Stryker Orthopaedics To Honor Veteran With Donation Of Fourth Service Dog With K9s For Warriors At Charles Schwab Cup Championship

MAHWAH, N.J., Nov. 8, 2016 /PRNewswire/ — This week, Stryker Orthopaedics will wrap up its third year as the Official Joint Replacement Products of the PGA TOUR and PGA TOUR Champions® at the Charles Schwab Cup Championship in Scottsdale, AZ.  This weekend marks the eleventh tournament where the brand engaged with consumers and activated on-site with the “Stryker Mobility Zone” – a destination designed to educate golf fans on the importance of joint health and mobility. In honor of the company’s final stop of the year and to pay homage to its ongoing commitment to our nation’s military, Stryker will make its fourth K9s for Warriors donation this Friday, on Veteran’s Day at 11:00 AM MT in the Birdies for the Brave Patriots’ Outpost located on the 18th fairway at Desert Mountain’s Cochise Course.

Earlier this year Stryker announced a collaboration with K9s For Warriors, a nonprofit organization dedicated to providing service canines to military veterans suffering from Post-Traumatic Stress Disability, traumatic brain injury or other trauma as a result of military service post 9/11. As one of many activities dedicated to the military during Charles Schwab Cup, Stryker will host a special ceremony to present one veteran hero with a sponsored service dog.  Over the course of the year, Stryker has presented three other service dogs to military veterans across the country, in addition to making a donation to the organization for every Stryker hat purchased at the Stryker Mobility Zone.

“I’m very proud of the relationship Stryker has developed with the PGA TOUR over the years, combining our mission to educate people about joint health with our commitment to honoring our military,” said Bill Huffnagle, President, Stryker’s Reconstructive Division.  “We are excited for next year and are looking forward to seeing the relationship continue to evolve.”

Additionally, fans attending the tournament are encouraged to stop by the Stryker Mobility Zone to participate in the Stryker Challenge, a series of golf-inspired activities related to joint health and mobility. While at the Stryker Mobility Zone, fans can learn more about hip and knee pain treatment options, and how they can enter for a chance to win a trip for two to TPC® Sawgrass to play alongside former PLAYERS Championship winners and Stryker ambassadors, Fred Funk and Hal Sutton.1,2 

For additional information on the Stryker Challenge as well as K9s For Warriors involvement, please visit: www.StrykerChallenge.com.

  1. Healthcare Professionals (HCPs) are not eligible to enter the Stryker Challenge Sweepstakes or participate in the any of these promotions. HCPs are defined as those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Stryker’s products.
  2. No purchase necessary to enter or win Sweepstakes.  Void where prohibited by law.  For official rules visit StrykerChallenge.com.  Open to legal residents of the US & US Territories, 21+ as of date of entry.  Sweepstakes begins at 12 am ET on 3/21/16 and ends at 11:59 pm ET on 11/13/16.  Sponsored by Stryker.

About Stryker 

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

About PGA TOUR 

The PGA TOUR is the world’s premier membership organization for touring professional golfers, co-sanctioning more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR China.

The PGA TOUR’s mission is to entertain and inspire its fans, deliver substantial value to its partners, create outlets for volunteers to give back, generate significant charitable and economic impact in the communities in which it plays, and provide financial opportunities for TOUR players.

Worldwide, PGA TOUR tournaments are broadcast to more than 1 billion households in 226 countries and territories in 32 languages. Virtually all tournaments are organized as non-profit organizations in order to maximize charitable giving. In 2015, tournaments across all Tours generated a record $160 million for local and national charitable organizations, bringing the all-time total to $2.3 billion.

The PGA TOUR’s web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, FL.

Logo – http://photos.prnewswire.com/prnh/20160706/386690LOGO

SOURCE Stryker Orthopaedics

Amedica Corporation to Release Third Quarter 2016 Financial Results and Host Conference Call

SALT LAKE CITY, UT–(Marketwired – Oct 28, 2016) – Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that it will release financial results for its third quarter 2016 on Thursday, November 10, 2016, after the market closes.

Following the release, that same day the Company will host a conference call and simultaneous audio webcast with Dr. Sonny Bal, Chairman and CEO of Amedica Corporation to review its third quarter 2016 financial results. Details related to this call are as follows:

Date: Thursday, November 10, 2016

Time: 5:00 p.m. Eastern Time

Conference ID: 13649236

Dial-in:
Toll-free 877-524-8416
International 412-902-1028

Webcast: Investors section of the Company’s website

For those who are not available to listen to the live webcast, a digital replay will be archived on the investor relations section of the Amedica website under Events & Presentations.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world’s largest ceramic manufacturer. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

CONTACT INFORMATION

CollPlant Signs Exclusive Distribution Agreement with Arthrex for Vergenix™STR

NESS ZIONA, Israel, November 8, 2016 /PRNewswire/ —

CollPlant Ltd. (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based recombinant human collagen (rhCollagen) technology for tissue repair products, today announced that it has signed an exclusive distribution agreement with Arthrex for Vergenix™STR for the treatment of tendinopathy. Under terms of the agreement, beginning December 1, 2016, Arthrex will serve as the exclusive distributor of CE Marked Vergenix™STR in Europe, the Middle-East, India and certain African countries. The agreement includes common commercial terms and the first order is expected to be supplied next month.

Yehiel Tal, Chief Executive Officer of CollPlant, stated, “We are honored to have solidified this relationship with Arthrex, a worldwide leader in the orthopedic space. With a well established reputation and global footprint, Arthrex is the perfect partner for Vergenix™STR, which has shown to provide superior tendinopathy healing characteristics versus published results from steroid treatments, currently regarded as the standard of care.”

“We are extremely pleased to partner with CollPlant for the distribution of the company’s novel, Vergenix™STR treatment for tendinopathy,” noted Stefan Krupp, Managing Director of Arthrex GmbH. “We consider CollPlant’s rhCollagen-based technology to be revolutionary, and believe that, over time, our collaboration with CollPlant will expand to additional therapeutic areas.”

About Arthrex

Arthrex is a leading medical orthopedic products company.  The company operates throughout the world and has developed over 10,000 products and medical procedures.  Arthrex’s corporate headquarters is located in Southwest Florida. Additional locations include a global division in Munich, Germany as well as several subsidiaries and distribution centers throughout, among others, Europe- Middle East – Africa (EMEA). Also see the following Arthrex website: https://www.arthrex.com/corporate/aboutus

About Vergenix™STR

VergenixSTR is primarily made of crosslinked recombinant human collagen (rhCollagen) and is intended to be combined with platelet-rich plasma (PRP), a concentrated blood plasma derived from the patient’s own blood that contains high levels of platelets, which are critical to the healing process. Platelets contain growth factors which are responsible for stimulating tissue generation and repair, including soft tissue repair, bone regeneration, development of new blood vessels, and stimulation of the healing process. Upon administration, CollPlant’s VergenixSTR serves as a scaffold to support cell adhesion and proliferation involved in tendon healing, while maintaining growth factor-containing PRP in the vicinity of the injury. After injection into the affected area, the product forms a viscous gel matrix, holding the platelet concentrate in place. The formed matrix then has the ability to release growth factors in a controlled manner and with controlled biodegradation time, thereby enabling optimal healing.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: VergenixSTR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; VergenixFG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and a surgical matrix that we co-develop with Bioventus llc., for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:            
Eran Rotem
Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC
Paula Schwartz (for US Investors)
Managing Director
Tel: +917-322-2216
Email: pschwartz@RxIR.com

 

SOURCE CollPlant Ltd

DJO Global Announces Financial Results for Third Quarter

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 third quarter ended September 30, 2016.

Third Quarter Highlights

Net sales grew 3.2% quarter over quarter to $287.0 million

  • Bracing & Vascular – 0.9% growth
  • Recovery Sciences – 5.0% growth
  • Surgical – 8.5% growth (28% organic growth)
  • International – 3.5% growth (4.7% constant currency growth)

“During the third quarter, we had strong revenue growth in our Surgical, Recovery Sciences and International segments, offset by slower growth in our Bracing & Vascular segment,” said Mike Mogul, DJO’s President and Chief Executive Officer. “The Vascular business was impacted negatively, as we restored service in the quarter following challenges integrating that business into our Oracle ERP system. We also initiated the restructuring of our business units, in which we will fold our Recovery Sciences segment into our other business units, in order to streamline our costs and our operating model,” continued Mike Mogul.

Sales Results

DJOFL achieved net sales for the third quarter of 2016 of $287.0 million, reflecting growth of 3.2%, compared with net sales of $278.3 million for the third quarter of 2015. Changes in foreign currency exchange rates did not have a material impact on the third quarter results.

Net sales for DJO’s Bracing and Vascular segment were $134.4 million in the third quarter of 2016, reflecting an increase of 0.9%, compared to the third quarter of 2015, due to continued momentum in DJO’s Consumer products, offset by continued market pressures in DJO’s Dr. Comfort business.

Net sales for DJO’s Recovery Sciences segment were $39.8 million in the third quarter of 2016, reflecting an increase of 5.0%, compared to the third quarter of 2015, driven by strong sales of Chattanooga rehabilitation equipment and Compex Muscle Stimulators.

Net sales for the Surgical Implant segment were $40.9 million for the third quarter of 2016, reflecting growth of 8.5% over net sales in the third quarter of 2015. The increase was primarily driven by strong organic growth of 27.6% across our existing Shoulder (23%), Hip (23%) and Knee (69%) products, partially offset by a decline of our acquired Biomet bone cement business.

Net sales for DJO’s International segment were $72.0 million in the third quarter of 2016, reflecting an increase of 3.5% (4.7% on a constant currency basis) from the third quarter of 2015, primarily driven by stronger sales in our established direct markets, especially in France, Canada, Italy, Spain and Australia, and increased sales penetration in emerging markets.

Earnings Results

For the third quarter of 2016, DJOFL reported a net loss attributable to DJOFL of $22.6 million, compared to a net loss of $177.8 million for the third quarter of 2015. As detailed in the attached financial tables, the results for the current and prior year third quarter periods and the current and prior year nine month periods were impacted by significant non-cash items, non-recurring items and other adjustments.

Adjusted EBITDA for the third quarter of 2016 was $63.3 million, or 22.1% of net sales, reflecting a decrease of 0.2% as reported when compared with Adjusted EBITDA of $63.4 million, or 22.8% of net sales, for the third quarter of 2015. For the twelve months ended September 30, 2016, including cost savings programs currently underway of $13.8 million, Adjusted EBITDA was $258.5 million, or 22.2% percent of LTM net sales.

The Company defines Adjusted EBITDA as net (loss) income 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 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.

As of September 30, 2016, the Company had cash balances of $46.4 million and available liquidity of $78.8 million under its $150 million revolving credit facility.

“We also initiated the restructuring of our business units, with Recovery Sciences being folded into our other business units, in order to streamline our costs and our operating model,” continued Mike Mogul. “This restructuring addresses many of the stranded costs left from last year’s Empi discontinuation and will simplify our operating structure and costs.”

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 1:00 pm Eastern Time, Tuesday, November 8, 2016. 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 orthopedic 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 orthopedic 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 its growth in revenue and Adjusted EBITDA and its opportunities to improve commercial execution and to develop new products and services. 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 strategies relative to its Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the successful execution of the Company’s restructuring of its business units to realize anticipated cost savings; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the successful execution of the Company’s acquisition strategies; 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; costs associated with 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     Nine Months Ended
September 30,
2016
    September 26,
2015
September 30,
2016
    September 26,
2015
Net sales $ 287,040 $ 278,263 $ 858,798 $ 805,676
Operating expenses:
Cost of sales (exclusive of amortization, see note 1) 122,533 114,239 361,090 333,893
Selling, general and administrative 114,788 113,704 358,344 329,501
Research and development 8,481 7,598 28,457 25,150
Amortization of intangible assets   18,994     20,242     57,657     59,888  
  264,796     255,783     805,548     748,432  
Operating income 22,244 22,480 53,250 57,244
Other (expense) income:
Interest expense, net (42,683 ) (42,127 ) (127,349 ) (129,557 )
Loss on extinguishment of debt (335 ) (68,302 )
Other (expense) income, net   (20 )   (3,056 )   732     (6,469 )
  (42,703 )   (45,518 )   (126,617 )   (204,328 )
Loss before income taxes (20,459 ) (23,038 ) (73,367 ) (147,084 )
Income tax provision   (2,166 )   (2,124 )   (11,156 )   (9,980 )
Net loss from continuing operations (22,625 ) (25,162 ) (84,523 ) (157,064 )
Net income (loss) from discontinued operations   142     (152,536 )   807     (133,671 )
Net loss (22,483 ) (177,698 ) (83,716 ) (290,735 )
Net income attributable to noncontrolling interests   (99 )   (140 )   (461 )   (606 )
Net loss attributable to DJO Finance LLC $ (22,582 ) $ (177,838 ) $ (84,177 ) $ (291,341 )
 

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $7,057 and $21,544 for the three months and nine months ended September 30, 2016 and $7,864 and $22,934 for the three and nine months ended September 26, 2015, respectively.

 
DJO Finance LLC
Unaudited Condensed Consolidated Balance Sheets
(In thousands)
 
        September 30,
2016
    December 31,
2015
Assets
Current assets:
Cash and cash equivalents $ 46,434 $ 48,943
Accounts receivable, net 181,814 172,360
Inventories, net 183,122 174,573
Prepaid expenses and other current assets 23,818 21,179
Current assets of discontinued operations   511     2,878  
Total current assets 435,699 419,933
Property and equipment, net 129,760 117,273
Goodwill 1,019,510 1,018,104
Intangible assets, net 691,604 749,045
Other assets 7,260 5,174
Non-current assets of discontinued operations       29  
Total assets $ 2,283,833   $ 2,309,558  
Liabilities and Deficit
Current liabilities:
Accounts payable $ 69,938 $ 58,492
Accrued interest 45,521 16,998
Current portion of debt obligations 10,550 10,550
Other current liabilities 94,234 102,173
Current liabilities of discontinued operations   262     13,371  
Total current liabilities 220,505 201,584
Long-term debt obligations 2,377,418 2,344,562
Deferred tax liabilities, net 222,376 213,856
Other long-term liabilities   21,145     15,092  
Total liabilities $ 2,841,444   $ 2,775,094  
Commitments and contingencies
Deficit:
DJO Finance LLC membership deficit:
Member capital 842,912 841,510
Accumulated deficit (1,377,516 ) (1,293,339 )
Accumulated other comprehensive loss   (26,174 )   (16,341 )
Total membership deficit (560,778 ) (468,170 )
Noncontrolling interests   3,167     2,634  
Total deficit   (557,611 )   (465,536 )
Total liabilities and deficit $ 2,283,833   $ 2,309,558  
 
 

 

DJO Finance LLC
Unaudited Segment Information
(In thousands)
 
    Three Months Ended     Nine Months Ended
September 30,
2016
    September 26,
2015
September 30,
2016
    September 26,
2015
Net sales:
Bracing and Vascular $ 134,421 $ 133,204 $ 390,388 $ 383,287
Recovery Sciences 39,793 37,895 114,817 112,522
Surgical Implant 40,852 37,651 126,477 92,648
International   71,974     69,513     227,116     217,219  
$ 287,040   $ 278,263   $ 858,798   $ 805,676  
Operating income:
Bracing and Vascular $ 30,393 $ 31,902 $ 79,999 $ 84,295
Recovery Sciences 7,683 7,916 22,184 19,318
Surgical Implant 7,908 7,819 21,190 16,531
International 11,657 11,548 35,299 37,245
Expenses not allocated to segments and eliminations   (35,397 )   (36,705 )   (105,422 )   (100,145 )
$ 22,244   $ 22,480   $ 53,250   $ 57,244  
 

DJO Finance LLC
Adjusted EBITDA

For the Three and Nine Months Ended September 30, 2016 and September 26, 2015
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,044.5 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 $65.0 million was outstanding as of September 30, 2016, 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) 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:

                   
Twelve Months
Three Months Ended Nine Months Ended Ended
September 30, September 26, September 30, September 26, September 30,
2016 2015 2016 2015 2016
Net loss attributable to DJO Finance LLC $ (22,582 ) $ (177,838 ) $ (84,177 ) $ (291,341 ) $ (133,763 )
(Income) loss from discontinued operations, net (142 ) 152,536 (806 ) 133,671 23,103
Interest expense, net 42,683 42,127 127,349 129,557 170,085
Income tax provision 2,166 2,124 11,156 9,980 13,431
Depreciation and amortization 29,031 28,904 88,208 85,416 120,276
Non-cash charges (a) 338 1,076 2,941 2,330 4,014
Non-recurring and integration charges (b) 9,895 9,140 25,832 20,656 39,152
Other adjustment items (c)   1,938     5,356     5,302     80,807     8,372  
63,327 63,425 175,805 171,076 244,670
Permitted pro forma adjustments applicable to the twelve month period only (d)
Future cost savings                           13,807  
Adjusted EBITDA $ 63,327   $ 63,425   $ 175,805   $ 171,076   $ 258,477  
 

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

                    Twelve Months
Three Months Ended Nine Months Ended Ended
September 30, September 26, September 30, September 26, September 30,
2016 2015 2016 2015 2016
Stock compensation expense $ 285 $ 298 $ 1,806 $ 1,450 $ 2,161
(Gain) loss on disposal of fixed assets and assets held for sale, net (4 ) 396 886 211 1,452
Purchase accounting adjustments (1)   57     382   249   669   401
Total non-cash charges $ 338   $ 1,076 $ 2,941 $ 2,330 $ 4,014

 

   
(1) 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 Nine Months Ended Ended
September 30, September 26, September 30, September 26, September 30,
2016 2015 2016 2015 2016
Integration charges:
Global business unit reorganization and integration $ 1,177 $ 2,486 $ 3,998 $ 6,978 $ 5,616
Acquisition related expenses and integration (1) 2,873 2,927 8,855 3,982 13,508
CFO Transition 914 954 954
Litigation and regulatory costs and settlements, net (2) 4,576 1,304 11,062 3,890 16,036
Other non-recurring items (3) 287 1,343 895 3,168 1,974
Automation projects   68   1,080   68   2,638   1,064
Total non-recurring and integration charges $ 9,895 $ 9,140 $ 25,832 $ 20,656 $ 39,152

 

(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 September 30, 2016, litigation and regulatory costs consisted of $2.8 million in litigation costs related to ongoing product liability issues and $13.2 million related to other litigation and regulatory costs and settlements.
(3) For the twelve months ended September 30, 2016, other non-recurring items consisted of $1.7 million in specifically identified non-recurring operational and regulatory projects and $0.2 million in other non-recurring travel and professional fees.
 

(c) Other adjustment items before permitted pro forma adjustments are comprised of the following:

                    Twelve Months
Three Months Ended Nine Months Ended Ended
September 30, September 26, September 30, September 26, September 30,
2016 2015 2016 2015 2016
Blackstone monitoring fees $ 1,750 $ 1,750 $ 5,250 $ 5,250 $ 7,000
Non-controlling interests 99 140 461 606 695
Loss on modification and extinguishment of debt (1) 335 68,302 172
Other (2)   89   3,131   (409 )   6,649   505
Total other adjustment items $ 1,938 $ 5,356 $ 5,302   $ 80,807 $ 8,372

 

(1)   Loss on modification and extinguishment of debt for the nine months ended September 26, 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 $8.3 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 related to the exit of our Empi business and the restructuring of our Recovery Sciences Segment.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161108005409/en/

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
Matt Simons, 760-734-5548
SVP Business Development and Investor Relations
matt.simons@DJOglobal.com

 

Source: DJO Global, Inc.

Flexion Therapeutics Reports Third Quarter 2016 Financial Results

BURLINGTON, Mass., Nov. 07, 2016 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the third quarter ended September 30, 2016.

“Through recent executive hires and further expansion of our commercial and sales teams, we are laying the groundwork to realize our commercialization goals for our investigational therapy, Zilretta™ (also referred to as FX006), in 2017,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “We are looking forward to the upcoming podium presentation of Phase 3 data evaluating Zilretta in patients with osteoarthritis of the knee at the American Association of Knee and Hip Surgeons (AAHKS) meeting on November 11th and remain on track to submit a new drug application (NDA) for Zilretta to the U.S. Food and Drug Administration in December.”

Third-Quarter Financial Results

The company reported a net loss of $17.8 million for the third quarter of 2016, compared to a net loss of $11.1 million for the third quarter of 2015.

Research and development expenses increased to $9.0 million in the third quarter of 2016, compared to $7.8 million for the same period in 2015, due to an increase in personnel and other employee-related costs for additional headcount and stock based compensation.

General and administrative expenses increased to $8.4 million in the third quarter of 2016, as compared to $3.2 million for the same period in 2015, due primarily to additional costs associated with building a commercial infrastructure to effectively support the potential commercialization of Zilretta.

As of September 30, 2016, the company had $161.5 million in cash, cash equivalents, and marketable securities compared to $118.6 million as of December 31, 2015.

Third Quarter Highlights and Recent News:

  • Met primary endpoint in clinical trial evaluating Zilretta in Type 2 diabetes patients with knee osteoarthritis; results demonstrated a markedly lower rise in blood glucose in patients receiving a Zilretta injection compared to patients receiving an immediate-release triamcinolone acetonide (TCA) injection; difference was statistically significant (p<0.05, 2-sided) and clinically relevant.
  • Successfully completed the transfer of the Zilretta manufacturing technology to Patheon marking an important milestone that enables NDA submission in December.
  • Hired several senior level executives in preparation of an anticipated Zilretta commercial launch in 2017, including:
    • Carolyn Beaty Scimemi, Esq. Chief Compliance Officer
    • Mark Fraga, Vice President, Marketing
    • John Magee, Vice President of Sales
    • Adam Muzikant, Ph.D., Vice President, Business Development
    • Dan Thornton, Vice President, Market Access
  • Appointed Mark Stejbach to Flexion’s Board of Directors. Mr. Stejbach is Senior Vice President and Chief Commercial Officer at Alkermes plc.

About Zilretta

Zilretta is being investigated as the first intra-articular extended-release, non-opioid treatment for patients with moderate to severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.

To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. Zilretta is an investigational agent and, as such, has not been approved by the FDA or any other regulatory agencies.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually.

Conference Call

At 4:30 p.m. ET today, Flexion’s management will host a conference call and webcast to review third quarter financial results and provide a general business update. The dial-in number for the conference call is 855-770-0022 for domestic participants and 908-982-4677 for international participants, with Conference ID# 4388754. The live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website at www.flexiontherapeutics.com. A webcast replay will be available online after the call.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta, including the expected timing for commercial launch and Zilretta’s market potential; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

    FLEXION THERAPEUTICS
  CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
  (in thousands, except for per share information)
Three Months Ended
September 30,
2016 2015
Revenue $   – $   –
Operating expenses:
Research and development 9,047 7,829
General and administrative 8,388 3,197
Total expenses 17,435 11,026
Loss from operations   (17,435 )   (11,026 )
Interest income (expense), net (140 ) 72
Other income (expense)   (207 )   (182 )
Loss from operations before income tax   (17,782 ) (11,136 )
Net loss   (17,782 )   (11,136 )
Basic and diluted net loss per share $ (0.65 ) $ (0.52 )
Basic and diluted weighted average number of common shares outstanding 27,524 21,507
FLEXION THERAPEUTICS
SELECTED BALANCE SHEET DATA
(in thousands)
September 30, December 31,
2016   2015
Cash and cash equivalents $   66,809 $   62,944
Marketable securities 94,696   55,660
Total current assets 161,086   112,103
Working capital 148,699   104,044
Total assets 174,421   127,139
Total notes payable 30,298 15,002
Total stockholders’ equity (deficit) 138,031   103,987
Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

PR Contact
Danielle Lewis
Lazar Partners LTD
T: 212-843-0211
dlewis@lazarpartners.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

InVivo Therapeutics Reports 2016 Third Quarter Financial Results and Business Update

November 04, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the quarter ended September 30, 2016.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the third quarter, we continued to make fundamental progress at InVivo. One of the most notable achievements was the expansion of the INSPIRE study to allow for twenty evaluable patients. Just a few weeks later, we had a fifth patient improve from complete to incomplete paralysis making our current conversion rate approximately four times the rate in natural history databases (62.5% vs. 16%). Due in large part to the encouraging clinical outcomes achieved to date, we appointed Pam Stahl as Chief Commercial Officer to lead pre-commercialization efforts in preparation for establishing a commercial organization. We expanded the INSPIRE footprint when we received Investigational Testing Authorization from Health Canada and added our first ex-U.S. investigator and site: Dr. Fehlings at Toronto Western Hospital. We also added Northwestern Medicine and Ben Taub Hospital/Baylor College of Medicine. We had one of our most active quarters in terms of domestic and international speaking engagements: for the investment audience, we presented at annual conferences for Cantor Fitzgerald, Rodman & Renshaw, and Ladenburg Thalmann; for the medical audience, we presented at the International Spinal Cord Society Annual Scientific Meeting and had multiple presentations at the 2016 Congress of Neurological Surgeons Annual Meeting, including a late-breaking oral presentation; and for the scientific audience, we presented at the Cell & Gene Meeting on the Mesa. We ended the quarter in a strong financial position and believe our funds will last us through the end of 2017.”

Financial Results

For the quarter ended September 30, 2016, the Company reported a net loss of approximately $6,196,000, or $.19 per diluted share, compared to a net loss of $2,308,000, or $.09 per diluted share, for the quarter ended September 30, 2015. The Company’s results for the three months ended September 30, 2016 were unfavorably impacted by a loss on the Company’s derivative warrant liability (a non-cash item) of $336,000, driven by an increase in the fair market value of the Company’s warrants. The results for the three months ended September 30, 2015 were favorably impacted by a gain on the Company’s derivative warrant liability of $3,591,000 driven by a decrease in the fair market value of the Company’s warrants. Excluding these charges, for the quarters ended September 30, 2016 and September 30, 2015, adjusted net loss per diluted share was $.18 and $.22, respectively.

The Company ended the quarter with $37,665,000 of cash and cash equivalents.

For the nine months ended September 30, 2016, the Company reported a net loss of approximately $18,004,000, or $.59 per diluted share, compared to a net loss of $28,581,000, or $1.09 per diluted share, for the nine months ended September 30, 2015. The Company’s results for the nine months ended September 30, 2016 were adversely impacted by a loss on the derivative warrant liability of $788,000, reflecting increases in the fair market value of the warrants. The results for the nine months ended September 30, 2015 were adversely impacted by a loss on the derivative warrant liability of $11,349,000. Excluding these charges, for the nine months ended September 30, 2016 and September 30, 2015, adjusted net loss per diluted share was $.56 and $.66, respectively.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the items noted. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors, enabling them to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding these identified items.

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the Company’s beliefs regarding its cash position. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to complete the INSPIRE study and submit an HDE; the Company’s ability to receive regulatory approval for the Neuro-Spinal Scaffold; the Company’s ability to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
As of
September 30,
2016

December 31,
2015

ASSETS:
Current assets:
Cash and cash equivalents 37,665 20,194
Restricted cash 361 361
Prepaid expenses and other current assets 413 184
Total current assets 38,439 20,739
Property, equipment and leasehold improvements, net 630 938
Other assets 411 115
Total assets 39,480 21,792
LIABILITIES AND STOCKHOLDERS’ DEFICIT:
Current liabilities:
Accounts payable 556 521
Loan payable, current portion 416 395
Derivative warrant liability 2,695 1,907
Deferred rent, current portion 134 115
Accrued expenses 1,704 374
Total current liabilities 5,505 3,312
Loan payable, net of current portion 960 1,275
Deferred rent, net of current portion 175 276
Total liabilities 6,640 4,863
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares, issued and
outstanding 32,033,094 at September 30, 2016; and authorized 50,000,000 shares, issued
and outstanding 27,555,948 shares at December 31, 2015 1 1
Additional paid-in capital 184,411 150,497
Accumulated deficit (151,572 ) (133,569 )
Total stockholders’ equity 32,840 16,929
Total liabilities and stockholders’ equity 39,480 21,792
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2016 2015 2016 2015
Operating expenses:
Research and development 3,294 2,432 8,659 7,280
General and administrative 2,584 3,437 8,573 9,861
Total operating expenses 5,878 5,869 17,232 17,141
Operating loss (5,878 ) (5,869 ) (17,232 ) (17,141 )
Other income (expense):
Interest income 50 2 133 6
Interest expense (32 ) (32 ) (117 ) (97 )
Derivatives (loss) gain (336 ) 3,591 (788 ) (11,349 )
Other income (expense), net (318 ) 3,561 (772 ) (11,440 )
Net loss (6,196 ) (2,308 ) (18,004 ) (28,581 )
Net loss per share, basic and diluted (0.19 ) (0.09 ) (0.59 ) (1.09 )
Weighted average number of
common shares outstanding,
basic and diluted 31,968,357 27,010,444 30,687,263 26,150,525
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2016 2015 2016 2015
Reported GAAP net income (loss) (6,196 ) (2,308 ) (18,004 ) (28,581 )
Derivative (gain)/ loss 336 (3,591 ) 788 11,349
Adjusted net loss (5,860 ) (5,899 ) (17,216 ) (17,232 )
Reported GAAP net loss per diluted share (0.19 ) (0.09 ) (0.59 ) (1.09 )
Derivative loss per diluted share 0.01 (0.13 ) 0.03 0.43
Adjusted net loss per diluted share (0.18 ) (0.22 ) (0.56 ) (0.66 )

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

Spine Implants Market in the US 2016-2020; New Report Launched

Bangalore, Karnataka — (SBWIRE) — 11/04/2016 — The spine implants help in correcting deformities of the spine and restoring the function of the spine. Some of the conditions that require the use of spine implants are spondylolisthesis, chronic degenerative disc diseases (DDDs), traumatic fracture, and other forms of spinal instability including scoliosis. These implants are mainly composed of titanium, stainless steel, polyether ether ketone (PEEK), carbon fiber, and other bio-absorbable materials.

Report forecast the spine implants market in the US to grow at a CAGR of 5.29% during the period 2016-2020.

The report covers the present scenario and the growth prospects of the spine implants market in the US for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales generated from the sales of spine implants.

Spine Implants Market in the US 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Key vendors
– Medtronic
– DeBuy Synthes
– Stryker
– NuVasive

Other prominent vendors
– AccelSPINE (CTL Medical Group)
– AESCULAP
– Alliance Spine
– Alphatec Spine
– Amedica Corporation
– Globus Medical
– K2M
– LDR
– Life Spine
– Orthofix International
– Paradigm Spine
– Precision Spine
– RTI Surgical
– Spine Surgical Innovations
– Spineology
– Titan Spine
– TranS1
– Wenzel Spine
– Zimmer Biomet
– Zyga Technology

Market driver
– Increasing prevalence of spinal disorders such as spinal stenosis
– For a full, detailed list, view our report

Market challenge
– Lack of product differentiation
– For a full, detailed list, view our report

Market trend
– Emerging motion preservation technology (non-fusion)
– For a full, detailed list, view our report

Key questions answered in this report
– What will the market size be in 2020 and what will the growth rate be?
– What are the key market trends?
– What is driving this market?
– What are the challenges to market growth?
– Who are the key vendors in this market space?
– What are the market opportunities and threats faced by the key vendors?
– What are the strengths and weaknesses of the key vendors?

Spanning over 80 pages “Spine Implants Market in the US 2016-2020” report covers Executive summary, Scope of the report, Market research methodology, Introduction, Market landscape, Market segmentation by product, Market segmentation by procedure, Market segmentation by end-user, Market drivers, Impact of drivers, Market challenges, Impact of drivers and challenges, Market trends, Vendor landscape, Key vendor analysis, Appendix.

For more information Visit at: http://www.drugpipeline.net/technavio/spine-implants-market-us-2016-2020

About DrugPipeline.net
DrugPipeline.net is a market research reports distribution platform which hosts research reports from all leading global market research firms related to pharma industry. It also assist decision makers locate the right market research solution from a single place.

ConforMIS Reports Third Quarter 2016 Financial Results

BEDFORD, Mass., Nov. 03, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today financial results for the third quarter ended September 30, 2016.

Q3 Summary:

  • Total revenue of $18.6 million, up 34% year-over-year on a reported basis and up 35%  year-over-year on a constant currency basis.
  • Product revenue of $18.4 million, up 36% year-over-year on a reported basis and up 37% year-over-year on a constant currency basis
    • U.S. product revenue increased 43% year-over-year
    • Rest of World product revenue increased 14% year-over-year on a reported basis and 18% year-over-year on a constant currency basis

“We had a solid third quarter of 2016,” said Philipp Lang, MD, MBA, President and Chief Executive Officer of ConforMIS, Inc.  “We saw double digit growth in our base business year-over-year with iTotal CR and our partial knee systems. The revenue growth for our newest product, iTotal PS, has been impressive. This innovative product approximately triples the addressable market for ConforMIS and is rapidly becoming our flagship product for new surgeon acquisition.”

Dr. Lang continued, “We have completed enrollment in our single timepoint study comparing iTotal CR to leading off-the-shelf implants in over 800 patients. The results to-date show that patients that received an iTotal CR implant were significantly faster at completing three functional tests of daily living, including walking, than patients with an off-the-shelf implant. We believe that this and other direct comparative studies will help us increase the utilization of our implants with current and new surgeons.”

Third Quarter 2016 Financial Results

  Three months ended September 30, Increase/decrease
($, in thousands)   2016     2015    $
Change
%
Change
%
Change
         (as reported)  (constant currency)
United States $ 14,954   $ 10,466   $ 4,488     43 %   43 %
Rest of world   3,446     3,024     421     14 %   18 %
Product revenue   18,400     13,490     4,910     36 %   37 %
Royalty revenue   243     404     (161 )   -40 %   -40 %
Total revenue $ 18,643   $ 13,894   $ 4,749     34 %   35 %
           

Total revenue increased $4.7 million to $18.6 million, or 34% year-over-year on a reported basis and 35% year-over-year on a constant currency basis, as compared to the third quarter of 2015, which was affected by our product recall. Total revenue in the third quarter of 2016 included royalty revenue of $0.2 million as compared to $0.4 million in the third quarter of 2015.

Product revenue increased $4.9 million to $18.4 million, or 36% year-over-year on a reported basis and 37% year-over-year on a constant currency basis. U.S. product revenue increased $4.5 million to $15.0 million, or 43% year-over-year, and Rest of World product revenue increased $0.4 million to $3.4 million, or 14% year-over-year on a reported basis and 18% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni increased $1.7 million to $14.4 million, or 13% year-over-year on a reported basis and 14% year-over-year on a constant currency basis. Product revenue from sales of iTotal PS increased $3.2 million to $4.0 million, or 401% year-over-year on a reported basis and 403% year-over-year on a constant currency basis.

Gross profit increased $3.2 million to $6.0 million, or 32% of revenue, which included $1.3 million in unused product, in the third quarter of 2016, compared to $2.8 million, or 20% of revenue, which included $0.8 million in unused product, in the third quarter of 2015. This increase in gross profit was driven primarily by higher product revenue in 2016 compared to 2015.

Total operating expenses decreased $0.1 million to $18.9 million, or 0.4% year-over-year. The decrease in expenses was driven primarily by lower sales and marketing costs and lower general and administrative costs, offset by slightly higher research and development costs compared to the third quarter of 2015.

Net loss was $12.8 million, or $0.31 per basic share, in the third quarter of 2016, compared to a net loss of $17.1 million, or $0.45 per basic share, for the same period last year. This decrease in net loss was driven primarily by higher product revenue in 2016 compared to 2015.

As of September 30, 2016, the Company’s cash and cash equivalents and short and long-term investments totaled $75.8 million, compared to $117.2 million as of December 31, 2015.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Conference Call

As previously announced, ConforMIS will conduct a conference call and webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 5481072 or listen to the webcast in the investor relations section of the company’s website at ir.conformis.com. The online archive of the webcast will be available on the company’s website for 30 days.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, operating trends, the potential impact and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, expenses, and other results of operations, growth in our customer base, the impact of the CJR program, contracting trends, the impact of our voluntary recall on financial results and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(in thousands, except share and per share data)
                     
              Three Months Ended September 30, Nine Months Ended September 30,
                2016     2015     2016     2015  
                     
Revenue            
  Product   $ 18,400   $ 13,490   $ 57,486   $ 43,953  
  Royalty       243     404     740     3,863  
Total revenue   18,643     13,894     58,226     47,816  
Cost of revenue   12,645     11,132     39,564     32,371  
  Gross profit   5,998     2,762     18,662     15,445  
                     
Operating expenses        
  Sales and marketing   9,301     9,433     31,063     27,584  
  Research and development   4,099     3,885     12,474     12,218  
  General and administrative   5,503     5,656     17,285     16,790  
                     
    Total operating expenses   18,903     18,974     60,822     56,592  
Loss from operations   (12,905 )   (16,212 )   (42,160 )   (41,147 )
                     
Other income and expenses        
  Interest income   127     24     409     92  
  Interest expense   (4 )   (911 )   (104 )   (1,380 )
  Other income (expense)   34         34     208  
    Total other expenses   157     (887 )   339     (1,080 )
Loss before income taxes   (12,748 )   (17,099 )   (41,821 )   (42,227 )
  Income tax provision   14     8     27     29  
                     
Net loss     $ (12,762 ) $ (17,107 ) $ (41,848 ) $ (42,256 )
                     
Net loss per share – basic and diluted $ (0.31 ) $ (0.45 ) $ (1.01 ) $ (2.69 )
Weighted average common shares outstanding – basic and diluted   41,682,244     37,933,069     41,332,958     15,688,686  
                         

 

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)
                   
              September 30, 2016   December 31, 2015
               
Assets        (unaudited)    
  Current Assets      
    Cash and cash equivalents $ 34,986     $ 117,185  
    Investments   38,337        
    Accounts receivable, net   13,839       14,867  
    Inventories   11,755       11,520  
    Prepaid expenses and other current assets   2,242       2,451  
      Total current assets   101,159       146,023  
  Property and equipment, net   14,985       10,966  
  Other Assets      
    Restricted cash   300       600  
    Investments   2,497        
    Intangible assets, net   808       995  
    Goodwill   753       753  
    Other long-term assets   29       32  
      Total assets $ 120,531     $ 159,369  
                   
Liabilities and stockholder’s equity      
  Current liabilities      
    Accounts payable $ 4,392     $ 4,718  
    Accrued expenses   6,246       7,811  
    Deferred revenue   305       305  
    Current portion of long-term debt   257       295  
      Total current liabilities   11,200       13,129  
    Other long-term liabilities   166       220  
    Deferred revenue   4,396       4,625  
    Long-term debt         183  
      Total liabilities   15,762       18,157  
Stockholders’ equity      
  Preferred stock, $0.00001 par value:      
    Authorized: 5,000,000 and zero shares authorized at September 30, 2016 and    
        December 31, 2015; no shares issued and outstanding as of September 30, 2016 and December 31, 2015          
  Common stock, $0.00001 par value:      
    Authorized: 200,000,000 shares at September 30, 2016 and December 31, 2015;    
        42,758,693 and 41,110,127 shares issued and outstanding at September, 2016 and December 31, 2015, respectively          
  Additional paid-in capital   472,778       467,075  
  Accumulated deficit   (367,190 )     (325,342 )
  Accumulated other comprehensive loss   (819 )     (521 )
    Total stockholders’ equity   104,769       141,212  
    Total liabilities and stockholders’ equity $ 120,531     $ 159,369  
                   

CONTACT: Investor contact

Oksana Bradley

ir@conformis.com

(781) 374-5598

ConforMIS, Inc

Integra LifeSciences Announces Plans for a Two-For-One Stock Split and Increase in Authorized Shares

PLAINSBORO, N.J., Oct. 27, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that its Board of Directors has recommended an increase in the number of authorized shares and a two-for-one stock split.

“The recommendation from the board of directors acknowledges the inflection point the Company has gone through and demonstrates their confidence in our long-term outlook,” said Peter Arduini, President and Chief Executive Officer, Integra Lifesciences. “This is the first increase in authorized shares in our 20-year history as a public company,” continued Mr. Arduini. “This authorization enhances our capital flexibility and better positions the Company for long-term growth.”

Stockholder approval is required for the proposal to amend the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 60,000,000 to 240,000,000 shares for the purpose of, among other things, effecting a two-for-one stock split (the “Amendment”). A special meeting of stockholders is expected to be held on Wednesday, December 21, 2016 at the Company’s Corporate Headquarters, 315 Enterprise Drive, Plainsboro, New Jersey.

If approved, the Company currently anticipates filing the Amendment with the Delaware Secretary of State on December 21, 2016. Holders of shares of the Company’s common stock at the time of the filing of the Amendment with the Delaware Secretary of State will be entitled to receive new shares, which are expected to be distributed on or about January 3, 2017.

Integra LifeSciences does not expect the stock split or increase in authorized shares to have any impact on 2016 financial performance.

About Integra

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for caregivers, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect Integra LifeSciences’ judgment as of the date of this release. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. These risks and uncertainties include market conditions and other factors beyond Integra LifeSciences’ control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A of Integra LifeSciences’ Annual Report on Form 10-K for the year ended December 31, 2015, and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results. These forward-looking statements are made only as the date thereof, and Integra LifeSciences undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations: 
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com 

Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Intellijoint Surgical® Raises $11M to Expand the US Launch of intellijoint HIP®

November 1, 2016 (Waterloo, Ontario) – Intellijoint Surgical®, Inc., an innovative medical technology company that develops and commercializes 3D mini-optical navigation solutions for surgery, is excited to announce the completion of its Series A with $11MM in financing. The Series A was led by private investors from the Waterloo-Toronto corridor and closed in multiple tranches. Intellijoint is committed to improving patient outcomes through innovative technology made accessible for every patient, every surgeon and every healthcare facility.

“The US launch of the next generation intellijoint HIP® earlier this year is being extremely well received in the marketplace and is seeing significant growth,” commented Intellijoint Surgical® CEO and Co-Founder, Armen Bakirtzian. “This Series A capital will allow Intellijoint to enhance its product offering with the Direct Anterior Approach Application and allow for expansion into new US markets while enabling deeper penetration of Intellijoint’s presence in New York and Illinois.”

Intellijoint Surgical’s flagship product, intellijoint HIP®, is a mini-optical navigation solution that assists orthopaedic surgeons in reaching preoperative surgical targets by providing real-time, intraoperative measurements for cup position, leg length, offset and hip center of rotation during a Total Hip Arthroplasty (THA). intellijoint HIP® has been used in over 500 procedures in Canada and US, and is both Health Canada licensed and FDA approved.

“Intellijoint has addressed the shortcoming of traditional navigation. The miniature optical camera provides accurate measurements while compensating for patient movement, which is routine during a total hip replacement. It provides me with valuable information and I choose to use it in every case,” added Dr. Wayne Paprosky, Midwest Orthopaedics at Rush and member of Intellijoint’s scientific medical advisory board.

About Intellijoint Surgical, Inc.

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical has plans to use its core technology to expand into other orthopaedic procedures.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com