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Misonix to Report Fiscal 2018 Second Quarter Financial Results, Host Conference Call and Webcast on February 6

Posted On January 30, 2018 By OrthoSpineNews In Financial /  

FARMINGDALE, N.Y., Jan. 29, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today that it will report its fiscal 2018 second quarter financial results after the market closes on Tuesday, February 6, 2018. The Company will host a conference call and webcast at 4:30 p.m. ET that day to review the results. Both the call and webcast are open to the general public.

To access the conference call, interested parties may dial 800/281-7973 (domestic) or 323/794-2093 (international) conference ID 1246600.  Participants may also listen to a live webcast of the call through the “Events and Presentations” section under “Investor Relations” on Misonix’s website at www.misonix.com. A webcast replay will be available for 30 days following the live event at www.misonix.com.

Please call five minutes in advance to ensure that you are connected. Questions and answers will be taken only from participants on the conference call. For the webcast, please allow 15 minutes to register, download and install any necessary software.

About Misonix, Inc.
Misonix, Inc. (Nasdaq:MSON) designs, develops, manufactures and markets ultrasonic medical devices for the precise removal of hard and soft tissue, including bone removal, wound debridement and ultrasonic aspiration. Misonix is focused on leveraging its proprietary ultrasonic technology to become the standard of care in operating rooms and clinics around the world. Misonix’s proprietary ultrasonic medical devices are used in a growing number of medical procedures, including spine surgery, neurosurgery, orthopedic surgery, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. At Misonix, Better Matters to us. That is why throughout the Company’s 59-year history, Misonix has maintained its commitment to medical technology innovation and the development of ultrasonic surgical products that radically improve patient outcomes. Additional information is available on the Company’s web site at www.misonix.com.

Contact:
Joe Dwyer
Chief Financial Officer
Misonix, Inc.
631-694-9113

Joseph Jaffoni, Norberto Aja, Jennifer Neuman
JCIR
212-835-8500 or mson@jcir.com

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Histogenics Corporation Announces Closing of Underwritten Registered Direct Offering of Common Stock and Full Exercise of Option to Purchase Additional Shares

Posted On January 29, 2018 By OrthoSpineNews In Financial /  

WALTHAM, Mass., Jan. 25, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies, today announced the closing of its previously announced underwritten registered direct offering of 2,691,494 shares of its common stock, which includes 351,064 shares sold in connection with the exercise in full by the underwriter of its option to purchase additional shares. The total net proceeds of the offering are approximately $5.9 million after deducting the underwriting discounts and commissions payable by Histogenics.

Canaccord Genuity acted as the sole book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-216741) relating to the underwritten registered direct offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the SEC) and declared effective by the SEC on March 30, 2017. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on January 24, 2018 and is available on the SEC’s web site at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to Canaccord Genuity Inc., Attention: Syndicate Department, 99 High Street, 12th Floor, Boston, Massachusetts 02110, by telephone at (617) 371-3900, or by email at prospectus@canaccordgenuity.com.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.




	

		

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InVivo Therapeutics Announces Purchase Agreement for up to $15 Million with Lincoln Park Capital

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Financial

	/	

	 
	


		


		

	
January 26, 2018








CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today announced that it has entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), a Chicago-based institutional investor, under which the Company has the right to sell up to $15 million in shares of common stock to Lincoln Park over a twenty-four-month period, subject to certain limitations and conditions set forth in the purchase agreement and registration rights agreement, including:


    

  • the company, in its sole discretion, controls the timing and amount of any sales of common stock;
    • 

  • the purchase price is based on prevailing market prices with no warrants;
    • 

  • Lincoln Park cannot require the company to make sales, but is obligated to make purchases as the company directs in accordance with the terms of the purchase agreement;
    • 

  • there are no upper limits on the price per share that Lincoln Park could be obligated to pay for shares of common stock under the purchase agreement;
    • 

  • there are no financial covenants, rights of first refusal, participation rights or liquidated damages; and
    • 

  • the SEC declares effective a registration statement, registering the shares of common stock that Lincoln Park purchases pursuant to the purchase agreement.
    • 



“We are pleased to enter into this purchase agreement with Lincoln Park, which offers us financial flexibility on favorable terms to the company and its shareholders,” said Richard Toselli, M.D., Acting Chief Executive Officer. “We welcome their investment as we pursue our near-term strategic objectives and continue our discussions with the FDA regarding a randomized controlled study in acute complete thoracic spinal cord injury that evaluates the Neuro-Spinal Scaffold™ compared to standard of care.”


In consideration for entering into the purchase agreement, the company has issued shares of common stock to Lincoln Park as a commitment fee. The purchase agreement may be terminated by the company at any time, in its sole discretion.


A more detailed description of the purchase agreement and registration rights agreement is set forth in the company’s Current Report on Form 8-K as filed with the SEC which the company encourages be reviewed carefully.


About InVivo Therapeutics


InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™ implant received the 2015 Becker’s Healthcare Spine Device Award. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.


Safe Harbor Statement


Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the status of the company’s clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s discussions and engagement with the FDA; the company’s ability to initiate, conduct and complete clinical trials; the expected benefits and potential efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical trials and future product commercialization; and other risks associated with the company’s business, research, product development, attainment of regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report on Form 10-K for the three months ended September 30, 2017, and its other filings with the SEC, including the company’s most recent Form 10-K, its Form 10-Qs and its current reports on Form 8-K. The company does not undertake to update these forward-looking statements.






Contacts


InVivo Therapeutics Holdings Corp

Heather Hamel, 617-863-5530

Investor Relations

Investor-relations@invivotherapeutics.com










	

		

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Amedica Provides Business Update

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Financial

	/	

	 
	


		


		

	
SALT LAKE CITY, UT, Jan. 25, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided a business update related to its business strategy and certain recent developments.


BUSINESS UPDATE AND RELATED DEVELOPMENTS


Commercialization Report


In 2017, Amedica successfully launched its updated Taurus™ Pedicle Screw System, a pedicle screw system designed for degenerative spine surgery.  With over 250 procedures performed, this product has generated almost $1.3 million in new revenue since its introduction to the market. The company released additional instrument sets in the fourth quarter of 2017 to meet surgeon demand.


Other commercialization highlights include:


    

  • 40% increase in surgeon users during 2017, predominantly from surgeons performing lumbar fusion surgeries utilizing Valeo II silicon nitride implants and Taurus pedicle screws.
    • 

  • 14 new sales agents added in 2017, primarily to establish representation in underrepresented areas of the United States.
    • 

  • The hire of a new Area Vice President for the Western Region, resulted in all members of the sales team having significant experience in spine surgery related sales.
    • 

  • The product pipeline was prioritized and defined for 2018 and beyond, with the goal of launching several new products in 2018.
    • 

  • Year-over-year revenue growth in Brazil from 2016 to 2017.
    • 

  • Expanded sales channel in the UK in 2017.
    • 

  • Identification of potential distribution partners in Australia.
    • 

  • Progress toward regulatory clearance in Japan.
    • 



The company has received feedback from the FDA on its 510k submission for the “C+CSC with Lumen” spinal implant and is submitting a response.


Clinical


With over 33,000 silicon nitride spinal interbody implants implanted since 2008, Amedica is comprehensively reviewing its large-scale clinical outcomes – a requirement under the new European Medical Device Regulation.  The resulting data will be published later in 2018.


The company has completed the data collection associated with its Level 1 SNAP lumbar spine clinical trial.  Initial review supports the efficacy of silicon nitride as a spine fusion material, consistent with a large volume of data already published by Amedica.  Results of the SNAP trial are expected to be published during 2018.


The company is planning several international clinical investigations during 2018 to strengthen clinical evidence of the advantages of silicon nitride, i.e., ease of imaging, improved spinal fusion, and antibacterial properties.  These studies are expected to build upon the existing foundation of extensive material science data supporting the use of silicon nitride in spine fusion surgery.


Research and Development


During 2017 the company had 20 peer-reviewed publications, 10 published conference proceedings, and participated in 27 presentations at conferences and scientific meetings. These R&D efforts have validated the underlying science of silicon nitride, and contributed to increased company visibility that has attracted inquiries and collaborations in areas outside of spine surgery.  Scientific and clinical data are critical toward attracting new surgeons to silicon nitride implants, both in the United States and overseas markets.


Financial Update


The company continues to focus on stabilizing its finances, having substantially reduced its monthly cash burn during 2014-2017.  On January 3, 2018, Amedica paid off its loan with Hercules Capital via a debt exchange transaction with other accredited investors – a significant step in reducing costs.


Strategic Direction


“Our strategic priorities are three-fold. The first priority is revenue growth, while controlling expenses, with the goal of financial self-sufficiency.  Second, we will continue to investigate the full potential of silicon nitride ceramic and build collaborations with external partners.  Third, while we consider ourselves to be a leader in the scientific knowledge of silicon nitride, the company is focused on building a strong portfolio of clinical evidence.  Taken together, revenue growth, external collaborations, and clinical validation of our products are necessary to support product acceptance, and long-term sales growth,” said B. Sonny Bal, MD, MBA, JD, PhD; Chairman and CEO of Amedica.


About Amedica Corporation


Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its FDA registered and ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, as well as OEM and private label partnerships.


For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.


Forward-Looking Statements


This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements, which include statements regarding the company’s goal to release several new products in 2018, anticipated future revenues, FDA clearance of our products, addition of new surgeon users, and, results of clinical studies are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K/A, filed with the Securities and Exchange Commission (SEC) on December 27, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.


Contacts:
Amedica IR
801-839-3502
IR@amedica.com


	

		

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SpineGuard Announces Significant Improvement to its Operating Result

			


	Posted On January 26, 2018

	By OrthoSpineNews

	In Financial

	/	

	 
	


		


		

	
January 25, 2018




PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News: SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, reported today its preliminary Operating Result and cash position for the full-year of 2017.


Following the publication on January 4, 2018 of its consolidated full-year 2017 revenues of €8.2 million1, SpineGuard now reports its preliminary and non-audited Operating Result of € -2.5M, an improvement of 31% vs. 2016.


In the second half of 2017, SpineGuard estimates that the operating loss was reduced to €-1.0M vs. €-1.5M in the first half of 2017 (1H17), an improvement of 36%.


The cash position at year end of €1.2M plus the secured convertible bond facility for €2.0M means that the total cash available to the Company is €3.2M.


Stéphane Bette, CEO and co-founder of SpineGuard, said: “We are very pleased with these preliminary results which demonstrate our commitment towards the operating profitability goal for the end of 2018, while continuing to deliver solid growth and to deploy our innovative technology platform.”


These preliminary results are unaudited and are based on management’s initial analysis of operations for the period ended December 31, 2017, and are therefore subject to change. The company expects to announce its full year 2017 financial and operating results on March 14, 2018.


Next financial press release: 2017 annual results on March 14, 2018.


About SpineGuard®

Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.


Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.


1 up 10% and 12% at constant exchange rate (cc)






Contacts


SpineGuard

Stéphane Bette

Chief Executive Officer

Tel: +33 (0) 1 45 18 45 19

s.bette@spineguard.com

or

Manuel Lanfossi

Chief Financial Officer

Tel: +33 (0)1 45 18 45 19

m.lanfossi@spineguard.com

or

NewCap

Investor Relations & Financial Communication

Florent Alba / Pierre Laurent

Tel: +33 (0)1 44 71 94 94

spineguard@newcap.fr




	

		

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ConforMIS Announces Proposed Public Offering of Common Stock

			


	Posted On January 24, 2018

	By OrthoSpineNews

	In Financial

	/	

	 
	


		


		

	
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


	

		

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IMPLANET: 2017 Revenue of €7.8 Million

			


	Posted On January 24, 2018

	By OrthoSpineNews

	In Financial

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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




	

		

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Johnson & Johnson Reports 2017 Fourth-Quarter Results

			


	Posted On January 24, 2018

	By OrthoSpineNews

	In Financial

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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.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)




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
























 


READ THE REST HERE


 


 


 


 


 


 


	

		

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

			


	Posted On January 23, 2018

	By OrthoSpineNews

	In Financial

	/	

	 
	


		


		

	


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 Facebook, Twitter, Instagram, LinkedIn 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


	

		

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Zimmer Biomet Holdings Announces Audio Webcast and Conference Call of Fourth Quarter and Full-Year 2017 Results

			


	Posted On January 18, 2018

	By OrthoSpineNews

	In Financial

	/	

	 
	


		


		

	
WARSAW, Ind., Jan. 18, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced its fourth quarter and full-year sales and earnings conference call will be broadcast over the Internet on Tuesday, January 30, 2018, at 8 a.m. Eastern Time.  A news release detailing the quarterly and full-year results will be made available at 7 a.m. Eastern Time the morning of the conference call.


The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. It will be archived for replay following the conference call.


Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985.  For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from January 31, 2018 to March 1, 2018.  To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.


About the Company

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


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


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


SOURCE Zimmer Biomet Holdings, Inc.


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