ITGR Integer Holdings Corporation

Aleva Neurotherapeutics, a leading company developing next-generation implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor, today announced a strategic development, supply, and manufacturing relationship with Greatbatch Ltd., a subsidiary of Greatbatch, Inc. (NYSE:GB). In addition, Greatbatch will invest in Aleva Neurotherapeutics’ current Series C financing round.

Under terms of the development agreement, Greatbatch’s design and development team QiG Group, which is expected to be spun-off as Nuvectra Corporation, will provide Aleva with access to its unique implantable neurostimulation platform. Specifically, Aleva will receive a license to utilize Nuvectra’s platform in the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary microDBS™ technology platform, which includes cutting-edge directSTIM™ electrode technology for directional deep brain stimulation, into a complete system with Nuvectra’s proprietary 24-channel neurostimulator and paradigm-shifting programmers. The complete system is aimed to provide patients and doctors with an unparalleled, next-generation DBS solution resulting in increased efficacy and improved therapy control that may lead to improved outcomes for patients with Parkinson’s disease and essential tremor.

Nuvectra will also continue work with Aleva’s engineering team on the development of next-generation DBS technologies. In addition, Greatbatch will enter into an exclusive manufacturing and supply agreement for certain devices of the system.

“As a result of our partnership with Greatbatch and Nuvectra, we will significantly reduce our time-to-market and enhance our ability to deliver our novel Directional DBS therapy to patients in need,” said Andre Mercanzini, Chief Technology Officer and Founder of Aleva. “We are delighted to be working with some of the very best people in the neuromodulation business to commercialize our work.”

“We’re excited to be partnering with true pioneers in the field of DBS," said Scott Drees, CEO of Nuvectra. “Aleva’s approach of building next-generation DBS therapies for this highly underserved market aligns perfectly with our plans to establish Nuvectra as an innovative player in the neuromodulation marketplace. We believe the Aleva partnership validates our strategy of developing platform technology that can be leveraged across multiple neurostimulation indications.”

Aleva is currently raising a Series C financing round, which will be led by Greatbatch. Existing investors BioMedPartners, BB Biotech Ventures, Banexi Ventures and Initiative Capital Romandie are also participating in the round. The proceeds will be dedicated to obtaining the CE mark for its proprietary directSTIM™ Directional Deep Brain Stimulation System and the completion of a chronic study in 60 Parkinson’s disease patients. The successful results of Aleva’s pilot study were published in BRAIN in 2014.

In October 2015, Greatbatch, Inc. completed its acquisition of Lake Region Medical, with the combined company expected to be renamed Integer Holdings Corporation later this year (subject to shareholder approval).

About Aleva NeurotherapeuticsAleva Neurotherapeutics develops next-generation neurostimulation technologies and devices for Deep Brain Stimulation (DBS) therapy. Its solutions are designed to be more precise and more efficient than currently available DBS approaches while causing fewer side effects. Based on its proprietary microDBS™ technology, Aleva has developed two novel brain stimulating products with different properties. The first, called directSTIM™, is a complete Directional Deep Brain Stimulation System for long-term therapy in Parkinson’s Disease and Essential Tremor; the second, called spiderSTIM™, is a full solution for intra-surgical placement of DBS electrodes.  

The company is a spin-off from the Ecole Polytechnique Fédérale de Lausanne (EPFL) Microsystems Laboratory of Prof. Philippe Renaud. Aleva Neurotherapeutics has raised EUR 22 million from renowned private and institutional investors, among them BioMedPartners, BB Biotech Ventures LP, Banexi Ventures Partners, Initiative Capital Romandie and selected private investors.

About Greatbatch, Inc.Greatbatch, Inc. (NYSE:GB) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and portable medical markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at www.greatbatch.com.

About QiG Group/NuvectraQiG Group, LLC is a Greatbatch subsidiary initially focused on the development and commercialization of a neurostimulation technology platform for the treatment of a variety of neurological disorders. The Algovita Spinal Cord Stimulation System is the company’s first implantable medical device. Algovita is approved in the United States and Europe for the treatment of chronic pain of the trunk and limbs. QiG Group is currently in the process of being spun-off from Greatbatch under the name of Nuvectra Corporation. The spin-off is expected to be complete in Q1, 2016.

About Deep Brain StimulationDeep brain stimulation (DBS) is approved worldwide for the treatment of Parkinson’s disease (PD), essential tremor, dystonia, obsessive-compulsive disorder (OCD) and epilepsy. It is also under investigation for the treatment of a number of other conditions, including major depression. DBS is a therapy that relies on the delivery of mild electrical pulses to specific areas in the brain via an implanted lead connected to a battery-powered pulse generator placed in the patient’s upper chest area. A physician is able to vary and control the stimulation delivered through the lead to the brain using an external, hand-held programmer. At present, DBS systems use leads with electrodes that send out electrical current in all directions, which can result in unwanted side effects.

Contact:

Aleva Neurotherapeutics
André Mercanzini
Founder and CTO
andre.mercanzini@aleva-neuro.com

Media Inquiries:

akampion
Dr. Ludger Wess / Ines-Regina Buth
Tel. +49 40 88165964 / +49 30 2363 2768
info@akampion.com

Greatbatch, Inc.
Christopher Knospe
Senior Director, Global Communications & Corporate Affairs
Tel. +1 716-759-5727
cknospe@greatbatch.com