Propelling the radial closure market forward
Chip Corrigan, founder and CEO of Medical Ingenuities, is a man brimming with new ideas.
In his 25 years in the medical industry, he’s been involved with eight startup companies which brought 28 new medical devices to market. But more importantly, he’s been in over 8,000 worldwide cardiac interventional cases, working with physicians on developing new technologies and figuring out how to implement them.
Chip’s collective experiences have led him to come up with a solution to a well-documented medical problem: how to apply the correct amount of pressure to the radial artery so that hemostasis, the stopping of bleeding, is achieved without occlusion. Occlusion is the crushing of the radial artery which cut’s off blood flow to the hand.
With over 80 articles dedicated to discussing this very problem, as well as a worldwide conference held on this topic each year, there can be little doubt that the medical world is looking for an innovative solution.
Radial Occlusion, A “Pressing” Problem
Knowing how much pressure to apply to the radial artery to reach hemostasis without occlusion is challenging because of the location of the radial artery. Just under the wrist, the radial artery has many advantages as an interventional access point versus the femoral artery in the leg. However, one drawback is that the radial artery is more easily crushed because of how close it is to the tissue.
When blood flow through the radial artery is inadvertently ceased, it is often asymptomatic. If the radial artery is blocked for too long, clotting may occurred and blood supply may not return., If this occurs,
the patient will later experience long-term side effects such as tingling in the hands, weakness, and pain. Furthermore, that artery may become inaccessible for future vascular procedures which potentially have serious adverse health impacts on the patient.
The PH Band’s Unique Solution: Doppler Feedback
PH stands for patent hemostasis. Chip and Medical Ingenuities are creating a smart radial compression band which uses a built-in Doppler system that tells the operator exactly how much pressure to apply to achieve hemostasis, while allowing the artery to remain patent, or open to the flow of blood.
Have you ever tried to stop a cut on your finger from bleeding by pressing firmly on the wound? You probably noticed that the end of your finger was turning bright red because you were cutting off blood flow. A similar thing happens in the wrist. However, with the radial artery, it’s more difficult to tell if too much pressure is being applied and blood flow is being blocked. Real-time feedback is needed. That’s exactly what the PH Band will provide.
The Future of Radial Access
When Chip spent time in Europe, he saw that over 80% of cardiac interventional procedures used radial access as opposed to femoral access.
The U.S. is rapidly making the switch because of the reduced risk of complications in radial access. Femoral access in the leg has a 38% complication rate because of the difficulty of closing the femoral artery.
The rate of complication is further increased if the patient is overweight because of excess fat tissue in the thigh area. Radial closure in the wrist is significantly easier in patients of any weight. The only drawback is that even slight pressure can crush the radial artery, the problem which the PH Band seeks to solve.
Patient recovery from radial access is much quicker. With femoral access, the patient has to remain in bed for 4 to 8 hours afterward because the closure on the artery could actually pop and start bleeding internally.
If a device larger than a 6 French, which is two-millimeters, is needed then the femoral artery will have to be used. But approximately 90% of cases can be done through the radial artery.
Medical Ingenuities conducted its feasibility study at Rex Healthcare where they successfully obtained radial hemostasis in 18 patients. But in order to learn the nuances of how to tweak their product, they have many more procedures planned in order to have a strong protocol in place before launching nationally.
Medical Ingenuities is focusing its initial launch on key opinion leader hospitals where new physicians are being trained in how to perform radial access.
In total, Medical Ingenuities has 10 Healthcare Systems interested in participating in the initial product launch over a six-month period. Thankfully, several of these Healthcare Systems perform a high volume of surgeries; one does 6,000 cardiac interventional procedures a year with 80% being radial.
Chip learned about Genesis Innovation Group’s cultivate(MD) Capital Funds the good, old-fashioned way: the Internet. At first, Chip thought the fund was focused exclusively on orthopedics, but after a little more research, he learned that the fund invests in a variety of medical devices. Chip decided to contact Rob Ball for more information.
Chip was excited that Rob responded to him in less than 24 hours, his first sign that this could be a good fit. Next Chip and several cultivate(MD) Managing Directors worked through an efficient diligence process, and before long, both parties wanted to move forward. Although the PH Band represents a slightly different area of medicine than some previous investments, the PH Band is the type of product that cultivate(MD) is set up to invest in.
Medical Ingenuities has finished its product design and has a manufactured product. They plan to use cultivate(MD)’s investment to complete the FDA regulatory process. Medical Ingenuities is using an experienced partner who has experience preparing and submitting 510K FDA applications for closure devices. This partner is speaking with the FDA to confirm exactly what they need to get the approval which will eliminate questions that may arise later in the regulatory process. Medical Ingenuities plans to submit the application in March or April 2019, with a targeted approval 90 days later.