Tag: directSTIM™

Company News: Aleva Neurotherapeutics Announces Promising Clinical Data on Directional Deep Brain Stimulation with directSTIM™

– Data Presented at the 2013 Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) –

Tokyo, Japan, May 30, 2013 – Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced interim clinical data of an interventional, intraoperative pilot study of its novel directSTIM™ electrode. Data were presented at the 2013 Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) in Tokyo, Japan, on May 30.

In the ongoing pilot study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using the directSTIM™ lead. It features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions. After assessment, directSTIM™ was removed and replaced by a classical, ring-shaped permanent DBS lead.

The data reported in Tokyo are based on 5 males with Parkinson Disease, which underwent Subthalamic Nucleus (STN) DBS, and 2 males with essential tremor, which underwent Ventral Intermediate Nucleus of the Thalamus (Vim) DBS. Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (TW, defined as the electrical current threshold at which side effects occur minus the current threshold at which a significant therapeutic effect is observed) of directional and classical stimulation. Directional stimulation resulted in an improved therapeutic window in five of six patients (the ratio could not be measured in one of seven patients). No adverse event took place.

“This is a real breakthrough in the field of DBS. At present, DBS is carried out using ring-shaped electrodes,” said Claudio Pollo, MD, Head of Functional Neurosurgery at the University Hospital, Bern, Switzerland and Principal Investigator of the study. “This intraoperative study is the first to investigate the proof-of-concept of directional stimulation in humans. The increased therapeutic window demonstrated in the study suggests that directional stimulation is more selective for beneficial effects while avoiding side effects. Moreover, the observed side effects were consistent with what we expected given the anatomical structures surrounding the stimulated area.”

“We are very pleased with the data, as we have proof-of-concept in an intraoperative setting that directional stimulation is measurable and that it is different from classical stimulation,“ said Jean-Pierre Rosat, CEO of Aleva Neurotherapeutics. “This is very promising as it indicates that the effectiveness of DBS may be improved by our novel electrodes.”

Alain Dransart, Aleva’s Clinical and Regulatory Director, concluded: “We are delighted by the way the study is conducted and by the excellent collaboration with the investigators. The pilot study will be completed by the end of this year and we believe its results will pave the way for a future directSTIMTM chronic study.”

Company News: Aleva Neurotherapeutics Closes EUR 9.5 Million Series A Financing Round

– Novel Products for Deep Brain Stimulation (DBS) to Be Advanced Into the Clinic –

Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced the closing of a Series A financing round totaling EUR 9.5 million. Aleva was founded in 2008 as a spin-off from the Ecole Polytechnique Fédérale de Lausanne (EPFL) Microsystems Laboratory.

The round was funded by a group of seasoned industry specialists and co-led by BioMedInvest AG (managed by BioMedPartners AG, Basel, Switzerland) and BB BIOTECH VENTURES III, L.P. (advised by Bellevue Asset Management AG, Kuesnacht, Switzerland). Initiative Capital Romandie (Lausanne, Switzerland) and renowned private investors also participated in the financing.

The proceeds will be used to support the development of Aleva’s pioneering product pipeline for neurostimulation, which is based on the company’s proprietary microDBS™ technology. microDBS™ is a next-generation technology addressing Deep Brain Stimulation therapy, currently a US$ 450 million market with strong double-digit growth rates.

Aleva’s microDBS™ technology for target-specific stimulation has been developed to significantly reduce the side effects and potential complications as well as the costs of DBS therapy. Moreover, its features allow for expanding the existing DBS market to new indications which cannot be addressed by currently available technologies.

The company is developing three products based on its microDBS™ technology: directSTIM™, an intelligent electrode compatible with existing DBS platforms; spiderSTIM™, a full solution for both intra-surgical and long-term therapeutic use; and the cortiSTIM™ device for cortical stimulation. All products will be compatible with marketed pulse generators. Clinical trials of the lead product, directSTIM™, are scheduled to start later this year.