Stimwave LLC

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.

Stimwave—which filed for bankruptcy last June and subsequently sold off “substantially all of its assets” in an auction, per the U.S. Department of Justice—signed on to a now-unsealed non-prosecution agreement in October that required the company to pay a penalty of $10 million. Laura Perryman, former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud insurers. Perryman has been charged with one count of healthcare fraud and one count of conspiracy to commit wire fraud and healthcare fraud, the U.S. Department of Justice (DOJ) announced Thursday. The indictments carry maximum potential sentences of 10 years and 20 years in prison, respectively. Meanwhile, Stimwave—which filed for bankruptcy last June and subsequently sold off “substantially all of its assets” in an auction, per the DOJ—signed on to a now-unsealed non-prosecution agreement in October that requires the company to admit to “an extensive statement of facts” about the case, maintain a strict compliance program, cooperate fully with the government in its ongoing investigation and pay a penalty of $10 million. The devicemaker also settled a civil fraud lawsuit filed under the False Claims Act, according to the DOJ. In that settlement, Stimwave agreed to admit to and accept responsibility for the government’s allegations of fraud and to shell out $8.6 million, which will be credited to the $10 million fine. The legal actions stem from a scheme that Perryman allegedly concocted around 2017. Stimwave’s flagship offering was a peripheral nerve stimulation system dubbed StimQ. It was cleared (PDF) by the FDA in 2016 as a prescription-only treatment for severe chronic pain, and it was comprised of an implantable neurostimulator, an externally worn battery pack that was used to power the device and an implanted receiver that served as a go-between between the battery and the neurostimulator. As the commercial rollout of the StimQ system began in 2017, according to the DOJ, doctors began to complain to Stimwave about the difficulty of implanting the 23-centimeter-long receiver, known as the “pink stylet,” into some patients. The pink stylet couldn’t be trimmed or otherwise shortened, but without it, the device—which was sold to healthcare providers for more than $16,000 per system—would only be eligible for between $4,000 and $6,000 in reimbursement from insurers. Perryman’s solution? Allegedly, to replace the copper-containing pink stylet with the “white stylet,” which could be shortened as needed to fit each patient—but which was made entirely of plastic and offered no actual medical purpose. The DOJ accused the former CEO of not only directing the company to create the phony component, but also overseeing training programs that assured doctors the so-called receiver was functional and asking employees to vouch for its functionality. With that bogus information, doctors were “unwittingly” billing private and public insurers for the full system, Michael Driscoll, assistant director of the FBI, said in the DOJ’s release. Under standard billing codes, the fake receiver alone could be reimbursed at a rate between $16,000 and $18,000. “As a result of [Perryman’s] illegal actions, not only did patients undergo unnecessary implanting procedures, but Medicare was defrauded of millions of dollars,” Driscoll said. Perryman, who helped found Stimwave in 2010, was voted out of the company in 2019, though the fake receiver allegedly continued to be sold as part of the StimQ system into 2020, per the DOJ.