EBS Technologies | Overview

Innovative Therapy Method Can Improve Vision in the Case of Neurologically-Based Scotoma

Thus far, experts have assumed that a person's vision cannot be restored once it has been lost. Intensive research on the human brain, however, has shown that visual impairments are caused not only by defects of the eye itself, but also by neurological damage within the visual system. For instance, strokes frequently damage neural networks. These networks are essential to signal transmission from the eyes to the visual processing center of the brain. As a result, damage to these networks may cause visual field loss (see animation), which could be treated only to a very limited extent so far. The EBS NEXT WAVE™ system has the potential to repair these damaged neural networks in order to partly restore a patient's vision in many cases.

In 2014, the company generated approximately EUR 100,000 in revenue for the first time and is now very well prepared for a full-scale market entry: The EBS NEXT WAVE™ system has convinced more and more medical experts since its CE certification in 2013, and the first patients successfully completed their therapy programs last summer using the non-invasive and low-risk method (most of them in the context of trials).

Milestones Reached

For the fast-growing global medical technology market, the German company EBS Technologies has developed NEXT WAVE™, a unique therapy method that has been patented in the EU and in the U.S. and whose effectiveness has been proven for neurologically-based visual impairments, for instance those caused by glaucoma, eye infarcts, strokes, or traumatic brain injuries. EBS Technologies addresses 375,000 potential patients in Germany, 2.3 millions in Europe, and 1.5 million in the U.S.; because of increasing average ages and stress levels, this number is currently increasing and will most likely keep doing so in a significant fashion in the future. People affected by visual field loss often experience major changes to their life, e.g., the loss of their independence in everyday life.

Our therapy method is highly innovative and can directly treat the effects of such visual impairments in many cases. Neurons caused to be inoperative by the damage may often be reactivated through the NEXT WAVE™ stimulation technology, and new neural networks may be established within the brain.

Clinical trials have confirmed that the EBS NEXT WAVE™ therapy method is effective, and the method has already been CE certified in Germany and Europe. Furthermore, the system has already been used to treat more than 1,100 patients, most of them in the context of clinical studies, and it has been used commercially since early 2014.

Previous Investments in EBS

To date, EBS Technologies has been able to acquire total investments of 8 million euros from the High Tech Gründerfonds (high-tech start-up fund), the ILB (investment bank of the state of Brandenburg), and Earlybird (one of the most renowned German venture capital companies). As commercial use of the technology started in 2014, the existing investors intend to finance EBS Technologies until it reaches breakeven point in mid-2016.

The last contribution of capital was made in Q4 2014, when the company received € 1m. For instance, we received investments worth EUR 1m in Q4 2014. Companists may now invest in EBS at the same valuation. Additional capital raised through Companisto will be used to speed up company value development. 

 The EBS NEXT WAVE™-System

When the optic nerve had been damaged by a stroke, a traumatic brain injury, or certain ophthalmic (eye-related) diseases, there used to be very few therapy options. In fact, for a long time, the scientific consensus was that malfunctions of this central visual organ are irreversible. However, as is known today, certain types of vision loss and limitations of the visual field are due not to dying neurons, but to cell inactivity and a lack of cell synchronization within the brain areas relevant to visual perception. This is precisely where our new method comes into play: Through the EBS NEXT WAVE™ system, neurons can be synchronized by means of alternating current pulses and thus be stimulated to resume normal operation in many cases.

The EBS NEXT WAVE™ technology is intended to reactivate surviving but inactive neurons and to integrate these neurons into a working neural network (neural synchronization). In so doing, our technology takes advantage of the ability of neurons to adapt to changed circumstances (the neuroplastic effect). This approach has been confirmed recently in the renowned specialist publication Neurology (Source: Bola M, Gall C, Moewes C, et al. Brain functional connectivity network breakdown and restoration in blindness, Neurology 2014; 83;542-551).

In addition to the neuroplastic effect, alternating current stimulation also has a protective effect on neurons, which may often slow down or even prevent the death of additional neurons.

Thus, in many cases, the brain's function can be partially restored through our therapy method, and a progressing loss of function may be prevented.

Patient Wearing EEG Cap and Stimulation Goggles at the Patient Unit of the EBS System

During therapy sessions, patients wear an EEG cap and stimulation goggles, both of which are connected to the NEXT WAVE™ patient unit, the most important system component. By means of a highly precise EEG amplifier, the patient unit measures select brainwaves that are then used by an electric stimulator to generate electric pulses tailored to the patient's needs and to transmit these pulses to the patient via the stimulation goggles. Patients perceive these electric pulses as flashes of light, also called phosphenes, but the therapy method itself is painless. Using the system's supervisor unit, the therapist monitors whether the therapy session progresses in a correct manner (Figure 1). Our therapy program consists of ten sessions on ten consecutive working days. A single therapy session, including the preliminaries, takes approx. 70 minutes.

At the moment, the main area of application of the EBS NEXT WAVE™ therapy method is ophthalmology. Nevertheless, the NEXT WAVE™ system, which was developed as a platform, already contains all major technological components necessary for the treatment of various neurological diseases. For instance, EBS will receive a patent related to non-invasive deep brain stimulation in the U.S. in early 2015.

EBS is already cooperating with the following centers from the fields of neurology and ophthalmology (the science of the eye):

• Augenklinik am Wittenbergplatz, Prof. Dr. Carl Erb, Berlin (Germany)
• MVZ an der Brandenburg Klinik, Prof. Dr. Michael Jöbges, Bernau (Germany)
• MVZ Prof. Dr. Thomas Neuhann, München (Germany)

EBS provides these centers with the NEXT WAVE™ system for the treatment of patients, which has the advantage that therapy centers do not have to make an investment first and that we may introduce our therapy method to the market without having to spend much time or capital. Afterward, EBS charges the therapy centers a usage fee for each patient, which in turn represents our company's revenue. Our therapy method is currently offered in the centers for approximately EUR 4,000. Through this business model, we aim to ensure that therapy centers use state-of-the-art technology at any time and do not have to make additional investments (which they would have to do if they bought the device).

As EBS NEXT WAVE™ is a new therapy method for the treatment of specific visual impairments, therapy costs are not yet covered by statutory health insurance companies in Germany. Consequently, patients have to cover these costs themselves. In a few individual cases, private health insurance companies have started covering the costs of the EBS NEXT WAVE™ therapy partially or completely. Nonetheless, there is no legal obligation for health insurance companies to cover the costs (Figure 2).

The EBS Business Model

When a company introduces a new therapy method, its most important task is to attract the attention of doctors and patients. At the same time, the initially limited access to the new therapy method has to be compensated. Therefore, a key element of the business model of EBS Technologies is the creation of an internet platform for patients in order to provide them with valuable information on this new therapy method and on the diseases for which it may be used. Combining this internet platform with strategic public relations activities, we want to reach a large number of patients and inform them about the therapy centers available. In the future, statutory health insurance companies may also decide to cover the costs.

Our company will continuously benefit from this business model and from the use of our technology in clinical centers, which is why we aim for above-average returns in the growing and very promising medical technology industry.

Non-invasive electrical stimulation has been used to treat certain diseases for a very long time, in many areas (e.g., TENS stimulation of muscles after sports injuries etc.), and in many different ways (e.g., direct current, transmagnetic stimulation, or alternating current). The unique selling proposition of the EBS NEXT WAVE™ system is its integrated combination of EEG and alternating current stimulation, which enables an adaptation of the therapy method to each patient's individual needs for maximum efficiency. Moreover, it is the only system on the market approved explicitly for the treatment of neurologically-based visual impairments.

• New: Our therapy method consists of electrical stimulation for treating the causes of neurologically-based limitations of the visual field in the intended target group, and the method's effectiveness has been validated by scientific studies.
• Non-invasive: Our innovative method has the advantage that it does not require surgery because electrical stimulation and EEG measurements can be conducted very effectively through electrodes placed on the head.
• Low risk: To date, no relevant side effects have been observed. Consequently, the method can be considered safe and may normally be used by doctors without any problems.
• Tailored to patients' needs: Adaptation of the stimulation to the individual patient, which takes place on each day of the therapy program, ensures an ideal effect and is essential to the therapy's success.
• Patented: EBS has received patents on its technology in the EU and in the U.S.

Business Partners and Customers

In addition to product development and approval, the creation of a network of highly renowned specialist medical centers making the therapy method available to patients was very important to EBS. EBS is already cooperating with 3 centers from the fields of ophthalmology (the science of the eye) and neurology. Until the end of 2015, we intend to have made our therapy method available to a large number of patients in 8 centers situated in the most important metropolitan areas in Germany. 

Our target group includes all patients suffering from neurologically-based visual field loss. Since we treat such impairments at the neural level, various types of eye diseases, such as glaucoma, eye infarcts, and visual field impairments due to strokes or traumatic brain injuries, can essentially be treated using our system. Consequently, we can access a market consisting of approx. 375,000 potential patients (see figure 1) in Germany alone. In the near future, we also want to target the remaining European market (2.3 million patients) and the American market (1.5 million patients).

Comparison of the Potential Markets for EBS Technologies in Europe and in the U.S.

The development and market introduction of an innovative medical product requires competent and experienced employees from various areas of expertise. By now, the EBS team has grown to 10 employees working in development, operations and finances, marketing, and management. 

Ulf Pommerening (CEO)

serves as the company's CEO and supervises the areas of business development and marketing & sales. Throughout the 20 years he worked for Johnson & Johnson, Ulf Pommerening gained an in-depth knowledge about the market introduction, sale, and marketing of medical products at the national and international level. Ulf Pommerening has not only worked in the field of neurology for several years, but has also gained an in-depth knowledge in the fields of cardiology, surgery, and anesthesia. The main focus of his previous work in various positions was the introduction of medical products and the related close cooperation with medical experts from the respective fields. Ulf Pommerening holds a Diplom degree in business administration from the University of Applied Sciences in Kiel.

Dr. Karl Schweitzer (Chairman of the Board)

actively supports the strategic orientation of EBS Technologies and, through his extensive network, enables close cooperation with major medical technology companies for a potential exit. He has gained considerable international and operational experience in leading companies from the area of medical technology. After serving as an executive at Guidant and Boston Scientific, where he supervised the region of central and eastern Europe as the vice president, he joined Medtronic in 2004. For almost 10 years, Dr. Schweitzer served as the vice president of several business segments, and he became the international general manager of the neuromodulation segment in 2011. In early 2014, Dr. Schweitzer took over the global agendas of the chief commercial officer at Autonomic Technologies. Dr. Schweitzer received his doctorate from the University of Vienna's department of law. Simultaneously, he studied business informatics at the Vienna University of Economics and Business and received an MBA from INSEAD in Fontainebleau. 

Today, the company is very well prepared for a full-scale market entry: The EBS NEXT WAVE™ system has convinced more and more medical experts since its approval in 2013, and the first patients successfully completed their therapy programs last summer (most of them in the context of trials). At that time, we started establishing our network of therapy centers in order to provide the necessary framework for successful commercial use of our technology. Since early 2014, our therapy method is offered by select neurological and ophthalmological centers as a regular therapy method, and we have been working constantly on increasing the number of centers cooperating with us. In 2014, our company has already generated approximately € 100,000 in revenue.

Currently, our most important task is to increase awareness of our therapy method and to ensure that this method is established in Germany through additional medical centers.

We have gotten in contact with promising partners and have made some progress in our negotiations with relevant specialist medical centers and hospitals. Moreover, more and more important specialists from the relevant fields are convinced of the uniqueness and long-term effects of our therapy method.

In order to inform people about the unique mechanism of the therapy method and to increase the method's popularity, EBS is currently working on an information portal specifically for patients among other things. Communication with patients and industry experts is supplemented by closed PR campaigns, quality articles in specialist journals, and partnerships with support groups, convention organizers, and important networks of experts. We also plan to attend important trade fairs and conferences.

Our existing investors – HTGF, Earlybird, and the ILB – will ensure financing of the company until it reaches breakeven point in 2016. Even though this is already an important milestone, our company value may increase even more if the NEXT WAVE™ technology can be used to treat additional diseases. Technologically speaking, the product is already able to do so today, and important physicians are convinced of these other areas of application because of practical trials.

To demonstrate that our technology is also suitable for other areas of application, additional clinical trials are necessary and thus have to be financed. Together with opinion leaders, EBS has already identified and planned such projects in a concrete way, so these activities may start as soon as we receive additional investments. Thus, the Companists will invest directly in an increase of the company value.

If we reach a total investment of 100,000 euros or more, we plan to

• introduce an independent registry of glaucoma patients for the long-term storage of therapy results in order to support future applications to insurance companies for coverage of the costs. A patient registry supports particularly those physicians using a new therapy method and substantially increases the credibility of a new method.

If we reach a total investment of 500,000 euros or more, we also plan to

• conduct two independent observation studies in the field of neurorehabilitation focusing on strokes in order to access this group of patients as well.

If we reach a total investment of 1,000,000 euros or more, we also plan to

• access another group of patients by conducting a multi-center stroke study for patients suffering from infarcts in the posterior cerebral artery (PCA syndrome), which affect the visual processing center particularly frequently. As a result, these people (most of which still work) suffer from visual field impairments. Once we have proven that our technology also works for these people, we will have access to another very promising potential market. From this total investment onward and in connection with access to new patient groups, EBS also intends to enter the international market.