2022 Neurotech Leaders Forum

Embassy Suites, San Francisco Airport Waterfront and Zoom

November 7-8, 2022

Keynote Speaker

Mudit Jain, Ph.D., Founder and General Partner, Treo Ventures

Mudit is founding General Partner of Treo Ventures, and the CEO and co-founder of NuXcel, a medical device accelerator. Mudit also co-founded and serves as Chairman of the Board of ShiraTronics, Inc., a NuXcel spin off company. Mudit brings more than two decades of medical device industry experience across company formation, R&D, business development, and venture capital, with a global perspective on healthcare based on his experiences in the U.S., Ireland, and India. Mudit has served on the boards of several medical device companies, from early to commercial growth stage, resulting in successful IPOs and M&A transactions. Most recently, as a General Partner with Synergy Life Science Partners, Mudit delivered top quartile performance. In addition to his private venture capital experiences at Treo, and Synergy Life Science Partners, Mudit also brings a strategic investment perspective based on his tenure at Johnson & Johnson Development Corporation. Prior to his investing career, Mudit held operational roles in the Cardiac Rhythm Management Division of Guidant Corporation, and played a key role in developing novel device technologies for heart failure, remote monitoring, and cardiac ablation. Mudit also played an important role in product development for start-ups like Epicor, Inc. (acquired: St. Jude Medical), and Cardiac Pathways Corporation (acquired: Boston Scientific). Mudit holds eight issued patents and has authored several peer reviewed publications. Mudit also serves on the Board of Visitors of the Graduate School at Duke University, External Advisory Board of John Hopkins University Center for Bioengineering Innovation and Design, and on the Board of One Heart Health, a healthcare focused non-profit focused on providing access to pediatric populations in underprivileged geographies. Mudit graduated with a B.E. in Electrical Engineering from REC, Nagpur, India, where he was a gold medal recipient for academic achievements. He received his Ph.D. in Biomedical Engineering from Duke University, and his M.B.A. from the Wharton School, University of Pennsylvania.

Conference Moderators

James Cavuoto, Editor and Publisher, Neurotech Reports

James Cavuoto is editor and publisher of Neurotech Business Report and the founder of Neurotech Reports. He is the lead author of "The Market for Neurotechnology," and "The Market for Bioelectronic Medicine," two market research reports published by Neurotech Reports. Cavuoto was the founder of Micro Publishing Press, Inc., a publishing company that helped pioneer the market for electronic publishing, digital imaging, and computer graphics. He holds a degree in biomedical engineering from Case Western Reserve University, where he studied under pioneers in the field of functional electrical stimulation. He has also studied human factors engineering at University of Southern California in Los Angeles. Cavuoto spent three years as a member of the technical staff at Hughes Aircraft Company in Los Angeles, where he worked on simulation, training, and publication products produced for the U.S. Department of Defense. Cavuoto was an adjunct professor at Rochester Institute of Technology and the author of eight books on computer graphics, electronic publishing, and digital imaging. He is a member of the IEEE Engineering in Medicine and Biology Society. He has authored a chapter in the textbook Neuromodulation (Elsevier, 2009), as well as articles in Neuromodulation, Journal of Neural Engineering, Medical Device Daily, IEEE Spectrum, MX magazine, and the International Journal of Medical Marketing. He is coauthor, with Jennifer French, of Bionic Pioneers: Brave Neurotech Users Blaze the Trail to New Therapies (Neurotech Press, 2014).

Jeremy Koff, Senior Consulting Editor, Neurotech Reports

Mr. Koff is senior consulting editor for Neurotech Reports and president of Colibri Partners Inc., a strategic and marketing consulting firm with a primary focus in the medical device sector. The company offers services related to market and risk analysis, clinical and technology assessments, business plan development, business/financial modeling, and market research. Mr. Koff has nearly 20 years of global experience in the medical device industry with companies including Advanced Bionics Corp., Boston Scientific, MiniMed Inc., Bioness Inc, and many others. His business plans have attracted tens of millions in start-up capital. Mr. Koff holds a Bachelor's degree in biology from Middlebury College, a Masters of Public Affairs from Indiana University, and an MBA from UCLA. He is an active classically-trained musician, supporter of the arts, and is a board member of the Fender Music Foundation.

Jo Jo Platt, Contributing Editor, Neurotech Reports

Jo Jo Platt brings more than 10 years experience as a neurotechnology consulant to Neurotech Reports. As the founder and president of Platt & Associates, she has helped leadership identify new opportunities, transform organizations, and build teams from the ground up. Most recently, she was a strategic development consultant for the Feinstein Institute for Medical Research, where she helped identify and establish strategic partnerships in the emerging field of bioelectronic medicine and was instrumental in the launch of the Center for Bioelectronic Medicine. Previously, Jo Jo communications director for eDigital, where she managed all internal and external communications and built braand recognition through tradeshows and consumer events. Platt holds a bachelor's degree in communication and media studies from National University. She is currently the finance chair for the IEEE Engineering in Medicine and Biology Neural Engineering 2019 meeting.

Jennifer French, Senior Contributing Editor, Neurotech Reports

Jennifer French is senior contributing editor of Neurotech Reports. She is the founder of Neurotech Network, a nonprofit organization that focuses on education and advocacy for neurotechnology end users. Jennifer became a tetraplegic due to a spinal cord injury in 1998 and is an active user of a neuroprosthetic system. She is a silver medalist from the 2012 Paralympic Games and was named the 2012 Rolex Yachtswoman of the Year; the first woman with a disability receive this distinction. She has helped launch successful programs, ventures, and divisions in such organizations as Bombardier Capital, PC Connection, and USMMA Sailing Foundation. Jennifer received her MBA from Wichita State University. She works with for-profit and not-for-profit organizations, large and small, to help them penetrate new markets, profile target customers, and create and build systems to support marketing and sales efforts. She is the author of On My Feet Again (Neurotech Press, 2012), her personal story of rehabilitation using neurotechnology and co-author of Bionic Pioneers: Brave Neurotech Users Blaze the Trail to New Therapies (Neurotech Press, 2014).

Panelists and Presenters

Ariane Tom, Ph.D., Founder & Managing Director, Kaleida Capital

Ariane Tom is Founder and Managing Director of Kaleida Capital, a San-Diego based firm focused on development of early-stage startups. Throughout her academic career at Stanford, Dr. Tom pioneered interdisciplinary research programs with in neural interfaces with applications in brain-mapping, prosthetics, drug delivery, and neuromodulation. She is a published co-author with Karl Deisseroth and Zhenan Bao (h-indexes 171, 194, respectively) in top-tier research journals Science and Nature Portfolio and co-inventor of multiple patents in biomaterials synthesis. As an investor at Anzu Partners, Dr. Tom drove and supported life science investments as a Board Observer across cancer diagnostics, gene therapy, and drug discovery. Prior to venture capital, she was an associate at Schox Patent Group, an SF-based patent law firm specializing in startups, crafting patents and defining IP strategy for clients in the medical device and wearable tech spaces. Dr. Tom holds a B.S. in Materials Science & Engineering, an M.S. in Bioengineering, and a Ph.D. in Bioengineering from Stanford University.

Suraj Mudichintala, Senior Associate, Action Potential Venture Capital

Suraj Mudichintala is a senior associate at Action Potential Venture Capital. He represents the firm on the boards of Axon Therapies and Alpheus Medical as an observer. He was previously an investor at Arboretum Ventures, where he served as a Board observer for Allay Therapeutics, Avation Medical, Francis Medical, Health Scholars, Koya Medical, and RareCyte. Prior to investing, Suraj was an associate with L.E.K. Consulting, a global strategy consulting firm. While at L.E.K., Suraj completed more than 20 engagements predominantly for life sciences and private equity clients.

Amy Kruse, Ph.D., General Partner, Prime Movers Lab

Amy Kruse is a General Partner of Prime Movers Lab where she leads life sciences investments. As a neuroscientist and biologist, she discovers emerging new companies and leads in-depth due diligence into potential investments across areas including neuroscience, human augmentation, synthetic biology, longevity/regeneration and agriculture. She also supports portfolio companies in evaluating and overcoming scientific and implementation challenges, with a specific emphasis on deploying complex technology into real-world environments. She serves on the boards of our portfolio companies, Paradromics, Gilgamesh Pharmaceuticals, and Attune Neurosciences. Amy is formerly the Chief Scientific Officer at Optios, an applied neuroscience company. She built the company’s scientific vision and completed acquisitions that resulted in a robust intellectual property portfolio. Amy also served as the VP and CTO at Cubic Global Defense overseeing innovation and the R&D portfolio across the entire defense enterprise. Early in her career, she served as a government civilian program manager at DARPA where she created and oversaw the Agency’s first performance-oriented neuroscience programs, with a combined budget of over $300M. Amy is Founding Member of the Loomis Innovation Council and a Guest Lecturer for Singularity University. She earned a BS in Cell and Structural Biology and a PhD in Neuroscience from University of Illinois Champaign-Urbana, where she was awarded an NSF Graduate Fellowship.

Nick Langhals, Ph.D., Program Director, Neural Engineering, National Institutes of Health

Nick Langhals serves as program director for neural engineering within the Repair and Plasticity Cluster at the National Institute of Neurological Disorders and Stroke. He is heavily involved in both the BRAIN Initiative as well as the NIH SPARC program. Dr. Langhals received his B.S. in Engineering from Arizona State University. He received both an M.S. in Engineering as well as a Ph.D. in biomedical engineering from the University of Michigan. Dr. Langhals has worked as a senior research engineer within the Center for Neural Communication Technology and also served as a consultant for Neuronexus Technologies, Biotectix, and Michigan State University. He was also a co-founder of Rhythm Solutions, a University of Michigan startup company focused on the development and commercialization of automated algorithms and technologies for the diagnosis and monitoring of atrial fibrillation. Prior to arriving at the NIH in 2015, Dr. Langhals served as a research assistant professor in the plastic surgery section of the department of surgery and assistant research scientist of biomedical engineering at the University of Michigan. Dr. Langhals served as co-director of the Neuromuscular Laboratory, which has developed a regenerative peripheral nerve interface to extract prosthetic control signals and restore lost sensation to amputees for the control of replacement upper and lower extremity prostheses. His previous research activities have spanned: neural engineering, muscle/nerve physiology, regenerative medicine, tissue engineering, muscle and nerve grafts and regeneration, tissue histology/immunohistochemistry, neuroprosthetics, neuromodulation, sensory restoration, cardiac electrophysiology, electrode design/fabrication, advanced materials, electrode modification using conductive polymers, signal processing and noise reduction, neural decoding algorithms, brain-computer interfaces, and drug delivery in the brain.

Lothar Krinke, Ph.D., CEO, Newronika Spa

Dr. Krinke has nearly 20 years neuromodulation experience. As CEO and board member of Newronika, he is responsible for building a high-value closed loop neuromodulation company. Lothar was the CEO of Welcony from 2017 to 2022. He was responsible for integrating Technomed, an intraoperative nerve monitoring company, with Magstim, the company that started the field of transcranial magnetic stimulation. In 2020, he identified and managed the acquisition of EGI, a high-density EEG and transcranial electric stimulation company. Lothar was named Vice President & General Manager of the Medtronic Brain Modulation (DBS) business in May 2011 and held that position until May 2017. In a prior role as Vice President, Research and Business Development at Medtronic Neuromodulation, he was responsible for managing internal and external research programs. Prior to joining Medtronic in 2004 as Senior Director, Bioscience Technology Development, he served as Vice President for Business Development and executive team member of Endogeny Bio Corp., a biotechnology startup company. Krinke completed his postdoctoral as American Cancer Society Fellow at the California Institute of Technology and he holds a Ph.D. in molecular biology from the University at Albany. He is a board member of the Brain Mapping Medical Research Organization at UCLA. He is also an adjunct assistant professor, neuroscience at West Virginia University and the Rockefeller Neuroscience Institute.

Erika Ross, Ph.D., Director, Applied Research and Development, Abbott Neuromodulation

Erika is the director of Applied Research at Abbott Neuromodulation, leading applied research strategy, external partnerships, portfolio, and execution. Applied research includes computational modeling, pre-clinical, feasibility, and clinical safety trials that feed new products and indications within Abbott Neuromodulaiton. Prior to her role at Abbott, Erika was the neuroscience director at Cala Health, a Stanford Biodesign-incubated start-up that has been developing a noninvasive, digitally enabled neuromodulation solution for treating essential tremor. She has held roles of increasing leadership at Cala Health as the company completed development and prepared for commercialization. Prior to Cala Health, Erika held the roles of assistant professor of Neurologic Surgery and deputy director of the Surgical Device Innovation Accelerator at the Mayo Clinic in Rochester, MN. Erika has a bachelor’s degree in biology and a master’s begree in molecular biology from the University of Denver. She holds a Ph.D. in Neuroscience from the Mayo Clinic Graduate School of Biomedical Sciences, located in Rochester, MN. Her Ph.D. thesis was titled “Circuit mechanisms of deep brain stimulation: Preclinical strategies toward improving therapeutic outcome.”

Jacob Robinson, Ph.D., Co-Founder and CEO, Motif Neurotech

Jacob Robinson is Co-founder and CEO at Motif Neurotech, a startup in Houston, TX. He has led a neurotechnology lab at Rice university for nearly 10 years. He helped raise over $36 million in research funding for Rice University, including an $18M DARPA contract to develop nonsurgical brain-computer interfaces.He has also developed magnetoelectric power transfer for bioelectronics.

Marcus Gerhardt, Co-Founder, Blackrock Microsystems

Marcus is an entrepreneur and investment advisor focused on innovation technologies and alternative investment markets. In 1999, Marcus helped set up his first start-up, Mondus, a pioneering ecommerce platform. As Managing Director UK, he oversaw the growth of the company to 145 employees. He coordinated several funding rounds, raising in excess of $170 million, providing shareholders with a 10-fold exit through a trade sale to Seat Pagine Gialle. Subsequently, Marcus co-founded BBI, which advises technology companies on funding, commercialization and growth, strategies. He holds various board and advisory positions at companies such as ComoneaPro. Marcus has an MPhil from Oxford University.

Rob Barnes, Principal Consultant, Amazon Web Services

Rob works with higher education institutions and research computing groups to address risk management, security, and compliance in complex environments at scale through automation. Rob’s focus is in technological and organizational transformation using cloud-based technologies in ways that demonstrate “the art of the possible.”

Anna Wexler, Ph.D., Assistant Professor, Medical Ethics and Health Policy, University of Pennsylvania School of Medicine

Anna Wexler is an assistant professor in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania. She is the principal investigator of the Wexler Lab, where she studies the ethical, legal, and social issues surrounding emerging technology, with a particular focus on neurotechnology, neuroethics, and direct-to-consumer healthcare. Dr. Wexler is the recipient of a 2018 NIH Director's Early Independence Award and a senior fellow at the Leonard Davis Institute for Health Economics. She received her Ph.D. from MIT in the HASTS (History, Anthropology, Science, Technology & Society) Program. Her essays have been published in outlets such as The New York Times, Washington Post, Boston Globe, Slate, and STAT.

Marco Sorani, Ph.D., Executive Director, Development Sciences, Genentech, Inc.

Marco Sorani is a biopharma executive with 30 years of experience in drug and technology development. He is currently an Executive Director and the Chief of Staff in the Development Sciences group in Genentech's research and early development organization. In his role, he manages operations, oversees the implementation of group strategy, and leads numerous business initiatives. In his 15 years at Genentech, Marco has worked across Research, Development and Commercial in San Francisco and Basel, Switzerland. In prior Genentech roles, Marco led a business management team in Personalized Healthcare that supported Real World Data Science operations, including program and alliance management with industry and academic collaborations. Before joining Genentech, Marco was the co-founder of SSB Technologies (now called Level Access), a company that develops software tools that help to make software applications more accessible for people with disabilities. He also worked as an IT manager at Oracle, and as an IT systems consultant at Accenture and Ernst & Young. Marco earned a B.S. in Operations Research from Princeton University and a Ph.D. in Biological & Medical Informatics from UCSF. He is the author of over 30 peer-reviewed publications, and he has been an adjunct assistant professor in the Dept. of Neurosurgery at UCSF and an Instructor in Biopharmaceutical Sciences at UC Berkeley Extension.

Eric Hsu, Partner, Wilson Sonsini Goodrich & Rosati

Eric Hsu is a corporate and securities partner in the life sciences practice at Wilson Sonsini Goodrich & Rosati. He represents emerging growth companies in areas such as medical devices, digital health, and biotechnology. Eric advises public and private companies on general corporate matters, mergers and acquisitions, initial public offerings, public company reporting, strategic partnerships, venture capital financings, and private equity and debt financings. During law school, Eric served as an extern with the UC Davis Technology Transfer Office, Innovation Access, where he performed threshold patent analysis and drafted contracts and licenses. He also assisted service members in the Armed Forces as an extern for the U.S. Air Force Judge Advocate General at Travis Air Force Base, and worked as an extern for Justice Nathan Mihara of the California Court of Appeal for the Sixth District on a wide variety of civil and criminal appeals. Prior to attending law school, Eric worked in flu vaccine research and development for MedImmune Inc.

Victor Pikov, Ph.D., Co-Founder and CEO, Medipace, Inc.

Victor Pikov is a co-founder and CEO of Medipace Inc, a startup developing implantable neuromodulation therapies for auto-immune intestinal diseases. Victor previously worked at Galvani Bioelectronics and GlaxoSmithKline, where he oversaw development and testing of implantable pulse generators and stimulation leads for several clinical applications, including auto-immune and metabolic diseases. At the Huntington Medical Research Institutes, Victor developed neural interfaces for various chronic diseases, such as infertility, bladder paralysis, bladder spasticity/hyperreflexia, hearing and vision loss, tinnitus, obstructive sleep apnea, and obesity. At the California Institute of Technology, Victor developed optogenetic viral vectors for neuronal stimulation. Victor has several patent applications for implantable neural interfaces, closed-loop neuromodulation therapies, and non-invasive glucose measurement.

Chris Hanna, CEO, Pacific Therapy Access

Chris Hanna is the founder and CEO of Pacific Access, a full-service consulting firm specializing in the commercialization of innovative implantable and wearable medical devices. He is also the founder and CEO of CLH Healthcare Academy, a provider of online healthcare education designed to improve the economics of healthcare delivery in the US. Mr. Hanna is a proven leader in the medical device arena with 20 years of experience in Commercial Launch, Health Policy, and Reimbursement. His leadership has helped launch and support therapies in neurostimulation. Mr. Hanna is an Adjunct Professor of U.S. Health Policy at Southern Methodist University. His courses focus on the history and evolution of the US healthcare system within the US Federalist construct, the Constitution, and Supreme Court rulings. He holds an MBA from Southern Methodist University and a Bachelor of Finance from Clemson University. Mr. Hanna was born and raised on Long Island, NY. He currently lives with his wife and family in Dallas, TX.

James Makous, Ph.D., President and CEO, Makous Research LLC

Dr. Makous has worked in the field of neuromodulation for 25+ years. His experience includes CEO of ReStalsis Health, Vice President of Scientific and Clinical Affairs at Nalu Medical, Director of Emerging Indications and Director of Deep Brain Stimulation at Boston Scientific. He has also held high level positions at Nevro, Advanced Bionics, and Senseonics, and he is a named inventor on more than 60 patents and patent applications. Dr. Makous received a B.S. in neuroscience from the University of Rochester and a Ph.D. in Neuroscience from University of Florida.

Richard Foust, CEO, MicroTransponder Inc.

Richard is an entrepreneur and investor with over 20 years of global commercial leadership experience in the healthcare industry. He has expertise in building organizations to successfully execute GTM strategies with medical devices and digital health platforms. Richard previously worked at Abbott, Analyte Health, Honor, Velano Vascular, and 3D Strategy Consulting, where he held roles in engineering, sales, marketing, and general management. He currently resides in San Francisco, CA. Richard holds a B.S. in Applied Physics from Emory University and an MSME in Bioengineering from Georgia Institute of Technology.

Michael Fink

Jeremiah Robison, Founder and CEO, Cionic

Jeremiah Robison is the founder and CEO of CIONIC, an innovative company that builds lightweight and durable bionic clothing driven by powerful algorithms that adapt in real time to each individual's mobility needs. He started the company in 2018 after his daughter was diagnosed with cerebral palsy and he was frustrated at the lack of effective technology available to help improve her mobility. Four years later, CIONIC introduced the breakthrough, FDA-cleared Cionic Neural Sleeve, the first product to combine sensing, analysis and augmentation into a wearable garment. Prior to CIONIC, Jeremiah spent 20 years at the intersection of data, algorithms, and the human body, driving innovation in sensing and machine learning at Apple, Openwave Systems, Slide, and Jawbone. Jeremiah has a BS and MS in Computer Science from Stanford University.

Michael Fink

Andrew Kelly, Director of Applications Engineering, Cirtec Medical

Andrew Kelly is the Director of Applications Engineering at Cirtec Medical - formerly Cactus Semiconductor - located in Chandler, AZ. Prior to joining Cactus Semiconductor, he was a Senior Principal IC Design Engineer at the Medtronic Microelectronics Center. Throughout his 30+ year career, he has defined and designed more than 30 full-custom mixed-signal ICs for a wide range of portable, wearable, implantable, and ingestible medical devices such as glucose meters, hearing aids, cardiac pacemakers, drug infusion devices, neuro-stimulators, bio-sensors, orthopedic sensors, and ingestible sensors. He is a Senior Member of IEEE and serves as Chairman of the Workshop Committee for the Phoenix chapter of the Engineering in Medicine & Biology Society. He also serves as Chairman of the Industry Advisory Board at the Center for Neurotechnology.

Peter Putnam, Regional Manager, Micro Systems Technologies Inc.

Peter Putnam has been involved in the semiconductor and microelectronics industry for over forty years, providing business development services and solutions to medical device companies for almost twenty years. His passion for neuromodulation began while attending a Cleveland Clinic Innovation Summit led by Dr. Ali Rezai many years ago. He was directly involved in the launch of the first commercially available wireless chip for implant medical devices. MST celebrates its 10th year as a sponsor of the Neurotech Leaders Forum in 2022.

Hannah Claridge, Ph.D., Head of Neurotechnology, TTP plc

Hannah Claridge leads the Neurotechnology team at TTP, Europe’s largest independent deep tech consultancy. As a product development physicist with a Ph.D. in neuroscience, Hannah specializes in creating new neurotechnology and other disruptive hardware for healthcare applications. She helps to bring new products to the market by balancing the complexities of technology development with the realities of healthcare businesses. While at TTP Hannah has developed clinical technologies for some of the world’s largest Med Tech companies as well as contributing to the success of ambitious start-ups. Before joining TTP she spent some time as a quantitative analyst at UBS, and was also an intern with GE Healthcare in the medical imaging department. She earned a Master’s degree in physics and a Ph.D. in clinical neurosciences from the University of Oxford.

Ramana Naidu, M.D., Pain Physician and Anesthesiologist, California Orthopedics and Spine

Ramana (Ramo) Naidu is an anesthesiologist and pain physician who is the medical director of pain management at MarinHealth Medical Center and the medical director of Marin Specialty Surgery Center. He helps patients manage, reduce, or eliminate pain and suffering that occurs after medical illness, trauma, or surgery and puts an emphasis on preventing pain from becoming persistent. Naidu is primarily based at California Orthopedics & Spine, serving to help patients with pain before and after surgery. He emphasizes trying to manage pain without relying on opioid medications using a multi-disciplinary approach involving pain psychologists, physical therapists, complementary and integrative approaches. He performs advanced interventional procedures with the goal of sustained relief. Beyond epidural, joint, sympathetic and peripheral nerve injections, Naidu performs radiofrequency ablation of major joints and nerves and minimally-invasive-spine procedures such as indirect and direct lumbar decompression, posterior sacroiliac joint fusion, and intradiscal therapeutics. As a neuromodulator, he is an expert on spinal cord stimulation, dorsal root ganglion stimulation, and peripheral nerve stimulation. Naidu earned a medical degree at the University of Wisconsin School of Medicine and Public Health in Madison where he was born and raised. He completed a residency in anesthesiology at the University of Washington in Seattle, followed by a fellowship in pain management at University of California – San Francisco (UCSF) where he continued to practice for another five years as an assistant professor. He was a Fulbright Scholar in public health in Copenhagen, Denmark, with the World Health Organization Regional Office for Europe.

Devjani Saha, Ph.D., Director, Neurology Regulatory Affairs, MCRA

Dr. Saha is biomedical engineer by training with over 7 years of FDA experience and over 10 years of research experience in medical robotics and prosthetics. She has extensive knowledge of US regulatory processes associated with neurology and physical medicine devices. Her specialty is in the review of medical exoskeletons, brain computer interfaces, physical rehabilitation devices including wearable technology, and early feasibility studies. While at FDA, she contributed to the development of the several policies and guidances, including the leapfrog guidance on brain computer interface, policies for the regulation of wearable devices for physical rehabilitation, and standards supporting exoskeleton testing. Prior to joining MCRA, Dr. Saha worked for seven years at the FDA as a premarket lead reviewer in the Office of Neurology and Physical Medicine Devices and the Office of Cardiovascular Devices. She reviewed hundreds of regulatory submissions, including 510(k)s, PMA, De Novos, IDEs, 513(g)s, Breakthrough Designations, and pre-submissions. Dr. Saha specialized in the review of novel state of the art technologies in the early feasibility stages of review. In addition to these roles, she also served as the Early Feasibility Program representative and as a policy analyst for the Office of Clinical Evidence and Analysis with a focus on the Safer Technologies Program and Real-World Evidence. She also helped to launch the Safer Technologies Program (STeP) and provided programmatic expertise during the review of STeP submissions. Before joining the FDA, Dr. Saha was a researcher in the field of prosthetics and robotic technologies for rehabilitation. She also worked at Mako Surgical where she helped train clinicians and company personnel on the use of a robotic application for orthopedic surgery. Devjani holds a Bachelor of Science in Bioengineering from the University of Pennsylvania and a Master of Science and Ph.D. in Biomedical Engineering from Northwestern University. .

Michael Fink

Entrepreneur Presenters

Byoung Kwan Kim, CEO, gBrain

Byoung Kwan Kim is CEO of gBrain, a graphene-based brain engineering company based in Korea. He has several years experience in pharmaceutical product planning and pipeline analysis in areas such as cardiovascular medicine, oncology, autoimmune disease, and infectious diseases. He was previously with Celltrion Inc., a leading biosimilar company, as director of pharmaceutical quality. He received a Ph.D. in microbiology from the University of Illinois at Urbana-Champaign.

Luca Ravagnon

Luca Ravagnon, Ph.D., CEO, WISE Srl

Dr. Ravagnon co-founded and has been CEO of WISE since 2011. He has long-term experience in basic and applied research in the field of nanotechnology and developed and patented WISE’s proprietary supersonic technology. Since 2019, he has been a member of the management board of the Lombardy’s Life Sciences Cluster and in 2020 he became an Endeavor Entrepreneur. He holds a Ph.D. in Physics and an Executive MBA from SDA Bocconi.

Luca Ravagnon

Ingrid van Welie, Ph.D., Founder and CEO, Neural Dynamics Technologies

Ingrid van Welie, is the founder and CEO of Neural Dynamics Technologies. She is also a research affiliate at the Picower Institute for Learning and Memory at MIT. Ingrid is an experienced neuroscientist, specialized in the study of the biophysical properties of neurons and how these change during learning and memory. She is an expert in various electrophysiological recording technologies and recently, while at MIT, worked on developing new technologies for recording and manipulating the electrical properties of neurons. Ingrid hails from the Netherlands, where she obtained her Ph.D. in neuroscience from the University of Amsterdam.

Richard Hanbury, CEO, Sana Health

Richard Hanbury is the founder of Sana Health, a neuromodulation platform for pain relief and deep relaxation. Richard developed the technology behind Sana to eradicate his own life threatening pain problem follow a spinal chord injury from a Jeep crash near Sana in Yemen in 1992. Richard has an MBA (Healthcare) from the Wharton School, and  DipLaw (College of Law London). He has spent 25 years developing the Sana technology from the original benchtop device to the current device undergoing clinical trials. Sana uses pulsed light and sound, and a heart rate variability feedback loop, to guide the user into a deep state of relaxation. Clinical trials have just been completed in Opioid Use disorder.

Perry Teevens, CEO and Co-Founder, REVAI

Perry Teevens holds more than 20 years of experience in executive management and business development positions in technology companies. Most recently, Perry was the CEO of Dysonics, a University of California Davis spin-out, where he led the company through a successful merger with Google. At Dysonics he led a team of engineers and research scientists developing advanced DSP, HRTF, and AI/ML technology which was licensed to OEMs across several key markets including consumer gaming, enterprise communications, automotive, and AR/VR. Previously he was CEO at Comhear, Inc., a spin-out of the Qualcomm Institute at the University of California San Diego. He served as the Head of Business Development at Skype (acquired by Microsoft), where he was responsible for strategic planning and global business development for Skype-for-Business. Perry serves on boards of directors and is also an advisor to early-stage start-up companies. Mr. Teevens holds a Bachelor of Science Degree in Business Administration from California State University.

Yi-Kai Lo, Ph.D., CEO, Aneuvo

Yi-Kai Lo is an entrepreneur, engineer, and scientist who started his career as an integrated circuit designer and then eventually dived deeply into the interdisciplinary field of neuroscience, neuroengineering, and bioelectronic medicine. His objective was to investigate underlying biological mechanisms and then develop and validate relevant new devices and technologies. In 2016, he co-founded Niche Biomedical, now Aneuvo, a company dedicated to developing bioelectronic treatments for diseases and injuries incurable through pharmaceutical agents. As the co-founder and CEO of the company, he has built a team with complementary skills and domain knowledge in hardware/firmware/software engineering, medical device development, clinical and medical science, and FDA regulatory processes. Yi-Kai is excited to be leading a company that develops cutting-edge medical technologies for patients in need to improve their quality of life.

Colin Kealey, M.D., CEO, NeuroSigma, Inc.

Dr. Kealey is CEO of NeuroSigma Inc. He was previously chief medical officer of NSVascular and also served as director of global medical affairs and corporate projects for NeuroSigma since March 2014. Dr. Kealey joined NeuroSigma in 2011, and previously served as manager of business development. In this role, Dr. Kealey spearheaded the introduction of eTNS to major epilepsy centers throughout the EU and Canada, and interfaced with key opinion leaders in the field to convey the science behind eTNS and how it may fit into their current clinical practice. Dr. Kealey also served as co-principal investigator on two National Institutes of Health grants. In addition, he assisted with the preparation of materials submitted to the FDA, which led to the approval of NeuroSigma's IDE application, and has been a major contributor to the design of a planned pivotal trial of eTNS for epilepsy. Prior to joining NeuroSigma, Dr. Kealey was a resident physician in the UCLA department of surgery from 2007 to 2011. During his time at UCLA, Dr. Kealey was responsible for all aspects of the care of surgical patients, ranging from outpatient procedures to critically ill patients in the intensive care unit. From 2009 to 2011, Dr. Kealey also served as a post-doctoral researcher at the UCLA Center for Advanced Surgical and Interventional Technology, where he performed pre-clinical research and development on novel medical devices. Dr. Kealey earned his B.S. in biochemistry and molecular biology from the University of Wisconsin – Madison and his M.D. from the University of Iowa Carver College of Medicine.

Manfred Franke, Ph.D., Founder, NeuronOff Inc.

Manfred Franke is an entrepreneur with an extensive research background, developing class II and III medical devices to restore and improve organ function using minimally-invasive neuromodulation. Prior to founding NeuronOff, Franke worked at Oculeve (acquired by Allergan) and Boston Scientific neuromodulation, conceiving and developing implantable and topical neuromodulation devices. He is the lead inventor on 90 of 130 patent applications, of which 24 have been granted so far. Franke obtained his Ph.D. from Case Western Reserve University.

Nader Yaghoubi, M.D., Ph.D., President and CEO, PathMaker Neurosystems Inc.

Dr. Yaghoubi has over 20 years of experience in the creation, operations, and financing of life science companies. Before starting PathMaker Neurosystems, he established, as president and Founding CEO, Symbiotix Biotherapies, a pioneering microbiome company developing novel molecular therapeutics based on the human microbiome. Prior to that, he was the first employee at Selecta Biosciences and BIND Therapeutics, where he worked with the founders to launch the companies and establish operations and corporate development. Previously, he was at Zero Stage Capital, a venture capital firm where he was responsible for investing in the life sciences sector, and earlier completed an internship at Advent International. Prior to this, he was a Health Care Entrepreneurship Fellow at Boston University, where he worked with scientists and physicians to develop new businesses in the healthcare and life science sector. Before his fellowship, he was a surgical resident in the Department of Surgery at Lenox Hill Hospital in New York. Dr. Yaghoubi received an M.D. and Ph.D. in Molecular Pharmacology from the combined degree program at Boston University School of Medicine. His doctorate work on the development of high-throughput automated electrophysiological systems resulted in five issued U.S. patents, received one of the University’s highest awards for dissertational research, and was the basis of a venture-backed biotechnology company focused on neuroscience. He is extensively involved in mentoring young companies, and has served/serves as a mentor, advisor and reviewer with MBC’s MassCONNECT program, Mass Life Sciences Center programs, Springboard Venture Capital Forum, and numerous university business plan competitions.

Israel Gasperin, Founder and CEO, Zentrela Inc.

Israel Gasperin is the founder & CEO of Zentrela, a Canadian neurotechnology company that specializes in studying the psychoactive and mood effects of cannabis on the brain. Zentrela’s proprietary neurotechnology platform, called Cognalyzer, uses EEG technology and AI to train models that objectively predict and quantify the cannabis effects consumers experience after trying a product. Zentrela helps licensed cannabis producers reliably study the efficacy of their products to create pleasant and desired effects for their target audiences. Israel founded Zentrela from McMaster University in 2016. From 2018 - 2020, Israel raised ~$1.2 million in non-dilutive funds from the Ontario Brain Institute and the Ontario Centre of Innovation to fully develop Zentrela’s neurotechnology, patent their invention, and scientifically validate it in two peer-reviewed publications. In 2020, Zentrela raised ~$1 million in seed funding from angel investors to start the commercialization phase of the Cognalyzer. Since then, Zentrela’s research service has been helping Canadian and U.S. recreational cannabis manufacturers to boost product sales by objectively proving to consumers the effects their products create,to discontinue/reformulate products that create unpleasant effects, or to internally test new formulations to guarantee their success in the market.

      

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