ConforMIS Announces Proposed Public Offering of Common Stock

BILLERICA, Mass., Jan. 24, 2018 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, today announced that it has commenced an underwritten public offering of its common stock. ConforMIS also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by ConforMIS.

Cowen and Canaccord Genuity are acting as joint book-running managers for the proposed offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

The shares are being offered by ConforMIS pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective by, the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (631) 274-2806 or by contacting Canaccord Genuity Inc., 99 High Street, 12th Floor, Boston, MA 02110, Attn: Syndicate Department, by telephone at (617) 371-3900 or by e-mail at prospectus@canaccordgenuity.com . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

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 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 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” of ConforMIS within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, those relating to ConforMIS’ expectations regarding the completion, timing and size of the public offering, and its expectations with respect to granting the underwriters a 30-day option to purchase additional shares. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties related to completion of the proposed public offering on the anticipated terms, or at all, include, but are not limited to, market conditions and the satisfaction of customary closing conditions related to the proposed public offering. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause ConforMIS’ actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in ConforMIS’ most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in ConforMIS’ other filings with the SEC, including those contained or incorporated by reference in the preliminary prospectus supplement related to the proposed public offering to be filed with the SEC. All information in this press release is as of the date of the release, and ConforMIS undertakes no duty to update this information unless required by law.

Investor Contact

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

Global Sports Medicine Market 2018-2023: Key Players are Arthrex, Smith & Nephew, DePuy Synthes, Stryker, CONMED, Zimmer Biomet, Breg, DonJoy, and Mueller Sports Medicine

DUBLINJan. 24, 2018 /PRNewswire/ —

The “Sports Medicine Market – Industry Trends, Opportunities and Forecasts to 2023” report has been added to ResearchAndMarkets.com’s offering.

Sports medicine is a branch of medicine that deals with physical fitness and treatment and prevention of injuries related to sports and exercise. Increasing adoption of western sports worldwide has resulted in growing number of sports injuries which is driving the market for sports medicine globally. Rise in the point-of-care testing by various diagnostic products and growing number of sports associations around the world are other factors which further boost the growth of sports medicine market.

Sports complication related to knees, hips, elbows, shoulder, and spine are augmenting the demand for minimally invasive surgical procedures, thereby impacting the overall market growth. Growing popularity of robot-assisted surgeries, development of novel technologies such as 3D MRI, for better and accurate diagnosis, and high investments by the vendors and government for R&D activities will provide a great opportunity for the expansion of global sports medicine market.

By application, shoulder and knee treatment will gain the fastest growth in the sports medicine market. Geographically, Americas holds the largest market share of global sports medicine market owing to widespread acceptance of various sports such as football, basketball, and baseball in which players do get injured. Europe is also witnessing a significant rise in demand for sports medicines in order to provide on the spot treatment for sport-related injuries. APAC region will witness the highest market growth due to favorable government regulations growing sports infrastructure and rising interest of the youth in various western sports such as football and basketball. However, the high cost of sports medicinal instruments and lack of trained professionals will act as a major challenge to the adoption of sports medicine in the developing and underdeveloped countries.

Competitive intelligence section deals with major players in the market, growth strategies, products, financials, and recent investments among others. Key industry players profiled as part of this section are Arthrex, Smith & Nephew, DePuy Synthes, Stryker Corporation, CONMED Corporation, Zimmer Biomet Holdings, Breg, DonJoy, and Mueller Sports Medicine.

Segmentation

By Function

  • Reconstruction
  • Support and Recovery
  • Body Monitoring and Evaluation
  • Others

By Application

  • Knee
  • Shoulder
  • Hip
  • Spine
  • Others

Key Topics Covered:

1. Introduction

2. Research Methodology

3. Executive Summary

4. Market Dynamics

5. Sports Medicine Market Forecast by Function (US$ billion)

6. Sports Medicine Market Forecast by Application (US$ billion)

7. Sports Medicine Market Forecast by Geography (US$ billion)

8. Competitive Intelligence

9. Company Profiles

  • Arthrex
  • Smith & Nephew
  • DePuy Synthes
  • Stryker Corporation
  • CONMED Corporation
  • Zimmer Biomet
  • Breg
  • DonJoy
  • Mueller Sports Medicine

For more information about this report visit https://www.researchandmarkets.com/research/xrgm2q/global_sports?w=5

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

 

IMPLANET: 2017 Revenue of €7.8 Million

January 23, 2018

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

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, is today announcing its revenue for the fourth quarter and for the financial year ended December 31, 2017.

Ludovic Lastennet, CEO of IMPLANET, says: “The increase in JAZZ® sales in 2017 confirmed the success of our international roll-out of JAZZ® technology, as we moved into new markets such as Germany, Australia and New Zealand. The acceleration of our commercial development is also reflected by the talks we are currently holding with L&K BIOMED Co. which will enable us, among other things, to have direct access to additional surgeons in North America. Market recognition of the technological benefits of the JAZZ® Platform grows quarter after quarter. This, together with the tight management of our expenses, will have a positive impact on our performance. As a result, we remain confident in our growth prospects in all regions.”

Revenue (in thousands of euros – IFRS) 2017 2016 Change
First-quarter revenue 2,048 1,988 +3%
Second-quarter revenue 2,071 2,107 -2%
Third-quarter revenue 1,774 1,481 +20%
Spine (JAZZ®) 1,208 1,241 -3%
Knee + Arthroscopy 739 1,008 -27%
Total fourth-quarter revenue 1,947 2,249 -13%
Spine (JAZZ®) 4,715 4,102 +15%
Knee + Arthroscopy 3,126 3,723 -16%
Total full-year revenue 7,841 7,825

Fourth-quarter 2017 revenue came to €1.9 million including the anticipated 27% decline in the Knee business to €0.7 million, pursuant to closure of arthroscopy implant distribution, first announced in early 2017. Although revenue from the JAZZ® business remained stable at €1.2 million, volumes showed a significant increase due to the country mix (number of units sold up 16% to 2,821 in the fourth quarter of 2017 compared to 2,437 last year).

Over 2017 as a whole, IMPLANET’s revenue totaled €7.8 million, on the back of strong JAZZ® sales growth (up 30% in volume to 9,117 units and up 15% in value) to €4.7 million.

Thanks to this increase, JAZZ® sales, IMPLANET’s core business, now contributes 60% of total revenue (52% in 2016).

In France, IMPLANET sold 4,101 JAZZ® units, generating €1.5 million in revenue (up 16%). A total of 3,479 units (up 74%) were sold in the rest of the world, generating €1.2 million in revenue (up 58%). These performances reflect the fast pace of international expansion, with the establishment of a commercial presence in new countries such as Germany, Europe’s #1 spinal surgery market, Australia and South America.

In the United States, 1,537 JAZZ® units were sold (up 6%) generating €2.0 million in revenue, stable compared to 2016. As announced in December 2017, following the preliminary agreement with South Korean company L&K BIOMED Co., Ltd, talks continue about pooling the resources of both companies in the United States. This agreement should enable IMPLANET to accelerate its US growth by significantly increasing direct surgeon access.

Although sales of our total knee prosthesis, a proprietary product, were stable, the Knee business recorded a 16% decline following the planned closure of arthroscopy distribution.

Next financial press release: full-year 2017 results on Thursday, March 14, 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 48 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

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

Johnson & Johnson Reports 2017 Fourth-Quarter Results

NEW BRUNSWICK, N.J.Jan. 23, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $20.2 billion for the fourth quarter of 2017, an increase of 11.5% as compared to the fourth quarter of 2016. Operational sales results increased 9.4% and the positive impact of currency was 2.1%. Domestic sales increased 9.8%. International sales increased 13.5%, reflecting operational growth of 9.0% and a positive currency impact of 4.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales for the fourth quarter of 2017 increased 4.2%, domestic sales increased 4.1% and international sales increased 4.3%.*

Worldwide sales for the full-year 2017 were $76.5 billion, an increase of 6.3% versus 2016. Operational results increased 6.0% and the positive impact of currency was 0.3%. Domestic sales increased 5.4%. International sales increased 7.4%, reflecting operational growth of 6.6% and a positive currency impact of 0.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales for the full-year 2017 increased 2.4%, domestic sales increased 1.6% and international sales increased 3.3%.*

Net loss and diluted loss per share for the fourth quarter of 2017 were $10.7 billion and $3.99, respectively. Fourth-quarter 2017 net loss included after-tax intangible amortization expense of approximately $0.9 billion and a net charge for after-tax special items of approximately $14.6 billion. Included in these special items is a provisional amount of approximately $13.6 billion associated with the recent enactment of tax legislation.** Fourth-quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.3 billion and a net charge for after-tax special items of approximately $0.3 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.8 billion and adjusted diluted earnings per share were $1.74, representing increases of 9.5% and 10.1%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share increased 5.7%.A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

Net earnings and diluted earnings per share for the full-year 2017 were $1.3 billion and $0.47, respectively.  Full-year net earnings included after-tax intangible amortization expense of approximately $2.5 billion and a charge for after-tax special items of approximately $16.2 billion. Included in these special items is a provisional amount of approximately $13.6 billion associated with the recent enactment of tax legislation.** Full-year 2016 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $1.3 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the full-year of 2017 were $20.0 billion and adjusted diluted earnings per share were $7.30, representing increases of 6.8% and 8.5%, respectively, as compared to the same period in 2016.* On an operational basis, adjusted diluted earnings per share also increased 7.6%.A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

“Johnson & Johnson delivered strong adjusted earnings per share growth of 8.5% and total shareholder return of greater than 24% in 2017, driven by the robust performance of our Pharmaceutical business, while continuing to make investments in acquisitions, innovation and strategic partnerships to accelerate growth in each of our businesses,” said Alex Gorsky, Chairman and Chief Executive Officer. “As we enter 2018 and look beyond, we are experiencing an incredible pace of change in health care. Johnson & Johnson is uniquely positioned to lead during this dynamic era and deliver innovative solutions for patients and consumers that drive sustainable, long-term growth. We are pleased with the passage of recent legislation modernizing the U.S. tax system, which enables Johnson & Johnson to invest in innovation at higher levels to help address the most challenging unmet medical needs facing health care today.”

Mr. Gorsky continued, “I want to thank all of our talented colleagues for their commitment, passion and dedication to transforming the lives of patients and consumers worldwide.”

The Company announced its 2018 full-year guidance for sales of $80.6 billion to $81.4 billion reflecting expected operational growth in the range of 3.5% to 4.5%. The Company also announced adjusted earnings guidance for full-year 2018 of $8.00 to $8.20 per share reflecting expected operational growth in the range of 6.8% to 9.6%.* Adjusted earnings guidance excludes the impact of after-tax intangible amortization expense and special items.

Segment Sales Performance
Worldwide Consumer sales of $13.6 billion for the full-year 2017 represented an increase of 2.2% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 0.9%. Domestic sales increased 2.7%; international sales increased 1.9%, which reflected an operational increase of 0.4% and a positive currency impact of 1.5%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.5%, domestic sales decreased 0.7% and international sales decreased 0.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by declines in the Baby Care and Oral Care businesses, mostly offset by growth in over-the-counter products, including TYLENOL® analgesics and upper respiratory products, and NEUTROGENA® beauty products.

Worldwide Pharmaceutical sales of $36.3 billion for the full-year 2017 represented an increase of 8.3% versus the prior year with an operational increase of 8.0% and a positive impact from currency of 0.3%. Domestic sales increased 6.7%; international sales increased 10.8%, which reflected an operational increase of 10.1% and a positive currency impact of 0.7%. Sales included the impact of the acquisition of Actelion Ltd. which was completed in June 2017 and contributed 4.2% to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.2%, domestic sales increased 3.1% and international sales increased 5.8%.*  Worldwide operational sales growth was negatively impacted by approximately 1.8 points due to a positive adjustment of U.S. rebate accruals in the first half of 2016, which did not repeat in the first half  of 2017.

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, IMBRUVICA® (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer and TREMFYA® (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis.

Additional contributors to operational sales growth included STELARA® (ustekinumab), a biologic for the treatment of  a number of immune-mediated inflammatory diseases, INVEGA® SUSTENNA®/XEPLION®/TRINZA® (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, ZYTIGA® (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, and XARELTO® (rivaroxaban), an oral anticoagulant, partially offset by declines in REMICADE® (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, due to biosimilar entrants.

During the quarter, the U.S. Food and Drug Administration (FDA) approved JULUCA® (rilpivirine and dolutegravir), the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection; a 10 mg once-daily dose of XARELTO® (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial anticoagulation therapy; and SIMPONI ARIA®(golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. The European Commission approved TREMFYA® (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis and granted approval to broaden the existing marketing authorization for ZYTIGA® (abiraterone acetate) plus prednisone / prednisolone to include the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer.

Regulatory applications for approval were submitted to the FDA and European Medicines Agency to expand the current indication of DARZALEX® (daratumumab) for use in combination with bortezomib, melphalan and prednisone, as a treatment for newly diagnosed patients with multiple myeloma ineligible for autologous stem cell transplantation.  In addition, a supplemental New Drug Application was submitted to the FDA for two new XARELTO® (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD.

Also in the quarter, a worldwide collaboration and license agreement was executed with Legend Biotech, a subsidiary of GenScript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell therapy, LCAR-B38M, targeting BCMA for the treatment of multiple myeloma.

Worldwide Medical Devices sales of $26.6 billion for the full-year 2017 represented an increase of 5.9% versus the prior year consisting of an operational increase of 5.7% and a positive currency impact of 0.2%. Domestic sales increased 4.5%; international sales increased 7.1%, which reflected an operational increase of 6.7% and a positive currency impact of 0.4%. Sales included the impact of the acquisition of Abbott Medical Optics which contributed 4.5%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.5%, domestic sales were flat and international sales increased 3.0%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters and biosurgicals in the Advanced Surgery 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 and spine products in the Orthopaedics business.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

* 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.

** The provisional estimates are based on the Company’s initial analysis of the Tax Cuts and Jobs Act (the “Act”) as of January 18, 2018.  Given the significant complexity of the Act, anticipated guidance from the U. S. Treasury about implementing the Act, and the potential for additional guidance from the Securities and Exchange Commission or the Financial Accounting Standards Board related to the Act, these estimates may be adjusted during 2018.

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; significant adverse litigation or government action, including related to product liability claims and allegations concerning opioid marketing practices; 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.govwww.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)

FOURTH QUARTER

TWELVE 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.

$   1,379

1,387

(0.6)

%

(0.6)

$   5,565

5,420

2.7

%

2.7

    International

2,161

2,045

5.7

1.2

4.5

8,037

7,887

1.9

0.4

1.5

3,540

3,432

3.1

0.4

2.7

13,602

13,307

2.2

1.3

0.9

Pharmaceutical

    U.S.

5,776

5,002

15.5

15.5

21,474

20,125

6.7

6.7

    International

3,905

3,230

20.9

15.5

5.4

14,782

13,339

10.8

10.1

0.7

9,681

8,232

17.6

15.5

2.1

36,256

33,464

8.3

8.0

0.3

Medical Devices

    U.S.

3,314

3,148

5.3

5.3

12,824

12,266

4.5

4.5

    International

3,660

3,294

11.1

7.5

3.6

13,768

12,853

7.1

6.7

0.4

6,974

6,442

8.3

6.5

1.8

26,592

25,119

5.9

5.7

0.2

U.S.

10,469

9,537

9.8

9.8

39,863

37,811

5.4

5.4

International

9,726

8,569

13.5

9.0

4.5

36,587

34,079

7.4

6.6

0.8

Worldwide

$ 20,195

18,106

11.5

%

9.4

2.1

$ 76,450

71,890

6.3

%

6.0

0.3

 

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Centric Medical Announces FDA 510(k) Clearance of Foot and Ankle Plating System

January 23, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the FDA 510(k) clearance of the new Foot and Ankle Plating System. This clearance offers multiple surgical solutions by Centric Medical, to be used in Foot & Ankle reconstruction procedures.

The Centric Medical Foot and Ankle Plating System is comprised of a variety of plates and screws intended to stabilize and fixate bone for a myriad of procedures. The low-profile plates and self-drilling and self-tapping screws were designed to minimize soft tissue disruption and irritation. They are offered in non-sterile, single use implantable components and are provided in a multitude of sizes and shapes which include plates specifically designed for metatarsal phalangeal fusions, lapidus fusions, midfoot fusions and calcaneal slide osteotomies.

“The new Centric Medical Foot and Ankle Plating System is an integral and essential system which adds to a portfolio previously comprised of novel technologies. When paired with our recently FDA cleared Cannulated Screw Internal Fixation System, and our existing OSTEO-LINK® DBM biologics product, we have the potential for excellent clinical outcomes,” said Mariusz Knap, Vice President of Marketing for Life Spine. “As one of the fastest-growing, most innovative companies in our space it is crucial to our surgeons and patients that we continue to advance our offerings.”

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

For Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Spine Wave Announces the Commercial Launch of the GraftMag® Graft Delivery System

SHELTON, Conn., Jan. 23, 2018 (GLOBE NEWSWIRE) — Spine Wave is pleased to announce its commercial launch of the GraftMag® Graft Delivery System.  The GraftMag® Graft Delivery System is designed to safely and rapidly deliver large amounts of bone graft.  The system can transform the tedious and sometimes frustrating graft delivery process into a more efficient part of thoracolumbar spinal fusion surgeries and, due to less instrument passes by sensitive patient anatomy, may reduce the risk of injury.

The GraftMag® Graft Delivery System is comprised of two single use, 5cc graft magazines that are loaded with bone graft on the back table.  The magazines couple with the system’s specially-designed funnels to rapidly deliver large amounts of graft in 1cc increments.  This new grafting approach can reduce frustrating funnel jams and requires only one instrument pass into the graft site to complete the grafting procedure.  The GraftMag® Graft Delivery System can be used in virtually any thoracolumbar spine fusion procedure and with any interbody device.  However, it fits particularly well with Spine Wave’s exciting line of expandable interbody fusion products, especially the Leva® Interbody Devices, which are well known for uniquely accommodating large amounts of bone graft with their use.

“Clinical research indicates that fusion rates are positively correlated with the amount of implanted graft material.  I developed the GraftMag® Graft Delivery System with Spine Wave to make delivering large amounts of graft material faster, easier, safer, and less costly when used in conjunction with any interbody device,” said Dennis Crandall, M.D., Medical Director of Sonoran Spine in Tempe Arizona, and Chairman of the Sonoran Spine Research and Education Foundation.  “Using the GraftMag® Graft Delivery System in conjunction with Spine Wave’s line of Leva® Interbody Devices is a particularly compelling option for many of my thoracolumbar spinal fusion procedures because those devices can accommodate so much graft.”

About Spine Wave
Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable more efficient and less invasive solutions for spine surgeons and their patients. In addition to the GraftMag® Graft Delivery System, Spine Wave also offers a broad portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names.  The expandable technologies can be utilized in posterior, anterior and lateral surgical approaches.  To complement the expandable spacers, Spine Wave offers a comprehensive line of pedicle screws for both minimally invasive and traditional open approaches. Additionally, Spine Wave recently launched the Proficient® Posterior Cervical Spine System which is being very well received due to the high degree of angulation offered by its unique screw design.  The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth.  For more information on Spine Wave and its products, please visit www.spinewave.com.

Contact
Terry Brennan, Chief Financial Officer
tbrennan@spinewave.com
(203) 712-1810

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

WASHINGTONJan. 23, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of the first orthopedic de novo by the U.S. Food and Drug Administration (FDA) on December 19, 2017, enabling IlluminOss Medical, Inc. to initiate commercialization in the U.S. of the Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.

IlluminOss Medical retained MCRA in August of 2016 to lead interactions and correspondence with the FDA for the Bone Stabilization System. The IlluminOss System is a PET balloon infused with a photodynamic monomer, which when exposed to light, polymerizes the monomer, resulting in a solid intramedullary (IM) rod. This is an important treatment option for the fixation and stabilization of actual and impending pathological fractures of the humerus through a minimally invasive procedure. IlluminOss Medical’s Founder & Chief Technical Officer, Robert Rabiner said “Being granted the first orthopedic de novo by the FDA is a significant achievement for both IlluminOss Medical and our partner, MCRA. We knew messaging and presentation of data was critical to the success of our submission, and we knew MCRA had an incredible track record of positive FDA interactions, regulatory strategies, and success. After our successful U.S. clinical trial, MCRA was able to effectively present our clinical and performance data to the FDA in a clear concise manner. Their interactions minimized the potential miscommunications with the agency, and delivered the first Ortho de novo.”

Dave McGurl, Director of Regulatory Affairs, at MCRA, said “We are pleased that FDA has implemented the de novo pathway which allows innovative technologies, such as those being developed by IlluminOss Medical, find a pathway to U.S. market and ultimately to patients. MCRA is at the forefront of helping companies navigate this relatively new regulatory pathway, and achieve success in bringing novel devices to the U.S. market that was not possible even a few years ago.”

About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DCManchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

K2M Group Holdings, Inc. to Release Fourth Quarter and Fiscal Year 2017 Financial Results on February 28th

LEESBURG, Va., Jan. 23, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that fourth quarter and fiscal year 2017 financial results will be released after the market close on February 28th.

Management will host a conference call at 5:00 p.m. Eastern Time on February 28th to discuss the results of the fourth quarter and fiscal year 2017, and to host a question and answer session. Those who would like to participate may dial 844-579-6824 (734-385-2616 for international callers) and provide access code 3754359 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 855-859-2056 (404-537-3406 for international callers); access code 3754359. The webcast will be archived on the investor relations section of the Company’s website.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on FacebookTwitterInstagramLinkedIn and YouTube.

Forward-Looking Statements

Certain statements made in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements are based on management’s expectations, estimates, projections, and assumptions. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors. Additional information regarding these factors is contained in the sections entitled “Risk Factors” and “Management Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as such factors are updated from time to time in our periodic filings with the SEC, each of which is accessible on the SEC’s website.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Source: K2M Group Holdings, Inc.

 

This article appears in: News Headlines

Referenced Stocks: KTWO

BioRestorative Therapies Announces the Appointment of Adam D. Bergstein as Sr. VP, Planning and Business Development

MELVILLE, N.Y., Jan. 22, 2018 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (OTC:BRTX), a life sciences company focused on stem cell-based therapies, today announced the appointment of Adam Bergstein as Senior Vice President, Planning and Business Development. In this capacity, Mr. Bergstein will be responsible for strategic planning, business development, capital market activities and related endeavors.

From 2008 until 2017, Mr. Bergstein founded and operated PharmaShield, an analytics company that created the first known data model that accurately predicts litigation loss and the timing of outcomes in branded pharmaceutical patent cases. From 2006 through 2008, Mr. Bergstein worked as a consultant to a health economics group inside RAND Corporation, during which time he created derivatives to help mitigate risk within the broader healthcare markets. From 1998 through 2006, Mr. Bergstein was a private equity investor in the healthcare and technology sectors.

Mr. Bergstein has an MBA from the J.L. Kellogg Graduate School of Management with concentrations in finance and organizational behavior, as well as a Bachelor of Arts degree in Economics with distinction from the University of Pennsylvania.

“Based on the 33 human patients that received the precursor to BRTX-100, I believe that BioRestorative’s disc therapy stands an excellent chance of receiving regulatory clearance from the FDA within a relatively short time frame.  I believe the therapy will significantly improve the lives of so many with chronic lumbar disc disease,” Mr. Bergstein commented.

Mark Weinreb, CEO of BioRestorative, further commented, “We are extremely excited to have Adam join BioRestorative at this important time of our development. With his industry expertise, capital markets experience and impressive track record, Adam will be a strong addition to our senior management team as we accelerate our clinical, regulatory and business development activities.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells.  Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The BRTX-100 production process involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.  In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery.  We have received clearance from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.

• Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains “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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company’s Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: ir@biorestorative.com

Henry Ford Allegiance Health First in Michigan to Introduce an Innovative Minimally Invasive Robotic Spine Surgery System to Improve Patient Outcomes

JACKSON, Mich.Jan. 19, 2018 /PRNewswire/ — Henry Ford Allegiance Health is the first in Michigan to offer patients the advantages of the ExcelciusGPSTM surgical system. Innovative designs like the ExcelciusGPS are revolutionizing minimally invasive spine surgery and optimizing patient care by combining the benefits of navigation and robotics into one technology. This technology is designed to increase safety for patients and accuracy for their surgeons.

“Robot-assisted surgery is a new, emerging area that will become the standard in care,” said Henry Ford Allegiance Health neurosurgeon Frank La Marca, MD. “At Henry Ford Allegiance Health, we are committed to providing the highest quality of care for our spine surgery patients. We are excited to offer our patients the advantages of the Excelcius system, which allows us to perform minimally invasive procedures which may result in less blood loss, less muscle damage and a potentially faster recovery.”

One of the advantages of the ExcelciusGPS system is the inclusion of a GPS 3-D guidance system, designed to improve accuracy and optimize patient care by combining robotics with navigation, much like the GPS in a car. This advanced technology allows a neurosurgeon to place screws and implants in a very precise fashion while seeing exactly where to place their instruments in real-time.

Henry Ford Allegiance neurosurgeon Azam Basheer, MD, said, “The GPS navigation gives me continuous feedback and allows me to see everything in real time. Now, my colleagues and I can preprogram coordinates, so the robotic arm can assist in guiding us to precise locations in the patient’s spine. The result is safer, faster surgery with less radiation exposure and less need to reposition my patient.”

“Another advantage of ExcelciusGPS is that it allows us to make even safer, more consistent and smaller incisions,” said Henry Ford Allegiance neurosurgeon Armitraj Loganathan, MD. “This is valuable because it promotes healing and lessens scarring.”

About Henry Ford Allegiance Health
Henry Ford Allegiance Health (HFAH) is a 475-bed health system in Jackson, Michigan. HFAH complements traditional acute care services with mission-based services to support patient care across the continuum at every stage of life. With its Level II Trauma Center, Henry Ford Allegiance Health provides comprehensive care for severely injured patients. As a teaching hospital, Henry Ford Allegiance Health continually looks to the future with its Center for Health Innovation & Education and Graduate Medical Education program. Through its Health Improvement Organization (HIO), HFAH is also a national leader in forming community partnerships that innovatively address regional wellness and prevention needs. Visit HenryFordAllegiance.com to learn more.

About Henry Ford Health System
Henry Ford Health System (HFHS) is a six hospital system headquartered in Detroit, Michigan. HFHS is one of the nation’s leading comprehensive, integrated health systems, recognized for clinical excellence and innovation. It provides health insurance and health care delivery, including acute, specialty, primary and preventive care services backed by excellence in research and education. HFHS is a 2011 Malcolm Baldrige National Quality Award recipient. Visit henryford.com to learn more.

SOURCE Henry Ford Allegiance Health

PHOTO: Henry Ford Allegiance Health neurosurgeons Azam Basheer, MD, (left) and Amritraj Loganathan, MD, with the ExcelciusGPS robot

Related Links

http://HenryFordAllegiance.com