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.

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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.

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Laminate Medical brings in $12m for dialysis vascular support device

Laminate Medical Technologies

Israeli medtech start-up Laminate Medical Technologies said today that it raised $12 million in a new round of financing slated to support its VasQ vascular support device.

The company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure.

The VasQ regulates flow by constraining and shaping optimal geometrical parameters of the fistula, the company said, and reinforces and shields the vulnerable perianastomotic vein against high pressure, wall tension and flow levels.

The round was joined by Asahi Kasei (TYO:3407) and Tal Capital, as well as a number of private investors, Laminate Medical Tech said.

“We are so happy to be a part of the company’s journey. I believe VasQ has a high potential to become the standard of care for vascular access surgery,” Asahi Kasei Medical prez Takeshi Himeno said in a prepared statement.

The company said that it recently launched U.S.-based clinical trials of the VasQ system as it seeks FDA approval of the device. The system already has CE Mark approval in the European Union.

“After the success of treatments in Europe, including application of the device in hundreds of patients in Germany and other European countries, we are now preparing to enter the American market. We have completed the infrastructure for this, and are working in cooperation with leading hospitals across the USA to carry out the necessary clinical trials for FDA approval. The current round is an important expression of faith on the part of the existing investors, and a significant boost from investors with experience in a variety of fields, who understand the need for the solution and the answer that it provides for dialysis patients. Furthermore, the fact that Asahi Kasei Medical has joined us as an investor in the company gives us an important advantage for a future entry into the Japanese market,” Laminate co-founder & CEO Tammy Gilon said in a press release.

In February 2017, Laminate Medical said that it raised $8 million Series B financing round to support the VasQ device.

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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.

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Baxter launches on-demand peritoneal dialysis solution device trial

Baxter

Baxter (NYSE:BAX) said yesterday that it launched an FDA-cleared clinical trial of its on-demand peritoneal dialysis solution generation system intended to allow patients to make peritoneal dialysis solutions in small batches at home.

The system is designed to use a small water filtration device, concentrates and Deerfield, Ill.-based Baxter’s Amia automated peritoneal dialysis system to turn a patient’s tap water into dialysis solution as needed for therapy sessions.

Baxter said that it has enrolled the first patient in the trial, which looks to assess the efficacy and safety of the new system for participants over 12 weeks. The company said it hopes to use data from the trial to support a New Drug Application for the concentrates and 510(k) clearance for the device.

“We are on a journey to transform how kidney disease is identified, managed and treated, with a focus on improving outcomes for patients. Our on-demand technology is the cornerstone of our innovation pipeline, as we believe the technology will open up new possibilities for therapy delivery while improving the experience for patients today,” renal care biz GM Laura Angelini said in a press release.

In November, Baxter said that it expanded its share purchase program to $3.4 billion.

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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.

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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.

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NxStage Medical, Fresenius again delay $2B merger

NxStage Medical (NSDQ:NXTM) yesterday once more delayed its pending $2 billion merger with Fresenius (NYSE:FMS) as the U.S. Federal Trade Commission continues to examine the deal.

In July, the German renal care giant and Lawrence, Mass.-based NxStage extended the deal’s closing date by 90 days, from August 7 to Nov. 5, saying it still expected to close the deal this year.

Yesterday, in a regulatory filing with the U.S. Securities & Exchange Commission, NxStage said the companies agreed this week to push the target back another thee months, to Feb. 5, 2019. For its part, Fresenius said it still expects to close the acquisition this year.

It’s been more than 14 months since the companies announced their merger plans. 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.

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Fresenius plunges on missed prelims, guidance cut

Fresenius Medical CareFresenius (NYSE:FMS) shares closed down some $17% yesterday after it cut its outlook for the rest of the year on lower-than-expected third-quarter results.

The German dialysis giant released preliminary figures for the three months ended Sept. 30, saying it expects to report profits of €285 million on sales of €4.06 billion. Analysts were looking for sales of €4.12 billion.

Fresenius cut its forecast for 2018, saying it now expects to log adjusted net income growth of 2% to 3%, down from 7% to 9% previously. Sales growth is now pegged at 2% to 3%, compared with 5% to 7% previously, “due to a weaker-than-expected growth in the healthcare services business in North America and the difficult economic environment in certain emerging countries,” the company said.

“The underlying growth trends and business drivers remain intact. While we were able to improve profitability in North America, the growth acceleration in the region did not materialize as fast as anticipated. In addition, the business performance in some emerging countries was muted due to a challenging economic environment. Based on these developments, which are not expected to be fully recovered in the fourth quarter, we adjust our targets for fiscal 2018,” CEO Rice Powell said in prepared remarks. “To protect the access of our patients to dialysis care, we contributed to the opposition to the ballot initiatives in the U.S.”

The news depressed FMS shares to a $41.48 close yesterday, down -16.8%. The stock was off -3.1% at $40.19 per share this morning in pre-market trading.

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Fresenius Medical Care offers $585m in notes

Fresenius Medical Care (NYSE:FMS; ETR:FRE) this week successfully placed notes with an aggregate principal amount of €500 million ($584.9 million).

The notes will mature in 7 years and have an annual coupon of 1.5%, the company noted. Fresenius reported that the issue price is 99.704% and the resulting yield amounts to 1.545%.

“The transaction was very well received by investors and substantially oversubscribed. The proceeds will be used for general corporate purposes, including the refinancing of upcoming maturities,” Fresenius said in a press release.

Last week, the medtech giant inked a $150 million strategic partnership with Humacyte, landing exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology.

Research Triangle Park, N.C.-based Humacyte is positioning its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal disease who cannot have fistula placement.

According to the terms of the deal, Fresenius Medical will be responsible for the marketing, sales and distribution of Humacyl following appropriate regulatory approval. Fresenius is also slated to make a $150 million equity investment to obtain a 19% fully diluted ownership stake in Humacyte, with the deal expected to close next month.

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