Medtronic Expands Operations in Heerlen, the Netherlands

Global medical technology company Medtronic has started construction of its new distribution facility in Heerlen, the Netherlands. Located next to the company’s existing Center of Excellence, the 355,200-square-foot facility will begin operations in 2017. It will support the creation of 140 new jobs in addition to the existing 1,000 jobs Medtronic has in Heerlen. Medtronic will use the facility to store and distribute medical devices like implants, surgical instruments and patient monitoring systems.

Distribution Growth

Heerlen’s central location and logistics infrastructure will improve Medtronic’s distribution. Medtronic will work closely with global supply chain management company CEVA Logistics to reach more than 15,000 European hospitals and clinics within 24 hours.

“We strive to ensure the timely delivery of our medical technology products to hospitals and patients, and the unique geographical location of this new facility is aimed at supporting anticipated growth across the European market. We look forward to enhancing our presence in this community,” said Sikko Zoer, Vice President of Customer and Supply Chain at Medtronic EMEA (Europe, Middle East and Africa).

South Limburg’s Medical Logistics Cluster

The Dutch province of Limburg, specifically the city of Heerlen, is becoming a hub for medical logistical activities. Companies benefit from similar operations in the region and government support.

“The city of Heerlen offers tremendous opportunities for companies in the medical logistical sector. This investment, in close cooperation with WDP and CEVA Logistics, is a key indicator of growth in the existing medical logistical cluster in the region, highlighting Medtronic’s status as the largest commercial employer in the region,” said Martin de Beer, Alderman Economic Affairs of the Municipality of Heerlen.

Source: CEVA Logistics

November 15, 2016

16 November 2016

FDA Clears EOS Imaging’s Surgical Planning Software

November 16, 2016

EOS imaging has received FDA 510(k) clearance for its knee EOS 3D surgical planning software for total knee arthroplasty, which means the company can now market the software in the United States.

Leveraging weight-bearing 3D images and data from the EOS system, the online 3D planning software can provide an optimized surgical plan for total knee arthroplasty. The software facilitates surgical preparation and alignment in 3D while illustrating relevant clinical parameters in real time, and that generates an initial proposal for the size selection and position of the implant components.

“The knee EOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market,” says Marie Meynadier, EOS imaging’s CEO. Explaining further, she says the solution will support the growing adoption of EOS images, 3D models, and patient-specific datasets throughout the care continuum.

For patients, this means personalized treatments, absent the high dose and cost associated with CT imaging.

For more information about this software, visit EOS imaging.

Jury Hands Doctor $20.3M Verdict In Medtronic Patent Suit

By Kelcee Griffis

Law360, New York (November 14, 2016, 8:58 PM EST) — Medtronic Inc. must pay $20.3 million in damages to a doctor who sued the medical device company for patent infringement, a Texas jury decided Friday.

The jury found Medtronic “actively induced” infringement on both of the patents in question held by Mark A. Barry, a doctor who sued the company in 2014 for allegedly infringing on his devices that align vertebrae in patients with conditions such as scoliosis.

The patents cover hardware such as specialized screws and a method of implanting them by surgeons to correct certain spinal deformities.

Barry said Medtronic reproduced and sold implants that compete with his own across the U.S. and internationally. In a motion for judgment as a matter of law filed toward the end of the trial Thursday, the company fired back, saying that there was no way to prove surgeons relied on that highly specific set of screws and tools to complete the surgery.

The jury disagreed, awarding $17.6 million for infringement that occurred within the U.S. and the rest for infringement that took place outside the country.

The trial began Nov. 3 and wrapped up Nov. 11, said Sean P. DeBruine of Kilpatrick Townsend & Stockton LLP, the lead attorney representing Barry. The 10 jurors deliberated for about five hours before coming to a unanimous verdict, he said.

DeBruine said the jury was admirable for spending the Veteran’s Day holiday deciding on the verdict.

READ THE REST HERE

 

Xtant Medical Closes Rights Offering for Gross Proceeds of $3.8 Million

BELGRADE, Mont., Nov. 17, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, announced today the closing of its rights offering (the “Offering”) of units at a subscription price of $0.75 per unit, for aggregate gross proceeds to the Company of approximately $3.8 million.

Pursuant to the Rights Offering, Xtant sold an aggregate of 5,055,345 units consisting of a total of 5,055,345 shares of common stock and 5,055,345 warrants, with each warrant exercisable to purchase one share of common stock an exercise price of $0.90 for five years from the date of issuance. The warrants are anticipated to commence trading on the OTCBB under the symbol “XTNTW” as early as Wednesday, November 23, 2016.

Maxim Group LLC acted as sole dealer manager for the Offering.

If you have questions about the offering, please contact Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, email: syndicate@maximgrp.com or telephone 212-895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Xtant Medical’s registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on October 31, 2016. The final prospectus, prospectus supplement no. 1 thereto dated November 9, 2016, and all of Xtant Medical’s SEC filings may be found on the SEC’s website at http://www.sec.gov.

About Xtant Medical Holdings

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant MedicalMolly Mason
mmason@xtantmedical.com

Source: Xtant Medical Holdings, Inc.

 

 

Zimmer Biomet Announces Launch of the Comprehensive® Vault Reconstruction System – the First Commercially Available Patient-matched Glenoid Implant

WARSAW, Ind., Nov. 17, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of the Comprehensive® Vault Reconstruction System (VRS), the first patient-matched glenoid implant cleared to specifically treat patients with a severely deficient rotator cuff and extensive bone loss which precludes the use of a standard glenoid baseplate. The VRS uses CT imaging and advanced 3D reconstruction techniques to allow surgeons to personalize each patient’s implant.

“The treatment options for extensive glenoid deficiencies were limited to bone grafting or hemi-arthroplasties, both of which were unreliable and had marginal success,” said Dr. David Dines, Orthopedic Surgeon at the Hospital for Special Surgery in New York and Professor of Orthopedic Surgery at Weill Cornell Medical College.  “The Comprehensive Vault Reconstruction System represents an important advance in shoulder reconstruction by streamlining and personalizing the implant procedure in hope of more predictable outcomes and results that extend beyond pain relief, to restoring function and improving overall quality of life.”

The first implantation of the VRS took place on September 21, 2016, at the University of Virginia Hospital in Charlottesville, Va. and was successfully performed by Dr. Stephen Brockmeier.

“The Comprehensive Vault Reconstruction System is another example of our commitment to addressing the clinical and unmet needs of shoulder specialists,” said Orsa Britton, Vice President and General Manager of Zimmer Biomet’s global Extremities business. “This innovative, patient-specific implant, coupled with extensive pre-operative planning software, will expand viable treatment options for patients with severe glenoid deformities.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

Orthofix to Present at Piper Jaffray Healthcare Conference

November 17, 2016

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Piper Jaffray Healthcare Conference on Wednesday, November 30, 2016 at 9:10 a.m. Eastern Time in New York, NY.

A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
Investor Relations
markquick@orthofix.com
or
Denise Landry, 214-937-2529
Media Relations
deniselandry@orthofix.com

Spine Wave, Inc. To Present At The 28th Annual Piper Jaffray Healthcare Conference

SHELTON, CT–(Marketwired – November 17, 2016) – Spine Wave, Inc. is committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Spine Wave is pleased to announce that Chief Executive Officer Mark LoGuidice will present at the upcoming 28th Annual Piper Jaffray Healthcare Conference in New York City. The presentation will begin at 4:10 p.m. on Tuesday, November 29th in the Kennedy 1 Room at the Lotte New York Palace.

Mr. LoGuidice’s presentation will highlight Spine Wave’s recent commercial success with new expandable interbody product introductions, as well as provide a glimpse into the 2017 pipeline which will significantly expand both the company’s product portfolio and the addressable market segments.

About Spine Wave

Spine Wave’s vision is to leverage our intellectual property portfolio and engineering expertise to deliver a steady stream of highly differentiated spinal technologies with a particular emphasis on expandable interbody devices. Spine Wave’s portfolio of expandable products now includes the Velocity® Interbody Device, the Leva® Interbody Device and the StaXx® family of products, of which over 50,000 devices have been implanted. Other novel products in the portfolio include the Annex® Adjacent Level System, the Sniper® Spine System, which has developed a reputation as a leading MIS screw system, and the recently acquired True Position® Pivoting Spacer System which is comprised of a “crescent-style” interbody device and a unique delivery mechanism which simplifies accurate and reproducible placement of the implant. Spine Wave is committed to delivering a robust pipeline in 2017 that will allow the company to address every major spine market segment with a highly differentiated offering.

For further information on all of the Spine Wave products please visit the Company’s website at www.SpineWave.com.

CONTACT INFORMATION

  • Contact:
    Terry Brennan
    Chief Financial Officer
    Email contact
    203-712-1810

Antimicrobial Resistance Concerns Leach into FDA’s Classification of Wound Dressings Containing Drugs

Posted in Regulatory and Compliance by MDDI Staff on November 15, 2016

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely used to treat medical conditions ranging from minor cuts and burns, to diabetic foot ulcers and historically have been cleared by FDA through the 510(k) process. While this is not the first time FDA has looked to experts to help evaluate the classification of wound dressings containing drugs, this panel meeting was prompted in part by evolutions in technology, the breadth of cleared indications for use, the extensive list of ingredients (many with known or potential chemical activity), and the public health implications associated with antimicrobial resistance (as evidenced by FDA’s recent ban of 19 antibacterial agents in soaps).

The panel’s main focus was on dressings containing antimicrobial drugs, but certain single entity dressings containing materials that are not antimicrobial drugs or preservatives, but that act solely within the dressing to enhance its barrier properties, were also discussed. The panel discussion was largely consistent with FDA’s historical regulatory approach for devices containing drugs, but also highlighted that these products present unique regulatory challenges and public health concerns.

A critical point of discussion involved the differentiation of these products based on the purpose of the drug and how such differences could lead to different regulatory pathways. The use of antimicrobial agents that could lead to increased antimicrobial resistance or toxicity also was a focal point of the discussion and was of particular interest to the panel members. The panel believed that increased scrutiny and regulation may be necessary for some of these products to prevent or limit future increases in antimicrobial resistance.

FDA’s Regulatory Framework and Antimicrobial Resistance Concerns

Antimicrobial agents, which are commonly used to treat, manage, and prevent infectious diseases, come in many forms, all of which are expected to kill or inhibit the growth of microorganisms including bacteria, viruses, fungi, and parasites. Antimicrobials have been added to a variety of medical devices to reduce the risk of infections, including through the prevention of microbial growth on the device itself.

FDA frequently views the addition of an antimicrobial agent to increase the risks associated with a medical device. Many Class I, 510(k)-exempt devices, including hydrogel wound dressings and mattress covers for medical purposes, for example, require 510(k) clearance when an antimicrobial agent is added. FDA generally considers the addition of these agents to change the fundamental scientific technology of the device, thus exceeding the limitations of their 510(k) exemptions.

 

READ THE REST HERE

Flexion Therapeutics Announces Pricing of Public Offering of Common Stock

BURLINGTON, Mass., Nov. 16, 2016 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (FLXN) today announced the pricing of an underwritten public offering of 3,600,000 shares of its common stock at a price to the public of $18.00 per share.  The gross proceeds from this offering are expected to be approximately $64.8 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Flexion.  The offering is expected to close on or about November 21, 2016, subject to customary closing conditions.  Flexion has also granted the underwriters a 30-day option to purchase up to 540,000 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

Wells Fargo Securities, RBC Capital Markets and BMO Capital Markets are acting as joint book-running managers.

The shares of common stock described above are being offered pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by email at cmclientsupport@wellsfargo.com, or by telephone at (800) 326-5897; from RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822-4089, or by email at equityprospectus@rbccm.com; or from BMO Capital Markets Corp., 3 Times Square, 25th Floor, New York, NY 10036, Attention: Equity Syndicate Department, or by telephone at (800) 414-3627, or by email at bmoprospectus@bmo.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Flexion’s securities. No offer, solicitation or sale will be made in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA). The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive intra-articular (IA) injections for knee OA annually.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to expectations regarding the completion, timing and proceeds of the public offering, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with market conditions and the satisfaction of customary closing conditions related to the offering; and other risks and uncertainties described in our filings with the SEC, including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Anika to Present at the Piper Jaffray 28th Annual Healthcare Conference on November 29, 2016

November 15, 2016

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that its Chief Financial Officer, Sylvia Cheung, will make a presentation at the Piper Jaffray 28th Annual Healthcare Conference on Tuesday, November 29, 2016 at 8:50 am ET. The conference is being held at the Lotte New York Palace hotel in New York City.

A live audio webcast of the presentation may be accessed via the “Investor Relations” section of Anika’s website at www.anikatherapeutics.com. An audio archive of the presentation also will be available on the website.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications, Inc.
Susan Heins, 864.286.9597