Dr. Fischell received his BSME degree from Duke University and MS and Sc.D. degrees from the University of Maryland. Dr. Fischell was employed at the Johns Hopkins University where he was the Chief Engineer of the Space Department and worked on more than 50 spacecraft. His interests at Johns Hopkins then turned to the invention of new medical devices such as pacemakers and implantable heart defibrillators. Starting in 1969, Dr. Fischell began the formation of 14 private companies that licensed his patents on medical devices. These companies include Pacesetter Systems, Inc. (now called St. Jude Medical), IsoStent, Inc., NeuroPace, Inc., Neuralieve, Inc., Angel Medical Systems, Inc, and Svelte Medical Systems, Inc. Dr. Fischell is a prolific inventor with over 200 issued U.S. and foreign patents, many of which have been the basis for new medical device companies. Continue reading
Dr. David R. Fischell is a serial entrepreneur who has founded nine biomedical device companies in the last fifteen years. He is chairman of the Cornell University Biomedical Engineering Advisory Board, and a Fellow of the American Institute for Medical and Biological Engineering.
After earning his Ph.D. in Applied Physics from Cornell University, Dr. Fischell joined Bell Laboratories in 1979 where, for 11 years, he performed and directed a wide range of research and development projects. He left Bell Labs in 1991 to work full time on medical devices. He currently holds 85 issued U.S. patents, and has published numerous papers in the fields of telecommunications, cardiology, radiobiology, and radiation dosimetry. Continue reading
NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy.
Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus. Continue reading
Cyberonics was founded in Houston, TX in 1987 to develop an implantable device for the treatment of epilepsy. In July 1997, The FDA approved the VNS Therapy System (formerly known as the NCP® NeuroCybernetic Prosthesis System) as an adjunctive epilepsy treatment for adults and children over 12 years of age with partial onset seizures refractory to drugs.
Cyberonics currently markets the VNS Pulse and VNS Demipulse IPGs, which offer approximately 6 years of longevity at nominal stimulation settings (2 mA, 20 Hz, 500 msec, 10% duty cycle into a 4 kOhm load).
Respicardia, Inc. (formerly Cardiac Concepts, Inc.) is a privately held medical device company incorporated in 2006. It is located in Minneapolis, Minnesota, USA. It is developing an implantable system intended to improve the outcomes for Heart Failure patients by developing an implantable stimulation therapy to treat Central Sleep Apnea.
The remedē System is an implantable medical device that is being investigated in a clinical research study for the treatment of Central Sleep Apnea in patients with Heart Failure. It consists of three implantable components:
- remedē Pulse Generator comprised of electronic circuitry components and a battery, which are hermetically sealed in a titanium case
- remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves
- a sensing lead to detect respiration Continue reading
The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. The system is comprised of a surgically‐placed multi‐contact electrode specifically designed for the Hypoglossal nerve, and a lead that connects the electrode to a programmable implantable pulse generator (IPG) that is placed in the anterior chest wall. The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep. Continue reading
MedicalApnex Medical, Inc. is located in St. Paul, MN. It was founded in 2006 and has developed the Hypoglossal Nerve Stimulation System (HGNS® System) for the treatment of obstructive sleep apnea (OSA). The HGNS System has been evaluated in feasibility studies and is now being assessed in an Investigational Device Exemption (IDE) Study (Apnex®Clinical Study).
The Apnex HGNS System is an implantable therapy that is intended to work by activating the muscles in the upper airway to ensure that the airway remains open during sleep. During sleep, the system detects the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the muscles of the tongue, to keep the airway open. The stimulation is timed to a patient’s own breathing pattern. The HGNS System is programmed to work only when the patient is asleep, or it can be turned on and off as needed through a handheld controller. Continue reading
Inspire Medical Systems, based in Minneapolis, Minnesota, develops implantable neurostimulation systems to treat Obstructive Sleep Apnea (OSA). Inspire Medical Systems was formed when the Inspire intellectual property and technology was licensed and spun out from Medtronic in 2007.
Inspire therapy is designed to deliver physiologically-timed, mild stimulation to the hypoglossal nerve on each breathing cycle to prevent airway obstruction during sleep.
Angel Medical was founded by Dr. Robert E. Fischell and Dr. David R. Fischell. The AngelMed Guardian® system is an implantable cardiac device, designed to detect rapid ST segment shifts that may signify major cardiac events, such as coronary artery occlusions caused by life-threatening vulnerable plaque ruptures. Once an ST shift is detected, the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings. The AngelMed Guardian system is intended to address the challenge of patients not recognizing nor responding quickly to heart attacks. Continue reading
Brainsgate‘s implantable pulse generator is designed to stimulate the Spheno-Palatine Ganglion. It is activated by an external transcutaneous energy transmitter. Brainsgate is evaluating the system’s capability to augment cerebral blood flow as a treatment of ischemic stroke or dementia. Continue reading
Yossi Gross (born February 5, 1947) is an Israeli medical device innovator and entrepreneur. His medical-device companies are incubated through Rainbow Medical.
Currently, the following companies led by Yossi Gross are focusing on active implantable medical devices:
- BetaStim, developing a new neurostimulation treatment for diabetes
- Brainsgate, developing an implantable device for acute stroke treatment and brain drug-delivery technology
- BioControl Medical, developing neurostimulation devices
- Enopace Biomedical, developing implantable devices for heart failure treatment through stimulation of the aorta
- CerebralRx, a spin-off from Biocontrol developing vagus nerve stimulators for the treatment of epilepsy
Dr. Shlomo Ben-Haim has held faculty appointments as a Professor of Medicine, Physiology and Biophysics, at both Harvard University and the Technion – Israel Institute of Technology. His formal education is in the fields of nuclear physics, mathematics, biomedical engineering, philosophy, and medicine. Dr. Ben-Haim has published his research in over 100 scientific papers, in peer-reviewed journals. He holds over 180 patents and patent applications.
Currently, two companies led by Dr. Ben-Haim are focusing on active implantable medical devices:
Mir A. Imran (born 1956, Hyderabad, India), is an Indian entrepreneur and venture capitalist. Imran has formed 19 companies since the early 80s and holds over 140 patents. He is the founder and Chairman of InCube Laboratories, Inc., a research laboratory and business incubator for medical and technology companies
Currently, four InCube companies are focusing on active implantable medical devices:
- Intrapace, which is developing an implantable device to treat obesity
- Spinal Modulation, which is developing a novel therapy for the management of chronic pain with an implantable microstimulator
- Neurolink, which is developing a novel therapy for epilepsy
- Corhythm, which is focused on the treatment of AFIB
Spinal Modulation is a company based in Menlo Park, CA. It has developed a neurostimulator for chronic intractable pain management.
According to the company, the Spinal Modulation System utilizes low-level electrical signals to modulate neural structures of primary sensory neurons located within the dorsal root ganglion (DRG). These cell bodies have been implicated in the development and maintenance of chronic pain conditions. Continue reading
Morgan Technical Ceramics (MTC) announced that its Bedford, Ohio site manufactures the piezoelectric ceramic materials used in EBR Systems, Inc.’s innovative new WiCS® Wireless Cardiac Stimulation System. The PZT (lead zirconate titanate) material made by MTC is critical to the efficiency of the WiCS system, which is powered by a battery with a 10-year lifespan.
The WiCS technology, which recently began clinical trials, is the first truly wireless pacing device. It was developed to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. Continue reading