Shoulder Basic Science Reconfirms Benefits of Inlay Arthroplasty

FRANKLIN, Mass., May 10, 2017 /PRNewswire/ — Arthrosurface, Inc., the Global Leader in Inlay Arthroplasty announced new evidence showing dramatic differences between the company’s inlay glenoid technology and the standard of care in total shoulder replacement.

According to a comparative study in the Journal of Shoulder and Elbow Surgery, the inlay glenoid (socket) design was far superior to the onlay alternative with respect to the biomechanical stability. “Increased stress on the implant edge resulted in loosening of all onlays through a rocking horse phenomenon, whereas none of the inlays became loose during testing,” said the lead author Jeffrey Gagliano, MD from the Boulder Bone and Joint in Colorado. Richard Hawkins, MD, from the Steadman Hawkins Clinic of the Carolinas, Greenville, SC and senior author of the study concluded, “given the results of the study, future research and development should be directed toward inlay glenoid prosthetic design, matching native anatomy and size variation.”

The American Academy of Orthopaedic Surgeons estimates about 53,000 people in the United States have shoulder replacement surgery each year. The benefits of replacing both sides of the joint with a total shoulder arthroplasty have been well established, however, glenoid loosening remains the Achilles Heel of the procedure.

“According to the literature, 2-10% of patients treated with a standard total shoulder replacement will require a revision procedure within the first decade following surgery due to onlay glenoid component loosening. Inlay arthroplasty may provide a solution to lower the revision burden on patients and the healthcare system,” said Matthias Schurhoff, VP of Clinical Operations and Scientific Affairs at Arthrosurface.

The company’s OVO™ Primary Stemless Shoulder System with inlay glenoid replacement was launched in the US in 2009 and has experienced excellent surgeon adoption. The inherent advantages are particularly well suited for younger and active patients requiring shoulder joint replacement surgery.

About Arthrosurface

Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and orthobiologics designed to preserve and restore joints so patients can regain and maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons in the treatment of a wide variety of joint pathologies. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years. For more information, please go to our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

Intrinsic Therapeutics Announces the Completion of a $49m Financing

BOSTON, May 10, 2017 /PRNewswire/ — Intrinsic Therapeutics, Inc. a medical device company that has developed a product to improve outcomes in lumbar discectomy patients, announced today that it recently closed a $49 million round of financing.  The financing included a $28 million equity round co-led by New Enterprise Associates (NEA) and Delos Capital, coupled with a $21 million debt facility with CRG.  Other investors include Greenspring Associates, Quadrille Capital and a corporate strategic. The Company’s Barricaid Anular Closure Device is designed to prevent repeat herniation in patients undergoing lumbar discectomy surgery to treat sciatic pain caused by a herniated disc.  Luke Dϋster with CRG commented, “We are very happy to join with a prestigious group of investors to support Intrinsic as they bring this important technology to the market in the U.S. and around the world.  In today’s changing healthcare environment, technologies that conserve resources and reduce costs to the healthcare system will fit squarely within the paradigm of hospital and payer cost-containment.”

In December 2016, the Company successfully filed a Pre-Market Application (PMA) with FDA for approval in the United States. This filing is based on the outcomes of a two-year, multi-center, prospective randomized superiority trial of 554 subjects at the greatest risk of reherniation and reoperation.  This is the first superiority trial for such a spinal device.

Jeani Delagardelle, who has joined Intrinsic’s Board representing Delos, commented, “We are extremely excited to be investing in Intrinsic at this later stage of their development.  The company has generated conclusive clinical data which supports a large global opportunity including the US market as early as next year.”

Describing the market opportunity, Prof. P. Douglas Klassen, Chief of Neurosurgery at St. Bonifatius Hospital, Lingen, Germany stated, “Approximately 1 million discectomies are performed every year around the globe and 40% of these patients will leave the operating room after discectomy with a large hole remaining in the outer rim of the disc, the anulus.  By simply sealing these large defects, patient outcomes can be improved significantly.”

“We are excited to welcome Delos and CRG as partners as we continue the process toward US market access,” said Cary Hagan, Intrinsic’s President and Chief Executive Officer. “The additional capital will allow us to continue our development efforts on reimbursement pathways for this compelling new technology with a sharp focus on demonstrating clear health economic value to surgeons, payers and hospital systems.”

About Intrinsic Therapeutics

Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery.  Intrinsic currently markets and sells the Barricaid in Europe, Australia, Mexico, S. America, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device.  See http://www.in-thera.com for more information.

Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.

About NEA

New Enterprise Associates, Inc. (NEA) is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $17 billion in cumulative committed capital since inception NEA invests in technology and healthcare companies at all stages in a company’s lifecycle, from seed stage through IPO. The firm’s long track record of successful investing includes more than 200 portfolio company IPOs and more than 320 acquisitions. www.nea.com.

About CRG

CRG is a premier healthcare-focused investment firm with more than $3 billion of assets under management across more than 45 portfolio companies.  The firm seeks to commit between $20 to $300 million in each company and invests across the healthcare spectrum, including: medical devices, biopharmaceuticals, tools & diagnostics, services and information technology. CRG provides growth capital in the form of long-term debt and equity to support innovative, commercial-stage healthcare companies that address large, unmet medical needs.  The firm partners with public and private companies to provide flexible financing solutions and world-class support to achieve exceptional growth objectives with minimal dilution. CRG maintains offices in Boulder, Houston and New York. For more information, please visit www.crglp.com.

About Delos Capital, LLC

Delos Capital is a healthcare-focused fund that invests in growth platforms in Greater China and innovation in the US in the areas of therapeutics and medical technology. Delos Capital seeks to achieve returns through supporting these companies in their development and also helping to create additional value from collaboration between these companies. Founded in 2014, Delos Capital operates from its main office in Hong Kong.

This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including and without limitation, statements relating to the potential approval by the FDA of the Company’s PMA submissions for the Barricaid Anular Closure device and the success of the Company’s launch preparedness efforts. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Intrinsic does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.

Media Contact:
Cary Hagan
clinical@in-thera.com

SOURCE Intrinsic Therapeutics, Inc.

Related Links

http://www.in-thera.com

Providence Medical Technology Secures New Financing of $10.5 Million From Bridge Bank

WALNUT CREEK, Calif., May 10, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing cervical spine technology, today announced the closing of a $10.5 million debt agreement with Bridge Bank.

“We are pleased that we have partnered with Bridge Bank to bolster our balance sheet with this debt facility,” said Greg Curhan, Chief Financial Officer of Providence. “This financing, coupled with our recently completed equity financing, puts us in a great position to continue to expand our distribution both across the United States as well as in international markets to deliver innovative spinal technology to help patients enjoy pain-free lives.”

“Bridge Bank is excited to be partnering with Providence Medical Technology,” said Rob Lake, senior vice president and head of Bridge Bank’s life sciences group. “I am impressed with the management team, the company’s eloquent and innovative technology, as well as the commercial progress over the past 24 months. We are delighted to be a resource to help Providence achieve its immediate and long-term goals.”

Providence’s differentiated, tissue-sparing devices and instruments are designed to increase procedural efficiency, improve clinical outcomes, minimize complications, and reduce recovery times for cervical fusions. The technology has seen continued, rapid adoption by spine surgeons, hospitals, and ambulatory surgery centers.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com.

About Bridge Bank
Bridge Bank is a division of Western Alliance Bank, Member FDIC, the go-to bank for business in its growing markets. Bridge Bank was founded in 2001 in Silicon Valley to offer a better way to bank for small-market and middle-market businesses across many industries, as well as emerging technology companies and the private equity community. Geared to serving both venture-backed and non-venture-backed companies, Bridge Bank offers a broad scope of financial solutions including growth capital, equipment and working capital credit facilities, sustainable energy project finance, venture debt, treasury management, asset-based lending, SBA and commercial real estate loans, ESOP finance and a full line of international products and services. Based in San Jose, Bridge Bank has eight offices in major markets across the country along with Western Alliance Bank’s robust national platform of specialized financial services. Western Alliance Bank is the primary subsidiary of Phoenix-based Western Alliance Bancorporation, one of the country’s top-performing banking companies. For more information, visit www.bridgebank.com.

Related Links: www.providencemt.com | www.bridgebank.com

 

SOURCE Providence Medical Technology, Inc.

Related Links

http://www.providencemt.com

Shareholders Approve the Transfer of the Implanet SA Listing to the Alternext Market in Paris

May 10, 2017

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, announces that, on May 5, 2017, the Company’s Shareholders’ Meeting, in accordance with the provisions of article L.421-14 V of the Monetary and Financial Code, transfer was approved of the listing of Implanet SA shares from the Euronext regulated market in Paris (compartment C) to the Alternext Paris multilateral trading facility.

This transfer allows Implanet to be listed on a more appropriate market for the Group’s size and market cap while offering a better-suited regulatory framework. It should thus simplify the administrative burden on Implanet and significantly reduce the listing costs, whilst enabling it to continue benefiting from financial market appeal.

Subject to the consent of Euronext Paris SA, the Company’s listing on the Alternext market will be carried out via the fast-track admission to trading of the Company’s existing shares, without any new shares being issued.

In terms of protecting minority shareholders (non exhaustive list):

  • the protection of minority shareholders, should control change hands, will be ensured by Alternext Paris through the public offering mechanism if the 50% threshold is exceeded in terms of capital or voting rights, either directly or indirectly and by one party or jointly;
  • furthermore, companies listed on Alternext Paris are only duty bound to inform the market, in terms of changes in the shareholding structure, of shareholdings moving above or below 50% and 95% of the company’s capital or voting rights;
  • however, in accordance with regulatory provisions and for a period of 3 months after its listing is removed from the Euronext regulated market in Paris, Implanet will remain subject to the mandatory public offering system and the continuance of information duties regarding the crossing of thresholds and stated intentions applicable to companies listed on the Euronext regulated market in Paris.

Regarding periodic financial information, less restrictive financial information requirements, including the following (non exhaustive list):

  • extension of the timeframe for publishing half-year results – comprising a balance sheet, a P&L statement and comments regarding this period – to 4 months after the half-year ends;
  • a chairman’s report on the internal audit and corporate governance is no longer mandatory;
  • the company can choose which accounting system (French or IFRS) it uses when drawing up its consolidated accounts. However, as the Company’s accounts are already drawn up in IFRS, and in order to ensure transparency vis-à-vis its investors and shareholders, Implanet will continue to apply IFRS.

Implanet intends to continue publishing its revenue on a quarterly basis and to inform the public of any news or information liable to have an impact on its share price.

Indicative timetable of the transfer

March 27, 2017 The Board votes to submit the planned transfer of Implanet SA’s listing to Alternext to a Shareholders’ Meeting

April 3, 2017 Information published regarding the planned request for admission (1st press release)

May 5, 2017 Shareholders’ Meeting to notably approve the transfer to Alternext Paris

May 9, 2017 Information published regarding the definitive transfer decision (2nd press release)

July 10, 2017 Decision from Euronext Paris SA to admit shares for trading on Alternext Paris, shares
at the earliest removed from the Euronext regulated market and first listing on Alternext Paris

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Disclaimer
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 3, 2017 under number D.17-0292 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements.

This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

DJO Global Announces Financial Results for First Quarter 2017

May 10, 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 first quarter ended April 1, 2017.

First Quarter Highlights

  • Net sales grew 3.4% as reported to $288.4 million and grew 4.7% on a sales per day constant currency basis.
  • Net loss was $40.0 million compared to $38.3 million in the prior year period.
  • Adjusted EBITDA increased 17.0% as reported to $57.2 million, an improvement of 15.4% in constant currency, or greater than 3 times revenue growth.
  • Net cash provided by continuing operating activities grew $25.2 million to $38.6 million.

“We are off to a solid start in 2017 with growth across our global business, earnings growing faster than revenue and improvement in our cash flow during the first quarter,” said Brady Shirley, DJO’s President and Chief Executive Officer. “Our business transformation is underway and we have begun initiatives to improve liquidity, organization effectiveness, procurement optimization, manufacturing, sales and operations planning, and customer and product profitability, and we are beginning to see early positive results of our efforts. There is still a lot of work ahead of us, but I am confident that this transformation positions the company for sustainable long-term financial performance and value creation for all of our stakeholders.”

Sales Results

DJOFL achieved net sales for the first quarter of 2017 of $288.4 million, reflecting as reported growth of 3.4%, compared with net sales of $278.9 million for the first quarter of 2016. Additionally, the first quarter of 2017 included 64 shipping days, while the comparable period in 2016 included 65 shipping days. Sales in the first quarter of 2017 grew 4.7% on a sales per day constant currency basis over sales in the first quarter of 2016.

Net sales for the Surgical Implant segment were $49.6 million for the first quarter of 2017, reflecting as reported growth of 15.2% compared to the first quarter of 2016. Surgical sales grew 17.0% on a sales day per day basis. The continued growth in the Surgical Implant segment was primarily driven by strong organic growth across the Company’s shoulder, hip and knee products.

Net sales for DJO’s International segment were $78.2 million in the first quarter of 2017, reflecting as reported growth of 4.2% over net sales in the first quarter of 2016. International sales grew 4.9% on a sales per day constant currency basis, driven by stronger sales in the Company’s direct markets, primarily Australia, France, and Spain.

Net sales for DJO’s Recovery Sciences segment were $38.5 million in the first quarter of 2017, reflecting as reported growth of 5.3% compared to the first quarter of 2016. Recovery Sciences sales grew 6.9% on a sales per day basis, reflecting continued strong growth in the segment’s consumer products and Chattanooga rehabilitation equipment product line.

Net sales for DJO’s Bracing and Vascular segment were $122.1 million in the first quarter of 2017, a reported decline of 1.7%, compared to the first quarter of 2016. Bracing and Vascular sales declined 0.2% on a sales per day basis, reflecting softness in the Company’s Aircast and Procare, deep vein thrombosis, and Dr. Comfort products, offset by growth in the Company’s OfficeCare channel, direct consumer and DonJoy products.

Earnings Results

For the first quarter of 2017, DJOFL reported a net loss attributable to DJOFL of $40.0 million, compared to a net loss of $38.3 million for the first quarter of 2016. As detailed in the attached financial tables, the results for the current and prior year first quarter periods and the current and prior year twelve-month periods were impacted by significant non-cash items, non-recurring items and other adjustments.

Adjusted EBITDA for the first quarter of 2017 was $57.2 million compared with Adjusted EBITDA of $48.9 million in the first quarter of 2016, representing 17.0% growth over the prior year and 15.4% growth on a constant currency basis. Strong productivity during the period drove growth in Adjusted EBITDA at over three times the rate of revenue growth. Including projected future savings from cost savings programs currently underway of $6.2 million as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended April 1, 2017 was $249.9 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 first quarter of 2017 was $38.6 million compared to $13.4 million for the first quarter of 2016. The improvement in cash flow was primarily attributable to 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 4:30 p.m., Eastern Time Wednesday, May 10, 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, 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
April 1, April 1,
2017 2016
Net sales $ 288,389 $ 278,906
Operating expenses:
Cost of sales (exclusive of amortization, see note 1) 119,569 118,083
Selling, general and administrative 134,162 121,929
Research and development 9,139 9,854
Amortization of intangible assets 18,845 19,578
281,715 269,444
Operating income 6,674 9,462
Other (expense) income:
Interest expense, net (42,687 ) (42,270 )
Other income, net 288 284
(42,399 ) (41,986 )
Loss before income taxes (35,725 ) (32,524 )
Income tax provision (4,078 ) (5,413 )
Net loss from continuing operations (39,803 ) (37,937 )
Net income (loss) from discontinued operations 58 (190 )
Net loss (39,745 ) (38,127 )
Net income attributable to noncontrolling interests (224 ) (193 )
Net loss attributable to DJO Finance LLC $ (39,969 ) $ (38,320 )

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $6,981 and $7,407 for the three months ended April 1, 2017 and 2016, respectively.

DJO Finance LLC
Unaudited Condensed Consolidated Balance Sheets

(In thousands)

April 1, December 31,
2017 2016
Assets
Current assets:
Cash and cash equivalents $ 55,000 $ 35,212
Accounts receivable, net 172,844 178,193
Inventories, net 152,329 151,557
Prepaid expenses and other current assets 20,849 23,650
Current assets of discontinued operations 511 511
Total current assets 401,533 389,123
Property and equipment, net 128,632 128,019
Goodwill 856,589 855,626
Intangible assets, net 653,427 672,134
Other assets 5,249 5,536
Total assets $ 2,045,430 $ 2,050,438
Liabilities and Deficit
Current liabilities:
Accounts payable $ 76,981 $ 63,822
Accrued interest 45,342 16,740
Current portion of debt obligations 10,550 10,550
Other current liabilities 111,015 113,265
Total current liabilities 243,888 204,377
Long-term debt obligations 2,385,619 2,392,238
Deferred tax liabilities, net 204,801 202,740
Other long-term liabilities 14,818 14,932
Total liabilities $ 2,849,126 $ 2,814,287
Commitments and contingencies
Deficit:
DJO Finance LLC membership deficit:
Member capital 841,597 844,294
Accumulated deficit (1,619,611 ) (1,579,642 )
Accumulated other comprehensive loss (28,014 ) (30,580 )
Total membership deficit (806,028 ) (765,928 )
Noncontrolling interests 2,332 2,079
Total deficit (803,696 ) (763,849 )
Total liabilities and deficit $ 2,045,430 $ 2,050,438
DJO Finance LLC
Unaudited Segment Information

(In thousands)

Three Months Ended
April 1, April 1,
2017 2016
Net sales:
Bracing and Vascular $ 122,053 $ 124,216
Recovery Sciences 38,503 36,575
Surgical Implant 49,592 43,050
International 78,241 75,065
$ 288,389 $ 278,906
Operating income:
Bracing and Vascular $ 21,007 $ 20,534
Recovery Sciences 8,907 6,445
Surgical Implant 8,140 7,229
International 13,610 8,989
Expenses not allocated to segments and eliminations (44,990 ) (33,735 )
$ 6,674 $ 9,462

DJO Finance LLC
Adjusted EBITDA

For the Three Months Ended April 1, 2017 and 2016
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,039.2 million term loan facility and a $150.0 million asset-based revolving credit facility, under which $76.0 million was outstanding as of April 1, 2017, and the Indentures governing our $1,015.0 million of 8.125% second lien notes and $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 interest expense, net, 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) attributable to DJOFL 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) attributable to DJOFL 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) attributable to DJOFL. 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 a reconciliation between net loss attributable to DJO Finance LLC and Adjusted EBITDA:

Twelve
Months
Three Months Ended Ended
April 1, April 1, April 1,
2017 2016 2017
Net loss attributable to DJO Finance LLC $ (39,969 ) $ (38,320 ) $ (287,952 )
(Income) loss from discontinued operations, net (58 ) 190 (1,386 )
Interest expense, net 42,687 42,270 170,498
Income tax provision 4,078 5,413 (8,188 )
Depreciation and amortization 29,774 29,902 117,764
Non-cash charges (a) 571 399 182,571
Non-recurring and integration charges (b) 18,389 7,332 59,732
Other adjustment items (c) 1,769 1,728 10,594
57,241 48,914 243,633

Permitted pro forma adjustments applicable to the twelve month period only (d)

Future cost savings 6,242
Adjusted EBITDA $ 57,241 $ 48,914 $ 249,875
(a) Non-cash charges are comprised of the following:
Twelve
Months
Three Months Ended Ended
April 1, April 1, April 1,
2017 2016 2017
Stock compensation expense $ 454 $ 205 $ 3,437

Loss on disposal of fixed assets and assets held for sale, net

117 107 959
Impairment of goodwill (1) 160,000
Inventory adjustments (2) 18,013
Purchase accounting adjustments (3) 87 162
Total non-cash charges $ 571 $ 399 $ 182,571
(1) Impairment of goodwill and intangible assets for the twelve months ended April 1, 2017 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 for which management has decided not to strategically relocate.
(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:
Twelve
Months
Three Months Ended Ended
April 1, April 1, April 1,
2017 2016 2017
Restructuring and reorganization $ 15,796 $ 1,993 $ 30,641
Acquisition related expenses and integration (1) 302 3,325 7,327
Executive transition 4,856

Litigation and regulatory costs and settlements, net (2)

2,102 2,014 16,650
IT automation projects 189 258
Total non-recurring and integration charges $ 18,389 $ 7,332 $ 59,732
(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 April 1, 2017, litigation and regulatory costs consisted of $2.6 million in litigation costs related to ongoing product liability issues and $14.1 million related to other litigation and regulatory costs and settlements.

(c)

Other adjustment items are comprised of the following:
Twelve
Months
Three Months Ended Ended
April 1, April 1, April 1,
2017 2016 2017
Blackstone monitoring fees $ 1,750 $ 1,750 $ 7,000
Non-controlling interests 224 193 654
Other (1) (205 ) (215 ) 2,940
Total other adjustment items $ 1,769 $ 1,728 $ 10,594
(1) Other adjustments consist primarily of net realized and unrealized foreign currency transaction gains and losses.

(d)

Permitted pro forma adjustments include future cost savings related to the exit of our Empi business and the restructuring of our Recovery Sciences Segment.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
760.734.3075
ir@djoglobal.com

Xtant™ Medical Reports First Quarter Revenue of $22.1 million, 5% Growth Compared to the Prior Year Period

BELGRADE, Mont., May 09, 2017 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today reported its financial results for the quarter ended March 31st, 2017. The Company reported first quarter 2017 revenue of approximately $22.1 million and an EBITDA gain of approximately $577,000 for the period.

Revenue

Consolidated first quarter 2017 revenue was approximately $22.1 million, an increase of 5.3% compared to revenue of approximately $21.0 million for the same period of 2016. The increase in revenue was primarily driven by the continuing increase the Company’s revenue from biologics product lines.

Gross Profit

Consolidated gross profit for the first quarter of 2017 was $15.5 million or 70.3% of revenues, compared to gross profit of $14.1 million or 67.2% of revenues for the first quarter of 2016. The increase in gross margin was primarily due to product mix and the continued focus on improved operating efficiency.

Sales and Marketing Expenses

Consolidated first quarter 2017 sales and marketing expenses increased to $11.0 million, compared to sales and marketing expenses of $10.5 million during the same period in 2016. For the quarter, sales and marketing as a percentage of revenues decreased slightly to 49.8%, compared to 50.1% in the first quarter of 2016.

General and Administrative Expenses

In the first quarter of 2017, consolidated general and administrative expenses increased to $4.1 million, compared to general and administrative expenses of

$3.5 million for the same period last year. As a percentage of revenues, general and administrative expenses were 18.7% during the period, compared to 16.6% for the same period of 2016.

Net Income / Loss

First quarter 2017 consolidated net loss narrowed to ($5.2) million, compared to net loss of ($5.6) million during the year-ago period. First quarter 2016 consolidated loss per share was $0.29, compared to a loss per share of $0.47 in the first quarter of 2016.

EBITDA

The Company defines earnings before interest, taxes, depreciation and amortization (“EBITDA”) as net income/loss from operations before depreciation, amortization, impairment charges, non-recurring expenses and non-cash stock-based compensation. Consolidated EBITDA for the first quarter of 2017 was a gain of approximately $577,000 compared to a loss of ($145,000) for the same period during 2016.

Calculation of Consolidated EBITDA for the Three Months Ended March 31, 2017 and 2016 (Unaudited)
For the three months ended March 31,
2017 2016
Net Loss (5,166,929 ) (5,596,072 )
Tax (Benefit) Provision 0 0
Other (Income) Expense (12,344 ) 425,000
Change in Warrant Derivative Liability (170,031 ) (18,690 )
Interest Expense 3,400,389 2,827,174
Separation Related Expenses 224,372 0
Acquisition and Integration Related Expenses 0 301,773
Non-cash Compensation 230,424 136,079
Depreciation & Amortization 2,071,337 1,779,987
EBITDA Gain (Loss) 577,218 (144,749 )

Financial Liquidity

Cash on hand as of March 31, 2017, was $2.5 million, as compared to $2.6 million as of December 31, 2016. Net working capital as of March 31, 2017 remained flat at $17.9 million, as compared to $17.9 million as of December 31, 2016.

Outlook for Full Year 2017

As a result of the Company’s ongoing review of its capital structure, the Company has made a decision to withdraw its previously provided 2017 financial guidance. The company will provide an update to shareholders once the review and related discussions have been finalized.

Conference Call to be Held May 10, 2017

An accompanying listen-only conference call will be hosted by Carl O’Connell, Chief Executive Officer, and John Gandolfo, Chief Financial Officer, to discuss the results. The call will be held at 10:00 AM ET, on May 10, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

Conference date:May 10, 2017, 10:00 AM ET

Conference dial-in: 877-269-7756

International dial-in: 201-689-7817

Conference Call Name:Xtant Medical’s First Quarter 2017 Results Call

Webcast Registration: Click Here

Following the live call, a replay will be available on the Company’s website, www.xtantmedical.com, under “Investor Info.”

About Xtant™ Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others:  the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Contact:

CG CAPITAL

877.889.1972

investorrelations@cg.capital

cg.capital

XTANT MEDICAL HOLDINGS, INC.
Consolidated Statement of Operations for the Three Months Ended March 31, 2017 and 2016
Unaudited
For the Three Months Ended Mar 31,
2017 2016
% of % of
Amount Revenue Amount Revenue
Orthopedic Product Sales $ 21,996,315 99.6 % $ 20,808,035 99.2 %
Other 86,354 0.4 % 169,300 0.8 %
Total Revenue 22,082,669 100.0 % 20,977,335 100.0 %
Cost of sales 6,557,602 29.7 % 6,877,267 32.8 %
Gross Profit 15,525,067 70.3 % 14,100,068 67.2 %
Operating Expenses
General and administrative 4,128,268 18.7 % 3,484,712 16.6 %
Sales and marketing 10,997,019 49.8 % 10,512,966 50.1 %
Research and development 698,635 3.2 % 899,575 4.3 %
Depreciation and amortization 1,280,965 5.8 % 1,208,334 5.8 %
Acquisition and Integration related expenses 0 0.0 % 301,773 1.4 %
Separation related expenses 224,372 1.0 % 0 0.0 %
Non-cash consulting 144,723 0.7 % 55,296 0.3 %
Total Operating Expenses 17,473,981 79.1 % 16,462,656 78.5 %
Net Gain (Loss) from Operations (1,948,913 ) -8.8 % (2,362,588 ) -11.3 %
Other Income (Expense)
Interest expense (3,400,389 ) -15.4 % (2,827,174 ) -13.5 %
Change in warrant derivative liability 170,031 0.8 % 18,690 0.1 %
Other income (expense) 12,344 0.1 % (425,000 ) -2.0 %
Total Other Income (Expense) (3,218,014 ) -14.6 % (3,233,484 ) -15.4 %
Net Gain (Loss) from Operations Before Benefit (Provision) for Income Taxes (5,166,927 ) -23.4 % (5,596,072 ) -26.7 %
Benefit (Provision) for Income Taxes
Current 0 0.0 % 0 0.0 %
Deferred 0 0.0 % 0 0.0 %
Net Income (Loss) $ (5,166,927 ) -23.4 % $ (5,596,072 ) -26.7 %
Net Income (loss) per share:
Basic ($0.29 ) ($0.47 )
Dilutive ($0.29 ) ($0.47 )
Shares used in the computation:
Basic 17,933,315 11,897,601
Dilutive 17,933,315 11,897,601

 

XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Unaudited
For the Three months ended March 31,
2017 2016
Operating activities:
Net loss $ (5,166,929 ) $ (5,596,072 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 2,071,337 1,779,986
Non-cash Interest 3,151,227 2,822,980
Non-cash consulting expense/stock option expense 230,424 136,079
Provision for losses on accounts receivable and inventory 312,588 (72,313 )
Change in derivative warrant liability (170,031 ) (18,690 )
Changes in operating assets and liabilities:
Accounts receivable 2,536,242 328,290
Inventories 261,189 (1,144,652 )
Prepaid and other assets (648,769 ) (235,779 )
Accounts payable (1,743,541 ) 3,734,694
Accrued liabilities (397,532 ) (707,214 )
Net cash used in operating activities 436,205 1,027,309
Investing activities:
Purchases of property and equipment and intangible assets (310,078 ) (2,718,985 )
Net cash used in investing activities (310,078 ) (2,718,985 )
Financing activities:
Payments on capital leases (62,978 ) (7,985 )
Net proceeds from the issuance of stock (154,577 ) 0
Net cash provided by financing activities (217,555 ) (7,985 )
Net change in cash and cash equivalents (91,428 ) (1,699,661 )
Cash and cash equivalents at beginning of period 2,578,267 6,368,016
Cash and cash equivalents at end of period $ 2,486,839 $ 4,668,355

 

XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
As of March 31, 2017 (Unaudited) and As of December 31, 2016 (Audited)
As of Mar. 31, As of Dec. 31,
2017 2016
ASSETS
Current Assets:
Cash and cash equivalents $ 2,486,839 $ 2,578,267
Trade accounts receivable, net of allowance for doubtful accounts of $1,635,385 and $2,579,634, respectively 16,320,038 18,991,872
Inventories, net 26,359,272 26,266,457
Prepaid and other current assets 1,651,187 1,149,615
Total current assets 46,817,336 48,986,211
Non-current inventories 440,853 971,854
Property and equipment, net 15,219,725 15,840,730
Goodwill 41,534,626 41,534,626
Intangible assets, net 34,800,556 35,940,810
Other assets 874,561 827,374
Total Assets $ 139,687,657 $ 144,101,605
LIABILITIES & STOCKHOLDERS’ (DEFICIT) EQUITY
Current Liabilities:
Accounts payable $ 8,896,188 $ 10,471,944
Accounts payable – related party 472,657 640,442
Accrued liabilities 8,815,400 8,982,187
Revolving Line of Credit 10,293,706 10,448,283
Warrant derivative liability 163,582 333,613
Current portion of capital lease obligations 259,027 244,847
Total current liabilities 28,900,560 31,121,317
Long-term Liabilities:
Capital lease obligation, less current portion 754,994 832,152
Long term convertible debt, less current portion 70,636,665 68,937,247
Long-term debt, less current portion 51,069,961 50,284,187
Total Liabilities 151,362,180 151,174,903
Commitments and Contingencies
Stockholders’ Equity
Preferred stock 0
Common stock 18 17
Additional paid-in capital 86,026,911 85,461,210
Accumulated deficit (97,701,452 ) (92,534,524 )
Total Stockholders’ Equity (Deficit) (11,674,523 ) (7,073,297 )
Total Liabilities & Stockholders’ Equity $ 139,687,657 $ 144,101,606

 

XTANT MEDICAL HOLDINGS, INC.
Calculation of Consolidated EBITDA for the Three Ended March 31, 2017 and 2016
Unaudited
For the three months ended March 31,
2017 2016
Net Loss (5,166,927 ) (5,596,072 )
Tax (Benefit) Provision 0 0
Other (Income) Expense (12,344 ) 425,000
Change in warrant derivative liability (170,031 ) (18,690 )
Interest expense 3,400,389 2,827,174
Separation related expenses 224,372 0
Acquisition and Integration related expenses 0 301,773
Non-Cash Compensation 230,424 136,079
Depreciation & Amortization 2,071,337 1,779,987
EBITDA Gain (Loss) 577,220 (144,749 )

Source: Xtant Medical Holdings, Inc.

This article appears in: News Headlines

Referenced Stocks: XTNT

Read more: http://www.nasdaq.com/press-release/xtant-medical-reports-first-quarter-revenue-of-221-million-5-growth-compared-to-the-prior-year-20170509-01972#ixzz4gmpNtnxY

Mazor Robotics Reports Record First Quarter 2017 Revenue which Increases 83%

May 10, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical guidance systems, reported record first quarter revenue of $11.7 million. As previously announced, the Company received purchase orders for six systems in the 2017 first quarter and ended the quarter with a backlog of 14 systems.

“Our first quarter of 2017 was highlighted by record first quarter revenue and expanded utilization of our Renaissance system installed base,” commented Ori Hadomi, Chief Executive Officer. “Our revenue growth was driven by two factors. First, we supplied 12 Mazor X systems as we continued to process our 2016 year-end backlog. Second, we had record utilization by our installed base during the quarter. The enthusiasm for the Mazor X continues, and to date we have received four purchase orders for the Mazor X in the second quarter of 2017.”

FIRST QUARTER 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended March 31, 2017 increased 83% to $11.7 million compared to $6.4 million in the year-ago first quarter. U.S. revenue increased 100% to $11.2 million compared to $5.6 million in the year-ago first quarter, as the Company recognized revenue from 12 Mazor X systems, compared to four Renaissance systems in the 2016 first quarter. The Company ended the quarter with a backlog of 14 Mazor X systems; revenue from these systems is expected to be recorded in 2017. International revenue was $0.5 million compared to $0.8 million in the year-ago first quarter. Recurring revenue from kit sales, services and others increased 37% to $5.2 million in the first quarter of 2017, compared to $3.8 million in the year-ago first quarter. The growth is attributed mainly to the increase of the installed base.

The Company’s gross margin for the three months ended March 31, 2017 was 64.6% compared to 74.2% in the year-ago first quarter. This expected decrease is attributed mainly to discounted pricing to the Company’s Mazor X distribution partner, the higher manufacturing costs of the Mazor X compared to the Renaissance system, and the inclusion of two Renaissance trade-ins to Mazor X. Total operating expenses were $13.3 million compared to $10.0 million in the year-ago first quarter primarily reflecting the Company’s increased investments in sales and marketing activities. Operating loss was $5.7 million compared to an operating loss of $5.2 million in the year-ago first quarter. Net loss for the first quarter of 2017 was $5.2 million, or $0.11 per share, compared to a net loss of $5.1 million, or $0.12 per share, for the year-ago first quarter.

Cash generated by operating activities during the first quarter was $0.7 million compared to $2.9 million cash used in operating activities in the year-ago first quarter. As of March 31, 2017, cash, cash equivalents and investments totaled $63.9 million.

FIRST QUARTER 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

The tables below include reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation relates to non-cash expenses in the amount of $1.3 million with respect to amortization of intangible assets and to share-based expenses recorded in the first quarter of 2017. On a non-GAAP basis, the net loss in the first quarter of 2017 was $3.9 million, or $0.08 per share, compared to $4.2 million, or $0.10 per share, for the year-ago first quarter.

CONFERENCE CALL INFORMATION

The Company will host a conference call to discuss its first quarter financial results as well as recent corporate developments on May 10, 2017 at 8:30 AM EDT (3:30 PM IDT). Investors within the United States interested in participating are invited to call 888-298-3457. Participants in Israel can use the toll-free dial-in number 1-80-924-5906. All other international participants can use the dial-in number 719-457-2689.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 8737181. All international callers can dial +1-719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

Use of Non-GAAP Measures

In addition to disclosing financial results calculated in accordance with generally accepted accounting principles in conformity with International Financial Reporting Standards (GAAP), this press release contains Non-GAAP financial measures for gross profit, operating expenses, operating loss, net loss and basic and diluted earnings per share that exclude the effects of non-cash expense of amortization of intangible assets and share-based expenses. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s net income and earnings per share and to compare them to historical net income and earnings per share.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the Company’s momentum for 2017, second quarter sales, the amount of and timing of recording of additional revenue from backlog, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Mazor Robotics Ltd.
CONSOLIDATED STATEMENT OF INCOME
(in thousands, except per share data)
Three month period
ended March 31,
2017 2016
(Unaudited) (Unaudited)
Revenue

$

11,719

$

6,419

Cost of revenue

$

4,149

$

1,654

Gross profit $

7,570

$ 4,765
Operating costs and expenses:
Research and development, net $

1,792

$ 2,131
Selling and marketing $

9,893

$ 6,873
General and administrative $

1,571

$ 983
Total operating costs and expenses $

13,256

$ 9,987
Loss from operations $

(5,686)

$ (5,222)
Financing income, net $

211

$ 175
Loss before taxes on income $

(5,475)

$ (5,047)
Income tax expense (benefit) $

(243)

$ 65
Net loss $

(5,232)

$ (5,112)
Net loss per share – Basic and diluted $

(0.11)

$ (0.12)
Weighted average common shares outstanding – Basic and diluted

47,750

42,414
Mazor Robotics Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS OF
(U.S. Dollars in thousands)
March 31, December 31,
2017 2016
(Unaudited) (Audited)
Current assets
Cash and cash equivalents

$

25,896

$

14,954

Short-term investments

32,654

37,862

Trade receivables

3,076

8,225

Other current assets

2,109

1,728

Inventory

5,777

4,715

Total current assets

69,512

67,484

Non-current assets
Long-term investments

5,366

9,017

Property and equipment, net

4,045

3,615

Intangible assets, net

2,176

2,258

Other non-current assets

980

351

Total non-current assets

12,567

15,241

Total assets

$

82,079

$

82,725

Current liabilities
Trade payables

$

2,314

$

5,018

Deferred revenue

5,879

4,031

Other current liabilities

9,998

8,462

Total current liabilities

18,191

17,511

Non-current liabilities
Employee benefits

403

325

Total non-current liabilities

403

325

Total liabilities

18,594

17,836

Equity
Share capital

125

124

Share premium

178,252

174,647

Capital reserve for share-based payment transactions

10,081

9,859

Foreign currency translation reserve

2,119

2,119

Accumulated loss

(127,092)

(121,860)

Total equity

63,485

64,889

Total liabilities and equity

$

82,079

$

82,725

Mazor Robotics Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
(U.S. Dollars in thousands)
Three month period
ended March 31,
2017 2016
(Unaudited) (Unaudited)
Cash flows from operating activities:
Loss for the period

$

(5,232)

$

(5,112)

Adjustments:
Depreciation and amortization

$

342

$

146

Finance income, net

$

(50)

$

(142)

Share-based payment

$

1,201

$

916
Income tax expense (tax benefit)

$

(243)

$

65

$

1,250

$

985
Change in inventory

$

(1,362)

$ (25)
Change in trade and other accounts receivable

$

4,771

$ 1,738
Change in prepaid lease fees

$

(21)

$ (10)
Change in trade and other accounts payable

$

1,103

$ (536)
Change in employee benefits

$

78

$ 76

$

4,569

$ 1,243
Interest received

$

72

$ 64
Income tax paid

$

$ (37)

$

72

$ 27
Net cash provided by (used in) operating activities

$

659

$ (2,857)
Cash flows from investing activities:
Proceeds from short-term investments, net

$

8,957

$ 6,646
Investments in long-term investments

$

(98)

$ (496)
Purchase of property and equipment

$

(809)

$ (418)
Net cash provided by investing activities

$

8,050

$ 5,732
Cash flows from financing activities:
Proceeds from exercise of share options and warrants, net

$

$ 481
Proceeds from exercise of share options by employees

$

2,259

$ 75
Net cash provided by financing activities

$

2,259

$

556
Net increase in cash and cash equivalents

$

10,968

$ 3,431
Cash and cash equivalents at the beginning of the period

$

14,954

$ 13,519
Effect of exchange rate differences on balances of
cash and cash equivalents

$

(26)

$ 58
Cash and cash equivalents at the end of the period

$

25,896

$ 17,008
Supplementary cash flows information:
Purchase of property and equipment in credit

$

(148)

$ (107)
Classification of inventory to fixed assets

$

300

$

Mazor Robotics Ltd.
RECONCILIATIONS OF GAAP TO NON-GAAP FINANCIAL MEASURES
(U.S. Dollars in thousands, except per share data)
(UNAUDITED)
Three month period
ended March 31,
2017 2016
GAAP gross profit

$

7,570

$ 4,765
Amortization of intangible assets

82

Share-based payments

53

36
Non-GAAP gross profit

$

7,705

$ 4,801
GAAP gross profit as percentage of revenues

64.6%

74.2%
Non-GAAP gross profit as percentage of revenues

65.7%

74.8%
GAAP operating expenses

$

13,256

$ 9,987
Share-based payments:
Research and development

$

158

$ 150
Selling and marketing

$

440

$ 520
General and administrative

$

550

$ 210
Non-GAAP operating expenses

$

12,108

$ 9,107
GAAP operating loss

$

(5,686)

$ (5,222)
Non-GAAP operating loss

$

(4,403)

$ (4,306)
GAAP net loss

$

(5,232)

$ (5,112)
Amortization of intangible assets

82

Share-based payments

$

1,201

$ 916
Non-GAAP net loss

$

(3,949)

$ (4,196)
GAAP basic and diluted loss per share

$

(0.11)

$ (0.12)
Non-GAAP basic and diluted loss per share

$

(0.08)

$ (0.10)

Contacts

U.S. Contacts:
EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com;
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com
or
Financial Media Contact
Tom Gibson, 201-476-0322
tom@tomgibsoncommunications.com

Cook Medical Sells Vertebroplasty Product Family to IZI Medical Products

May 10, 2017

BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical is pleased to announce the sale of its comprehensive family of vertebroplasty products to IZI Medical Products, LLC. This sale includes the Duro-Ject® Osteo-Site®, Osteo-Force® and Vertefix® brands in addition to other needles, injectors and cements. Moving this product family from Cook Medical to IZI Medical Products is a positive decision for both companies and for the patients impacted by spinal fractures.

“In the US, there’s an estimated 700,000 vertebral fractures a year due to osteoporosis1,” said Pete Yonkman, president of Cook Medical and Cook Group. “We were not giving this product family the resources it needed to continue to advance, so we’re pleased to have found it a new home with IZI Medical. The sale of our vertebroplasty product family allows us to concentrate on our primary product lines while allowing IZI Medical to focus on helping to treat patients suffering from spinal fractures.”

The vertebroplasty product family is used in the growing market for treating vertebral compression fractures through a minimally invasive procedure. IZI has planned a significant investment in a dedicated sales force, international distributor network, select product enhancements and new product development.

This product family is manufactured in Cook Medical’s Bloomington, Indiana, facility where many other products are built. This change will not impact that facility or its employees.

IZI Medical is the interventional products platform of Shore Capital Partners.

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter,Facebook and LinkedIn.

1 Ensrud KE, Schousboe JT. Clinical practice. Vertebral fractures. N Engl J Med. 2011;364(17):1634–1642.

Contacts

Cook Medical
Marsha Lovejoy, Global Manager, External Corporate Communications
812-320-6903 (mobile)
812-339-2235, ext. 10-2750 (office)
marsha.lovejoy@cookmedical.com

FDA approves IDE study for Premia Spine’s TOPS™ System

PHILADELPHIA, PENNSYLVANIA, UNITED STATES, May 8, 2017 /EINPresswire.com/ — Premia Spine, Ltd. announced today that it has secured FDA approval for its pivotal study of the new TOPS™ System.

“We are excited about the opportunity to provide U.S. patients with access to the only posterior arthroplasty device for degenerative grade I spondylolisthesis and spinal stenosis, with thickening of the ligament or scarring of the facet capsule,” said Ron Sacher, CEO of Premia Spine.

The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over 5 years.

The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS™ System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.

The study’s lead investigator is Dom Coric, Chief of Neurosurgery, at Carolinas Medical Center. Clinicians who have received approval or are in the process of securing IRB approval include Josh Ammerman and Josh Wind (Sibley Hospital), Neel Anand and Hyun Bae (Cedar Sinai), Steve DeLuca (Orthopedic Institute of Pennsylvania), Jason Huang (Baylor Scott & White), Armen Khachatryan (The Disc Replacement Center at Jordan Valley Medical Center), Andy Kranenburg (Providence Medford Medical Center), Scott Leary (Scripps Health), Ali Mesiwala (Southern California Center for Neuroscience and Spine), Kent New, Steve Pirris, Eric Nottmeier, and Ali Chahlavi (St. Vincent’s Medical Center), Pierce Nunley (Spine Institute of Louisiana), Rick Sasso (Indiana Spine Group), Bill Smith (Western Regional Brain & Spine), Don Whiting (Allegheny Health Network), Phil Yuan (Memorial Long Beach Hospital) and Jim Zucherman, Ken Hsu, and Dimitriy Kondrashov (St. Mary’s Medical Center). Other leading spine research centers are preparing their IRB submissions to join what will prove to be the one of the most watched spine studies.

Clinical sites will be measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the TOPS™ System versus traditional lumbar spinal fusion,” explains Mr. Sacher.

About Premia Spine. Premia Spine licensed the TOPS System technology in 2011 from Impliant, Ltd. Over $100 million has been invested to design, develop, and commercialize the TOPS System, with over 12 years of clinical use and 1,000 patients.

Ron Sacher
Premia Spine, Ltd.
ronsacher@premiaspine.com
email us here

Powered by EIN Presswire

ZipLine® Medical Receives India Regulatory Approval for Non-Invasive Zip® Skin Closure System

May 09, 2017

CAMPBELL, Calif.–(BUSINESS WIRE)–ZipLine® Medical, Inc., an innovator in skin closure, today announced Central Drugs Standard Control Organization (CDSCO) approval of its Zip® Surgical Skin Closure device in India. This clearance will give the company access to the $3.5 billion medical device market in India, including growing specialties where the Zip has shown significant clinical and economic benefits, such as total joint replacement in orthopedics, and Cesarean-section and hysterectomy in obstetrics and gynecology.

The Zip is a non-invasive and easy to use skin closure device that replaces sutures, staples and glue for surgical incisions and lacerations. Clinical studies have demonstrated significant time savings and less procedure variability that can decrease hospital costs and improve efficiencies. Studies have also demonstrated fewer wound complications, and the comfortable and simple removal can reduce post-discharge home health and clinic visits that affect overall healthcare cost in a bundled care environment.

A patented force distribution design results in secure wound closure, excellent scar quality and high patient satisfaction. The Zip’s micro-adjustability and reversibility provide surgeons with precise control during closure, and care teams with security that they can adjust closure post-surgery, if needed. Unlike staples or sutures, there are no skin punctures with the Zip that can create pathways for bacteria. The Zip’s benefits have been demonstrated in clinical studies in orthopedic total-joint arthroplasty, foot and ankle surgery, pediatric cardiothoracic surgery, electrophysiology and dermatology.

In addition, clinical study results from the University of Florida demonstrated an 18 percentage point higher tissue perfusion rate versus baseline with the Zip compared to staples (p<0.001) after closure for total ankle replacement procedures. The results were presented in a poster at the American College of Foot and Ankle Surgeons (ACFAS) conference in Las Vegas in March.

Jason Piraino, DPM, MS, FACFAS, who presented the results, commented, “Maintaining adequate perfusion is one of the most important factors in ensuring wound healing. High perfusion correlates to fewer complications, such as dehiscence and infection. The Zip demonstrated a significant perfusion advantage over staples in our study.”

ABOUT ZIPLINE MEDICAL

ZipLine Medical is an innovator in cost-effective, non-invasive surgical skin closure devices that deliver high patient satisfaction and surgeon efficiency. Zip Surgical Skin Closure devices have been used in more than 100,000 cases, and in over 30 countries. worldwide. ZipLine Medical was founded by Amir Belson, M.D. and is headquartered in Campbell, CA. For more information, visit www.ziplinemedical.com.

Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received the CE Mark and CFDA approval.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 310-902-1274
michelle@chronic-comm.com