John Masonis, MD to Educate on Direct Anterior Approach Hip Replacement Using OrthoGrid’s HipGrid™ System at AAOS 2017

Posted On March 10, 2017 By OrthoSpineNews In Recon /

SALT LAKE CITY, March 9, 2017 /PRNewswire/ — OrthoGrid Systems, Inc., a leading innovator of medical imaging technology for orthopedics, is excited to announce its exhibition at Booth #649 on March 15-17 at the American Association of Orthopedic Surgeons (AAOS) 2017 Annual Meeting in San Diego, CA.

OrthoGrid will be showcasing its unique and proprietary HipGrid™ System, a patented image-enhancement device engineered to help orthopedic surgeons improve acetabular cup angle, leg length, and hip offset. The HipGrid™ System has also been shown to reduce average surgical time and is widely utilized in the Direct Anterior Approach Hip Arthroplasty, a fast-growing technique that accounts for nearly a third of all hip replacement surgeries in the USA.¹

In addition to the HipGrid™ System technical exhibit, OrthoGrid is pleased to offer an educational lecture by renowned physician John Masonis, MD, of OrthoCarolina in Charlotte, NC, in which he will discuss the effective use of fluoroscopy in Direct Anterior Approach Hip Arthroplasty and the proper application of OrthoGrid’s HipGrid™ System.

“OrthoGrid’s unique HipGrid™ System has tremendous potential to aid physicians with implant positioning and component placement in total hip arthroplasty procedures. By attaching directly to mobile C-Arm systems and providing instantaneous feedback, surgeons can anticipate greater confidence in limb alignment and leg length, two key metrics that directly influence surgical outcomes and patient satisfaction,” explained Edouard Saget, President of OrthoGrid Systems.”

The HipGrid™ is available for sale in the USA through OrthoGrid’s rapidly expanding distributor network. Please visit our website at www.orthogrid.com to learn more about our company and how to schedule a free product trial.

Reference: Gililland JM, Anderson LA, Boffeli SL, Pelt CE, Peters CL & Kubiak EN. 2012. A Fluoroscopic Grid in Supine Total Hip Arthroplasty: Improving Cup Position, Limb Length and Hip Offset. J Arthroplasty, Sep 27 (8 Suppl): 111-6.

About OrthoGrid Systems, Inc.
OrthoGrid Systems is a rapidly expanding global leader in orthopedic imaging technology with specialized applications available or in development for hip arthroplasty, trauma, knee replacement, and other common procedures performed over 1 million times per year in aggregate in the USA and 3 million times globally. OrthoGrid helps to overcome the limitations of traditional low resolution, distorted imaging technology by providing computerized image correction and image guidance direction to physicians performing orthopedic procedures. Learn more about OrthoGrid and our products by visiting our website at www.orthogrid.com.

Media Contact: Edouard Saget, President
Email: 149737@email4pr.com
Phone: 801-703-5866

SOURCE OrthoGrid Systems

Vertiflex, Inc. Completes $40 Million Financing Round

Posted On March 9, 2017 By OrthoSpineNews In Financial /

March 08, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex, Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, today announced completion of a $40M financing round. New investors, Endeavour Vision and H.I.G. BioHealth Partners led the financing alongside existing investors, New Enterprise Associates; Thomas, McNerney & Partners; and Alta Partners. Proceeds from the financing will primarily be used to fund U.S. commercial expansion of the company’s Superion® Indirect Decompression System, a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis, a painful and often debilitating condition that affects an estimated 500,000 new patients every year in the United States.

“Vertiflex has seen tremendous early success in the commercialization of the Superion System,” said Earl Fender, President and CEO of Vertiflex. “With favorable long-term clinical outcomes, a new Category I AMA CPT code and broad reimbursement in place, adoption of Superion has continued at a rapid and steady pace, driven by significant interest from both patients and treating physicians.”

Once implanted, Superion is intended to reduce pressure on the affected nerves and allow patients to return to a more active lifestyle. Following completion of a successful 391 patient randomized controlled trial, the Superion System received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA), and starting January 2017 the system is described by a new American Medical Association (AMA) Current Procedural Terminology (CPT) Category I code.

“I’m also excited to see continued momentum with our current investors who have steadfastly supported the company to date, and look forward to working closely with our new investors to realize the potential for the Superion System, as we further invest in the commercial expansion of an important treatment option for physicians and patients,” Fender added.

To accommodate its accelerating growth, Vertiflex recently relocated its corporate headquarters from San Clemente, CA, to a larger facility in Carlsbad, CA. The new location includes expanded distribution capability, and a state-of-the-art physician education center, as part of the company’s commitment to supporting physicians by providing didactic as well as hands-on cadaver training with Superion.

Nick Shamie, M.D., Chief of Orthopedic Spine Surgery and Professor of Orthopedic Surgery and Neurosurgery at UCLA School of Medicine, stated, “The Superion System offers patients a minimally invasive solution to treat leg pain associated with spinal stenosis. The implant, placed through a small tube the size of a dime, does not deconstruct any of the anatomical elements and provides immediate relief. I incorporated this treatment into my practice after seeing the clinical data from the FDA IDE clinical trial. The safety, efficacy, and five-year durability that the data presented made it a procedure I can stand behind.”

About Vertiflex, Inc.

Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, CA, Vertiflex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery. To date, Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflexspine.com.

About New Enterprise Associates

As one of the world’s largest and most active venture capital firms, NEA has developed deep domain expertise and insight into multiple industries. The NEA team channels that knowledge into every technology and healthcare investment they make – at any stage, in any location, around the globe. Visit www.nea.com.

About Endeavour Vision SA

Endeavour Vision is a growth investor in exceptional private medtech companies, and an ideal partner for medtech entrepreneurs. Headquartered in Geneva, Switzerland, with a presence in the United States, the Endeavour Vision team comprises experienced investors, seasoned entrepreneurs, and medtech specialists, all committed to helping entrepreneurs grow and develop thriving businesses. Endeavour’s latest $275 million fund is fully dedicated to investing in European and U.S. medtech companies that seek worldwide growth and aim to improve the quality and cost of care for patients across the globe.

About H.I.G. BioHealth Partners

H.I.G. BioHealth Partners is the dedicated life-science investment affiliate of H.I.G. Capital. H.I.G. BioHealth Partners invests in a broad range of healthcare opportunities across sectors and stages, principally in companies developing therapeutic drugs, medical devices, and diagnostics for significant unmet medical needs. With approximately $400 million in committed capital, H.I.G. BioHealth Partners invests $5 million to $40 million per company over the life of an investment. Visit www.higbio.com.

Contacts

Vertiflex, Inc.
Kathryn Larson, (442) 325 5900
info@vertiflexspine.com

DJO Global Announces Financial Results for Fourth Quarter and Fiscal Year End 2016

Posted On March 9, 2017 By OrthoSpineNews In Financial /

March 08, 2017

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, 2016.

Fourth Quarter Highlights

Net sales were $296.5 million, reflecting a decline of 3.7% as reported and growth of 3.3% on a sales per day constant currency basis
Net loss was $202.1 million, including goodwill impairment charges and non-cash inventory reserve adjustments totaling approximately $178.0 million
Adjusted EBITDA was $59.5 million
Business Transformation Office established, key priorities identified for 2017 and execution underway

Full Year Highlights

Net sales were $1.16 billion, reflecting 3.7% growth as reported and growth of 4.2% on a constant currency basis
Net loss was $286.3 million, including goodwill impairment charges and non-cash inventory reserve adjustments totaling approximately $178.0 million
Adjusted EBITDA was $235.3 million

“We saw continued growth across our global business in 2016,” said Brady Shirley, DJO’s President and Chief Executive Officer. “That is a testament to DJO’s strong brand recognition, great products and rapid growth in our Surgical Implant business, as well as a talented team of employees. Looking forward, we recognize that we need to make a step change improvement in our business to strengthen our long-term financial performance. Today we are taking bold steps to transform our business by focusing on four core priorities – liquidity, profitability, customer experience and growth.”

Mr. Shirley added, “When this transformation is complete, we will look very different than we do today. We will balance our priorities of improved liquidity, profitability, customer experience and above-market growth through a more efficient and effective organization. While these actions will take time to implement, we are executing them with the appropriate sense of urgency, led by an experienced leadership team, including numerous new additions who have specific transformation expertise. I’m excited about our vision for the future and I am confident that the steps we are taking today will position us to deliver sustainable value to our customers, our shareholders and our employees in the years to come.”

Business Transformation

Today the Company announced that it has embarked on an aggressive business transformation to improve liquidity, profitability, customer experience and growth. This business transformation will focus on delivering end-to-end productivity across the Company, including removing 7% to 10% of annualized cost across the entire organization by the end of 2018. While there will be certain one-time costs and investments required as part of the transformation, the Company has identified cost savings and working capital initiatives that are expected to exceed the cost to achieve these activities.

The Company is addressing the following priorities through this transformation:

Liquidity and Working Capital Improvements
Organizational Effectiveness
Procurement Spend Optimization
Manufacturing, Distribution and Sales and Operations Planning
Customer and Product Profitability Improvements

“We are entering a new era for DJO and I am excited to help lead the overall business transformation,” said Mike Eklund, DJO’s Chief Operating Officer and Chief Financial Officer. “We have been working diligently over the last couple of months to clearly identify our performance ambitions from a business and a financial point of view. Today, we have a bottoms-up plan, including tactics, resources, leadership talent and investments, and we are in execution mode. We have a great brand, great products, positive culture and an experienced leadership team. With that base, I am confident that we can quickly solve the challenges ahead of us and unleash the full potential of DJO’s incredible brands and deliver sustainable growth.”

Sales Results

DJOFL achieved net sales for the fourth quarter of 2016 of $296.5 million, reflecting as reported decline of 3.7%, compared with net sales of $308.0 million for the fourth quarter of 2015. Additionally, the fourth quarter of 2016 included 61 shipping days, while the comparable period in 2015 included 65 shipping days. On the basis of constant currency and selling days, sales in the fourth quarter of 2016 grew approximately 3.3% over sales in the fourth quarter of 2015. For the twelve months ended December 31, 2016, DJOFL achieved net sales of $1.16 billion, reflecting as reported growth of 3.7% and constant currency growth of 4.2%, compared to net sales of $1.11 billion for the twelve months ended December 31, 2015.

Net sales for DJO’s Bracing and Vascular segment were $132.2 million in the fourth quarter of 2016, a reported decline of 7.6%, compared to the fourth quarter of 2015. On the basis of selling days, sales declined 1.5%, reflecting positive growth in the DonJoy brand offset by continued market pressures in the Dr. Comfort Diabetic Footwear business. For the full year of 2016, net sales in this segment were $522.6 million, down 0.7% compared to 2015, also reflecting growth in the DonJoy brand, offset by challenges in the Dr. Comfort business during the second half of 2016.

Net sales for DJO’s Recovery Sciences segment were $42.2 million in the fourth quarter of 2016, a decline of 3.4%, compared to the fourth quarter of 2015. On the basis of selling days, sales grew 2.9%, reflecting strong growth in our Consumer business, offset by continued pressure in our Regen business. For the full year of 2016, net sales in this segment were $157.0 million, reflecting growth of 0.5%, compared to the full year of 2015.

Net sales for the Surgical Implant segment were $48.0 million for the fourth quarter of 2016, representing 13.8% growth over net sales in the fourth quarter of 2015. On the basis of selling days, sales grew 21.3%. For the full year of 2016, net sales for the Surgical Implant segment were $174.5 million, an increase of 29.4% over 2015, driven by strong sales of each of the Company’s shoulder, knee and hip product lines.

Net sales for DJO’s International segment were $74.1 million in the fourth quarter of 2016, a decline of 6.3% over net sales in the fourth quarter of 2015. On the basis of selling days and constant currency, sales grew 2.5%. For the full year of 2016, net sales for the International segment were $301.2 million, an increase of 1.7% over 2015, or 3.4% growth on a constant currency basis, reflecting stronger sales in most direct markets, offset by continued pressure in our export markets.

Earnings Results

For the fourth quarter of 2016, DJOFL reported a GAAP net loss attributable to DJOFL of $202.1 million, compared to a net loss of $49.6 million for the fourth quarter of 2015. The increase in the net loss was due primarily to impairments of goodwill of $160.0 million related to the Company’s CMF and Vascular businesses, as well as non-cash reserve adjustments of $18.0 million primarily related to changes in inventory methodology as part of the business transformation. For the twelve months of 2016, DJOFL reported a net loss attributable to DJOFL of $286.3 million, compared to a net loss attributable to DJOFL of $340.9 million for the twelve months of 2015. 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 2016 was $59.5 million, compared with Adjusted EBITDA of $68.9 million in the fourth quarter of 2015. Adjusted EBITDA for the twelve months of 2016 was $235.3 million, compared to Adjusted EBITDA of $239.9 million for the twelve months of 2015. Including the projected future savings from cost savings programs currently underway as permitted under our credit agreement, Adjusted EBITDA for the twelve months ended December 31, 2016, was $244.9 million, compared with Adjusted EBITDA of $249.0 million for the twelve months ended 2015.

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 senior secured credit facilities (“Senior Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. Reconciliation between net loss and Adjusted EBITDA is included in the attached financial tables.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 4:00 pm Eastern Time, Wednesday, March 8, 2017. 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 after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic specialists, spine 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, 2015, filed with the Securities and Exchange Commission on March 25, 2016. 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,
	2016			2015			2016			2015
Net sales	$	296,490		$	307,951		$	1,155,288		$	1,113,627
Costs and operating expenses:
Cost of sales (exclusive of amortization see note 1)		150,324			132,126			511,414			466,019
Selling, general and administrative		132,349			125,223			490,693			454,724
Research and development		9,253			9,955			37,710			35,105
Amortization of intangible assets		18,869			20,076			76,526			79,964
Impairment of goodwill		160,000			—			160,000			—
		470,795			287,380			1,276,343			1,035,812
Operating (loss) income		(174,305	)		20,571			(121,055	)		77,815
Other (expense) income:
Interest expense, net		(42,733	)		(42,733	)		(170,082	)		(172,290	)
Loss on modification and extinguishment of debt		—			(171	)		—			(68,473	)
Other expense, net		(3,266	)		(834	)		(2,534	)		(7,303	)
		(45,999	)		(43,738	)		(172,616	)		(248,066	)
Loss before income taxes		(220,304	)		(23,167	)		(293,671	)		(170,251	)
Income tax (benefit) provision		(18,009	)		2,276			(6,853	)		12,256
Net loss from continuing operations		(202,295	)		(25,443	)		(286,818	)		(182,507	)
Net income (loss) from discontinued operations		331			(23,909	)		1,138			(157,580	)
Net loss		(201,964	)		(49,352	)		(285,680	)		(340,087	)
Net income attributable to noncontrolling interests		(162	)		(234	)		(623	)		(840	)
Net loss attributable to DJO Finance LLC	$	(202,126	)	$	(49,586	)	$	(286,303	)	$	(340,927	)

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $6,981 and $28,525 for the three months and twelve months ended December 31, 2016, and $7,785 and $30,719 for the three and twelve months ended December 31, 2015, respectively.


DJO Finance LLC Unaudited Condensed Consolidated Balance Sheets (In thousands)

	December 31,
	2016			2015
Assets
Current assets:
Cash and cash equivalents	$	35,212		$	48,943
Accounts receivable, net		178,193			172,360
Inventories, net		151,557			174,573
Prepaid expenses and other current assets		23,650			21,179
Current assets of discontinued operations		511			2,878
Total current assets		389,123			419,933
Property and equipment, net		128,019			117,273
Goodwill		855,626			1,018,104
Intangible assets, net		672,134			749,045
Other assets		5,536			5,174
Non current assets of discontinued operations		—			29
Total assets	$	2,050,438		$	2,309,558

Liabilities and Deficit
Current liabilities:
Accounts payable	$	63,822		$	58,492
Accrued interest		16,740			16,998
Current portion of debt obligations		10,550			10,550
Other current liabilities		113,265			102,173
Current liabilities of discontinued operations		—			13,371
Total current liabilities		204,377			201,584
Long-term debt obligations		2,392,238			2,344,562
Deferred tax liabilities, net		202,740			213,856
Other long-term liabilities		14,932			15,092
Total liabilities	$	2,814,287		$	2,775,094
Commitments and contingencies
Deficit:
DJO Finance LLC membership deficit:
Member capital		844,294			841,510
Accumulated deficit		(1,579,642	)		(1,293,339	)
Accumulated other comprehensive loss		(30,580	)		(16,341	)
Total membership deficit		(765,928	)		(468,170	)
Noncontrolling interests		2,079			2,634
Total deficit		(763,849	)		(465,536	)
Total liabilities and deficit	$	2,050,438		$	2,309,558


DJO Finance LLC Unaudited Segment Information (In thousands)

	Three Months Ended December 31,						Twelve Months Ended December 31,
	2016			2015			2016			2015
Net sales:
Bracing and Vascular	$	132,212		$	143,008		$	522,600		$	526,295
Recovery Sciences		42,181			43,672			156,998			156,194
Surgical Implant		48,026			42,195			174,503			134,843
International		74,071			79,076			301,187			296,295
	$	296,490		$	307,951		$	1,155,288		$	1,113,627

Operating (loss) income:
Bracing and Vascular	$	22,134		$	31,496		$	102,133		$	115,791
Recovery Sciences		10,760			9,717			32,944			29,035
Surgical Implant		11,431			9,000			32,621			25,531
International		10,565			11,333			45,864			48,578
Expenses not allocated to segments and eliminations		(229,195	)		(40,975	)		(334,617	)		(141,120	)
	$	(174,305	)	$	20,571		$	(121,055	)	$	77,815

DJO Finance LLC
Adjusted EBITDA
For the Three and Twelve Months Ended December 31, 2016 and 2015
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,041.8 million term loan facility (including a $20.0 million delayed draw term loan facility) and a $150.0 million asset-based revolving credit facility, under which $82.0 million was outstanding as of December 31, 2016, and the Indentures governing our $1,015.0 million of 8.125% second lien notes, $298.5 million of 10.75% third lien notes (collectively, the “notes”) represent significant components of our capital structure. Under our Senior Secured Credit Facilities, we are required to maintain a specified senior secured first lien leverage ratio, which is determined based on our Adjusted EBITDA. If we fail to comply with the senior secured first lien leverage ratio under our Senior Secured Credit Facilities, we would be in default. Upon the occurrence of an event of default under the Senior Secured Credit Facilities, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facilities to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facilities could proceed against the collateral granted to them to secure that indebtedness. We have pledged substantially all of our assets as collateral under the Senior Secured Credit Facilities and under the notes. Any acceleration under the Senior Secured Credit Facilities would also result in a default under the Indentures governing the notes, which could lead to the note holders electing to declare the principal, premium, if any, and interest on the then outstanding notes immediately due and payable. In addition, under the Indentures governing the notes, our and our subsidiaries’ ability to engage in activities such as incurring additional indebtedness, making investments, refinancing subordinated indebtedness, paying dividends and entering into certain merger transactions is governed, in part, by our ability to satisfy tests based on Adjusted EBITDA. Our ability to meet the covenants specified in the Senior Secured Credit Facilities and the Indentures governing those notes will depend on future events, some of which are beyond our control, and we cannot assure you that we will meet those covenants.

Adjusted EBITDA is defined as net income (loss) 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 and other ratios under our Senior Secured Credit Facilities and the Indentures governing the notes. We believe that the presentation of Adjusted EBITDA is appropriate to provide additional information to investors about the calculation of, and compliance with, certain financial covenants and other ratios in our Senior Secured Credit Facilities and the Indentures governing the notes. Adjusted EBITDA is a material component of these calculations.

Adjusted EBITDA should not be considered as an alternative to net income (loss) or other performance measures presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”), or as an alternative to cash flow from operations as a measure of our liquidity. Adjusted EBITDA does not represent net income (loss) or cash flow from operations as those terms are defined by GAAP and does not necessarily indicate whether cash flows will be sufficient to fund cash needs. In particular, the definition of Adjusted EBITDA under our Senior Secured Credit Facilities and the Indentures governing the notes allows us to add back certain non-cash, extraordinary, unusual or non-recurring charges that are deducted in calculating net income (loss). However, these are expenses that may recur, vary greatly and are difficult to predict. While Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation.

The following table provides reconciliation between net loss and Adjusted EBITDA:

	Three Months Ended December 31,						Twelve Months Ended December 31,
(in thousands)	2016			2015			2016			2015
Net loss attributable to DJO Finance LLC	$	(202,126	)	$	(49,586	)	$	(286,303	)	$	(340,927	)
Net loss (income) from discontinued operations		(331	)		23,909			(1,138	)		157,580
Interest expense, net		42,733			42,733			170,082			172,290
Income tax (benefit) provision		(18,009	)		2,276			(6,853	)		12,256
Depreciation and amortization		29,685			32,039			117,893			117,455
Non-cash charges (a)		179,458			1,073			182,399			3,403
Non-recurring and integration charges (b)		22,843			13,320			48,675			33,976
Other adjustment items (c)		5,251			3,101			10,553			83,908
		59,504			68,865			235,308			239,941
Permitted pro forma adjustments (d)
Future cost savings								9,620			9,050
Adjusted EBITDA	$	59,504		$	68,865		$	244,928		$	248,991

(a) Non-cash charges are comprised of the following:

	Three Months Ended December 31,					Twelve Months Ended December 31,
(in thousands)	2016			2015		2016		2015
Stock compensation expense	$	1,382		$	355	$	3,188	$	1,805
Impairment of goodwill (1)		160,000			—		160,000		—
Inventory adjustments (2)		18,013			—		18,013		—
Purchase accounting adjustments (3)		(637	)		610		249		821
Loss on disposal of assets, net		700			108		949		777
Total non-cash items	$	179,458		$	1,073	$	182,399	$	3,403

(1)			Impairment of goodwill and intangible assets for the year ended December 31, 2016, consisted of a goodwill impairment charge of $99.0 million and $61.0 million related to the CMF and Vascular reporting units, respectively. The impairment charge for our CMF reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to disruption caused by our exit of the Empi business. The impairment charge for our Vascular reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to a loss of revenue caused by disruption as we transitioned our Dr. Comfort therapeutic footwear manufacturing and distribution to a new ERP system and market pressure in the therapeutic shoe market.
(2)			In the fourth quarter of fiscal 2016, current management implemented a new strategy relating to our procurement, manufacturing and liquidation philosophies in order to significantly reduce inventory levels. Historically, our strategy was to purchase inventory in large quantities to capture purchase discounts and rebates and provide an expansive mix of products for our customers. Our new strategy aims to integrate our supply chain services with customer demand through focused forecasted consumption and sales efforts, therefore limiting the range of SKUs we plan to offer. As a result of these changes, the Company recorded a charge to cost of sales and corresponding reduction in inventory of approximately $18.0 million. The E&O reserve expense in fiscal 2016 included $5.7 million related to the Company’s decision to discontinue certain SKUs mainly within the Bracing and Vascular product lines, $8.3 million related to holding inventory for shorter periods and the planned scrapping of long-dated inventory, $2.0 million related to new Surgical Implant products that changed the expected life cycle of its current product portfolio, and $2.0 million of slow moving consigned inventory within certain OfficeCare clinics.
(3)			Purchase accounting adjustments consisted of amortization of fair market value inventory adjustments for all periods presented.

(b) Non-recurring and integration charges are comprised of the following:

	Three Months Ended December 31,				Twelve Months Ended December 31,
(in thousands)	2016		2015		2016		2015
Integration charges:
Global business unit reorganization and integration	$	5,796	$	1,618	$	9,794	$	8,596
Acquisition related expenses and integration (1)		1,495		4,653		10,350		8,635
CFO transition		1,851		—		2,805		—
CEO transition		2,051		—		2,051		—
Litigation and regulatory costs and settlements, net (2) (3)		5,500		4,974		16,562		8,864
Other non-recurring items (4) (5)		6,149		1,079		7,044		4,247
ERP implementation and other automation projects		1		996		69		3,634
Total non-recurring and integration charges	$	22,843	$	13,320	$	48,675	$	33,976

(1)			Consists of direct acquisition costs and integration expenses related to acquired businesses and costs related to potential acquisitions.
(2)			For the twelve months ended December 31, 2016, litigation and regulatory costs consisted of $2.6 million in litigation costs related to ongoing product liability issues and $14.0 million related to other litigation and regulatory costs and settlements.
(3)			For the twelve months ended December 31, 2015, litigation and regulatory costs consisted of $3.5 million in litigation costs related to ongoing product liability issues and $5.4 million related to other litigation and regulatory costs and settlements.
(4)			For the twelve months ended December 31, 2016, other non-recurring items consisted of $4.3 million in specifically identified non-recurring operational and regulatory projects and $2.8 million in professional fees and other non-recurring charges.
(5)			For the twelve months ended December 31, 2015, other non-recurring items consisted of $4.2 million in specifically identified non-recurring operational and regulatory projects.

	Three Months Ended December 31,				Twelve Months Ended December 31,
(in thousands)	2016		2015		2016		2015
Blackstone monitoring fee	$	1,750	$	1,750	$	7,000	$	7,000
Noncontrolling interests		162		234		623		840
Loss on modification and extinguishment of debt (1)		—		171		—		68,473
Other (2)		3,339		946		2,930		7,595
Total other adjustment items before permitted pro forma adjustments	$	5,251	$	3,101	$	10,553	$	83,908

(1)			Loss on modification and extinguishment of debt for the twelve months ended December 31, 2015, consisted of $47.8 million in premiums related to the redemption of our 8.75% Notes, 9.875% Notes and 7.75% Notes, $11.9 million related to the non-cash write off of unamortized debt issuance costs and original issue discount associated with the portion of our debt that was extinguished, and $8.8 million of arrangement and amendment fees and other fees and expenses incurred in connection with the refinancing.
(2)			Other adjustments consist primarily of net realized and unrealized foreign currency transaction gains and losses.

(d) Permitted pro forma adjustments include future cost savings for the year ended December 31, 2016, related to the exit of our Empi business and the restructuring of our Recovery Sciences segment. Permitted pro forma adjustments include future cost savings for the year ended December 31, 2015, related to the exit of our Empi business.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
(760) 734-3075
ir@djoglobal.com

Study Finds Wide Use of Computed Tomography (CT) for Post-Operative Assessment of Spine Surgery, Despite Radiation Risks for Patients

Posted On March 9, 2017 By OrthoSpineNews In Spine, Top Stories /

March 08, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical, Inc., maker of the Simplify® cervical artificial disc designed to be clearly viewed on MRI with minimal artifact, announced findings from a new study published in BMC Musculoskeletal Disorders that is the first to estimate the magnitude of computed tomography (CT) imaging for post-operative assessment of spine surgery, which exposes patients to high doses of radiation. The Simplify Disc is considered an investigational device in the U.S.

The study found that CT prevalence following complex spine surgery increased more than two-fold from six months to five years, with patients averaging two scans over that period. Each CT scan has been estimated to deliver the equivalent radiation of 400 to 550 chest X-rays to the patient. The retrospective study utilized data drawn from a Humana database covering eight consecutive years from 2007 through 2014 and comprising adjudicated claims for more than 130,000 complex spine procedures.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, surgeons often switch to CT post-operatively because spinal implants usually include metal components. The metal creates artifacts in the MRI image, making the implants difficult to view and affecting visualization of the facets and adjacent levels.

The study authors state, “We detected a high frequency of CT utilization following complex spine surgery. There is emerging evidence of an increased cancer risk due to ionizing radiation exposure with CT. Thus, in the setting of complex spine surgery, actions to mitigate this risk should be considered…(including) adopting non-ferromagnetic implant biomaterials that facilitate MRI post-operatively.”

One device that may minimize the need for post-surgical CT scans is the Simplify Disc, a cervical artificial disc designed to be clearly viewed on MRI without artifact. Composed of PEEK-on-ceramic materials, the Simplify Disc is intended to minimize patient exposure to high-dose ionizing radiation from CT and its associated risks. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. The Simplify Disc is anatomically designed with low height implant options for patients with smaller cervical disc spaces for whom larger implants are not optimal.

The Simplify Disc is currently enrolling patients in a non-randomized pivotal clinical trial in the U.S. – where all patients will receive the device – comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. More information about the clinical trial is available at www.SimplifyTrial.com.

The Simplify Disc has received the CE Mark and has been used to treat 600 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores after treatment.

The Simplify Disc is designed to comply with two principles developed by the International Committee on Radiological Protection and endorsed by the U.S. Food and Drug Administration (FDA), which mandate that exams using ionizing radiation – such as CT – be performed only when medically necessary, and that patients should be exposed to the lowest possible radiation.

The BMC Musculoskeletal Disorders article was authored by Vikas Patel, MD, of the University of Colorado Hospital, Denver; Gunnar Andersson, MD, of Rush University Medical Center, Chicago; Steven Garfin, MD, and Donald Resnick, MD, both with the University of California, San Diego; and Jon Block, Ph.D.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit www.simplifymedical.com.

Caution: The Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications
Michelle McAdam, 949-545-6654
michelle@chronic-comm.com

Invibio: FDA reclassified semi-rigid spinal stabilization systems providing new possibilities for treating patients

Posted On March 9, 2017 By OrthoSpineNews In Regulatory, Spine /

THORNTON CLEVELEYS (UK) (PRWEB) MARCH 08, 2017

The US Food and Drug Administration (FDA) has recently reclassified semi-rigid spinal stabilization systems from Class III to Class II (*) offering a regulatory pathway to 510(k) clearance in the United States for innovative devices using PEEK-OPTIMA™ polymer based rods from Invibio Biomaterial Solutions (“Invibio”). When compared to rigid systems, semi-rigid PEEK-OPTIMA rods can deliver similar benefits to titanium and are strong enough to stabilize the spine. The FDA decision supports the safety of semi-rigid systems and provides greater options for surgeons who prefer more flexibility than traditional rigid pedicle screw systems to achieve fusion.

Invibio collaborated closely with medical device manufacturers and the FDA to provide clinical and biomechanical data in support of the use of semi-rigid PEEK-OPTIMA rods for spinal stabilization. The pioneering development and reclassification is expected to assist the medical profession in achieving progress in enhanced spinal fusion systems and procedures.

Clinical evidence: Invibio to support OEMs further with their submissions to the FDA

“The down classification of PEEK-OPTIMA rods as a Class II technology for spinal fusion is a welcome and progressive development for the medical device market. Substantial evidence was presented in reaching this conclusion, including data from over 51,000 PEEK rod implantations. We now have a growing body of clinical evidence that systems based on Invibio´s PEEK-OPTIMA rods have clearly defined advantages over all-metal constructs and have the potential to drive the future of posterior spine stabilization,” commented John Devine, Invibio medical business director.

“Healthcare globally is under pressure to control costs which is why Invibio offers PEEK-OPTIMA spinal rod components to the manufacturer. Compiling evidence that supports the safety and clinical benefits of our materials enables us to also provide an efficient route to market for our customers in terms of manufacturing and regulatory clearance. We look forward to working with our customers to achieve clearance for semi-rigid systems in order to offer improved options for surgeons and ultimately patients,” concluded Devine.

Metal alternative offers distinct advantages

For some time, the medical profession has been aware that spinal-rod components made from PEEK-OPTIMA polymers may be used as an alternative to metal to achieve semi-rigid fixation with posterior pedicle screw systems as an adjunct to fusion. And in fact, they offer distinct advantages over stabilization systems constructed from a metal such as titanium.

“PEEK-polymer solutions are widely recognized for spinal interbody fusion and are frequently used. The versatile PEEK-OPTIMA has a modulus close to that of human bone, and this allows it to be a natural bridge between very rigid metal implants, such as the titanium constructs, and more dynamic approaches. In fact, PEEK-polymer implants offer numerous benefits, including radiolucency, which of course metals don’t allow, while retaining the stability of titanium,” commented Dr. Thierry Desjardins, Neurosurgeon (Cagnes-sur-Mer, France), who has been using PEEK-OPTIMA spinal rods since June 2011 and has always been reluctant to use too rigid a system as this could accelerate degeneration at adjacent spinal segments.

Semi-rigid rods to bridge treatment gap: improved load sharing can encourage fusion

Spinal rods composed of metal are not without challenges, including, but not limited to, rod breakage, the loosening of screws, and accelerated degeneration at adjacent spinal segments. The high stiffness inherent in all-metal constructs is believed to contribute to these clinical challenges and negatively impact patient outcomes.1,2 In addition, a metal such as titanium lacks artifact-free imaging, and inevitably this impacts the ability of surgeons to position stabilization systems accurately.

PEEK-OPTIMA polymer based stabilization, on the other hand, effectively functions as a ‘bridge’ approach. Rods made from the material have sufficient strength to reduce the range of motion2,3 in order to stabilize the treated segment4, but possessing a modulus similar to that of cortical bone, they still allow physiological movement on adjacent upper and lower segments.3 As a result, clinical results increasingly suggest that PEEK-OPTIMA spinal rod components preserve or slow down the degeneration of adjacent discs.5 As a consequence, patients may benefit from improved load sharing to encourage fusion,2,6,7 and more physiologic loading at adjacent levels, which may decelerate degeneration.8,9

To learn more, please visit Invibio at the AAOS Annual Meeting – Booth 3545 – March 15-17, 2017

For more information please visit http://bridgethefusiongap

(*) The US Food and Drug Administration (FDA) renamed dynamic stabilization systems as “semi-rigid systems,” and defined them as a sub-type of pedicle screw systems, now referenced as “thoracolumbosacral pedicle screw systems”.
Further information for the final ruling can be found at “Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems.”

REFERENCES
1.Highsmith JM, et al. (2007). Flexible rods and the case for dynamic stabilization. Neurosurgical Focus, 22, 1-5.
2.Gornet MF, et al. (2011). Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs. Journal of Biomechanical Engineering, 133, 1-12.
3.Ponnapan RK, et al. (2009). Biomechanical evaluation and comparison of polyetheretherketone rod system to traditional titanium rod fixation. The Spine Journal, 9, 263-267.
4.Turner JL, et al. (2010). The mechanical effect of commercially pure titanium and polyetheretherketone rods on Spinal implants at the operative and adjacent levels. Spine, 35(21), E1076-E1082.
5.Athanasakopoulos M, et al. (2013) Posterior Spinal Fusion Using Pedicle Screws. Orthopedics, 36, e951-e957. doi: 10.3928/01477447-20130624-28
6.Moumene M, et al. (2008). Biomechanical Advantages of Expedium PEEK Rods. DePuy Spine, Inc.
7.Galbusera F, et al. (2010). Rigid and Flexible Spinal Stabilization Devices: A Biomechanical Comparison. Medical Engineering & Physics, 33, 490-496.
8.Ormond DR, et al. Polyetheretherketone (PEEK) rods in lumbar spine degenerative disease: a case series. J Spinal Disord Tec, 12(8), 693-701.
9.De Iure F, et al. (2012). Posterior lumbar fusion by PEEK rods in degenerative spine: preliminary report on 30 cases. Eur Spine J, 21(1), S50-S54.
10.Greene RJ, et al. (2011). Photoelastic Analysis of the Full-field Stress Distribution Induced by a Spinal Implant Construct. Poster #746 presented at the 2011 Orthopaedic Research Society Annual Meeting.

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in more than five million implanted devices worldwide.

About Victrex plc
Victrex, headquartered in the UK, is an innovative world leader in high performance polymer solutions focused on the Aerospace, Automotive, Electronics, Energy and Medical markets. Every day, millions of people rely on products or applications which contain our polymers, from smartphones, aeroplanes and cars to oil & gas operations and medical devices. With over 35 years’ experience, we are delivering leading edge solutions to shape future performance for our customers and our markets, and to drive value for our shareholders. Find out more at http://www.victrexplc.com

Consensus Launches First To Market Orthopedic Post-Surgical Wearable Device

Posted On March 9, 2017 By OrthoSpineNews In Recon /

SACRAMENTO, CA (PRWEB) MARCH 08, 2017

El Dorado Hills, CA, March 8th, 2017: Consensus Orthopedics, a joint reconstruction manufacturer, proudly announces its entry into the orthopedic wearable devices market. TracPatch is a groundbreaking wearable device that remotely monitors a patient’s post-surgical activities by continuously sending activity data, including range of motion (ROM), ambulation, exercise compliance, and wound site temperature trends. Healthcare Providers will now have insight 24/7 into how a patient is recovering from total joint surgery, thus improving outcomes and reducing costs. The TracPatch wearable device system will be debuted at next week’s American Academy of Orthopedic Surgeons Annual Meeting in San Diego, CA, March 14th-17th, 2017, Booth #1233.

The first six weeks of at-home recovery after total joint surgery are critical for a positive outcome. Visibility into the patient’s at-home activity is nonexistent. This limited insight along with the emergence of value-based medicine, including programs such as Comprehensive Care for Joint Replacement (CJR), signifies a new paradigm shift in cost control and responsibility for hospitals and surgeons. The Centers for Medicare & Medicaid Services, CMS, is sending a clear message with CJR: they want hospitals and post-acute providers to partner and coordinate for a patient’s entire 90-day episode of care. Through an IoT (Internet of Things) approach, TracPatch helps both the patient and healthcare provider coordinate care and accountability.

The TracPatch device is placed on the lower leg just below the joint line, using non-allergenic adhesive disposable pad. TracPatch is designed to enable any healthcare provider to collectively and continuously monitor their TracPatch patients’ progress. TracPatch will record patient’s range of motion (ROM), ambulation, exercise compliance, and temperature trends regardless of what implant system is used.

This machine learning device optimizes the patient’s entire episode of care by enabling a proactive approach. Whether the recovery is going well or needs immediate attention, the healthcare provider can adjust the patient’s post-surgical activities and goals anytime, anywhere to better facilitate and improve the patient’s recovery. The device transmits key post-surgical data points directly to a secure cloud-based platform, where healthcare providers can track patient progress on the TracPatch mobile app or web dashboard. The TracPatch app features an intuitive interface for easy operation on any smart phone or tablet with Bluetooth technology.

Dr. Shervin Oskouei, MD, Dept. of Orthopedic Surgery, Emory University School of Medicine, said “TracPatch can add tremendous value to the entire episode of care. This technology allows a healthcare provider insight into never-before-seen data for post-surgical rehabilitation. Being able to monitor your patient’s range of motion progress and exercise compliance daily is a game changer. TracPatch is making proactive care easy, so every patient has an excellent outcome.”

Curt Wiedenhoefer, President of Consensus Orthopedics, says, “In this new value-based healthcare environment, to be able to combine the exploding adoption of wearable technology and apply it to the total joint industry is going to revolutionize the way we deliver care. For the first time in the history of joint surgery, we are using microelectronics to passively capture valuable post-surgical recovery information. Now, healthcare providers have objective data for every patient, especially during those critical six weeks of post-acute care.”

With the launch of TracPatch, Consensus Orthopedics is ideally positioned to partner with all healthcare providers looking to improve outcomes, reduce costs and enhance patient satisfaction. With CJR bundled payments rolling out nationwide, TracPatch is a truly innovative product for the value-based healthcare market as well as any provider looking to redefine their episode of care.

Explore TracPatch by visiting Consensus Orthopedics Booth #1233 at the American Academy of Orthopedic Surgeons Annual Meeting in San Diego, March 15-17. See for yourself how this device can revolutionize the way you deliver care.

To learn more about the TracPatch wearable device system, visit tracpatch.com, call 916-355-7131, and visit Booth #1233 at AAOS.

About Consensus® Orthopedics, Inc.
Consensus Orthopedics was founded in 1992 as a medical device consulting company. In 1996, Consensus Orthopedics acquired US Medical Products, becoming a global manufacturer of reliable large joint orthopedic devices. In 2016, Consensus Orthopedics launched its innovative TracPatch division focused on creating transformative wearable technology designed for real time continuous post-surgical patient monitoring. With a focus on patient care, Consensus is dedicated to creating one team and providing exceptional outcomes. Learn more at http://www.consensusortho.com.

K2M to Debut Balance ACS™ at Leading Spine Meetings in March 2017

Posted On March 9, 2017 By OrthoSpineNews In Spine /

LEESBURG, Va., March 08, 2017 (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 announced that it will debut the Balance ACS™ (or BACS™) platform at the Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS) and the American Academy of Orthopaedic Surgeons Annual Meeting (AAOS). The Company will also participate in the British Association of Spine Surgeons (BASS) annual meeting, marking the international introduction of the Balance ACS platform.

Balance ACS is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

During the meetings, K2M will demo the BACS System, which provides the necessary services to facilitate quality surgical outcomes and support the intraoperative process. The Company will also unveil a BACS app, which serves as a convenient portal for surgeons to access the BACS System, including:

BACS Preauthorization: An easy-to-follow insurance documentation tool that displays payer- and patient-specific requirements.
BACS Surgical Planner: A surgical image measuring technology to assist in planning and preoperative implant selection.
BACS Anatomical Modeling: 3D-printed anatomical models to aid in visualization of patient anatomy for surgical planning and intraoperative use.
BACS Data Management: A data collection and operative reporting system to track patient quality metrics achieved with spinal balance.

“K2M is excited to introduce the Balance ACS platform of three-dimensional solutions and host educational workshops at leading spine conferences in the United States and internationally,” said K2M President and CEO Eric Major. “Our experience developing complex spine innovations and advancements in 3D solutions has led us to a comprehensive, next-generation BACS platform to help surgeons achieve quality outcomes and Total Body Balance for their patients.”

K2M Meeting Participation Details

K2M will showcase the Balance ACS platform and demo the BACS System and the BACS app. The Company will also host physician workshops featuring prominent spine surgeons presenting on the latest research and clinical applications of the platform.

Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves: March 8–10, Las Vegas, NV
- BACS Platform Exhibition and BACS App Demo: Booth #901
- Workshop: Techniques to Optimize Spinal Balance
  - Friday, March 10, 2017; Noon–1 p.m. (PST); Marquis 6
  - Faculty: Andrew Dailey, MD
American Academy of Orthopaedic Surgeons Annual Meeting: March 14–18, San Diego, CA
- BACS Platform Exhibition and BACS App Demo: Booth #425
British Association of Spine Surgeons: March 15–17, Manchester, UK
- BACS Platform Exhibition and BACS App Demo: Compass Room, Stand #C9
- Workshop: Techniques to Optimize Spinal Balance
  - Wednesday, March 15, 2017; 12:30–13:15; Aldridge Studio
  - Faculty: Robert Lee, BSc, MBBS, FRCS

For more information about Balance ACS and K2M, visit www.BACS.com and www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as ““outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. 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. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com 

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Bio2 Technologies, Inc. to Present Results from Ovine Spinal Fusion Study

Posted On March 9, 2017 By OrthoSpineNews In Biologics, Spine, Top Stories /

WOBURN, Mass., March 8, 2017 /PRNewswire/ — Bio2 Technologies will present a poster at the Annual Meeting of the Orthopaedic Research Society (http://www.ors.org) in San Diego, CA on March 22, 2017 reporting the results from an ovine interbody fusion study conducted at Colorado State University comparing Bio2’s Vitrium device to an implant of similar design constructed from PEEK polymer. Autograft bone was placed in the central lumen of both devices.

Vitrium is an advanced orthobiomaterial with structural properties similar to cortical bone. It is composed of bioactive glass, a material with well-established osteostimulative properties. Bio2 has developed a proprietary manufacturing process to produce a strong, three-dimensional structure featuring interconnected pores facilitating the propagation of new bone.

The biomechanical tests (performed by mdevdev, San Francisco, CA) evaluated Vitrium’s ability to exhibit the ideal characteristics of a spinal fusion product, prospectively defined as: a) an effective, safe resorption/bone formation profile, b) stimulation of new bone formation to increase fusion rates, and c) sufficient strength to bear/share physiologic loads. Janet Krevolin, Ph.D., Bio2’s Chief Technical Officer and co-author of the poster, stated “the test results clearly demonstrated that Vitrium achieved these objectives. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place for both the Vitrium and PEEK implants. Of note, in axial compressive load to failure testing the Vitrium fusion exhibited strength in excess of the adjoining vertebral bodies, whereas the PEEK fusion failed at the fusion site. The test data show the Vitrium devices exhibited the ideal characteristics of an interbody fusion product.”

Additional information on Vitrium and the ovine spinal fusion study may be found at: http://www.bio2tech.com

SOURCE Bio2 Technologies, Inc.

Alphatec Spine Appoints Jeffrey G. Black as Chief Financial Officer

Posted On March 8, 2017 By OrthoSpineNews In Financial, Spine /

CARLSBAD, Calif., March 06, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc. (Nasdaq:ATEC), a provider of spinal fusion technologies, announced today that it continues its investment in new executive talent with the hiring of Jeffrey G. Black as Executive Vice President and Chief Financial Officer.

Mr. Black is a seasoned executive with over 25 years of experience in financial and operations management, including senior-level finance roles for six publicly-traded companies. As the CFO at Alphatec, Mr. Black will lead the finance, investor relations and accounting organizations, architecting the appropriate capital structure for the Company to execute its strategy and build a sustainable financial foundation for future growth.

“Jeff’s financial insight, capital restructuring and financing experience, as well as his open leadership style will be great enhancements to the Alphatec team,” said Terry Rich, Chief Executive Officer of Alphatec Spine. “His history of successfully leading growing organizations, his Wall Street relationships in the healthcare sector, and his strong discipline in cost and cash control make him an ideal fit for Alphatec. I look forward to partnering with Jeff as we continue to build a high-growth U.S. spine company and improve surgeons’ experiences and patient outcomes through our differentiated product offerings. We also thank Dennis Nelson, Vice President, Finance, for serving as Alphatec’s Principal Accounting Officer, and offering strong leadership of our finance and accounting organizations while we engaged in the CFO search.”

Mr. Black, 48, previously served as the Chief Financial Officer of Applied Proteomics, Inc., a company that develops novel, non-invasive diagnostics using a proteomics-based platform. Before joining Applied Proteomics, Mr. Black served as the Chief Financial Officer of AltheaDx, Inc., a molecular diagnostics company specializing in pharmacogenetic testing. Prior to AltheaDx, Mr. Black served as Chief Financial Officer of Verenium Corporation (formerly Diversa Corporation), a Nasdaq-listed pioneer in the development and commercialization of high-performance enzymes for use in industrial processes. During his nine-year tenure at Verenium/Diversa, Mr. Black played a leadership role in more than $500 million of strategic, equity, and debt financing transactions, culminating in the sale of the company to BASF in 2013. Mr. Black is a certified public accountant (inactive) and began his career with Ernst & Young LLP. He currently serves on the Board of Directors of Cellana, Inc., a privately-held algae bioproducts company.

“I am pleased to be joining Terry and his high-caliber leadership team, with a proven record of success in the spine market,” said Mr. Black. “With this new team in place, a robust product portfolio, and a rich pipeline of new products, Alphatec is well-positioned to continue on an accelerated path to improve patient lives. I am excited to be a part of the company’s transformation, with an eye toward building value for shareholders.”

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on February 21, 2017, the Compensation Committee of the Board of Directors approved the following inducement awards to Mr. Black: 75,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 75,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan. Collectively, the RSUs and options were granted as inducements material to Mr. Black entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of Mr. Black’s first date of employment, assuming in each case that he remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (March 6, 2017). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case Mr. Black remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to the Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective February 21, 2017.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

Further information regarding the Company’s appointment of Jeffrey G. Black as Executive Vice President Finance and Chief Financial Officer is set forth in a Current Report on Form 8-K that was filed with the U.S. Securities and Exchange Commission (SEC) on March 6, 2017 and is available on both the SEC’s website at www.sec.gov and the Company’s website at www.alphatecspine.com.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the Company’s ability to build a high-growth U.S. spine company; ability to strengthen its position in the U.S. spine market; ability to improve surgeon’s experiences, patient outcomes and patient lives; ability to build value for shareholders; ability to architect the appropriate capital structure; ability to build a sustainable financial foundation for future growth; the potential of the Company’s pipeline of products; and the Company’s ability to achieve its strategic goals. The words “believe,” “will,” “should,” “expect,” “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. 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 uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; the failure to obtain FDA clearance or approval for new products or prolonged delays in the process; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; claims related to the Company’s intellectual property; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Vertos Medical’s mild® Procedure Receives Broad Coverage From Centers For Medicare & Medicaid Services

Posted On March 8, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ — Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received national coverage for its mild^® Procedure through a recently approved study under the Centers for Medicare & Medicaid Services’ (CMS) Coverage with Evidence Development (CED) Program. A clinically proven outpatient procedure performed through a portal the size of a baby aspirin, mild requires no stitches, no general anesthesia, no implants, and no overnight hospital stay.

Broad access to the mild procedure has been granted for Medicare patients via a CMS-approved claims-analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in the continuum of care for LSS. CMS’s recent decision to expand access follows the successful completion of the company’s CMS-approved randomized controlled study, MiDAS ENCORE.¹

“Patient and physician demand for the mild procedure has grown a great deal, and I’m excited to hear that my patients and fellow practitioners will now have access to this effective, proven method for relieving pain and getting people back to doing the things that make life enjoyable,” said Nagy Mekhail, M.D., Ph.D., Director of Evidence Based Pain Medicine Research and Education at Cleveland Clinic, who is an investigator of previous clinical studies of mild and has been performing the procedure since 2010. “Neurogenic claudication related to lumbar spinal stenosis can be extremely life limiting; this first-line treatment stands to benefit the many patients currently being treated for LSS in the United States, who have no viable treatment options.”

It is estimated that roughly 10% of Americans have lumbar spinal stenosis, and that by 2021 some 2.4 million will be experiencing considerable pain as a result of the condition.

“This is great news for the thousands of people who suffer from the debilitating symptoms related to their lumbar spinal stenosis with neurogenic claudication, who have struggled to find a safe, effective, low-cost solution,” said Eric Wichems, President and CEO of Vertos Medical.

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients. Peer-reviewed clinical data has demonstrated that mild helps patients suffering from LSS stand longer and walk further with less pain.²

¹Benyamin, R., et al. (2016). mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician, 19: 229-242. ISSN 1533-3159.

² Mekhail, Nagy, et al. (2012). Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x.

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild^®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild^®treats this condition by restoring space in the spinal canal using specialized mild^® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild^® can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild^® treats LSS click here.

SOURCE Vertos Medical

Month: March 2017

John Masonis, MD to Educate on Direct Anterior Approach Hip Replacement Using OrthoGrid’s HipGrid™ System at AAOS 2017

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