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Calendar Year 2013 Presentations

Wednesday, January 16, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

Restoring hearing through the teeth — the SoundBite™ Hearing System
Amir Abolfathi and Tim Proulx
Sonitus Medical, Inc.

The SoundBite™ Hearing System is the world's first non-surgical and removable prosthetic hearing solution that relies on bone conduction to imperceptibly transmit sound via the teeth. It is intended to help patients who are essentially deaf in one ear regain spatial hearing ability and rejoin the conversation of life. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device with piezoelectric actuator, custom made to fit around the upper back molars, and a small BTE (behind-the-ear) microphone unit which communicates wirelessly with the ITM. Currently FDA cleared and being marketed for the treatment of single sided deafness and Conductive Hearing Loss, the SoundBite system has intended future indications for hearing disorders such as mixed hearing loss and tinnitus, as well as consumer and covert communications.

Amir Abolfathi founded Sonitus Medical, Inc. in 2006, leveraging 24 years of experience in founding, building, and managing medical device companies. Prior to Sonitus, Amir served for six years as an Officer, Vice President of R&D at Align Technology Inc. (NASDAQ: ALGN), creators of a unique, invisible orthodontic product. Previously, in early 1995, Amir co-founded EndoTex Interventional Systems, developers of minimally invasive solutions for treatment of carotid artery disease, which was also acquired by Boston Scientific in 2006. Amir has also held various management and engineering positions at Pfizer, Guidant, and Baxter-Edwards. As a seasoned entrepreneur, Amir has over 60 issued and pending patent applications, including 11 publications in peer review journals. Amir received his M.S. in Engineering Management from the University of Southern California and a B.S. in Biomedical Engineering from UC San Diego.

Tim Proulx is Vice President of R&D at Sonitus Medical and has been responsible for SoundBite system development and research projects since 2010. Tim has spent most of his career in research and development of diagnostic and therapeutic ultrasound transducers and materials, piezoelectric devices and audio/RF signal processing algorithms. Prior to joining Sonitus in 2009, Tim was Director of Systems Development at Cabochon Aesthetics, Inc. which developed a high power ultrasound ablation system for aesthetics procedures. He has also held engineering and management positions at Siemens Medical Solutions (formerly Acuson) and BCTech, Inc. Tim has 14 issued and pending patents, several technical publications and has presented at IEEE UFFC and IHCON conferences. Tim is a graduate of Duke University (BS BME/EE) and Stanford University (MSEE) and has served on the Duke University BME Undergraduate Advisory Board.

Wednesday, February 18, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

The Use of High-Resolution Infrared Thermography to Analyze Thermal Profiles of RF Cardiac Ablation Catheter Technologies
Leslie Oley

Radiofrequency Ablation (RF) Catheters are often used to treat certain cardiac arrhythmias, like atrial fibrillation, during minimally-invasive cardiac ablation procedures. During these procedures, RF energy is applied to discreet areas in the cardiac tissue to form small scars (or “lesions”), rendering the tissue no longer electrically conductive and eliminating the arrhythmogenic electrical pathway in the heart. The physics behind lesion creation with different RF ablation catheter technologies has not been fully characterized, and is suspected to have an important effect on procedural safety and patient outcomes. This research used High Resolution Infrared (IR) Thermography to characterize the real-time thermal dynamics of several RF Catheter electrode designs in an in vitro model. An IR camera (ThermoVision A20M) acquired real-time thermal images during lesion formation with the catheters. Localized temperatures around the electrodes and at various locations in the myocardial tissue were tracked, analyzed and compared for the different catheter designs. This novel IR Thermography method determined that different RF electrode configurations and cooling mechanisms generated significantly different thermal profiles, and suggested that certain design characteristics may optimize lesion formation and procedural safety.

Leslie's career interests have focused on the integration of engineering and medicine to provide new therapeutic options to patients. She began her career with Boston Scientific in both R&D and Product Management roles, where she conducted ablation biophysics research and had responsibility for several commercial and next-generation Electrophysiology product lines. Most recently, Leslie spent 3 years at Voyage Medical, contributing to the development of a novel intracardiac visualization technology and the execution of a clinical feasibility trial. Leslie is currently a product strategy consultant, working with early-stage medical device companies in clinical areas such as peripheral vascular disease, chronic liver disease, and sleep apnea. Before entering the medtech industry, she spent several years conducting NSF-funded research in cardiovascular mechanics and imaging. Leslie earned a B.S. in Mechanical Engineering from Penn State University, and a M.S. in Mechanical Engineering, with a depth in Biomechanics, from Stanford University.

Wednesday, March 20, 2013, 7:30 PM
Location: Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

Title: Image Processing for Clinical OCT
Speakers: Jonathan Oakley and Daniel Russakoff
Co-founders, Voxeleron

Optical Coherence Tomography (OCT) is an imaging modality capable of generating in vivo, cross sectional images of tissue at sub-micron resolution. Its widespread adoption has been primarily driven by applications in ophthalmology, where structural measurements made on the data are used to support the clinical management and diagnosis of key ocular diseases such as macular degeneration and glaucoma. Such automated measurements are also used as end points in the clinical trials of pharmaceuticals that are being developed in an effort to cure these causes of blindness. The technologies underlying these measurements are image processing algorithms that analyze the volumetric data to extract quantitative metrics of the anatomical change indicative of pathology. This talk will focus on these algorithms, specifically what they are and how they work.
In addition to the core ophthalmic OCT applications, we will review new research in the wider field of neuro-ophthalmology. As an extension of the central nervous system, the retina and its layers have correlates with measurements made using MRI of the brain. Here, new structural measurements being taken from retinal OCT images are starting to be used clinically in the management of multiple sclerosis. While this field is very much in its infancy, the implications are far reaching for other neurodegenerative diseases and the development of neuro-protective agents. We will give an overview of the current state of the art, summarize the significant interest seen in the neuro-ophthalmic space, and again discuss the supporting image processing technologies.

Jonathan Oakley has a B.Sc. in Computer Science from the University of York, England, a Masters from the department of Medical Physics at University College, London, and a Ph.D. in medical image processing from the Swiss Federal Institute of Technology. Since then, he has spent more than a decade working on image processing algorithm development for KLA-Tencor, Fujifilm and, more recently, Carl Zeiss Meditec Inc. While at Zeiss, he worked solely on the development of algorithms for OCT and collaborated widely with academia to generate a number of key OCT-related clinical publications. This is also his current focus at Voxeleron, the company he co-founded in 2010 with Daniel Russakoff.

Daniel Russakoff received an A.B. in Geophysics from Harvard University and his Ph.D. in Computer Science from Stanford. His research interests are in computer vision and pattern recognition in general, and biomedical image analysis in particular. He has authored numerous conference and journal papers and holds several patents on topics ranging from stereo vision to medical image registration. He has worked as a Computer Scientist at the National Institute of Standards and Technology and as Chief Scientist at Fujifilm’s San Jose Research Lab. His more recent work has been using probabilistic shape analysis and machine learning for segmentation of deformable structures in 2D and 3D radiological images.

Wednesday, April 17, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

Magnetic Particle Imaging: A Safe New Angiography Modality
Professor Steven Conolly, UC Berkeley

Magnetic Particle Imaging (MPI) is a new imaging modality that re-uses FDA-approved iron oxide nanoparticle contrast agents in a new imaging scanner (i.e., we do not use an MRI scanner). One crucial physics advantage for MPI is that the iron oxide tracers have 10 million times the magnetization intensity than the nuclear paramagnetism of water observed in routine clinical 7.0 T MRI. Moreover, we receive absolutely no background signal from background tissue and there is absolutely no depth attenuation of the MPI signal. Hence, the MPI method has ideal SNR, penetration, linearity and contrast, and it is completely non-invasive. Moreover, compared to iodine and gadolinium, the iron oxide MPI contrast agents are much safer for patients with Chronic Kidney Disease (CKD). Nearly half of Americans over the age of 70 have CKD. Iodine poses significant risk for renal failure in CKD patients, and gadolinium is contraindicated for CKD patients due to the risk of Nephrogenic Systemic Fibrosis. Fortunately, iron oxide nanoparticle agents have been shown safe for CKD patients. One iron oxide nanoparticle agent (Faraheme) has even been approved as a treatment for anemia in CKD patients. My lab has designed and built all seven MPI scanners in North America, and we have devised a novel fast method of reconstructing the MPI image from the available signal. We have recently demonstrated experimental validation of the theoretical point spread function (PSF) for MPI and have created the world's only 3D Projection Reconstruction MPI scanner. Our 7 T/m 3D scanner is the world's highest spatial resolution MPI scanner. I will share some of our recent imaging studies. We are exploring numerous MPI applications including safe angiography, targeted cancer imaging, quantitative cell therapy tracking, molecular biosensors, and inflammation imaging.

Prof. Conolly holds MS and PhD degrees in Electrical Engineering from Stanford. In 2004, he was named one of "Stanford Outstanding Inventors." In 2005, he joined the Berkeley BioE faculty. From 2006 - 2009, he was Chair of the UCSF/UC Berkeley Joint Graduate Group in Bioengineering. He now serves as Head Graduate Advisor and BioE Vice Chair of Instruction at Berkeley. In 2010, he also joined the EECS faculty at UC Berkeley. He teaches EE C145B "Image Processing and Reconstruction Tomography," BioE 101 "Instrumentation for Biology and Medicine," and BioE 290 "Anti-Medical School," and alternates teaching a grad-level course "Principles of MRI" with EECS Prof. Miki Lustig. His research focuses on novel hardware approaches, often coupled with nanoscale magnetics, to provide diagnostic and monitoring information that can help physicians and patients care for illness. His lab collaborates with cardiologists and radiologists at Stanford, PAMF and UCSF, and with scientists at UC Berkeley.

Wednesday, June 19, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

The Magellan Robotic Catheter System
Frank Macnamara, VP at Hansen Medical Inc.

This talk will focus on the design and performance of the Magellan Robotic System, an intravascular catheter system that received FDA clearance in June 2012. The Magellan System is the successor to the company's Sensei X Robotic System, which has been used on more than 10,000 patients. The talk will begin with an overview of Hansen Medical Inc, a Mountain View company founded in 2002. It will then provide a background on flexible robotics, followed by a detailed presentation of the Magellan Robotic System. After a clinical review of intravascular cases to date, it will offer observations about the future of intravascular robotics.

Francis Macnamara is vice-president of Advanced Technology at Hansen Medical Inc. in Mountain View. Before joining Hansen Medical five years ago, he was with Boston Scientific for the eleven years, serving in various R&D roles, first in Ireland and then in Boston. He has launched eight medical devices ranging from coronary stents and disposable endoscopes to robotic catheter systems. He is the named inventor on five patents. He holds an MBA from Santa Clara University and a degree in mechanical engineering from the University of Limerick in Ireland.

Wednesday, September 18, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

The Supreme Court Weighs in On Gene Patents - and Implications for Software and Business Methods
Jim Fox, Patent Attorney

The recent Supreme Court decisions defining what sorts of things or actions are patentable - and what are not patentable, will be discussed. These decisions were based on biotech and pharmacological inventions, and discussed not only what materials may be patentable, but also discussed requirements for patentable methods. These decisions may affect software and business method patents as well.
The Supreme Court's recent decision in the Myriad Genetics case makes clear that natural products - here, gene sequences - are not patentable. However, man-made products - such as cDNA copies of gene sequences - may be patentable. Similarly, novel, useful methods using natural products may be patentable if the method includes steps that are more than merely routine and well-known.
In addition, the Supreme Court has also recently decided a case invalidating claims that required only a "mental step" - recognizing whether more or less drug should be administered to a patient based on comparing measured drug levels to upper and lower values; importantly, the claim did not require administering any drugs based on that recognition.

Possible implications of these decisions on patents, and intellectual property strategies will be discussed.

Jim Fox is a patent attorney, and has practiced patent law for a dozen years, focussing on the biotechnology and medical device industries. Prior to practicing law, he worked as a Product Line Manager in a scientific instrumentation company (producing hardware and software for electrophysiological and pharmaceutical research); worked as an electrophysiologist at a biotech company developing pharmaceuticals to treat stroke); and did postdoctoral research on retinal physiology after receiving a Ph.D. in Neuroscience from UCLA.

Wednesday, October 16th, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

Update on Artificial Pancreas studies at Stanford
Dr. Bruce Buckingham, MD
Professor of Pediatric Endocrinology, Stanford University

Diabetes is a chronic disease characterized by fluctuations in blood glucose levels. Hypoglycemia can results in seizures, and hyperglycemia can result in long term complications such as visual loss and kidney failure. Current management of juvenile onset (type-1) diabetes generally relies on 4 blood glucose tests each day. These tests often miss hypoglycemia occurring overnight and hyperglycemia occurring in the initial hours following a meal. Real-time continuous glucose monitoring offers the potential to prevent nocturnal hypoglycemia by the use of real-time alarms, by remote continuous monitoring, and by the use of closed-loop systems controlling insulin delivery.

Bruce Buckingham, M.D. is a Professor at Stanford University and Packard Children's Hospital. He received his MD from the University of California at San Diego, and his Pediatric Endocrinology training at the Children's Hospital of Los Angeles. He is a member of the American Diabetes Association. Dr. Buckingham's research interests have focused on continuous glucose monitoring in children and artificial pancreas (closed-loop studies). Dr. Buckingham has been the PI at Stanford on NIH, JDRF and Helmsley foundation grants to develop closed-loop systems.

Wednesday, November 20th, 2013, 7:30 pm
Room M-114, Stanford University Medical School

Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations)

Medical Electronics - Special Design Considerations
Jerry Twomey

Medical electronics devices sit within a complicated regulatory maze that is entirely different from other devices. Many engineers doing their first medical device hit a wall when trying to clear the compliance hurdle. Due to safety driven regulatory issues medical devices require special efforts in mechanics, electronics, and software. This presentation will go over many of the issues that need to be designed in from the start of a new product.
To be discussed:
  • IEC-60601-1 and IEC-61010 Target Devices
  • Patient Isolation Requirements
  • Risk Matrix Compliance
  • EMC Stress Testing and System Functionality
  • Programmable Devices and Software Regulatory Issues
In addition to regulatory requirements, circuits and systems techniques used to meet those requirements will be discussed.

Jerry Twomey has designed multiple medical, consumer, and commercial products. Medical devices include blood glucose monitors, wireless-wearable EEG systems, cranial hypothermia systems, and others. His experience in semiconductors, mixed signal systems, signal processing, and analog front end devices is now being used on medical devices. Jerry holds an MSEE from Worcester Polytechnic Institute, is a Senior Member of the IEEE, and is a contributing editor for Electronic Design Magazine. He can be reached at, and his web site can be found at: Effective Electrons .

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