Spineology Receives a Notice of Allowance for a New US Patent on its Duo™ Lumbar Interbody Fusion Implant

March 05, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application No. 15/476,911, “Mesh Spacer Hybrid.” The allowed claims include three independent device claims covering Spineology’s Duo implant, a novel proprietary intervertebral implant that includes PEEK intervertebral spacer elements and an expandable mesh graft containment element. Spineology expects the patent to be issued within the next several weeks.

“We always strive to attain protection for strategic intellectual property,” said John Booth, Chief Executive Officer of Spineology. “This Notice of Allowance is an important extension to our IP Portfolio.”

The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. This design dramatically reduces the access required to implant a device compared to traditional lateral systems. By significantly minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

Conformis iTotal CR Knee Replacement System Awarded “3A” Rating from the Orthopaedic Data Evaluation Panel in the United Kingdom

BILLERICA, Mass., March 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) (http://www.odep.org.uk/ODEPExplained.aspx)awarded the Conformis iTotal CR knee replacement system a “3A” rating.  The 3A rating is based on strong evidence of implant performance over three years, including low revision rates as indicated in the United Kingdom’s National Joint Registry.

ODEP is an independent panel of leading orthopedic surgeons and experts in the UK that evaluates data related to use of hip and knee implant technologies and provides a rating to indicate performance in key areas including survivorship. ODEP provides the National Health Service (NHS) with an approved list of products that meet the revision rate standard set by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. The 3A rating (as explained in more detail at http://www.odep.org.uk/ODEPExplained.aspx#2) is based on three-year performance data. ODEP ratings provide a simple, independently verified assessment as to the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants that they use comply with these national guidelines.  Only products that demonstrate compliance with NICE guidance are awarded a rating.

“The positive ODEP 3A rating reaffirms my experience treating patients with the Conformis iTotal CR knee replacement system, which I believe offers my patients a more natural feeling knee with improved performance and mobility,” said Mr. Ian McDermott FRCS, Senior Consultant Knee Surgeon at London Sports Orthopaedics, based at the London Bridge Hospital in London, UK. “The clinical evidence and three-year survivorship data together are consistent with the improvement I am seeing with my patients’ outcomes after knee replacement surgery using Conformis knee prostheses.”

“ODEP ratings provide a reliable, simple and independent assessment of the performance of an implant” said, Mr. Fahad G. Attar, MBChB, FRCS, Consultant Trauma & Orthopaedic Surgeon at BMI Alexandra and Whiston Hospital, St. Helens & Knowsley Teaching Hospitals, United Kingdom. “I expect that this 3A rating will now provide additional reassurance and peace of mind to my patients and reinforce the performance reputation of Conformis iTotal CR knee replacement implants that contribute to the improved clinical outcomes I am seeing in my practice.”

“The ODEP awarded the Conformis iTotal CR system a 3A rating based in part on positive implant survivorship and performance data from the UK National Joint Registry at three years’ post-surgery,” said Mark Augusti, Chief Executive Officer and President of Conformis.  “This rating provides another independent verification that our design philosophy, predicated on patient conforming implants, results in performance where it counts the most, in patients.  “We hope that this 3A rating also provides an opportunity for Conformis to expand our product offering to more patients receiving their healthcare in NHS facilities.”

More information on the ODEP can be found on their website at http://www.odep.org.uk/ODEPExplained.aspx

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 designed and manufactured to fit and conform to each patient’s unique anatomy.  Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital.  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.

For more information, visit www.conformis.com

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Conformis, including statements about the ability to offer implants to patients in the United Kingdom, that potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Conformis views as of the date hereof. Conformis anticipates that subsequent events and developments may cause Conformis’s views to change. However, while Conformis may elect to update these forward-looking statements at some point in the future, Conformis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Conformis’ views as of any date subsequent to the date hereof.

MEDIA CONTACT
Kelly Wakelee
Berry and Company Public Relations
kwakelee@berrypr.com
212.253.8881

INVESTOR RELATIONS CONTACT
Oksana Bradley
Investor Relations
ir@conformis.com
781.374.5598
www.conformis.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/acfb1db3-b005-40af-8b6e-dffa8c838cfe

 

RTI Surgical Announces Fourth Quarter and Full Year 2017 Results

March 01, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq:RTIX), a global surgical implant company, reported operating results for the fourth quarter and full year of 2017.

“We are pleased to have delivered on our 2017 commitments through four consecutive quarters and produced organic growth in every core product category,” said Camille Farhat, chief executive officer. “As I approach my first anniversary at the Company, I believe we have made significant progress. We have assembled a world class management team and began implementation of our strategic transformation. We successfully divested the cardiothoracic closure business to initiate the reduction in complexity and implemented programs to drive operational excellence and margin enhancement, while reorienting the organization around key customer segments. We are making the necessary investments to accelerate the growth of our spine franchise, most notably, the acquisition of Zyga Technology announced at the start of 2018.”

Farhat added, “While our initial progress is gratifying, we are still in the midst of our transformation with considerable work ahead of us. Moving forward, we are focused on executing our strategic initiatives to create a dynamic company focused on its core capabilities with consistent, predictable earnings and cash flow and growing spine focused operations.”

Fourth Quarter 2017

RTI’s worldwide revenues for the fourth quarter of 2017 were $70.8 million, a slight decline from the prior year quarter revenues of $71.3 million. Fourth quarter revenues were driven by stable performance in most product lines with growth in OEM, which were offset by a $2.8 million reduction from the sale of substantially all the assets of the cardiothoracic closure business completed in August 2017. Gross profit for the fourth quarter of 2017 was $36.3 million, or 51.2% of revenues, compared to $28.1 million, or 39.4% of revenues in the fourth quarter of 2016.

During the fourth quarter of 2017, RTI incurred substantial non-recurring pre-tax charges to support the ongoing strategic transformation of the business and to optimize the tax benefit of the related actions. The company incurred $1.6 million in severance and restructuring charges primarily in support of initiatives to reduce the complexity of its organizational structure; $2.8 million in executive transition costs primarily for non-cash executive inducement awards and stock-based compensation expenses; $3.7 million related to asset impairment and abandonments of certain long-term assets as part of efforts to reduce complexity and improve operational excellence; and $0.6 million in expenses related to the January 2018 acquisition of Zyga Technologies to support the acceleration of growth. During the fourth quarter of 2016, the company incurred $6.2 million of non-recurring pre-tax charges primarily driven by $5.4 million asset impairment and abandonment charges in our German facility.

Net loss applicable to common shares was $8.6 million loss, or $0.14 per fully diluted common share in the fourth quarter of 2017, compared to a net loss applicable to common shares of $11.8 million, or $0.20 per fully diluted common share in the fourth quarter of 2016. As outlined in the reconciliation tables that follow, excluding the impact of the various non-recurring charges and the impact of the Tax Cuts and Jobs Act in the fourth quarter of 2017, adjusted net income applicable to common shares was $1.6 million, or $0.03 per fully diluted common share in the fourth quarter of 2017.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)1, for the fourth quarter of 2017 was $9.4 million, or 13% of revenues compared with $6.1 million, or 9% of revenues for the fourth quarter of 2016. The increase in Adjusted EBITDA is primarily driven by the reduction in operating expenses through the efforts to reduce complexity and increase operational excellence implemented during 2017.

Full Year 2017

Worldwide revenues were $279.6 million for the full year 2017, an increase of 2.5 percent compared to revenues of $272.9 for the full year 2016. Growth across all product categories were offset by a $3.0 million reduction from the sale of substantially all of the assets of the cardiothoracic closure business in August 2017 and a reduction in other revenues. Gross profit for the full year 2017 was $142.5 million, or 51.0% of revenues compared to $132.3 million, or 48.5% of revenues in 2016.

During the year, the company recorded non-recurring pre-tax charges including: $12.2 of severance and restructuring charges; $2.8 million of executive transition expenses, $3.7 million of asset impairment and abandonment expenses; and $0.6 million in expenses related to the January 2018 acquisition of Zyga Technologies. During 2016 the Company incurred $26.6 million of pre-tax non-recurring charges.

During the third quarter of 2017, RTI completed the sale of substantially all the assets related to its cardiothoracic closure business for total consideration of $54 million, plus an additional $6 million in contingent cash consideration. In conjunction with the sale of the cardiothoracic closure business, the company recognized a gain of $34.1 million, or $18.2 million after tax.

Net income applicable to common shares was $2.5 million, or $0.04 per fully diluted common share for the full year 2017, compared to net loss applicable to common shares of $17.9 million, or $0.31 per fully diluted common share for the full year 2016. As outlined in the reconciliation tables that follow, excluding the after-tax impact of the non-recurring charges and the impact of the cardiothoracic closure sale gain, adjusted net income applicable to common shares was $3.1 million, or $0.05 per fully diluted common share in 2017.

Adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA) for the full year 2017 was $32.3 million, or 12% of revenues compared with $29.8 million, or 11% of revenues in 2016.

Fiscal 2018 Outlook

Based on its recent financial results and current business outlook, the Company is reiterating financial guidance for 2018, originally issued on January 5, 2018:

  • The Company expects full year revenues in the range of $280 million and $290 million.
  • The Company expects full year EBITDA to be in the range of $32 million to $38 million.

The Company noted the following assumptions are included in its guidance:

  • Relatively stable market conditions and regulatory environment;
  • Positive revenue contribution from the acquisition of Zyga Technology – announced January 4th, 2018;
  • Ongoing positive impact of efforts to reduce complexity and implement operational excellence; and
  • Continued marketing of map3® cellular allogeneic bone graft and minimal negative revenue impact related to recent FDA warning letter.

Farhat noted, “We believe 2018 will be a year of focused execution, which will include finalizing the remaining portfolio decisions to further reduce the complexity of our structure. We are also deploying lean manufacturing across additional manufacturing sites to continue the drive for operational excellence, while strengthening our R&D discipline and beginning to rebuild our innovation pipeline. In addition, we will opportunistically explore acquisition possibilities to further accelerate our growth trajectory.”

Conference Call

RTI will host a conference call and audio webcast at 9:00 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

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 and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. 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.

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
Three months ended Twelve months ended
December 31, December 31,
2017 2016 2017 2016
Revenues $ 70,816 $ 71,347 $ 279,563 $ 272,865
Costs of processing and distribution 34,548 43,246 137,042 140,516
Gross profit 36,268 28,101 142,521 132,349
Expenses:
Marketing, general and administrative 28,258 31,447 115,103 116,125
Research and development 3,146 4,056 13,375 16,090
Severance and restructuring costs 1,550 12,173 2,146
Strategic review costs 500 1,150
Executive transition costs 2,781 297 2,781 4,404
Contested proxy expenses 2,680
Asset impairment and abandonments 3,739 5,435 3,739 5,435
Acquisition expenses 630 630
Gain on cardiothoracic closure business divestiture (34,090 )
Total operating expenses 40,104 41,735 113,711 148,030
Operating (loss) income (3,836 ) (13,634 ) 28,810 (15,681 )
Total other expense – net (615 ) (667 ) (3,085 ) (1,779 )
(Loss) Income before income tax (provision) benefit (4,451 ) (14,301 ) 25,725 (17,460 )
Income tax (provision) benefit (3,202 ) 3,399 (19,453 ) 3,061
Net (loss) income (7,653 ) (10,902 ) 6,272 (14,399 )
Convertible preferred dividend (951 ) (897 ) (3,723 ) (3,508 )
Net (loss) income applicable to common shares $ (8,604 ) $ (11,799 ) $ 2,549 $ (17,907 )
Net (loss) income per common share – basic $ (0.14 ) $ (0.20 ) $ 0.04 $ (0.31 )
Net (loss) income per common share – diluted $ (0.14 ) $ (0.20 ) $ 0.04 $ (0.31 )
Weighted average shares outstanding – basic 61,601,040 58,426,241 59,684,289 58,236,745
Weighted average shares outstanding – diluted 62,495,577 58,426,241 60,599,952 58,236,745

 

READ THE REST HERE

 

Centrexion Therapeutics to Present CNTX-4975 Clinical Data at the American Academy of Orthopaedic Surgeons 2018 Annual Meeting

March 01, 2018

BOSTON, Mass.–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced it will present Phase 2b data of CNTX-4975 for the treatment of moderate to severe osteoarthritis knee pain at 4:00 p.m. CST on Tuesday, March 6 at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting taking place from March 6-10, 2018 at the Ernest N. Morial Convention Center in New Orleans, LA.

More information can be found at www.aaos.org. Details of the oral presentation are listed below.

Title: Intra-articular CNTX-4975 for Osteoarthritis Knee Pain: Analyses From a 24-Week Randomized Phase 2b Study
Paper Number: 868
Session Title: Adult Reconstruction Knee IX (868-882)
Presentation Time: Tuesday, March 6 at 4:00 p.m. CST
Location: Theater A, Ernest N. Morial Convention Center

About Osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, affecting approximately 14 million people in the United States.1 OA occurs when the protective cartilage on the ends of the bones wears down over time, and the bone around the joints harden and form edges. These changes cause pain, swelling and problems moving the joint. OA also causes an inflammatory process to occur in the affected joint, further damaging the cartilage. Although OA can damage the majority of joints in the body, it most commonly affects joints in the knees, hips, hands and spine. OA can cause pain severe enough that patients experience difficulty walking, climbing stairs or even rising from a chair. Despite currently available therapies, many patients opt for total joint replacement to manage the painful condition.

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI™ technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultra-pure, synthetic form of trans-capsaicin. CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe joint pain without affecting touch sensibility or position sense. CNTX-4975 works by targeting the capsaicin receptor (TRPV1) to selectively and rapidly inactivate the local pain fibers transmitting signals to the brain. With a short half-life, CNTX-4975 is cleared from the body within 24 hours. This approach is designed to provide pain relief that can last for months until the ends of the local pain fibers regenerate, while maintaining normal sensation, such as touch, pressure and position, and without the risks of toxicities of NSAIDs and injected corticosteroids, or the side effects, including abuse and addiction, associated with opioid treatments. In January 2018, CNTX-4975 was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of pain associated with knee osteoarthritis.

About Centrexion Therapeutics

Centrexion Therapeutics Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest, exclusively pain-focused pipelines of non-opioid, non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion people living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. For more information about Centrexion Therapeutics, visit http://www.centrexion.com.

1. Deshpande, B., et al. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care & Research. Published online November 3, 2016

Contacts

W2O pure
Media Contact
Julie Normart, +1 415-946-1087
jnormart@w2ogroup.com
or
Investor Contact
Courtney Dugan, +1 212-257-6723
cdugan@w2ogroup.com

Biomatlante Continues To Invest In Innovative Solutions For Active Healing Through Orthobiologics

After the success of the European program REBORNE (FP7) focused on safety and efficacy of the Biomatlante matrix combined with autologous bone marrow expanded mesenchymal stem cells (MSC), MBCP+™*, made from our well-known MBCP Technology, was confirmed as the adapted matrix for tissue engineering and chosen for 2 new European research programs (H2020): MAXIBONE and ORTHOUNION.

The current challenge is to compare the clinical performances of this Advanced Therapy Medicinal Product (MBCP+™/MSC) with autograft, considered as the gold-standard for bone reconstruction: MAXIBONE (150 patients) for bone augmentation in maxillofacial surgery before dental implant placement and ORTHOUNION (about 100 patients) focused on non-union after long bone fractures.

BIOMATLANTE will showcase its technology at the American Academy of Orthopaedic Surgeons (AAOS) Congress, held 6-10 March 2018 in New Orleans, USA.

About BIOMATLANTE, experts in bone regeneration 
Based near Nantes, France, Biomatlante specializes in synthetic biomaterials for bone regeneration and is a world leader in bone graft technologies, selling its products in over 50 countries. Biomatlante’s products are routinely used in orthopedics and trauma surgery, in spine and dental surgery. BIOMATLANTE strives to integrate a strategy of strong innovation and product development required to meet and exceed the needs of today’s market. Our R&D collaborates closely with universities and research centers across the world, bringing together competences in innovation, technological transfers of new biomaterials, surgical technologies and providing the intellectual protection required to foster long-term projects.

About MBCP™ Technology*, worldwide reference in synthetic bone graft 
The unique manufacturing process developed by BIOMATLANTE confers its core MBCP biphasic HA/ ß-TCP technology unique properties for hard tissue regeneration. Its micro-macroporous structure mimics that of human bone and provides an ideal osteogenic matrix for bone regeneration in general and tissue engineering in particular.

About REBORNE, Regenerating Bone Defects using New biomedical Engineering approaches 
The objective of REBORNE is to develop new biomaterials that stimulate bone tissue formation with a view to correcting bone regeneration defects in orthopedic and maxillofacial surgery. Biomaterials, combined with the use of stem cells, are interesting alternatives to biological grafts.

About MAXIBONE, Personalized maxillofacial bone regeneration 
This European project aims at performing a multicenter clinical trial on 150 patients for bone augmentation in maxillofacial surgery prior to dental implants with autologous bone marrow expanded mesenchymal stem cells and biomaterials versus autologous bone grafting. Personalized 3D printed calcium phosphate biomaterials are also developed and in the R&D workpackage, a new optimized smart scaffold for cells and drugs combination will also be tested and developed.

About ORTHOUNION MBCP+™
The “ORTHOpaedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs” (ORTHOUNION) is a 5 years project funded with 6M EUR by the EU H2020 programme, in the topic SCI-PM-11-2016-17: Clinical research on regenerative medicine.

For further information about BIOMATLANTE and its technologies, please visit http://www.biomatlante.com

  • This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use

SeaSpine Announces Fourth Quarter and Full-Year 2017 Results and Issues 2018 Financial Guidance

CARLSBAD, Calif., Feb. 28, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the three-months and full-year ended December 31, 2017 and provided guidance for 2018.

Summary Fourth Quarter 2017 Financial Results and Recent Accomplishments

  • Revenue of $34.0 million, an increase of 4.5% year-over-year
  • U.S. revenue of $31.2 million, an increase of 4.8% year-over-year
    º  U.S. Orthobiologics revenue of $16.6 million, an increase of 10.1% year-over-year
    º  U.S. Spinal Implants revenue of $14.6 million, essentially unchanged year-over-year
  • International revenue of $2.8 million, an increase of approximately 1% year-over-year
  • Limited commercial launch of OsteoStrand™ and OsteoStrand Plus Demineralized Bone Fibers and OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
  • Launch of an expanded Ventura™ NanoMetalene® posterior interbody device portfolio with sagittally oriented lordosis options to accommodate a larger range of posterior procedures and a wider variety of patient anatomies

“Our 2017 results are marked by several accomplishments underpinned by our commitment to delivering improved procedural spine solutions and clinical value through our expanding and innovative product portfolio,” said Keith Valentine, President and Chief Executive Officer. “As we enter 2018, we are well positioned to continue upgrading our global distribution footprint while we execute on our strategy and deliver accelerated revenue growth and expanded gross margins.”

Fourth Quarter 2017 Financial Results
Revenue for the fourth quarter of 2017 totaled $34.0 million, an increase of 4.5% compared to the same period of the prior year. U.S. revenue was $31.2 million, a 4.8% increase compared to the same period of the prior year due to strong volume growth in the U.S. Orthobiologics franchise that was driven by new distribution.

Orthobiologics revenue totaled $18.1 million, an 8.8% increase compared to the fourth quarter of 2016. The increase in orthobiologics revenue was primarily driven by growth in U.S. sales across multiple product lines generated by recently added distributors.

Spinal implants revenue totaled $15.9 million, essentially unchanged compared to the same period of the prior year. Spinal implant sales in the U.S. also was essentially flat compared to the prior year, as continued low single-digit price declines and decreased usage of the Company’s legacy systems were mostly offset by revenue growth from recently launched products.

Gross margin for the fourth quarter of 2017 was 63.3%, compared to 58.6% for the same period in 2016. The increase in gross margin was mainly driven by lower raw material and manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility and lower provisions for excess and obsolete inventory in the fourth quarter of 2017.

Operating expenses for the fourth quarter of 2017 totaled $29.2 million, compared to $28.6 million for the same period of the prior year. The $0.6 million increase was driven primarily by higher commission expense and marketing costs, partially offset by a $1.5 million non-cash gain recorded in the fourth quarter of 2017 related to the release of a foreign capital tax liability based on the passage of the statute of limitations and lower consulting expenses.

Net loss for the fourth quarter of 2017 was $7.5 million, compared to a net loss of $9.8 million for the fourth quarter of 2016.

Cash and cash equivalents at December 31, 2017 totaled $10.8 million, and the Company had no amounts outstanding under its $30.0 million credit facility.

2017 Financial Results
Revenue for the year ended December 31, 2017 totaled $131.8 million, an increase of 2.3% compared to the prior year. U.S. revenue was $118.4 million, a 1.4% increase compared to the prior year. Orthobiologics revenue totaled $69.1 million, a 4.4% increase compared to the prior year. Spinal implant revenue totaled $62.7 million, essentially unchanged compared to the prior year.

Gross margin for 2017 was 60.7%, compared to 56.9% for 2016. The increase in gross margin was mainly driven by lower raw material and manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility, and by lower provisions for excess and obsolete inventory in 2017.

Operating expenses for 2017 totaled $112.7 million, compared to $116.8 million for 2016.  The $4.1 million decrease was driven primarily by lower intangible asset amortization expense, the absence of a $0.9 million instrument impairment charge recorded in 2016, and a decrease in general and administrative expenses, all of which were partially offset by higher selling commissions and increased investment in marketing and product development in 2017.  The decrease in general and administrative expenses was driven primarily by lower consulting and legal expenses, the $1.5 million non-cash gain related to the release of a foreign capital tax liability, a $0.9 million non-cash gain recorded in 2017 related to a decrease in the fair value of contingent consideration liabilities related to the NLT acquisition, and lower facility and related operating costs resulting from the shutdown of the Company’s Vista, California facility in late 2016.

Net loss for 2017 was $32.1 million, compared to a net loss of $43.2 million for 2016.

2018 Financial Outlook
SeaSpine continues to expect full-year 2018 revenue to be in the range of $135 million to $139 million, reflecting growth of 2.5% to 5.5% over full-year 2017 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 7067009.  To listen to a live webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

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 include, but are not limited to, statements relating to: the Company delivering improved procedural spine solutions and clinical value through an expanded and innovative product portfolio; the Company’s position to continue to upgrade its global distribution footprint; and the Company’s expectations for full-year 2018 revenue, as well as to deliver accelerated revenue growth and expanded gross margins.  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: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; 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 Lewis
(415) 937-5402
ir@seaspine.com

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Quarter Ended December 31, Year Ended December 31,
2017 2016 2017 2016
Total revenue, net $ 33,982 $ 32,519 $ 131,814 $ 128,860
Cost of goods sold 12,484 13,450 51,826 55,544
Gross profit 21,498 19,069 79,988 73,316
Operating expenses:
Selling, general and administrative 25,410 24,899 97,303 101,065
Research and development 2,952 2,908 12,180 11,442
Intangible amortization 792 792 3,168 4,309
Total operating expenses 29,154 28,599 112,651 116,816
Operating loss (7,656 ) (9,530 ) (32,663 ) (43,500 )
Other (income) expense net (43 ) 231 (430 ) 264
Loss before income taxes (7,613 ) (9,761 ) (32,233 ) (43,764 )
Provision (benefit) for income taxes (106 ) 7 (118 ) (552 )
Net loss $ (7,507 ) $ (9,768 ) $ (32,115 ) $ (43,212 )
Net Loss per share, basic and diluted $ (0.56 ) $ (0.87 ) $ (2.58 ) $ (3.85 )
Weighted average shares used to compute basic and diluted net loss per share 13,413 11,271 12,426 11,222
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
 (In thousands)
December 31,
2017
December 31,
2016
Cash and cash equivalents $ 10,788 $ 14,566
Trade accounts receivable, net 21,872 20,982
Inventories 41,721 45,299
Total current liabilities 23,157 24,418
Short-term debt 445
Long-term borrowings under credit facility 3,835
Total stockholders’ equity 105,653 110,977

K2M Group Holdings, Inc. Reports Fourth Quarter and Full Year 2017 Financial Results

LEESBURG, Va., Feb. 28, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today reported financial results for its fourth quarter and fiscal year ended December 31, 2017.

Fiscal Year 2017 Financial Summary:

  • Total fiscal year 2017 revenue of $258.0 million, up 9% year-over-year on both a reported basis and on a constant currency basis.
  • Domestic fiscal year 2017 revenue of $197.3 million, up 9% year-over-year, comprised of:
    • U.S. Complex Spine growth of 8% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 16% year-over-year
    • U.S. Degenerative growth of 8% year-over-year
  • International fiscal year 2017 revenue of $60.7 million, up 9% year-over-year, or 10% on a constant currency basis.
  • Net loss of $37.1 million for fiscal year 2017, compared to a net loss of $41.7 million in prior year.
  • Adjusted EBITDA loss of $0.7 million for fiscal year 2017, compared to Adjusted EBITDA of $1.4 million in the prior year.

Fourth Quarter 2017 Financial Summary:

  • Total fourth quarter revenue of $67.8 million, up 10% year-over-year on a reported basis and 9% on a constant currency basis.
  • Domestic fourth quarter revenue of $51.9 million, up 9% year-over-year, comprised of:
    • U.S. Complex Spine growth of 12% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 11% year-over-year
    • U.S. Degenerative growth of 6% year-over-year
  • International fourth quarter revenue of $15.9 million, up 13% year-over-year, and 10% on a constant currency basis.
  • Net loss of $8.7 million for the fourth quarter, compared to a net loss of $12.5 million in the comparable quarter last year.
  • Adjusted EBITDA loss of $1.9 million for the fourth quarter, compared to Adjusted EBITDA loss of $28,000 in the comparable quarter last year.

Fourth Quarter Product Introductions and Strategic Highlights:

  • On October 4, 2017, the Company announced that President and Chief Executive Officer Eric Major had been elected Chairman of the Company’s Board of Directors, effective immediately. Major succeeded Dan Pelak, who assumed the role of Independent Lead Director after serving as Chairman since 2010.
  • On October 23, 2017, the Company announced that it has acquired from Cardinal Spine, a privately held medical device company, the PALO ALTO® Cervical Static Corpectomy Cage System. PALO ALTO, a cervical vertebral body replacement device, is the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance from the FDA. In addition to PALO ALTO, K2M has also acquired the associated intellectual property and product inventory.
  • On October 25, 2017, the Company announced a global compatibility and co-marketing agreement with Brainlab. The two companies will collaborate in the commercial release of future navigated K2M spinal systems, which would be compatible with Brainlab spinal navigation systems.
  • On November 30, 2017, the Company announced the completion of 300 surgical cases using the RHINE™ Cervical Disc System*. The RHINE Cervical Disc System* is an artificial disc replacement that features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel.
  • On December 20, 2017, the Company announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™ and the successful completion of its first surgical case.  * These products are intended for export and not sold or offered for sale in the United States.

“Our financial results for calendar year 2017 reflect total revenue growth of approximately 9% year-over-year, above the high-end of our guidance range,” said Chairman, President, and Chief Executive Officer, Eric Major. “We delivered approximately 9% growth in the United States in 2017—well above-market growth rates—driven by solid execution against our strategic goal of increasing market share by introducing new and innovative spinal implant solutions and expanding our distribution footprint. We have supplemented this organic growth activity with exciting product introductions in both the complex spine and degenerative categories.  Looking out to 2018, we are excited about the opportunity of our first-of-its-kind MOJAVE™ PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology and our YUKON™ OCT Spinal System that can be used with the PALO ALTO Cervical Static Corpectomy Cage System, the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance. We also announced an important strategic collaboration with Brainlab, one of the world’s leading imaging and navigation companies, that we believe will represent additional implant sales opportunities in the second half of 2018.  Our Brainlab collaboration will complement our recent launches of the BACS® platform and the EVEREST®Minimally Invasive XT Spinal System.”

Mr. Major continued, “We remain confident in our ability to drive above-market growth in the U.S., fueled by our continued focus on leading the spine market by introducing new and innovative spinal implant solutions to help surgeons care for patients around the world who suffer from debilitating spinal pathologies. We have introduced our 2018 guidance expectations for revenue growth of 9% to 10% with improved profitability.”

Fourth Quarter 2017 Financial Results

Three Months Ended December 31,   Increase / Decrease
($,thousands) 2017 2016   $ Change % Change % Change
(as reported)  (constant currency)
United States $ 51,856 $ 47,669 $ 4,187 8.8 % 8.8 %
International $ 15,945 $ 14,122 $ 1,823 12.9 % 9.8 %
Total Revenue: $ 67,801 $ 61,791   $ 6,010 9.7 % 9.0 %

Total revenue for the fourth quarter of 2017 increased $6.0 million, or 9.7%, to $67.8 million, compared to $61.8 million for the fourth quarter of 2016. Total revenue increased 9% year-over-year on a constant currency basis. The increase in revenue was primarily driven by higher sales volume from domestic new surgeon users and newer product offerings, and increased set investments by our distribution partners in Australia and Denmark.

Revenue in the United States increased $4.2 million, or 8.8% year-over-year, to $51.9 million, and international revenue increased $1.8 million, or 12.9% year-over-year, to $15.9 million. Fourth quarter 2017 international revenue increased 10% year-over-year on a constant currency basis. Foreign currency exchange positively impacted fourth quarter international revenue by $0.4 million, representing approximately 73 basis points of 2017 international growth year-over-year.

The following table represents domestic revenue by procedure category.

Three Months Ended December 31,   Increase / Decrease
($,thousands) 2017 2016   $ Change % Change
Complex Spine $ 20,004 $ 17,934 $ 2,070 11.5 %
Minimally Invasive 8,906 8,058 848 10.5 %
Degenerative 22,946 21,677 1,269 5.9 %
U.S Revenue: $ 51,856 $ 47,669   $ 4,187 8.8 %

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 38.6%, 17.2% and 44.2% of U.S. revenue, respectively, for the three months ended December 31, 2017.

Gross profit for the fourth quarter of 2017 increased 13.6% to $43.6 million, compared to $38.4 million for the fourth quarter of 2016.  Gross margin was 64.3% for the fourth quarter of 2017, compared to 62.1% for the prior year period. Gross profit includes amortization expense on investments in surgical instruments of $3.6 million, or 5.3% of sales, for the three months ended December 31, 2017, compared to $3.6 million, or 5.8% of sales, for the comparable period last year.

Operating expenses for the fourth quarter of 2017 increased $4.7 million, or 9.9%, to $52.5 million, compared to $47.7 million for the fourth quarter of 2016. The increase in operating expenses was driven primarily by a $4.9 million increase in sales and marketing expenses, compared to the comparable period last year.  The Company increased the number of domestic sales agencies who represent our products in the United States by nine agencies to a total of 109 independent sales agencies, an increase of 9% sequentially.  In addition, the Company’s U.S. and non-U.S. direct sales employees remained flat at 158 employees, despite active management of this group.

Loss from operations for the fourth quarter of 2017 decreased $0.5 million to $8.9 million compared to a loss from operations of $9.4 million for the comparable period last year. Loss from operations included intangible amortization of $0.2 million for the three months ended December 31, 2017, compared to $2.6 million for the comparable period last year.  The Company recorded approximately $1.4 million in non-recurring accruals primarily reflecting legal and administrative expenses updated in 2018 and inventory adjustments.

Total other expenses for the fourth quarter of 2017 decreased $1.6 million to $1.5 million, compared to $3.1 million last year. The decrease in other expense, net, was primarily attributable to a unrealized gain of $0.3 million from foreign currency remeasurement on intercompany payable balances, compared to unrealized loss of $1.3 million in the comparable period last year.

Net loss for the fourth quarter of 2017 was $8.7 million, or $0.20 per diluted share, compared to a loss of $12.5 million, or $0.30 per diluted share, for the fourth quarter of 2016.

Fiscal Year 2017 Financial Results

Year Ended December 31,   Increase / Decrease
($ in,thousands) 2017 2016   $ Change % Change % Change
(as reported)  (constant currency)
United States $ 197,312 $ 181,078 $ 16,234 9.0 % 9.0 %
International $ 60,719 $ 55,556 $ 5,163 9.3 % 9.7 %
Total Revenue: $ 258,031 $ 236,634   $ 21,397 9.0 % 9.1 %

For the fiscal year 2017, total revenue increased $21.4 million, or 9.0%, to $258.0 million, compared to $236.6 million for the fiscal year 2016. Total revenue increased 9.1% year-over-year on a constant currency basis. U.S. revenue increased $16.2 million, or 9.0%, to $197.3 million, compared to $181.1 million last year. International revenue increased $5.2 million, or 9.3%, to $60.7 million, compared to $55.6 million last year. International revenue increased 9.7% year-over-year on a constant currency basis.

The following table represents domestic revenue by procedure category:

Year Ended December 31,   Increase / Decrease
($,thousands) 2017 2016   $ Change % Change
Complex Spine $ 77,529 $ 71,915 $ 5,614 7.8 %
Minimally Invasive 33,257 28,711 $ 4,546 15.8 %
Degenerative 86,526 80,452 $ 6,074 7.5 %
U.S Revenue: $ 197,312 $ 181,078   $ 16,234 9.0 %

Sales in our complex spine, MIS and degenerative categories represented 39.3%, 16.9% and 43.9% of U.S. revenue, respectively, for the fiscal year 2017.

As of December 31, 2017, we had cash and cash equivalents of $24.0 million as compared to $45.5 million as of December 31, 2016. We had working capital of $99.6 million as of December 31, 2017 as compared to $115.9 million as of December 31, 2016.

At December 31, 2017, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $39.2 million and the capital lease obligation of $33.8 million. The Company had unused capacity on its revolving credit facility of $49.0 million and no borrowings outstanding as of December 31, 2017.

2018 Outlook

The Company is providing fiscal year 2018 revenue guidance expectations of:

  • Total revenue on an as reported basis in the range of $280.0 million to $284.0 million, representing growth of 9% to 10% year-over-year, compared to total revenue of $258.0 million in fiscal year 2017.
    • The Company expects growth in its U.S. business of approximately 10% to 11% year-over-year in 2018.
    • The Company expects growth in its International business of approximately 5% to 7% year-over-year in 2018.
    • Assuming current currency rates remain similar for the rest of the year, the Company expects currency to have a positive impact on total revenue in 2018 of approximately $2 million.

The Company is providing fiscal year 2018 guidance expectations for net loss and Adjusted EBITDA. The Company expects:

  • Total net loss of $34.0 million to $30.0 million, compared to net loss of $37.1 million in fiscal year 2017.
  • Adjusted EBITDA benefit in the range of $4.0 million to $8.0 million, compared to Adjusted EBITDA loss of $740,000 in fiscal year 2017.

Conference Call

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

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

 

 

READ THE REST HERE

 

Heraeus Medical to Introduce Medium Viscosity Bone Cement and Vacuum Mixing System Innovations at AAOS 2018 Annual Meeting

YARDLEY, Pa.Feb. 28, 2018 /PRNewswire/ — Heraeus Medical, a global leader in joint fixation and infection management announced today the introduction of innovations to its current PALACOS® product portfolio.  The exciting new products include the medium viscosity bone cement PALACOS MV variations, along with two mixing systems, PALAMIX® and PALABOWL®.

The innovative PALAMIX® and PALABOWL®, while created for use with PALACOS® bone cement, can be effectively used with other types of bone cements. These new products, along with the complete PALACOS® portfolio, will be displayed during the American Academy of Orthopedic Surgeons’ Annual Meeting, March 6-10, 2018 in New Orleans.  AAOS attendees wanting to learn more about the medium viscosity bone cement, versatile mixing options or view other ground-breaking products are encouraged to visit Heraeus Medical at booth 1713 and participate in demonstrations and discussions.

“The collaborative environment of AAOS provides an excellent opportunity to share our newest technologies with total joint arthroplasty surgeons and gain direct feedback,” said Devin Childers, Vice President and General Manager of Heraeus Medical LLC. “Heraeus is excited to share our rapidly growing portfolio with attendees.”

In January, the company announced it would provide PALACOS® customers with earlier access to its latest technologies by selling to them directly. PALACOS®, formerly sold exclusively through a distributor in the US, is now available directly through its pioneer and manufacturer, Heraeus Medical.

New and existing PALACOS® customers in the US are able to order products directly from Heraeus Medical by calling 1-833-PALACOS (725-2267). Heraeus Medical has successfully sold and supported PALACOS® customers directly in EuropeAustralia, and several other countries through an integrated ordering process that is now also available to US customers.

For more information or to order PALACOS® in the US, please visit www.heraeus-medical-usa.com or call 1-833-PALACOS (725-2267).

For more information during AAOS, please visit Heraeus Medical at booth 1713.

About the Heraeus Medical Global Business Unit
Heraeus Medical is known as a global leader in joint fixation and infection management in orthopedics and trauma surgery. This enables the company to make an important contribution to supporting surgeons and the surgical team and to improve surgery outcomes. In the area of biomaterials, Heraeus Medical focuses on products for use in bone and joint surgery. The core product PALACOS® is considered the gold standard among bone cements and has repeatedly proven itself over five decades of clinical use.

About Heraeus
Heraeus, the technology group headquartered in Hanau, Germany, is a leading international family-owned company formed in 1851. With expertise, a focus on innovations, operational excellence and an entrepreneurial leadership, we strive to continuously improve the businesses of our customers around the world.

We create high-quality solutions for our customers and strengthen their long-term competitiveness by combining material expertise with technological know-how. Our ideas are focused on important issues such as the environment, energy, health, mobility, and industrial applications. Our portfolio ranges from components to coordinated material systems which are used in a wide variety of industries, including the steel, electronics, chemical, automotive, and telecommunications industries.

In the 2016 financial year, the FORTUNE Global 500 listed company-generated revenues without precious metals of US$2.2 bn and a total revenue of US$23.8 bn. With approximately 12,400 employees worldwide in more than 100 subsidiaries in 40 countries, Heraeus holds a leading position in its global markets. In 2016, the Foundation for Family Businesses named Heraeus as one of the “Top 10 Family Businesses” in Germany.

 

SOURCE Heraeus Medical

Related Links

http://www.heraeus-medical-usa.com

Successful First in Human for OrthoSpin’s Robotic External Orthopedic Fixation System

MISGAV, IsraelFeb. 28, 2018 /PRNewswire/ — OrthoSpin Ltd. (“OrthoSpin”), a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T; OTCQX: TRNLY), announced that it successfully completed a first-in-human (FIH) case for its smart, robotic external fixation system for the treatment of an orthopedic deformity. The patient was a 15-year-old suffering from deformity of the tibia. The deformity caused shortening of the leg and a limp, limited his daily activity, had the potential to disrupt his growth, and had aesthetic consequences. Pediatric orthopedic surgeon Dr. Eitan Segev, of Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital, performed surgery to correct the deformity, which was followed by external fixation with the Taylor Spatial frame using OrthoSpin’s smart automatic control system.

Instead of conventional manual adjustment of the external fixator, the OrthoSpin system makes pre-programmed adjustments automatically and continuously — without the need for patient involvement. Integrated software enables physicians to chart patient progress and, if required, quickly adjust the treatment regimen. Physicians receive real-time feedback on computers or mobile devices to ensure that the prescribed course of treatment is followed. Using the system also eliminates the need for weekly x-rays to check status. The precise adjustments of OrthoSpin’s system resulted in a less painful process due to smaller, more incremental changes – in this case, an eighth of a millimeter in movement – which are expected to reduce soft tissue damage.

OrthoSpin CEO Oren Cohen remarked, “We are extremely pleased with the results of our FIH case. OrthoSpin’s innovative system has the potential to change the outcomes of these types of orthopedic treatments. Following the first patient, we will conduct additional trials and submit for regulatory clearance during 2018 in order to bring our product to market. OrthoSpin’s future plans are to enable the physician to collect many other treatment parameters due to the capabilities of the smart system.”

Dr. Segev, commented, “The OrthoSpin system allows for objective measurement, ease of use, and provides more piece of mind for the patient and family. We look forward to its routine integration in orthopedic treatment.”

Chairman and CEO of Trendlines, Todd Dollinger added, “We are very proud of this important achievement for OrthoSpin. The company has the ability to bring an automatic external fixation device to market that will significantly improve treatment and quality of life for the benefit of both patients and physicians.”

Meet OrthoSpin CEO Oren Cohen and see a working prototype of the OrthoSpin smart external fixation system at the AAOS Annual Meeting in New Orleans, Louisiana6-10 March 2018.

For more information:
Oren Cohen, CEO OrthoSpin
oren@orthospin.com
Phone: +972-54-334-2651
http://orthospin.com/

Photo credit: Studio Imaginet

 

Laser Spine Institute Announces Thomas Linton as Chief Patient Empowerment Officer

February 28, 2018 (TAMPA, Fla.) – Laser Spine Institute, the leader in minimally invasive spine surgery, today announced the appointment of Thomas Linton as its first-ever Chief Patient Empowerment Officer. Linton previously served as Vice President of Customer Experience at Assurant, a Fortune 500 insurance company.

“We look forward to leveraging Thomas’ expertise to further facilitate the delivery of exemplary experiences for our patients during every step of their care journey,” said Roger Cary, President and Chief Executive Officer, Laser Spine Institute. “Creating this position and adding someone with Thomas’ track record is a testament to our commitment to patient-centered care.”

As Chief Patient Empowerment Officer, Linton will have oversight of the organization’s patient-facing teammates who serve as the first touch in the patient experience, those who are the patient’s main contact throughout their journey and liaisons with physicians in local markets. Linton will also help identify patients’ interactions, which are critical moments of truth, to improve their overall experience.

Linton has more than 20 years of experience in marketing, sales and customer experience, with a focus on delivering customer-centered solutions. Prior to joining Laser Spine Institute, Linton also held leadership positions at AT&T, Bank of America and General Electric. Linton’s years of experience have made him known for his effectiveness in driving growth, improving efficiencies and finding customer solutions.

“I’m thrilled to be joining a purpose-driven organization and to play a part in continuing Laser Spine Institute’s mission to provide exceptional patient experiences and care,” Linton said. “We are known as the leader in minimally invasive spine surgery for a reason, and the impact our teammates and innovative medicine plays on our patients’ lives was instrumental in my decision to join the organization.”

Linton received his Master of Business Administration in marketing and strategic planning from the Wharton School at University of Pennsylvania. He also holds a Bachelor of Science in electrical engineering and a Master of Engineering from the University of Louisville. He serves on the Board of Directors for the George M. Hughes Foundation, which provides college scholarships to deserving high school seniors.

For more information, visit http://news.laserspineinstitute.com/.

Media Contact: Maura Devetski, Edelman
Phone: 404-832-6788
Email: maura.devetski@edelman.com

About Laser Spine Institute
Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven regional surgery centers across the country, in Tampa, Florida; Scottsdale, Arizona; Philadelphia; Oklahoma City; Cleveland, St. Louis and Cincinnati. Laser Spine Institute has helped more than 75,000 patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Patients often refer a friend or family member to have surgery at Laser Spine Institute; we have a patient recommendation score of 97 out of 100. Additionally, Laser Spine Institute has been repeatedly recognized for outstanding patient satisfaction and reports an enterprise patient satisfaction score of more than 96.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, Philly.com and okc.BIZ and a Most Admired Company by BestCompaniesAZ. Opening in Tampa in 2005 with one operating room and nine employees, Laser Spine Institute now has nearly 1,000 corporate and health care professionals across the country.