Fresenius wins FDA breakthrough device nod for fluid management software

Fresenius Medical CareFresenius (NYSE:FMS) said yesterday that it won FDA breakthrough device designation for its computer-assisted ultrafiltration control software intended to improve fluid management during hemodialysis.

The Waltham, Mass.-based company said that the software is designed to work with its newer hemodialysis machines using its CLiC device.

Fresenius said that with the software, it hopes to create a dialysis machine with embedded intelligent diagnostics to provide computer-assisted recommendations for achieving target levels of relative blood volume.

“This new software represents our commitment to driving innovation and aims to become an essential tool in reducing cardiovascular events for people living with kidney failure. Effective fluid management is critical to creating the best hemodialysis treatment possible for each individual. We are proud of this effort to further advance our proven Crit-Line technology,” renal therapies group prez Mark Costanzo said in a press release.

The company said that timelines for final development and approval of the computer-assisted ultrafiltration control software remains “uncertain given the nature of developing this complex and innovative technology.”

Earlier this week, Fresenius said that it’s planning a stock buyback of up to $370 million worth of its own shares.

The post Fresenius wins FDA breakthrough device nod for fluid management software appeared first on MassDevice.

Fresenius preps $370m stock buyback

Fresenius Medical CareFresenius (NYSE:FMS) said today that it’s planning a stock buyback of up to $370 million worth of its own shares.

Shareholders in the German renal care giant said its shareholders approved the roughly 6-million-share buyback in May 2016. The €330 million repurchasing plan is slated to run from today through May 10, Fresenius said.

If fully exercised the buyback would result in the cancellation of about 1.6% of total FMS shares, the company said.

The post Fresenius preps $370m stock buyback appeared first on MassDevice.

7 women in medtech you should know

Women-In-Medtech-2019

Women hold more executive leadership roles in the medtech industry today than they did 20 years ago, but there’s still a long way to go.

There is still a women’s leadership gap in the U.S., though. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S. Only 14.6% are CEOs. A mere 8.1% are top earners, and a scant 4.6% are Fortune 500 CEOs. The Equal Employment Opportunity Commission also reports that only a fifth of executives, senior officers and managers in the U.S. high-tech industries are women.

Keeping with the theme of Women’s History Month and International Women’s Day, here are seven women medtech executives making a difference in the industry.

Next >>

The post 7 women in medtech you should know appeared first on MassDevice.

Fresenius closes $2B NxStage buyout, settles FCPA case for $255m

Fresenius Medical CareFresenius Medical Care (NYSE:FMS; ETR:FRE) said today that it closed the $2 billion acquisition of NxStage Medical and settled self-reported violations of the U.S. Foreign Corrupt Practices Act for nearly $255 million.

The $30-per-share deal for the Lawrence, Mass.-based home hemodialysis pioneer, first announced in August 2017, was initially slated to close by the end of that year. But it was delayed several times by the government shutdown this year and by the U.S. Federal Trade Commission, which only cleared the transaction last week. To mollify the anti-trust regulators, NxStage last July agreed to deal its Medisystems bloodlines business to B. Braun.

“The closing of this transaction is an important milestone in enhancing our patients’ choice of dialysis treatment modality,” CEO Rice Powell said in prepared remarks. “By combining NxStage’s capabilities with our broad product and service offering, we can help patients to live even more independently. In addition to broadening our product portfolio, this acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies.”

“It’s a great pleasure to welcome our new NxStage colleagues. With their strong culture of innovation and transformation, they will help us to realize our vision of delivering access to superior patient care and outcomes in a lower-cost-of-care home setting to all the patients we care for. We are excited to execute on a strategy that is good for patients, the healthcare system and us,” added Fresenius Medical Care North America CEO Bill Valle.

Fresenius lowered its estimation of the deal’s integration costs, initially tabbed at $150 million, to $56.8 million to $85.2 million (€50 million to €75 million) over the next three years. Excluding those numbers, NxStage is expected to deliver net losses of -$85.2 million to -$73.9 million this year and -$45.5 million to -$34.1 million in 2020, on sales of $272.8 million to $295.5 million and $352.4 million to $375.1 million, respectively.

SEC, DoJ FCPA charges settled for $255m

The German dialysis giant also said that it had booked charges of $254.6 million (€224.0 million) as of Dec. 31, 2018, to cover the settlement of FCPA charges leveled by the Securities & Exchange Commission and the Justice Dept.

Fresenius said it voluntarily reported potential FCPA violations to the agencies after a whistleblower’s email in 2012 and cooperated with the ensuing government investigations.

“In the course of this dialogue, the company identified and reported to the government, and took remedial actions including employee disciplinary actions with respect to, conduct that resulted in the government seeking monetary penalties and other remedies against the company and disgorgement of related profits revolving principally around conduct in the company’s products business in a limited number of countries outside the United States,” Fresenius said in a Feb. 20 regulatory filing.

The settlement is an agreement in principle and must still be approved by the SEC and the Justice Dept., the company said.

($1 = €0.880133)

The post Fresenius closes $2B NxStage buyout, settles FCPA case for $255m appeared first on MassDevice.

FTC gives the go ahead to Fresenius, NxStage merger

Fresenius Medical Care acquires NxStage Medical

The U.S. Federal Trade Commission said yesterday that it cleared Fresenius (NYSE:FMS) in its $2 billion acquisition of NxStage Medical (NSDQ:NXTM).

As part of the approval, NxStage will have to part ways with its bloodline tubing set business, offloading them to B. Braun, according to the regulatory agency.

The vote to approve the merger was split, however, with Republicans Joseph Simons, Noah Phillips and Christine Wilson voting to approve while Democrats Rohit Chopra and Rebeca Slaughter dissented.

The FTC said that it had previously filed a complaint suggesting that the merger would harm competition for bloodline tubing compatible with hemodialysis machines in the U.S.

Late last month, Fresenius said that an interruption to the FTC’s review of the merger, caused by the partial U.S. government shutdown, delayed the end-date of the deal which has now been extended to August 6, 2019.

The $30-per-share deal represents a 29.6% premium on last year’s August 4 closing price of $23.14 for NXTM shares.

Fresenius said it plans to fund the deal with cash and debt and expects Lawrence, Mass.-based NxStage to add to net income and earnings per share within three years of the deal’s close.

Shares in Fresenius have risen approximately 4% in pre-market trading today, at $39.89 as of 9:23 a.m. EST.

The post FTC gives the go ahead to Fresenius, NxStage merger appeared first on MassDevice.

U.S. gov’t shutdown again delays closing for Fresenius-NxStage merger

Fresenius Medical Care acquires NxStage Medical

Fresenius (NYSE:FMS) said today that an interruption to the FTC’s review of its merger NxStage Medical (NSDQ:NXTM), caused by the partial U.S. government shutdown, has again delayed the end-date of the deal which has now been extended to August 6, 2019.

The end-date is not hard-set, Fresenius said, and could occur on an earlier date if there have been 60 consecutive days of full funding for the FTC, according to an SEC filing.

Fresenius said that it already signed a consent decree proposed by the staff of the FTC, but that it remains to be approved by the FTC Commissioners. Under the terms of the deal, Fresenius would divest NxStage’s bloodlines biz to B. Braun to address issues raised by FTC staff, according to an SEC filing.

The tie-up, which was delayed by NxStage in October in light of the FTC investigation, has been in the works for nearly a year and a half, having originally been announced last August.

Fresenius said late last month that it was still awaiting FTC approval of the tie-up, and that it pushed the closing date to some time early this year.

The hoped-for closing date was pushed to February 5, 2019 in October, though at the time Fresenius was hopeful it could see the acquisition complete before the end of 2018.

Last July, the German renal care giant and NxStage extended the deal’s closing date by 90 days, from August 7 to Nov. 5, but said they still expected to close the deal that year.

The post U.S. gov’t shutdown again delays closing for Fresenius-NxStage merger appeared first on MassDevice.

Fresenius still awaiting FTC approval for NxStage acquisition

Fresenius Medical Care acquires NxStage Medical

Fresenius (NYSE:FMS) said last Friday that it is still in the process of seeking approval from the U.S. Federal Trade Commission for its $2 billion merger with NxStage Medical (NSDQ:NXTM).

The tie-up, which was delayed by NxStage in October in light of the FTC investigation, has been in the works for nearly a year and a half, having originally been announced last August.

In an update released late last week, Fresenius Medical Care said that it is still seeking approval from the agency, and that it expects the acquisition to close early next year, according to a press release.

The hoped-for closing date was pushed to February 5, 2019 in October, though at the time Fresenius was hopeful it could see the acquisition complete before the end of 2018.

In July, the German renal care giant and NxStage extended the deal’s closing date by 90 days, from August 7 to Nov. 5, but said they still expected to close the deal this year.

The FTC said a year ago that it wanted more information on the deal’s details; Fresenius is a NxStage customer, complicating its anti-monopoly implications. Last July, NxStage agreed to deal its Medisystems bloodlines business to B. Braun in a bid to mollify the FTC’s concerns.

The post Fresenius still awaiting FTC approval for NxStage acquisition appeared first on MassDevice.

Del. supremes uphold Fresenius bailout on Akorn buy

Fresenius Kabi updated logoDelaware’s Supreme Court ruled last week to uphold a decision by the state’s Chancery Court that Fresenius (ETR:FRE) could walk away from its $4 billion merger with Akorn (NSDQ:AKRX).

The initial deal was designed to help Fresenius move into new therapeutic areas and dosage forms, including eye drugs, ear drops, nasal sprays and respiratory drugs. But Fresenius abandoned the purchase in April, pointing at an investigation that found material breaches of FDA data integrity requirements related to Akorn’s operations.

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

The post Del. supremes uphold Fresenius bailout on Akorn buy appeared first on MassDevice.

Fresenius slides on softened outlook

Fresenius Medical CareFresenius (NYSE:FMS) shares are down roughly 10% today after the German dialysis giant softened its outlook.

“Given its current expectations for 2018 and 2019, Fresenius now believes its ambitious group targets for 2020 will not be met,” Fresenius said.

Overall earnings next year are now expected to be flat on mid-single-digit sales growth, compared with prior guidance for earnings growth of 8.3% to 12.6% on sales growth of 7.1% to 10.3%, the company said.

Separately listed Fresenius Medical Care also lowered its expectations, predicting flat earnings on “solid” sales growth. Net income for this year is forecast at €1.35 billion to €1.37 billion on sales of €15.85 billion to €16.05 billion on a constant-currency basis.

“With the pending acquisition of NxStage Medical (NSDQ:NXTM), the corresponding build-out of our home dialysis services infrastructure in the United States as well as investments in future growth markets in the products as well as the services business such as China, we have an investment year ahead of us,” FMC CEO Rice Powell said in prepared remarks. “We would like to share as an early indication that 2019 will have a clear focus on preparing the company for future sustainable, profitable growth. For 2019, we currently broadly assume solid comparable(1) revenue growth and the comparable(1) net income to be around the level of FY 2018.”

FMS shares were down -9.6% to $35.48 apiece today in mid-day trading.

The post Fresenius slides on softened outlook appeared first on MassDevice.

Fresenius Kabi recalls sodium chloride injections over latex concern

Fresenius Kabi updated logoFresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise.

The company’s recall includes 0.9% injections in 10 mL vials and 20 mL vials. The product insert and the tray label for both kinds of vials say that the products’ stoppers do not contain natural rubber latex. Fresenius Kabi notified distributors and customers by letter, telling them that the stoppers do contain natural rubber latex.

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

The post Fresenius Kabi recalls sodium chloride injections over latex concern appeared first on MassDevice.