A new standard of care for treating perforations of the eardrum

Elaine Horn-Ranney, PhDPresident & CEO

elaine.horn@gmail.com

Middle ear infection – most prevalent infectious disease in the world

Ventilation tubes drain fluid from infection can leave chronic perforations in eardrum

The Problem

Ventilation tube

Tympanic membrane (eardrum)

Chronic tympanic membrane perforation

The Problem1,000,000 surgeries for tubes annually in the US• 15% × 1,000,000 = 150,000 perforations from tubes Infection, hearing loss, nerve and brain damage

Annual incidence of perforations: 700,000+ in US alone Ear surgery, blast injury, other trauma

The only treatment available: Surgery• $18,000 + 40% success rate per procedure Patch falls out, infection returns

Our product – Perf-Fix™

Patent application filed through Tulane

Exclusive licensing agreement with Tulane

The Solution

No expensive surgery Antimicrobial material Enhances healing

Design Criteria

Perf-Fix™

Outer ear

Middle ear

Inner ear Tympanicmembrane

Perf-Fix™gel patch

Blue

Lig

ht

Preliminary Study

80% success rate No surgery No recurring infection

Chronic perforation day 0

Perforation with gelday 0

Healed perforationday 14

Competitive Advantage• Addressing new, previously unmet market

• Replacing 1-hour surgery with 10-min office procedure

• Competitors’ products require hand-trimming by surgeon Lower success rates, long surgery times Perf-Fix™ resolves both of these issues

Product Function Surgery required?

GelFoam® (Pfizer) Packing Yes

MeroGel® (Medtronic) Packing Yes

EpiDisc® (Medtronic) Patch Yes

Perf-Fix™ (Tympanogen) Patch No

Management TeamElaine Horn-Ranney, PhD

• President & Chief Executive Officer• PhD in Biomedical Engineering• Leading team and research

Parastoo Khoshakhlagh, PhD• Senior Vice-President & Chief Scientific Officer• PhD in Biomedical Engineering• Leading clinical development

Jesse Ranney, MD• Chief Medical Officer• Fostering collaboration between engineers and

physicians

Next Steps

Perf-Fix™ will be a class II medical device• 510(k) application – No human trials• Seeking FDA clearance in Q1 of 2017

Bench testing at EVMS

Outsource additional regulatory testing to FDA-approved facilities

Pilot studies at hospitals after FDA clearance

Perf-Fix™ gel patch addresses an unmet medical need• 770,000 annual cases in potential US market• Nonsurgical approach is departure from current standard

Preliminary testing indicated Perf-Fix™ could double procedure success rates

Response from ENT community has been overwhelmingly positive

Summary

Thank you!