Aleva Neurotherapeutics
Blazing the Innovation Trail in Neurostimulation Technology

Parkinson’s disease (PD) is the most common neurodegenerative disease in the world, second only to Alzheimer’s. – CDC

Every year, approximately 60,000 Americans are diagnosed with Parkinson’s Disease (PD). And by the end of this year, nearly one million people will be living with PD. Although several treatments exist, they do not bear promising results. For instance, Levodopa is the most effective symptomatic treatment for PD today, and it is widely leveraged all across the world to control the progression of the disease. However, a prolonged therapy using the Levodopa drug can lead to several health deteriorations, including motor symptoms (freezing episodes, speech impairments), non-motor symptoms (mood and cognitive impairment), and other drug-related side effects (psychosis, dyskinesias, and motor fluctuations). But no longer, as Aleva Neurotherapeutics—developer of next-generation directional deep brain stimulation systems—is providing patients with a better alternative that not only improves the outcomes for patients suffering from PD but also reduces the side effects that accompany traditional treatments.

The directSTIMTM Directional Deep Brain Stimulation System is a high-resolution neurostimulation platform developed by Aleva Neurotherapeutics that is transforming the treatment of Parkinson’s and other neurogenerative diseases. “Our game-changing platform offers a more efficacious approach for treating PD as it can ensure effective therapies with high precision,” says Andre Mercanzini, Ph.D., co-founder and CEO of Aleva Neurotherapeutics, based in Switzerland. Since the platform ensures significantly higher stimulation success by only stimulating the brain areas that need to be treated, and avoiding all other areas, PD patients can greatly reduce their dependence on near-toxic drug therapies like Levodopa.

The Beginnings of a Revolutionary Neurostimulation Therapy

Aleva’s neurostimulation solution can be traced back to the Swiss Federal Institute of Technology (EPF Lausanne), one of the leading engineering schools in Europe. As a Ph.D. fellow, Mercanzini began the neurostimulation innovation journey under the mentorship of Professor Phillippe Renaud— famed as the professor with 13 healthcare startups—and in direct collaboration with Dr. Claudio Pollo, a Functional Neurosurgeon at the Bern University Hospital.

“During our research, we developed a unique design of implantable electrodes using microelectromechanical systems (MEMS) technology, which was not possible before,” says Mercanzini.

Mercanzini, Renaud, and Pollo, adopted this technology (commonly used to develop microchips in the electronics sector) and applied it to the fabrication of innovative microdevices (neural implants) for medical applications. Their exploration of the semiconductor industry’s unique design manufacturing capabilities marked a new page in the development of neurostimulation devices. In 2008, Mercanzini and his co-founders—backed by EPF Lausanne—converted their research on neural implants into the foundation of Aleva Neurotherapeutics. Since then, the company has grown from its initial focus on deep brain stimulation (DBS) and epilepsy surgeries into the broader spectrum of neurostimulation therapies.

Our platform offers a more efficacious approach for treating PD as it can ensure effective therapies with high selectivity

The Mechanisms behind Aleva’s Best-in- Class Technology

Aleva’s neurostimulation solution, directSTIMTM DBS System, uses an implantable pulse generator (IPG)—a battery-powered microelectronic device to generate electric pulses that stimulates the brain. The directSTIM IPG is a step up from the existing IPG devices currently used in the medical space. Instead of constant voltage (CV), Aleva’s IPG employs the far more effective constant current (CC) for neurostimulation, which reduces post-surgical visits and facilitates the clinician’s programming and parameter setting of the PD patients.

Notably, the 24-channel functionality of the directSTIMTM DBS System—with 12 electrodes in each hemisphere of the brain—offers a clear advantage over the traditional neurostimulation solutions, which use only four or eight channels. The electrodes are directional, meaning that the electric field can be precisely pointed into any one of three directions from the implant, and this is possible on four different levels. Since the multiple channels utilized in Aleva’s solution have dedicated current flow, the directional electrodes can be controlled independently, which opens the door to more accurate therapy in PD patients with multiple symptoms.

To make the entire process seamless for both patients and neurologists, Aleva also offers a tablet programmer for the Neurologist, which can be used to configure the IPG and tailor the simulation parameters as per the patient’s response and symptoms. The patients are also given a separate device with which they can control the stimulation parameters according to the configuration of the Neurologists.

Riding the Wave of Innovation in Neuromodulation

“The directional stimulation employed by our system has shown momentous improvement over the classical stimulation methods,” says Mercanzini. In fact, Aleva’s conducted proof of principle study demonstrates a phenomenal 42 percent increase in the therapeutic window, leading to greater benefits and better outcomes for PD patients, with significantly lesser side effects, in an acute setting. The results were published in Brain—the most prestigious neurological journal—in 2014.

Such positive results are encouraging neurosurgeons and neurologists around the world to seek out Aleva and leverage its technology. The clients are guided by Aleva, both when purchasing and utilizing the solution. To help neurosurgeons and neurologists familiarize themselves with the solution, Aleva provides an array of training materials for clinicians on its website, where they can explore the various features of its neurostimulation devices. Additionally, Aleva also conducts onsite training before surgical procedures so that neurosurgeons and neurologists can seamlessly leverage the device to facilitate enhanced patient outcomes.

Empowered by these successes, Aleva is quickly growing its client base across Germany and among several other countries in Europe. The next stride for the company is getting the approval of the FDA and expanding through the U.S. market. Hence, by the second quarter of 2021, Aleva will be all set to initiate its clinical study in the U.S. In parallel, Aleva is working to develop next-generation surgical methods for the treatment of various other neurogenerative diseases, such as epilepsy. “We will continue augmenting our R&D to develop new technologies that aim at improving the care of patients suffering from neurodegenerative diseases,” concludes Mercanzini.