; Pre-clinical IACUC and Clinical IRB clearance.• Co-development of FDA pivotal studies, responsibilities for safety and efficacy elements.• Design and execution of new White Space / exploratory clinical Neuromodulation studies.• Scientific Liaison interfacing between Clinical, Marketing, IP and Digital Platform.• Clinical site initiation & MD/OD training, incl. surgical training and support.• IP and support for PR / PublicationsResults• 13 Patent applications & DIV/CIP conversions in 2016, 21 (!) in 2017, 4 in 2018, and 8 in 2019.• 10+ papers / posters / book chapter for publication in 2016 & 2017.• Prototyped new class II & III devices and treatments; provided neural pathway MoA.• Quadrupled clinical device efficacy and reliability with new stimulation waveforms.• Developed alternative indications and Label Expansion for 2018.Patents GRANTED• US 9,737,702 • US 9,764,150 • US 9,687,652 • US 9,737,712 • US 9,440,065 • US appl. 14/920,852 • US appl. 15/676,910 History:Oculeve ==> Allergan:Allergan acquired Oculeve for a $125 million upfront payment and commercialization Milestone payments related to Oculeve's lead development program OD-01. The non-invasive nasal neurostimulation device OD-01 increases tear production in patients with dry eye disease. Oculeve has completed four clinical studies of OD-01 to date in more than 200 patients, showing positive safety and efficacy of the device. The acquisition also includes an additional earlier-stage dry eye device program.

Ran 2 programs, 10+studies, 20+ patent applicationsFunctions:• Preclinical and clinical lead for an implantable device line for the face. • Developed instrumentation, procedures, and IRB cleared protocol. • Led preclinical work from concept to IACUC clearance. Acquired data for IRB submission.• Led scientific research for MOA (mechanisms of action) pre- & clinical validation studies.General:• Clinical R&D work in a Handful of countries for Implantable and Non-implantable devices.• Principal Investigator / Pre-clinical R&D: safety & efficacy studies for Dry Eye.• IACUC and IRB submissions, participation in submissions for CE & FDA clearance.IP: • 56 patent applications filed, 40 of which are first-inventor.• Improved the user experience, device efficacy and safety profiles with patented solutions.• Conceived and drove development of novel implantable devices with leaner safety profile.Patents GRANTED• US 9,440,065• US 9,687,652• US 9,737,712 • US 9,764,150 • US 9,737,702 Patents pending• US 14/920,852• US 15/367,030• US 15/438,577• US 15/584,956• PCT/US2015/42130• PCT/US2015/057023• PCT/US2015/057021• PCT/US2015/057019• CA 2956176 A1 (Canadian Patent Office)• CA 2965363 A1 • CA 2965186 A1 • CA 2965514 A1 • EP 3171928 (A1) (European PO)• AU 2015292278 (A1) (Australian PO)• AU 2015335774 (A1) • AU 2015335776 (A1)• AU 2015335772 (A1)• Nine provisional patent applications filed in 2016, several more in in 2017.

Internship gone wild: 2 projects, 8 pre-clin studies, 42 patent applications. Developed fundamentally new technologies for selective interfacing with specific nerve fibers allowing therapeutic effect with fewer or no side effects from neural stimulation. Concept and experimental design, IACUC work, preclinical acute and chronic implant studies, extensive IP work and device development were conducted to prepare the acquisition of new markets. IP: 36 first-inventor patent applications filed; total of 42.Patents GRANTED• US 9,370,659 • US 9,517,350 (MF added as inventor in June 2017)• EP 3094369 B1 • US 9,974,597 • EP 3094366 B1 • US appl. 14/597,145• EP 15701908 B2• AU 2015206540 B2• AU 2015206541 B2• EU 3077044 B1• US appl. 14/597,137Patents pending• US 14/596,409• US 14/597,112• US 14/597,131• US 14/658,676• PCT/US 2015/011458• PCT/US 2015/011461• PCT/US 2015/011467• PCT/US 2015/011468• PCT/US 2015/011305• PCT/US 2015/020994• 13-0474CN01 (Chinese Patent Office)• 13-0488CN01• 13-0489CN01• 13-0491CN01• AU 2015206540 A1 (Australian Patent Office)• AU 2015206541 A1• EP 3094370 A1• EP 3094372 A1• JP 2017502786 A (Japanese Patent Office)• and moreTopics covered with IP:• Algorithms determining optimal neural stimulation live & based on a patient's bio-potentials• Selective neural stimulation• Directional neural activation and deactivation• Control of various organs and organ systems• Specific Autonomic therapy• Further advanced Nerve Block technologies• Technologies for assessing the interface between technology and biology• Reduction of unwanted side effects using improved neural stimulation paradigms• Applications in the product space of Electroceuticals and ElectRxAll applications and new technologies developed during this internship were independent of PhD work on kHFAC and/or DC nerve block, ensuring separated IP between Case Western & BSC.Details:https://www.researchgate.net/profile/Manfred_Franke/contributions

PhD Excellence Award @ Case School of Medicine SOM. 3 OR years, 2 projects, 37 patent appsNeural Engineering Center (Advisors: Kilgore, Bhadra², Gustafson, and Durand).Primary Objective:Translating Electric Nerve Block from Research to clinical Application. Conducted acute and chronic pre-clinical studies as well as in-vitro work to ensure better understanding and control of electrical parameters and safety margins. Filed various patents covering Electronics and technologies for Nerve Block and selective Neural Interfacing.Projects included • Chronic implementation of Kilohertz / High Frequency Alternating Current (KHFAC) Nerve Block.• Bladder management neuroprosthesis post spinal cord injury. Automated One-button System.• Acute studies of a Safe, Non-damaging direct-current (DC) nerve block.• Charge-balanced Direct Current (CBDC) and Multi-Phased DC nerve block.• Electrode enhancement and stimulator development (KHFAC and DC).• Onset-free KHFAC and combined AC/DC nerve block.Comprehensive 3-year surgical training allowed various acute and chronic preclinical studies. Sterile chronic surgeries performed in PNS and CNS to implant electronics; human grade protocol level. IACUC protocol work within the university and the Department of Veteran's Affairs (VA).Concentration at the end of the PhD on compiling a portfolio of intellectual property (IP) to aid in the translation of the new technologies from bench to bedside.IP: 26 patent applications filed in total, 9 of which are first-inventor.Some IP:• US 9,119,966• US 9,205,265• US 9,333,356• US 9,387,322• US 9,694,181 • US 9,889,291 • US 10,071,241 • AU 2013274091 B2• AU2017202381 B2• US appl. 15/344,959• US 15/178,633 • US 14/266,027 • US 14/707,541• US 14/969,826• PCT/US2013/045859• AU 2013274091• CA 2876297 A1• EP 2861296 A1 • JP 2015517451Thesis:https://www.researchgate.net/publication/267328309_Translating_Electric_KHFAC_and_DC_Nerve_Block_from_Research_to_Application

Development of testing equipment for electrodes intended for neural interfacing.

Development of a universal, current controlled, arbitrary waveform Neuro-Stimulator. Compliance with DIN EN 60601 (MPG). Long-term testing of High-Q surface-optimized Pt black micro electrodes.

Member of the VDE Youngnet executive board, national level: Lead for Public Relations and Marketing. The VDE is the German equivalent of the IEEE. The VDE Youngnet is the sub-organization of all young members (EE / IT / MST students in college, university, and up to 5 years post PhD) within the VDE.

The VDE Hochschulgruppe (HSG) Freiburg was founded to establish a regional office of the VDE Youngnet in the area of south Baden-Würtemberg (Südbaden). It is now the leading HSG in the area. The VDE is the German equivalent of IEEE.

IAESTE-Day Founder & 1st Coordinator of the first world-wide IAESTE Day in 2005 (www.iaeste-day.com).Positions on International, National (board member) and Local level (LC president).