Treating Rare Diseases with NI-ES
There are no approved treatments for many rare retinal and optic nerve diseases. Even after receiving a correct diagnosis, they have few to no options for treatment. NI-ES of the Retina increases oxygen flow and nutrition to the cells, turns them on and improves their efficiency, thereby improving vision and slowing progression. NI-ES will give them hope and allow them to maximize their dominant sense, vision. 80-90% of what is perceived, comprehended, and remembered comes from vision. Those missing out on over 3/4 of their world will have their lives altered. With improved vision, independence improves as does the quality of life.The lives of over 11.2 billion people will be positively impacted globally.
Obstacles for these patients include delays in correct diagnosis, lack of information, expertise, and treatment options. Lack of knowledge of physicians is also a problem. There are medical, physical, and mental challenges for the patient and financial and emotional burdens for the patient’s family and greater geographical distances between patients and specialists who can treat them. The time between the presence of first symptoms and the diagnosis is problematic and the delays allow progression and worsening of symptoms.
Through the use of telemedicine, electronic health records, patient registries, and organizations for the rare diseases, the data can be leveraged to identify undiagnosed, misdiagnosed, and diagnosed patients and can aid in connecting them with doctors who can treat them from a distance, allowing them to get the proper care quicker.
Retinal and optic nerve rare diseases including, Best Macular Dystrophy, Charles Bonnet Syndrome, Cone Dystrophy, North Carolina Macular Dystrophy, Optic Neuritis, Pattern Dystrophy, Retinitis Pigmentosa, Stargardt Disease. In the US, 5,675,967 are affected and 11,215,721,038 globally.
My solution gives a treatment option that decreases symptoms and slows progression, gives hope and real life changing results while educating physicians and connecting patients to doctors who can successfully treat their rare conditions.
Non-Invasive Electrical Stimulation (NI-ES) of the Retina and Optic Nerve
Every cell in the body has a chemical charge. Every day the cells go through their work and by-products result. Normally, the by-products are taken away by the blood supply, but in these rare conditions, they are not and they build up in the cells, making the cells dormant or toxic. The NI-ES turns on the cells in the blood vessels, retina, and optic nerve and they work more efficiently, allowing them to produce more energy (ATP) and they can then pump out the by-products. When the cells turn on, they function better, and vision improves.
NI-ES is not a cure, but a treatment that needs to be repeated consistently to sustain the improvement. The vision improves and then, plateaus. Further treatments sustain the improvements and keep it from progressing.
An ocular interface is used that allows treatment through the closed eyelids. It is connected to a signal generator that creates the microcurrent. NI-ES is safe and effective as has been proven by 2 FDA studies in which I was an Investigator. I have received an Ophan Device Designation for the technology being used.
The target population are those with rare retinal and optic nerve conditions that currently have no approved treatment. They include children and adults who have no treatment options. They experience psychological challenges, emotional issues, inability to work, lack of financial stability, poor self esteem, and rejection and are underserved by the medical community.
Late and misdiagnoses of their rare diseases are common and often result in multiple doctor visits with no resolution and no treatment. A Rare disease impact report: insights from patients and the medical community 2013 reported that rare disease patients in the US and the UK waited an average of 5.6 to 7.6 years to be properly diagnosed.
By talking to them personally, examining them, treating them, and supporting and answering their questions in an online support group, I understand and address their needs. Through this input, I have fine tuned the technology and treatment.
My solution will treat their conditions, improve their vision, slow the progression, give them hope, and change their lives.
- Unlock collaboration among patients, scientists, and health care providers to improve patient outcomes
The problem, solution, and target population align well with the Challenge and relate to two dimensions.
Data can be leveraged to improve diagnosis time and treatment by using telemedicine, electronic health records, patient registries, and organizations for the rare diseases.
By working together with patients, scientists, specialists, and other health care providers, we can educate, train, and treat the rare ocular conditions and improve patient outcomes.
The solution is achievable and will be profitable. NI-ES uses new technology to address the needs of those with rare ocular diseases who are underserved and it will positively impact their lives.
- Pilot: An organization deploying a tested product, service, or business model in at least one community.
The Pilot stage of development was chosen because studies have already been done treating Stargardt's Disease and proved that it is safe and effective in mitigating the symptoms and improving vision. The technology and instrumentation, treatment, and business model are ready to hit the market to be tested by 2000-4000 patients diagnosed with Stargardt's Disease.
- A new technology
NI-ES is non-invasive and the microcurrent is of a form that the body likes. All the cells have a chemical charge and introducing low current through the closed eyelids improves function at the cellular level, allowing the processes to work more naturally. The body adapts to the changes that occur due to the rare disease. Neuroplasticity occurs. It is the ability of networks of nerves to change through growth and reorganization and neuron pathways making new connections. Since NI-ES improves blood circulation and works on the cells and their function, it works in conjunction with the new connections.
Artificial retinas and implanted electrical arrays are very invasive and haven’t been overly successful because their premise is to replace the affected cells and have them work as they originally did. Neuroplasticity changes the connections that the nerves originally had to restore the lost function and these implants don’t take that into account.
Others have treated eyes with microcurrent, but the delivery systems were not overly successful or as efficient as this solution. The delivery system is the key.
NI-ES can be a catalyst to bring credibility to electrical stimulation and electrotherapy and to change the market proving that alternative medical innovations will dramatically improve health outcomes, reduce the cost of health care, and stimulate global economic growth.
NI-ES uses new and existing technology. The new technology is used in delivering the microcurrent stimulation more efficiently and effectively to the structures and cells of the eye. Existing technology is used in generating the electrical current needed to perform to treatment.
Electrical Stimulation or electrotherapy was a widely used and accepted form of treatment until the early 1900s and into the 1930s. In the 1970s, there was a return to its medical use.
Electrical Stimulation as a Means for Improving Vision - ScienceDirect
Microcurrent stimulation in the treatment of dry and wet macular degeneration - PubMed (nih.gov)
Electrical stimulation of anterior visual pathways in retinitis pigmentosa - PubMed (nih.gov)
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016 - PubMed (nih.gov)
Repetitive Transcranial Magnetic Stimulation-Induced Charles Bonnet Syndrome-MedSci.cn
- Big Data
- Biotechnology / Bioengineering
- Manufacturing Technology
The electrical current signal generator is a currently marketed medical device that has a safety profile of 40 years, with millions of treatments safely performed with few to no adverse events.
Animal and human research has provided a strong scientific foundation that noninvasive electrical stimulation (NI-ES) is very low risk and a beneficial therapy for improving or recovering vision in retinal diseases. A review of current literature provides ample evidence that the effects of NI-ES are very valuable in treating the eye, especially promising in those diseases where no treatments are available, such as Stargardt’s Disease and other orphan retinal dystrophies.
Sehic et al. reviewed and summarized current literature on NI-ES in animal and clinical studies. They reported that NI-ES only touching the skin has the benefit of being minimally invasive and has had only minor adverse effects reported, if any. NI-ES therapy significantly decreases the risk of severe complications that have been reported with retinal prostheses. They observed that NI-ES has transitioned into clinical practice and its favorable safety profile is likely to increase the momentum of using NI-ES for treating eye diseases.
Sehic A, Guo S, Cho KS, Corraya RM, Chen DF, Utheim TP. Electrical Stimulation as a Means for Improving Vision. American Journal of Pathology. 2016;186(11):2783-2797.
In 23 years of treating and doing clinical studies using NI-ES, I have seen no adverse reactions and only benefits to those suffering from eye diseases.
- Women & Girls
- LGBTQ+
- Children & Adolescents
- Elderly
- Rural
- Peri-Urban
- Urban
- Poor
- Low-Income
- Middle-Income
- Refugees & Internally Displaced Persons
- Minorities & Previously Excluded Populations
- Persons with Disabilities
- 3. Good Health and Well-being
- 5. Gender Equality
- 10. Reduced Inequality
- United States
- Canada
- Germany
- United States
Currently, the patient population to be served is 2000-4000. In 5 years, we will be serving approximately 480,000 people with rare ocular diseases.
The goal for the next year is to obtain approvals for the solution for 3 more rare eye diseases that have no approved or successful treatments. When approved, then the solution can be marketed for those applications. This will lay the ground work over the next 5 years for approval for treatment of other blinding eye conditions that are not considered rare and affect over 20 million people worldwide.
Good health and well-being, reduced gender inequalities, and reduced inequalities are measurable indicators that have been used to measure the progress of the solution. Gender inequalities and general inequalities are reduced through treatment with the solution and allowing better access to education, productivity, self-esteem, economic success, and the ability to make better choices about their lives. By improving their vision and their lives, those suffering from rare eye diseases can be active, productive people again. The solution allows for better health and better quality of life.
- For-profit, including B-Corp or similar models
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We have experienced device designers, researchers, clinicians, technicians, and support staff. We work one on one with those we serve everyday. Their input is invaluable to the design and implementation of the solution.
Our team includes men and women, those with various professional degrees, and all are a valued part of the team. Our goals include building key skills, such as empathy, active listening, and appreciative inquiry for inclusive leadership. We will review our programs and services in regard to inclusion, equity, impact, and success across diverse groups. Then, we will track our progress.
No
- Individual consumers or stakeholders (B2C)
To gain exposure world wide, gain experience, and to obtain a possible funding streams and collaborations.
- Financial (e.g. improving accounting practices, pitching to investors)
Funding is the main lack and stumbling block.
I would be open to any and all collaborations and/or partnerships.
Optometrist