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Thomas Sandgaard
Founder, President, Chief Executive Officer & Chairman, ZYNEX INC

Zynex Inc. Gains FDA Clearance for New TensWave Device, Expands Pain Management Solutions

🎥 Sep 04, 2024 📺 Proactive Investors ⏱ 5m 👁 614 views
Zynex Inc CEO Thomas Sandgaard joined Steve Darling from Proactive to announce the FDA clearance of its latest device, the ...
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About Thomas Sandgaard

Thomas Sandgaard, founder and CEO of Zynex, has been discussing the company's growth and product development in multiple media appearances. He stated that Zynex expects to reach $200 million in revenue in 2024, up from $13 million in 2016, and projected long-term revenue of $800 million in the pain management division. Sandgaard described the company's flagship NextWave device and noted that the sales force has grown to nearly 500 representatives, with plans to add 300 more. He also announced FDA clearance for a new TensWave device, which he said is intended for patients who cannot use the NextWave or when insurance prefers a TENS device. Sandgaard has also highlighted the company's hospital monitoring division, which he said has four products in development. He described a laser-based pulse oximetry device as a potential "game changer" that could more accurately measure oxygen, carbon monoxide, and methemoglobin levels, and could help detect sepsis. Sandgaard noted that the monitoring division has not yet generated revenue but that one product is nearing FDA submission. He also mentioned that Zynex has helped over one million patients with pain management and emphasized the company's focus on non-addictive alternatives to opioids.

Source: AI-verified profile updated from Thomas Sandgaard's recent appearances. Browse all interviews →

Transcript (13 segments)
I
Interviewer0:00
It's about breaking into the industry. It's more of the same. It's our sales force becoming more productive and getting a better foothold in clinics that see patients with pain.
Welcome back inside our proactive newsroom. And joining me now is Thomas Sandgaard. He is the CEO of Zynex. And Thomas, it's great to see you. How are you?
T
Thomas Sandgaard0:24
Hi Steve, good morning.
I
Interviewer0:28
Awesome, good stuff. We have significant news out from the company that you've received FDA clearance for the new TensWave device. So before we talk about the clearance, what that means, maybe just remind everyone a little bit about the TensWave device. And this is part of your pain management solution, correct?
T
Thomas Sandgaard0:44
That's right. Yeah. We offer a number of products for pain management. Our flagship, the NextWave, is obviously best selling. That includes the interventional modality. There is a part of the market where there is a need for the more traditional TENS wave, a much lower frequency and only one channel at a time version of what an interventional device does. In this situation, for instance, if someone had metal in their leg where interventional simply goes too deep and turns around more the surface would be affected. What we have done is come up with a prescription-strength version of TENS devices versus the heated TVM, much less expensive and not very effective devices you can find on the market, usually sold for what is considered in FDA terms over-the-counter, meaning it doesn't require a prescription, but it is TENS. So it was a great complement to our NextWave device. And it has several modalities built in that are just very beneficial. One of them being the burst mode that is really good at inducing endorphins in the body. The body's own anesthesia can help mask pain throughout the body. Sometimes that's effective if an X-ray or the TENS wave is not able to treat a specific area, just getting that general anesthetic in the body through endorphins is very helpful.
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Interviewer2:30
Yeah. And so I imagine this is a large swath of people that would be able to use something like this because we've heard about the many people who are recovering from injuries and pain, and this is something that I think would be utilized quite a bit all over North America.
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Thomas Sandgaard2:46
That's right. Pain or treating pain is a 30 billion dollar industry in this country. And that in itself indicates how big of an issue it is. We still expect the NextWave to be selling just like it is today. The TENS wave is more to be prescribed or provided to patients when there is an issue where the NextWave wouldn't work that well, or if an insurance company prefers we bill them for a TENS device instead of the multi-modality NextWave device.
I
Interviewer3:25
Yeah. So now that you have FDA clearance for this, what is the process moving forward? And this clearance really is important as far as the insurance carriers are concerned as well.
T
Thomas Sandgaard3:35
That's right. That would be helpful so that we can provide some coverage for patients. But if they have a different insurance policy, going forward, it's about breaking into the industry. It's more of the same. It's our sales force becoming more productive and getting a better foothold in clinics that see patients with pain.
I
Interviewer4:02
Yeah. And just on that, Thomas, quickly, I would imagine that a lot of it is show and tell, to go out and show these people who are dealing with pain management how this works and why it works that way. And that seems to spread word of mouth-wise, because it really is a small industry of people that are doing this type of work.
T
Thomas Sandgaard4:21
Well, I would say it's actually a very, very large industry. Our sales force visits a lot of different medical specialties, anywhere from orthopedic surgeons. It could be family physicians. It could be in some cases chiropractors, physical therapy, and interventional pain. There's a wide range of specialties that prescribe for pain. So yeah, I'd say it's actually a very, very large market. And as you mentioned, it's show and tell. A lot of it is about providing an in-service for those professionals in the clinic and making sure we build relationships. Our business is very reliant on getting repeat business. So once physicians get the experience with how well it works for the patients and they get treated well by our customer service and insurances pay, then they typically continue to write prescriptions, and then it becomes more of a maintenance sale.
I
Interviewer5:28
Absolutely. And when you bring in orthopedic surgeons and chiropractors and all that, you're right. It does become a huge, large market. Absolutely. So, Thomas, thanks very much. Congratulations on this FDA clearance. Exciting news for the company.
T
Thomas Sandgaard5:39
Yes, thank you. Appreciate it.