Fresenius closes $2B sale of Sound Inpatient Physicians

Fresenius Medical Care (NYSE:FMS; ETR:FRE) said late last week it closed its divestiture of its Sound Inpatient Physician Holdings to an investment consortium led by Summit Partners for approximately $2.2 billion (EU €1.9 billion).

Bad Homburg vor der Höhe, Germany-based Fresenius said that the divestiture is part of the company’s overall goal of “sharpening the profile of the company’s care coordination portfolio,” according to an SEC filing.

The company said it expects the divestiture to improve net income by approximately $752 million, which includes the half-year impact from the increase in valuation of Sound’s share-based payment program.

Fresenius said that its financial targets for 2018 and 2020 do not include effects from the divestment, and that it expects to see a reduction to its revenue of approximately $754.5 million (EU €650 million) and net income by $46.4 million (EU €40 million), according to an SEC filing.

Last month, Fresenius said it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology.

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Woven Orthopedics raises $5m

Woven Orthopedic Technologies has raised $5.4 million in a new round of equity and options financing, according to an SEC filing posted this week.

Manchester, Conn.-based Woven Orthopedics is developing orthopedic products which aim to improve fixation, specifically for procedures using screws, according to the company’s website.

The company produces the OGmend implant system which uses biotextiles to enhance fixation. The first generation version of the device is designed from a biopolymer intended to increase surface area contact between bone and screw to distribute load transfer and aid in bone healing and remodeling, according to the company’s website.

A total of 64 unnamed investors have joined in the round so far, with the first sale date noted last August 9. The round has a minimum investment of $50,000, according to the filing.

Of the funds raised so far, $469,000 will be used to pay the CEO and six directors of the company for its calendar year 2018. The company is looking to raise an additional $12.6 million in the round, according to the filing.

The total amount raised so far includes converted principal and accrued interest of convertible notes sold in an offering opened January 3, 2017 and from a second closing on February 1 this year, according to the SEC filing.

Funds raised in the round will be used for R&D, pre-clinical testing and to support regulatory and intellectual property developments, according to an Ortopedics This Week report.

“The funds are mainly being used for research and development. We are also dedicating funds for pre-clinical testing, quality systems, regulatory strategy and to expand our IP coverage to continue erecting barriers to entry for potential future competition. In addition, a small amount of funds are being utilized to build-out the systems necessary to reach the market (i.e., reimbursement, compliance, education) and we expect that this will increase as the business gets closer to commercialization. We are developing a technology intended to offer a bone-friendly solution that enhances fixation to prevent loss of screw engagement and the additional treatments that typically follow (including reoperations). AO [Foundation], the leading global organization in trauma research identified fracture fixation in osteoporotic bone as a focal area of interest so developing a solution to provide better, faster, and cheaper fixation in various fracture scenarios plays a pivotal role in our business strategy,” strategy & finance VP Brandon Bendes told Orthopedics This Week.

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ReWalk Robotics inks soft exoskeleton research, licensing deal with Harvard

ReWalk Robotics (NSDQ:RWLK) has inked both a collaborative research and exclusive licensing agreement with Harvard Collage, looking to partner on research for the development of its soft-suit exoskeleton, according to a recently posted SEC filing.

Through the collaborative deal, both groups will join to aid in the development of soft-suit exoskeleton technologies designed to treat lower limb disabilities, the Marlborough, Mass.-based company said. The suit is intended to treat stroke, multiple sclerosis, mobility limitations for the elderly and other medical applications, ReWalk said.

The licensing agreement will grant ReWalk Robotics an exclusive, worldwide royalty-bearing license for certain patents related to the lightweight soft-suit exoskeleton technologies, according to an SEC filing.

The collaborative agreement was inked on May 1, while the licensing deal was signed on April 1, according to the filing.

Last week, ReWalk Robotics said it plans to expand the clinical study of its ReStore soft exo-suit device to five US research centers.

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Creo looks to raise $26m – or more

Creo Medical Group (LON:CREO) said today that it hopes to raise $26 million or more as it preps for a full commercial launch next year for its Speedboat RS2 electromagnetic surgery device.

Citing “current momentum” and its board’s desired to “exploit the opportunities,” the Chepstow, Wales-based company said it’s planning a secondary offering of £15 million to £20 million ($19.7 million to $26.3 million), “but given investor feedback to date the board may choose to raise a higher amount than this.”

The proceeds would go toward physician training, further development of its gastro-intestinal product line, R&D, international distribution deals and the acceleration of product rollout “by scaling up the current manufacturing capabilities and accelerating a USA roll out,” Creo said.

“The board believes that additional funds would make the company an increasingly attractive prospect for strategic partners and allow the exploration of possible strategic M&A,” the company said in a statement.

Creo would look to price the equity offering as close as possible to its June 27 closing price of £1.24 (~$1.63), it said.

($1 = £0.761395)

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Clot-buster captures tiny particles, too

MIVI Neuroscience’s next-generation DAISe blood clot management system has had its first-in-human use for treatment of ischemic stroke.

The procedure took place in South America, the company said in a statement. DAISe is designed to remove a clot as well as filter and capture clot emboli that fracture during removal.  It has a three-dimensional, vessel-conforming meshwork of hundreds of polymeric fibers that act as a mechanical backstop to capture debris as small as 40 um while maintaining blood flow through the device. Device delivery is similar to that of a stent retriever.

Get the full story on our sister site, Medical Design & Outsourcing.

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CHF Solutions prices $5m offering

CHF Solutions (NSDQ:CHFS) last week priced a $4.7 million offering to support expanding its field sales force and commercial organization.

The Eden Prairie, Minn.-based company said it plans to offer 2.2 million shares of its common stock at $2.12 per share. The offering includes a 45-day underwriter’s option for an additional 332,239 shares at the public offering price.

Ladenburg Thalmann & Co are acting as sole book-running manager for the offering, with Dawson James Securities acting as co-manager, according to a press release. The offering is expected to close July 3.

CHF Solutions said it plans to use net proceeds for general corporate purposes, including the expansion of its field sales force and commercial organization.

In May, CHF Solutions saw shares fall after the heart-focused medical device maker missed expectations on Wall Street with its first quarter earnings results.

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Nuvectra shares dive on FDA, EU requests for more data on Virtis neuromod device

Nuvectra, which spun out of Greatbatch in 2016, saw shares fall nearly 25% after it updated on its applications for FDA and CE Mark clearance in the European Union for its Virtis sacral neuromod device, saying it has been asked to submit additional information and clinical study data to the regulatory bodies.

The Plano, Texas-based company said that the FDA requested additional information as part of a review of its premarket approval application submitted in April. The federal watchdog is requesting supplemental info related to modifications or changes to the device, labeling and manufacturing data and clarifications of data related to MRI.

After receiving the data, the FDA will have 180 days to review it, pushing possible time to clearance back in the US. Nuvectra said it is in active communications with the FDA, and that it plans to work proactively to complete the review process “as soon as possible.”

Nuvectra said that a European regulatory body responsible for CE Mark approval also requested clinical study data before it can approve the Virtis system. The company said it is continuing discussions with the body regarding the application to “clarify the breadth of clinical data that may be requested.”

“Our primary focus is gaining FDA approval of the Virtis system in order to both provide therapy to patients and to address the significant market opportunity for SNM in the U.S. We remain encouraged by our recent interactions with the FDA and believe that our responses will adequately address the FDA’s requests.  We are pleased that our facility and pre-PMA audit have been completed without findings. We will continue to work cooperatively with the FDA to conclude the review of our application expeditiously and look forward to entering the U.S. SNM market as soon as possible following FDA approval. We will revisit our corporate strategy to enter the SNM market in Europe and will engage with TÜV SÜD to determine a reasonable clinical pathway to CE Mark approval,” CEO Scott Drees said in a press release.

Shares in Nuvectra have fallen 24.1% so far today, at $15.58 as of 10:51 a.m. EDT.

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