The Problem
In 2011, there were approximately 65,000 shoulder replacements performed in the United States, and the volume is expected to grow. The overall estimated rate of deep infection after shoulder replacement is approximately 1%. Surgical site infection accounts for 22% of all healthcare-related infection costs estimated from $1–10 billion annually.
Cutibacterium acnes (C. acnes), formerly known as Propionibacterium acnes, causes more than 50% of infections after shoulder arthroplasty. Because the organism forms a biofilm, it is protected from the body's immune defenses. The only way to cure an infection caused by C. acnes is to remove the infected shoulder replacement and place a new one.
In the US, two-stage reimplantation is the most common treatment strategy. The mean overall hospital cost for a two-stage treatment is $35,824 — more than double the cost of a primary shoulder replacement. These patients are hospitalized twice, and revision surgeries are longer, require more anesthesia, have higher blood loss, and increase morbidity.
Currently, Irrisept is a popular medical product that performs a similar function, but targets Staphylococcus infections using chlorhexidine gluconate (CHG), which are less of a problem in shoulder surgery. C. acnes is not completely eliminated by CHG or Betadine (povidone iodine) because topical surgical preparations cannot reach the bacteria in the sebaceous glands. No current strategies have been proven to decrease the risk of postoperative C. acnes infection.
The Solution
We are developing a low-cost medical device using a proprietary formula which reduces the infection rate significantly. We aim to sell this device for $80–$120 to hospitals. We will be able to use the FDA's 510(k) process using Irrisept as a substantially equivalent medical device.
The Market
With over 500,000 annual surgeries performed in the United States that could benefit from this device (including neck, face, and upper back surgery), a 50% market penetration could yield $25MM ARR. We will be targeting surgeons, hospitals, and insurance companies. We have spoken to orthopaedic surgeons about the idea, and they expressed an interest in using this product, once on the market.
