Friday, May 29, 2015

News: Zimmer Announces Agreements in Furtherance of Pending Biomet Merger

WARSAW, Ind.May 28, 2015 /PRNewswire/ -- Zimmer Holdings, Inc. (NYSE and SIX: ZMH) ("Zimmer") announced today that it has finalized agreements with buyers to divest in the United States certain Zimmer® Unicompartmental High-Flex Knee System assets, Biomet Discovery® Elbow System assets and Cobalt™ bone cement assets.  These divestiture agreements are in furtherance of Zimmer's pending acquisition of Biomet, Inc. ("Biomet").  
Image result for zimmer holdings logoZimmer continues to work constructively with the Bureau of Competition Staff of the U.S. Federal Trade Commission (the "FTC" and, such staff, the "FTC Staff") and is highly confident that within the next few weeks it can finalize the agreement in principle it reached previously with FTC Staff to resolve FTC Staff's competitive concerns regarding the proposed acquisition.   
The divestiture agreements are subject to further review by the FTC and acceptance of a consent order by the Commissioners of the FTC.  The closing of these transactions is also subject to other customary conditions.
As previously announced, both the European Commission and the Japan Fair Trade Commission have cleared Zimmer's proposed acquisition of Biomet.  Upon the acceptance of the consent order by the FTC and the satisfaction of other customary closing conditions, Zimmer intends to close the Biomet merger at the earliest possible date, which is currently anticipated to be mid-June, 2015.
About Zimmer
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants and related surgical products.  Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer's 2014 sales were approximately $4.7 billion.  Zimmer is supported by the efforts of more than 9,000 employees worldwide.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "anticipates," "plans," "estimates," "projects," "assumes," "guides," "targets," "forecasts," and "seeks" or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, statements about the benefits of the proposed merger between Zimmer and LVB Acquisition, Inc. ("LVB"), the parent company of Biomet, including future financial and operating results, the combined company's plans, objectives, expectations and intentions, the expected timing of completion of the transaction and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Zimmer's management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties include, but are not limited to: the possibility that the anticipated synergies and other benefits from the proposed merger of Zimmer and LVB will not be realized, or will not be realized within the expected time periods; the inability to obtain regulatory approvals of the merger (including the approval of antitrust authorities necessary to complete the transaction) on the terms desired or anticipated; the timing of such approvals and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the transaction; the risk that a condition to closing the transaction may not be satisfied on a timely basis or at all; the risk that the proposed transaction fails to close for any other reason; the risks and uncertainties related to Zimmer's ability to successfully integrate the operations, products and employees of Zimmer and Biomet; the effect of the potential disruption of management's attention from ongoing business operations due to the pending merger; the effect of the announcement of the proposed merger on Zimmer's and Biomet's relationships with their respective customers, vendors and lenders and on their respective operating results and businesses generally; risks relating to the value of the Zimmer shares to be issued in the transaction; the outcome of any legal proceedings related to the proposed merger; the risks and uncertainties normally incidental to the orthopaedic industry, including price and product competition; the success of the companies' quality and operational excellence initiatives; changes in customer demand for Zimmer's or Biomet's products and services caused by demographic changes or other factors; the impact of healthcare reform measures, including the impact of the U.S. excise tax on medical devices; reductions in reimbursement levels by third-party payors and cost containment efforts of healthcare purchasing organizations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of Zimmer's or Biomet's products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; the ability to form and implement alliances; challenges relating to changes in and compliance with governmental laws and regulations, including regulations of the U.S. Food and Drug Administration (the "FDA") and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA; changes in tax obligations arising from tax reform measures or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market Zimmer's and Biomet's products; dependence on a limited number of suppliers for key raw materials and outsourced activities; changes in general industry and market conditions, including domestic and international growth rates and general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing economic uncertainty affecting countries in the Euro zone on the ability to collect accounts receivable in affected countries. For a further list and description of such risks and uncertainties, see Zimmer's periodic reports filed with the U.S. Securities and Exchange Commission (the "SEC"). Copies of these filings, as well as subsequent filings, are available online at www.sec.govwww.zimmer.com or on request from Zimmer. Zimmer disclaims 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 its periodic reports. Readers of this communication 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 communication.
Additional Information and Where to Find It
Zimmer filed with the SEC, and the SEC declared effective on September 29, 2014, a registration statement on Form S-4 that includes a consent solicitation statement of LVB that also constitutes a prospectus of Zimmer. INVESTORS AND SECURITYHOLDERS OF LVB ARE URGED TO READ THE CONSENT SOLICITATION STATEMENT/PROSPECTUS AND OTHER FILINGS MADE WITH THE SEC IN CONNECTION WITH THE MERGER CAREFULLY AND IN THEIR ENTIRETY, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE MERGER. The registration statement and consent solicitation statement/prospectus and other documents filed by Zimmer with the SEC may be obtained free of charge at the SEC's website atwww.sec.gov or from Zimmer at www.zimmer.com. You may also read and copy any reports, statements and other information filed by Zimmer, LVB and Biomet with the SEC at the SEC public reference room at 100 F Street N.E., Room 1580, Washington, D.C.20549. Please call the SEC at (800) 732-0330 or visit the SEC's website for further information on its public reference room. Certain executive officers and directors of LVB have interests in the proposed transaction that may differ from the interests of stockholders generally, including benefits conferred under retention, severance and change in control arrangements and continuation of director and officer insurance and indemnification.
This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to appropriate registration or qualification under the securities laws of such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
SOURCE Zimmer Holdings, Inc.
Published @ PR Newswire

News: Dymicron, Inc., Announces the First Human Implantation of their Triadyme-CTM Cervical Total Disc Replacement Device in Cyprus

May 28, 2015

Orem, UT—Dymicron, Inc., (dymicron.com) confirmed the successful completion of their first in-human surgeries using their unique Triadyme-C cervical total disc replacement device. The two surgeries were performed by noted surgeon Dr. William D. Smith at the American Institute of Minimally Invasive Surgery (AIMIS) in Cyprus.
“The patients are responding well to the implantation of the Dymicron devices,” said Dr. William D. Smith, Chairman of AIMIS Spine Center and Chief of Neurosurgery for the University Medical Center, Las Vegas, Nevada. “The Triadyme-C is unique in its composition and design, most notably for its diamond compact. This design may place Dymicron as a front runner in cervical TDR devices in a time when research has shown cervical TDR is often superior to fusion.”
The Triadyme-C is the flagship product of Dymicron, Inc., a company focused on designing, developing and commercializing medical devices leveraging their proprietary Orthopedic DiamondTM material.
Triadyme-C will address two immediate areas of concern in the total disc replacement field – minimizing wear debris generation and emulation of natural constrained motion in the spine.
Dymicron’s biocompatible Orthopedic Diamond material is made of polycrystalline diamond compact (PDC), one of the hardest and most durable substances known to man. With extreme durability and a low coefficient of friction, Triadyme-C resists the structural breakdown that can release dangerous wear debris into the body.
The proprietary tri-lobe technology developed by Dymicron features an articulation mechanism made of three spherical lobes seated within three non-congruent, spherical pockets. The motion of the three lobes within their associated pockets generates a smooth, gentle centering force that emulates the natural motion of the spine.
“We are extremely pleased that we have successfully completed our first in-man procedures. Based on our unique technology and design, we’re confident that the Triadyme-C will become a preferred option for patients suffering from cervical degenerative disc disease,” said Jeff Bennett, President of Dymicron.
Following the successful completion of the first in-human procedures, Dymicron is slated to begin three clinical studies in England, Germany and South Africa in Q3 of 2015.
Founded in 1997, Dymicron, Inc. is a privately-held company located in Orem, Utah. They are an innovation-based medical device company that focuses on the design, development, manufacturing and marketing of a new generation of orthopedic implant devices utilizing their proprietary biocompatible Orthopedic Diamond material. For additional information about Dymicron, please contact Angela Bailey, Vice President of Marketing at (801) 580-4049 or at abailey(AT)dymicron.com.

Published @ PRWeb

News: SPINEART ANNOUNCES CHINA CFDA CLEARANCE OF EXTENSIVE FUSION PORTFOLIO

27 MAY 2015

HomeIt includes cervical cages, plates and cage-plates (TRYPTIK®), lumbar cages (JULIET® PLIF, TLIF, ALIF) and the renowned thoracolumbar osteosynthesis system, ROMEO®2. This enables Spineart to address 90% of the fast-growing Chinese market (DDD, trauma, and deformities). 

Published @ Spinart

News: EOS imaging Announces CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty

PARIS--()--EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging and associated solutions, today announced the CE mark of kneeEOS, the first 3D planning software for total knee arthroplasty (TKA) based on EOS bi-planar imaging. The Company will showcase the planning suite at the 16th European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress, held May 27-29 in Prague.
kneeEOS is the second software offering powered by EOS images following hipEOS, which was CE Marked and FDA cleared in 2014. This 3D surgical planning platform is based on EOS’ low dose 3D images and technology from OneFit Medical, a company acquired by EOS imaging in late 2013. kneeEOS will initially be deployed as an online service to assist surgeons in patient’s leg alignment simulation in functional position, knee prosthesis selection, and placement simulation based upon 3D images generated by the EOS system.
Marie Meynadier, CEO of EOS imaging, said, “Leg alignment and component positioning are known to significantly influence surgical outcomes for total knee replacement. kneeEOS is the first and only 3D planning software for TKA in a functional weight bearing position. We are proud that our work has driven this new development and placed our Company at the leading edge of 3D surgical planning tool innovation that maximizes the potential of EOS’ technology for our surgeon users and their patients. Following the launch of hipEOS and our EOS 3D Service, kneeEOS marks the continued expansion of our cloud based services based on EOS unique images and associated patient datasets.”
The EOS® system provides full-body stereo-radiographic images of patients in functional positions, in both 2D and 3D. EOS exams require a radiation dose 50% to 85% less than Digital Radiology and 95% less than basic CT scans, as well as related software solutions. The new EOS Micro Dose option, recently cleared by the Food and Drug Administration, allows a further drastic step towards the ALARA principle (As Low As Reasonably Achievable) by bringing pediatric spine follow up exams at a dose level equivalent to a week of natural background radiation on Earth.
For further information about the Company or EOS®, the first full body, low dose 2D/3D imaging system, please visit http://www.eos-imaging.com/.
EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.
EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Next press release: revenue for the 1st half of 2015, on July 20, 2015 (after market).
About EOS imaging:
EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system based on technology that enabled George Charpak to win the Nobel Prize for Physics, as well as associated solutions. The Company is authorized to market in 48 countries, including the United States (FDA), Japan and the European Union (EU). As of December 31, 2014 the Group posted 2014 consolidated revenue of €20.1 million and employed 107 people including an R&D team of 39 engineers. The Group is based in Paris and holds four subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada) and Frankfurt (Germany), and offices in Singapore.

Contacts

EOS imaging
Anne Renevot, +33 (0)1 55 25 61 24
CFO
or
NewCap
Antoine Denry/ Pierre Laurent, +33 (0)1 44 71 94 91
Financial communication and investor relations
or
The Ruth Group (US)
Calvin Allen, 646-536-7002
Press relations

News: VertiFlex®, Inc. Announces FDA PMA Approval for the Superion® Interspinous Spacer

SAN CLEMENTE, Calif.--()--VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosisannounced today that the U.S. Food and Drug Administration (FDA) has issued a PMA Approval Order for the company’s Superion® Interspinous Spacer System, clearing the way for commercialization in the United States. The Approval Order follows a February FDA Advisory Panel vote that Superion® demonstrated safety, effectiveness, and a favorable risk benefit profile based on the results from a 470 patient, multi-center, prospective and randomized controlled IDE trial.
“Superion® has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population. Countless numbers of patients in the United States will now benefit from this important technological advancement.”
Superion® is indicated for moderate lumbar spinal stenosis, and is the least invasive motion preserving device in the category of interspinous spacers.
Highlights:
  • Largest, most robust IDE device trial for moderate lumbar spinal stenosis
  • Superion® demonstrated clinical success of >80% in all major components of the composite primary endpoint at 24 months, maintaining durability of effect through 36 months
  • Superion® patients exhibited similar leg pain improvement, as measured by VAS, compared to published literature on open surgical decompression
  • Healthcare economic data was captured, demonstrating Superion’s cost-effective equivalency to open surgical decompression
  • Superion® has been successfully implanted in over 2,000 patients around the world, and will soon be available in the United States
“We are delighted with this PMA approval based on compelling level one evidence developed in the Superion® IDE Trial,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex. “Superion® has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population. Countless numbers of patients in the United States will now benefit from this important technological advancement.”
Nick Shamie, MD, Professor & Chief, UCLA Orthopaedic Spine Surgery, and co-Medical Director for VertiFlex, commented: “As an early adopter of interspinous spacers, they have provided tremendous improvement for my patients suffering from lumbar stenosis. As a next-generation technology, Superion® offers the potential for even greater clinical benefit, with the least invasive indirect decompression possible, and the ability for patients to avoid traditional open spine surgery.”
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, providing new options for interventional spine physicians and less invasive options for traditional spine surgeons. To date, VertiFlex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis.

Contacts

VertiFlex, Inc.
Jeff Swiecki, 949-940-1400
info@vertiflexspine.com
www.vertiflexspine.com

News: NuVasive Appoints Gregory T. Lucier Chief Executive Officer

SAN DIEGO, CA--(Marketwired - May 26, 2015) - NuVasive, Inc. (NASDAQNUVA) ("NuVasive" or the "Company"), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that Gregory T. Lucier has been appointed Chief Executive Officer, effective immediately. Mr. Lucier, who has been serving as Interim Chief Executive Officer since April 1, 2015, will continue as Chairman of the NuVasive Board of Directors.
"Since being appointed Interim CEO, Greg has hit the ground running with an intense focus on driving NuVasive's industry leadership," said Jack R. Blair, Lead Independent Director of the NuVasive Board. "As the Board considered the needs of the Company, we determined that this focus as well as Greg's broad healthcare and leadership experience made him the right person to lead NuVasive forward. In addition to having a solid understanding of our strategy and business as a director, Greg brings a record of execution in areas that are also areas of strategic growth for NuVasive, including driving cutting-edge innovation, increased operational efficiencies and targeted expansion in key markets and geographies. With the support of our talented team of employee shareowners, we are confident that Greg will apply his skill set to the spine market to also drive compelling growth and value creation at NuVasive."
Mr. Lucier said, "NuVasive benefits from a dedicated and passionate team, a culture of innovation and strong surgeon customer relationships. I am excited to work as CEO alongside NuVasive's exceptional management team and more than 1,500 employee shareowners around the world to capitalize on the strength of the Company's market share-taking strategies, integrated procedural offerings and significant growth potential. Together, we are committed to scaling our business and more efficiently deploying resources, rapidly growing our presence outside the U.S. and leading innovation in the spine market through the introduction of game-changing technologies such as our recently launched Integrated Global Alignment platform. We have a tremendous amount of opportunity ahead of us, and I am confident in our ability to accelerate our positive momentum and continue to generate value for our shareholders in 2015 and beyond."
About Gregory T. Lucier
Mr. Lucier has served as a member of the NuVasive Board of Directors since December 2013.
From May 2003 to February 2014, Mr. Lucier served as Chairman and Chief Executive Officer of Life Technologies, a global life sciences company acquired by Thermo Fisher Scientific in 2014. During Mr. Lucier's 11-year tenure at Life Technologies, he led the company from a small start-up known as Invitrogen in 2003, directed the acquisition and merger of Invitrogen with Applied Biosystems in 2008 into the renamed Life Technologies, and then transformed the organization by 2013 into a global, world-leading biotechnology firm with 50,000 products, 12,000 employees and nearly $4 billion in sales in more than 180 countries. Serving in his leadership role, Mr. Lucier was responsible for fostering a culture of excellence and applied his more than 25 years of strategic management experience to deliver industry-leading operating margins, double-digit compounded annual growth in earnings per share and significant free cash flow.
Mr. Lucier previously was a Corporate Officer of General Electric and served as an executive at GE Medical Systems.
He received a bachelor's degree in engineering from Pennsylvania State University and a masters of business administration from Harvard Business School. In addition to serving on the Board of NuVasive, Mr. Lucier serves as the Board Chairman for Sanford Burnham Medical Research Institute, is a member of the Catalent, Inc. Board of Directors and is a former director of CareFusion Corporation, now part of Becton, Dickinson & Co.
About NuVasive
NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally-integrated solutions for the spine. The Company is the third largest player in the $9.0 billion global spine market. NuVasive offers a comprehensive spine portfolio of more than 90 unique products developed to improve spine surgery and patient outcomes. The Company's principal procedural solution is its Maximum Access Surgery, or MAS®, platform for lateral spine fusion. MAS was designed to provide safe, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure, and a broad offering of application-specific implants and fixation devices designed to address a variety of pathologies.
Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA™ platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

News: Aurora Spine Corporation Files Consolidated Financial Statements for the Three Months Ended March 31, 2015

CARLSBAD, CALIFORNIA--(Marketwired - May 27, 2015)
NOT FOR DISTRIBUTION IN THE UNITED STATES OR OVER UNITED STATES WIRE SERVICES
Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSX VENTURE:ASG) announces financial results for the three months ended March 31, 2015.
To our Shareholders:
Aurora Spine CorporationQ1 2015 saw an increase in sales over Q4 2014. During Q1 2015 we expanded availability of the family of products in the Screwless Procedure™, a cutting-edge surgical approach to spine fusion. The Screwless Procedure features: the ZIP™ MIS Fusion System, the TiNano® MIS Interbody cages, and the new COMPASS 4D™ MIS retractor system.
Highlights from Q1 2015
  • Achieved over $1.3M in total sales for the quarter, up approximately 456% over 2014 Q1.
  • Increased gross profits from $177K in Q1 2014 to $676K in Q1 2015, representing a 380% increase.
  • ZIP sales totaled approximately $660K of the Q1 revenue.
  • Introduced ZIP LP™, the slimmest design in the ZIP family.
  • Continued the growth of interbody cages featuring Aurora's new TiNano titanium spray coating technology, becoming the fastest growing product line, representing approximately 38% of our Q1 revenues.
  • TiNano Discovery cervical interbody cage sales increased by 257% in Q1 2015 over Q4 2014.
  • Sold and shipped the first ZIP implant order to Canada.
  • Added new customers: 12 hospitals, 19 surgeons, and 15 distributors.
The Screwless Procedure has been developed to increase the possibility of significant benefits to patients, hospitals, and surgeons, including reduced surgery time, less blood loss, shorter hospital stays, and significantly faster recovery time. These benefits will continue to be the driving force of Aurora Spine's competitive advantage and growth.
Sales outside of the United States represented approximately 15% of revenues in Q1 2015 and we anticipate an ongoing international presence.
Aurora 2015 focus:
  • Continue the strategy of building a strong revenue base in the North American, European, and the Middle Eastern markets. We will accomplish this by expanding product usage and product offering, with the current distribution network, developing new distribution channels and training new surgeons on the Aurora product advantages;
  • Introduce the MIS VOX™ Lateral Lumbar Interbody Fusion (LLIF) system, featuring Aurora's TiNano technology in Q2;
  • Introduce the ZIP 51™ product for sacro-lumbar fixation.
  • Add targeted regional sales leadership in key US markets;
  • Continue to add new hospitals, surgeons and distributors to our customer base.
  • Add complementary products to augment Aurora's MIS portfolio.
None of this would be possible without the dedication and commitment of our hardworking colleagues at Aurora. I want to thank them for the great accomplishments they have made this year, for Aurora and ultimately, for patients. They have embraced change and risen to the numerous challenges before them, and I am grateful for their ongoing support of our company and our mission.
I would also like to thank you, our investors, for your continued support. Together, we have built a strong foundation, and I look forward to the opportunities ahead of us. I am truly grateful to be part of an organization that makes such a positive improvement in the lives of patients around the world.
The statements together with the Management Discussion and Analysis can be found on SEDAR at www.sedar.com.
Sincerely,
Trent J. Northcutt
President and Chief Executive Officer
About Aurora Spine
Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.

CONTACT INFORMATION

  • Aurora Spine Corporation
    Trent Northcutt
    President and Chief Executive Officer
    (760) 424-2004

    Aurora Spine Corporation
    Eric Fronk
    Chief Financial Officer
    (760) 424-2004

Published @ Market Wired

News: SI-BONE, Inc. Appoints Laura Francis Chief Financial Officer and Closes Additional Round of Growth Capital

SAN JOSE, Calif.May 26, 2015 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced today that Laura Francis has joined the company as chief financial officer effective immediately.   Ms. Francis joins the executive management team bringing a wealth of experience from both public and private companies in executive leadership positions. 
Prior to joining SI-BONE, Ms. Francis was chief financial officer for Auxogyn, Inc., a venture-backed life science start-up in the Silicon Valley.  Prior to Auxogyn, she was vice president of finance, chief financial officer and treasurer for Promega Corporation, a privately held life sciences company.  While at Promega, she led multiple acquisitions of businesses in Asia Pacific countries.  Before joining Promega, Ms. Francis was the chief financial officer of Bruker BioSciences Corporation, a publicly traded life science company where she led their post IPO merger and secondary offering.  Earlier in her career, Ms. Francis was an engagement manager with consulting firm McKinsey & Co., and an audit manager with accounting firm PricewaterhouseCoopers.  Ms. Francis holds an M.B.A. from Stanford University, a B.B.A. from the University of Wisconsin, and a C.P.A. from the State of California.
"I could not be more excited to welcome Laura to the SI-BONE team.  She has extensive corporate finance experience in both large and small, public and private, companies. This, coupled with  her experience with acquisition transactions in global markets and managing a successful public offering, will help us achieve our growth goals in the coming years," said Jeffrey Dunn, President and CEO of SI-BONE.
"This is a unique opportunity for me to join an innovative company with a dynamic team that is focused on improving patients' lives everyday, but more importantly  has multiple areas of opportunity for significant growth and expansion," said Ms. Francis. "I am excited to work with Jeff and the team to continue to build the company's business."
In addition, the company also announced the closing of a $21 million round of growth capital financing.  New investor Redline Capital Management led the round that included participation from all existing major investors.  Proceeds from the financing will be used primarily to fund further expansion in the U.S. and Europe in anticipation of increased demand in the growing minimally invasive surgical (MIS) SI joint fusion market in these regions.  Procedure growth in the U.S. alone, as predicted by iData Research's 2014 SI joint fusion market report, is expected to grow six-fold over the next three years from the more than 8,000 surgeries performed in 2014.  Additional proceeds will be used to support entry into markets outside the U.S. and Europe, including countries in the Middle EastAsia and South America.
Clinical publications have identified the SI joint as a pain generator in 15% to 30% of low back pain patients.1-4  In addition, the prevalence of SI joint pain in post-lumbar fusion, so called "failed back surgery" patients, has been shown to be up to 43%.5  Of these patients, some may have degenerative sacroiliitis or SI joint disruptions.  Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical management of the SI joint fails, surgical options such as the iFuse procedure may be considered. 
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010. 
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit:www.si-bone.com/risks.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders.  The company has developed, and is manufacturing and marketing, minimally invasive products for patients with certain SI joint disorders.  SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices.  SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2015 SI-BONE, Inc. All Rights Reserved. 9199.052615
Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3 Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4 Sembrano JNa, Polly DW.a How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32. 
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine.2011;12:732-9.
Disclosures
Investigators in a clinical research study sponsored by SI-BONE, but they have no financial interest in the company. 
Published @ PR Newswire