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Aurenar

Aurenar is improving stroke outcomes and reducing hospital stays/costs with an easy-to-use non-invasive ear stimulation device that activates the body's naturally healing vagal nerve response--with validated clinical results from a recent randomized controlled clinical study

St. Louis, MO, USA

One Liner

One Liner
Aurenar is improving stroke outcomes and reducing hospital stays/costs with an easy-to-use non-invasive ear stimulation device that activates the body's naturally healing vagal nerve response--with validated clinical results from a recent randomized controlled clinical study

What Problem We are Solving

Problem
Aurenar is addressing life-threatening and costly secondary complications that result from hemorrhagic stroke (e.g. vasospasm, hydrocephalus, infection). Following the initial repair of a brain hemorrhage, stroke patients are held in a neurocritical care unit to monitor and treat serious secondary complications, requiring expensive hospital stays ranging from weeks to months. 

Aurenar has already performed an NIH-funded randomized controlled clinical study (N=24) with exciting results that validate its novel ear stimulation technology. Clinical results demonstrate large and statistically significant improvements in patient outcomes, reduction of hospital stays, and reduction in overall costs for patients that received the novel therapy vs patients that did not. 

About Us

About Us
Aurenar is a unique seed-stage startup that is launching from a solid foundation—supportive clinical data, an IP portfolio that includes 13 granted patents, and comprehensive development, regulatory, and go-to-market strategies. Aurenar is led by co-founding neurosurgeon and serial entrepreneur, Dr. Eric Leuthardt, and supported by a seasoned team that blends business, engineering, regulatory, and clinical trial expertise. Aurenar is currently raising a seed round to develop its product, V-Link, under FDA-required design controls and perform required validation and safety testing necessary to initiate a final pivotal clinical trial. Two planned follow-on rounds will support the pivotal clinical trial and commercial launch.

Venture Highlights

Highlights
Aurenar is a unique seed-stage neurotechnology company with impactful accomplishments that surpass most series-A stage companies—specifically:
  • overwhelmingly supportive CLINICAL DATA from a randomized controlled study 
  • a robust IP portfolio that includes 13 GRANTED PATENTS

Aurenar’s NIH-funded clinical study was conducted with non-dilutive funding and demonstrated statistically significant improvements in stroke patient outcomes while simultaneously reducing hospital stays and medical costs.  Beyond the benefit of DE-RISKED TECHNOLOGY, these positive results provide the basis for Aurenar’s VALIDATED BUSINESS MODEL, demonstrating medical and cost benefits to patients, hospitals, and insurers.  Importantly, early completion of this study results in an ACCELERATED PATH TO MARKET by eliminating years of time and millions of dollars otherwise required for an equivalent future pilot study.

Additional value-adding achievements include:
  • Candidate for ACCELERATED REGULATORY PATHWAY via FDA Breakthrough program and de novo marketing pathway, based on a third-party analysis conducted by world-leading regulatory consulting agency, Hogan-Lovells
  • STRONG COMPETITIVE ADVANTAGE based upon a third-party analysis conducted by world-leading product consulting agency, Simbex
  • GO-TO-MARKET STRATEGY targeting the most costly and in-need stroke population, sub-arachnoid hemorrhage, followed by intracerebral stroke, and many more markets beyond

Aurenar is ahead of the game with a team of experts who have devised integrated plans spanning product development, regulatory, clinical, and go-to-market strategy.  Collectively, these valuable early achievements have Aurenar positioned for rapid success.

Business Model

Business Model
Aurenar’s V-Link COST OF GOODS SOLD (COGS) IS $25 per device (estimated) and SALE PRICE IS $250 per device.  This equates to a GROSS PROFIT MARGIN OF 90%.  For each stroke patient, a new disposable V-Link device is anticipated to be used each day (to mitigate risk of hospital acquired infection) for a total of 14 days during the typical length of stay in the neurocritical unit, equating to $7,000 per patient. 

Aurenar’s V-Link neurostimulation device provides both CLINICAL AND COST BENEFITS TO PATIENTS, HOSPITALS, AND PAYERS (i.e. insurers who reimburse medical costs), demonstrating STRONG MARKET PULL for V-Link and a ROBUST BUSINESS MODEL.

A recent randomized controlled study validated Aurenar’s business model by demonstrating large and statistically significant improvements in stroke patient outcomes, reduction of hospital length of stay by 3 days, and reduction of medical costs by more than $15,000 per patient with potential for additional downstream cost savings.

V-LINK  DEVICES ARE SOLD DIRECTLY TO HOSPITALS.  Following initial hemorrhage repair, hospitals monitor and treat stroke patients for secondary complications for approximately 2 weeks in a neurocritical care unit. Common secondary complications include vasospasm, hydrocephalus, and infection—all of which are significantly reduced by the V-Link therapy, as demonstrated in Aurenar’s randomized controlled clinical study.    

HOSPITALS HAVE A STRONG CLINICAL AND ECONOMIC MOTIVATION TO USE V-LINK to improve patient outcomes, reduce length of stay to free up beds for treating new patients, increase profits, and reduce penalties.  Hospitals are reimbursed by insurers for some or all of incurred medical costs at a fixed pre-negotiated amount.  Hospitals are financially incentivized to perform at a cost below this amount to increase profit (V-Link is proven to reduce costs) and are financially penalized for hospital acquired infections (V-Link is proven to reduce infections).  

Competitive Advantage

Quote
Aurenar is a unique seed-stage startup that is launching with high-value accomplishments that surpass most series-A stage companies:
  • DE-RISKED PRODUCT validated by CLINICAL DATA from a randomized controlled study
  • REDUCED TIME AND COST by completing a pilot study supported by a non-dilutive grant
  • ACCELERATED REGULATORY PATHWAY via FDA Breakthrough program and de novo marketing pathway 
  • STRONG COMPETITIVE ADVANTAGE based upon a third-party analysis 
  • a robust IP portfolio that includes 13 GRANTED PATENTS to block competitors
  • COMPREHENSIVE PLANS for development, regulatory, and go-to-market strategies
  • VALIDATED BUSINESS MODEL and MARKET ENTHUSIASM supported by clinical and economic evidence

Aurenar is led by co-founding NEUROSURGEON AND SERIAL ENTREPRENEUR, Dr. Eric Leuthardt, and supported by a SEASONED TEAM that blends business, engineering, regulatory, and clinical trial expertise.  

Aurenar is uniquely positioned for RAPID SUCCESS and looks forward to partnering with you!

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Margins
90%

Go-To Market Strategy

Business Strategy
Aurenar’s initial market segment will focus on stroke patients in the United States with sub-arachnoid hemorrhage (SAH) ($210M market), followed by intracerebral hemorrhage (ICH) ($470M market), and finally all of stroke ($5.6B market).  

The first year of sales for SAH may be associated with a soft launch at a subsidized price to create success stories at the highest volume neurocritical care units.  The soft launch will feed marketing assets and drive higher adoption rates during subsequent years of sales at full price.  This strategy has proven to be successful in adjacent medical device markets.

Aurenar will rapidly follow the SAH entry market with progressively larger markets targeting ICH and all of stroke in the United States and then expand to European markets.

Competitive Analysis

Competitive Analysys
A THIRD-PARTY COMPETITIVE ANALYSIS performed by world-leading medical product consulting firm, Simbex, determined there are NO EXISTING COMPETITORS IN THE STROKE MARKET.
 
No existing drug or medical device is capable of achieving improved clinical outcomes, reduction of vasospasm, reduction of hydrocephalus, and reduction of infection.  AURENAR’S V-LINK PRODUCT ACHIEVED REDUCTION OF EACH MAJOR STROKE-RELATED COMPLICATION IN A RANDOMIZED CONTROLLED CLINICAL STUDY.  Additionally, V-Link significantly reduced hospital length of stay and medical costs.
 
No existing medical device is capable of addressing key challenges for use in the intensive care unit.  Specific challenges include fast and easy placement by nursing staff, elimination of infection caused by re-use, reduction of capital equipment costs, and burden of maintenance.  AURENAR’S V-LINK PRODUCT SOLVES EACH CHALLENGE FOR USE IN THE INTENSIVE CARE UNIT.  V-Link is easy to place on the ear by nursing staff, is pre-programmed to apply a self-timed 20 minute stimulation therapy, is single use and disposable to eliminate risk of infection, and has no capital equipment cost or maintenance.
 
The third-party competitive analysis identified two existing medical device products that activate the vagal nerve via minimally-invasive neural stimulation for non-stroke related applications.  Neither device is suitable for use within the intensive care unit. 
 
The first product identified, GammaCore, non-invasively stimulates the vagus nerve through the neck, requiring the hand-held device to be held in place for approximately 30 minutes to treat migraines.  This technology is not FDA-approved for stroke, requires careful placement to target the vagus nerve, is impractical for intensive care nursing staff to hold in place for extended periods, introduces risk of infection through re-use, and requires capital equipment cost and maintenance.
 
The second product identified, Masimo Bridge, stimulates the auricular nerve branch in the ear using penetrating needle electrodes inserted into the ear to treat opiod withdrawal symptoms.  This technology is not FDA-approved for stroke, requires tedious placement using transillumination of the ear with a flashlight tool to locate hidden nerve branches, is impractical for intensive care nursing staff administer, introduces risk of infection through re-use, and requires capital equipment cost and maintenance.
Competitor Website
Masimo Bridge www.masimo.com
GammaCore www.gammacore.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 $750,000.00
Amount Raised (This Round) $1,250,000.00
Amount Raise To Date $653K
Type of Raise SAFE

Valuation
$10M
Grant Dollars Awarded
$653K

TAM SAM SOM

TAM
$85.4B
SAM
$5.6B
SOM
$680M

Business Stage

Business Stage
Seed

Business Type

Business Types
Investor-Backed

Categories

B2B
Technology
Healthcare
Engineering
Biotechnology

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Last Updated: 01/21/24

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