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Neurava Inc.

SUDEP (sudden unexpected death) is a terrible risk faced by 65M epilepsy patients globally, and there is no device currently available to monitor for this risk. Neurava is developing wearables to monitor and alert for seizures, cardiorespiratory dysfunctions, and impending SUDEP risk in epilepsy patients.

West Lafayette, IN, USA

One Liner

One Liner
SUDEP (sudden unexpected death) is a terrible risk faced by 65M epilepsy patients globally, and there is no device currently available to monitor for this risk. Neurava is developing wearables to monitor and alert for seizures, cardiorespiratory dysfunctions, and impending SUDEP risk in epilepsy patients.

What Problem We are Solving

Problem
SUDEP claims the lives of at least 4,000 Americans annually, leading to 101,000 years of potential life lost, which is second only to stroke among all neurological disorders. There is no device that monitors SUDEP risk and no effective way to identify those at highest risk, and so families face enormous stress & anxiety as they try to monitor their loved ones.

About Us

About Us
Neurava is developing novel wearables on the arm and neck for nighttime monitoring and alerting of seizures, cardiorespiratory dysfunctions and SUDEP risk in epilepsy patients. The recorded data will also enable physicians to expedite formulation of treatment plans and to triage and further assess patients with the highest individual SUDEP risk. We raised a pre-seed round of ~$650k in 2021; completed development of our wearables, smartphone app and clinical portal; expanded our team; validated our regulatory strategy through a pre-submission with the FDA; and completed our first usability study with our arm wearable on epilepsy patients at our partnering clinical sites, capturing 100% of all seizures that occurred within 30 seconds, including a near SUDEP seizure. We have closed on ~$1.35M of our current fundraising round, which is a preferred equity round led by Life Science Angels with major participation from UCB Biopharma, our epilepsy strategic investors, as well as all other investors. We are currently fundraising to raise the remaining ~$650K of our round. Neurava aims to be a global leader in medical devices/digital health transforming epilepsy care and management and improving the quality of lives of patients and their families by developing life-saving devices and algorithms. 

Venture Highlights

Highlights
We have completed a prototype of our entire wearable platform and have so far validated our seizure detection arm wearable on 30 adult epilepsy patients, admitted to two of our partnering clinical sites. We captured 100% of all convulsive seizures within 30 seconds, including a near-SUDEP seizure illustrating our value proposition. We captured over 1300 hours of continuous data and received good usability scores with all patients, on average, indicating that the arm wearable was comfortable, stable, secure, did not interfere with normal activities like sleeping, and that they would wear the device to sleep and would recommend it to others. We completed the development of our neck wearable and have validated it on internal subjects, both adults and children. We have also developed prototypes of our clinical portal and smartphone app. 

We signed a license agreement with Purdue for three patents and filed a provisional patent application for the neck wearable (Neurava owned), which we plan to convert to a non-provisional later this year. 

We have expanded our team and added Dr. Michael Privitera to our group of clinical advisors. He is the Director of the Epilepsy Center at the University of Cincinnati Gardner Neuroscience Institute and is the former President of the American Epilepsy Society. We plan to conduct a second study with our full system in his clinic later this year.

Lastly, including the closings of our current round, we have raised $2M to date, including two investments from an important strategic investor, UCB Biopharma, a global leader in epilepsy who develop and manufacture some of the most commonly used and important anti-seizure medications.

Business Model

Business Model
We will sell our device to patients through physician prescriptions and insurance reimbursements. We will charge a one-time cost of $1600 for the both wearables, along with two monthly subscriptions, one for an app/patient database and another for the replaceable adhesive patches, each at $30/month.

Competitive Advantage

Quote
As SUDEP occurs due to a seizure and then an induced cardiorespiratory collapse, our wearables can transform epilepsy care as a powerful tool with life-saving potential by monitoring and alerting for seizures, cardiorespiratory dysfunctions, and impending SUDEP risk, unlike any other available system. Our solution can also enable SUDEP risk stratification by physicians through documented evidence of seizures and the induced cardiorespiratory dysfunctions. Our device can improve the quality of life of patients and their families through more effective nighttime monitoring, which will improve their quality of sleep, provide peace of mind, and reduce their stress and anxiety. Monitoring for seizures and the induced cardiorespiratory dysfunctions can also provide a more complete picture of each individual's unique presentation, enabling more effective and timely treatment aimed at reducing seizure severity & frequency and minimizing epilepsy-associated comorbidities. Cardiac and respiratory monitoring will also enable us to monitor for multiple types of seizures, unlike our competitors. 

Neurava has established partnerships with world-class clinical collaborators: Dr. George Richerson (Univ. of Iowa), Dr. Nobis (Vanderbilt Univ.), Dr. Samden Lhatoo (UT Health), and Dr. Michael Privitera (Univ. of Cincinnati). They are leading experts in epilepsy and SUDEP, provide clinical guidance to the company, and partners for our clinical studies. Also, we have secured a strategic investment from global epilepsy leader, UCB Biopharma, who bring massive epilepsy related business experience to our team. 

We have also partnered with 3M and their manufacturing partners, Marian Inc., to further develop our wearable adhesive and electrode technology. We have also validated our regulatory strategy through a pre-submission with the FDA and work closely with our regulatory consultants - Dr. Carlos Pena, former FDA CDRH director and former Assistant Director of the White House Office of Emerging technologies (2012-2014) and Dr. Allison Komiyama at RQM+, the world's largest regulatory and quality consulting firm focused on medical devices.

Revenue

Revenue To Date
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MRR
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Revenue YTD
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Burn Rate
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Users

Total Users
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Total Users (Past 30 Days)
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MoM Growth Users
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Organic Traffic %
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Customer Costs

CAC
$258.00
LTV
$2.04K
Churn
N/A
Margins
80%

Go-To Market Strategy

Business Strategy
To market our wearable system, we will incorporate a strategy consisting of direct sales, strategic partnerships, and eventually independent contributors/in-house sales team. Given that physician recommendations are the best way to enter the market, we will initially target and form partnerships with the EMUs of our clinical advisors, before scaling to all epilepsy centers in the US and our customer acquisition plan will consist of two fronts, one for physicians and another for patients. For physicians, with early feasibility data in hand, we will present at epilepsy and neurology conferences, like American Epilepsy Society and American Academy of Neurology. In the future, we will also use third party medical device distributors and an in-house sales team to market our product to physicians and other key opinion leaders. On the patient front, the epilepsy community is very close-knit with various support groups and so we will partner with major epilepsy support groups, like the Epilepsy Foundation and the Danny Did Foundation, to raise awareness about SUDEP and our device and use an in-house team to advertise to customers looking to purchase our device directly through both print and social media. We will also leverage our strategic corporate partners, like UCB Biopharma, with an established epilepsy market and incorporate our marketing plan within their existing channels and also engage in joint advertising for our wearable system.

Competitive Analysis

Competitive Analysys
Currently, there are no devices on the market that monitor SUDEP risk. Epilepsy patients instead use seizure monitoring devices from competitors Empatica, Nightwatch and Brain Sentinel (acquired by Neureka). These devices detect only 1 type of seizure, and by relying on seizure detection alone, these devices are limited in their ability to prevent SUDEP.  These also can suffer from high false alarms, do not monitor the crucial cardiac and respiratory dysfunctions, cannot provide physicians with actionable information, and do not provide enough evidence for physicians to determine patients at highest risk of SUDEP and other comorbidities.

Competitor Website
NightWatch nightwatchepilepsy.com
Neureka www.neureka.ai
Empatica www.empatica.com

Networking

Networking
We are open to meeting up to grab a coffee, or just to chat. We would really enjoy your feedback and insight into our venture and would be happy to discuss anything that you are currently working on to see if we can be of service!

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Capital

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Name Amount
Amount Left $755,000.00
Amount Raised (This Round) $1,245,000.00
Amount Raise To Date $744K
Investment Type N/A
Type of Raise Equity

Valuation
$6M
Preseed
$676K
Grant Dollars Awarded
$67.3K

TAM SAM SOM

TAM
$8.1B
SAM
$2.8B
SOM
$512M

Business Stage

Business Stage
Seed

Business Type

Business Types
Investor-Backed, Venture Capital Backed

Categories

Healthcare
Engineering
Biotechnology