Stimwave LLC

DUBLIN--( BUSINESS WIRE )--The "Pain Management Devices - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. The global market for Pain Management Devices is estimated at US$5.1 billion in 2024 and is anticipated to post a CAGR of 8.4% during the 2024-2030 analysis period and stand at a projected US$8.3 billion by 2030. This global report on Pain Management Devices analyzes the market based on type, application, and end-users. In addition to providing profiles of major companies operating in this space, the latest corporate and industrial developments have been covered to offer a clear panorama of how and where the market is progressing. Neuromodulation and neurostimulation devices, such as spinal cord stimulators (SCS), deep brain stimulators (DBS), and vagus nerve stimulators, apply electrical impulses to disrupt pain signals. Electrical stimulators, such as TENS and NMES, offer pain relief by sending electrical currents to the skin or muscles, while ablation devices like radiofrequency and cryoablation target and eliminate tissues that cause pain. Furthermore, analgesic Infusion pumps provide controlled amounts of medication directly to the area experiencing pain. The pain management devices market is primarily driven by the rising incidence of chronic diseases, such as cancer and heart disease, which often lead to severe pain and increased demand for effective pain management solutions. The rise in surgical procedures further propels this market, as these devices are essential for providing anesthesia, controlling pain during and after surgery, and facilitating faster recovery. The aging population, who are more vulnerable to chronic pain and surgical procedures, further boosts the demand for these devices. Growing awareness among consumers regarding pain management devices and technological advancements improve both the efficacy and availability of these solutions, resulting in better usage in treating conditions such as cancer pain, arthritis, and neuropathic pain. The pain rehabilitation centers and government initiatives to improve pain management options further contribute to market growth. North America leads the global pain management devices market, cornering the share of 47.9% in 2024, driven by the rapid adoption of devices, rising per capita income, and increasing demand for drug-free therapies during a rising prevalence of chronic pain conditions. This region's market growth is supported by high rates of chronic diseases, a rising geriatric population, established vendors, and favorable reimbursement policies. In contrast, the Asia-Pacific region is projected to be the fastest growing market with a CAGR of 9.8% during the analysis period 2024-2030, fueled by developing healthcare infrastructure, increasing awareness of electrical stimulation techniques, and the penetration of established market players, with India and China poised for the fastest growth due to large patient populations and heightened demand for modern medical facilities. Pain Management Devices Market Analysis by Type The neuromodulation and neurostimulation devices segment is expected to hold a 41.8% market share in 2024, leading the pain management devices market due to clinical validations, an increase in chronic pain disorders, a rise in neurological disorders, an aging population, and a preference for minimally invasive alternatives to traditional surgery. Techniques like spinal cord and peripheral nerve stimulation effectively treat conditions such as neuropathic pain and fibromyalgia, enhancing patients' quality of life while reducing opioid dependence. On the other hand, the ablation devices segment is expected to record the fastest CAGR of 9.2% during the forecast period 2024-2030, driven by their use in pain management and oncology, especially for patients with multiple tumors. Among the various types of ablation devices, radiofrequency ablation is expected to demonstrate the most rapid growth due to its efficacy in managing chronic pain and its widespread application in surgical oncology and other medical areas. Pain Management Devices Market Analysis by Application The neuropathic pain segment leads the pain management devices application market in 2024, with an estimated 29.7% market share, driven by an increasing incidence of conditions such as diabetes, HIV, multiple sclerosis, and cancer, along with advancements in pain management technology. Neuropathic pain is a chronic disorder resulting from somatosensory nervous system injury, necessitating effective treatments like spinal cord stimulation and peripheral nerve stimulation. Increased industry initiatives and the demand for effective pain management options further bolster this segment's dominance. Meanwhile, the cancer pain segment is projected to grow at the fastest CAGR of 9.1% during the 2024-2030 analysis period, fueled by the rising number of cancer patients and the need for devices to alleviate pain associated with nerve compression from tumors, including cases of genetic disorders like Acute Lymphoblastic Leukemia (ALL). Pain Management Devices Market Analysis by End-User The Hospitals & Clinics segment is the largest end-user market in pain management devices, accounting for a share of 51.2% in 2024 due to the increasing use of pain management devices for various conditions and an emphasis on handling post-surgical pain. On the other hand, the Homecare segment is anticipated to experience rapid growth, with a CAGR of 9.6% from 2024 to 2030, fueled by the increasing occurrence of chronic diseases, an aging population, and technological advancements. Patients opt to manage pain at home for convenience and privacy, using easy-to-use devices such as TENS units, which decrease healthcare costs linked to frequent hospital visits. Key Attributes: Report Attribute Details No. of Pages 261 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $5.1 billion Forecasted Market Value (USD) by 2030 $8.3 billion Compound Annual Growth Rate 8.4% Regions Covered Global Pain Management Devices Report Scope Pain Management Devices Key Players Abbott Laboratories Avanos Medical, Inc. B. Braun Melsungen AG. Baxter International Inc. Becton, Dickinson and Company (BD) Boston Scientific Corporation Enovis Corporation ICU Medical, Inc. Johnson & Johnson Kimberly-Clark Corporation LivaNova, plc Medtronic plc Nevro Corp. OMRON Healthcare, Inc. Pfizer Inc. SPR Therapeutics, Inc. Stimwave LLC Stryker Corporation Key Metrics Historical Period: 2021-2023 Base Year: 2023 Forecast Period: 2024-2030 Units: Value market in US$ Pain Management Devices Market by Geographic Region North America (The United States, Canada, and Mexico) Europe (Germany, France, United Kingdom, Italy, Spain, and Rest of Europe) Asia-Pacific (Japan, China, India, South Korea, and Rest of Asia-Pacific) South America (Brazil, Argentina, and Rest of South America) Rest of World Pain Management Devices Market by Type Neuromodulation & Neurostimulation Devices Ablation Devices Analgesic Infusion Pumps Electrical Stimulation Devices Pain Management Devices Market by Application Neuropathic Pain Musculoskeletal Pain Cancer Pain Facial & Migraine Pain Other Applications (Including Brain, Trauma, Menstrual Pain, Postoperative Pain, Pediatric Pain, Geriatric Pain and others) Pain Management Devices Market by End-User Hospitals and Clinics Rehabilitation Centers Home Care Settings For more information about this report visit https://www.researchandmarkets.com/r/lpdnjx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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POMPANO BEACH, Fla., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Today, Curonix LLC, a leading peripheral nerve stimulation company celebrated its first anniversary. In November 2022, Curonix completed the purchase of substantially all assets, excluding liabilities, of Stimwave Technologies. During its first 12 months, Curonix: Received positive new AMA CPT® coding clarification published October 2023.Rapidly expanded throughout the US and select international markets with 75 new hires.Partnered with leading healthcare professionals and societies to complete advanced Freedom® PNS training for over 500 healthcare professionals.Announced six clinical publications regarding the long-term safety and efficacy of the Freedom PNS system.Supported a growing skilled and dedicated physician community prepared to treat more patients with Freedom PNS and its proprietary HF-EMC technology platform. Following its formation, Curonix received backing from Kennedy Lewis Investment Management, an asset manager with an estimated $14 billion of assets under management and Broadfin Holding LLC, a healthcare-focused investment firm with extensive experience in the neuromodulation market. “We are just getting started!” said Aure Bruneau, Chief Executive Officer. “Curonix is a new company that was formed to deliver much-needed non-opioid chronic pain relief with our innovative HF-EMC technology platform. We are committed to serving our customers and patients and are focused on continued product development, medical and patient education and clinical studies. We also continue to invest in our quality and regulatory systems to ensure that our products meet all global quality, regulatory and compliance standards.” Curonix is also pleased to announce that the American Medical Association CPT® (AMA CPT®) published CPT® 2024 which contained important clarifications, code revisions and new CPT® codes for peripheral and spinal neurostimulation procedures. Curonix leadership continued to lead this initiative as part of an industry coalition alongside professional societies. The coding changes provide important clarity and added confidence for physicians committed to providing PNS and SCS neurostimulation therapy solutions for their patients. Curonix is thankful for the professional collaboration within the AMA process and grateful to know that this comprehensive clarification will positively impact the lives of thousands of patients suffering from debilitating chronic pain. “We are excited to support Curonix as it serves patients and physicians,” said David Kho, Curonix Chairman of the Board, and Managing Director at Kennedy Lewis. “We believe in the importance of providing effective long term alternative solutions to opioids, and our investment in Curonix reflects our belief in the team, technology and PNS treatment.” About CuronixCuronix LLC is a Delaware medical technology company dedicated to developing and commercializing innovative therapies intended to free patients from chronic pain and improve their quality of life. The Freedom® PNS System uses high-frequency electromagnetic coupling (HF-EMC) technology to power the implanted neurostimulator. Each stimulator comprises an electrode array(s) with 4 or 8 contacts, and the electrode array is connected to a separate implanted receiver(s). A small, external rechargeable transmitter supplies the energy and data to the implanted neurostimulator through the skin. The device uses pulsed electric current to create an electrical field that acts on nerves to inhibit the transmission of pain signals to the brain. Contact:Ashley BrownDirector, Marketing CommunicationsAshley.brown@curonix.com512-791-4743

Patients seeking a non-opioid method to treat chronic pain were heartened when a neurostimulation device, the StimQ PNS system, came on the market in late 2016. The medical device may have worked, but it turned out that the manufacturer was also working the system. Developed by Stimwave LLC, a medical device company founded in Florida in 2010 by CEO Laura Perryman, the StimQ PNS received 510(k) clearance from the FDA in March 2016. At the time, Stimwave said, "Thanks to our revolutionary wireless device, we are the only neuromodulation company cleared by the FDA to help patients with reducing their chronic neuropathic pain at most locations throughout the body." The device included a receiver that had to be surgically implanted to transmit energy from an externally worn battery to the neurostimulator. It turned out, however, that a second iteration of the receiver was made entirely of non-conductive plastic. Its sole function was to bilk Medicare and private insurers out of more than $16,000 for each procedure. Last week, Perryman was indicted by the US Department of Justice for conspiracy to commit wire and healthcare fraud, which carry a combined maximum potential sentence of 30 years in prison, reports the International Consortium of Investigative Journalists (ICIJ). Just a piece of plastic “As alleged, at the direction of its founder and CEO Laura Perryman, Stimwave created a dummy medical device component — made entirely of plastic — designed to be implanted in patients for the sole purpose of causing doctors to unwittingly bill Medicare and private insurance companies more than $16,000 for each implantation of the piece of plastic,” said US Attorney for the Southern District of New York Damian Williams in a release issued by the DOJ on March 9, when Perryman was arrested. “The defendant and Stimwave did this so that they could charge medical providers many thousands of dollars for purchasing their medical device. Our office will continue to do everything in its power to bring to justice anyone responsible for perpetuating healthcare fraud, which in this case led to patients being used as nothing more than tools for financial enrichment.” Stimwave filed for bankruptcy on June 15, 2022. A non-prosecution agreement entered into on Oct. 29, 2022, was also unsealed last week. Under the terms of the agreement, Stimwave accepted responsibility for its conduct. It was fined $10 million and will be required to maintain a compliance program overseen by a Chief Compliance Officer for three years. In the beginning Perryman didn’t start out with the intention to commit fraud, as the timeline laid out by the DOJ shows. When the device was initially brought to market, it contained three components — an implantable electrode array, the lead, which stimulates the nerve; a battery worn externally; and an implantable receiver that transmits energy from the battery to the lead. Called the Pink Stylet, because of its distinctive pink handle, this receiver was fit for purpose, but it had to be a certain length to work. After it was introduced, physicians told the company they were having problems implanting the stylet in some patients because of its length. Stimwave addressed their concerns by developing the White Stylet, which, the company said, could be cut to size. The only problem, which Stimwave failed to disclose to doctors, was that the White Stylet was a “dummy component made entirely of plastic that served no medical purpose,” in the words of the DOJ. So why did Perryman do this? Follow the money. Stimwave sold the device to medical providers for approximately $16,000. As the DOJ explains in its news release: “Medical insurance providers, including Medicare, would reimburse medical practitioners for implanting the device into patients through two separate reimbursement codes, one for implantation of the lead and a second for implantation of the Pink Stylet. The billing code for implanting the lead provided for reimbursement at a rate of between approximately $4,000 and $6,000, while the billing code for implanting a receiver, like the Pink Stylet, provided for reimbursement at a rate of between approximately $16,000 and $18,000.” Capiche ? It would have been next-to-impossible to sell the device at the list price without reimbursement for implanting the receiver since the medical provider would have been losing money with each procedure. So, Stimwave kept selling its device with the White Stylet while submitting “fraudulent reimbursement claims for implantation . . . to Medicare, resulting in millions of dollars in losses to the federal government,” said the DOJ. The FBI conducted investigative work in the case and the FDA provided assistance. In addition to the indictment by the DOJ, Stimwave faces a civil lawsuit. And maybe one day Pennyman and Elizabeth Holmes will be roommates.