History: The Foundation and its scientists have a track record of bringing innovative technical solutions to improve the life of persons suffering from debilitating medical impairments.

In 1968, Al Mann made a donation to the Johns Hopkins University Applied Physics Laboratory to further the development of a long-lasting small cardiac pacemaker. The best technology of the time was a device that weighed nearly a pound, was an inch thick, causing a large bulge on the chest, and needed to be surgically replaced every twelve to eighteen months. Mr. Mann knew that miniaturizing the pacemaker and putting in a rechargeable battery would better serve the patients who needed these devices to survive.

Al Mann also knew that while many great research developments from universities are published in scientific literature, rarely are they developed into products from which the public can benefit. To ensure that this new pacemaker would make it to the market, Mr. Mann obtained the manufacturing rights and began the quest to develop the device. In 1969, Mann engaged Joe Schulman, Ph.D., to take the technology from the Applied Physics Lab and set up a production line to manufacture commercial quantities of the pacemaker, as well as to help develop new products. In 1973, four years and two major design changes later, the first commercial rechargeable cardiac pacemaker was implanted, and Pacesetter Systems Inc. was born. The device Pacesetter manufactured was the first pacemaker with two-way telemetry, which enabled a clinician to interrogate and review all the important electrical characteristics prior to programming. The device was also the first to use a rechargeable, long-life battery. These innovations and others developed by Pacesetter set a standard in the industry that other companies soon followed. Pacesetter was sold to the Siemens Corp in 1985.

From the Pacesetter experience, Al Mann recognized the high cost of developing medical technologies for the specific purpose of bringing innovative new products to the public. In 1985 he established a non-profit corporation, the Alfred E. Mann Foundation for Scientific Research (AMF™), with Joe Schulman at the helm and a mandate to develop medical technologies that might not be economically feasible for a for-profit Corporation.

AMF immediately undertook the development of a long-term implantable glucose sensor. This sensor was to be part of a closed-loop system, along with an insulin pump, that could be used as an artificial pancreas for diabetic patients. According to the National Diabetes Education Program, 5-10% of the 20.8 million Americans who are diabetic have Type 1 diabetes, the insulin-dependent form of the disease. Most of these patients must tolerate frequent insulin injections. Even patients who use an insulin pump must still test their blood sugar levels several times a day, usually with painful finger sticks. The addition of an implantable glucose sensor would eliminate these inconveniences and provide an alternative treatment that could be easier for these patients to manage. The glucose sensor work that AMF began continues with Medical Research Group, which was sold to Medtronic, Inc. in 2001.

In 1986, AMF took on the development of an implantable high-speed cochlear implant with two-way telemetry to restore more normal hearing to patients with severe to profound hearing loss. Cochlear implants of the day only interpreted sound up to 1500 Hz. Since normal telephones transfer speech up to 3500 Hz, normal telephone use was difficult for implant recipients. Music frequencies range from 20 Hz to 20,000 Hz; so much of the sound of music was also unavailable to these patients. AMF's innovations to the cochlear implant allowed, for the first time, frequencies up to 7000Hz to be interpreted, vastly enriching patients€™ ability to understand speech, use the telephone, and listen to music. This technology, named the Clarion Cochlear Implant, was licensed in 1993 to Advanced Bionics Corporation (now a Boston Scientific Company), for manufacture and distribution. Since 1996, when FDA clearance to implant the Clarion was obtained, thousands of patients have been implanted with this cochlear implant. AMF's advanced technology also forced the other companies in the field to improve their devices in order to compete, and thus even patients implanted with other cochlear implants today benefit from AMF's innovations.

Today, AMF is focusing on implantable neurostimulator systems that could potentially be used to improve the lives and health of patients with a variety of conditions and ailments, from stroke and spinal cord injuries to migraines, epilepsy and obesity. Electrical stimulation to reanimate muscles that have been paralyzed has long been a source of hope for patients who suffer from a variety of neurological problems. However, the technology currently available to patients has many limitations: external stimulation systems are difficult to put on and can only access muscles close to the surface of the skin; implantable systems designed to stimulate more than one muscle require individual electrodes to be tethered to a central electrode pulse generator, requiring invasive surgeries. A system that consists of a network of small microstimulator implants that can be placed at the site where stimulation is required via a needle injection and can communicate wirelessly with a central processing unit can resolve many of the problems and inconveniences of these older systems, and AMF was up to the challenge of developing it.

Since beginning the project in 1989, AMF has been through many iterations of the microstimulator device. AMF is currently using one version of the microstimulator in a clinical trial in the United Kingdom to rehabilitate arm movement in patients who are hemiplegic as a result of a stroke. The microstimulator technology has been licensed to Advanced Bionics Corporation, which developed a battery-powered version of the device, named the BION®, which has been used in clinical trials to treat urinary urge incontinence and migraine headaches. The BION® device was the first to incorporate Quallion LLC's miniature battery technology. These miniature batteries are also being used in a new microstimulator now in development at AMF that will contain sensors and high-speed telemetry. These features will allow the implants not only to stimulate but also to detect movement and communicate to a central processing unit which can, in turn, use the sensor information to adjust the timing and level of stimulation to hundreds of individual implants. The number of uses for such a flexible system is limited only by the imagination. Fortunately, imagination is a quality not lacking at AMF.