Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

1d2c76e445c828347fdd9adb97f29181-1-1.jpg

July 27, 2018 OrthoSpineNews

July 26, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its establishment in Germany.

Following the opening of the Implanet UK sales branch in June 2018, Implanet continues direct operational expansion in the European market at a rapid pace with the opening of Implanet GmbH, in Frankfurt am Main. Implanet targets the German degenerative spine disease market, the largest in Europe, estimated at 300 million dollars1, with approximately 1,000 potential surgeon customers. Like Implanet UK, this new German branch will capitalize on the success of Implanet’s strategy in France and the United States by setting up a mixed network of direct sales representatives and exclusive sales agents.

Implanet GmbH is headed by Jana Heuer, with 10 years of experience as a sales leader in the spinal surgery market, most recently at Paradigm Spine for four years and K2M for six years.

Ludovic Lastennet, Chief Executive Officer of Implanet, said: “After announcing Implanet UK in June, the opening of Implanet GmbH in Germany represents a new milestone in the implementation of our 2018-2019 strategic plan: this consists in promoting Implanet’s product range directly in key European markets and preparing to integrate the products of our partner L&K Biomed.”

Next press release: first-half 2018 results, Wednesday 19 September 2018

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 Company estimates

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net


download-12bto-3.jpg

July 27, 2018 OrthoSpineNews

HERZELIYA, IsraelJuly 26, 2018 /PRNewswire/ — CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear system provides unique clinical advantages to spine cancer patients and their physicians. Among those advantages are: no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue, minimal attenuation of External Beam Radiation (EBRT), allowing radiation to pass through the implant with almost zero reduction in the radiation dose level; and no artifact in CT, for optimal radiation CT planning. CarboClear spinal implants also offers superior fatigue strength, beneficial for a patient population known for extended delays in healing.  Additionally, the CarboClear Pedicle Screw System offers enhanced follow up abilities due to minimal CT/MRI artifact.

Dr. Stefano Boriani, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milano, said of his clinical experience with the CarboClear® system: “This unique material provide us with additional treatment options that we didn’t have in the past, and in our experience provides better clinical outcomes for the treated patients.”

About CarboFix Orthopedics LTD.

CarboFix Orthopedic Ltd, is recognized as the world’s leading company in developing, manufacturing and marketing innovative carbon fiber orthopedic solutions. CarboFix Orthopedics’ headquarters and manufacturing are located in Herzeliya, Israel, with additional manufacturing for the Asia market in Guangzhou, China. CarboFix is working in the United States through its subsidiary CarboFix Inc. and in the rest of the world through a network of distributors. The company’s products are approved by the FDA, CE and other regulatory bodies.

For more information, please visit www.Carbo-fix.com, or reach out directly to 

Ron Szekely

Int’l V.P., Sales & Marketing

Ron@carbo-fix.com

SOURCE CarboFix Orthopedics LTD.

Related Links

http://www.carbo-fix.com


AMPLITUDE-1-123-1-1-1.jpg

July 27, 2018 OrthoSpineNews

July 26, 2018

VALENCE, France–(BUSINESS WIRE)–regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces its sales for its 2017-18 financial year.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Exceeding €100 million in annual sales illustrates Amplitude Surgical’s positive momentum, with continuous organic growth since the Company’s creation in 1997. Our ongoing innovation strategy, our developments – notably on the major American market – and our solid financial structure will continue to drive our growth and our future economic and financial performances, our target being to double our sales in five years”.

Q4 2017-18 sales

30/06/2018 30/06/2017 Δ actual

Δ on a
comparable
basis*

€ thousands – IFRS
France 16,223 13,883 16.9% 7.8%
International 10,569 10,285 2.8% 9.4%
of which: Subsidiaries 7,118 7,400 -3.8% 5.3%
of which: Distributors 3,451 2,885 19.6% 19.7%
Total 26,791 24,168 10.9% 8.5%

FY 2017-18 sales

30/06/2018 30/06/2017 Δ actual Δ on a comparable basis*
€ thousands – IFRS
France 63,636 58,145 9.4% 7.2%
International 36,710 35,192 4.3% 9.8%
of which: Subsidiaries 26,633 25,380 4.9% 12.5%
of which: Distributors 10,077 9,812 2.7% 2.8%
Total 100,346 93,337 7.5% 8.2%

* constant currency and perimeter

During its 2017-18 financial year to June 30, 2018, Amplitude Surgical maintained a solid commercial momentum with sales totaling €100.3 million, up +7.5% in actual terms and +8.2% on a comparable basis (constant currency and perimeter).

Over the fourth quarter alone (April to June), sales totaled €26.8 million, up +10.9% in actual terms and +8.5% on a comparable basis.

On the French market, Amplitude Surgical recorded further solid growth with annual sales totaling €63.6 million, +9.4%, and fourth-quarter sales totaling €16.2 million, +16.9%. The strengthening of the teams, with the newly-acquired direct management of key territories in the East of the country and the Paris region leading to the recruitment of numerous surgeons, has enabled the Group to continue increasing its market share. The sales figure also benefited from the non-Group activity of the SOFAB industrial subsidiary, now completely consolidated.

Amplitude Surgical also continued to record strong international growth, with sales totaling €36.7 million over the year, up +9.8% at constant currency, notably thanks to the fine performance recorded by subsidiaries, which generated sales of €26.6 million, +12.5% at constant currency.

Over the financial year, the activity of the Group’s subsidiaries, which now account for 73% of international sales, beyond the French market, notably benefited from the dynamism of the Australian, Swiss and Benelux markets as well as the contribution of more than €2 million from the new subsidiaries in Japan and South Africa.

For the fourth year of marketing of Novastep’s products, innovative solutions for lower-limb (foot and ankle) surgery, sales totaled €6.6 million, up close to +9%, and accounted for 7% of Group sales with over 50% of its activity recorded abroad.

Good cash position at end-June

With cash and cash equivalents of almost €30 million at the end of its 2017/2018 financial year, Amplitude Surgical has the necessary means to finance its growth.

Recent highlights

  • Amplitude Surgical has just launched EVOK®, a cementless femoral stem. Having obtained CE marking, Amplitude Surgical will soon initiate the marketing of this high-added-value product;
  • In the United States, Amplitude Surgical has signed a contract with a distributor in Illinois. With more than 25 years of experience in the orthopedic industry and accompanied by 5 employees, this representative will quickly present Amplitude’s portfolio with the main users of the state;
  • On the industrial side, the new recently-certified white room delivered its first batches in June. It should be remembered that the insourcing of this key stage in the production process will have a positive impact on the Group’s EBITDA from the 2018-19 financial year.

Next financial press release: 2017-18 annual results, on Wednesday October 17, 2018, after market.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2018, Amplitude Surgical had a workforce of nearly 400 employees and recorded sales of over 100 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
CFO
finances@amplitude-surgical.com
+33 (0)4 75 41 87 41
or
NewCap
Investor Relations
Marc Willaume
amplitude@newcap.eu
+33 (0)1 44 71 00 13
or
NewCap
Media Relations
Nicolas Merigeau
amplitude@newcap.eu
+33 (0)1 44 71 98 55


6492704-1435765856-600x337-12bto-1.jpg

July 27, 2018 OrthoSpineNews

BY JOHN MURAWSKI / July 24, 2018

North Carolina’s largest health insurer is proposing a solution to control runaway health care costs: paying people to use cheaper doctors and procedures.

Blue Cross and Blue Shield will offer customers between $25 and $500 per medical procedure for more than 100 procedures. The amount of the rebate depends on the procedure’s complexity and the cost savings of the cheaper option.

A Blue Cross spokesman pointed out that picking a cheaper option is more valuable than just the cash rebate.

“There is also the big cost-saving potential where you can shop, find a high-quality provider, and really reduce your out-of-pocket costs,” said Blue Cross spokesman Austin Vevurka.

Insurers have for years sought to influence patient decisions through co-payments and high deductibles as a shared financial responsibility for medical costs. Blue Cross is taking the concept further by offering to share savings with the customer as a thank-you for reducing costs. In the past, this approach has been tried by financially rewarding doctors and hospitals for achieving cost savings.

Some health care experts are excited at the prospect of pulling back the veil on health care costs, saying that pricing transparency is long overdue. But others warn that using money to influence private medical decisions can be harmful, noting that not all doctors are equal.

“I would caution patients to be careful,” said Raleigh orthopedist Dr. Bradley Vaughn who operates at UNC Rex Hospital. “If someone saves $500 from a hip or knee replacement and suffers a serious complication, that $500 will be a drop in the bucket compared to all the misery they’ll experience.”

 

READ THE REST HERE

 


1491601885513-Y-1-1-1.png

July 27, 2018 OrthoSpineNews

WARSAW, Ind.July 27, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended June 30, 2018.  The Company reported second quarter net sales of $2.008 billion, an increase of 3.0% over the prior year period, and an increase of 1.0% on a constant currency basis.  Diluted earnings per share for the second quarter were $0.90, flat when compared to the prior year period.  Second quarter adjusted diluted earnings per share were $1.92, a decrease of 7.7% from the prior year period.

Bryan Hanson, President and CEO of Zimmer Biomet, said:  “Our achievements during the second quarter, including the improvement of our global Knee and Hip sales performance and ongoing growth within the Asia Pacific region, validate our confidence in our full-year outlook.  To continue building on our year-to-date progress, we will remain focused on strategies to support long-term, sustainable revenue growth and value-creation.  These priorities include the completion of quality remediation activities, supply recovery efforts, new product introductions and the continuous enhancement of our culture.”

Net earnings for the second quarter were $185.0 million, and $392.0 million on an adjusted basis.  Operating cash flow for the second quarter was $393.3 million.  Free cash flow in the quarter was $300.6 million.

In the quarter, the Company paid $48.8 million in dividends and declared a second quarter dividend of $0.24 per share.

Guidance

The Company is updating its full-year 2018 revenue guidance.  For the full year, the Company now expects revenue growth to be in a range of 1.0% to 2.5% compared to the prior year, including the positive contribution of between 100 and 150 basis points of foreign currency translation.  Additionally, the Company now expects its full-year free cash flow to be in a range of $1.2 billion to $1.35 billion (1).  All other prior guidance for 2018 remains unchanged.

(1)

Reconciliation of Projected Free Cash Flow for the Year Ending December 31, 2018

(in millions)

Low

High

Net Cash Provided by Operating Activities

$1,685

$1,805

Additions to Instruments and Other Property, Plant and Equipment

(485)

(455)

Free Cash Flow

$1,200

$1,350

Conference Call

The Company will conduct its second quarter 2018 investor conference call today, July 27, 2018, at 8:30 a.m. Eastern Time.  The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com.  It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985.  For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from July 28, 2018 to August 27, 2018.  To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820 and enter the Access Code ID 7278985.

Sales Tables

The following sales tables provide results by geography and product category, as well as the percentage change compared to the prior year quarter and six months, on both a reported basis and a constant currency basis.

NET SALES – THREE MONTHS ENDED JUNE 30, 2018

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

1,216

1.0

%

0.9

%

EMEA

458

4.4

(1.8)

Asia Pacific

334

8.5

5.4

Total

$

2,008

3.0

%

1.0

%

Product Categories

Knees

Americas

$

408

0.7

%

0.5

%

EMEA

171

7.0

1.1

Asia Pacific

124

8.1

5.1

Total

703

3.4

1.4

Hips

Americas

250

2.7

2.5

EMEA

134

2.2

(3.8)

Asia Pacific

103

9.9

6.5

Total

487

4.0

1.5

S.E.T *

434

3.0

1.2

Dental

107

(3.2)

(5.5)

Spine & CMF**

198

2.5

1.3

Other

79

2.8

1.2

Total

$

2,008

3.0

%

1.0

%

* Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

** Craniomaxillofacial

NET SALES – SIX MONTHS ENDED JUNE 30, 2018

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

2,424

(0.4)

%

(0.6)

%

EMEA

954

7.0

(2.4)

Asia Pacific

647

8.4

4.0

Total

$

4,025

2.6

%

(0.3)

%

Product Categories

Knees

Americas

$

825

(1.0)

%

(1.1)

%

EMEA

360

9.8

0.5

Asia Pacific

231

5.3

1.2

Total

1,416

2.6

(0.4)

Hips

Americas

$

498

2.0

1.7

EMEA

276

3.4

(5.7)

Asia Pacific

205

9.7

5.0

Total

979

3.9

0.3

S.E.T *

876

3.7

1.2

Dental

215

(1.7)

(5.1)

Spine & CMF**

381

0.5

(1.2)

Other

158

0.8

(1.5)

Total

$

4,025

2.6

%

(0.3)

%

* Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

** Craniomaxillofacial


 About the Company

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

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

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

Website Information

We routinely post important information for investors on our website, www.zimmerbiomet.com, in the “Investor Relations” section.  We use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD.  Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts.  The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document.

Reclassifications

Beginning this quarter, in our consolidated statements of earnings we have reclassified expenses that were previously recognized in a financial statement line item labeled, “Acquisition, quality remediation and other” to the financial statement line items of “Research and development”, “Selling, general and administrative”, “Intangible asset impairment”, “Acquisition, integration and related”, and “Quality remediation”.  Prior periods have been reclassified to conform to the current year presentation.

Note on Non-GAAP Financial Measures

This press release includes non-GAAP financial measures that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).  These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP.

Sales change information for the three and six-month periods ended June 30, 2018 are presented on a GAAP (reported) basis and on a constant currency basis.  Constant currency percentage changes exclude the effects of foreign currency exchange rates.  They are calculated by translating current and prior-period sales at the same predetermined exchange rate.  The translated results are then used to determine year-over-year percentage increases or decreases.

Net earnings and diluted earnings per share for the three and six-month periods ended June 30, 2018 are presented on a GAAP (reported) basis and on an adjusted basis.  Adjusted earnings and adjusted diluted earnings per share exclude the effects of inventory step-up; certain inventory and manufacturing-related charges including charges to discontinue certain product lines; intangible asset amortization; intangible asset impairment; acquisition, integration and related expenses; quality remediation expenses; certain litigation gains and charges; other charges; and any related effects on our income tax provision associated with these items; and other certain tax adjustments.

Free cash flow and projected free cash flow are additional non-GAAP measures that are presented in this press release. Free cash flow is computed by deducting additions to instruments and other property, plant and equipment from net cash provided by operating activities.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in this press release. This press release also contains supplemental reconciliations of additional non-GAAP financial measures that the Company presents in other contexts. These additional non-GAAP financial measures are computed from the most directly comparable GAAP financial measure as indicated in the applicable reconciliation.

Management uses non-GAAP financial measures internally to evaluate the performance of the business.  Additionally, management believes these non-GAAP measures provide meaningful incremental information to investors to consider when evaluating the performance of the Company.  Management believes these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported income but that do not impact the fundamentals of our operations.  The non-GAAP measures enable the evaluation of operating results and trend analysis by allowing a reader to better identify operating trends that may otherwise be masked or distorted by these types of items that are excluded from the non-GAAP measures.  In addition, constant currency sales changes, adjusted operating profit, adjusted diluted net earnings per share and free cash flow are used as performance metrics in our incentive compensation programs.

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding sales and earnings guidance and any statements about our expectations, plans, strategies or prospects.   We generally use the words “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees,” “seeks,” “should,” “could,” “intends” and similar expressions to identify forward-looking statements.   All statements other than statements of historical or current fact are, or may be deemed to be, forward-looking statements.   Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  These risks, uncertainties and changes in circumstances include, but are not limited to:  our chief executive officer transition, including disruptions and uncertainties related thereto, the potential impact on our business and future strategic direction resulting from our transition to a new chief executive officer, and our ability to recruit and retain other key members of senior management; the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and businesses generally; compliance with the Deferred Prosecution Agreement entered into in January 2017; the success of our quality and operational excellence initiatives, including ongoing quality remediation efforts at our Warsaw North Campus facility; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration (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, while continuing to satisfy the demand for our products; the outcome of government investigations; competition; pricing pressures; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures; 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 our 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; changes in tax obligations arising from tax reform measures, including European Union rules on state aid, or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market our 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; changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing financial and political uncertainty on 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 our reports filed with the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2017.  Copies of these filings, as well as subsequent filings, are available online at www.sec.govwww.zimmerbiomet.com or on request from us.  Forward-looking statements speak only as of the date they are made, and we disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since 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 release.

ZIMMER BIOMET HOLDINGS, INC.

CONSOLIDATED STATEMENTS OF EARNINGS

FOR THE THREE MONTHS ENDED JUNE 30, 2018 and 2017

(in millions, except per share amounts, unaudited)

2018

2017

Net Sales

$

2,007.6

$

1,949.5

Cost of products sold, excluding intangible asset amortization

583.7

527.7

Intangible asset amortization

149.5

147.7

Research and development

99.1

92.6

Selling, general and administrative

791.3

752.2

Intangible asset impairment

26.8

Acquisition, integration and related

50.5

72.5

Quality remediation

37.5

49.9

Operating expenses

1,711.6

1,669.4

Operating Profit

296.0

280.1

Other expense, net

(2.9)

(1.7)

Interest income

0.6

0.3

Interest expense

(75.9)

(82.3)

Earnings before income taxes

217.8

196.4

Provision for income taxes

32.9

12.3

Net Earnings

184.9

184.1

Less: Net Loss attributable to noncontrolling interest

(0.1)

(0.1)

Net Earnings of Zimmer Biomet Holdings, Inc.

$

185.0

$

184.2

Earnings Per Common Share

Basic

$

0.91

$

0.91

Diluted

$

0.90

$

0.90

Weighted Average Common Shares Outstanding

Basic

203.3

201.8

Diluted

204.6

203.7

Cash Dividends Declared Per Common Share

$

0.24

$

0.24

 

READ THE REST HERE

 


NuVasive-Headquarters-1.jpg

July 27, 2018 OrthoSpineNews

SAN DIEGOJuly 27, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Pulse™ surgical automation platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the foundation for Surgical Intelligence™, the Company’s ecosystem enabling better surgery. Pulse introduces 2D- and 3D-navigation and smart imaging capabilities while integrating the Company’s leading neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies. This single platform addresses a broad range of clinical challenges, with enhanced utility and intuitive workflow. The fusion of these technologies supports reproducible spine surgery at facilities ranging from major health systems to ambulatory surgery centers.

“Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room,” said Dr. Stephen Ryu, neurosurgeon at the Palo Alto Medical Foundation in Palo Alto, Calif. “Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”

Pulse’s FDA clearance marks a major milestone in the Company’s commitment to introduce 2D- and 3D-navigation technology built on a platform of the Company’s NVM5® nerve monitoring systemLessRay®Bendini® and Integrated Global Alignment® (iGA®) systems. The Pulse platform provides an intuitive surgeon experience by anticipating user needs and fusing these technologies to create a seamless, optimized workflow for operating rooms (OR). Through Wi-Fi connectivity and independent device access, case participants can simultaneously view the technologies’ imaging and insights in real time, allowing them to utilize various modules in parallel and further drive OR efficiencies.

“With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized applications,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”

To help surgeons overcome frequent visualization challenges during spine surgery, Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays to drive uninterrupted line-of-sight and optimized procedural workflow. Additionally, Pulse introduces advanced artificial intelligence (AI) by automating several technologies utilized throughout a procedure.

NuVasive will showcase the Pulse platform at the North American Spine Society 2018 Annual Meeting held September 26-29, 2018 in Los Angeles, Calif.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. 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.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


image2f20182f052forthopedic-medical-devices-12bto.jpg

July 27, 2018 OrthoSpineNews

ROCKVILLE, Md.July 27, 2018 /PRNewswire/ — Healthcare market researcher Kalorama Information believes this week’s vote to repeal the medical device tax in the House could have real effects on a relatively slow-growing U.S. device market, though those effects might be long-term.  The United States device market revenues grow 22% slower than the global market, according to the firm’s report The Global Market for Medical Devices, 8th Edition The firm said that although the largest component of the market is in the United States, the majority of sales are non-US, and considerable future growth is occurring in other markets.

“Repeal won’t immediately lead to a spike to revenues, but we do suspect some revisited R&D budgets and more interest from venture capital in medical devices,” said Bruce Carlson.  “That in turn could fuel investment which may lead to new products, and new innovations boost markets.”

The same report said the market for medical devices was estimated at $386.1 billion in 2016.  With average 3.8% growth, the market will grow to $483.8 billion in 2022.  The United States is the largest medical device market with 47% of the global market and over $180 billion dollars in revenue.  Growth in device sales are expected to be at 3.1% over the next five years.  The use of technologically superior devices combined with a steady replacement rate to remain competitive in the industry will be significant factors for growth.

Another development that could be even more helpful for the U.S. device tax repeal – aging population with more healthcare needs and shifting many reusable devices for single-use devices due to risk mitigation strategies to reduce healthcare acquired infections.

As part of the Affordable Care Act, the medical device industry was taxed 2.3% on medical devices products sold.  The healthcare market researcher said that while there are other challenges U.S. devicemakers face, such as limited reimbursement, recent increases in registration fees and FDA approval processes, the tax was an additional burden and its repeal will be welcomed by the industry.

Beyond the market dynamic, Kalorama believes medical devices also have impacts on the general healthcare economy and patient outcomes.  While medical device spending has grown, as total spending has, the price of most medical devices have not risen as fast as other medical services and products.  The cost of medical devices has remained constant as a share of total national health expenditures.  During much of the past fifteen years, a significant driver of changed medical practice has been the development of new medical devices from stents to implantable defibrillators to artificial hips and knees to new imaging modalities to new diagnostic tests to new surgical tools.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website: https://www.kaloramainformation.com/.

Press Contact: 

Bruce Carlson 

212 807 2262      

bcarlson@marketresearch.com

SOURCE Kalorama Information

Related Links

https://www.kaloramainformation.com


capitol_hill_lg-1.jpg

July 26, 2018 OrthoSpineNews

July 25, 2018 – Julia Cohen | Reporter

A bipartisan majority in the House voted to repeal President Barack Obama’s 2.3 percent medical device tax Tuesday.

The repeal passed 283-132, with 57 Democrats and all but one Republican voting in favor. North Carolina Republican Rep. Walter Jones was the sole Republican against the bill.

“Minnesota’s innovators can breathe easier since we’re one step closer to ending the medical device tax for good,” Minnesota Republican Rep. Erik Paulsen, the bill’s sponsor, said in a Tuesday press release. “Today’s vote shows strong bipartisan support for lifting this burden on innovators in an industry so important to Minnesota. I’m more optimistic than ever we’ll be successful in giving these job creators the certainty and predictability they need to thrive.”

The repeal will reduce federal tax revenue by about $22 million over the next 10 years, according to a Wall Street Journal article.

The tax was temporarily rolled back in 2016, and Congress extended the rollback to 2020. Paulsen’s bill makes the repeal permanent.

“This bipartisan legislation will make healthcare more affordable and ensure Americans have access to the most innovative life-saving and life-improving medical technology,” Speaker Paul Ryan tweeted Tuesday.

Despite bipartisan support, some senators are unsure if the bill will make it to the Senate floor by the end of 2018.

 

READ THE REST HERE


im-2439-1.jpeg

July 26, 2018 OrthoSpineNews

DrinHallHITNistock_11-1.jpg

July 26, 2018 OrthoSpineNews

July 25, 2018 – Beth Jones Sanborn, Managing Editor

Evidence continues to mount that non-physician providers can positively contribute to a medical practice’s vitality, both in terms of care and the bottom line. New data from the Medical Group Management Association found that medical practices that use more non-physician providers see a boost in both revenue and productivity.

Based on comparative data from more than 3,000 organizations, the 2018 MGMA DataDive cost and revenue data represents various practice types including physician and hospital-owned, as well as small and large practices.

Primary care practices with 0.41 NPPs per physician or more did report greater expenses, but they also reported earning more revenue after operating costs than practices with fewer NPPs (0.20 or fewer NPPs per physician), no matter the specialty. Practices with 0.41 or more NPPs reported $100,748 more in revenue after operating expenses per physician and in hospital-owned primary care practices, the difference was $131,770 more in revenue per physician after operating costs.

“Because these non-physician providers can effectively complement primary care services for the organization, access to care increases. Ultimately, both the number of patient encounters as well as their satisfaction can increase,” said Ken Hertz, principal consultant at MGMA.

The DataDive results showed that over the past five years, median operating costs for primary care practices had gone from $391,798 per physician to $441,559 per physician, a rise of 13 percent.  Evergreen expenses are a steady presence, such as general operating costs, which make up 32 cents of every dollar collected in physician-owned practices. IT represents 2 cents, drug supply 6 cents, and building occupancy 6 cents.

 

READ THE REST HERE