Archive:
6.24.2020 Cuticlens Whitepaper
8.31.2020 Cuticlens Proposal
9.8.2020 Project Development Plan
9.15.2020 Project Development Plan
10.4.2020 Testing Protocol
12.1.2020 Preclinical Trial Results (null)
Provisional Specification Patent
Renderings For Patent
The Problem:
In 2011, there were approximately 65,000 shoulder replacements performed in the United States, and the volume isW expected to grow. The overall estimated rate of deep infection after shoulder replacement is approximately 1%. Surgical site infection accounts for 22% of all health carerelated infection costs estimated from $1-10 billion annually. Cutibacteriumacnes (C. acnes), formerly known as Propionibacterium acnes, causes more than50% 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 used for the infected shoulder replacement. The mean overall hospital cost for a two stage treatment of a patient with an infected shoulder replacement is $35,824 which is more than double the cost of a primary shoulder replacement. These patients are hospitalized twice, once to remove the infected shoulder replacement and then again to re-implant a new shoulder replacement 3-6 months in the future. Unlike primary shoulder replacements, revision surgeries are longer, require more anesthesia, have higher blood loss and increases in morbidity. Currently, Irrisept isa popular medical product that preforms a similar function, but targetsStaphylococcus infections using chlorhexidine gluconate (CHG), which are lessof a problem in shoulder surgery. C. acnes is not completely eliminated by CHGor Betadine (povidone iodine) because topical surgical preparations cannot reach the bacteria in the sebaceous glands. In fact, 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 the cost of $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 in some way (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.
