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Globus Medical Launches QUARTEX™ OCT Stabilization System

Posted On October 25, 2016 By OrthoSpineNews In Spine /  

AUDUBON, Pa., Oct. 25, 2016 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, continues to innovate in the treatment of complex spinal instability and deformity with today’s announcement of the launch of the QUARTEX™ OCT Stabilization System.

QUARTEX™ offers a variety of solutions to the challenges associated with posterior OCT fusion while delivering paramount reliability and ease of use.  QUARTEX™ screw heads accept 3.5mm or 4.0mm rods in either titanium or cobalt chrome alloy and offer 90° of conical angulation.  QUARTEX™ allows surgeons to take full advantage of thoracic anatomy through the use of larger screws with diameters up to 5.5mm. Refined instruments facilitate construct assembly with efficient reduction options and intuitive screwdrivers.

“QUARTEX™ provides a single, seamless solution to posterior OCT fixation,” said Chad Glerum, Director of Fixation, Product Development.  “Our design team of engineers and spine surgeons scrutinized every aspect of the implants and instruments to optimize flow and functionality. We are excited to see QUARTEX™ provide a versatile OCT solution to propel Globus’ continued growth in this market.”

Dr. Richard Frisch added, “I’m excited that I can choose a 4.0mm rod for my longer constructs and larger diameter screws in the upper thoracic pedicles. The increased stiffness and bone purchase gives me a lot of confidence in the stability of the construct. The drivers provide firm attachment to the screws and the threaded locking caps engage easily, which help my cases run smoothly. QUARTEX™ is the most versatile system I have used and is a great addition to my practice.”

Indications

The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/ or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Dan Scavilla
Senior Vice President and Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com
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Life Spine® to Showcase Additions to Its Full Procedural TLIF Offering at NASS Annual Meeting

Posted On October 25, 2016 By OrthoSpineNews In Spine /  

October 25, 2016

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it will be participating in the 31st North American Spine Society (NASS) Annual Meeting, taking place in Boston, October 26-29th, 2016. The meeting is expected to attract over 3,000 surgeons and other healthcare professionals from across the globe.

Life Spine is pleased to introduce two new Transforaminal Lumbar Interbody Fusion (TLIF) products at the 2016 NASS conference in Boston. The new TLIF Retractor was designed in close collaboration with leading spine surgeons with the goal of reducing tissue disruption, while maximizing the exposure for better surgeon visualization. The retractor features independent angulating blades and modular taps, which anchor to the pedicles and allow for optimal disc space distraction. Also, PLATEAU®-LO, an innovative new oblique, lordotic interbody cage, devised to assist with patient sagittal alignment, is a great complement to the already robust line of interbody devices sold by Life Spine.

Life Spine will be showing both the TLIF Retractor as well as PLATEAU-LO, in addition to the entire company portfolio of products, at booth #1031 at the NASS meeting.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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NuVasive First-to-Market With New Spine Innovations Featured at NASS 2016

Posted On October 25, 2016 By OrthoSpineNews In Spine /  

SAN DIEGO, CA–(Marketwired – October 25, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the introduction of new spine innovations at the North American Spine Society (NASS) 31st Annual Meeting held October 26-29, 2016 at the Boston Convention and Exhibition Center. NuVasive will showcase the Company’s expanded Integrated Global Alignment™ (iGA) platform, now supporting all spinal procedures, including cervical alignment. In addition, the Company will introduce proprietary image enhancement software that allows the surgical staff to significantly reduce exposure to surgical radiation in the operating room (OR), and directly addresses a known safety concern of surgeons and OR staff.

iGA Platform for Cervical

iGA is a proprietary, procedurally-integrated digital platform of specialized products designed to help surgeons achieve more precise spinal column alignment. The expanded platform makes NuVasive the first company to offer a solution to address spinal alignment for all spine procedures and provides surgeons an intuitive surgical workflow during pre-, intra- and post-operative that consists of software and hardware. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life.

NuVasive’s differentiated technology helps surgeons:

  • Calculate the patient’s cervical alignment and preoperatively plan prior to surgery,
  • Correct and assess the cervical spine intraoperatively through integrated procedural solutions, and
  • Confirm postoperatively to reconcile the preoperative plan and the intraoperative assessment.

Part of the expanded platform includes the launch of Bendini® OCT, the innovative computer-assisted, rod bending system, which now has the ability to bend spinal rods for occipito-cervico-thoracic (OTC) cases. Bendini OCT is used in combination with NuvaPlanning™ software, integrated into surgical workflow for pre-, intra- and post-operative planning and confirmation, and NuvaMap™ O.R., the industry’s first and only real-time intraoperative assessment tool to assess the correction achieved prior to finishing the case. Also, as part of the cervical iGA platform, the Company will be launching the CoRoent® Small Interlock™ Hyperlordotic system, the first anterior cervical interfixated implant designed to treat cervical alignment deformities by offering multiple lordotic options to address patient-specific correction.

“Based on the identified clinical need and scientific foundation of driving improved clinical outcomes through optimized global sagittal alignment, we have expanded our iGA platform to now address cervical alignment. Building on the tremendous success the Company has seen with iGA, we are proud to offer the only available solution to address spinal alignment for all spine procedures,” said Jason Hannon, NuVasive’s president and chief operating officer. “This cutting-edge surgical planning technology enables surgeons to more completely plan for and achieve total sagittal alignment, including for patients suffering from cervical conditions. It represents another step forward in our mission to transform spine surgery.”

Improving OR Safety with LessRay® Technology

Physicians can exceed their lifetime Occupational Radiation Limit within the first decade of their career.

As surgery trends increasingly towards minimally invasive surgery (MIS) due to patient benefits, surgeon familiarity and superior clinical and economical outcomes, radiation exposure to surgeons and OR staff may increase.

To directly address this potential barrier to widespread adoption of MIS, NuVasive acquired the LessRay software technology suite from a private company called SafeRay Spine. The LessRay software is designed to be integrated into current surgeon workflow and utilizes an algorithm to drive image registration and enable management of radiation exposure, while maintaining high-quality, intra-operative images on existing C-Arm workflow without loss of visual accuracy.

“NuVasive has a strong history of delivering disruptive spine technology. From XLIF to iGA, we continually outpace our peers when addressing unmet clinical and market requirements. Radiation in the OR is a known issue, one that plagues the surgeon, the staff and the patient,” said Mr. Hannon. “This proprietary technology is aimed at supporting the surgeon and their staff, transforming their environment to be safer and more productive, while directly addressing one of the leading barriers to adopt MIS without any disruption to their familiar workflow. We see workflow familiarity as a key requirement for broad and rapid adoption of any successful technology platform.

“In addition, the technology fits our portfolio of differentiated solutions as a foundational element of our imaging, navigation and surgical automation development strategy. Our unmatched spine platform includes industry-leading hardware, software and services, transforming spine surgery through reproducible clinical and economic outcomes,” added Mr. Hannon.

NuVasive NASS Participation Details

NuVasive will showcase and demo its new technologies at NuVasive Booth #1315 on the NASS exhibit floor.

The Company will also feature the new BASE™ Interfixated Titanium system, a key addition to the iGA platform. BASE is designed to achieve fusion goals and spinal alignment objectives with precision, innovative functionality and a wide range of implant size and lordosis options. Titanium implants have a proven strength profile compared to that of other materials on the market. The new system offers versatile fixation options with a distinctive locking mechanism and anatomic implant design to help rebuild spinal foundation.

NuVasive’s participation at NASS includes a series of in-booth presentations and workshops. Visit the Company’s website for presentation details.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

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.

CONTACT INFORMATION

  • Investor Contact:
    Suzanne Hatcher
    NuVasive, Inc.
    858-458-2240
    Email contact


    Media Contact:
    Michael Farrington
    NuVasive, Inc.
    858-909-1940
    Email contact

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NuVasive Reports Third Quarter 2016 Financial Results

Posted On October 25, 2016 By OrthoSpineNews In Financial /  

SAN DIEGO, CA–(Marketwired – October 25, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today financial results for the quarter ended September 30, 2016.

Third Quarter 2016 Highlights

  • Revenue increased 19.5% to $239.6 million, or 18.9% on a constant currency basis
  • GAAP operating profit margin of 8.8%; Non-GAAP operating profit margin of 16.1%
  • GAAP diluted earnings per share of $0.07; Non-GAAP diluted earnings per share up 14.3% from prior year to $0.40

“Our results for the third quarter reflect continued strength in procedural volumes across the United States, as well as strong performances in our European and Australian markets,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “While our revenue results for the quarter were lower than our expectations due to capital and stocking orders in the United States that did not come through late in the quarter as planned, we believe this minor disruption is temporary. During the quarter, we continued to experience positive trends, including domestic procedural volumes in line with prior quarters and the conversion of surgeons at an increasingly faster pace, signaling stable market trends and competitive dynamics that favor our innovation and spine-only focused strategy.

“As anticipated, our results were also impacted by our dilator being off the market in Japan for a large portion of the quarter, which resulted in lower XLIF revenues. If XLIF procedures in Japan had been performed at their normal pace, the underlying revenue growth rate of our core business would have been in the mid-to-high single digits. We have resubmitted our dilator for approval with the Japanese Ministry of Health, and to be prudent, we have updated our financial guidance to reflect the removal of XLIF revenues in Japan for the fourth quarter.”

Lucier continued, “Our intense focus on operational excellence is paying off as we delivered profitability and earnings that were significantly higher than our internal expectations, while continuing to invest in a broader innovation agenda and our new manufacturing facility in Ohio to drive long-term shareholder value creation. Based on these dynamics, we are reiterating our full year 2016 financial guidance in line with prior expectations, with the exception of revenue.”

A full reconciliation of GAAP to non-GAAP measures can be found in the tables of this news release.

Third Quarter 2016 Results

NuVasive’s financial results for the third quarter 2016 are inclusive of results from Ellipse Technologies, Inc. Mega Surgical and Biotronic NeuroNetwork, as these previously disclosed acquisitions were completed earlier in the year. Ellipse Technologies now operates as the renamed division NuVasive Specialized Orthopedics (NSO). Biotronic NeuroNetwork now operates alongside the Company’s existing Impulse Monitoring business under the renamed division NuVasive Clinical Services (NCS).

NuVasive reported third quarter 2016 total revenue of $239.6 million, a 19.5% increase compared to $200.5 million for the third quarter 2015. On a constant currency basis, third quarter 2016 total revenue increased 18.9% compared to the same period last year.

For the third quarter 2016, GAAP and non-GAAP gross profit was $180.5 million and $182.9 million, respectively, while GAAP and non-GAAP gross margin was 75.3% and 76.3%, respectively. These results compared to GAAP and non-GAAP gross profit of $151.4 million and GAAP and non-GAAP gross margin of 75.5% for the third quarter 2015. Total GAAP and non-GAAP operating expenses were $159.3 million and $144.4 million, respectively, for the third quarter of 2016. These results compared to GAAP and non-GAAP operating expenses of $123.3 million and $118.7 million, respectively, for the third quarter 2015.

NuVasive reported a GAAP net income of $3.9 million, or $0.07 per diluted share, for the third quarter 2016 compared to $13.0 million, or $0.24 per diluted share, for the third quarter 2015.

On a non-GAAP basis, the Company reported net income of $21.1 million, or $0.40 per diluted share for the third quarter 2016 compared to $18.1 million, or $0.35 per diluted share, for the third quarter 2015.

Cash, cash equivalents and short and long-term marketable securities were approximately $204 million at September 30, 2016.

Updated Guidance for 2016

The Company reiterated full year 2016 financial guidance in line with prior expectations, with the exception of revenue. The Company expects full year 2016 revenue to be lower than prior expectations based on the Company’s third quarter 2016 revenue results and the Company’s revised forecast for fourth quarter 2016 revenue in Japan.

  • Revenue of approximately $952.0 million for 2016, which includes a $1 million benefit from currency or approximately 17.4% growth compared to revenue of $811.1 million for 2015; versus a prior expectation of $962.0 million for 2016;
  • Non-GAAP diluted earnings per share of approximately $1.64, an increase of approximately 25% and in line with the prior expectation of $1.64, compared to non-GAAP diluted earnings per share of $1.31 for 2015;
  • Non-GAAP operating profit margin of approximately 16.0%, an increase of 60 basis points compared to 15.4% for 2015; in line with the prior expectation of approximately 16.0% for 2016;
  • Adjusted EBITDA margin of approximately 25.4% for 2016; in line with the prior expectation of approximately 25.4% for 2016, compared to 25.2% for 2015; and
  • Non-GAAP effective tax expense rate of approximately 37%; in line with the prior expectation of approximately 37% for 2016.

Supplementary Financial Information

Reconciliation of Full Year EPS Guidance
2016 Guidance
2015
Actuals		 Prior 1,2 Current 1,3
GAAP net income per share $ 1.26 $ 0.84 $ 0.76
Impact of change to diluted share count 0.03 0.03 0.03
GAAP net income per share, adjusted to diluted Non-GAAP share count $ 1.30 $ 0.88 $ 0.79
Litigation liability gain (0.82 ) (0.83 ) (0.83 )
Business transition costs 4 0.27 0.20 0.26
Non-cash interest expense on convertible notes 0.31 0.38 0.38
Non-cash purchase accounting adjustments on acquisitions 5 – 0.28 0.28
Loss on repurchase of convertible notes – 0.34 0.34
Amortization of intangible assets 0.24 0.73 0.78
In-process research & development 0.02 – –
Tax effect of adjustments 6 (0.01 ) (0.34 ) (0.36 )
Non-GAAP earnings per share $ 1.31 $ 1.64 $ 1.64
GAAP Weighted shares outstanding – basic 48,687 50,004 50,050
GAAP Weighted shares outstanding – diluted 52,425 53,942 54,100
Non-GAAP Weighted shares outstanding – diluted 51,110 52,000 52,050
1 Prior guidance provided July 26, 2016. Current guidance reflects guidance provided October 25, 2016, as updated for the expected changes in currency.
2 Effective tax expense rate of approximately 41% applied to GAAP earnings and approximately 37% applied to Non-GAAP earnings.
3 Effective tax expense rate of approximately 42% applied to GAAP earnings and approximately 37% applied to Non-GAAP earnings.
4 Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.
5 Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.
6 The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of approximately 37% on a non-GAAP basis.
Reconciliation of Non-GAAP Operating Margin %
2016 Guidance
(in thousands, except %) 2015 Actuals Prior 1 Current 1
Non-GAAP Gross Margin % [A] 76.0 % 76.4 % 76.4 %
Non-cash purchase accounting adjustments on acquisitions 2 0.0 % (1.5 %) (1.5 %)
GAAP Gross Margin [B] 76.0 % 74.9 % 74.8 %
GAAP & Non-GAAP Sales, Marketing & Administrative Expense [C] 56.4 % 55.4 % 55.3 %
Non-GAAP Research & Development Expense [D] 4.3 % 5.1 % 5.1 %
In-process research & development 0.1 % 0.0 % 0.0 %
GAAP Research & Development Expense [E] 4.4 % 5.1 % 5.1 %
Litigation liability [F] (5.2 %) (4.5 %) (4.5 %)
Amortization of intangible assets [G] 1.5 % 4.0 % 4.3 %
Business transition costs [H] 3 1.7 % 1.2 % 1.5 %
Non-GAAP Operating Margin % [A – C – D] 15.4 % 16.0 % 16.0 %
GAAP Operating Margin % [B – C – E – F – G – H] 17.1 % 13.7 % 13.2 %
1 Prior guidance provided July 26, 2016. Current guidance reflects guidance provided October 25, 2016, as updated for the expected changes in currency.
2 Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.
3 Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.
Reconciliation of EBITDA %
2016 Guidance
(in thousands, except %) 2015
Actuals		 Prior 1 Current 1
Net Income / (Loss) 8.2% 4.7% 4.3%
Interest (income) / expense, net 3.4% 5.9% 6.0%
Provision for income taxes 5.8% 3.2% 3.1%
Depreciation and amortization 8.1% 10.5% 10.6%
EBITDA 25.5% 24.3% 24.1%
Non-cash stock based compensation 3.1% 2.9% 2.9%
Business transition costs 2 1.7% 1.1% 1.4%
Non-cash purchase accounting adjustments on acquisitions 3 0.0% 1.5% 1.5%
In-process research & development 0.1% 0.0% 0.0%
Litigation liability gain (5.2%) (4.5%) (4.5%)
Adjusted EBITDA 25.2% 25.4% 25.4%
1 Prior guidance provided July 26, 2016. Current guidance reflects guidance provided October 25, 2016, as updated for the expected changes in currency.
2 Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.
3 Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

For additional financial detail, please visit the Investor Relations section at www.nuvasive.com to access Supplementary Financial Information.

Reconciliation of Non-GAAP Information

Management uses certain non-GAAP financial measures such as non-GAAP earnings per share, non-GAAP net income, non-GAAP operating expenses and non-GAAP operating profit margin, which exclude amortization of intangible assets, non-cash purchase accounting adjustments on acquisitions, business transition costs, CEO transition related costs, certain litigation charges, significant one-time items, non-cash interest expense and/or losses on repurchase of convertible notes, and the impact from taxes related to these items, including those taxes that would have occurred in lieu of these items. Management also uses certain non-GAAP measures which are intended to exclude the impact of foreign exchange currency fluctuations. The measure constant currency is the use of an exchange rate that eliminates fluctuations when calculating financial performance numbers.

The Company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital. Additionally, the Company uses an adjusted EBITDA measure which represents earnings before interest, taxes, depreciation and amortization and excludes the impact of stock-based compensation, non-cash purchase accounting adjustments on acquisition, business transition costs, CEO transition related costs, certain litigation charges, and other significant one-time items. Management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to further and more consistently analyze the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional information to enable them to assess, in the same way management assesses, the Company’s current and future continuing operations. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Reconciliation of Third Quarter 2016 Results
GAAP Net Income per Share to Non-GAAP Earnings per Share
(in thousands, except per share data) Adjustments Diluted Earnings
Per Share
GAAP net income $ 3,926 $ 0.07
Business transition costs 1 3,451
Non-cash interest expense on convertible notes 5,186
Non-cash purchase accounting adjustments on acquisitions 2 2,457
Amortization of intangible assets 11,115
Tax effect of adjustments 3 (5,010 )
Adjustments to GAAP net loss 17,199 0.33
Non-GAAP earnings $ 21,125 $ 0.40
GAAP weighted shares outstanding – diluted 55,782
Non-GAAP weighted shares outstanding – diluted 52,633
1 Costs related to acquisition, integration and business transition activities which includes severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.
2 Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.
3 The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of approximately 37% on a non-GAAP basis. The result of these adjustments is a change in the annual effective tax rate from approximately 29% to 37%. The Company adopted ASU 2016-09 Stock Compensation in Q2 2016 which was effective as of January 1, 2016 with retrospective adjustment. The result of the retrospective adjustment resulted in a change in the Q1 2016 quarterly effective tax rate on a non-GAAP basis from approximately 41% to 36%.
Reconciliation of Year To Date 2016 Results
GAAP Net Income per Share to Non-GAAP Earnings per Share
(in thousands, except per share data) Adjustments Diluted Earnings
Per Share
GAAP net income $ 30,771 $ 0.58
Litigation liability gain (43,310 )
Business transition costs 1 11,514
Non-cash interest expense on convertible notes 14,547
Non-cash purchase accounting adjustments on acquisitions 2 14,747
Loss on repurchases of convertible notes 17,444
Amortization of intangible assets 28,945
Tax effect of adjustments 3 (15,759 )
Adjustments to GAAP net income 28,128 0.54
Non-GAAP earnings $ 58,899 $ 1.14
GAAP weighted shares outstanding – diluted 53,498
Non-GAAP weighted shares outstanding – diluted 51,841
1 Costs related to acquisition, integration and business transition activities which includes severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.
2 Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.
3 The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of approximately 37% on a non-GAAP basis. The result of these adjustments is a change in the annual effective tax rate from approximately 29% to 37%. The Company adopted ASU 2016-09 Stock Compensation in Q2 2016 which was effective as of January 1, 2016 with retrospective adjustment. The result of the retrospective adjustment resulted in a change in the Q1 2016 quarterly effective tax rate on a non-GAAP basis from approximately 41% to 36%.
Reconciliation of Third Quarter and Nine Months 2016 Results
GAAP net income to Adjusted EBITDA
Three months ended Nine months ended
(in thousands, except per share data) September 30, 2016 September 30, 2016
GAAP net income $ 3,926 $ 30,771
Interest (income) / expense, net 1 10,789 46,508
Provision for income taxes 6,972 17,383
Depreciation and amortization 27,158 72,865
EBITDA $ 48,845 $ 167,527
Litigation liability gain — (43,310 )
Non-cash purchase accounting related charges 2 2,457 14,747
Business transition costs 3 3,451 11,514
Non-cash stock based compensation 7,288 19,645
Adjusted EBITDA $ 62,041 $ 170,123
As a percentage of revenue 25.9 % 24.6 %
1 Included in Interest (income) / expense, net for the nine months ended September 30, 2016 is loss on extinguishment of debt for $17.4 million.
2 Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.
3 Costs related to acquisition, integration and business transition activities which includes severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

Investor Conference Call

NuVasive will hold a conference call today at 5:30 p.m. ET / 2:30 p.m. PT to discuss the results of its financial performance for the third quarter 2016. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. After the live webcast, the call will remain available on NuVasive’s website through November 28, 2016. In addition, a telephone replay of the call will be available until November 2, 2016. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13646026.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

NuVasive cautions you that statements included in this news release or made on the investor conference call referenced herein 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. In addition, this news release contains selected financial results from the third quarter 2016, as well as projections for 2016 financial guidance and longer-term financial performance goals. The Company’s projections for 2016 financial guidance and longer-term financial performance goals represent current estimates, including initial estimates of the potential benefits, synergies and cost savings associated with acquisitions, which are subject to the risk of being inaccurate because of the preliminary nature of the forecasts, the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability. The potential risks and uncertainties that could cause actual growth and results to differ materially include, but are not limited to: the risk that NuVasive’s revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the risk of further adjustment to financial results or future financial expectations; unanticipated difficulty in selling products, generating revenue or producing expected profitability; the risk that acquisitions will not be integrated successfully or that the benefits and synergies from the acquisition may not be fully realized or may take longer to realize than expected; and those other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available atwww.sec.gov.com. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

NuVasive, Inc.
Consolidated Statements of Operations
(in thousands, except per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2016 2015 2016 2015
(unaudited)
Revenue $ 239,649 $ 200,538 $ 690,963 $ 595,831
Cost of goods sold (excluding below amortization of intangible assets) 59,196 49,167 173,167 143,246
Gross profit 180,453 151,371 517,796 452,585
Operating expenses:
Sales, marketing and administrative 131,886 110,554 391,211 338,444
Research and development 12,516 9,189 35,016 27,227
Amortization of intangible assets 11,438 3,067 29,912 9,037
Litigation liability gain — (500 ) (43,310 ) (42,507 )
Business transition costs 3,451 950 11,514 10,845
Total operating expenses 159,291 123,260 424,343 343,046
Interest and other expense, net:
Interest income 190 362 924 1,125
Interest expense (10,979 ) (7,307 ) (29,988 ) (21,675 )
Loss on repurchases of convertible notes — — (17,444 ) —
Other income (loss), net 94 387 (102 ) 530
Total interest and other expense, net (10,695 ) (6,558 ) (46,610 ) (20,020 )
Income before income taxes 10,467 21,553 46,843 89,519
Income tax expense (6,972 ) (8,803 ) (17,383 ) (35,332 )
Consolidated net income $ 3,495 $ 12,750 $ 29,460 $ 54,187
Add back net loss attributable to non-controlling interests $ (431 ) $ (210 ) $ (1,311 ) $ (601 )
Net income attributable to NuVasive, Inc. $ 3,926 $ 12,960 $ 30,771 $ 54,788
Net income per share attributable to NuVasive, Inc.:
Basic $ 0.08 $ 0.26 $ 0.62 $ 1.13
Diluted $ 0.07 $ 0.24 $ 0.58 $ 1.05
Weighted average shares outstanding:
Basic 50,264 48,993 49,970 48,513
Diluted 55,782 53,199 53,498 52,202
NuVasive, Inc.
Consolidated Balance Sheets
(in thousands, except par values and share amounts)
September 30, 2016 December 31, 2015
ASSETS (Unaudited)
Current assets:
Cash and cash equivalents $ 203,818 $ 192,339
Short-term marketable securities — 165,423
Accounts receivable, net of allowances of $8,335 and $5,320, respectively 143,818 127,595
Inventory, net 212,784 168,140
Prepaid income taxes 46,904 40,540
Prepaid expenses and other current assets 9,573 8,790
Total current assets 616,897 702,827
Property and equipment, net 179,913 141,441
Long-term marketable securities — 112,332
Intangible assets, net 303,928 85,076
Goodwill 498,686 154,281
Deferred tax assets 4,633 83,691
Restricted cash and investments 7,420 5,615
Other assets 24,568 17,404
Total assets $ 1,636,045 $ 1,302,667
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 72,581 $ 60,985
Contingent consideration liabilities 45,005 —
Accrued payroll and related expenses 41,010 37,641
Income tax liabilities 828 990
Short-term senior convertible notes 120,975 —
Total current liabilities 280,399 99,616
Long term senior convertible notes 559,950 372,920
Deferred and income tax liabilities, non-current 26,239 8,602
Non-current litigation liabilities — 88,261
Other long-term liabilities 46,643 14,425
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized, none outstanding — —
Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2016 and December 31, 2015, 55,096,226 and 52,616,471 issued and outstanding at September 30, 2016 and December 31, 2015, respectively 55 53
Additional paid-in capital 1,033,298 989,387
Accumulated other comprehensive loss (5,891 ) (12,112 )
Accumulated deficit (73,235 ) (104,006 )
Treasury stock at cost; 4,751,464 shares and 3,316,794 shares at September 30, 2016 and December 31, 2015, respectively (237,411 ) (161,788 )
Total NuVasive, Inc. stockholders’ equity 716,816 711,534
Non-controlling interests 5,998 7,309
Total equity $ 722,814 $ 718,843
Total liabilities and equity $ 1,636,045 $ 1,302,667
NuVasive, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Nine Months Ended September 30,
2016 2015
(unaudited)
Operating activities:
Consolidated net income $ 29,460 $ 54,187
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 73,765 49,006
Loss on repurchases of convertible notes 17,444 —
Amortization of non-cash interest 16,906 13,255
Stock-based compensation 19,645 20,570
Reserves on current assets 9,027 7,232
Other non-cash adjustments 11,369 13,127
Deferred income taxes 24,810 37,047
Changes in operating assets and liabilities, net of effects from acquisitions:
Accounts receivable (3,038 ) 2,163
Inventory (22,423 ) (19,768 )
Prepaid expenses and other current assets (3,457 ) 2,512
Accounts payable and accrued liabilities 5,939 8,828
Accrued royalties (85 ) (46,999 )
Accrued payroll and related expenses (1,670 ) (5,080 )
Litigation liability (88,450 ) (35,333 )
Income taxes 6,778 (52,739 )
Net cash provided by operating activities 96,020 48,008
Investing activities:
Acquisition of Ellipse Technologies, net of cash acquired (380,080 ) —
Other acquisitions and investments (108,150 ) (1,357 )
Purchases of intangible assets (5,918 ) (28,589 )
Proceeds from sales of property and equipment 40
Purchases of property and equipment (73,882 ) (59,905 )
Purchases of marketable securities (128,956 ) (320,177 )
Proceeds from sales of marketable securities 407,032 272,666
Sales of restricted investments — 180,694
Purchases of restricted investments — (62,625 )
Net cash used in investing activities (289,954 ) (19,253 )
Financing activities:
Incremental tax benefits related to stock-based compensation awards — 15,185
Proceeds from the issuance of common stock 6,668 9,040
Payment of contingent consideration — (514 )
Purchase of treasury stock (24,441 ) (52,532 )
Proceeds from issuance of convertible debt, net of issuance costs 634,140 —
Proceeds from sale of warrants 44,850 —
Purchase of convertible note hedge (111,150 ) —
Repurchases of convertible notes (343,835 ) —
Proceeds from revolving line of credit 50,000 —
Repayments on revolving line of credit (50,000 ) —
Other financing activities (1,701 ) (131 )
Net cash provided by (used in) financing activities 204,531 (28,952 )
Effect of exchange rate changes on cash 882 (862 )
Increase (decrease) in cash and cash equivalents 11,479 (1,059 )
Cash and cash equivalents at beginning of period 192,339 142,387
Cash and cash equivalents at end of period $ 203,818 $ 141,328

CONTACT INFORMATION

  • Investor Contact:
    Suzanne Hatcher
    NuVasive, Inc.
    1-858-458-2240
    Email contact

    Media Contact:
    Michael Farrington
    NuVasive, Inc.
    1-858-909-1940
    Email contact

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Surgeons use nose cells to repair damaged knee joints

Posted On October 25, 2016 By OrthoSpineNews In Recon /  

October 20, 2016 – By Susan Scutti, CNN

(CNN)-Swiss surgeons successfully used an experimental technique, which includes harvesting cells from the nasal septum, to repair damaged knee joints in patients. Two years later, these patients report improvements in pain and knee function, according to a study published Thursday in the journal The Lancet.

“The treatment is safe and feasible,” said study co-author, Dr. Ivan Martin.

Between 2004 and 2011, nearly two million Americans underwent a knee surgery due to cartilage problems. As the population ages, these surgeries will become increasingly common, experts say, however the existing techniques aren’t optimal. This study indicates a promising new option could be within sight.

“Moreover, results indicate that the tissue being formed at the patients’ repair site improves in composition over time, getting more and more similar to healthy cartilage,” said Martin, a professor of surgery and biomedicine at University Hospital Basel in Switzerland. “Patients’ satisfaction was also, on average, improving over time.”

Engineered Cartilage

Joint conditions in the knee often begin with damage to articular cartilage — the tissue at the end of a bone that cushions the joint. This cartilage is necessary for pain-free movement. Unfortunately, cartilage lacks its own blood supply, so it has very little ability to repair itself once damaged.

Since 2001, Martin and his team have been investigating a new surgical approach to repairing knees. It uses engineered cartilage tissue grown from patients’ own cells, taken from the nasal septum.

The rationale behind this is based on the fact that nasal cells “have a larger and more reproducible capacity to form new cartilage,” said Martin. In fact, he and his team demonstrated this in past studies.

“We further established that the cartilage tissue generated by nasal chondrocytes [one type of cell] can respond to physical forces (mechanical loads) similar to articular cartilage and has the ‘plasticity’ to adapt to a joint environment,” added Martin. In one of their pre-tests for the current study, he implanted engineered tissue into goat joints and found it “efficiently integrated with surrounding articular cartilage.”

For the new study, Martin and his colleagues took the all-important step of testing their ideas in humans. They began by enlisting the help of 10 patients, who range in age from 18 to 55, all with cartilage lesions of the knee.

 

READ THE REST HERE

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Spineology Announces FDA Clearance of Rampart™ Duo™ Interbody Fusion System

Posted On October 25, 2016 By OrthoSpineNews In Regulatory /  

October 25, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in anatomy-conserving surgery™, is excited to announce FDA clearance of the Rampart Duo Interbody Fusion System. The Rampart Duo Interbody Fusion Device is the first device of its kind to combine PEEK, titanium, and graft containment mesh elements.

“Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh® technology,” said John Booth, CEO of Spineology. “The 510(k) clearance of Rampart Duo opens the door to the commercialization of a family of hybrid PEEK and graft containment mesh implants designed for interbody fusion. The implant is a great addition to our anatomy-conserving product offering.”

“The implant design allows for decreased retraction requirements when compared to current interbody systems. The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach,” said Dr. Sandeep Kunwar, San Francisco, CA.

“The device has been anatomically designed. The PEEK spacer blocks are positioned on the lateral aspects of the vertebral body, where the bone is naturally strongest, to provide solid anterior support,” adds Dr. Michael Wang, Miami, FL. “In addition, the central graft containment mesh allows for broad device deployment which increases graft footprint and facilitates conforming apposition of the graft to the endplate for fusion.”

“The small tubular retractor and streamlined instruments, including ones that allow for the placement of the device when a high iliac crest is present, may help preserve patient anatomy and limit operating room time,” said Dr. Craig Kuhns, Austin, TX.

The Rampart Duo implant design includes PEEK spacer blocks that are positioned at each end of the device and a flexible porous graft containment mesh which creates a central graft cavity. Following implantation, the porous graft containment mesh is filled with bone graft to deploy the device in the anterior-posterior direction, which allows for a wide graft footprint, and in the superior-inferior direction to provide conforming apposition with the vertebral endplates.

About Spineology

Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

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FDA is working with hospitals to modernize data collection about medical devices

Posted On October 25, 2016 By OrthoSpineNews In Regulatory /  

America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of ways.

From helping set a broken leg or responding to an emerging viral threat, to assisting and performing delicate heart surgeries on tiny newborns, these hospital personnel are the front line of surveillance, vigilance, and intervention.

Throughout their work day, hospital staff use a variety of medical devices: imaging machines, EKGs and in vitro tests to make diagnoses; infusion pumps, ventilators and robotics to provide treatment, and an array of implants to replace diseased joints and organs. And, as the nation’s hubs for real-time health care data, hospitals are uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of already known safety problems because they use these technologies in the real-world setting of clinical practice, outside of the more controlled setting  of a clinical trial.

FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices.

Given the greater diversity and complexity of medical devices today; the rapid technological advances and iterative nature of medical device product development; the interface between the technology and the user – including the learning curve associated with adopting new technology; and, in some cases, a relatively short product life cycle that can be measured in months, not years; FDA’s evaluation of medical device safety presents unique challenges not seen with drugs and biologics. Therefore, assuring the safety of medical devices depends on many factors and should a problem arise, it could be due to a variety of causes.

At the time of premarket evaluation, however, it is not feasible to identify all possible risks or to have absolute certainty regarding a technology’s benefit-risk profile. Among other reasons, studies required to do so would likely be prohibitively large in order to capture less frequent and more unpredictable effects or consequences. In addition, such larger studies still may not reflect the true benefit-risk profile of the device. Once a device is on the market, for example, doctors may use it beyond the FDA cleared intended use. In addition, subsequent modifications to the device or changes in how the device is used in practice can result in new safety risks or greater frequency of known risks.

 

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Spinal Elements® Announces Expansion of Sales Team

Posted On October 25, 2016 By OrthoSpineNews In Spine /  

Spinal Elements, a spine technology company, announced the expansion of its Sales team with the addition of Steve Haayen. Mr. Haayen is taking the role of Area Vice President of Sales in the Western United States.

Haayen brings over 10 years of spine sales and management experience to Spinal Elements, having previously held roles with Stryker Spine, Globus Medical, Lanx, and Biomet. In his roles with each company, Haayen has led sales growth while achieving multiple President’s & Chairman’s Club Awards, and Sales Director of the Year along with leading the Representative and Distributor of the Year from his region. Furthermore, he has a depth of experience in minimally invasive (MIS) and lateral access spine systems, an area of focus for Spinal Elements.

“We are very fortunate to have someone with Steve’s depth of knowledge in the space of our new expanding technologies. Steve’s business acumen, procedural and industry knowledge will help us continue the strong sales growth we have seen in 2016,” added Paul Cory, Vice President of Sales at Spinal Elements.

Spinal Elements is introducing several new technologies over the coming months including a novel MIS lateral access system, expandable interbody devices that aid in the restoration of proper sagittal balance by expanding and lordosing, and an MIS interspinous process fixation device. The company expects strong demand for these new procedurally driven surgical solutions in addition to the robust growth seen in its current line of products. Additional Sales management positions will be filled to help address ongoing expansion.

Spinal Elements will be exhibiting (Exhibit 1341) October 26th through the 28th at the North American Spine Society meeting in Boston. The company has seen over 20% growth this year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond titanium coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Follow us on Twitter @SpinalElements and on LinkedIn for continuous company updates.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161025005585/en/

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Innovative Product and Service Offering for the Future of Spinal Surgery To Be Introduced at NASS 2016

Posted On October 25, 2016 By OrthoSpineNews In Spine /  

October 25, 2016 – ALLENDALE, N.J.–(BUSINESS WIRE)

Ascential, an innovative implant and delivery solution for lower acuity spinal procedures in the ambulatory surgery center (ASC) and hospital settings, will be introduced at the North American Spine Society (NASS) Annual Meeting in Boston, Oct. 26-29, 2016 (booth No. 1511).

Ascential offers a portfolio of newly designed sterile-packaged implants, customized service levels, and a streamlined distribution model. The innovative Ascential solution is intended to provide operational efficiencies, competitive pricing, and reduced operating costs so that staff can spend less time managing logistics and more time and resources on patient care.

Ascential implants are manufactured by Stryker in accordance with the company’s stringent quality standards. Products available with Ascential include:

  • The ACP 1 Anterior Cervical Plating System, offering a simple backout prevention mechanism, high degree of screw angulation, and streamlined instrumentation.
  • The IBD PeekC Anterior Cervical Spacer System, featuring a chamfered leading edge, a large open graft window, and a collet-style inserter.
  • VBA Vitoss Foam Pack, the top-selling synthetic bone graft, a versatile material that is stable in a fluid environment, can soak and hold bone marrow, is compression-resistant, and can be mixed with local bone.

Ascential is enabled with optional end-to-end radio-frequency identification (RFID) inventory management using proprietary technology. As a result, it allows sales representatives and facility staff to easily monitor and manage inventory pre-, post- and intra-operatively to help reduce labor costs and ensure implant availability. The implants are also sterile-packaged to reduce the sterilization burden and chance of infection.1,2 All implant packaging is UDI (Unique Device Identification) compliant and includes patient labels to promote traceability.

Unlike conventional inventory management methods, which generally require sales representatives to drop off equipment a few days prior to surgery, then come back to attend the surgery, and take the instruments back for reprocessing post-surgery, Ascential enables instruments to remain with the customer to be processed and sterilized on a schedule that makes sense for each facility. Dedicated and optimized instrument sets with sterile-packaged implants help ensure availability, reduce case scheduling activities, and enable more flexible sterilization workflows.

This new inventory management program can be customized for each facility based on an analysis of the number of spine cases, surgical days, number of surgeons, and other variables and priorities. “Ambulatory surgery centers are often focused on improving logistics, increasing efficiency, and reducing costs,” said Orrin Levine, Senior Director, Business Solutions at Stryker. “The new Ascential solution positively impacts all three—once it’s up and running, processes for spinal fusion procedures can become even more simplified, repeatable, and scalable.”

About Ascential

Ascential is a new approach to spine healthcare that offers high-quality products with increased efficiency and profitability for hospitals and outpatient surgery centers. Ascential is manufactured by Stryker, one of the world’s leading medical technology companies. For more information, please visit us at www.ascentialhealth.com.

References

1. Bible J, O’Neill K, Crosby C, Schoenecker J, McGirt M, Devin C. Implant contamination during spine surgery. Spine J.2013;13(6):637-640.

2. Menekse G, Kuscu F, Suntur B, et al. Evaluation of the time-dependent contamination of spinal implants: prospective randomized trial. Spine. 2015;40(16):1247-1251.

Content ID ACP1-PR-1_12074

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ConforMIS Names Industry Veteran Mark Augusti President and Chief Executive Officer

Posted On October 24, 2016 By OrthoSpineNews In Recon /  

BEDFORD, Mass., Oct. 24, 2016 (GLOBE NEWSWIRE) — ConforMIS Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, announced today that Mark A. Augusti has been named the Company’s President and Chief Executive Officer, effective when he joins the Company on November 14, 2016.  The Company also expects that Mr. Augusti will be appointed to the Company’s Board of Directors following the commencement of his employment. Mr. Augusti will succeed current President and Chief Executive Officer, Philipp Lang, M.D. MBA, and Dr. Lang will continue to serve on the Board of the Company.

Mr. Augusti’s 27-year business career has been marked with executive management responsibility in medical technology sales, marketing and general management.  Mr. Augusti joined Integra LifeSciences Corporation (Integra) in April 2014 and is Integra’s Corporate Vice President and President of Orthopedics and Tissue Technologies. Mr. Augusti is responsible for the management of the Orthopedics and Tissue Technologies global division which includes spine and extremity implants, orthobiologics, tissue products, and the private label business. His responsibilities include U.S. commercial leadership, global portfolio management, evaluation of corporate development opportunities and overall strategic direction. Prior to joining Integra, Mr. Augusti served as Chief Executive Officer at Bioventus LLC, from May 2012 to August 2013, and was a member of the company’s Board of Directors during the same period. Prior to that Mr. Augusti spent nine years with Smith & Nephew Inc., from April 2003 to April 2012, in a series of leadership roles, including President of Smith & Nephew’s Biologic Division, where he was appointed to lead Smith & Nephew’s new biologics initiative.  He also served as Smith & Nephew’s President of the Orthopaedic Trauma & Clinical Therapies Global Business and Senior Vice President and General Manager of the Trauma business. In 2000, Mr. Augusti joined J.P. Morgan Securities as a Vice President in the Private Funds group.  Prior to that, from 1987 to 2000, he spent 13 years at GE Medical Systems Inc., where he held various sales, marketing and strategic management roles, both in the U.S. and internationally. Mr. Augusti received his M.B.A. from the UCLA Anderson School of Management and his B.S. in Computer Science and Economics from Duke University.

Kenneth P. Fallon, III, Chairman of the Board of ConforMIS, said, “Mark Augusti’s experience and performance in a number of challenging roles was a significant factor in his selection as ConforMIS’ President and Chief Executive Officer. Mark has led teams that delivered strong growth during his tenure at Integra.  In Integra’s most recently reported quarter, Mark’s Orthopedics and Tissue Technologies division revenue grew 38% from the prior-year period for both the quarter and six-months ended June 30, 2016. Our Board is looking forward to his commercial and operational leadership in unlocking the full value of our proprietary technology for customized joint implants.”

Mr. Augusti said, “I am extremely honored to be joining ConforMIS. I am impressed with this compelling technology and unique value proposition for the advancement of joint arthroplasty.  From my discussions with surgeons that use ConforMIS customized implants, it is clear to me that the clinical benefits gained from ConforMIS’ customized implant systems are tremendous – not only for patients, but for doctors and hospitals as well. Surgeons that use ConforMIS implants are passionate about the results they are achieving.  I look forward to working with Dr. Philipp Lang and the ConforMIS Board as we continue to move the company forward.”

Dr. Lang said, “ConforMIS’ vision is ‘One Patient, One Implant’, each customized and designed to restore the natural shape of a patient’s knee. The clinical benefits to the patient paired with the potential for economic savings to the hospital, when compared to leading off-the-shelf brands, have helped transform ConforMIS into a rapidly growing medical device company. Just a few weeks ago, we announced that we had sold over 50,000 customized knee implants since our inception, which represents a substantial increase over the 30,000 we had sold as of June of 2015 at the time of our IPO. This is a testament to our cutting-edge technology, and I am really excited about the prospects of ConforMIS as we move forward.”

Mr. Fallon said, “The Board appreciates Dr. Lang’s contributions to ConforMIS as founder and Chief Executive Officer. Dr. Lang has been instrumental in building a great company, and we look forward to his continued contributions as a member of our Board.”

About ConforMIS Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.ConforMIS.com. To receive future releases in e-mail alerts, sign up athttp://ir.ConforMIS.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our Board, strategy, future operations, future financial position and results, market growth, total revenue, the potential impact and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, expenses, gross margins and other results of operations, employee transition, retention and hiring plans, the impact of our voluntary recall on financial results and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONTACT:

Investor contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

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