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Establishment Labs CFO stepping down, interim replacement announced

Establishment Labs today announced that its chief financial officer Renee Gaeta will be stepping down later this month and Raj Denhoy will be her interim replacement.

Santa Barbara, Calif.-based Establishment Labs said Gaeta is stepping down to pursue other opportunities outside of the company on July 30 following the planned release of the second quarter financial results.

“I am grateful for my time at Establishment Labs,” Gaeta said in a news release. “When I joined in 2017, we were a private company excited to achieve $35 million in annual sales. Now, just four years later, we are a public company with more than three times the revenue, an ongoing FDA trial, and we are preparing to build our third facility to meet demand. I have complete faith in Establishment Labs’ ability to achieve its goal of being the global leader in breast aesthetics and reconstruction. It has been a wonderful experience and my decision to leave was not easy, but I am ready for a new …

MedTech 100 roundup: Industry continues climb

One week after hitting an all-time best mark, the medtech industry has done it again, reaching new heights on Wall Street.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — continued its rise, finishing the week (July 9) at 114.79 points, a rise of 0.2% from the 114.59-point mark registered a week prior on July 2.

The new high comes in was just 0.21 points ahead of the 114.58-point mark set in April — the industry’s all-time best performance before last week beat it by one point.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 24.3% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.6% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The positive movement in medtech aligns with an uptick in the overall markets this past week, as the S&P 500 Index ri…

Avanos Medical names senior VP, general counsel

Avanos Medical (NYSE:AVNS) today said it has appointed Moji James as senior VP and general counsel.

James will be responsible for the Alpharetta, Ga.-based company’s legal, government relations and global security functions.

Prior to joining the company, James most recently served as executive VP, chief legal and compliance officer for Tmunity Therapeutics. She has also held leadership roles at Iroko Pharmaceuticals and Wyeth Pharmaceuticals.

“Moji’s extensive global and diversified legal experience, along with her knowledge of the healthcare sector and exceptional track record of managing complex business and legal strategies, makes her uniquely qualified for this role,” CEO Joe Woody said in a news release. “In addition to her role as general counsel, I am excited to have Moji’s broad business experience and capabilities add to our overall strategy and vision of getting patients back to the things that matter.”

Cigarette maker spending $1.2 billion on company with inhaled medical therapies

Philip Morris (NYSE:PM) announced today that it agreed to acquire inhaled drug delivery technology developer Vectura for $1.2 billion.

New York-based Philip Morris agreed with the board of Vectura Group on the all-cash, recommended offer under which Vectura shareholders would be entitled to receive $2.07 per share (150 pence), representing a 46% premium to the ex-dividend closing price per Vectura share of $1.42 (103 pence) on May 25, 2021.

Get the full story at our sister site, Drug Delivery Business News.

Avanos Medical to pay more than $22M to resolve criminal charges with DOJ

The U.S. Justice Dept. announced that Avanos Medical (NYSE:AVNS) agreed to pay more than $22 million to resolve a criminal charge related to fraudulent misbranding.

Charges levied against the Alpharetta, Ga.-based medical device company relate to alleged fraudulent misbranding of its MicroCool surgical gowns.

According to a DOJ news release, criminal information filed on July 7 in the U.S. District Court for the Northern District of Texas charged Avanos with one count of introducing misbranded surgical gowns into interstate commerce with the intent do defraud and mislead.

Court filings allege that Avanos falsely labeled the gowns as providing “the highest level of protection against fluid and virus penetration.”

The company agreed to pay $22,228,000, comprised of a victim compensation payment of $8,939,000, a criminal monetary penalty of $12.6 million and a disgorgement payment of $689,000.

“Companies that sell medical products …

Abbott to pay $27M to settle St. Jude Medical heart devices suit

[Image from Unsplash]Abbott (NYSE:ABT) has reached a settlement with the U.S. Department of Justice over a False Claims Act lawsuit involving St. Jude Medical and its ICD batteries.

The lawsuit — filed in U.S. District Court in Maryland — claimed that St. Jude Medical knowingly sold ICDs with battery problems between November 2014 and October 2016. Abbott acquired St. Jude Medical for $25 billion in January 2017.

Without admitting liability, Abbott has agreed to pay $27 million to settle the case.

“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration (FDA), and the U.S. government will not pay for devices that are unsafe and risk injury or death,” said acting U.S. Attorney Jonathan F. Lenzner for the District of Maryland.

“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, ha…

Eurofins, Rite Aid launch OTC at-home COVID-19 test in U.S.

Eurofins, its empowerDX subsidiary and Rite Aid announced the launch of an over-the-counter, at-home COVID-19 PCR test kit.

Luxembourg-based Eurofins’ co-branded kits will be made available at all Rite Aid locations across 17 U.S. states, offering both symptomatic and asymptomatic users a way to test for COVID-19 at home, according to a news release.

Eurofins Viracor, an infectious disease testing laboratory, developed the test based on the company’s FDA emergency use authorized SARS-CoV-2 RT-PCR assay. Eurofins said its test is among the first COVID-19 tests to be authorized through an EUA for OTC use.

“We are excited to partner with Rite Aid and launch this at-home COVID-19 testing kit, making access to test kits widely available to people across the U.S through Rite Aid’s national network,” Eurofins CEO Gilles Martin said in the release. “Increasing population testing rates is an important step in fighting the pandemic, a…

Hyperfine, Liminal to go public in $580M SPAC deal

Hyperfine and Liminal Sciences today said they will go public by merging with a SPAC called HealthCor Catalio Acquisition Corp.

The merger is valued at approximately $580 million upon closing and is expected to have a combined entity of $375 million in cash. The combined company’s estimated cash balance will be $207 million from the SPAC trust fund, $126 million from PIPE investors and $66 million from the balance sheets of Hyperfine and Liminal and less than $24 million in transaction expenses.

Through the deal, HealthCor Catalio will be renamed as Hyperfine and will be listed on the NASDAQ stock exchange under the ticker symbol HYPR.

“The combination of Hyperfine, Liminal and HealthCor Catalio presents an inspiring opportunity to transform the global MR imaging and brain-sensing paradigm,” Hyperfine president and CEO Dave Scott said in a news release. “This business combination will empower Hyperfine with the expanded resources, financing, and ex…

FDA warns of biocompatibility concerns with NuVasive’s Precise devices

The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA).

Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.

According to an FDA notice, there have been reports describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices. The adverse events could be related to corrosion, wear and previously unanticipated exposure of components that are undergoing biocompatibility testing.

NuVasive posted a statement on April 5 to inform healthcare providers of ongoing testing with Precice devices, placing a global ship hold for all of them.

The FDA noted that, at this time, it remains uncertain if the root c…

Abbott laying off hundreds of workers as testing demand drops

Abbott (NYSE:ABT) is reportedly laying off as many as 400 workers in Maine as a result of a drop in demand for its COVID-19 diagnostics.

WMTW-TV reported that about 300 Abbott employees will be laid off in Westbrook, Me., as confirmed by the town’s mayor. Additionally, the station reported that about 100 workers at the company’s Scarborough, Me., location will be laid off.

According to an AP report, Abbott announced in May 2020 that it would expand its workforce into Westbrook with approximately 1,200 workers at a facility producing COVID-19 test kits. The company added several jobs for such purposes due to heightened demand for its COVID-19 tests during the pandemic, including around 2,000 in Illinois last September.

“We’ve recently seen a significant, rapid decline in COVID-19 testing demand and anticipate this trend will continue,” Abbott wrote in a statement to WMTW-TV. “Because of this, we are reducing our workforce tha…

Lumos Diagnostics raises $46.8M IPO to go public in Australia

Lumos Diagnostics announced today that it raised $46.8 million ($63 million AUD) in an initial public offering in Australia.

Sarasota, Fla.-based Lumos (which has its corporate head offices in Melbourne, Australia), a fully integrated developer and manufacturer of custom point-of-care diagnostic tests, was admitted to the Australian Securities Exchange (ASX) with trading commencing after July 5 thanks to the IPO, according to a news release.

The company said top-tier institutional funds, along with existing investors including Australian Unity, Perennial, Soul Pattinson and Ellerston all participated in the IPO.

Lumos develops FebriDx, a fingerstick test for identifying patients with bacterial and viral respiratory infections that has European, Canadian and Australian approval with an FDA review ongoing in the U.S. Additionally, the company develops CoviDx, a CE-marked COVID-19 antigen test.

The funds brought in through the IPO are earmarked for L…

Augmedics adds J&J, Stryker veterans to board leadership

Augmedics announced that it appointed Rick Anderson as executive chairman of its board and Bradley Paddock as the board’s independent director.

Chicago-based Augmedics said yesterday in a news release that Anderson joined the board in March upon the closing of Augmedics’ oversubscribed $36 million Series C financing round. Paddock then joined in May and both will assume their new roles effective immediately.

Anderson spent more than three decades as an executive, investor and board member for emerging growth and market-leading healthcare companies. He also serves as the chairman of Revival Healthcare Capital, having previously served as chairman & CEO of ConvaTec, as well as company group chairman at Johnson & Johnson.

Paddock holds over 25 years of experience in medical devices and currently serves as president & CEO at CeQur. Other executive roles for Paddock include global president of spine at Stryker, VP of global sales &…