Johnson & Johnson Reports 2017 Third-Quarter Results

Posted On October 17, 2017 By OrthoSpineNews In Financial /

NEW BRUNSWICK, N.J., Oct. 17, 2017 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $19.7 billion for the third quarter of 2017, an increase of 10.3% as compared to the third quarter of 2016. Operational sales results increased 9.5% and the positive impact of currency was 0.8%. Domestic sales increased 9.7%. International sales increased 10.9%, reflecting operational growth of 9.3% and a positive currency impact of 1.6%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide, domestic and international sales each increased 3.8%.^*

Net earnings and diluted earnings per share for the third quarter of 2017 were $3.8 billion and $1.37, respectively. Third-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $0.5 billion. Third-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.2 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.2 billion and adjusted diluted earnings per share were $1.90, representing increases of 11.2% and 13.1%, respectively, as compared to the same period in 2016.^* On an operational basis, adjusted diluted earnings per share also increased 10.1%.^*A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

“Johnson & Johnson accelerated growth in the third quarter. This is driven by the strong performance of our Pharmaceutical business, and augmented by Actelion and other recent acquisitions across the enterprise that will continue to fuel growth,” said Alex Gorsky, Chairman and Chief Executive Officer. “Our dedicated colleagues continue to focus on advancing our pipelines to bring innovative solutions to patients and consumers around the globe.”

The Company increased its sales guidance for the full-year 2017 to a range of $76.1 billion to $76.5 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2017 to $7.25 – $7.30 per share.*

Worldwide Consumer sales of $3.4 billion for the third quarter 2017 represented an increase of 2.9% versus the prior year, consisting of an operational increase of 1.6% and a positive impact from currency of 1.3%. Domestic sales decreased 0.5%, international sales increased 5.1%, which reflected an operational increase of 3.0% and a positive currency impact of 2.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales decreased 0.7% and international sales increased 2.3%^*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by over-the-counter products primarily TYLENOL^®analgesic products and international smoking cessation aids; as well as OGX^® and NEUTROGENA^® beauty products partially offset by the negative impact of domestic baby care products.

During the quarter, the divestiture of COMPEED^®to HRA Pharma was completed.

Worldwide Pharmaceutical sales of $9.7 billion for the third quarter 2017 represented an increase of 15.4% versus the prior year with an operational increase of 14.6% and a positive impact from currency of 0.8%. Domestic sales increased 15.4%; international sales increased 15.5%, which reflected an operational increase of 13.5% and a positive currency impact of 2.0%. Sales included the impact of the first full quarter of the acquisition of Actelion Ltd. which contributed 7.9%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.7%, domestic sales increased 7.7% and international sales increased 5.1%.^*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX^®(daratumumab), for the treatment of patients with multiple myeloma and IMBRUVICA^® (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer. Additional contributors to operational sales growth included STELARA^® (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, XARELTO^®(rivaroxaban), an oral anticoagulant, ZYTIGA^® (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and INVEGA^®SUSTENNA^®/XEPLION^®/TRINZA^®(paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for IMBRUVICA^®(ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease after failure of one or more lines of systemic therapy. The European Commission granted approval for SYMTUZA^® (darunavir/cobicistat/ emtricitabine/tenofovir alafenamide) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients aged 12 years and older.

New Drug Applications were submitted to the FDA for apalutamide, an oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer and also for darunavir/cobicistat/emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults and pediatric patients aged 12 years and older. In addition, a supplemental New Drug Application (sNDA) was submitted to the FDA to expand the indication for ZYTIGA^®(abiraterone acetate), in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naïve prostate cancer or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer.

The Company has made a decision not to pursue global approvals of sirukumab for the treatment of moderately to severely active rheumatoid arthritis. In addition, the clinical trial for talacotuzumab, an investigational compound being studied in patients with acute myeloid leukemia, has been discontinued.

Worldwide Medical Devices sales of $6.6 billion for the third quarter 2017 represented an increase of 7.1% versus the prior year consisting of an operational increase of 6.6% and a positive currency impact of 0.5%. Domestic sales increased 4.6%; international sales increased 9.6%, which reflected an operational increase of 8.6% and a positive currency impact of 1.0%. Sales included the impact of the acquisition of Abbott Medical Optics which contributed 5.2%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.2%, domestic sales decreased 0.8% and international sales increased 3.2%.^*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business, ACUVUE^® contact lenses in the Vision Care business, and wound closure products in the General Surgery business, partially offset by declines in the Diabetes Care business.

During the quarter, the acquisitions of TearScience, Inc., a manufacturer of products dedicated to treating meibomian gland dysfunction and Sightbox, Inc., an e-commerce company that provides subscription vision care services connecting consumers with eye care professionals for their contact lens needs, were completed.

Subsequent to the quarter, the Company announced the completion of the divestiture of its Codman Neurosurgery business to Integra LifeSciences Holding Corporation.

About Johnson & Johnson

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 134,100 employees at more than 250 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

^* Operational sales growth excluding the net impact of acquisitions and divestitures, as well as adjusted net earnings, adjusted diluted earnings per share and operational adjusted diluted earnings per share excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company’s website at www.investor.jnj.com. Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Johnson & Johnson will conduct a conference call with investors to discuss this news release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website at www.investor.jnj.com. A replay and podcast will be available approximately two hours after the live webcast by visiting www.investor.jnj.com.

Copies of the financial schedules accompanying this press release are available at www.investor.jnj.com/historical-sales.cfm. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, a pharmaceutical pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can be found on the company’s website at www.investor.jnj.com.

NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic and financial market factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures, including the Company’s ability to successfully integrate Actelion Ltd.’s products and operations and realize the expected benefits and opportunities of the transaction in the expected time frame or at all; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; increased scrutiny of the health care industry by government agencies; and the potential failure to meet obligations in compliance agreements with government bodies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Johnson & Johnson and Subsidiaries
Supplementary Sales Data

(Unaudited; Dollars in Millions)	THIRD QUARTER						NINE MONTHS
			Percent Change						Percent Change
	2017	2016	Total		Operations	Currency	2017	2016	Total		Operations	Currency
Sales to customers by
segment of business

Consumer
U.S.	$ 1,285	$ 1,291	(0.5)	%	(0.5)	–	$ 4,186	$ 4,033	3.8	%	3.8	–
International	2,071	1,970	5.1		3.0	2.1	5,876	5,842	0.6		0.2	0.4
	3,356	3,261	2.9		1.6	1.3	10,062	9,875	1.9		1.6	0.3

Pharmaceutical
U.S.	5,816	5,042	15.4		15.4	–	15,698	15,123	3.8		3.8	–
International	3,879	3,358	15.5		13.5	2.0	10,877	10,109	7.6		8.4	(0.8)
	9,695	8,400	15.4		14.6	0.8	26,575	25,232	5.3		5.6	(0.3)

Medical Devices
U.S.	3,189	3,048	4.6		4.6	–	9,510	9,118	4.3		4.3	–
International	3,410	3,111	9.6		8.6	1.0	10,108	9,559	5.7		6.3	(0.6)
	6,599	6,159	7.1		6.6	0.5	19,618	18,677	5.0		5.3	(0.3)

U.S.	10,290	9,381	9.7		9.7	–	29,394	28,274	4.0		4.0	–
International	9,360	8,439	10.9		9.3	1.6	26,861	25,510	5.3		5.8	(0.5)
Worldwide	$ 19,650	$ 17,820	10.3	%	9.5	0.8	$ 56,255	$ 53,784	4.6	%	4.8	(0.2)

Johnson & Johnson and Subsidiaries
Supplementary Sales Data

(Unaudited; Dollars in Millions)	THIRD QUARTER						NINE MONTHS
			Percent Change						Percent Change
	2017	2016	Total		Operations	Currency	2017	2016	Total		Operations	Currency
Sales to customers by
geographic area

U.S.	$ 10,290	$ 9,381	9.7	%	9.7	–	$ 29,394	$ 28,274	4.0	%	4.0	–

Europe	4,308	3,832	12.4		7.9	4.5	12,398	11,769	5.3		6.2	(0.9)
Western Hemisphere excluding U.S.	1,569	1,396	12.4		10.1	2.3	4,522	4,269	5.9		3.1	2.8
Asia-Pacific, Africa	3,483	3,211	8.5		10.6	(2.1)	9,941	9,472	5.0		6.4	(1.4)
International	9,360	8,439	10.9		9.3	1.6	26,861	25,510	5.3		5.8	(0.5)

Worldwide	$ 19,650	$ 17,820	10.3	%	9.5	0.8	$ 56,255	$ 53,784	4.6	%	4.8	(0.2)

Johnson & Johnson and Subsidiaries
Condensed Consolidated Statement of Earnings

(Unaudited; in Millions Except Per Share Figures)	THIRD QUARTER

	2017			2016			Percent
			Percent			Percent	Increase
	Amount		to Sales	Amount		to Sales	(Decrease)
Sales to customers	$ 19,650		100.0	$ 17,820		100.0	10.3
Cost of products sold	6,902		35.1	5,486		30.8	25.8
Selling, marketing and administrative expenses	5,396		27.5	4,772		26.8	13.1
Research and development expense	2,574		13.1	2,178		12.2	18.2
Interest (income) expense, net	155		0.8	95		0.5
Other (income) expense, net	(236)		(1.2)	(54)		(0.2)
Restructuring	69		0.3	62		0.3
Earnings before provision for taxes on income	4,790		24.4	5,281		29.6	(9.3)
Provision for taxes on income	1,026		5.2	1,009		5.6	1.7
Net earnings	$ 3,764		19.2	$ 4,272		24.0	(11.9)

Net earnings per share (Diluted)	$ 1.37			$ 1.53			(10.5)

Average shares outstanding (Diluted)	2,737.7			2,785.4

Effective tax rate	21.4	%		19.1	%

Adjusted earnings before provision for taxes and net earnings ⁽¹⁾
Earnings before provision for taxes on income	$ 6,573		33.5	$ 5,831		32.7	12.7
Net earnings	$ 5,208		26.5	$ 4,683		26.3	11.2
Net earnings per share (Diluted)	$ 1.90			$ 1.68			13.1
Effective tax rate	20.8	%		19.7	%

⁽¹⁾See Reconciliation of Non-GAAP Financial Measures.

Johnson & Johnson and Subsidiaries
Condensed Consolidated Statement of Earnings

(Unaudited; in Millions Except Per Share Figures)	NINE MONTHS

	2017			2016			Percent
			Percent			Percent	Increase
	Amount		to Sales	Amount		to Sales	(Decrease)
Sales to customers	$ 56,255		100.0	$ 53,784		100.0	4.6
Cost of products sold	18,111		32.2	16,151		30.0	12.1
Selling, marketing and administrative expenses	15,395		27.4	14,636		27.2	5.2
Research and development expense	6,919		12.3	6,455		12.0	7.2
In-process research and development	–		–	29		0.1
Interest (income) expense, net	360		0.6	274		0.5
Other (income) expense, net	192		0.3	464		0.9
Restructuring	165		0.3	296		0.5
Earnings before provision for taxes on income	15,113		26.9	15,479		28.8	(2.4)
Provision for taxes on income	3,100		5.5	2,753		5.1	12.6
Net earnings	$ 12,013		21.4	$ 12,726		23.7	(5.6)

Net earnings per share (Diluted)	$ 4.37			$ 4.55			(4.0)

Average shares outstanding (Diluted)	2,746.4			2,796.6

Effective tax rate	20.5	%		17.8	%

Adjusted earnings before provision for taxes and net earnings ⁽¹⁾
Earnings before provision for taxes on income	$ 18,961		33.7	$ 17,656		32.8	7.4
Net earnings	$ 15,263		27.1	$ 14,403		26.8	6.0
Net earnings per share (Diluted)	$ 5.56			$ 5.15			8.0
Effective tax rate	19.5	%		18.4	%

⁽¹⁾See Reconciliation of Non-GAAP Financial Measures.

Johnson & Johnson and Subsidiaries
Reconciliation of Non-GAAP Financial Measures

	Third Quarter		% Incr. /		Nine Months YTD		% Incr. /
(Dollars in Millions Except Per Share Data)	2017	2016	(Decr.)		2017	2016	(Decr.)

Earnings before provision for taxes on income – as reported	$ 4,790	5,281	(9.3)	%	$ 15,113	15,479	(2.4)	%

Intangible asset amortization expense	1,077	319			1,886	927

Litigation expense, net	118	55			611	721

Restructuring/Other (1)	187	109			476	387

Actelion acquisition related cost	367	–			580	–

Diabetes asset impairment	(2)	–			180	–

AMO acquisition related cost	36	–			115	–

In-process research and development	–	–			–	29

Other	–	67			–	113

Earnings before provision for taxes on income – as adjusted	$ 6,573	5,831	12.7	%	$ 18,961	17,656	7.4	%

Net Earnings – as reported	$ 3,764	4,272	(11.9)	%	$ 12,013	12,726	(5.6)	%

Intangible asset amortization expense	933	236			1,555	679

Litigation expense, net	97	46			449	595

Restructuring/Other	136	76			358	293

Actelion acquisition related cost	255	–			454	–

Diabetes asset impairment	(5)	–			120	–

AMO acquisition related cost	28	–			314	–

In-process research and development	–	–			–	23

Other	–	53			–	87

Net Earnings – as adjusted	$ 5,208	4,683	11.2	%	$ 15,263	14,403	6.0	%

Diluted Net Earnings per share – as reported	$ 1.37	1.53	(10.5)	%	$ 4.37	4.55	(4.0)	%

Intangible asset amortization expense	0.34	0.08			0.57	0.24

Litigation expense, net	0.04	0.02			0.16	0.21

Restructuring/Other	0.05	0.03			0.14	0.11

Actelion acquisition related cost	0.09	–			0.16	–

Diabetes asset impairment	–	–			0.05	–

AMO acquisition related cost	0.01	–			0.11	–

In-process research and development	–	–			–	0.01

Other	–	0.02			–	0.03

Diluted Net Earnings per share – as adjusted	$ 1.90	1.68	13.1	%	$ 5.56	5.15	8.0	%

Operational Diluted Net Earnings per share – as adjusted at 2015 foreign currency exchange rates		1.68				5.19

Impact of currency at 2016 foreign currency exchange rates	(0.05)	–			0.01	(0.04)

Operational Diluted Net Earnings per share – as adjusted at 2016 foreign currency exchange rates	$ 1.85	1.68	10.1	%	$ 5.57	5.15	8.2	%


(1) Includes $29M recorded in cost of products sold and $89M recorded in other (income) expense for the third quarter 2017. Includes $46M recorded in cost of products sold
and $265M recorded in other (income) expense for nine months 2017 YTD. Includes $3M recorded in cost of products sold and $44M recorded in other (income) expense for the
third quarter 2016. Includes $27M recorded in cost of products sold and $64M recorded in other (income) expense for nine months 2016 YTD.

Johnson & Johnson and Subsidiaries
Reconciliation of Non-GAAP Financial Measure

Operational Sales Growth Excluding Acquisitions and Divestitures
THIRD QUARTER 2017 ACTUAL vs. 2016 ACTUAL


Segments

	Consumer	Pharmaceutical	Medical Devices	Total
	Operational %⁽¹⁾
WW As Reported:	1.6%	14.6%	6.6%	9.5%
U.S.	(0.5)%	15.4%	4.6%	9.7%
International	3.0%	13.5%	8.6%	9.3%

Beauty
*Dr. Ci: Labo*	(0.6)			(0.1)
U.S.	0.0			0.0
International	(1.0)			(0.2)

Vision Care
*Abbott Medical Optics*			(5.2)	(1.8)
U.S.			(4.6)	(1.5)
International			(5.7)	(2.1)

Pulmonary Hypertension
*Actelion*		(7.9)		(3.7)
U.S.		(7.7)		(4.1)
International		(8.4)		(3.3)


All Other Acquisitions and Divestitures	0.1		(0.2)	(0.1)
U.S.	(0.2)		(0.8)	(0.3)
International	0.3		0.3	0.1

WW Ops excluding Acquisitions and Divestitures	1.1%	6.7%	1.2%	3.8%
U.S.	(0.7)%	7.7%	(0.8)%	3.8%
International	2.3%	5.1%	3.2%	3.8%

⁽¹⁾Operational growth excludes the effect of translational currency

Johnson & Johnson and Subsidiaries
Reconciliation of Non-GAAP Financial Measure

Operational Sales Growth Excluding Acquisitions and Divestitures
NINE MONTHS 2017 ACTUAL vs. 2016 ACTUAL

Segments

	Consumer	Pharmaceutical	Medical Devices	Total
	Operational %⁽¹⁾
WW As Reported:	1.6%	5.6%	5.3%	4.8%
U.S.	3.8%	3.8%	4.3%	4.0%
International	0.2%	8.4%	6.3%	5.8%

Beauty
*Vogue*	(1.9)			(0.4)
U.S.	(4.1)			(0.6)
International	(0.5)			(0.1)

Other Neuroscience
*Controlled Substance Raw Material and API Business*		0.5		0.2
U.S.		0.6		0.3
International		0.3		0.1

Diagnostics
*Ortho-Clinical Diagnostics*			0.4	0.1
U.S.			0.0	0.0
International			0.8	0.3

Beauty
*Dr. Ci: Labo*	(0.3)			(0.1)
U.S.	0.0			0.0
International	(0.5)			(0.1)

Vision Care
*Abbott Medical Optics*			(4.1)	(1.4)
U.S.			(3.7)	(1.2)
International			(4.6)	(1.7)

Pulmonary Hypertension
*Actelion*		(3.0)		(1.4)
U.S.		(2.8)		(1.5)
International		(3.3)		(1.3)

All Other Acquisitions and Divestitures	(0.1)		(0.3)	0.0
U.S.	(0.4)		(0.7)	(0.3)
International	0.2		0.2	0.0

WW Ops excluding Acquisitions and Divestitures	(0.7)%	3.1%	1.3%	1.8%
U.S.	(0.7)%	1.6%	(0.1)%	0.7%
International	(0.6)%	5.4%	2.7%	3.0%

⁽¹⁾Operational growth excludes the effect of translational currency

View Table Fullscreen

THIRD QUARTER

NINE MONTHS

% Change

2017

2016

Reported

Operational ⁽¹⁾

Currency

2017

2016

Reported

Operational ⁽¹⁾

Currency

CONSUMER SEGMENT ^{(2) (3)}

BABY CARE

$ 100

$ 118

-15.3%

–

$ 326

$ 365

-10.7%

–

Intl

377

0.0%

1,100

1,143

-3.8%

0.0%

477

495

-3.6%

0.0%

1,426

1,508

-5.4%

0.0%

BEAUTY

523

517

1.2%

–

1,739

1,555

11.8%

–

Intl

510

462

10.4%

8.0%

2.4%

1,351

1,279

5.6%

5.4%

0.2%

1,033

979

5.5%

4.4%

1.1%

3,090

2,834

9.0%

8.9%

0.1%

ORAL CARE

154

156

-1.3%

–

460

485

-5.2%

–

Intl

228

227

0.4%

-1.4%

1.8%

678

686

-1.2%

-1.6%

0.4%

382

383

-0.3%

-1.3%

1.0%

1,138

1,171

-2.8%

-3.0%

0.2%

OTC

401

386

3.9%

–

1,310

1,257

4.2%

–

Intl

601

557

7.9%

4.7%

3.2%

1,711

1,681

1.8%

1.4%

0.4%

1,002

943

6.3%

4.4%

1.9%

3,021

2,938

2.8%

2.6%

0.2%

WOMEN’S HEALTH

0.0%

–

-43.8%

–

Intl

267

266

0.4%

-1.9%

2.3%

779

787

-1.0%

-2.6%

1.6%

270

269

0.4%

-1.8%

2.2%

788

803

-1.9%

-3.5%

1.6%

WOUND CARE / OTHER

104

111

-6.3%

–

342

355

-3.7%

–

Intl

8.6%

5.9%

2.7%

257

266

-3.4%

-4.0%

0.6%

192

0.0%

-1.2%

1.2%

599

621

-3.5%

-3.8%

0.3%

TOTAL CONSUMER

1,285

1,291

-0.5%

–

4,186

4,033

3.8%

–

Intl

2,071

1,970

5.1%

3.0%

2.1%

5,876

5,842

0.6%

0.2%

0.4%

$ 3,356

$ 3,261

2.9%

1.6%

1.3%

$ 10,062

$ 9,875

1.9%

1.6%

0.3%

REPORTED SALES vs. PRIOR PERIOD ($MM)

THIRD QUARTER

NINE MONTHS

% Change

2017

2016

Reported

Operational ⁽¹⁾

Currency

2017

2016

Reported

Operational ⁽¹⁾

Currency

PHARMACEUTICAL SEGMENT ^{(2) (3)}

IMMUNOLOGY

$ 2,420

$ 2,294

5.5%

–

$ 6,644

$ 6,689

-0.7%

–

Intl

849

790

7.5%

4.9%

2.6%

2,514

2,343

7.3%

0.0%

3,269

3,084

6.0%

5.3%

0.7%

9,158

9,032

1.4%

0.0%

REMICADE

1,206

1,222

-1.3%

–

3,452

3,669

-5.9%

–

US Exports ⁽⁴⁾

156

255

-38.8%

–

448

673

-33.4%

–

Intl

285

306

-6.9%

-10.2%

3.3%

949

1,000

-5.1%

-5.9%

0.8%

1,647

1,783

-7.6%

-8.2%

0.6%

4,849

5,342

-9.2%

-9.4%

0.2%

SIMPONI / SIMPONI ARIA

242

256

-5.5%

–

701

716

-2.1%

–

Intl

234

225

4.0%

3.2%

0.8%

642

603

6.5%

6.6%

-0.1%

476

481

-1.0%

-1.4%

0.4%

1,343

1,319

1.8%

1.9%

-0.1%

STELARA

800

561

42.6%

–

2,027

1,631

24.3%

–

Intl

324

253

28.1%

24.7%

3.4%

903

722

25.1%

26.1%

-1.0%

1,124

814

38.1%

37.0%

1.1%

2,930

2,353

24.5%

24.8%

-0.3%

OTHER IMMUNOLOGY

–

Intl

–

11.1%

9.4%

1.7%

–

100.0%

98.3%

1.7%

INFECTIOUS DISEASES

353

387

-8.8%

–

1,020

1,107

-7.9%

–

Intl

460

455

1.1%

-2.3%

3.4%

1,334

1,340

-0.4%

0.0%

813

842

-3.4%

-5.3%

1.9%

2,354

2,447

-3.8%

0.0%

EDURANT

15.4%

–

15.8%

–

Intl

179

136

31.6%

26.0%

5.6%

478

370

29.2%

28.9%

0.3%

194

149

30.2%

25.1%

5.1%

522

408

27.9%

27.7%

0.2%

PREZISTA / PREZCOBIX / REZOLSTA

287

310

-7.4%

–

824

860

-4.2%

–

Intl

180

183

-1.6%

-5.5%

3.9%

527

544

-3.1%

-2.7%

-0.4%

467

493

-5.3%

-6.7%

1.4%

1,351

1,404

-3.8%

-3.7%

-0.1%

OTHER INFECTIOUS DISEASES

-20.3%

–

152

209

-27.3%

–

Intl

101

136

-25.7%

-26.4%

0.7%

329

426

-22.8%

-23.1%

0.3%

152

200

-24.0%

-24.5%

0.5%

481

635

-24.3%

-24.5%

0.2%

See footnotes at end of schedule

REPORTED SALES vs. PRIOR PERIOD ($MM)

THIRD QUARTER

NINE MONTHS

% Change

2017

2016

Reported

Operational ⁽¹⁾

Currency

2017

2016

Reported

Operational ⁽¹⁾

Currency

NEUROSCIENCE

647

622

4.0%

–

1,931

1,997

-3.3%

–

Intl

851

842

1.1%

0.6%

0.5%

2,531

2,618

-3.3%

-2.2%

-1.1%

1,498

1,464

2.3%

2.0%

0.3%

4,462

4,615

-3.3%

-2.7%

-0.6%

CONCERTA / METHYLPHENIDATE

100

102

-2.0%

–

284

365

-22.2%

–

Intl

11.4%

10.5%

0.9%

304

294

3.4%

4.1%

-0.7%

198

190

4.2%

3.8%

0.4%

588

659

-10.8%

-10.5%

-0.3%

INVEGA SUSTENNA / XEPLION / TRINZA

395

339

16.5%

–

1,154

983

17.4%

–

Intl

248

217

14.3%

11.0%

3.3%

722

646

11.8%

12.8%

-1.0%

643

556

15.6%

14.3%

1.3%

1,876

1,629

15.2%

15.6%

-0.4%

RISPERDAL CONSTA

-7.4%

–

273

289

-5.5%

–

Intl

107

128

-16.4%

-18.0%

1.6%

335

394

-15.0%

-14.0%

-1.0%

194

222

-12.6%

-13.5%

0.9%

608

683

-11.0%

-10.4%

-0.6%

OTHER NEUROSCIENCE

-25.3%

–

220

360

-38.9%

–

Intl

398

409

-2.7%

-1.4%

-1.3%

1,170

1,284

-8.9%

-7.7%

-1.2%

463

496

-6.7%

-5.6%

-1.1%

1,390

1,644

-15.5%

-14.5%

-1.0%

ONCOLOGY

846

622

36.0%

–

2,207

1,740

26.8%

–

Intl

1,052

895

17.5%

15.2%

2.3%

3,012

2,605

15.6%

16.8%

-1.2%

1,898

1,517

25.1%

23.8%

1.3%

5,219

4,345

20.1%

20.8%

-0.7%

DARZALEX

230

124

85.5%

–

643

320

–

Intl

228

317

163

94.5%

92.0%

2.5%

871

372

IMBRUVICA

230

179

28.5%

–

622

455

36.7%

–

Intl

282

170

65.9%

61.8%

4.1%

749

450

66.4%

67.7%

-1.3%

512

349

46.7%

44.7%

2.0%

1,371

905

51.5%

52.1%

-0.6%

VELCADE

–

Intl

273

304

-10.2%

-11.2%

1.0%

843

950

-11.3%

-9.8%

-1.5%

273

304

-10.2%

-11.2%

1.0%

843

950

-11.3%

-9.8%

-1.5%

ZYTIGA

352

282

24.8%

–

826

840

-1.7%

–

Intl

317

300

5.7%

4.4%

1.3%

924

901

2.6%

3.5%

-0.9%

669

582

14.9%

14.2%

0.7%

1,750

1,741

0.5%

1.0%

-0.5%

OTHER ONCOLOGY

-8.1%

–

116

125

-7.2%

–

Intl

13.4%

11.1%

2.3%

268

252

6.3%

7.3%

-1.0%

127

119

6.7%

5.1%

1.6%

384

377

1.9%

2.6%

-0.7%

PULMONARY HYPERTENSION⁽⁵⁾

387

–

427

–

Intl

283

–

334

–

670

–

761

–

OPSUMIT

–

150

–

174

–

Intl

109

–

130

–

259

–

304

–

TRACLEER

–

Intl

127

–

151

–

210

–

236

–

UPTRAVI

–

113

–

121

–

Intl

–

124

–

133

–

OTHER

–

Intl

–

CARDIOVASCULAR / METABOLISM / OTHER

1,163

1,117

4.1%

–

3,469

3,590

-3.4%

–

Intl

384

376

2.1%

1.0%

1.1%

1,152

1,203

-4.2%

-2.2%

-2.0%

1,547

1,493

3.6%

3.3%

0.3%

4,621

4,793

-3.6%

-3.1%

-0.5%

XARELTO

635

529

20.0%

–

1,790

1,690

5.9%

–

Intl

–

635

529

20.0%

–

1,790

1,690

5.9%

–

INVOKANA / INVOKAMET

220

294

-25.2%

–

723

939

-23.0%

–

Intl

32.4%

31.6%

0.8%

121

24.7%

26.5%

-1.8%

265

328

-19.2%

-19.3%

0.1%

844

1,036

-18.5%

-18.3%

-0.2%

PROCRIT / EPREX

168

0.0%

–

511

581

-12.0%

–

Intl

-14.6%

-17.6%

3.0%

229

265

-13.6%

-13.3%

-0.3%

238

250

-4.8%

-5.8%

1.0%

740

846

-12.5%

-12.4%

-0.1%

OTHER

140

126

11.1%

–

445

380

17.1%

–

Intl

269

260

3.5%

2.9%

0.6%

802

841

-4.6%

-2.1%

-2.5%

409

386

6.0%

5.6%

0.4%

1,247

1,221

2.1%

3.8%

-1.7%

TOTAL PHARMACEUTICAL

5,816

5,042

15.4%

–

15,698

15,123

3.8%

–

Intl

3,879

3,358

15.5%

13.5%

2.0%

10,877

10,109

7.6%

8.4%

-0.8%

$ 9,695

8,400

15.4%

14.6%

0.8%

$ 26,575

25,232

5.3%

5.6%

-0.3%

See footnotes at end of schedule

REPORTED SALES vs. PRIOR PERIOD ($MM)

THIRD QUARTER

NINE MONTHS

% Change

MEDICAL DEVICES SEGMENT ⁽²⁾

2017

2016

Reported

Operational ⁽¹⁾

Currency

2017

2016

Reported

Operational ⁽¹⁾

Currency

CARDIOVASCULAR

$ 261

235

11.1%

–

$ 785

701

12.0%

–

Intl

245

216

13.4%

13.9%

-0.5%

743

663

12.1%

13.5%

-1.4%

506

451

12.2%

12.5%

-0.3%

1,528

1,364

12.0%

12.7%

-0.7%

DIABETES CARE

168

191

-12.0%

–

482

548

-12.0%

–

Intl

237

236

0.4%

-2.6%

3.0%

743

779

-4.6%

0.0%

405

427

-5.2%

-6.9%

1.7%

1,225

1,327

-7.7%

0.0%

DIAGNOSTICS

–

Intl

–

ORTHOPAEDICS

1,326

1,343

-1.3%

–

4,092

4,099

-0.2%

–

Intl

925

908

1.9%

0.0%

1.9%

2,827

2,848

-0.7%

-0.2%

-0.5%

2,251

0.0%

-0.8%

0.8%

6,919

6,947

-0.4%

-0.2%

HIPS

195

190

2.6%

–

612

590

3.7%

–

Intl

133

130

2.3%

-0.1%

2.4%

418

421

-0.7%

-0.1%

-0.6%

328

320

2.5%

1.5%

1.0%

1,030

1,011

1.9%

2.2%

-0.3%

KNEES

220

223

-1.3%

–

702

696

0.9%

–

Intl

123

132

-6.8%

-9.5%

2.7%

424

433

-2.1%

-1.4%

-0.7%

343

355

-3.4%

-4.4%

1.0%

1,126

1,129

-0.3%

0.0%

-0.3%

TRAUMA

398

389

2.3%

–

1,179

1,151

2.4%

–

Intl

264

248

6.5%

4.6%

1.9%

768

764

0.5%

0.8%

-0.3%

662

637

3.9%

3.1%

0.8%

1,947

1,915

1.7%

1.8%

-0.1%

SPINE & OTHER

513

541

-5.2%

–

1,599

1,662

-3.8%

–

Intl

405

398

1.8%

0.3%

1.5%

1,217

1,230

-1.1%

-0.5%

-0.6%

918

939

-2.2%

-2.8%

0.6%

2,816

2,892

-2.6%

-2.3%

-0.3%

SURGERY

1,002

0.0%

–

3,009

3,003

0.2%

–

Intl

1,344

1,282

4.8%

3.7%

1.1%

3,992

3,906

2.2%

2.9%

-0.7%

2,346

2,284

2.7%

2.1%

0.6%

7,001

6,909

1.3%

1.7%

-0.4%

ADVANCED

398

390

2.1%

–

1,190

1,131

5.2%

–

Intl

525

494

6.3%

5.3%

1.0%

1,543

1,478

4.4%

5.4%

-1.0%

923

884

4.4%

3.9%

0.5%

2,733

2,609

4.8%

5.3%

-0.5%

GENERAL

430

414

3.9%

–

1,276

1,254

1.8%

–

Intl

675

649

4.0%

2.8%

1.2%

2,017

2,006

0.5%

1.1%

-0.6%

1,105

1,063

4.0%

3.2%

0.8%

3,293

3,260

1.0%

1.4%

-0.4%

SPECIALTY

174

198

-12.1%

–

543

618

-12.1%

–

Intl

144

139

3.6%

2.8%

0.8%

432

422

2.4%

2.1%

0.3%

318

337

-5.6%

-5.9%

0.3%

975

1,040

-6.3%

-6.4%

0.1%

VISION CARE

432

277

56.0%

–

1,142

767

48.9%

–

Intl

659

462

42.6%

43.9%

-1.3%

1,802

1,297

38.9%

39.8%

-0.9%

1,091

739

47.6%

48.4%

-0.8%

2,944

2,064

42.6%

43.2%

-0.6%

CONTACT LENSES / OTHER

302

277

9.0%

–

832

767

8.5%

–

Intl

498

462

7.8%

9.1%

-1.3%

1,404

1,297

8.2%

9.1%

-0.9%

800

739

8.3%

9.1%

-0.8%

2,236

2,064

8.3%

8.9%

-0.6%

SURGICAL

130

–

310

–

Intl

161

–

398

–

291

–

708

–

TOTAL MEDICAL DEVICES

3,189

3,048

4.6%

–

9,510

9,118

4.3%

–

Intl

3,410

3,111

9.6%

8.6%

1.0%

10,108

9,559

5.7%

6.3%

-0.6%

$ 6,599

6,159

7.1%

6.6%

0.5%

$ 19,618

18,677

5.0%

5.3%

-0.3%

* Percentage greater than 100% or not meaningful

(1) Operational growth excludes the effect of translational currency

(2) Unaudited

(3) Prior year amounts have been reclassified to conform to current year product disclosure

(4) Reported as U.S. sales

(5) Actelion acquisition completed June 16, 2017

SOURCE Johnson & Johnson

MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee

Posted On October 17, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

MARIETTA, Ga., Oct. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has been notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) Phase 2B clinical study for osteoarthritis of the knee may proceed.

The clinical study consists of a Phase 2B, prospective, double-blinded, randomized controlled trial of MiMedx’s AmnioFix® Injectable (micronized dehydrated Human Amnion Chorion Membrane), compared to saline placebo in the treatment of knee osteoarthritis. The trial will enroll approximately 318 patients and the Company expects patient enrollment to commence in the next quarter.

In the Company’s press release of September 19, 2017, MiMedx announced that it had filed for this IND Phase 2 to be initiated. In that press release, the Company indicated the IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of osteoarthritis of the knee. The primary efficacy endpoints of this study will be the change in Visual Analog Scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group. The primary safety endpoint will be the proportion of product-related Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during 12 months following injection in the AmnioFix Injectable group versus the placebo-control group.

Parker H. “Pete” Petit, CEO, said, “This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix Injectable. We are pleased to receive the FDA’s notification that we can proceed with another IND study in the Orthopedic/Sports Medicine area. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities.”

Bill Taylor, President and COO, stated, “The first two ‘Biologics License Application (BLA) indications for use’ we are currently targeting for AmnioFix Injectable are General Tendonitis and Osteoarthritic Knee Pain, which represent approximately 80% of the more than 15 million injections done each year to treat musculoskeletal pain. We believe the results of our BLA clinical trials and safety profile will demand a price per dose of $1,000 or more. This expands the musculoskeletal degeneration market for our first two BLA products to more than a $12 billion U.S. market opportunity. We believe the non-degenerative aspect and potential reduction in opioid use due to our Amniotic Injectable product will drive significant adoption. We expect the study results to be compelling, and we look forward to the prospects of clinicians utilizing AmnioFix Injectable in the treatment of these debilitating conditions.”

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee, expectations as to pricing and market opportunity, and expectations that study results will be compelling. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; reimbursement decisions by public and private payers may not occur as expected; and market opportunities may not materialize or may change in the future. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

MiMedx Warns Of Fake Emails

Posted On October 17, 2017 By OrthoSpineNews In Biologics, Top Stories /

MARIETTA, Ga., Oct. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, warned today that certain individuals or entities not associated with the Company are establishing fake email accounts to impersonate executives at the Company.

The Company is aware of at least one instance in which emails were sent by someone using the CEO’s name and a Gmail account that had not, in fact, been set up by that Company executive. The emails were sent to an analyst who reports on the Company. The Company warns that any emails purporting to be from Company executives from non-MiMedx email accounts should be viewed skeptically. The Company encourages anyone who has received a suspicious email to notify the Company. This type of impersonation is quite unusual, and it is a crime. The Company has turned the investigation over to the authorities.

Parker H. “Pete” Petit, Chairman and CEO, commented, “We believe this activity is related to the recent short seller attacks on the Company. This particular group of short sellers continues to resort to ridiculous and unscrupulous means to attempt to do damage to MiMedx. Of course, their ultimate goal is to depress the price of our stock. However, by impersonating me in emails to our analysts, with comments that create insecurity relative to our Company’s performance or my ethics and integrity, is reprehensible and unlawful. We have also seen other indications of unlawful activity. The Company will continue to quietly go about its investigation of all these issues in a professional manner, and if and when we find violations of laws or regulations, they will be turned over to the proper authorities.”

Petit continued, “Within reason, we will continue to update our website with facts that refute some of the allegations. However, as we stated, the allegations are becoming quite bizarre and are not relevant to any MiMedx related business processes or relationships. Reasonable professionals trying to make points that regulators will review will present credible information from credible sources. That has not happened in our case.”

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that there is a connection between the establishment of fake email accounts and short sell attacks. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Southern Spine Announces “Clinical and Biomechanical Advantages of Interspinous Process Fixation: A Review”

Posted On October 17, 2017 By OrthoSpineNews In Spine, Top Stories /

October 17, 2017

MACON, Ga.–(BUSINESS WIRE)–Southern Spine, LLC, an ISO 13485:2003 certified manufacturer of implants and instruments for spinal surgery, announced today the release of a current literature review on the “Clinical and Biomechanical Advantages of Interspinous Process Fixation.” This in-depth review covers the use of interspinous process fixation devices such as their StabiLink^®MIS Interlaminar Spinal Fixation System that offer the benefits of fewer intraoperative complications, quicker recovery times and lower adjacent segment disease while providing comparable rigidity, fusions rates and patient-reported outcomes when compared to pedicle screw fixation.

Southern Spine is making this 10-page publication available to anyone who would like a copy. Please email your request to Southern Spine at info@southernspine.net and state that you would like either an electronic or hard copy of this comprehensive literature review and bibliography sent to your attention.

“We have confidence that our latest designs of the Dual Lamina and eZ Lamina StabiLink^® Systems with our Laminar-Lock^TMtechnology offer surgeons and patients one of the best clinical choices for treating their pain and instability without limiting any of their future options,” stated David Field, CEO of Southern Spine. “We believe that choosing an Interspinous Process Fixation device is the best first option for many patients and that our StabiLink^® MIS System is the ultimate interlaminar fixation system available.”

The StabiLink^® MIS Spinal Fixation System is FDA Cleared and CE Marked and has been successfully used in thousands of clinical procedures. You can get a “Hands On” demonstration of the innovative StabiLink^® MIS System at the upcoming 2017 North American Spine Society (NASS) in Orlando, FL, October 25-27 at Booth #229.

www.SouthernSpine.net

Patent Information at http://www.SS-IP.com

StabiLink is a registered trademark of Southern Spine, LLC

PG, Laminar-Lock and Southern Spine Logo are trademarks of Southern Spine, LLC

Contacts

Southern Spine, LLC
Calder Clay III, 1-478-745-0000
info@SouthernSpine.net

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MICRO INVASIVE EXPANDABLE TECHNOLOGY AT NASS 2017

Posted On October 17, 2017 By OrthoSpineNews In Spine /

Huntley, IL, October 17, 2017–

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 32^nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27^th, 2017. The meeting is expected to attract over 3,000 surgeons and other healthcare professionals from across the globe.

Life Spine is excited to showcase its Procedural Solutions Product Portfolio highlighted by Micro Invasive Expandable Technology.

Life Spine’s Micro Invasive Expandable Technology is a series of innovative implants that offer surgeons various methods of expansion. ProLift^® Expandable TLIF/PLIF Spacer System expands cephalad/caudal for maximum disc height restoration and decompression of neural elements. TiBOW™ Expandable TLIF Spacer System expands anterior/posterior for maximum endplate coverage and stability. LONGBOW^® Lateral Expandable Spacer System, winner of the 2016 RYOrtho Innovations Award, is an anterior/posterior expanding interbody designed to minimize psoas disruption while maximizing endplate coverage.

ProLift^® and TiBOW™ Expandable Spacer Systems incorporate OSSEO-LOC™ Titanium Surface Treatment Technology that creates a unique osteophylic surface architecture designed to maximize boney on-growth potential. OSSEO-LOC is featured on other key Life Spine implants including PLATEAU^®-C Ti, PLATEAU-Z Ti, PRO-LINK^® Ti, and PLATEAU Ti, providing surgeons with a full portfolio of titanium solutions.

Life Spine will be presenting its Micro Invasive Expandable Technologies, as well as their full procedural solutions portfolio at booth #1109 during the 2017 NASS conference.

Camber Spine Announces Surgeon Presenters For NASS 2017

Posted On October 17, 2017 By OrthoSpineNews In Spine /

WAYNE, Pa., Oct. 17, 2017 /PRNewswire/ — Camber Spine is pleased to announce that Dr. John Malloy IV, D.O. of East Coast Orthopaedics and Dr. Luis E. Duarte, M.D. of Shannon Medical Center will be featured presenters for the company during North American Spine Society’s 2017 Annual Meeting to be held in Orlando, Florida later this month. Camber Spine is focusing on two quickly-growing subsegments within spine: SI Joint Disease Diagnostics and Treatment and Anterior to Psoas (ATP) Lumbar Approach for Fusion.

Each surgeon will be leading daily talks at the Camber Spine booth (550), as well as a lab on the show floor as part of the NASS Surgical Innovation Lab series. Dr. Malloy will be building off of his popular presentation from ISASS 2017. He will discuss how Camber Spine’s sacroiliac fusion products, PROLIX™ and SICONUS™, provide direct visualization and maximized fusion in the treatment of sacroiliac pain. Dr. Duarte will be discussing Right-Sided vs. Left-Sided Anterior to Psoas Approaches and the benefits of the newly FDA-cleared SPIRA™ Open Matrix ALIF.

“We are honored to have two well-esteemed surgeons who are leading innovation in alternative approaches to traditional fusion procedures,” stated Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies. “Their enthusiasm for driving surgical advances aligns with Camber’s vision to solve surgeon frustrations through innovation.”

Sacroiliac Fusion by Camber Spine Technologies is a two-step minimally invasive procedure which consists of the implantation of Prolix™, a machined allograft implant, through direct visualization and a supplemental lateral fixation of the SI Joint using Siconus™ bone screws. The combined use of Prolix™ SI Joint Fusion System and Siconus™ SI Joint Fixation System may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint.

SPIRA™ Open Matrix ALIF was designed specifically to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

Camber Spine NASS 2017 Presentation Schedule
Wednesday, October 25^th
9:15AM: New Techniques For Fusion and Fixation Of The SI Joint with Dr. John Malloy IV, D.O.
11-1PM: Prolix/Siconus Lab with Dr. John Malloy IV, D.O.
Thursday, October 26^th
9:30AM: New Frontiers in MIS Spine Surgery; Advanced Implants and Anteriorpsoas/Anterior Lumbar approaches with Dr. Louis Duarte, M.D.
Thurs 11-1 Spira Lab with Dr. Louis Duarte, M.D.

*For more information or to register please contact Mindy Elgart at melgart@cambermedtech.com

About John Malloy IV
Dr. John (Sean) P. Malloy is an orthopedic surgeon specializing in Lumbar and Cervical surgery as well as minimally invasive procedures used to treat musculoskeletal and spinal injuries or disorders. He completed his orthopedic surgery residency at Pinnacle Health Hospital System and Penn State Hershey medical center where he was named Chief Resident in the Department of Orthopedic Surgery. He has authored numerous publications in the orthopedic and spinal surgery literature and has presented and continues to speak at conferences both locally and on a national level.

About Luis Duarte
Dr. Luis E. Duarte, MD is a practicing Neurosurgeon in San Angelo, TX. Dr. Duarte graduated from Jefferson Medical College of Thomas Jefferson University in 1987 and has been in practice for 30 years. He completed a residency at Hahnemann University Hospital. He currently practices at Brain & Spine Institute and is affiliated with Shannon Medical Center.

About Camber Spine Technologies, LLP
Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. Camber Spine Technologies, LLP is an ISO 13485 certified medical device company located in Wayne, Pennsylvania, that markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. The company is committed to delivering surgeon inspired new technologies to the spine market.

For further information please visit www.cambermedtech.com. For inquiries about any of our products or distribution opportunities please call 484-427-7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

SOURCE Camber Spine Technologies

Leader of Johnson & Johnson 3D Printing Center of Excellence Outlines Advantages of Customized Knee Implants

Posted On October 16, 2017 By OrthoSpineNews In Recon /

Photo: ConforMIS 3D Printing and Additive Manufacturing Facility; Wilmington, MA

BILLERICA, Mass., Oct. 16, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that, while the industry has begun to acknowledge the value of customized knee replacement implant systems compared to traditional off-the-shelf implant systems, it has obtained additional positive clinical data regarding the performance of its customized partial knee replacement implants.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/38f395f7-6e0c-415c-b971-eafda91979ec

Recently, Sam Onukuri, head of Johnson & Johnson’s 3D Printing Center of Excellence, acknowledged the advantages of customized knee implants and instruments that are developed based on a CT or MRI scan of a patient’s anatomy. In an interview generally discussing the advantages of additive manufacturing published in GE Reports by General Electric (GE) and in an “Employee Spotlight” article published by Johnson & Johnson, Onukuri noted the potential advantages of customized knee implants that may reduce both “pain and the recuperation time” compared to traditional off-the-shelf implant systems that come in a limited range of sizes. “Physicians make every effort to find the implant that fits best,” Onukuri says. “But it’s never a perfect match, and the same is true for the tools. As a result, the surgery takes longer — and so can healing and recovery — and the fit may not be perfect.” On the other hand, Onukuri noted that “customized solutions” based on patient CT or MRI scans “can achieve an exact fit for the joint.”

While the orthopedic industry researches potential customized alternatives to traditional off-the-shelf implant technology, ConforMIS continues to develop a growing body of positive clinical data regarding its existing customized knee implants. Most recently, in a study evaluating knee strength and mechanics that compared healthy control patients to those with either a modern off-the-shelf total knee replacement (TKR) or a customized bi-compartmental knee replacement (BKR), the authors concluded that the “study shows that BKR patients exhibit better strength and mechanics while performing activities of daily living.” According to the study results: the TKR group walked significantly slower when compared to both the BKR group and healthy controls (p < 0.05); the TKR knee had less peak extensor moment at stance than both the BKR and healthy control knees (p < 0.05); and both the BKR and healthy control knees displayed larger internal rotation at stance than that of the TKR knee (p < 0.05). The results of the study, for which ConforMIS provided financial support, were published online by International Orthopaedics on September 4, 2017.

“We are very pleased that the industry is now beginning to recognize the advantages and potentially transformative nature of customized knee implant and instrumentation solutions,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “ConforMIS has been a champion of customized implant technology for over a decade, and the body of clinical data demonstrating both the clinical and the economic advantages of customized total and partial knee implant systems continues to grow.”

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 450 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.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the transformative nature of customized implant systems, the economic or other impacts 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 product development and commercialization efforts, 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 ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

The photo is also available via AP PhotoExpress.

CONTACT:

Beth Best
beth.best@conformis.com
(781) 345-9032

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

TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System

Posted On October 16, 2017 By OrthoSpineNews In Regulatory, Robotics, Top Stories /

October 13, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has received FDA 510(k) clearance for the Senhance™ Surgical Robotic System.

“The clearance of the Senhance System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “Millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”

With this clearance, the Senhance becomes the first new market entrant into the field of abdominal surgical robotics since 2000. Using the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. The system builds on the foundation of laparoscopy and features the security of haptic feedback and eye-sensing camera control for the first time in a robotic surgery platform. Additionally, the Senhance utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. The system is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments.

“Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries,” said Dr. Steve Eubanks, a general surgeon and Executive Director of Academic Surgery at Florida Hospital. “The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”

TransEnterix will host a conference call on Tuesday, October 17, 2017 at 8:00 AM ET to discuss the FDA clearance of the Senhance. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, reference conference code 1546349. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has received FDA 510(k) clearance and has been granted a CE Mark. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance Surgical Robot will deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals, whether the Senhance System will maximize value for hospitals and whether the Senhance platform grants laparoscopic surgeons robotic precision, control of surgeon’s vision and haptic feedback while minimizing procedural costs. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
Mohan Nathan, +1-919-765-8400
media@transenterix.com

Anika Announces Regulatory Approval for MONOVISC® in Australia

Posted On October 16, 2017 By OrthoSpineNews In Extremities, Regulatory /

October 16, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in Australia granted approval to MONOVISC^®, Anika’s single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee. MONOVISC is commercially available in over twenty countries, including the United States, Canada, and various European countries. MONOVISC also recently received approval in the Asia-Pacific countries of India and Taiwan. Anika intends to further expand MONOVISC into additional international markets in 2018.

“The Asia-Pacific region presents an important growth opportunity for our global orthobiologics franchise, and we’re excited to bring MONOVISC to patients in Australia and New Zealand,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With this approval, MONOVISC is poised to become the most widely available single-injection viscosupplement in the world and will be a key driver in growing global market share.”

The global expansion of MONOVISC is an important international orthobiologics revenue driver for Anika, and Australia and New Zealand represent a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Surgical Specialties Pty. Ltd. to market MONOVISC in Australia and New Zealand. Established in 2006, Surgical Specialties is an independent distributor of innovative medical devices, with a team of over 70 people in sales offices throughout Australia and New Zealand. Surgical Specialties is an ideal partner for Anika with its established relationships with leading orthopaedic surgeons and sports physicians, a successful track record, and a highly skilled and dedicated national sales force.

About MONOVISC

MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

About Anika Therapeutics, Inc.

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

Forward-Looking Statements

The statements made in the last sentences of the first and second paragraphs and first sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s international expansion plans for MONOVISC, the market for the Company’s products in foreign countries, including Australia and New Zealand, and the status of MONOVISC as a global revenue driver for the Company. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures

Posted On October 16, 2017 By OrthoSpineNews In Regulatory, Spine /

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine.

The TLX interbody system is a market-leading solution that is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. NuVasive developed a minimally invasive approach for the TLIF procedure, the MAS® TLIF or Maximum Access Surgery (MAS) TLIF. Designed to be used with a minimally invasive spine surgery approach, TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design. A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.

Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. The recent clearance includes a 20 degree expandable interbody, and additional indications for use with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The new indications also include use in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. Use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. The TLX system’s size offerings provide multiple options for varying patient size and anatomic considerations.

“With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. “This clearance highlights our persistant investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”

The TLX interbody system, coupled with the Company’s Integrated Global Alignment® (iGA) suite of software that allows surgeons to calculate, correct and confirm a patient’s pathology, has the ability to improve TLIF procedures overall. The software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap® and can intraoperatively correct using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.

“The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures,” said William Hunter, MD, neurosurgeon at The Spine Clinic at Neuroscience and Spine Center of the Carolinas. “The platform also allows me to confirm restoration of my patients’ lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients.”

NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new TLX interbody system in NuVasive Booth #713 at the North American Spine Society Annual Meeting held October 25-28, 2017 in Orlando, Fla.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 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.

Month: October 2017

Johnson & Johnson Reports 2017 Third-Quarter Results

MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee

Related Links

MiMedx Warns Of Fake Emails

Related Links

Southern Spine Announces “Clinical and Biomechanical Advantages of Interspinous Process Fixation: A Review”

Contacts

MICRO INVASIVE EXPANDABLE TECHNOLOGY AT NASS 2017

Camber Spine Announces Surgeon Presenters For NASS 2017

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Leader of Johnson & Johnson 3D Printing Center of Excellence Outlines Advantages of Customized Knee Implants

Photo: ConforMIS 3D Printing and Additive Manufacturing Facility; Wilmington, MA

TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System

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Anika Announces Regulatory Approval for MONOVISC® in Australia

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NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures

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