May 29, 2023

Tenex Health Announces 510(k) US FDA Clearance for TX®-Bone, the Latest in Cutting-Edge Ultrasonic Technology to Help Patients Restore Musculoskeletal Function Without Invasive Surgery

Company started around 2010 and the motivation was to try to address a common problem that has a number of treatment options but nothing definitive if you will and that that problem was tendinopathy penix has a mission that is stated and directs our activities which is to be the definitive treatment for chronic refractory tendinopathy in all of its anatomic sites

And manifestations 10x has changed the way i treat tendinopathy completely usually we start with therapy and if patients fail therapy the book tells you to wait for 13 months and the problem should go away well usually the patient goes away but i don’t know if the problem goes away so 10x offers an excellent stopgap for me between therapy and open surgery i think

The big advantage of the 10x technology is that we don’t burn any bridges in terms of you know it’s still going with a traditional surgery if this doesn’t work so we really see it as kind of growing the pie in terms of available options to people while these patients are not gonna have traditional surgery at least they’re not ready for it yet but they are willing

To use the 10x technology to do an ultrasound-guided procedure percutaneous tenotomy using 10x is quick and easy for both the patient and the provider typically we bring you in prep the area just with standard alcohol and climaxing wash and then inject numbing medicine local anesthesia into the area make a small nick in the skin and at that point i’m guiding the

Procedure under ultrasound use the ultrasound to visualize the area of the tendon that’s bad and needs treatment and then put the probe right into the area that needs to be treated hit the foot pedal and the machine uses ultrasound to cut and remove a bad tissue put a bandaid on and an ace wrap depending on the site the treatment takes somewhere between 40 seconds

And two and a half minutes the ultrasonic energy cuts the diseased tissue but it has a very safe profile because it doesn’t interfere or damage normal tissue to any extent it’s also a hollow probe so it actually removes the diseased tissue so in that sense it’s like surgery those are the features that make this a game-changer so if you already have a level of

Confidence to do ultrasound guided injections for example you have the psychomotor skills to do that the experience to do that the 10x technology is just a natural extension of that it’s a very easy technology to adapt to your existing skill set documentation is very important when you’re trying to develop the new technology and it’s a really a requirement the one

Study that i’m very fond of is from mayo clinic where one of the individuals who actually conceived of the idea of using ultrasound guidance to treat various tendinopathy over and above injections and he found that about 95% of his patients did well in a year the other thing that we intentionally did is we encourage physicians with different specialties to document

Their experience so we have documentation from birth peak surgeons documentation from non-op the sports doctors interventional radiologists and podiatrists so that indicates that the procedure can be done not just by an orthopedic surgeon but by anybody that sees ten enough my results are 80 to 90 percent success rate which is about as good as anything we have in

Medicine and the patients love it they’re very very happy with it they love that they don’t have to have general anesthesia they love that they don’t have to have stitches they love that there’s no splinting they love that they get back to their lives faster but i think makes this technology exciting and separates it from other options is the fact that we’ve done

Over 85 thousand procedures and there’s fewer than 20 complications so it’s extremely safe the term game-changer has been used to address the product i used it the first time when i was asked my opinion about it and it was just a concept and i said if it’s safe and effective and easily done and easily learned it’ll be a game-changer and it has been we now have a

Probe that will remove bone and that makes it even more of a game-changer because we can now apply the technology to problems that weren’t able to address before you treat a patient they have excellent results and then they want you to continue to help them in other parts of their body so sometimes you’ll see somebody for a foot and then you end up doing their hip

Or an elbow and end up doing their knee it’s i think it’s real testament to the 10x technology that patients can immediately see that there’s an improvement and they want to know if this technology can be used in other places to help them with their pain

Transcribed from video
Tenex Health Technology Overview Video By Tenex Health