Advanced Biomedical Technologies Inc. Granted New Patent Strengthening its Core Technology

Posted On February 1, 2018 By OrthoSpineNews In Regulatory /

SHENZHEN, CHINA and NEW YORK, Jan. 30, 2018 (GLOBE NEWSWIRE) — Advanced Biomedical Technologies Inc. (OTCQB:ABMT), a developer and manufacturer of orthopaedic internal fixation devices, today announced the State Intellectual Property Office of The People’s Republic of China (“SIPO”) has issued the Company a new patent titled “Bone Fracture Plate Made of High Polymer Materials”.

The company’s subsidiary Shenzhen Changhua Biomedical Engineering Company Limited is entitled for the new patent (ZL 2014 1 0647464.1), which strengthens the Company’s position in manufacturing process and related controls using our unique polyamide materials (“PA”).

Ms. Wang Hui, CEO of the company said, “This new patent strengthens our IP rights and enables us to develop new products. The combination of fiber-reinforced technology and bionic structure design, allows the medical devices to contain similar mechanical properties to human bone. The elastic fixation does not produce stress shielding, resulting in good fixation effect and biocompatibility. The devices can stimulate bone tissues to achieve effective biological integration, which will benefit bone regeneration. Our uniquely formulated materials can be widely used in the field of orthopaedic internal fixation in an ever-growing and prospective market which is currently dominated by existing materials such as metal and Poly-Lactic-Acid based devices.”

About Advanced Biomedical Technologies Inc. (OTCQB: ABMT)

Advanced Biomedical Technologies, Inc.’s primary product line includes internal fixation devices consisting of proprietary high grade polymers (polyamide – “PA”). Our products are used in a variety of applications including orthopaedic trauma, sports related medical treatment, or cartilage injuries, and reconstructive dental procedures. During the healing process, the products stimulate new bone growth which replaces the degrading device, leaving newer, stronger bone in the exact location of the injury; thus making the site of the injury stronger and more resistant to recurring damage.

These products provide an alternative to metal implants and overcome the limitations of other re-absorbable fixation devices. The material is utilized in producing human body implant screws, binding wires, rods and related implantation products. With over 15 years of meticulous in clinical trials, the company has developed the internal fixation devices to be clinically effective and safe.

The products and materials that the Company has created differ from competing bio-degradable and metal based products being marketed today by:

– The ability to control the speed that the device degrades; therefore improving upon the healing time.

– Eliminating the need for a second surgery to replace device due to infection or other post-operative complications.

– The capability of being evenly absorbed from outer layer inwards, so that it gives enough restoration time for bone healing and re-growth.

The company is establishing broad and new intellectual property protection schemes around our unique PA product lines, not only on its combination compounds, but also to lead as an outstanding material in the future of clinical activity.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development or marketing of our products, government regulatory agencies may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop bone fixation devices may be unsuccessful, our common stock could be delisted from the over-the-counter market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Twitter: https://twitter.com/biomedical_inc

Linkedin: https://www.linkedin.com/company/advanced-biomedical-technologies-inc/

Facebook: https://www.facebook.com/Advanced-Biomedical-Technologies-Inc-183454282241087/

Contact:

Kai Gui

Advanced Biomedical Technologies Inc.

TEL: 1-718-766-7898

EMAIL: info@abtbiomedical.com

Source: Advanced Biomedical Technologies Inc.

Ceterix Announces Completion of Groundbreaking Study of Repair for Meniscal Tears Previously Thought Unrepairable

Posted On February 1, 2018 By OrthoSpineNews In Extremities /

January 31, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix^®Orthopaedics, Inc., a developer of novel surgical tools that improve a surgeon’s ability to perform minimally invasive orthopaedic procedures, today announced completion of enrollment in STITCH (A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears¹), the first-ever prospective multicenter investigation of suture-based repair for patients with horizontal meniscus tears, a common type of knee injury.

Because common opinion has held that meniscus repair is not effective for this tear type, horizontal cleavage tears are often treated with meniscectomy – partial removal of the meniscus – despite meniscectomy’s well-established limitations and long-term consequences, including the increased risk of arthritis.²In fact, a systemic literature review shows that healing rates for horizontal cleavage tears are comparable to other meniscal tear types that are routinely repaired³, suggesting that more horizontal cleavage tears could be repaired, saving patients the risks of meniscectomy.

The primary objectives of the STITCH study are to assess the success of horizontal meniscus tear repair using Ceterix’s NovoStitch^®meniscal repair system or other suture-only techniques, and to assess improvements in knee pain and function after repair. The study targeted enrollment of 30 adults who are 60 and younger at 10 investigational sites in the United States.

“This study aimed to establish the therapeutic value of repair of horizontal tears in multiple practices and across a broad age range,” said orthopaedic surgeon Peter Kurzweil, M.D., principal investigator of the STITCH study. “This study will provide the most credible evidence yet available about this very prevalent and important tear type.”

Arthroscopic surgery is a minimally invasive surgical procedure performed by an orthopaedic surgeon in which a damaged joint is treated, through small incisions with specialized tools, under the guidance of a tiny camera called an arthroscope. Meniscus surgeries are the most common arthroscopic surgery in the United States, with roughly one million procedures annually.

“We are proud to invest in increased understanding of the benefits of our technologies,” said John McCutcheon, president and CEO of Ceterix. “We hope that the results of this study will mean that more patients are spared the potential downsides of meniscectomy through increased use of suture-based repair for these types of tears.”

Ceterix’s NovoStitch meniscal repair system enables surgeons to place stitches arthroscopically in tight joint compartments and thereby address complex knee, hip and shoulder injuries that have not been amenable to repair in the past.

About Ceterix^® Orthopaedics

Ceterix^® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com.

¹http://www.clinicaltrials.gov/ct2/show/NCT02237001

²Papalia, R. et. al. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011; 99:89-106.

³Kurzweil, P. et.al. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014 Aug 6.

Contacts

for Ceterix Orthopaedics
Sierra Smith, 408-540-4296
sierra@healthandcommerce.com

SeaSpine Expands Ventura™ NanoMetalene® Implant Offering to Accommodate Larger Range of Posterior Procedures

Posted On February 1, 2018 By OrthoSpineNews In Spine /

Carlsbad, Calif. / Jan. 31, 2018 – SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the portfolio expansion of the Ventura™ NanoMetalene^® posterior interbody device. Ventura NanoMetalene, which has been commercially available since 2015, has expanded its size offerings to accommodate a larger range of posterior procedures and a wider variety of patient anatomies. These new sizes include additional lengths and oblique placement options with sagittally oriented lordosis.

The Ventura interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide implants a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.

Ali Chahlavi, MD, a neurosurgeon practicing in Jacksonville, FL and an early adopter of NanoMetalene, commented, “NanoMetalene has been an integral part of my fusion procedures. These implants deliver the same surface characteristics of titanium while maintaining PEEK’s radiolucency for clear assessment of fusion post-operatively, which has not always been my experience with a full titanium device.” With respect to the new lordotic options, he said, “the additional lordosis will improve my ability to restore better natural alignment to my patients.”

SeaSpine’s entire portfolio of posterior lumbar NanoMetalene interbody devices is cleared for use with both autograft and allograft. Having the additional indication allows surgeons more bone grafting options, including using Ventura NanoMetalene with SeaSpine’s new line of allograft demineralized bone fiber products.

“NanoMetalene is a differentiated product in a market that has become increasingly competitive,” stated Troy Woolley, Vice President of Marketing. “The expansion of this technology coupled with our advanced orthobiologics demonstrates our commitment to provide complementary, cost-effective procedural solutions to surgeons, hospitals and patients.”

About SeaSpine

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements may include, but are not limited to, statements relating to: the design and other benefits of the Ventura NanoMetalene portfolio; its ability to restore better natural alignment to patients; and the ability of the Ventura NanoMetalene product to provide complementary, cost-effective procedural solutions to surgeons, hospitals and patients. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of the expanded Ventura NanoMetalene portfolio to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

###
Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

Additional Strategic Funding for CartiHeal’s Ongoing AGILI-C™ IDE Clinical Study $2.5M boost by Bioventus brings latest investment round to $21M

Posted On February 1, 2018 By OrthoSpineNews In Financial, Top Stories /

KFAR SABA, ISRAEL and DURHAM, NC– January 31, 2018 CartiHeal, developer of the proprietary Agili-C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints, has secured a $2.5M investment from Bioventus, a global leader in orthobiologics – reflecting the growing interest in CartiHeal’s technology.

Bioventus’s $2.5M boost complements CartiHeal’s latest financing round, led by aMoon, together with Johnson & Johnson Innovation (JJDC Inc.), Peregrine Ventures, and Elron, bringing the total round to $21M.

The funding will focus on CartiHeal’s ongoing Agili-C IDE clinical study. Further to the trial’s initiation 3 months ago, over thirty patients were already enrolled, according to enrollment rate forecasts.

CartiHeal CEO, Nir Altschuler: “This investment is a vote of confidence by an important orthobiologic strategic player. Bioventus joins our team of strategic investors who perceived the potential of the Agili-C implant. We are confident that Bioventus will bring substantial added value to CartiHeal.”

“Agili-C shows great promise to relieve osteoarthritis pain for a large patient population and we look forward following the pivotal trial to a successful culmination,” said Tony Bihl, CEO, Bioventus.

About CartiHeal

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

About the Agili-C™ implant IDE multinational pivotal study

The Agili-C™ IDE study is set to include a minimum of 250 patients in US and OUS centers, aiming for a PMA submission. The trial’s objective is to demonstrate the superiority of the Agili-C™ implant over the surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both osteoarthritic knees and knees without degenerative changes.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus and the Bioventus logo are registered trademarks of Bioventus, LLC.

For Bioventus Contact: Thomas Hill, 919-474-6715, thomashill@bioventusglobal.com

For CartiHeal Contact: info@cartiheal.com

CollPlant Announces ADS Listing on NASDAQ

Posted On January 31, 2018 By OrthoSpineNews In Biologics /

NESS ZIONA, Israel, January 31, 2018 /PRNewswire/ —

CollPlant (NASDAQ: CLGN) (TASE: CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), announced that its American Depository Shares (“ADSs”) have been approved for listing on The Nasdaq Capital Market. Trading commenced on Wednesday, January 31, 2018 under the ticker symbol “CLGN”. In addition, and simultaneously, Collplant’s ordinary shares will continue to trade on the Tel-Aviv Stock Exchange market (TASE: CLPT).

Yehiel Tal, CEO of CollPlant stated “We believe the Nasdaq listing gives us the opportunity to increase the trading liquidity of our securities, broaden our shareholder base and significantly raise our profile in the investment community. CollPlant’s proprietary product line addresses indications for a diverse fields of organ and tissue repair, and is making a real impact in the field of regenerative medicine. Our flagship rhCollagen BioInk product offering is being developed for 3D bioprinting of tissues and organs, and our Vergenix line of rhCollagen products includes a soft tissue repair matrix for the treatment of tendinopathy, as well as a wound repair matrix to promote rapid, optimal healing of acute and chronic wounds. Trading of CollPlant’s ADSs on Nasdaq is a natural extension of our growth goals.”

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix^®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix^®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Forward-Looking Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Collplant’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Collplant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Collplant’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which we operate; projected capital expenditures and liquidity; changes in our strategy; our ability to cooperate with third party collaborators; government regulations and approvals; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting Collplant is contained under the heading “Risk Factors” included in Collplant’s most recent registration statement on Form F-1 filed with the SEC on January 29, 2018, and in other filings that Collplant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Collplant’s current views with respect to future events, and Collplant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at CollPlant:
Eran Rotem
Deputy CEO & Chief Financial Officer
Tel: +972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC:
Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

Camber Spine Reports Strong Performance Results for 2017

Posted On January 31, 2018 By OrthoSpineNews In Financial /

WAYNE, Pa., Jan. 31, 2018 /PRNewswire/ — Camber Spine, a leading innovator in spine and medical technologies, today reports a strong finish to 2017 with record fourth quarter sales and year-over-year growth.

2017 was by all accounts a very strong year for Camber Spine with 54.2% growth in Q4 and 46% year-over-year growth largely driven by an increase of 97% of active surgeon users in the past 12 months.

“We attribute our sizable growth directly to expansion of our sales team and significant additions to our product portfolio,” said Daniel Pontecorvo, CEO. “In 2017 Camber made a big investment with the addition of very talented area directors which have enabled us to expand into additional markets across the country. This past year also saw the launch of three new products, Ti-Diagon™ Anatomic Oblique TLIF, SPIRA™ Open Matrix ALIF and SPIRA-C™ Open Matrix Cervical Interbody.”

SPIRA™ ALIF and SPIRA™-C are part of the SPIRA™ proprietary technology platform of spinal implants that feature SURFACE BY DESIGN™ together with the SPIRA™ open architecture arched design which enables the goal of endplate-to-endplate fusion and long-term stability.

“As we look ahead to the future, we anticipate a strong 2018 with the planned launch of three exceptional new products – the second generation of ENZA™ MIS ALIF, SPIRA™-L Open Architecture Lateral Cage and SPIRA™V Open Matrix Corpectomy. We have an active product development pipeline and expect submission and approval of 6 new products for FDA clearance this year.”

About Camber Spine

Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber Spine, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.

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

www.cambermedtech.com

SOURCE Camber Spine

IMPLANET: Update on the L&K BIOMED Partnership

Posted On January 31, 2018 By OrthoSpineNews In Spine /

January 30, 2018

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

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY) (Paris:ALIMP) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants has released a progress update on the partnership it entered into with South Korean company L&K BIOMED Co. Ltd in December 2017.

On December 6, IMPLANET announced it had entered into a preliminary agreement concerning the implementation of a worldwide partnership with L&K BIOMED in order to accelerate its expansion, especially in the United States and in Asia.

The distribution agreement with AEGIS SPINE, L&K BIOMED’s US subsidiary, has now been completed, in line with previous announcements. IMPLANET will capitalize on the expertise of Aegis Spine to complement the existing commercialization efforts in the United States, the company’s priority market.
The first surgeries with AEGIS SPINE’s KOLs are scheduled for early February.

In conjunction, both companies’ Asian and European teams are working on regulatory, marketing and commercial aspects of the two product line launches in their respective markets. L&K BIOMED’s technical and sales teams will undergo training at IMPLANET’s headquarters in early February. Cross-distribution agreements covering these geographical territories are due to be signed in the next few weeks.

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

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
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

Zimmer Biomet Announces Fourth Quarter and Full-Year 2017 Results

Posted On January 31, 2018 By OrthoSpineNews In Financial /

WARSAW, Ind., Jan. 30, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter and full year ended December 31, 2017. The Company reported fourth quarter net sales of $2.074 billion, an increase of 3.0% over the prior year period, and an increase of 1.5% on a constant currency basis. Diluted earnings per share for the fourth quarter were $6.16, and include a one-time tax benefit of approximately $6.40 resulting from the recently enacted U.S. tax reform legislation. Fourth quarter adjusted diluted earnings per share were $2.10, a decrease of 1.9% from the prior year period.

Full-year 2017 net sales were $7.824 billion, an increase of 1.8% over the prior year, on both a reported and constant currency basis. Full-year revenues increased by 0.5% over the prior year on a constant currency basis, excluding approximately 130 basis points of contribution from the LDR Holding Corporation acquisition. Diluted earnings per share for the full year were $9.03. Adjusted diluted earnings per share for the full year were $8.03, an increase of 0.9% over the prior year.

Bryan Hanson, President and CEO of Zimmer Biomet, said: “Since joining the Company last month, I have been performing a thorough review of the business. My immediate priorities are to improve Zimmer Biomet’s execution and address a number of near-term challenges that have impacted, and will continue to impact, our performance. With that said, I fully believe in the power of the Zimmer Biomet global brand and portfolio of products, and I am confident that with sound strategy and enhanced execution we can drive sustained shareholder value.”

Net earnings for the fourth quarter were $1.257 billion, and $428.5 million on an adjusted basis. Operating cash flow for the fourth quarter was $402.9 million.

Net earnings for full-year 2017 were $1.840 billion, and $1.636 billion on an adjusted basis.

In the quarter, the Company paid $48.6 million in dividends and declared a fourth quarter dividend of $0.24 per share. The Company also repaid $300.0 million of debt during the quarter. For full-year 2017, the Company paid $193.6 millionin dividends and repaid approximately $1.250 billion of debt.

⁽¹⁾ U.S. tax reform legislation resulted in a net favorable provisional adjustment due to the reduction of certain deferred tax liabilities which were partially offset by provisional tax charges related to the toll tax provision of U.S. tax reform. The amount recognized is a provisional estimate and subject to change, possibly materially, due to, among other things, refinements of the Company’s calculations, changes in interpretations and assumptions the Company has made or additional guidance issued by the U.S. Treasury, Securities and Exchange Commission or Financial Accounting Standards Board.

Guidance
For the first quarter of 2018, the Company expects revenue in the range of $1.955 billion to $1.995 billion, representing a change of negative 1.0% to positive 1.0% compared to the prior year period, and negative 4.0% to negative 2.0% on a constant currency basis compared to the prior year period, inclusive of negative impact related to approximately one less billing day compared to the prior year period.

Additionally, the Company expects its diluted earnings per share for the first quarter of 2018 to be in a range of $0.73 to $0.88, and in a range of $1.84 to $1.91 on an adjusted basis.

Conference Call
The Company will conduct its fourth quarter and full-year 2017 investor conference call today, January 30, 2018, at 8:00 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com. A digital recording will be available 24 hours after the completion of the conference call, from 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.

Sales Tables
The following fourth quarter and full-year sales tables provide results by geography and product category, as well as the percentage change compared to the prior year periods on a reported basis and a constant currency basis.

NET SALES – THREE MONTHS ENDED DECEMBER 31, 2017 (in millions, unaudited)

						Constant
	Net					Currency
	Sales		% Change			% Change
Geographic Results
Americas	$	1,280		0.9	%		0.8	%
EMEA		473		6.4			(0.3)
Asia Pacific		321		7.0			7.2
Total	$	2,074		3.0	%		1.5	%
Product Categories
Knees
Americas	$	443		(0.3)	%		(0.5)	%
EMEA		181		10.0			3.9
Asia Pacific		107		(4.1)			(4.4)
Total		731		1.4			(0.1)
Hips
Americas		256		0.8			0.5
EMEA		137		1.5			(5.3)
Asia Pacific		106		13.8			14.6
Total		499		3.5			1.6
S.E.T ^*		454		5.9			4.6
Dental		108		2.1			(0.4)
Spine & CMF		194		1.5			0.5
Other		88		4.3			2.9
Total	$	2,074		3.0	%		1.5	%

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

NET SALES – YEAR ENDED DECEMBER 31, 2017 (in millions, unaudited)

						Constant
	Net					Currency
	Sales		% Change			% Change
Geographic Results
Americas	$	4,866		1.3	%		1.2	%
EMEA		1,745		0.9			0.2
Asia Pacific		1,213		5.4			6.3
Total	$	7,824		1.8	%		1.8	%
Product Categories
Knees
Americas	$	1,660		(1.7)	%		(1.7)	%
EMEA		644		1.0			0.9
Asia Pacific		433		1.5			1.6
Total		2,737		(0.6)			(0.6)
Hips
Americas	$	975		(1.2)			(1.3)
EMEA		519		(0.7)			(1.8)
Asia Pacific		385		7.5			9.1
Total		1,879		0.6			0.6
S.E.T ^*		1,709		3.9			4.0
Dental		419		(2.2)			(2.6)
Spine & CMF		759		14.7			14.4
Other		321		(2.5)			(2.6)
Total	$	7,824		1.8	%		1.8	%

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

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

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

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

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

Note on Non-GAAP Financial Measures

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

Sales change information for the three-month period and the year ended December 31, 2017 is presented on a GAAP (reported) basis and on a constant currency basis. The sales change information for the full year is also presented on a constant currency basis that excludes the contribution from the Company’s acquisition of LDR Holding Corporation in July 2016. Projected revenue change information is also presented on a GAAP basis and on a constant currency basis. Constant currency rates exclude the effects of foreign currency exchange rates. They are calculated by translating current and prior-period sales at the same predetermined exchange rate. The translated results are then used to determine year-over-year percentage increases or decreases.

Net earnings, diluted earnings per share and projected diluted earnings per share are presented on a GAAP (reported) basis and on an adjusted basis. Adjusted earnings and adjusted diluted earnings per share exclude the effects of inventory step-up; certain inventory and manufacturing-related charges connected to discontinuing certain product lines, quality enhancement and remediation efforts; special items; intangible asset amortization; certain claims; goodwill impairment; debt extinguishment charges; any related effects on our income tax provision associated with these items; the effect of U.S. tax reform; and other certain tax adjustments. Special items include expenses resulting directly from our business combinations and/or global restructuring, quality and operational excellence initiatives, including employee termination benefits, certain contract terminations, consulting and professional fees, dedicated project personnel, asset impairment or loss on disposal charges, certain litigation matters, costs of complying with our deferred prosecution agreement and other items. Other certain tax adjustments include a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting, net favorable resolutions of various tax matters, a favorable tax rate change in a foreign jurisdiction and charges from internal restructuring transactions that provide the Company access to cash in a tax efficient manner.

Management uses these non-GAAP financial measures internally to evaluate the performance of the business and believes they are useful measures that provide meaningful supplemental information to investors to consider when evaluating the performance of the Company. Management believes these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported operating results, to perform trend analysis, to better identify operating trends that may otherwise be masked or distorted by these types of items and to provide additional transparency of certain items. In addition, certain of these non-GAAP financial measures are used as performance metrics in the Company’s incentive compensation programs.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are included in this press release.

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Medicrea Reports Directors’ Dealings Disclosure

Posted On January 30, 2018 By OrthoSpineNews In Financial /

January 30, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA Group (Euronext Growth: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD^® ASI technology, announces transactions on securities of the Company by its Chairman and Chief Executive Officer.

In accordance with Article 19 of Regulation (EU) No 596/2014 of April 16^th, 2014, the Company has declared to the AMF the acquisition of 90,045 shares between January 22^nd and 25^th, 2018 by its Chairman and Chief Executive Officer, Denys Sournac.

About Medicrea (www.Medicrea.com)

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 40 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

For further information, please visit: www.medicrea.com

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

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

Author: OrthoSpineNews

Contacts

Contacts

Contacts