We develop medical devices that streamline ear, nose, and throat procedures using our proprietary gel technology.
Richmond, VA, USA
One Liner
One Liner
We develop medical devices that streamline ear, nose, and throat procedures using our proprietary gel technology.
What Problem We are Solving
Problem
Middle ear infection is the most common childhood disease in the world. Over 1,000,000 US patients receive ear tubes annually, and about 170,000 of these patients will have a chronic eardrum perforation after the tube is removed. Untreated perforations can result in recurring infection, hearing loss, and significantly decreased quality-of-life.
About Us
About Us
We are a medical device company that offers offer ear, nose, and throat surgeons (ENTs) efficiency in their practice alongside exceptional care. We do this through thoughtfully designed solutions that fit existing clinical workflows. We develop, manufacture, and market medical devices based on proprietary gel technology. Our first product, Perf-Fix Otologic Gel Patch, replaces surgical eardrum repair with a clinic visit.
Venture Highlights
Highlights
We have had two SBIR grants - one Phase I from the Dept of Defense, and a Phase II from the NIH.
We have doubled our headcount in the last year and expect to double again this year.
We won another grant for $737K to support a clinical study next year.
We won the ENTrepreneur Faceoff competition at the Academy of Otolaryngology-Head Neck Surgery annual meeting in 2021.
We have had 3 meetings with FDA and our regulatory pathway is crystal clear.
Business Model
Business Model
After FDA clearance by de novo in Q2 2024, Perf-Fix will be sold directly to ENT practices and hospital systems, either by Tympanogen or a distributor. Buyers will purchase a Starter Kit that includes the reusable curing light and 2 Perf-Fix patches for $4,000. Revenue is generated from Refill Kits ($20,000 for 10 patches, reorder every 2 months). Existing CPT and HCPCS II codes will cover Perf-Fix and its application Anticipated pricing with existing codes will reimburse ENTs $1,000 for the procedure and $2,000 for the Perf-Fix patch. New ENT products will launch after Perf-Fix.
Competitive Advantage
Quote
Perf-Fix gives ENTs the choice to move away from surgery for safety reasons, as well as the financial choice to move toward a time-saving procedure that will reimburse at a higher rate. ENTs who switch to Perf-Fix from surgery can be more profitable through increased patient volume compared to surgery. By transitioning eardrum repair out of the operating room and into the clinic, the operating room time is now available for higher margin procedures and the ENT sees profitability in their clinic where they traditionally break even. Through the de novo pathway, Perf-Fix will be the only marketed device for eardrum repair with a pediatric indication, clearing the way to market dominance.
Revenue
Revenue To Date
N/A
MRR
N/A
Revenue YTD
N/A
Burn Rate
N/A
Customer Costs
CAC
N/A
LTV
N/A
Churn
N/A
Margins
N/A
Go-To Market Strategy
Business Strategy
We are building a pre-sales list of ENT KOLs to capture the ~230 customers needed to break even in 2024. These customers will be recruited by our internal sales personnel. After launch, the majority of new customers will come from a distribution partner with a broad ENT network to reach customers quickly (n=200-300 new customers/year). We have active discussions with potential distribution partners focused on ENT devices. Onboarding includes training with simulator to ensure success with first patient.
The standard patch used to repair eardrum perforations is cartilage or fascia from the patient's ear, which stays in the eardrum indefinitely and requires an extra surgical step. Cook Medical and Medtronic make eardrum-repair products that still require surgery to apply and hand-trimming to fit the dimensions of the perforation. This leads to longer surgery and recovery times, both of which are issues eliminated by using Perf-Fix. Additionally, neither Cook nor Medtronic's products have pediatric indications, preventing these entities from marketing their products to the largest patient segment.
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!
Share
Capital
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Name
Amount
Amount Left
$1,300,000.00
Amount Raised (This Round)
$1,200,000.00
Amount Raise To Date
$3.94M
Type of Raise
Convertible Note
Valuation
$8M
Friends & Family
$90K
Preseed
$350K
Grant Dollars Awarded
$3.5M
TAM SAM SOM
TAM
$340M
SAM
$120M
SOM
$40M
Business Stage
Business Stage
Seed
Business Type
Business Types
Investor-Backed
Categories
Technology
Healthcare
Engineering
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