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Meyerson BA, Hakansson J. Alleviation of atypical trigeminal pain by stimulation of the Gasserian ganglion via an implanted electrode. Goroszeniuk T. The effect of peripheral neuromodulation on pain from the sacroiliac joint: A retrospective cohort study. Follow-up of subjects in this trial will continue for a total of 5 years, providing additional insights into the long-term benefits, risks, and reliability of this device. This was a relatively small study (n = 44) with only 1-year follow-up. as an approval or endorsement of the product(s) by the PDAC, DME MACs, or Medicare, nor does it The potential for competition is also underpriced - for instance HCW assumes competition does not enter until 2028 and Ladenburg applies a 6x multiple to 2022 revenues. "Because it's illegal. Recent literature highlighted a myriad of therapeutic options ranging from conservative treatment and minimally invasive options to surgical management; however, there are no comprehensive review articles comparing these treatment modalities. Koca I, Boyaci A, Tutoglu A, et al. J Bodyw Mov Ther. Minerva Anestesiol. In our view, the sell-side is also wrong or has done minimal diligence on the CM-1500. 1997;1(6):1-137. Or just look at its business model (Exhibit 1) and now its new catalog business. So, it's really all regulated by the insurance companies, and they obviously get an initial amount of supplies when we ship the device, and from there on out, it's really what kind of quantities that the insurance company allows.". And this doesn't account for completed offerings - thousands more were sold in just the last three months in 80+ listings. Diabetes Care. This has contributed to retail shareholders and sell-side analysts misinterpreting industry dynamics including market size and risks, especially associated with reimbursement. 95-0642. USE HCPCS CODE E0730 WHEN PROVIDED AS A TENS. Each patient was implanted with a neurostimulation device. 2014;10:CD011324. While SCS has shown promise for severe truncal and extremity PHN, it has no impact on neuralgias of cranial nerve origin. Neuromodulation. 2006;15:227-233. First, more objective methods to examine nociceptive pain are needed, such as von Frey test for nociceptive peri-orbital pain threshold; thus, more evaluations need to be carried out for assessment of migraine except video recordings for associated behavior of migraine in the future. The author described the cases in which an 86-year-old man and a 76-year-old woman with intractable PHN of greater than 6 and 4 years, respectively, were effectively treated with PNS of the ophthalmic division of the trigeminal nerve. Acute pain management: Operative or medical procedures and trauma. Owning Zynex is a bet that insurance abuses or inefficiencies can persist indefinitely. Johnson M, Martinson M. Efficacy of electrical nerve stimulation for chronic musculoskeletal pain: A meta-analysis of randomized controlled trials. After unblinding and the switch from sham to therapeutic stimulation in the sham-control group, improvements increased over time out to 1 year in the combined cohort. Other research considers the pathophysiology of a disorder and then gradually develops and improves a methodology. Consider Cheetah Medical whose Nicom hemodynamic monitoring system uses an advanced form of impedance analysis. Although the primary endpoint was inconclusive, overall data from the blinded phase of this trial were consistent with a clinically meaningful benefit at 120 days. My complaint is this company's billing practices. Orthopedics. The 2016 "study", administered by ZYXI's Director of Strategy and Business Development, consisted of eight volunteers whose index changes were recorded during a local blood draw Zynex hosted at its headquarters. TRICARE's negative coverage decision puts TENS units under a spotlight. Pain Med. 2017;9:CD011976. The extensive evaluation ruled out the underlining pathology. Pricing should be stable and we know the size of the market. An implantable neurostimulation system that aims to restore multifidus motor control by stimulating the L2 medial branch of the dorsal ramus (ReActiv8, Mainstay Medical) and thereby relieving pain and reducing disability has demonstrated clinically significant benefits in the clinical trial setting. Moore SR, Shurman J. Deer et al (2021) noted that PNS is a promising treatment for axial LBP; however, the use of conventional permanently implanted PNS systems has been limited by the invasiveness of the procedure and is technically challenging because of the lack of dedicated hardware. Kovacic K, Kolacz J, Lewis GF, Porges SW. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. To allow for the assessment of meaningful longer-term outcome, implants for all 12 patients had been in place for a minimum of 18 months to a maximum of 36 months prior to the formal review. Subjects (n = 15) with a return of chronic axial pain after RFA underwent implantation of percutaneous PNS leads targeting the medial branch nerves. The Healthcare Common Procedure Coding System (HCPCS) codes at issue include A4556, A4557, A4630 and E1399, which are described as electrodes, lead wires, . Carpal tunnel syndrome: Effectiveness of physical therapy and electrophysical modalities. 2022;12(7):795-804. 32: 327-333. The H-wave signal is a bipolar, exponential decaying waveform that supposedly overcomes the disadvantages of other electrotherapy machines. This would mean ZYXI resold about $22.6mn of electrodes last year. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow-ups. 2017;906:387-406. We believe the device will follow a path similar to that of every other device ZYXI has touted in the past and end up as a failure. Medscape Neurol Neurosurg. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. At 4 years, 2 of 3 patients were satisfied with the treatment results. Leak WD, Ansel AE. Fourth, outcome data to 1 year were presented. The financial implications are considerable. Deckers K, De Smedt K, Mitchell B, et al. Patients were randomly assigned to groups that received PENFS (n = 27; median age of 15.3 years; 24 female) or a sham stimulation (n = 23; median age of 15.6 years; 21 female), 5 days/week for 4 weeks. To our knowledge, no notable public M&A has occurred in the space since 2005 so investors and analysts have not had a benchmark in over 15 years. The authors concluded that neither ET nor US proved to be effective as adjuvants to exercise therapy for soft tissue shoulder disorders. They stated that further research into the mechanism of action of TENS is needed, as well as more rigorous studies for determination of efficacy. Australas J Dermatol. This effect was supported by a significant correlation between baseline VE and degree of pain reduction only in the treatment group. Slight group differences such as longer pain duration and higher rates of depression along with temporary stressors may have influenced results. Electrical stimulation for the treatment of headaches [summary]. Robb K, Oxberry SG, Bennett MI, et al. Ventafridda V, et al. Zynex NexWave TENS Unit Review - Does The NexWave TENS Work - YouTube make recommendations based on the research, and. Recommendations for neuropathic pain treatment. TRICARE, the health plan for military members, retirees and their families, recently decided to stop covering TENS units for lower-back pain beginning June 1, 2020. Durable Medical Equipment (DME) Medicare Administrative Carrier (MAC) Jurisdiction A. Hingham, MA: NHIC; 2008. 2022 Sep 29 [Online ahead of print]. We also discuss factors contributing to the stock's mispricing and present a valuation based on comparative multiples and DCF which prices the stock at least 70% lower. Electromyogr Clin Neurophysiol. 2011;12(6):953-960. J Sport Rehabil. 2021b Dec 18 [Online ahead of print]. Osteoarthritis Cartilage. Please contact Patient Support at (720) 912-3415 or patientsupport@zynex.com One former employee told us Zynex frequently uses the back brace to "bust deductibles". Chou R, Huffman LH; American Pain Society; American College of Physicians. Riederer F, Penning S, Schoenen J. Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly() device for migraine prevention: A Review of the Available Data. Sources: Empi [Pg. Magis D, D'Ostilio K, Thibaut A, et al. Pre-specified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Jul 29, 2021 11:15 am EDT. Five months after PNS, 93 % (n=14/15) reported clinically meaningful improvement in 1 or more outcome measures, and a majority experienced clinically meaningful improvements in all 3 outcomes (i.e., pain intensity, disability, and pain interference). PP Raj, ed. Vij et al (2022) stated that the prevalence of suprascapular neuropathy is higher than previously estimated. Pachman DR, Watson JC, Loprinzi CL. Neurology. The current price of $24 is pricing in nonsensical outcomes. Afterwards Medicare payments on TENS units fell from approximately $400 to $65 and from $32 to $10 on a monthly pack of supplies (which includes batteries and electrodes) [Pg. Revenue per order fell for device but increased sharply for supplies. Cephalalgia. We see similarities to Philidor in Zynex's minimal R&D, monthly prescription auto-renewals, and routine copay waivers. HCPCS Code Range E0720-E0770 . 2019;27(5):1765-1774. Furthermore, the small number of males prohibited assessment of sex interactions. Invasive surgical methods (e.g., fusion) that alter the anatomy of the spine with considerable rates of failure and high AEs rates are often considered before neurostimulation. Manufactured by Aspen Medical Products, the Horizon 637 can be found online for around $100, but reimbursement fees range from $1050 to $1400. PDF Corporate Medical Policy Neurostimulation, Electrical - Blue Cross NC J Headache Pain. 2021;14:463-479. Brodsky JB, Mark JB. A total of 2 patients with severe SIJ pain were treated by implanting a neuro-prosthesis at the 3rd sacral nerve roots. Overview of upper extremity peripheral nerve syndromes. Long-term outcomes of restorative neurostimulation in patients with refractory chronic low back pain secondary to multifidus dysfunction: Two-year results of the ReActiv8-B Pivotal Trial. Traditional equity investors had little reason to look at the sector and as a result, investor awareness is limited. More simply, at a stock price of $24, ZYXI's market cap of $840mn is over 3-times TAM. Analysts mistake Zynex as a Medical Technology company. In a randomized, double-blind study, these researchers examined the efficacy of PENFS in adolescents with irritable bowel syndrome (IBS). 2010;40(6):883-891. U.S. Department of Veterans Affairs, Technology Assessment Program (VATAP). Hoffman et al (2022) described the team approach of an interventional pain management practice, with particular emphasis on advanced practice providers (APPs), in the selection, education, care, and management of PNS patients. Neuromodulation. Liao C-C, Li J-M, Hsieh C-L. Auricular electrical stimulation alleviates headache through CGRP/COX-2/TRPV1/TRPA1 signaling pathways in a nitroglycerin-induced migraine rat model. Twelve months after stimulation, 6 of 7 patients considered their treatment a success with an average ODI of 21 % (p < 0.0005), VAS 1.7 (p < 0.0001), and IPSI 1.3. Zynex management has successfully shaped this narrative, at least to retail investors. 2008;25(7):644-657. Does The NexWave TENS Work. Cochrane Database Syst Rev. The NexWave device is not a TENS unit, it is a multi-modality device that includes TENS, NMES, and IFC modalities. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach. 2015;23(4):943-951. The dual primary treatment effect outcome measures were cumulative opioid consumption (in oral morphine equivalents); and mean values of the "average" daily pain scores measured on the 0 to 10 NRS within the first 7 post-operative days. Cochrane Database Syst Rev. Celiac plexus neurolysis provides pain relief of variable duration. The authors concluded that this double-blind, randomized, sham-controlled trial provided important insights and design considerations for future neuromodulation trials. National Institute for Health and Clinical Excellence (NICE). Low JL. Oper Neurosurg (Hagerstown). A total of 108 patient cases with BP-IBS were included in this study. The MSRP on a Zynex NexWave device is $1,995. 2010;89(1):10-15. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. It is intended to help with the management of chronic LBP associated with the muscular weakness of the lumbar multifidus muscle in patients who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery. Exhibit 7. In acute hemarthroses pain treatment must continue until total disappearance (checked by ultrasonography) and include hematologic treatment, short-term rest of the involved joint, cryotherapy, joint aspiration and analgesic medication (paracetamol in mild pain, metamizole for more intense pain, and in a few precise patients, soft opioids such as codeine or tramadol). ("NexWave" is not even trademarked. . The bull case rests on several key assumptions. Osteoarthritis Cartilage. Statistically significant improvements in pain, disability, and QOL from baseline were observed at all assessment times-points. Accessed May 22, 2002. A total of 24 patients were randomly allocated into 2 groups: Rodriguez-Merchan (2018) noted that musculoskeletal pain treatment is inadequate in many hemophilic patients. And now add excitement of a new device with a supposed multi-billion dollar TAM. . Latzanich CM, Gilmore R, Burke HB. eMedicine J. PE Wells, et al., eds. 2017;37(9):881-891. Pediatr Blood Cancer. J Pain Res. DMERC Region A/B. Postal Code. Van Der Heijden GJ, Leffers P, Wolters PJ, et al. Report of two cases. A recently published study by researchers at the Medical College of Wisconsin showed that a form of taVNS, percutaneous electrical nerve field stimulation, applied externally to the ear can relieve pain associated with IBS in adolescents. This interventional pain treatment modality entails modulating peripheral nerves for a variety of chronic pain conditions. Similarly, Valeant and Philidor created an insurance-subsidized artificial market for absurdly expensive branded drugs. Chughtai M, Elmallah RD, Mistry JB, et al. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. BMC Musculoskelet Disord. We're aware of this issue and are working on it urgently. Palmetto GBA - DMECS Zynex NexWave | Prescription Pain Management Tens Unit Boston, MA: VATAP; November 2001. van Tulder MW, Koes BW, Bouter LM. one group received high-frequency TENS; and. Tricenturion LLC. However, the Zynex spokesperson disputed this, saying that "E1399 is an accurate procedure code to be used with our NexWave device. Functional abdominal pain in children and adolescents: Management in primary care. Cochrane Database Syst Rev. Identification of patients with reduced VE may help individualize and target therapy for functional gastro-intestinal (GI) disorders, findings not previously described. Transcutaneous electrical nerve stimulation for neuropathic pain. Effect of transcutaneous electrical nerve stimulation on symptomatic diabetic peripheral neuropathy: A meta-analysis of randomized controlled trials. Cerebral metabolism before and after external trigeminal nerve stimulation in episodic migraine. To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. 2012;20(2):405-12. If it is ordered for use with 4 leads, the medical record must document why 2 leads are insufficient to meet the member's needs. The authors concluded that the minimal invasiveness of neurostimulation remains a compelling reason for patients to seek this therapeutic option for the treatment of axial LBP. We've heard from bulls who own Zynex in part because they believe regulators and insurers have bigger issues to worry about, that Zynex is inconsequential and can stay under the radar even if they are price gouging insurers.

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