First U.S. Patient Implanted in Functional Neuromodulation Study of Deep Brain Stimulation for Alzheimer’s Disease

  First U.S. Patient Implanted in Functional Neuromodulation Study of Deep
  Brain Stimulation for Alzheimer’s Disease

              University of Pennsylvania Joins the ADvance Study

Business Wire

TORONTO -- December 06, 2012

The first U.S. patient to enroll in Functional Neuromodulation’s ADvance Study
was successfully implanted with a deep brain stimulation (DBS) system. ADvance
will evaluate the safety and potential clinical benefit of DBS of the fornix
(DBS-f), a major inflow and output pathway in the brain’s memory circuit, for
patients with mild Alzheimer’s.

The ADvance Study is making rapid progress, with six implants conducted to
date. The first U.S. implant was done at Johns Hopkins and five patients have
been implanted at Toronto Western Hospital. The University of Pennsylvania has
joined the study, bringing the total to five leading North American research
centers participating in ADvance.

“In just two years, we have partnered with expert clinical researchers and
assembled a lean team of seasoned professionals that have propelled the
company through funding, regulatory requirements, study initiation and
significant patient enrollment,” said Todd Langevin, President and COO of
Functional Neuromodulation.

“Given the urgent need for progress and the ongoing challenges in drug
research for Alzheimer’s, we are excited to assess a completely new
circuitry-based approach that could offer hope,” commented David Wolk, MD,
Assistant Professor of Neurology and Assistant Director of the Penn Memory
Center. “Pre-clinical testing has suggested that DBS may result in
physiological changes that could alter disease progression. ADvance will help
us to determine whether stimulation of the fornix can drive activity in the
memory circuit to improve memory and lead to better clinical outcomes.”

About ADvance

ADvance is a randomized double-blind controlled trial initially involving 20
people aged 55-80 with mild Alzheimer’s disease. Patients are currently being
recruited to participate in the study at the Banner Alzheimer’s Institute in
Phoenix, AZ, Johns Hopkins Bayview Medical Center, Toronto Western Hospital,
University of Florida Center for Movement Disorders and Neurorestoration and
the University of Pennsylvania. The trial will compare the effects of DBS
turned on to those observed with the system turned off. The patients will
undergo regular physiological, psychological and cognitive assessments for 12
months at which time those patients in the off group will be eligible to have
the system activated. Brain imaging measures of changes in glucose metabolism
and the size of key structures involved in memory will also be assessed at
multiple time points.

ADvance is co-chaired by Andres Lozano, MD, PhD, R.R. Tasker Chair in
Stereotactic and Functional Neurosurgery at the University Health Network and
University of Toronto and Scientific Founder of the company; and Constantine
Lyketsos, MD, MHS, Elizabeth Plank Althouse Professor, Johns Hopkins
University, and Director, Johns Hopkins Memory and Alzheimer's Treatment
Center.

About Deep Brain Stimulation

Deep brain stimulation (DBS) uses a surgically implanted medical device,
similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely
targeted areas of the brain. Medtronic, in collaboration with leading
physicians around the world, pioneered DBS therapy, which was first approved
in Europe in 1995 and in the United States in 1997. The therapy is currently
licensed in Canada and approved in other regions, including the European Union
and the United States, for the treatment of the disabling symptoms of
essential tremor, advanced Parkinson's disease and chronic intractable primary
dystonia, for which approval in the United States is under a Humanitarian
Device Exemption (HDE)^1. In Europe and Canada, DBS therapy is approved for
the treatment of refractory epilepsy. The therapy is also approved for the
treatment of severe, treatment-resistant obsessive-compulsive disorder in the
European Union and in the United States under an HDE^2. More than 100,000
people worldwide have received DBS therapy.

About Functional Neuromodulation, Ltd.

Founded in Toronto, Ontario in 2010, Functional Neuromodulation is dedicated
to advancing the application of deep brain stimulation (DBS) therapies to help
improve the lives of people with Alzheimer’s and other memory and cognitive
disorders. The Company has received funding from Genesys Capital, Foundation
Medical Partners and Medtronic. For more information, visit
www.functionalneuromodulation.com.

^1 Humanitarian Device in the U.S.: The effectiveness of this device for the
treatment of dystonia has not been demonstrated.
^2 Humanitarian Device in the U.S.: The effectiveness of this device for the
treatment of obsessive-compulsive disorder has not been demonstrated.

Contact:

Functional Neuromodulation, Ltd.
Susan Klees, 434-466-8930
Director of Communications
sklees@fxneuromod.com