Globus Medical Reports Third Quarter 2016 Results

Posted On November 9, 2016 By OrthoSpineNews In Financial /

AUDUBON, PA, November 8, 2016: Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the third quarter ended September 30, 2016.

Worldwide sales decreased 1.0% as reported to $135.7 million, or a decrease of 0.7% on a
constant currency basis
Third quarter net income was $26.2 million, or 19.3% of sales
Diluted earnings per share (EPS) were $0.27
Non-GAAP diluted EPS were $0.29
Non-GAAP adjusted EBITDA (AEBITDA) remained at 37.0% of sales
Company issues new 2016 guidance for sales of $560 million

David Paul, Chairman and CEO said, “Third quarter sales were $135.7 million, a year-over-year decrease of 1%. Despite our increased spending in support of our pending robotics and trauma launches, our EBITDA margins remained stable with the prior year, at 37.0%. We also delivered non-GAAP EPS of $0.29, in line with the prior year.

“During the third quarter, we continued progress with product development, sales force expansion and completed the acquisition of Alphatec’s international business. We also made further progress expanding our in-house manufacturing capacity. We launched 7 new products in the third quarter, bringing our 2016 total to 15. We remain confident in our long term growth prospects and our ability to sustain our industry leading profitability by the continued execution of our strategy of introducing innovative products, expanding our U.S. and international sales footprint, and diligent expense control.”

Third quarter sales in the U.S. decreased by 4.1% compared to the third quarter of 2015. International sales increased by 34.1% over the third quarter of 2015 on an as reported basis and 38.0% on a constant currency basis.

Third quarter net income was $26.2 million, a decrease of 1.0% over the same period last year. Diluted EPS for the third quarter was $0.27, as compared to $0.28 for the third quarter 2015. Non-GAAP diluted EPS for the third quarter, was $0.29, consistent with the third quarter of 2015.

The company generated net cash provided by operating activities of $41.9 million and non-GAAP free cash flow of $24.6 million in the third quarter. Cash, cash equivalents and marketable securities ended the quarter at $322.4 million. The company remains debt free.

2016 and 2017 Annual Guidance
The company today issued new guidance for full year 2016 sales of $560 million and GAAP earnings per share of approximately $1.13. Guidance for non-GAAP diluted EPS, remains unchanged at $1.20 per share. The company currently projects 2017 full year sales of $625 million and expects to provide further guidance at the fourth quarter call.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2016 third quarter results with the investment community at 5:30 p.m. Eastern Time today. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

If you are unable to participate during the live teleconference, the call will be archived until Tuesday, November 15, 2016. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 1961965.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures. For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provisions for litigation, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense. Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections. Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized. Acquisition related costs represents the change in fair value of business acquisition related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition related professional fees.

In addition, for the period ended September 30, 2016 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments. We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends. Additionally, for the periods ended September 30, 2016 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment. We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions. Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period. We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP. These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results. Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable. Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forwardlooking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forwardlooking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Download The Full Report Here

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

Asterias Biotherapeutics Announces Treatment of First Spinal Cord Injury Patient with Maximum Dose of AST-OPC1 in SCiStar Clinical Trial

Posted On November 8, 2016 By OrthoSpineNews In Biologics, Neuro /

FREMONT, Calif., Nov. 8, 2016 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that the first patient with complete (AIS-A) cervical spinal cord injury was successfully administered the highest dose of 20 million cells of AST-OPC1 (oligodendrocyte progenitor cells) in the SCiStar clinical trial at Santa Clara Valley Medical Center (SCVMC) in San Jose, CA. In addition, enrollment continues in the AIS-B 10 million cell cohort with a second patient now dosed.

Dose escalation to 20 million cells followed the Data Monitoring Committee (DMC) review of safety data from the prior 2 million cell and 10 million cell dose cohorts, and was based on AST-OPC1’s continued favorable safety profile observed in the ongoing clinical study. The company recently presented positive early efficacy data from the 10 million cell cohort. These data reached the 6 month efficacy target within 3 months and suggested the emergence of a possible early dose response for AST-OPC1.

“We have been very encouraged by the early clinical efficacy and safety data for AST-OPC1, and we now look forward to evaluating the 20 million cell dose in complete cervical spinal cord injury patients,” said Dr. Edward Wirth, Chief Medical Officer of Asterias. “Based on extensive pre-clinical research, this is in the dosing range where we would expect to see optimal clinical improvement in these patients.”

Stephen McKenna, MD, Chief of the Rehabilitation Trauma Center at SCVMC, said, “The early efficacy results presented in September from the 10 million cell AIS-A cohort were quite encouraging, and we’re looking forward to seeing if those meaningful functional improvements are maintained through six months and beyond. We are also looking forward to seeing the results in patients from the higher 20 million cell AST-OPC1 dose, as well as results in the first AIS-B patients.”

The trial results to date continue to support a positive safety profile for AST-OPC1. There have been no serious or unexpected adverse events related to AST-OPC1, the administration procedure or the accompanying short course of low-dose immunosuppression in any of the patients treated with AST-OPC1, including five patients in an earlier Phase 1 trial with neurologically complete thoracic SCI.

In September, Asterias reported positive early efficacy data for AST-OPC1 from five AIS-A patients that had been dosed with 10 million AST-OPC1 cells in the SCiStar study. While early in the study, by Day 90 of follow-up, all patients have shown at least one motor level of improvement and the efficacy target of 2 of 5 patients in the cohort achieving two motor levels of improvement on at least one side of their body was achieved. Patient improvements are being measured by the ISNCSCI neurological classification scale widely used to quantify functional status of patients with spinal cord injuries. As suggested by existing research in patients with complete cervical spinal cord injuries, a two motor level improvement is correlated with a significant increase in functional ability, as well as the ability for patients to care for themselves, since so many activities of daily living are dependent on arm and hand function [Steeves, et al, 2012].

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites that have enrolled and dosed patients in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) in Los Angeles and Santa Clara Valley Medical Center in San Jose.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with the administration of the cells, with AST-OPC1 itself, or the immunosuppressive regimen. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with complete cervical spine injuries, which represents the first targeted population for registration trials.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury.

AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias after demonstrating promise in a Phase 2 study in Acute Myeloid Leukemia (AML) and completing a successful end-of-Phase 2 meeting with the FDA. The company is currently focused on streamlining and modernizing the manufacturing process for AST-VAC1 in advance of a planned initiation of a confirmatory phase 2b study in 2018. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

Forward Looking Statements

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

SOURCE Asterias Biotherapeutics, Inc.

KATOR Receives FDA Clearance for Knotless Suture Anchor System

Posted On November 8, 2016 By OrthoSpineNews In Regulatory /

LOGAN, Utah, Nov. 8, 2016 /PRNewswire/ — KATOR, a start-up medical device company focused on advanced tissue-to-bone reattachment systems, announces that it has received its second FDA 510(k) clearance for its innovative KATOR Suture Anchor System.

The KATOR Suture Anchor System was previously cleared by the FDA for use with #2 high strength suture. This new FDA clearance now expands the system for use with 2mm wide high strength suture tape. Made from PEEK material, a single KATOR Suture Anchor is now FDA cleared for use with up to 4 strands of #2 suture or up to 2 strands of 2mm wide suture tape.

The KATOR Suture Anchor System represents a new paradigm in tissue-to-bone reattachment. The system combines a transosseous technique with knotless suture anchor fixation to provide repair constructs with superior strength compared to currently marketed suture anchors (data on file). Because of this superior strength, surgeons can repair torn rotator cuffs or reattach Achilles tendons using fewer suture anchors, preserving more bone, increasing the “footprint” area and increasing the blood flow available for tendon healing.

KATOR is a medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contact:

Mr. Lane Hale
Executive Vice President
132370@email4pr.com
www.surgicalfrontiers.com
800-230-3710

SOURCE KATOR, LLC

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

Posted On November 8, 2016 By OrthoSpineNews In Financial /

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 18^th 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.

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.
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

Posted On November 8, 2016 By OrthoSpineNews In Financial /

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

Contacts:
Kevin Ontiveros
801-839-3502
IR@amedica.com

BRH Medical Receives Patents in Both the USA and in China for Its Innovative Wound Healing Therapy

Posted On November 8, 2016 By OrthoSpineNews In Regulatory /

JERUSALEM, Nov. 8, 2016 — (Healthcare Sales & Marketing Network) — BRH Medical announced today that the USA and China issued patents for its innovative wound healing system for the treatment of Diabetic Leg Wounds, Venous Leg Ulcers, and Pressure Ulcers. The patent issued in China covers the treatment of skin ulcers, while the patent issued by the US Patent and Trademark Office covers both the technology developed for treatment of skin ulcers and the advanced documentation technology integrated into the system.

“Patents in both of these markets highlight the uniqueness of our wound healing product,” said Motti Oderberg, CEO, BRH Medical. “Both the USA and China have a very large market potential and achieving patents in these countries represent an important stage in the penetration of these markets.” Oderberg added.

The BRH wound treatment solution is based on ultrasound and electric fields integrated in one system. Each system is equipped with a built-in digital photo measurement assembly as well as documentation software for tracking the wound healing progress.

Ilan Feferberg, BRH Medical Chief Technology Officer and the inventor behind the patented technology explained, “It has always been my desire to develop a product that would truly help to cure people. Our grateful patients are proof of the effectiveness of the technology.”

The system has been clinically proven to reduce wound pain as well as accelerate wound healing. A published study-related paper showed that after only one month of treatments, more than 50% of the Diabetic Foot Ulcers responded positively and resulted in wound closure.

Mr. Oderberg concluded, “The market for wound healing products is large and growing and vision is to become the gold standard for treatment of chronic wounds of all kinds, including pressure wounds, diabetic leg wounds and wounds caused as a result of ischemia.”

About BRH Medical

BRH Medical designs, develops and manufactures advanced medical devices and solutions for chronic wound care. The company’s products implement a novel, patented technology that combines therapeutic ultrasound and electrical fields. The company is currently expanding efforts to expand its global presence and will be participating at the Medica Trade Show (Dusseldorf, November 2016).

For more information, visit our web site: http://www.brhmedical.com.

Source: BRH Medical

CollPlant Signs Exclusive Distribution Agreement with Arthrex for Vergenix™STR

Posted On November 8, 2016 By OrthoSpineNews In Financial /

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

Vergenix^™STR 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 Vergenix^™STR 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: Vergenix^™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; Vergenix^™FG (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

MIGHTY OAK MEDICAL RECEIVES SECOND FDA CLEARANCE FOR PATIENT-SPECIFIC 3D PRINTED FIREFLY® PEDICLE SCREW NAVIGATION GUIDES

Posted On November 8, 2016 By OrthoSpineNews In Regulatory /

Englewood, CO — November 7, 2016 — Mighty Oak Medical (http://www.mightyoakmedical.com) announced today that its patient-specific, 3D printed FIREFLY® Pedicle Screw Navigation Guides have received a second FDA clearance extending compatibility to essentially all currently cleared pedicle screw systems. The new clearance also extends the indications for use to T1-S2/ilium. By choice, Mighty Oak does not have its own proprietary screw system, and is actively collaborating with strategic channel partners.

At the recent NASS meeting, a number of complex navigation options were on display in the $1 million range. With navigation gaining traction as a way to improve screw placement accuracy, surgeon interest is high. But in light of health care economics today, it will be a struggle for navigation to become standard of care at a $1 million price point.

FIREFLY® Pedicle Screw Navigation Guides are a notable exception to the prevailing complexity and expense of current navigation equipment. The FIREFLY® Technology platform has already received two prestigious Spine Technology Awards for its 3D printed patient-specific solutions to challenges in spinal surgery, including the one it received last week.

FIREFLY® does not require an upfront capital expenditure and is single-use and scalable. It features concierge pre-surgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, surgeon-approved preselected trajectories, an intraoperative plan, and 3D printed patient-specific guides to mechanically constrain the drill and tap to follow the preselected trajectories. FIREFLY® is highly accurate and limits intraoperative radiation exposure; in 10 of 14 recent FIREFLY® surgeries, no fluoroscopy was used for drilling, tapping or pedicle screw placement. The system does not disrupt surgical flow and is designed to increase OR efficiency. It is also the only patient-specific pedicle screw guide indicated for use in pediatric patients.

FIREFLY® Technology should also be able to help hospitals faced with scheduling conflicts for their current navigation systems. By being open platform and compatible with essentially all currently cleared pedicle screw systems, these patented 3D printed patient-specific guides are an exciting new option on the navigation menu.

According to Brent Ness, the Chief Operating Officer for Mighty Oak and former VP of Global Sales and Marketing for Medtronic Navigation: “FIREFLY® Technology is at the epicenter of three strong trends: 3D printing, personalized medicine, and pre-surgical planning. It is uniquely situated to bring navigation to standard of care around the world.”

About Mighty Oak:

Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to info@mightyoakmedical.com.

K162419 contains the exact indications for use.

MEDIA CONTACT:

Laura Charlton (formerly Johnson) for Mighty Oak Medical

laurajohnsonpr@yahoo.com

(760) 450-7749 cell

DJO Global Announces Financial Results for Third Quarter

Posted On November 8, 2016 By OrthoSpineNews In Financial /

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.

										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

Posted On November 7, 2016 By OrthoSpineNews In Financial /

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 11^th 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

Month: November 2016

CONTACT INFORMATION

Contacts