Epiparma

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Introduction

Currently, over 3 million adults suffer from epilepsy each year, with 30-40% of those seizures being drug resistant1. Patients who do not react to drug therapies or who suffer from generalized seizures that originate and spread to multiple parts of the brain often lack any treatment options. Founded on the notion that no individual should have to suffer the unmitigated effects of periodic seizures, Epiparma uses a neurostimulation implantable device to treat epilepsy, providing the first form of treatment for patients with generalized and drug-resistant seizures. Recently, a research lab from UPenn Litt Labs has patented a closed loop algorithm that detects, analyzes, and prevents seizures by administering an electrical impulse; Litt Labs is actively looking for a collaborator. Epiparma will license this technology to design and manufacture a commercially viable implantable device that will identify, predict, and analyze seizures in order to determine a seizure’s severity and deliver the correct dosage of the treatment.

Product Description

As the first seizure therapy of its class, the Epiparma implantable device monitors the patient’s neural networks, employs neurostimulation to prevent seizures, and offers a user-friendly app to empower the patients. Currently, the only medically implanted device to treat seizures available to the public is Neuropace; however, like other forms of treatment, Neuropace can only be used for patients that suffer from focal seizures in one part of the brain. Our product is a closed loop system, or fully automated control system, that performs three distinct functions: First, the device identifies and maps the epileptic networks of the brain by reading neural activity; by detecting abnormalities in these networks, the device can then predict oncoming seizures. Next, the device will analyze the brain activity to distinguish the severity of the oncoming seizure in order to adjust dosage parameters. Finally, the system will incorporate the patient's EEG data inputs and deliver the proper dosage -- which will result in a seizure reduction of 85%. Patients who opt to adopt our product as their treatment option will undergo a minimally invasive surgery. The device will be implanted under the patient’s skull and will not require patient interaction with the device; this will allow for a huge increase in quality of life due to 85% seizure reduction and safety for any individual who is not eligible for current treatments or is experiencing the many common adverse side effects with multiple treatment medications such as confusion, cognitive impairment, and metabolic slowdowns in the liver and bone tissue density. Epiparma’s product will also offer a companion mobile app that records and displays the patient’s neural activity data, which can be used by doctors to track the patient’s epilepsy as well as empower the patient to have more access to their medical data and better monitor their epilepsy. The platform will allow patients to access their seizure history via a user-friendly interface, connect directly with their neurologist, as well as connect with other Epiparma patients.

Market Landscape

Epiparma is targeting the $6 billion global implant market, which is growing at 11.2% CAGR in the next 6 years and is forecasted to reach over 6.03 billion USD in 20204. This rapid growth is fueled by greater diagnosis of neurological disorders and the increase in new treatment options, which motivate investments in medical device innovations. Venture funding for medical devices is increasing, indicating opportunities for our companies to enter this market. In addition, the competitive landscape consists of competitor products to Epiparma such as responsive neurostimulation systems (RNS) and vagus nerve systems (VNS). However, Epiparma has the distinct competitive advantage of treating generalized seizures, having lower invasive surgery and achieving a higher seizure control rate.

Sales and Market Plans

Our primary customers are neurologists, who have the major impact on adopting new therapy. Our end users are generalized seizure patients who are drug resistant. We will focus more on the neurologists, convincing them of the safety and efficacy of Epiparma with clinical data generated during the FDA approval process. A key component of adoption of our product is the endorsement from key opinion leaders (KOLs), or leading neurologists who work at innovative health centers. Along with a search engine optimized website, we will host webinars to inform potential clients and rigorously reach out to hospitals via a dedicated sales staff and KOLs. Clinical data proving the efficacy of Epiparma will be crucial to onboard new customers, and as we expand we will be able to reach a wider audience of publications and endorsements from influential institutions such as the American Academy of Neurology and the Epilepsy Foundation. Once neurologists recommend Epiparma to their patients, they will refer their patients to a neurosurgeon who will surgically implant the device in a 1.5 hour procedure, requiring 2 days of post-op recovery. We will outsource the device manufacturing to an exclusive partner in order to reduce capital expenditures and instead be able to focus on our sales strategy. Once a neurologist orders our product, the in-house technicians will assemble the parts from the supplier and deliver it to the hospital by our sales representatives. Epiparma will focus on building to develop and sell our device through sales efforts, prototyping, user interviews and feedback for iteration, and procuring venture capital. By partnering closely with Litt Labs, we will refine the current prototype and ensure safety protocols for implantation in humans.

Management Team

We have organized a leading management team that is deeply committed to bringing this product to life. Irene is the Executive Officer. With her experience strategies for health consulting, she led the vision and trajectory of the company. Andreana is the Financial Officer who will be responsible for Epiparma’s financial analysis and develop Epiparma’s revenue model. As Operations Officer, Judy has business development experience in a healthIT startup and will be responsible for outlining an operational strategy. Our Marketing Officer, Lisa, will use her Wharton experience and work to develop an appropriate marketing strategy. Finally, Echo is serving as our Technology Officer to define the product and overseeing manufacturing. Overall, the management team will need to secure outside partnerships with manufacturers and insurance companies, while also maintaining close relationships with the researchers at Litt Labs, board of directors and advisors, and other key stakeholders to see this product from design to commercialization.

Financial Projection

We project the product development and FDA approval process will last 7 years until our product commercially launches in 2028. Our primary stream of revenue will occur in 2028 by selling Epiparma to early adopters. Our device will be priced $35K, in the current range of other implantable seizure devices. In order to maintain continuous funding to our key operations, Epiparma will seek $17MM in total investment that will support FDA approval, outsourced manufacturing, and a growing sales team. Our company will offer a world of opportunity for increased quality of life for the hundreds of thousands of epileptic patients that are not currently offered a treatment plan. Epiparma is built on the foundation of leading industry technology, led by data driven market analysis, and formed on the breaking the boundaries of current medical treatment.