Soranus Smart Neuromodulation

I am a 20-year medical doctor and working at a university hospital for the last 10 years. I have been focusing the diagnosis and treatment of pelvic floor diseases. I am the Board Member and General Secretary at Turkish Urogynecology Society. Since 2012, I have been a member of the Regulatory Board and Director of numerous cadavers and live surgical practices. I have given more than 50 lectures at workshops, courses and congresses. I have more than 100 publications in international and domestic journals. I established Soranus Co. in 2018 to manufacture solutions in a field that I know the best. We obtained funding from the H2020 European Innovation Council Accelerator Fund, the most prestigious fund in the EU.I put a team of professionals with many successes in their fields under Soranus Co.  This team I lead is now working for relieving pain caused by pelvic floor disorders.

Overactive bladder (OAB) is a common chronic public health issue. OAB may make life unbearable, with effects on work, travel, sleep quality and social life. OAB treatments are not sufficiently available. Almost half of all patients with OAB either cannot access or complete treatments with proven high efficacy. The main problem is patient compliance.The economic burden of OAB has increased up to $82.6 billion in the United States. Our Project is a new treatment modality. It is a wearable technology can be controlled via a smartphones application, delivering treatment monitoring and patient feedback. We propose is a communication-oriented, feedback-driven, effective, economical and non-invasive home treatment. As stated by many patients, this treatment will give them a new life. Our solution, affecting millions of people, will create employment in manufacturing, marketing and sales all over the world, and along with the decreased costs, social welfare will also improve.

Overactive bladder (OAB) is a symptom syndrome characterized by a sudden urge to urinate, usually accompanied by frequent urination and nocturia, as well as urinary incontinence in severe cases. OAB is a common chronic public health issue affecting 16% of adults, with an incidence and severity that increases with age (Figure 1).

OAB may make life unbearable, with effects on work, travel, sleep quality and social life. Social isolation and depression are not rare, driven by concerns of urinary tract infections, skin irritation and foul odor. 

A multiple-stage system is recommended for OAB treatment.

In the United States, the disease represents a financial burden of $82.6 billion, with half of the 33 million OAB cases becoming candidates for tertiary care every year (Figure 2). 

Despite a treatment success rate of 60–70%, only 3% of cases receive treatment, attributable to the high costs, lack of third-line treatment delivery, insufficient time of clinicians, and tiredness and despair after prolonged treatment.  Millions of people with OAB live with an impaired quality of life, and with economic, social and mental problems due to the lack of access to efficient treatment. A notable 70% of cases are treatable. 

A recent study established a 600%-increase in the continuation of treatment of refractory OAB cases, i.e., those requiring tertiary care, who received motivational and informative weekly phone interviews. Despite this, 75% of patients do not complete treatment, as the available technology and systems cannot keep patients in the system and maintain treatment. The solution takes the form of effective, home-based, monitorable, interactive, customizable and affordable treatment. Posterior tibial nerve neuromodulation (PTNS), botulinum toxin injection or sacral neuromodulation surgery have similar therapeutic efficacies, and while PTNS has the lowest cost, it is a prolonged and exhausting solution. Our PTNS-type solution of a wearable technology can be controlled via a smartphones application, delivering treatment monitoring and patient feedback. The system allows the physician to adjust the treatment course and pharmaceutical dosages based on the data analysis of the physician. It will thereby be a simple, accessible, interactive and affordable solution.

Millions of people without access to effective and applicable treatment suffer from a severely impaired quality of life due to urinary incontinence-related skin irritation, nocturia-associated sleep disorders, job loss, fall-related fractures in the elderly, the need for prolonged hospitalization and nursing home care, as well as the shame, social isolation and depression related to the associated with foul odor.OAB has one the lowest levels of treatment compliance and continuity among chronic diseases (Figure 3). 

This is attributable to the persistence of complaints despite multiple treatments, and long-term and frequent hospital visits for new and expensive treatments. Patients that have failed to respond to previous treatments or that are seeking an appropriate solution, as well as healthcare personnel with limited time, have been waiting for such a solution for years, and so it will be quickly accepted and become widespread. We have come to understand how important digital and home-based solutions are during these “coronavirus days”. What we propose is a communication-oriented, feedback-driven, effective, economical and non-invasive home treatment. Seeing patients benefit from the treatment is very satisfying. As stated by many patients, this treatment will give them a new life. 

The economic burden of OAB has increased from $12.6 billion to $82.6 billion in the United States over the last 20 years, while the direct treatment cost per patient has increased from €269 to €706 in Europe. Both figures are increasing, and millions of patients still cannot access efficient treatment. This will prevail as long as the side effects, costs and difficulties in implementation of the currently unsustainable treatment remain the same. Through our proposed individualized, traceable, affordable and non-invasive home treatment, we aim to improve the quality of healthcare and to contribute to social welfare by decreasing cumulative costs.

I am an academician who has been applying the available treatment alternatives to hundreds of patients, and have been providing training to dozens of physicians and specialist physicians for many years. In my search for generalized, easier and accessible treatment approaches, I established a start-up focused on minimally invasive solutions to pelvic floor disorders, working with an academician specialized in technology transfer, commercialization and entrepreneurship. The treatment of OAB patients was the most challenging part of my clinical practice. The available treatments are not sustainable, despite their efficacy, due to the associated side effects and costs. There are an increasing number of patients who have been diagnosed who are yet to find a solution, and who try to live with palliative solutions, such as incontinence pads. Currently, less than 10% of hospitals are able to offer all treatment options. Many of my colleagues have similar opinions.  We identified and focused on a generalized treatment solution that proved to be effective among patients who felt guilt and shame, who were desperate and who had lost their jobs. We turned a treatment with proven efficacy into a non-invasive home treatment that will allow healthcare personnel to access more patients

I’ve been treating OAB patients for 10 years. One in every two female OAB patients – whether young or old; educated or not; poor or rich – cannot access effective treatment, and the situation for men is not different. Deep frustration, social isolation, depression, poor sex life, and multiple pointless hospital and doctor visits await them. The problem is about compliance, resulting from implementation methods rather than the lack of an effective solution. High costs, multiple hospital applications, and insufficient numbers of suitable centers or personnel impair patient compliance. It may become widespread, if there is an effective treatment that is simple, plain, affordable and easily applicable. Once we realized this, we decided we should focus on increasing patient compliance rather than treatment efficacy. Upon observing that many issues with my patients were resolved through WhatsApp, being quick and practical, even in the elderly patients, we determined the roadmap of the new method. We designed a method that was easily applicable at home by the patient, that could be remotely monitored and controlled, and that was measurable for effects, with focus always on the patient. The responses received from patients and colleagues showed that we were on the right track. 

OAB treatments are not sufficiently available. Almost half of all patients with OAB either cannot access or complete treatments with proven high efficacy. The main problem is patient compliance.  To come up with a simple and sustainable solution to a complicated problem with impaired compliance, we built a team of physicians specialized in anatomy, gynecology, physical therapy, urology and psychiatry, as well as a commercialization and IP management expert, a digital product marketing expert and R&D engineers. This team seeks to develop simple, effective, economic and generalizable treatment methods. Our surgical therapy project related to stress urinary incontinence in women with generalized pelvic floor disorders was evaluated as disruptive, and received support from the European Union’s H2020-EIC-SMEInst program, and we are now preparing our products for the market. We are inspired by the principles of “first do no harm” and “there is no disease but the patient” of the wise physicians Hippocrates and Soranus. 

I am a 20-year medical doctor who has been working at a university hospital for the last 10 years. My contract with the university covers healthcare, training and scientific research. However, as a scientist, I seek to transferring my scientific research results to the economy, and to manufacture simple solutions to complicated problems. Through my own resources, I established Soranus for the manufacture of solutions in a field that I know the best, undertaking all risks. I recruited a fellow academician at my university with skills in entrepreneurship and commercialization, and we became company partners. Since I was engaged in R&D projects, I first accessed national and then international funding through the appropriate support mechanisms. Soranus became the second firm in Turkey to be awarded from the H2020 European Innovation Council Accelerator Fund, the most prestigious fund in the EU. At this time, I sought well-informed solution partners to cooperate with me when lacked sufficient knowledge. Instead of earning 10 times more than my salary through private practice, I preferred to lead a team dedicated to creating value for humanity. Starting from scratch, our company is today valued at €5 million.  

I am a faculty member of the Ege University Medical School and the founder of Soranus Co.  In the last 10 years, I’ve trained many physicians and have improved people’s health in hundreds of surgeries. During surgeries, decisions are momentary, you don’t have time to think. Momentary decisions should be based on good judgment blended with knowledge and experience. I have shared my experiences with my colleagues at various meetings. All these efforts led me to the General Secretary of Turkish Urogynecology Association. I experienced that some of the existing problems in this field were yet to be resolved. Using my own resources, I established Soranus Co. to manufacture solutions in a field that I know the best, undertaking all risks. I approached a fellow academician at my university with skills in entrepreneurship and commercialization, and we became company partners. As a result of my R&D projects, we first obtained national funding then international funding from the H2020 European Innovation Council Accelerator Fund, the most prestigious fund in the EU.  I put a team of professionals with many successes in their fields under Soranus Co.  This team I lead is now working for relieving pain caused by pelvic floor disorders.

OAB affects one in every six adults, with severity increasing with age. A multi-stage approach is recommended for treatment and, the success criterion is the improvement of recovery of symptoms. Management of OAB is showed below:

Almost half of all cases require third-line treatment options. Only 3% of such treatments are completed, due to such reasons as cost, applicability, insufficient healthcare personnel, and the older age, limited mobility and co-morbidities of the patients requiring this set of treatments. Consequently, millions of people have to live with deep frustration, social isolation, depression, poor sex life, and multiple pointless hospital and doctor visits. The cost of OAB to the budget has increased from $12.6 billion to $82.6 billion in the United States over the last 20 years, while the direct treatment cost per patient has increased from €269 to €706 according to the data of five European countries. Both figures are increasing, and millions of patients still cannot access efficient treatment. Our solution will removes the disadvantages associated with existing treatments, such as side effects, costs and implementation difficulties, that make the treatment unsustainable. It is a home treatment, free of any invasive interventions or implant applications upon treatment planning. Throughout the treatment, the wellbeing and quality of life of the patient are monitored, and interventions can be made when required. We provide an effective, reliable and low-cost solution.

OAB can have destructive effects on quality of life by affecting the work, travel, sleep quality and social life domains. In the elderly, nocturia and sudden urges to urinate can lead to falls and fatal injuries. Social isolation and depression are not rare, due to concerns about urinary tract infections, skin irritation and foul odor. Our solution will be home-based, affordable, reliable and monitorable, just like being at hospital, with interventions made when required, as well as easy for anyone who has a smartphone. This treatment will occur upon R&D activities, developing specific software, clinical trials, and developing intellectual property rights and system assistants. The currently available treatments are unable to meet almost half of all therapeutic requirements, which means millions of people endure without treatment. According to literature, only 3% of such people have access to adequate treatment. In order to maximize treatment accessibility, costs, implementation difficulties and the frequency of hospital visits should be reduced, while the numbers of physicians, nurses and hospitals should be increased, more time should be made available for such patients, and awareness should be raised. In a previous study, allocating more time and raising awareness was found to increase treatment access by 600%, although still 75% of cases remained without treatment. Our solution turns the patient into a solution partner through a different positioning, and creates a warm and strong physician-patient bond. The physical treatment is no different from to the treatment that would be prescribed by a physician under normal circumstances. The solution will be presented with the highest level of applicability upon feedback from clinical trials. People becoming continent following treatment can work, mobilize, exercise and regain their self-esteem, and may see a return of their normal personal relationships, and social and sex lives. The life of those around the patients will also be positively affected. Health costs, and the work loads of both hospitals and physicians will decrease. Our solution, affecting millions of people, will create employment in manufacturing, marketing and sales all over the world, and along with the decreased costs, social welfare will also improve. 

Our project consists of three stages. The first stage includes system design and prototype development. This stage is about to be concluded, and the first tests have produced positive outcomes. The second stage involves scripting and testing the remote monitoring system, and conducting clinical trials. For this stage, we have ongoing software works and are currently seeking funding.  The final stage will include CE and FDA certification processes. We are continuing to develop our product, with 5 personal following work packages and through service procurement in certain expertise-requiring fields.

The total number of patients in need of this treatment is 38% and 43% among men and women aged over 40, respectively, In other words, the total number of patients in need around the world today is around 272 million. In the first year, the target is to reach 0.05% of the total market. The targeted market share for the first 5 years is summarized below. 

After obtaining CE and FDA approvals for the product, our targets for the first year and next 5 years are as follows:

Our first year targets:

• To build a digital marketing website introducing the product and service in six different languages,
• To begin the sales drive by first introducing the product to the Turkish and European markets,
• To extend our sales network via dealerships in 10 countries in Europe,

Our next targets for the next 5 years:

• To appoint a professional company executive,
• To globalize, and to enter the United States and Canada in particular,
• To reach 10% of the total market,
• To develop a new version of the product

• Additional financial resources are needed to create the business model of the current product.
• CE and FDA certification will be required in the second year, for which substantial financial support will be needed.
• A proper marketing and distribution company is needed to secure international market access.

We are trying to gain access to different financial resources, particularly national and international funds, in order to meet the financial requirements. We also aim to include investors through direct interviews with certain investment and manufacturing companies. 

We are currently working with a design company on the development of the product design. Our target is to make the product easy to use for all patients. Secondly, we are receiving professional support in the preparation of digital marketing and visual materials. We are in discussions with two different manufacturers and with one company with a global sales and marketing network, from whom we are receiving information on sales and marketing. Outsourced professional support is also received for an accurate and effective execution of IP. 

The main target audience of our product is OAB patients who have had difficulty in treatment compliance and those who are unable to access effective treatment. Considering the global population data, this relates to approximately 274 million people as of 2020. The unique software abilities of the new treatment we are developing will minimize the workload of healthcare providers, and will allow a reliable and traceable home-based treatment without compromising on treatment efficacy. We are continuing to create software content that will eases use, as the backbone of the business model, for which we are working with process stakeholders, physicians, nurses, physiotherapists and of course, patients. Due to the nature of our solution, it will become popular and accepted very quickly through digital marketing. Our home-based, easy, affordable and effective treatment system will be accessed by patients online and via direct sales after being recommended by physicians. The new neuromodulation device we have developed will be patent protected. Patients will be able to access all product-related information online, and all necessary technical support will be provided via phone or online.

The financial table for the first 5 years (between 2022-2026) is presented below. 

Approximately $30,000 has been used to date from the national public R&D fund. A manufacturing company that has declared an interest in the project has provided material and service support amounting to $33,000.

We are continuing our search for the necessary funds to realize our project. In this regard, two applications have been prepared requesting access to various public funding sources. We have also join various national and international project competitions.

The amount spent in the first 6 months of 2020, as the business development process continued, was $48,500, and the estimated outlay for the rest of the year is €50,000. Accordingly, an amount of $98,500 was planned for the first stage of business development and for R&D for 2020. However, the product is expected to enter the market in 2021 and our estimated expenses for 2021 amount to $29,553.500. In 2021, the CE and FDA certification works related to the product will be launched. A total of $442,000 is required for the consulting services required for these certification processes, for the product prototypes and tests, for clinical trials, for CRO services, for certification body costs, and for advertising and marketing activities. 

The list of cost item and amount are provided below table:

The total estimated budget for the project is 442.000$. The national funding agencies are providing R&D supports for only certain activities with and average 50% maximum funding rate. Furthermore, the budget first spent and reimburse later. Therefore, we don’t have such financial capacity either co-finance or fully cover the above mentioned budget. 

The Technology Readiness Level of the project is 4. Thus, it is early stage and VCs are not willing to invest the project at this stage. Some of the VCs are not proposing fair deal due to early stage of the research. 
The other reason applying for the Elevate Prize is the theme of the project. We are targeting to solve problem which is limiting freedom and living standards of people, mainly women. This is also one of the main target of the Elevate Prize. For this reason we see a big match between our target and Prize target. That is also another reason for applying the prize. 
Last but not least, we believe that the Prize will also increase the awareness of the product among different ecosystem which will lead better business performance.