Zimmer Biomet Announces First Quarter 2018 Financial Results

WARSAW, Ind.April 26, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended March 31, 2018.  The Company reported first quarter net sales of $2.018 billion, an increase of 2.3% over the prior year period, and a decrease of 1.5% on a constant currency basis.  Diluted earnings per share for the first quarter were $0.85, a decrease of 42.2% from the prior year period.  First quarter adjusted diluted earnings per share were $1.91, a decrease of 10.3% from the prior year period.

“As expected, in the first quarter our performance continued to reflect supply headwinds associated with key brands within our Knee, Hip and S.E.T. portfolios, as well as the ongoing quality remediation work at our Warsaw North Campus facility,” said Bryan Hanson, President and CEO of Zimmer Biomet.  “As we look out over the course of the next 18 to 24 months, we will stay laser-focused on taking the necessary actions to narrow our gap to market and drive sustained shareholder value.  These actions include successfully driving our ongoing quality remediation program, restoring supply, and scaling up the commercial launch of compelling new technologies, all of which remain on track.”

Net earnings for the first quarter were $174.7 million, and $390.9 million on an adjusted basis.  Operating cash flow for the first quarter was $490.5 million.  Free cash flow in the quarter was $403.4 million.

In the quarter, the Company paid $48.6 million in dividends and declared a first quarter dividend of $0.24 per share.


The Company provided the following full-year 2018 financial guidance:

Projected Year Ending December 31, 2018

2018 Sales Growth vs Prior Year(1)

1.5% – 3.5%

Adjusted Operating Profit Margin(2)

27.5% – 28.5%

Adjusted Tax Rate(2)

18.5% – 19.5%

Adjusted Diluted EPS(2)

$7.60 – $7.80

Free Cash Flow(3)

$1.1 billion – $1.3 billion


2018 sales growth vs prior year is provided on an as reported basis and includes 200 to 300 basis points of positive foreign exchange impact


These measures are non-GAAP financial measures for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts.  See “Forward-Looking Non-GAAP Financial Measures.”


Projected Year Ending December 31, 2018

(in millions)



Net Cash Provided by Operating Activities



Additions to Instruments and Other Property, Plant and Equipment



Free Cash Flow



Conference Call

The Company will conduct its first quarter 2018 investor conference call today, April 26, 2018, at 8:30 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 April 27, 2018 to May 26, 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 Table

The following first quarter sales table provides results by geography and product category, as well as the percentage change compared to the prior year quarter on a reported basis and a constant currency basis.


(in millions, unaudited)





% Change

% Change

Geographic Results












Asia Pacific











Product Categories













Asia Pacific

















Asia Pacific








S.E.T *








Spine & CMF















* 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.




New PROTI 360° Family of Implants from DePuy Synthes Is Designed to Enhance Spinal Fusion Surgery Outcomes

RAYNHAM, Mass.April 26, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of the PROTI 360° Integrated Titanium Family of interbody devices to advance care for patients who have degenerative disc disease in the neck and back.  This new offering underscores the commitment of DePuy Synthes to expand the company’s portfolio of interbody fusion devices designed to help improve outcomes after spinal fusion surgery.

Episurf Medical enters into distribution agreement in Hong Kong and establishes subsidiary in the US

APR 26, 2018

Episurf Medical (NASDAQ: EPIS B) today announces that the company has entered into a distribution agreement in Hong Kong with Pacific Medical Systems. This is a first step in the company’s strategy of opening new markets in Asia. Pål Ryfors, CEO Episurf Medical, says that “we have received very encouraging feedback from leading surgeons in Hong Kong, confirming that Episealer® will help them to treat patients in the so-called treatment gap. We are happy to have appointed Pacific Medical Systems as our distributor, and Hong Kong will, as our first market in Asia where our technology is ready to be marketed, also be an important reference during our further expansion in the region.”

The company also communicates that it has established a subsidiary in the US, Episurf Medical Inc. This subsidiary is established for the purpose of conducting clinical studies for regulatory purposes in the US, as previously communicated.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

OrthAlign, Inc. Announces First Cases Completed in Australia for Direct Anterior Hip Replacements Using HipAlign® Technology

Adelaide, Australia, April 25, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the first set of HipAlign® cases successfully completed for direct anterior total hip arthroplasty (THA) in Australia. These cases were completed by Adelaide-based orthopaedic surgeon Dr. Andrew Comley and continue to reflect the rapid adoption of OrthAlign’s handheld precision alignment and positioning technologies, by surgeons throughout the world.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits in recovery for the patient.

“The accuracy and simplicity of HipAlign was outstanding,” said Dr. Comley, who operates out of Wakefield Hospital in Adelaide. “The technology is very easy to use with no interruption to my regular workflow and my post-ops showed that the cups were placed where I wanted them. I have increasingly been using the Direct Anterior approach for my THA patients and I have definitely seen the benefits for them… I will continue using the technology, as I believe it is the right thing for my patients, giving me more confidence and precision toward their results. Additionally, I teach and mentor younger surgeons who wish to master the Direct Anterior technique and I believe HipAlign can provide a valuable teaching tool and reassurance for those surgeons on the learning curve.”

Direct Anterior HipAlign does not require any pre-operative imaging or intraoperative fluoroscopy, while providing more clinically relevant positioning for cup placement and leg length measurement. Early clinical data from the United States demonstrates that surgeons can expect to reduce fluoroscopy exposure time by about 45%. Early clinical data from Japan shows cup placement (for both inclination and anteversion) accuracy of ±10°, with at least 95.9% confidence.

“OrthAlign is delighted to have successfully completed its first HipAlign cases in Australia,” said Andy Turner, OrthAlign’s Country Director for Australia/New Zealand. “The Australian market is thirsting for a cost-effective solution that helps surgeons achieve quicker, more precise results for their THA patients, without having to alter their existing surgical workflows. We are thrilled to be starting our launch of HipAlign for Direct Anterior THAs here in Australia and that it will not only help surgeons gain more confidence in their surgeries, but also lead to better outcomes for patients.”

About OrthAlign, Inc.
OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com.

James Young Kim
OrthAlign, Inc.

SPINEWAY : 2017 annual results and first quarter 2018 activity

2017 annual results

  • Strong revenue growth
  • Improved results

Mixed activity for the 1st quarter of 2018: €1.8M

  In thousands of euros
  Consolidated accounts
2017* 2016
Revenue 9 138 4 643
Gross margin
% Revenue
6 151
3 074
Gross operating surplus 150 – 1 227
Operating income – 845 – 2 257
Current income before taxes – 1 013 – 2 432
Net income – 965 – 2 690

* Audited accounts

Spineway’s Board of Directors, chaired by Stéphane Le Roux, met on 24 April 2018 and closed the 2017 annual accounts. The Group’s Statutory Auditors performed their auditing duties on these accounts and their reports are being prepared.

Improved results

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), confirms the strong growth of its consolidated revenue for the 2017 financial year, at €9.1M (+97%). This increase in activity logically resulted in the all-around improvement of the Group’s results.
Spineway’s consolidated accounts, which include those of the US subsidiary, showed a gross margin of 67.3% compared with 66.2% the previous year. Thanks to dynamic sales, the gross operating surplus was once more in the black at €150k, compared with a loss of -€1 227k at the end of 2016.

Operating income was of – €845k, showing an improvement of €1.4M compared with 31 December 2016. As announced, during the second half of the year the Group required heavier costs in order to strengthen teams in both France and the United States to accompany this strong growth. The operating income takes into account the increases in purchases and changes in inventory (+€1 419k), other purchases and external expenses (+€501k) and personnel expenses (+€1 190k).

The net income reaped the benefits of a positive extraordinary income of €47k (-€258k in 2016) and amounted to -€965k compared with a loss of €2 690k the previous year.

The WCR expressed as days of revenue also improved greatly, at 143 days compared with 221 days as at the end of 2016. This improvement is due, in particular, to a decrease in inventory and trade receivables while revenue increased sharply.

The Group’s financial structure was strengthened during the second half of 2017 thanks to the reserved issue of ORNANE (tranche warrants for notes) with warrants representing €1M and the exercise of €1.6M in warrants by the Chinese company Tinavi Medical Technologies.

These events brought the shareholders’ equity to €1 773k at the end of December 2017 compared with €1 300k at the end of December 2016. Available cash at the end of December amounted to €2.4M, allowing for a gearing (net debt/equity) of 174% compared with 207% the previous year.

A mixed start to 2018

As per its strategy, the Group will be reinforcing its R&D investments in order to offer surgeons implants and instruments that meet their needs. For the first quarter of 2018, the Group posted revenue of €1.8M, down 41% from Q1 2017, with, in particular, an unfavorable comparison base in the US (a $2M order initially scheduled for 2016 was delayed until Q1 2017).

Without this basis, the Group showed a 17% increase in its consolidated activity.

The US activity represented €105k for the period, with poor visibility following the replacement of its main US distributor’s CEO.

In the rest of the world (outside the US), Spineway continued its commercial growth, particularly in Latin America where, at the end of March, it posted €914k in activity, up 14%. This growth is driven by the success of the Mont-Blanc product lines. The Middle-East sector remains on the right track, with revenue of €234k, up 80%, and Europe generated €303k compared with €340k in Q1 2017, with the drop due mainly to Spain, where Spineway recently closed its subsidiary.

Asia continues its climb with a 63% growth in activity, representing revenue of €277k. While awaiting approval Spineway’s products in China, which is expected by the end of 2018, the Group is working on developing implants and instruments for the surgical robot developed by its Chinese partner, Tinavi.

Current sales in the United States, which could affect the 2018 roadmap and goals, are pushing Spineway to study possible changes to its strategic plan in order to accelerate profitable development.

Find out all about Spineway at www.spineway.com

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) -INPI Talent award (2015). 
ISIN code: FR0011398874 – ALSPW              


Investor relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
  Financial communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68


Fidia Announces Presentation of New Data Evaluating HYMOVIS® Effects on Cartilage Volume and Type II Collagen Turnover at Osteoarthritis Research Society Int’l (OARSI) World Congress Meeting

April 25, 2018

ABANO TERME, Italy–(BUSINESS WIRE)–Fidia Farmaceutici, a world leader in the research, development and manufacturing of hyaluronic acid (HA)-based products and its wholly owned subsidiary, Fidia Pharma USA Inc., announces that new data will be presented at the Osteoarthritis Research Society International (OARSI) World Congress Meeting in Liverpool, U.K., April 26-29.

The pilot study “MOKHA,” coordinated by Fidia Farmaceutici, which involved eight sites in France and Belgium, aimed to explore the potential structural modifying effect of HYMOVIS®, an HA viscosupplement, in patients suffering from symptomatic knee osteoarthritis (OA) using a combination of clinical outcomes and objective measurements including biological and MRI-based imaging markers. This open, multicenter, prospective study on 46 patients showed that HYMOVIS® significantly enhanced type II collagen turnover as suggested by the increase of Coll2-1 (p<0.001) and PIINAP (p<0.001) soluble biomarkers and by the decrease over time of the ratios Coll2-1/PIIANP and CTX-II/PIIANP (p<0.005). Cartilage volume and thickness enhancement was observed by MRI in some knee compartments (p<0.05). Furthermore, WORMS effusion (Whole-Organ Magnetic Resonance Imaging Score), an indicator of synovitis, significantly decreased (p<0.016).

In addition, global KOOS (Knee Injury and Osteoarthritis Outcome Score) and subscales significantly increased over time (p<0.001) while pain at rest, walking pain, and patients or investigators global assessment of disease activity decreased (p<0.001). Furthermore, HYMOVIS® showed a favorable safety profile with no serious adverse events related to the product and low incidence of injection-site pain. “Importantly, this study highlights the potential beneficial effect of HYMOVIS® on pain and function. Altogether, this data suggests that HYMOVIS® could have a structural modifying effect in knee OA and provides critical information for the design of a larger clinical trial,” said Dr. Pascal Richette, Service de Rhumatologie, Hôpital Lariboisière, Paris, France.

The new data will be presented at the Osteoarthritis Research Society International (OARSI) World Congress Meeting in Liverpool, U.K., April 26-29. Poster Title: “Hyaluronan Derivative Hymovis® Increases Cartilage Volume and Type II Collagen Turnover in Osteoarthritis Knee: Data from MOKHA (MRI, BiOmarkers, Knee, Hymovis®, OsteoArthritis) Study” – Henrotin Y. et al.


HYMOVIS® is a highly viscoelastic non-crosslinked hydrogel bioengineered using a proprietary process that increases lubrication and shock absorption properties. This results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in human joints. The formulation allows this unique molecule to recover its original structure, even after repetitive mechanical stress. Due to reversible hydrophobic interactions, the non-crosslinked HYMOVIS® has increased elasticity, viscosity and residence time in the joint.* Its unique molecular structure results in enhanced biomechanical properties and long-lasting efficacy, all in a convenient two-dose regimen.

*Preclinical studies may not be indicative of human clinical outcomes.

In Europe, HYMOVIS® is indicated for the treatment of pain in osteoarthritic joints and in the conservative treatment of the meniscal lesion of the knee and for the improvement of joint mobility through the enhancement of synovial fluid viscoelasticity.

In the U.S., HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics.

HYMOVIS® is contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram-positive bacterial proteins or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.hymovis.com.

Rx Only. HYMOVIS® and HYADD®4 are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2018 Fidia Pharma USA Inc., Florham Park, N.J., a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID622-04.2018

About Fidia Farmaceutici

Fidia Farmaceutici is part of Fidia Pharma Group, an Italian multinational company, with R&D, manufacturing and sales capabilities, and an extensive product portfolio mainly based on natural and functionalized hyaluronic acid (over 650 patents), in joint care, wound healing, ophthalmology, aesthetics and regenerative medicine. Manufacturing operations are FDA-inspected and approved, and the company extends its global reach through wholly-owned subsidiaries and partners in 100 countries worldwide. For more information, please visit www.fidiapharma.com.


For more information:
Tel: (+39) 0498232111
Carolyn Kong, 1-973-507-5120

MTF Biologics Wound Care To Introduce AmnioBand® Viable Membrane, Present Advanced Clinical and Scientific Research

EDISON, N.J.April 25, 2018 /PRNewswire/ — MTF Biologics Wound Care has expanded its portfolio of innovations with AmnioBand® Viable Membrane, an aseptically processed and cryopreserved human amnion membrane for use as an acute or chronic wound covering. MTF Biologics Wound Care will feature the novel tissue graft at the Symposium on Advanced Wound Care (SAWC) Spring | Wound Healing Society (WHS) meeting held at the Charlotte Convention Center in Charlotte, N.C.April 25-29, 2018.

In addition to introducing AmnioBand® Viable Membrane at the meeting, MTF Biologics Wound Care will host a symposium on outcomes for placental and dermal innovations in wound care, and its tissue grafts will be featured in three poster presentations.  It also will announce new support for SAWC’s 2018 Martin Salia Scholarship Fund.

“Wounds remain a significant challenge for the healthcare community,” said Kim Rounds, Vice President of Wound Care at MTF Biologics. “More than six million Americans will struggle with chronic non-healing wounds this year alone. AmnioBand® Viable Membrane is an important new option for clinicians working to heal difficult wounds of all kinds. Leveraging our 20 years of processing and providing living cell tissue forms, and recognizing that there is no single solution in wound care, we continue to deliver on our mission of honoring the donated gift, serving patients, and advancing science by releasing the next generation living allograft placental matrix.”

recent study published by Matthew Regulski, DPM, in Wounds titled, “Utilization of Viable Human Amnion Membrane Allograft in Elderly Patients with Chronic Lower Extremity Wounds of Various Etiologies,” demonstrates the potential for AmnioBand® Viable Membrane to help the closure of non-healing wounds in elderly patients with multiple comorbidities.

“We are dedicated to innovation in allograft science to improve clinical outcomes and support healthcare providers,” said Marc Long, PhD, Vice President of R&D at MTF Biologics. “We ensure that each AmnioBand® Viable donation is tested for viability, offer the tissue with an intelligent colorimetric change to indicate graft readiness, and provide the graft on a flexible backing for an enhanced yet intuitive clinical application. Processing and quality matters, and we are excited to showcase the translation of our scientific development with our proven clinical results.”

MTF Biologics has provided a grant to HMP, a leading healthcare events and education company, and organizers of the annual SAWC Spring and Fall meetings. The funding will be used to support the 2018 Martin Salia Scholarship Fund giving surgical residents from the Pan-African Academy of Christian Surgeons (PAACS) the opportunity to participate in the 2018 SAWC Fall meeting, taking place November 2-4, 2018, in Las Vegas, Nevada. The program is named in memory of Dr. Martin Salia, a graduate of the PAACS program. Dr. Salia was one of 136 physicians treating a population of 6 million in Sierra Leone when he contracted the Ebola virus and died in November of 2014.

“Access to advanced wound care therapies is limited in many rural African communities,” said Jeffrey Cartmell, PhD, Associate Director of Intellectual Property and Grants at MTF Biologics. “We are committed to the evidence-based education that recipients of the Martin Salia Scholarship will receive at SAWC. We are honored to play a role in assisting these physicians as they seek to improve their ability to care for the patients in their communities.”

MTF Biologics’ symposium, “Level 1 Clinical Outcomes for Placental & Dermal Innovations,” will feature perspective on recently published Level 1 clinical outcomes for aseptically processed placental and dermal innovations from Dennis Orgill, MD, PhD, Charles Zelen, DPM, FACFAS, Lawrence DiDomenico, DPM, FACFAS, and Jarrod P. Kaufman, MD, FACS. The complimentary lunch symposium will be held in Room 217D on Thursday, April 26, from 12 p.m. – 1:30 p.m. Onsite registration will be available.

Additional clinical & scientific poster presentations at the meeting will include:

  • The Safety, Efficacy, and Cost to Closure of a Unique Aseptically Processed Dehydrated Allogeneic Amnion and Chorion graft versus Standard of Care in the Treatment of Chronic Diabetic Foot Ulcers: A Prospective, Randomized, Controlled, Multi-centre Trial – DiDomenico et al. Abstract: CR-007
  • Preliminary Observations on the Mechanism of Viable Human Amnion Membrane Allograft* in the Diabetic Wound, using the db/db Mouse Splinted Excisional Wound Model – Xie et al. Abstract: LR -076
  • Aseptically Processed Dehydrated Human Amnion/Chorion Allografts Restores Type II Diabetic Cell-Mediated Granulation, Angiogenesis and Epithelialization Activities that Support Wound Healing – Dasgupta et al. Abstract: LR-014

About MTF Biologics
MTF Biologics, also known as the Musculoskeletal Transplant Foundation, is a nonprofit organization based in Edison, N.J. It is a consortium comprised of leading organ procurement organizations, tissue recovery organizations and academic medical institutions, and governed by a board of clinicians who are leading experts in tissue transplantation. As the world’s largest tissue bank, MTF Biologics saves and heals lives by honoring donated gifts, serving patients and advancing science. Since its inception in 1987, the organization has received tissue from more than 125,000 donors and distributed more than 8 million grafts for transplantation. Through its IIAM subsidiary, it has placed more than 55,000 non-transplantable organs for research. Through its Statline subsidiary, it has managed more than 10 million donor referrals. For more information, visit www.mtfbiologics.org.

SOURCE MTF Biologics

Related Links


OrthoSpineNews Interview with Lane Major, Chief Operating Officer at K2M

Good morning Lane, thank you for taking some time to talk with us this morning. If you wouldn’t mind introducing yourself to our readers and telling us a bit about your background to get started…

Sure thing, Mason. I truly appreciate the opportunity to share our K2M story with you. I have spent my entire career in the spinal devices space, beginning with a field-based role in Northern Virginia carrying primarily Stryker products. I was also exposed to several Globus products and some osteobiologics. Being in the operating room each day gave me a strong foundation in the spine industry. One that I keep with me today.

In January 2004, K2M was founded with a vision of improving the lives of people across the world with spinal deformities. I’ve been with the company ever since and am grateful for the work we do each day.

Thanks for that background, Lane. What is your biggest motivator for coming into work every day at K2M? 

When you are with a company that changes lives—particularly for children suffering from scoliosis—seeing the positive impact of our work is all that matters. The societal value we create has resulted in a corporate culture second to none. It’s something you feel when you walk through the door. We hear this all the time from surgeons and others who visit us from around the world.

Our commitment to social good begins in Loudoun County, VA—our global headquarters—as well as at a national and global level. One example is a program called Straight 2 Swimming. Just imagine children with scoliosis who never could swim because they’re embarrassed to take off their shirts. We help them build confidence; it’s a huge motivator for me. Another example is the FOCOS Hospital we helped found in Ghana. The fact that our products are used to treat the world’s most challenging deformity cases inspires us each day.

Wow, that is incredible, Lane. Thank you for sharing that with us. Furthermore, can you give us an overview of the various 3D Solutions K2M offers and how you first got into the space?

Absolutely. K2M is leading the way in the 3D printing of spinal devices. But this work started well before 3D printing became popular. It came about because we were seeking to overcome a challenge.

Because our products are used in 40 different countries around the world, we have gained valuable insights from surgeons on what tools they need to improve outcomes in patients. Years ago, we began hearing people talking about how there should be a better alternative to PEEK implants. So, we partnered with a team of global key opinion leaders to create the Alternative Materials Design Team. The design input from this team led us to solutions that simply couldn’t be manufactured traditionally. It required innovation.

To improve upon PEEK technology, we partnered with 3D Systems—the world’s foremost leader in 3D printing for medical purposes. Today, we have a world-class portfolio of 3D-printed devices that address a diverse range of degenerative, complex spine, and MIS procedures. All of which feature our innovative Lamellar 3D Titanium Technology™, which uses an advanced 3D-printing method to create structures that were once considered impossible with traditional manufacturing. It allows us to develop devices with a porosity and surface roughness that pre-clinical data have associated with bone growth activity, as well as a decreased radiographic signature. All of which help improve outcomes in patients undergoing spine surgery.

Having said that, what is your vision for where the company goes from here?

Our vision is to be the leader in complex spine and minimally invasive solutions. We have had consistently strong success in these areas, and today, patients and physicians are asking us to help in the other areas of treatment. Therefore, we are introducing new technologies—such as our Balance ACS® (BACS) platform—to help surgeons and patients in all phases of preoperative, intraoperative, and postoperative patient care. Balance ACS is game-changing, as it uses a 360-degree approach to the axial, coronal and sagittal planes so surgeons can take a more holistic and comprehensive approach to treatment. It also includes a suite of data management software that lets surgeons collect and analyze patient data to improve treatment.

As we move forward, we will continually find ways to drive costs down for the patient, make practices more intuitive for surgeons, ensure faster recovery time, and much more.

We are really looking forward to seeing everything that lies ahead for K2M. Can you leave us with some closing remarks or any predictions about the spine industry as a whole? 

There remains a significant opportunity for innovation in the spinal devices space. K2M is at the forefront of inventing solutions for the full continuum of care, not just limited to implants and instrumentation. The opportunity for innovation remains robust; we believe that K2M is well-positioned to position to continue leading.

Well Lane we really appreciate you taking the time to chat with us today. It was great to get some insights into the K2M story as well as what’s on the horizon. We wish you all the best moving forward. 

Thanks Mason, likewise. We really appreciate the opportunity. Take care.

Former Stryker Engineer Pleads Guilty To Accepting Bribe

Walter Eisner • Tue, April 17th, 2018

Daniel Lawrynowicz, a former Stryker Corporation engineering director, plead guilty on April 3, 2018 to accepting a $75,000 bribe for steering business to a New York metallurgy firm.

According to the Department of Justice (DoJ), Lawrynowicz, 48, pleaded guilty before U.S. District Judge Madeline Cox Arleo in Newark federal court to an information charging him with one count of violating the Federal Travel Act.

According to DOJ documents, in 2012, while Lawrynowicz was an employee of Stryker, Eugene Ostrovsky and two other individuals at Sanova LLC, sought a contract worth $5.5 million with Stryker. Lawrynowicz was in a position to make recommendations to others at Stryker related to the goods that Sanova sought to supply under the contract.

“Ostrovsky and the other individuals made illicit bribe payments to Lawrynowicz in exchange for his assistance in helping the technology company secure the contract with the medical device company. These payments included a cash payment of approximately $75,000 to Lawrynowicz after the contract between the two companies was signed.”

Sanova VP Pleads Guilty

In February, Ostrovsky, a vice president and partner at Sanova LLC, pleaded guilty to bribing Lawrynowicz in 2012 and 2013 to win the $5.5 million contract with Stryker. He was sentenced March 9 to six months in jail, six months of home confinement and two years of supervised release. Prosecutors said Ostrovsky will also forfeit $1.1 million.

Lawrynowicz’s LinkedIn page listed him as a 15-year Stryker employee who was senior director of advanced engineering, leading “a team of 41 engineers and scientists at the Mahwah, N.J. facility dedicated to supporting the Recon Business Units.”

The U.S. Patent and Trademark Office lists at least half a dozen patents filed by Daniel Lawrynowicz, of Monroe, along with others, between 2010 and 2013, while he worked for Howmedica Osteonics Corp., of Mahwah.

Jeanine Guilfoyle, a spokeswoman for Stryker, reportedly said the company would not comment on the case or Lawrynowicz’s employment at the company.



North America Minimally Invasive Surgical Instruments Market Analysis & Forecasts To 2023 – ResearchAndMarkets.com

April 25, 2018

DUBLIN–(BUSINESS WIRE)–The “North America Minimally Invasive Surgical Instruments Market – Forecasts from 2018 to 2023”report has been added to ResearchAndMarkets.com’s offering.

North America minimally invasive surgical instruments market is projected to grow at a CAGR of 7.28% from a market size of US$6.954 billion in 2017 during the forecast period and reach a market size of US$10.601 billion in 2023.

Early adoption of advanced technologies coupled with the presence of major market players in the region contributes to the growth of North America minimally invasive surgical instruments market. Growing geriatric population and high demand for quality healthcare services in this region further supports the market growth of minimally invasive surgical instruments market in the region.

This research study examines the current market trends related to the demand, supply, and sales, in addition to the recent developments. Major drivers, restraints, and opportunities have been covered to provide an exhaustive picture of the market. The analysis presents in-depth information regarding the development, trends, and industry policies and regulations implemented in each of the geographical regions. Further, the overall regulatory framework of the market has been exhaustively covered to offer stakeholders a better understanding of the key factors affecting the overall market environment.

Companies Mentioned

  • Ethicon US, LLC
  • Aesculap, Inc.
  • Medtronic
  • Stryker
  • Zimmer Biomet
  • CONMED Corporation
  • Microline Surgical
  • Abbott Laboratories

Key Topics Covered:

1. Introduction

2. Research Methodology

3. Executive Summary

4. Market Dynamics

5. North America Minimally Invasive Surgical Instruments Market By Type

6. North America Minimally Invasive Surgical Instruments Market By Application

7. North America Minimally Invasive Surgical Instruments Market By Geography

8. Competitive Intelligence

9. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/research/kh8zg4/north_america?w=4


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Related Topics: Surgical Devices