Pelvic Organ Prolapse

LOS ANGELES--(BUSINESS WIRE)--Caldera Medical, a leader in women’s health solutions, is proud to announce the appointment of John Pitstick as its new Chief Financial Officer & EVP Corporate Development. With a strategic focus on advancing Caldera Medical's position in the women’s health sector, Caldera Medical completed its acquisition of Atlantic Therapeutics based in Galway Ireland on September 1st of this year and maintains an innovation and operations team in Ireland as its European headquarters. John's appointment aligns with the company's accelerated growth and ambitious plans for future acquisitions. John Pitstick – A Synthesis of Expertise and Vision John Pitstick began his career with Ernst & Young managing a global client base and contributing to several IPOs. His distinguished career as a CFO is marked by significant achievements in growing both private and publicly traded technology and healthcare companies. John’s financial acumen and strategic insight is underscored by his role as a member of the board of directors of a publicly traded financial services company, where he also serves as chairman of the audit committee. Driving Growth through Strategic Acquisitions As CFO, John's expertise in leading Mergers and Acquisitions (M&A) will be pivotal. His experience in overseeing transactions exceeding $3 billion, coupled with his success in raising over $1 billion in financing, equips him to guide Caldera Medical through its ambitious expansion plans, including strategic acquisitions that will enhance the company’s portfolio and market presence. About Caldera Medical Caldera Medical is a medical device company solely focused on women’s health, committed to improving the quality of life for women. Caldera Medical develops, manufactures, and markets surgical products for treating Stress Urinary Incontinence, Pelvic Organ Prolapse, Polyps, and Fibroids. Known for its customer intimacy principle and significant humanitarian program, Caldera Medical is dedicated to treating one million women in underserved populations globally by 2025. Connect with Caldera Medical For more about Caldera Medical’s growth strategy and John Pitstick’s role, visit , LinkedIn, Twitter.

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally. That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders. For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices: Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000 Spending on the top five device categories totaled just under $11 million for all of 2022: Hernia mesh: $6.1 million CPAP machines: $2.1 million Exactech knee and hip implants: $1.4 million Physiomesh: $724,000 Pelvic mesh: $648,000 Other leading mass tort ad targets in 2023 included inferior vena cava (IVC) filters, heater-cooler devices, warming blankets, Mirena intrauterine devices (IUDs), Stryker’s Cartiva toe implants and Bayer’s Essure permanent birth control. More than 24,000 TV ads soliciting medical device injury claims aired in the first half of 2023, the firm said, with ad buys booming in the final month. “Estimated spending on medical device claims solicitation advertising increased dramatically from the first to the second quarter, when $4.25 million was spent to air these ads during television programming throughout the nation,” X Ante said in its latest report, covering Q2 2023. “In June alone, spending on these ads skyrocketed from the prior month to more than $3 million — the highest in a month since October 2019.” Pelvic mesh surged to the top of the list in Q2 2023, overcoming hernia mesh. Nearly all pelvic mesh ad spending in Q2 was from just two ads. Both ads solicited “claims referencing transvaginal mesh and other products included in Endo International’s bankruptcy settlement,” X Ante said. Compared to the mesh ads, the CPAP machine ad spending is relatively new, spurred by the massive Philips Respironics recall. And the military earplug spending, while relatively low compared to mesh products, is linked to a $6 billion 3M settlement announced in August. Mesh devices fuel litigation-related ad spending But it’s mesh products that continue to drive medical device lawsuit spending. Mesh manufacturers started recalls nearly two decades ago and have fought lawsuits ever since. These devices triggered billions of dollars worth of product liability lawsuits, which caught the attention of investors and lawyers trying to get a cut for themselves. One of the largest single settlements was the $830 million payout by Endo in 2014. (Endo’s more recent troubles are due to an $8 billion debt load, including nearly $600 million in opiod settlements.) The following list is by no means exhaustive, and litigation continues to this day. C.R. Bard was the first to recall mesh products in 2005 and expanded the recall in the following years. Becton, Dickinson & Co. bought Bard in 2017 and continues to battle lawsuits related to a range of mesh products. Facing lawsuits from hundreds of women, Johnson & Johnson’s Ethicon unit pulled its transvaginal mesh products from the market in 2012. The business recalled its Physiomesh product for hernia repairs in 2016. J&J paid $120 million to settle claims that year and another $117 million to settle claims across 41 states and Washington, D.C. in 2019. In 2019, the FDA banned sales of surgical mesh for transvaginal repair of pelvic organ prolapse. By that point, Boston Scientific and Coloplast were the only device companies still marketing pelvic mesh. Boston Scientific paid $119 million to settle mesh claims in 2015 and another $188 million in 2021 for a multi-state settlement over transvaginal surgical mesh marketing. Related: How medical device companies can better protect themselves from lawsuits

Caldera Medical , a women’s health medical device company, today announced the completion of its acquisition of Atlantic Therapeutics, a provider of non-invasive pelvic floor strengthening and nerve stimulation solutions for women. Caldera solely focuses on medical devices for women’s health, manufacturing and marketing surgical products for the treatment of stress urinary incontinence, pelvic organ prolapse polyps, and fibroids. Atlantic, which is based in Ireland, specializes in the development of medical devices, related software, and connected health technologies primarily to treat incontinence, and sexual health dysfunctions. Caldera’s portfolio includes its Desara family of surgical products to treat stress urinary incontinence, the Vertessa Lite polypropylene mesh for the treatment of pelvic organ prolapse, and the Benesta system for in-office polyp removal. Through the acquisition, Caldera adds Atlantic’s FDA-cleared Innovo device to its existing portfolio. The Innovo device is a urinary incontinence treatment option for at-home use where the user puts on the Innovo multipath shorts which contain electrical muscle stimulation technology connected to a remote-like controller. Through a 30-minute session, Innovo completes 180 pelvic floor contractions, helping to re-educate the muscles and make them stronger. Those stronger muscles have more control over the bladder. The device is currently priced at €399 for the starter kit , which includes the multipath shorts, prep spray, and controller. "We are thrilled to acquire Atlantic Therapeutics and scale the rapidly growing Innovo products worldwide," said Bryon Merade, CEO of Caldera, in a press release announcing the acquisition completion. "This acquisition aligns perfectly with our mission and allows us to offer an even more comprehensive suite of solutions to healthcare providers and patients alike." Caldera will maintain a European headquarters and innovation center in Galway, Ireland.