Our first product is the LaparoTense, a minimally invasive diagnostic surgical tool that enables personalization of anterior cruciate ligament (ACL) reconstructions. The LaparoTense is unique in that it determines the final tension within the graft, which is the most critical factor for the success of the surgery, while staying consistent with the current laparoscopic surgical approach.
In conjunction with the LaparoTense, we will determine and supplement optimal tensions based on graft type and important patient-specific factors, such as gender, age, weight and activity level, all of which have a large bearing on the requirements of the joint. This results in true personalization of the surgical procedure, which significantly improves patient outcomes while reducing error rates and healthcare costs.
Currently, 1 in 3 ACL reconstructions are ultimately unsuccessful. This is an astounding failure rate and causes a great deal of pain and loss in productivity for those injured.
ACL rupture is one of the most common injuries in the world. Most often, a full surgical reconstruction is necessary in order to provide stability to the knee and avoid pain, compromised functionality, eventual osteoarthritis, and end-stage treatments. As a result, ACL reconstruction is the 6th most common surgical procedure performed in the United States, with over 300,000 reconstructions performed annually.
Upwards of 8% of cases result in a total failure and require a subsequent revision surgery, which has a much lower success rate. Additionally, 18-30% of cases are deemed unsuccessful, indicated by failure to return the desired levels of functionality to the knee. All of these sub-par surgeries result in post-operative complications and lengthy down-times, which drive healthcare costs and employer costs up. Combined, our total target market reaches $3.1 Billion.
There is a large drop-off and variability in final graft tension following implantation, which is the most critical factor in determining the success of the surgery. There is no method to determine this tension while staying consistent with the current laparoscopic surgical approach, so it is left up to the discretion and feel of the operating surgeon. Consistently arriving at this optimal tension is a problem for all surgeons, regardless of experience. To compound the problem, 85% of surgeons who perform ACL reconstructions do less than 10 a year, which severely hurts the learning curve. This results in a dismal 67% average success rate in ACL surgeries. By supplementing surgeons with our critical diagnostic tool and customized data, we can enable all surgeons to consistently perform optimal surgeries.
Our initial conservative projection is over $750 Million in annual healthcare savings with the use of our patented device and data.
Our approach is consistent with current market trends in personalized medicine and interventional procedures. With the Affordable Care Act in place, there is a large incentive for insurance providers to reduce the cost of these surgeries. Additionally, hospital penalties for patient re-admissions due to failed surgeries or post-operative complications will triple over the next two years. This creates a large pressure for hospitals to improve patient outcomes and reduce these costly re-admissions.