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

Physical Therapy Patients Benefit from In-House Diagnostics

Posted On January 25, 2018 By OrthoSpineNews In Extremities /

For patients that seek treatment from physical therapists, the prospect of achieving faster and better results when rehabbing from injury or receiving treatment for pain is a no-brainer.

Now, with an increasing number of physical therapy clinics incorporating in-house diagnostics into the practice this is not only possible, but expected.

Armed with more objective results from established tests that include nerve conduction, musculoskeletal ultrasound and other tests, physical therapists are now able to troubleshoot issues with challenging patients much more quickly and accurately in the clinic.

As a result, patients are able to get back to work sooner, return to their beloved sports/exercises and even potentially lead a more pain-free existence without medication.

The traditional approach to PT

In the traditional approach, physical therapists evaluate patients through a physical examination to determine the ideal treatment plan. However, Physical Therapy physical evaluation tests may miss pathologies and lead to ineffective treatment.

“As physical therapists, a lot of what we do is relatively subjective testing,” explains Nathan Shields, co-owner of Rise Rehabilitation Specialists with 18 years as an orthopedic physical therapist. “Many of the tests are scientifically proven, but are still based upon the skill level and experience of the therapist.”

In the past, when more sophisticated diagnostic tests were required the patient was typically referred to a small universe of specialists in a process that could take several weeks to receive the results.

Now, however, PTs are regularly bringing this type of testing into the clinic. This not only requires a significant investment in the equipment, but also training to accurately conduct the tests.

Fortunately, this is being facilitated by national franchise organizations such as Hands-On Diagnostics that help physical therapy practices establish in-house diagnostic services. To date, the franchise has expanded to 18 different states with over 115 physical therapy facilities.

Among the tests that physical therapists can be trained on include electromyography (EMG), Nerve Conduction Studies (NCS), musculoskeletal and neuro ultrasound, vestibular testing to evaluate patients with vertigo and balance problems and Evoked Potential tests.

EMG/NCS testing is one of the most reliable diagnostic tools for many dysfunctions of the Neuromuscular System. An EMG measures the electrical activity of muscles at rest and during contraction. Nerve Conduction Studies (NCS) measure the health of the nerves.

Physical therapists have been able to perform EMG and nerve conduction tests for more than 45 years. In 1978, the American Physical Therapy Association established a specialty program through the American Board of Physical Therapist Specialties for certification in clinical electrophysiology.

The other diagnostic technique is Musculoskeletal Ultrasound (MSKUS) imaging, which uses sound waves to produce pictures of muscles, tendons, ligaments and joints throughout the body. It is used to help diagnose sprains, strains, tears, and other soft tissue conditions and to guide therapeutic procedures.

In addition to identifying the severity of the problem, EMG and MSKUS can be used to locate the actual source of pain conditions as well as to monitor ongoing improvement over the course of the physical therapy treatment plan.

Patient Feedback

According to a September 27, 2017 article in Musculoskeletal Care, “Physiotherapists utilizing diagnostic ultrasound in shoulder clinics. How useful do patients find immediate feedback from the scan as part of the management of their problem?” the utilization of diagnostic ultrasound by physical therapists in patients with shoulder problems concluded that patients highly rated the information gained from ultrasound imaging in a physical therapy environment and felt it assisted them in the understanding, reassurance and management of their problem.

According to the article, to arrive at this conclusion a questionnaire was offered to 103 patients that underwent ultrasound imaging as part of a shoulder assessment over a 6-month period.

According to the article, “Regarding the ability to understand their shoulder problem better and in feeling reassured about their problem, 97% of patients either strongly agreed or agreed that this was the case. Concerning the capability of managing their problem, 89% of patients strongly agreed or agreed that they felt more able to do this. In total, 96% of patients evaluated the ultrasound scan to be of very high/high value to them.”

For Physical Therapist Nathan Shields, perhaps the most important aspect is that patients are experiencing better, faster results.

“We are now able to treat patients with more certainty and, in some cases, we have been able to use the testing to create protocols and get immediate responses on the physical therapy side,” says Shields.

For more information, contact Hands-On Diagnostics at (888) 447-6014 or visit www.diagnosticsforpt.com

Inspired Spine Expands Global Access to Its Breakthrough Spinal Surgery

Posted On January 25, 2018 By OrthoSpineNews In Spine /

BURNSVILLE, MINN. (PRWEB) JANUARY 24, 2018

Inspired Spine today announced advancements in its strategy to evolve the global standard of care in spinal fusion surgery. Inspired Spine is creating a center for advanced minimally invasive spine surgery at the Canadian Specialty Hospital in Dubai, led by Dr. Mohammed Nooruldeen, and completed its first telemedicine consults with surgical patients there last week. As the first step in providing Inspired Spine’s advanced surgical solutions to their patients, surgeons in Seoul, South Korea participated in a live educational session to learn more about Inspired Spine’s innovative treatment approaches.

“We have established a true global presence for our cutting-edge advanced minimally invasive spine treatments and protocols,” said Dr. Hamid Abbasi, MD, FACS, FAANS, Chief Medical Officer. “Over the last two years, we have created the infrastructure and a rigorous training mechanism to enable other surgeons to learn our techniques. In addition, our protocols ensure that an Inspired Spine patient receives the same level of excellent care whether in the US, South Korea, Dubai, or anywhere else in the world.” Dr. Abbasi is the global leader in the Oblique Lateral Lumbar Interbody Fusion (OLLIF) technique, which is transforming the standard of care for treating many of the causes of chronic back pain, including: degenerative disc disease, herniated discs, spondylolisthesis, scoliosis, and spinal stenosis. For more information about the OLLIF procedure please visit: http://inspiredspine.com/minimally-invasive-ollif-faq/.

Inspired Spine recently opened a 120,000 square foot Total Spinal Health and Technology Campus in Burnsville, MN to scale its global training program, enabling more surgeons to learn its techniques. Six peer- reviewed studies have been published on the superior outcomes delivered by its surgical techniques versus the current standard of care, including a minimally invasive fusion approach for effectively treating adult degenerative scoliosis. Multiple surgeons throughout the world are in various stages of Inspired Spine’s “soft transition” training program.

About Inspired Spine
Minnesota-based Inspired Spine is a total spine care provider dedicated to improving treatment value and outcomes by applying the least invasive solutions to back-pain problems. Inspired Spine Centers offer a variety of treatment options for chronic back pain sufferers – from advanced diagnostic technologies, such as open, upright MRIs, to a range of conservative non-surgical therapies, in addition to unique minimally invasive outpatient keyhole surgical techniques. The company is building a network of comprehensive care centers that offer conservative care, such as physical therapy and pain management, as well as groundbreaking minimally invasive outpatient surgeries that reduce costs and speed recovery for patients. For more information, visit http://inspiredspine.com/ and follow Inspired Spine on Twitter @InspiredSpine.

Published Data Show Successful 24-Month Sacroiliac Joint Fusion and Pain Reduction with the SImmetry® System

Posted On January 25, 2018 By OrthoSpineNews In Spine, Top Stories /

January 24, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the peer-reviewed publication of two-year data of the SImmetry Sacroiliac Joint Fusion System in The Open Orthopaedics Journal. The data show SImmetry provides radiographically evident sacroiliac (SI) joint fusion as early as 12 months with higher fusion rates observed at 24 months, while effectively reducing pain in patients with SI joint disorders. The SImmetry Sacroiliac Joint Fusion System is designed to treat SI joint dysfunction, an underserved condition and, according to the Centers for Disease Control and Prevention (CDC), one of the nation’s leading causes of lower back pain.

“This study demonstrated the SImmetry System effectively promoted SI joint fusion through decortication and also demonstrated a reduction in pain,” said Camille Farhat, President and CEO, RTI Surgical.

This multi-site study evaluated long-term fusion and pain reduction in 18 patients. The study examined computed tomography (CT) evidence of fusion at 12 and 24 months following SI joint fusion performed with decortication and bone grafting. CT scans were independently assessed by three trained musculoskeletal radiologists blinded to one another’s assessments. Fusion was predefined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). At 24 months post-surgery, 17 of 18 patients (94 percent) had evidence of bridging bone, with 15 of 18 patients (83 percent) categorized as Solid fusion across the SI joint. Of the patients with bridging bone, 15 of 17 (88 percent) were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.

In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. No procedure- or device-related serious adverse events were reported. These data were presented at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting.

RTI Surgical recently acquired the SImmetry Sacroiliac Joint Fusion System, a burgeoning therapy that accentuates RTI’s robust spine portfolio and accelerates the company’s growth.

“This is the first of many publications of clinical data demonstrating the value of SImmetry for patients with SI joint pathology,” Farhat said. “RTI is committed to furthering the body of clinical evidence supporting this technology.”

RTI continues to gather clinical data to support SImmetry, including the EVoluSIon Clinical Study, to include up to 40 sites and 250 patients evaluating SI joint fusion and pain reduction. More than 150 patients have been enrolled to date. An early analysis of the first 50 patients reported in December 2017 showed 72 percent of patients achieved the minimal clinically important difference of ≥ 20-point improvement in SI joint pain through six months. Further, the study showed a 54 percent reduction in mean SI joint pain at six months and, notably, the reduction in opioid use (55 percent) was much greater than previously reported with other SI joint fusion products.

The CDC lists back problems as the second most common cause of disability in U.S. adults¹. Approximately 20 percent of all chronic low back pain derives from the sacroiliac joint².

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. Additionally, the statement relating to the expected size of the SIJF market in the United States in 2024 is a forward-looking statement. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

¹ Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.

² Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

Contacts

RTI Surgical, Inc.
MEDIA CONTACT:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
INVESTOR CONTACT:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

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

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

Posted On January 24, 2018 By OrthoSpineNews In Sports Medicine /

DUBLIN, Jan. 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

Posted On January 24, 2018 By OrthoSpineNews In Financial /

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

Posted On January 24, 2018 By OrthoSpineNews In Financial /

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

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

Posted On January 23, 2018 By OrthoSpineNews In Extremities /

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

Posted On January 23, 2018 By OrthoSpineNews In Spine /

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

Author: OrthoSpineNews

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