Latest news with #MedTechDive
Yahoo
11-06-2025
- Business
- Yahoo
Elekta appoints Jakob Just-Bomholt as CEO
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Name: Jakob Just-Bomholt New title: CEO, Elekta Previous title: CEO, 3Shape Elekta has appointed Jakob Just-Bomholt as president and CEO. Just-Bomholt will take up the positions on Sept. 1, filling a vacancy created in March when the cancer radiotherapy company's board decided a new leader was needed to improve profitability and growth. Stockholm-based Elekta competes with Siemens Healthineers' Varian in the radiotherapy market. Elekta is looking to its new Evo radiation therapy machine to strengthen its position. However, while the device is on the market in Europe, helping drive 3% global sales growth in the most recent quarter, Elekta has yet to launch Evo in the U.S. The company has said U.S. customers are waiting for Evo, suppressing sales. Just-Bomholt will oversee Elekta's attempt to recover in the U.S. and in China, where sales have been hit by the anti-corruption drive, and build on momentum in Europe. The executive stepped down as CEO of 3Shape, a Danish digital dental scanning firm, earlier this year. The privately held 3Shape said in a statement at the time that Just-Bomholt spent 'five successful years' as CEO. Laurent Leksell, Elekta's founder and chairman, said in a statement that Just-Bomholt is well-suited to his new role. Leksell cited Just-Bomholt's strategic leadership, international experience and ability to drive profitable growth and global expansion as evidence he is the right person for the job. Just-Bomholt is set to begin onboarding in August, working with interim CEO Jonas Bolander to transition into the CEO post on Sept. 1. Bolander has spent his time as interim CEO 'stabilizing and simplifying the business,' the executive said on an earnings call late last month, and oversaw a change in Elekta's plans for bringing Evo to the U.S. market. Elekta withdrew its filing for clearance of Evo, and as of the May 28 earnings call, was in the process of resubmitting its application. Bolander said the change in filing strategy is intended to better align with the Food and Drug Administration's approval process, with a greater focus on cybersecurity. The interim CEO expects the delay to have a 'limited' impact on the overall product launch. Recommended Reading Elekta CEO Gustaf Salford to leave after board sees need for new leader Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-06-2025
- Business
- Yahoo
Caris Life Sciences files for $424M IPO
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Precision medicine company Caris Life Sciences said Monday it expects to raise as much as $423.5 million in an initial public offering. The Irving, Texas-based company plans to list its common stock on the Nasdaq market under the symbol 'CAI,' offering 23.5 million shares at $16 to $18 each. Primarily focused on cancer, Caris' molecular profiling tools use artificial intelligence and machine learning algorithms to analyze disease for early detection, diagnosis, monitoring, therapy selection and drug development. Caris saw year-over-year revenue growth of about 50%, to $120.9 million, in the first quarter of 2025, driven primarily by its molecular profiling services, according to a securities filing. The company received Food and Drug Administration approval for its companion diagnostic test MI Cancer Seek in November. The test identifies cancer patients who may benefit from targeted treatments. Founded in 2008, Caris has identified about 915,000 unique pathogenic mutations to date, of which only about 17,000 were previously known, the company said in its filing. 'We can now identify a person's circulating pathogenic mutations and enable the design of a customized individualized therapy to that specific set of mutations,' David Dean Halbert, Caris founder and CEO, said in the filing. 'We believe this is going to create the opportunity for physicians to use our solutions to effectively prevent various chronic diseases before they ever get started at the earliest of stages.' In April, when the company closed a private funding round worth $168 million, it said it had raised a total of $1.86 billion in capital since 2018. Caris is among a handful of companies exploring a public offering in a medtech IPO market that's showing signs of emerging from a slump. Medical products supplier Medline has said it could go public, and Medtronic plans to separate its diabetes business into a standalone company, potentially through an IPO. Recommended Reading The medtech IPO window is finally open. Or is it? Sign in to access your portfolio
Yahoo
10-06-2025
- Business
- Yahoo
Judge rules J&J unit must pay $442M in antitrust case
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. A federal judge ruled on Thursday that a Johnson & Johnson subsidiary must pay $442 million in damages after a jury found last month that the company violated antitrust rules by withholding support to hospitals that bought reprocessed catheters. District Judge James Selna ruled that J&J must pay triple the $147 million in damages determined by the jury, as allowed under antitrust law. The amount is separate from costs and attorneys' fees. Daniel Vukelich, CEO of the Association of Medical Device Reprocessors, said the ruling was 'a seismic result.' A J&J spokesperson wrote in an email that the company plans to appeal but will comply with the ruling and any court-ordered relief in the meantime. 'We strongly disagree with the jury's verdict and believe it will not withstand appellate review,' the spokesperson wrote. Innovative Health, which sells reprocessed catheters, filed the lawsuit against J&J subsidiary Biosense Webster in 2019. The company claimed J&J had a monopoly on heart-mapping catheters, and that it tied support for its Carto 3 mapping system to purchases of mapping and ultrasound catheters. A jury found on May 16 that J&J had violated the Sherman Act and California's Cartwright Act by withholding support from reprocessed versions of J&J's catheters. Reprocessed devices have been used in a procedure before, and are disinfected or sterilized. AMDR's Vukelich said the ruling 'sends an unmistakable message to all device manufacturers: anti-competitive, anti-reprocessing tactics won't be tolerated by the courts or by hospitals committed to cost savings, sustainability, and patient care.' The case was filed in the U.S. District Court for the Central District of California, Southern Division. Recommended Reading J&J subsidiary ordered to pay $147M for violating antitrust rules Sign in to access your portfolio
Yahoo
06-06-2025
- Business
- Yahoo
Owens & Minor spikes $1.36B Rotech buyout over regulatory barriers
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Owens & Minor said Thursday it has terminated the planned $1.36 billion acquisition of home medical equipment company Rotech Healthcare Holdings. The companies mutually agreed to terminate the deal after getting regulatory clearance 'proved unviable in terms of time, expense and opportunity,' Owens & Minor CEO Edward Pesicka said in a statement. Owens & Minor originally aimed to close the takeover by the end of last year. However, the deal was held up by the Federal Trade Commission's review. Owens & Minor and Rotech announced the acquisition in July 2024. Having set the goal of almost doubling patient direct sales by 2028, Owens & Minor moved to boost its position in areas including respiratory and sleep apnea products by acquiring Rotech. Privately owned Rotech reported $750 million in net revenue in 2023. The closing date was delayed by an FTC investigation. Owens & Minor and Rotech entered into a timing agreement with the FTC that gave the federal agency until June 10 to complete its review of the deal. Days from the deadline, Owens & Minor and Rotech terminated the takeover agreement. Pesicka said the merger would have provided 'ample benefits to patients, payors, and providers.' Yet, the 'path to obtain regulatory clearance' proved unviable, the CEO said, driving the companies to drop the merger. Owens & Minor paid Rotech $80 million in conjunction with the termination. The company previously said the deal included a $70 million termination fee. The $80 million termination payment brings Owens & Minor's spending on the deal above $100 million. Acquisition-related costs totaled $22 million in 2024 and $16 million in the first quarter of 2025. The termination closed off an avenue to Owens & Minor's 2028 patient direct sales target but investors reacted positively to the news. Shares in Owens & Minor jumped 14% to close at $7.61 on Thursday. Rotech's revenue fell almost 4% to $725.8 million last year. Asked about the results on an earnings call with analysts last month, Owens & Minor CFO Jonathan Leon said the declines 'were largely anticipated and largely resulted from a lot of COVID-era benefit that the industry got to realize that fell off in early 2024.' Recommended Reading Owens & Minor inks $1.36B takeover of Rotech
Yahoo
06-06-2025
- Business
- Yahoo
EU plan would limit Chinese device makers in Europe
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. European Union member states this week voted to support a plan to adopt measures that would restrict Chinese medical device makers' access to the EU market. The member states took the action, under the EU's International Procurement Instrument, after concluding an investigation in January that looked at China's practices in the public procurement market for medical devices. The investigation found that government practices unfairly encouraged Chinese hospitals to choose domestic manufacturers' products. 'The Commission has identified measures and practices in the Chinese procurement market that lead to discrimination against EU operators and EU-made supplies,' Olof Gill, commission spokesperson, said Thursday in an emailed statement. 'This discrimination also harms both the Chinese healthcare infrastructure, which is deprived of quality equipment, and EU businesses, with a high cost in terms of jobs and economic activity in the EU.' The commission has discussed its concerns with Chinese authorities. However, a satisfactory solution has not been proposed, and the EU had no other option than to tackle the issue through an IPI investigation, Gill wrote. The commission said it could not disclose the content of the draft IPI measure or next steps in the process. Chinese manufacturers would be prohibited from bidding on public procurement contracts worth more than 5 million euros for five years. In addition, no more than 50% of a contract's value may be subcontracted to Chinese entities or include Chinese-origin medical devices, MedTech Europe said in a statement. The trade group said it would provide further updates once the IPI measures are published in the EU's official journal. The EU investigation into China's medical device procurement practices was the first use of the IPI, which was introduced in 2022. Getting fair access to Chinese markets became more challenging for medical device companies after the country launched a program calling for domestically produced medical equipment to achieve 50% market penetration in county-level hospitals by 2020 and 70% by 2025, according to a statement from the European Chamber, which represents European businesses in China. European and Chinese leaders will meet in July at a summit in Beijing. Recommended Reading EU mulls retaliation after showing China's bias against foreign device firms Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
