Our customers are the ~4400 otologists, pediatric ENTs, and general ENTs who perform eardrum repair procedures. We sell medical devices directly to ENT practices. Both the procedure and the device can be reimbursed under existing billing codes. We are targeting ENT practices, Ambulatory Surgery Centers, and major hospital systems that have outpatient centers. Our network of ENT surgeons has been largely generated through KOL advisors, conferences, investors, and word-of-mouth. We continue to expand our ENT network to generate excitement about Perf-Fix ahead of product launch. To recruit and onboard new ENT surgeon customers, we developed a training simulator and protocol that teaches surgeons how to use Perf-Fix so that they can be successful with the first application on a patient. This training is for marketing purposes only, and will not be submitted as part of the de novo application. We are also building a reimbursement plan that will show both ENT surgeons and practice managers how to reimburse for Perf-Fix using current billing structures. Both the training simulator and reimbursement guidance are intended to remove barriers to using Perf-Fix for any customer channel (private practice, outpatient, ASC, hospital, etc).

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. We are transforming a common surgery into a clinic-based procedure using existing reimbursement and procedural framework for minimal disruption of clinical workflow. Our device can heal subtotal perforations and regenerates the full structure of the eardrum, which has not been accomplished by any other graft material previously. We can also expand our gel technology into a pipeline of ENT products using much of our current manufacturing and supply chain assets.

Our customers are the ~4400 otologists, pediatric ENTs, and general ENTs who perform eardrum repair procedures. We use conferences to generate new sales leads and build our waitlist. We are building a wait-list of ENT customers to capture the ~160 customers needed to break even in 2026. Sales leads are generated through conferences (n=200-300 new customers/year). We are prioritizing speed over volume, with 75% of sales coming from clinical practices (faster onboarding) and 25% of sales coming from hospital systems (larger purchase volumes). Training with a provided training kit will be done virtually as part of onboarding.