Solvay’s high-strength Ixef® PARA enables next-generation Cervical-One™ single-procedure surgical instrument kit from ECA Medical Instruments

Posted On March 6, 2018 By OrthoSpineNews In Spine /

Alpharetta, Ga., March 6, 2018 — Solvay, a leading global supplier of specialty polymers, announced that its high-performance Ixef® polyarylamide (PARA) resin enabled ECA Medical Instruments to develop its Cervical-One™ single-use surgical instrument set for use in one- and two-level cervical spine implant procedures.

The novel Cervical-One™ kit includes the full complement of robust and ergonomically designed instruments needed by surgeons for cervical plate and interbody fixation, including precision torque-limiters and drivers. In addition to removing cost from individual instruments, the semi-custom design also empowers spinal implant OEMS to cost-effectively tailor or brand their own instrument set.

Compared to reusable instrumentation, ECA’s single-use instrument system can eliminate reprocessing costs, enhance operating room efficiency, streamline hospital and ASC inventory management, and play a significant role in eliminating the root causes of surgical site infections.

“When developing the Cervical-One™ platform, we required an engineered polymer that could withstand torsional, tamping and axial loads applied during the procedure,” said James Schultz, executive vice president for sales and marketing at ECA Medical Instruments. “Ixef® PARA delivers the robust mechanical performance needed for fixation of both cervical plates and screws and interbody devices. We also needed the tactile feel and weight and balance surgeons expect. Solvay’s collaborative support during the design process and proactive regulatory support – trusted throughout the industry – proved critical in reducing our time to market.”

Ixef® PARA compounds offer metal-like strength, rigidity and dimensional stability, while providing an exceptional surface finish. Ixef® PARA is optimized for sterilization using high-energy gamma radiation without significant change in appearance or performance and is available in a range of gamma-stabilized colors. Solvay’s compounds have been evaluated for ISO 10993 limited duration biocompatibility and are supported by an FDA Master Access File (MAF).

“This successful collaboration combines the strengths of both ECA and Solvay – the two leaders in their respective fields,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers global business unit. “As leading orthopedic device manufacturers continue their early conversions to single use systems, we are confident that our combined critical mass and industry-relevant experience will deliver real value to potential and existing customers.”

For more information about this application and related news about specialty polymers for healthcare, please go to solvayhealthcare.com.

® Ixef is a registered trademark of Solvay

™ Cervical-One is a trademark of ECA Medical Instruments

ECA Medical Instruments

ECA Medical Instruments®, headquartered in Thousand Oaks, Calif., is the industry leader in designing and manufacturing precision single-procedure torque-limiting instruments and surgical fixation kits. Founded in 1979, the company has delivered over 35 million torque-limiting instruments and procedural kits to the world’s leading cardio, neuromodulation, orthopaedic and spine implant companies. Every 15 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA, a LongueVue Capital Partners company, is an ISO 13485, CE Mark certified and FDA registered firm and was named Business of the Year 2017 by LivaNova and earned the LivaNova 2017 Supplier Excellence Award. www.ecamedical.com

Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that address key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its light-weighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 24,500 employees in 61 countries. Net sales were €10.1 billion in 2017, with 90% from activities where Solvay ranks among the world’s top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Solvay Specialty Polymers

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high-barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay’s high-performance Ixef® polyarylamide (PARA) resin enabled ECA Medical Instruments to develop its Cervical-One™ single-use surgical instrument set for use in one and two-level cervical spine implant procedures. Compared to reusable metal instruments, ECA’s single-use instruments can eliminate reprocessing costs, enhance operating room efficiency, streamline hospital and ASC inventory management, and play a significant role in eliminating the root causes of surgical site infections. Photo courtesy of ECA Medical Instruments.

Photo courtesy of ECA Medical Instruments.

Marla Witbrod
Solvay Specialty Polymers
+1 770 772 8451
marla.witbrod@solvay.com

Dan McCarthy
AH&M Marketing Communications
+1 413 448 2260 Ext. 200
dmccarthy@ahminc.com

Umberto Bianchi
Solvay Specialty Polymers
+39 02 2909 2127
umberto.bianchi@solvay.com

Alan Flower
Industrial Media Relations
+32 474 117 091
alan.flower@indmr.com

MicroPort Orthopedics Celebrates 20 Years of Stability with its Medial-Pivot Total Knee System

Posted On March 6, 2018 By OrthoSpineNews In Recon, Top Stories /

March 06, 2018

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting-edge joint replacement implants designed to help patients achieve full function faster, is celebrating 20 years of market experience with its medial-pivot total knee system. Since launching in 1998, over 550,000 patients have benefited from MicroPort’s medial-pivot technology, which touts compelling long-term clinical results.

“The medial-pivot knee system has now stood the test of time at 20 years demonstrating impressive survivorship and excellent patient satisfaction,” said C. Lowry Barnes, MD, Chair of Orthopedic Surgery at the University of Arkansas for Medical Sciences. “It is important to recognize that this isn’t just one single publication. Over the years, the Advance® and Evolution® Medial-Pivot Knee Systems have been included in over 90 peer-reviewed publications that validate its long-term durability and functionality.”

For many years, orthopedists have clung to the concept of a hinge-like knee design with multiple radii. However, studies show that on average, 20% of patients are not satisfied with the outcome of their total knee replacement. Challenging these traditional knee designs, pioneers such as J. David Blaha, MD, Mr. Michael Freeman, MD, and Richard Komistek, PhD provided kinematic and radiographic evidence supporting medial-pivoting kinematics and stability of the knee, paving the way for the release of MicroPort’s medial-pivot knee system.

“I began using MicroPort’s medial-pivot knee system in May of 1998,” said Joost Lagast, MD, Orthopedic Surgeon at Maria Middelares Hospital Ghent. “At the time, I was not 100% satisfied with my results and was looking for something new. I attended a meeting with Professor Blaha at AAOS and was very impressed with the medial-pivot concept. During my first case, it was love at first sight – the stability and natural motion were unlike anything I’d seen in my practice. Over the last 20 years, I’ve performed nearly 4,000 knee replacement surgeries using the system, and I’m still fantastically in love with it today.”

The Evolution® Medial-Pivot Knee System features medial ball-in-socket articulation and a mobile lateral compartment that pivots about the medial side, enhancing stability, providing high flexion, and allowing the prosthesis to replicate the natural feel and motion of the knee. Additionally, the medial stability of the Evolution® knee substitutes for both the ACL and PCL, allowing for normal quadriceps function and increased proprioception.

Former NFL quarterback and Hall-of-Famer, Terry Bradshaw, underwent total knee replacement surgery with the Evolution® Medial-Pivot Knee. “My knee was causing me all kinds of problems. I couldn’t sleep at night, I couldn’t take the stairs, and worst of all, I had a hard time playing with my granddaughter,” said Bradshaw, now 69 years old. “I underwent surgery on a Tuesday, left the hospital two days later, and was walking without assistance in two weeks. Today, I can do anything I want to do – walking down stairs, squatting, fishing, and golfing. The medial-pivot technology has been life changing for me. It feels just like my knee!”

“MicroPort Orthopedics is proud to celebrate the 20^th anniversary of our medial-pivot knee system,” said Aurelio Sahagun, President, MicroPort Orthopedics. “When we launched the system back in 1998, there was nothing else like it on the market – it challenged the basis of traditional designs. Change does not happen often in orthopedics, but at the time, we knew that the medial-pivot concept had the capability to revolutionize total knee replacement. 20 years later, clinical results have proven that this design delivers better outcomes for patients and surgeons. It is incredibly gratifying to offer a best-in-class knee replacement option, and we are looking forward to another 20 years of innovation as we expand the medial-pivot technology into the revision market.”

About MicroPort Orthopedics

Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort Scientific

MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements

Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

Contacts

MicroPort Orthopedics
Alex Piersiak, 617-909-5022
Alex.piersiak@ortho.microport.com

Synergy Biomedical Announces Regulatory Clearance and Launch of BIOSPHERE PUTTY in Australia

Posted On March 6, 2018 By OrthoSpineNews In Regulatory /

March 06, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of orthobiologic and biomaterial products, announced that it has received Therapeutic Goods Administration (TGA) clearance in Australia for its bioactive bone graft, BIOSPHERE PUTTY. BIOSPHERE PUTTY is an advanced synthetic bone graft product that has previously received FDA and CE Mark clearances, and has been on the market since 2013.

“We are very pleased with our TGA clearance and are excited to launch this innovative, synthetic bone graft in Australia,” indicated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “This clearance enables more surgeons worldwide access to our next-generation bone graft technology.”

“The launch of BioSphere Putty in Australia represents a significant milestone in expanding our distribution across the globe,” stated Kevin Booth, VP of Sales. “The Australian market provides Synergy with a sizable opportunity to grow our BioSphere Putty sales.”

BIOSPHERE PUTTY is a synthetic bone graft that utilizes a unique, spherical form of bioactive glass in combination with a resorbable carrier. The product provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass. The use of spherical particles allows for precise control over the properties of bioactive glass, and results in an optimal bone healing response. BIOSPHERE PUTTY is the first of several bioactive glass products being developed by Synergy Biomedical.

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing, and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com

DJO Global Announces Financial Results for Fourth Quarter and Fiscal Year End 2017

Posted On March 6, 2018 By OrthoSpineNews In Financial /

March 06, 2018

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the fourth quarter and fiscal year ended December 31, 2017.

Fourth Quarter Highlights

Net sales grew 5.3% to $312.2 million, or 3.7% on a constant currency, sales-per-day basis, compared to the fourth quarter of 2016.
Net income attributable to DJOFL was $61.2 million, including a one-time tax benefit of $69.9 million, compared to a net loss of $202.1 million in the prior year period.
Adjusted EBITDA increased 35.4% over the prior year quarter to $80.6 million.

Full Year Highlights

Net sales grew 2.7% to $1.19 billion, or 2.3% on a constant currency basis.
Net loss attributable to DJOFL was $35.9 million compared to $286.3 million in the prior year.
Adjusted EBITDA increased 14.0% to $268.2 million.

Business Transformation Outcomes

Business Transformation drove profitability expansion and remains on track to deliver 7% to 10% annual cost reductions by end of 2018.
Transformation actions taken to date expected to contribute $25.5 million in savings over the next four quarters.

“Our team delivered outstanding fourth quarter and full year operating results,” said Brady Shirley, DJO’s President and Chief Executive Officer. “We had continued double digit growth in the fourth quarter from our innovative surgical products, strong performance in our International business segment and realization of cost improvement from our broader business transformation. At 14% Adjusted EBITDA growth in 2017, we delivered not only our best performance in many years, but also believe we delivered a top performance in the Orthopaedic market. I am proud of the DJO team and happy to see their dedication and hard work pay off in 2017. We are excited to enter 2018 with a strong dedication to continued discipline and an opportunity to begin to invest in growth for the future.”

“With our transformation initiatives, we have greatly improved the foundation of our company both operationally and financially, producing the strongest Adjusted EBITDA growth for the company in many years,” commented Mike Eklund, DJO’s Chief Financial Officer and Chief Operating Officer. “There is certainly more work to do, but I am pleased with the team’s achievement thus far, and as confident as ever in our ability to continue improving operating metrics and profitability again in 2018.”

Sales Results

DJOFL achieved net sales for the fourth quarter of 2017 of $312.2 million, reflecting growth of 5.3%. The fourth quarter of 2017 included 61 selling days for our International segment compared to 62 for the same period in 2016, while domestic selling days remained constant at 61. On the basis of constant currency and sales per day, sales in the fourth quarter of 2017 grew 3.7% over sales in the fourth quarter of 2016. For the twelve months ending December 31, 2017, sales grew 2.7% over the comparable period in 2016 to $1.19 billion, or 2.3% on a constant currency basis.

Net sales for the Surgical Implant segment grew 12.8% in the fourth quarter of 2017 to $54.2 million. Sales across all three implant subcategories (knee, hip and shoulder) again grew at double digit rates compared to the prior year period. For the twelve months ending December 31, 2017, Surgical Implant sales grew 14.8% over the comparable period in 2016 to $200.4 million.

Net sales for DJO’s International segment grew 15.2% in the fourth quarter of 2017 to $85.3 million, or 9.1% on the basis of constant currency and sales per day. Growth was driven by strong performance in Germany, France and Australia. For the twelve months ending December 31, 2017, International sales grew 6.3% to $320.1 million, or 4.7% on a constant currency basis over the comparable period in 2016.

Net sales for DJO’s Recovery Sciences segment were $41.7 million in the fourth quarter of 2017, down 1.2% compared to the fourth quarter of 2016. For the twelve months ending December 31, 2017, Recovery Sciences sales grew 0.8% over the comparable period in 2016 to $158.3 million.

Net sales for DJO’s Bracing and Vascular segment were $131.0 million in the fourth quarter of 2017, a decline of 0.9% compared to the fourth quarter of 2016. For the twelve months ending December 31, 2017, Bracing and Vascular sales declined 2.9% from the comparable period in 2016 to $507.4 million.

Earnings Results

For the fourth quarter of 2017, DJOFL reported net income of $61.2 million, including an income tax benefit of $69.9 million attributable to the enactment of the Tax Cuts and Jobs Act of 2017, compared to a net loss of $202.1 million for the fourth quarter of 2016, which included goodwill impairment and other non-cash charges of $178.0 million. For the twelve months of 2017, DJOFL reported a net loss of $35.9 million compared to a net loss of $286.3 million for the twelve months of 2016. As detailed in the attached financial tables, the results for the current and prior fourth quarter and twelve month periods were impacted by significant non-cash items, non-recurring items and other adjustments.

Adjusted EBITDA for the fourth quarter of 2017 was $80.6 million compared with Adjusted EBITDA of $59.5 million in the fourth quarter of 2016. For the twelve months ending December 31, 2017, Adjusted EBITDA was $268.2 million compared with Adjusted EBITDA of $235.3 million for the twelve months ending December 31, 2016. Including projected future savings of $25.5 million from cost savings programs currently underway as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended December 2017 was $293.7 million.

The Company defines Adjusted EBITDA as net (loss) income attributable to DJOFL plus net interest expense, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance under the Company’s secured term loan and revolving credit facilities (“Senior Secured Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. A reconciliation between net loss attributable to DJOFL and Adjusted EBITDA is included in the attached financial tables.

Net cash provided by continuing operating activities for the twelve months ending December 31, 2017 was $44.6 million compared to $8.6 million in 2016. The improvement in cash flow was attributable to both higher earnings and working capital initiatives executed as part of the Company’s overall business transformation.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 11:00 am Eastern Time, Tuesday, March 6, 2018. Individuals interested in listening to the conference call may do so by dialing (866) 394-8509 (International callers please use (706) 643-6833), using the reservation code 22322226. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (855) 859-2056 and using the above reservation code. The live conference call and replay will be available via the Internet at www.DJOglobal.com.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for improved liquidity, estimated cost reductions associated with the execution of its business transformation plans and improved efficiencies. The words “believe,” “will,” “should,” “expect,” “target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: business strategies relative to our Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.


DJO Finance LLC Unaudited Condensed Consolidated Statements of Operations (In thousands)

	Three Months ended December 31,						Twelve Months ended December 31,
	2017			2016			2017			2016
Net sales	$	312,195		$	296,490		$	1,186,206		$	1,155,288
Costs and operating expenses:
Cost of sales (exclusive of amortization see Note 1)		131,328			150,324			498,107			511,414
Selling, general and administrative		118,556			132,349			510,523			490,693
Research and development		8,363			9,253			35,429			37,710
Amortization of intangible assets		15,433			18,869			66,146			76,526
Impairment of goodwill		—			160,000			—			160,000
		273,680			470,795			1,110,205			1,276,343
Operating income (loss)		38,515			(174,305	)		76,001			(121,055	)
Other (expense) income:
Interest expense, net		(44,792	)		(42,733	)		(174,238	)		(170,082	)
Other income (expense), net		105			(3,266	)		2,113			(2,534	)
		(44,687	)		(45,999	)		(172,125	)		(172,616	)
Loss before income taxes		(6,172	)		(220,304	)		(96,124	)		(293,671	)
Income tax benefit		(67,397	)		(18,009	)		(60,720	)		(6,853	)
Net Income (loss) from continuing operations		61,225			(202,295	)		(35,404	)		(286,818	)
Net income from discontinued operations		81			331			309			1,138
Net income (loss)		61,306			(201,964	)		(35,095	)		(285,680	)
Net income attributable to noncontrolling interests		(155	)		(162	)		(799	)		(623	)
Net income (loss) attributable to DJO Finance LLC	$	61,151		$	(202,126	)	$	(35,894	)	$	(286,303	)

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $6,790 and $27,732 for the three months and twelve months ended December 31, 2017 and $6,981 and $28,525 for the three and twelve months ended December 31, 2016, respectively.

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Bioventus Launches DUROLANE® in the US

Posted On March 5, 2018 By OrthoSpineNews In Biologics /

March 05, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today launched DUROLANE, its single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA).DUROLANE joins three-injection HA GELSYN-3^™ and the five-injection HA SUPARTZ FX^™ in the company’s OA portfolio making Bioventus the only orthobiologics company in the US with a single, three and five-injection HA option for treatment of knee OA.

“Introducing DUROLANE to the US market gives patients, physicians and payers access to a proven pain reliever for knee OA that has improved the lives of more than 1 million people worldwide,” said Tony Bihl, CEO of Bioventus. “In addition, DUROLANE is very safe for patients and has more level-1 clinical studies than any other single-injection HA knee therapy on the market today.”

Hyaluronic acid is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues within the knee. DUROLANE has been proven to provide greater reduction in knee pain versus Synvisc-One^®1* and longer lasting pain relief versus a steroid injection². DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.^{2, 3}

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3, is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corporation. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.

* Some patients were treated with a three-injection Synvisc regimen. A three-injection Synvisc regimen is equivalent to one injection of Synvisc-One.

Summary of Indication for Use: DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.

Do not inject DUROLANE in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site.

DUROLANE has not been tested in pregnant or lactating women, or children. Full prescribing information can be found in product labeling, at www.DUROLANE.com, or by contacting Bioventus Customer Service at 1-800-836-4080.

References: 1. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 2. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 3. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

(Photo: Business Wire)

Orthopaedic Industry Veteran Jeffrey R. Binder Joins Bill Petty, MD, as Co-Executive Chairman of Exactech

Posted On March 5, 2018 By OrthoSpineNews In Extremities /

March 05, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, announced today the appointment of Jeffrey R. Binder who joins Bill Petty, MD as Co-Executive Chairman following the company’s recent go-private merger agreement with TPG Capital.

Binder, 25-year veteran of the medical device and diagnostics industry, has proven expertise in helping companies realize growth opportunities. He has served in CEO roles for Biomet and Immucor, and previously held senior roles at Abbott and Johnson & Johnson.

Daniel Hann, who held leadership positions with Biomet for more than 25 years, has also joined Exactech as Senior Vice President of Business Development.

“I am excited to join a company that I have admired for many years.” Binder said. “Exactech has made its mark through its excellent products and also as a company that lives its values. I look forward to working with Dr. Petty, CEO David Petty and the rest of Exactech’s passionate team as we grow to reach even more surgeons and patients around the globe.”

Exactech CEO David Petty said, “We are excited to have Jeff and Dan joining the Exactech team. Their years of relevant experience and compatibility with our culture will make them valuable leaders and contributors to our future success.”

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

Medicrea to Participate in the Canaccord Genuity Musculoskeletal Conference and Present Clinical Results at AAOS 2018

Posted On March 5, 2018 By OrthoSpineNews In Spine /

March 05, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design and manufacturing with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that the Company will present at the Canaccord Genuity Musculoskeletal Conference on Tuesday, March 6, 2018 at 11:30 a.m. CT (6:30 p.m. GMT+1) at the Sheraton New Orleans Hotel in New Orleans, LA.

Clinical results on the Company’s patient-specific UNiD™ Rod will be presented by Dr. Andrew King at the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). The podium, entitled “Radiographic Comparison of Patient-Specific and Manually Contoured Conventional Rods in Adolescent Idiopathic Scoliosis Surgery”, will take place in the session beginning at 11:00 a.m. CT (6:00 p.m. GMT+1) held in Room 345 of the Morial Convention Center on Friday, March 9th.

About Medicrea (www.medicrea.com)

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

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

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

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

Contacts

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

Vivorté Continues Transformation with Announcement of Mark Wagner as Chief Executive Officer

Posted On March 5, 2018 By OrthoSpineNews In Biologics, Top Stories /

LOUISVILLE, KY — (March 5, 2018) — Vivorté, Inc., a vertically-integrated manufacturer and marketer of Performance Biologics™ including TRABEXUS®, FORTERA™ and REGENTO™ announced today that Mark Wagner will assume the role of CEO to spur the company through its next phase of exponential growth.

Wagner has extensive experience leading commercial organizations within the orthopedics sector and broader medical device industry. Prior to joining Vivorté, Wagner was Senior Director of Sales and Marketing at DCI Donor Services, leading the commercialization of a diverse product line servicing the orthopedics, spine and wound care market segments.

“It is a critical time in Vivorté’s history and we are excited to announce this transition”, said Robert Saunders, Vivorté Chairman. “Over the last several months, Vivorté has been actively implementing a variety of strategic initiatives that are beginning to bear fruit. As we continue to focus on commercial execution, we look forward to continued progress and growth under Mark’s direction. Additionally, the board of directors would like to acknowledge Ruth Voor, whose wealth of contributions include leading the Vivorté organization through the product development and regulatory clearance of Trabexus and establishment of the Company’s current portfolio of products.”

Wagner joined Vivorté in October 2017 and has made a significant impact by implementing new branding / marketing initiatives and energizing the company’s sales channels. Prior experience includes leadership positions at AmerisourceBergen, Angiotech Pharmaceuticals and RTI Surgical. Wagner holds a Master of Business Administration from the Kellogg School of Management at Northwestern University and a Bachelor of Arts from Dartmouth College.

“I’m excited to become Vivorté’s CEO at this pivotal point in the company’s history,” said Wagner. “Vivorté already has the two most important ingredients for success – great products and great people. The company is focused on delivering our game-changing products to the orthopedic marketplace and sharing the clinical product efficacy results we are now seeing from our early adopters.”

Representatives from Vivorté will be attending the upcoming American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, held March 6-10, 2018 in New Orleans, Louisiana to address corporate inquiries.

About Vivorté, Inc.

Vivorté, Inc., headquartered in Louisville, Kentucky is a privately-held, vertically-integrated manufacturer and marketer of Performance Biologics™. Vivorté is committed to developing innovative and cost-effective surgical products for the benefit of surgeons, hospitals and patients. The Company’s product portfolio includes Trabexus® Trabecular Osteoinductive Biocement, Fortera™ Fortifying Osteoconductive Biocement and Regento™ Regenerative Scaffold. To learn more, please visit our website at vivorte.com.

Media Contact: Therese Montano / 502-714-7234 / tmontano@vivorte.com

LimaCorporate in the Spotlight as the 2018 AAOS Annual Meeting Features Italy as Their Guest Nation

Posted On March 5, 2018 By OrthoSpineNews In Extremities /

SAN DANIELE DEL FRIULI, Italy, March 5, 2018 /PRNewswire/ —

LimaCorporate will be present at the upcoming American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, held in New Orleans from March 6^th to March 10^th, 2018. This year, the AAOS has selected Italy as the Guest Nation and LimaCorporate will be in the spotlight as a leading Orthopaedic company.

LimaCorporate was one of the first Italian companies to start processing Titanium over 40 years ago. At the time, LimaCorporate used Titanium for the manufacturing of surgical instruments as well as mechanical components in the automotive and aeronautical industries. Following many years of state of the art, technological innovation and timely investments in Orthopaedics, LimaCorporate took the decision to focus all efforts solely on the medical applications of Titanium. Conceived, patented and produced inhouse, LimaCorporate 3D prints Titanium to uniquely create Trabecular Titanium (TT) which is used in many LimaCorporate implants. TT has been available on the market since 2007, making LimaCorporate the only company with over 10 years of clinical heritage in 3D printing.

LimaCorporate is honored to co-host the AAOS 2018 Guest Nation Reception and take advantage of this opportunity to further highlight the potentialities of its innovative technologies which put our Company at the forefront of the Orthopaedic sector.

About LimaCorporate

LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit: limacorporate.com

Limacorporate S.p.A.
T: +39 0432 945511
E: info@limacorporate.com

SOURCE Limacorporate S.p.A

Intuitive Surgical, Creator of da Vinci® Robotic-Assisted Surgical System, Announces First General Manager in UK & Ireland

Posted On March 5, 2018 By OrthoSpineNews In Robotics /

March 05, 2018

LONDON–(BUSINESS WIRE)–Intuitive Surgical has named Phil Bradshaw as its first General Manager in the United Kingdom and Ireland (UK&I). Mr. Bradshaw will direct business strategy and operations for the company in these countries.

Intuitive pioneered the field of robotic-assisted, minimally invasive surgery with the creation of its da Vinci Surgical System. Now on its fourth-generation system, the Silicon Valley, California-based company has seen more than five million robotic-assisted surgical procedures performed worldwide, and the da Vinci Surgical Systems’ benefits explored in more than 15,000 peer-reviewed scientific publications to-date.

“Our commitment to the UK & Ireland has been increasing since we entered these markets ten years ago. Phil’s deep knowledge of the medical device industry and his enthusiasm for continued innovation in the UK and Irish markets, expands that commitment,” said Dr. Gary Guthart, CEO of Intuitive. “British surgeons have been at the forefront of driving innovation and improvements in patient care and economic value to the NHS using da Vinci robotic systems, where patients can recover and return home more quickly, saving the healthcare system money,” he added.

Mr. Bradshaw brings nearly three decades of experience in the medical device field working for market-leading companies, and more than eight years of general management experience in the UK and European markets. “Intuitive’s impressive experience and track record of working with surgeons to provide continuous developments in robotic-assisted surgery in the UK and Ireland was very important to me,” said Bradshaw. “The company’s commitment to ensuring that robotic-assisted surgery becomes a standardised option for surgeons in an increasing number of indications, will allow me to serve as a champion for increased patient access here in the UK and Ireland,” he continued.

Before joining Intuitive Surgical, Mr. Bradshaw worked at Medtronic as Strategic Alliance Director for EMEA within the Integrated Health Solutions Division. Prior to Medtronic, he established the Head & Neck Division at Stryker UK, working in the Neurosurgical and Cranio-maxillio facial market. Additionally, Mr. Bradshaw spent 18 years with Synthes, a medical device company specialising in orthopaedics, where he fulfilled a variety of graduated sales and marketing positions, including GM roles in both the UK and Portugal.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, California, is the pioneer in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci Surgical System. The Company’s mission is to make surgery more effective, less invasive and easier on surgeons, patients and their families.

About the da VinciSurgical System

There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

© 2018 Intuitive Surgical, Inc. All rights reserved. Intuitive Surgical^®, da Vinci^®, da Vinci S^®, da Vinci^® Si^™, da Vinci Xi^®, da Vinci X^®, OnSite^® and EndoWrist^® are trademarks or registered trademarks of Intuitive Surgical, Inc.

For more information, please visit the company’s web site at www.intuitivesurgical.com.

Important Safety Information

Serious complications may occur in any surgery, including da Vinci^®Surgery, up to and including death. Risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications. Individual surgical results may vary. Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci^®Surgery. Patients should talk to their doctors to decide if da Vinci^®Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. Please also refer to www.daVinciSurgery.com/Safety for Important Safety Information.

Contacts

For Intuitive Surgical:
JPA Health Communications
Kate Perry, 020 3884 0650
isipr@jpa.com

Month: March 2018

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