AMNIOX Highlights Study Demonstrating Improved Outcomes in Patients Treated with CLARIX® Regenerative Matrix as an Adjunct to Lumbar Discectomy

October 26, 2016

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech™, Inc., company, announced the results of a prospective randomized clinical study of its proprietary cryopreserved Amniotic Membrane (AM) as an adjunct to lumbar discectomy. The findings will be presented at the North American Spine Society 2016 Annual Meeting, by the study’s lead investigator, D. Greg Anderson, M.D. of the Rothman Institute in Philadelphia, PA.

The study included 80 patients, with half of the patients receiving CLARIX 100 in the disc space following removal of the disc herniation and half receiving the standard of care which involved removal of the herniation alone. Patients treated with CLARIX saw statistically significant improvement in Oswestry Disability Index (ODI) scores and SF-12 (Physical Composite Scale) at six weeks and two years. The ODI quantifies disability due to low back pain and the SF-12 assesses the patients’ physical and mental well-being. The study also reports that there were no recurrent herniations in the CLARIX treatment group during the 2-year follow-up period, compared to a 7.5 percent recurrence rate in the control group.

“Degenerative disc disease is the most common source of back pain and lumbar discectomy is the most common surgical intervention to treat this condition. However, residual back pain and recurrent herniations can be as high as 20%” said Dr. Anderson, Professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University and Clinical Director of the Spine Section of the Orthopaedic Research Laboratory. “These results indicate that the application of CLARIX can influence the healing response to significantly improve post-surgical outcomes. Patients experience reduced pain and a faster and sustained return to activities of daily living. Additionally, although it was not an endpoint identified in the study protocol, we observed a reduction in the use of narcotics in the patients treated with CLARIX.”

“This Level 1 study is the first one to evaluate the benefits of placental tissue in conjunction with discectomy and is clear evidence that the benefits of CLARIX that have been observed in other orthopedic procedures can be brought to patients undergoing spinal surgery” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Equally important to the clinical benefits observed are the enormous health economic implications of this study. Reductions in the rate of rehospitalization and in the number of future operations for reherniation make this a technology that will be embraced by payers as well as providers.”

Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 250,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.

About Amniox Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 25 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

Contacts

For AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883
cgale@greentarget.com

Life Spine® Announces Initial Clinical Cases with PRO-LINK® Ti Stand-Alone Cervical Spacer System

October 26, 2016 – HUNTLEY, Ill.–(BUSINESS WIRE)–

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the company has successfully completed initial cases with its recently launched PRO-LINK Ti Stand-Alone Cervical Spacer System. PRO-LINK Ti offers a low-profile, stand-alone cervical interbody, incorporating OSSEO-LOC, a proprietary surface treatment for titanium which helps create an environment for potential bone growth. The U.S. Food and Drug Administration (FDA) provided 510(k) marketing clearance for the PRO-LINK Ti System in September 2016.

Thomas B. Scully, M.D., of Northwest Neuro Specialists stated that, “Similar to the original PEEK version of PRO-LINK, which we have used for years with great results, this latest titanium addition to the PRO-LINK family gives us another great option to improve patient treatment. I personally prefer the titanium construction for ensured strength and increased likelihood of fusion.”

PRO-LINK Ti is scheduled for full product release this week at Life Spine’s booth #1031 at the 31st North American Spine Society (NASS) Annual Meeting, and is one of over twenty Life Spine products launching in 2016.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161026005339/en/

Globus Medical Launches INDEPENDENCE MIS™, a Minimally Invasive ALIF Integrated Plate-Spacer

AUDUBON, Pa., Oct. 25, 2016 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced the introduction of the INDEPENDENCE MIS™ System, an integrated ALIF plate-spacer system designed to simplify implantation and fixation of a commonly challenging procedure.

The INDEPENDENCE MIS™ system features advanced instruments that deploy three pre-loaded anchors through a small protected corridor no larger than the implant itself.  Most integrated ALIF systems either use screws, which tend to require a much larger access to insert due to their orientation, or wide blades impacted into the bone that can be hard to retrieve. INDEPENDENCE MIS™ streamlines the anterior procedure into three simple steps: inserting the implant, deploying the anchors, and locking the anchors.

“This device is a game-changer,” commented Andrew Iott, Senior Vice President of Product Development.  “It builds on the philosophy and success of the INDEPENDENCE® system by delivering a swift, streamlined procedure that enables surgeons to perform an ALIF in fewer steps while preserving the versatility to use screws.  INDEPENDENCE MIS is another proud addition to our innovative suite of MIS products.”

Indications

INDEPENDENCE® (including INDEPENDENCE MIS, INDEPENDENCE® TPS, and INDEPENDENCE MIS TPS) Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE MIS™ Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

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. Additional information can be accessed at http://www.globusmedical.com.

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 forward-looking 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 comply with changing laws and regulations that are 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 its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking 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.

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

Isto Biologics will join industry experts at the annual North American Spine Society (NASS) meeting in Boston this week

ST. LOUIS, Oct. 25, 2016 /PRNewswire/ — Isto Biologics is wasting no time in showcasing its bone-regeneration technologies and cell-based therapy to industry leaders and spine surgeons. Isto Biologics, resulting from the combination of Isto Technologies and Arteriocyte Medical Systems, will participate in the 2016 North American Spine Society (NASS) annual meeting in Boston Oct. 26-29.

“The combination of Isto Technologies and Arteriocyte Medical Systems expands our best-in-class product portfolios and builds upon our collective, deep scientific expertise in biologics and cell therapy to provide better patient outcomes,” said Phil Kuhn, Isto’s chief commercial officer. “I cannot think of a better place than the NASS meeting for our public debut.”

Orthopedic surgeon Enrico Stazzone, M.D., will give a presentation during the meeting’s Innovative Technologies Sessions highlighting his noteworthy research using concentrated bone marrow aspirate. Dr. Stazzone will share his research comparing marrow-derived progenitor cells from pediatric patients and adults.

We are looking forward to hearing Dr. Stazzone’s research presentation on marrow-derived progenitor cells and his experience using our CellPoint concentrated bone marrow aspirate system. We’re excited that he, along with other experts from our scientific and clinical team, will be on site to answer specific questions about our cutting-edge biologics,” stated Jenny Reid, director of marketing. “NASS provides us the perfect opportunity to share our company announcement and provide more information about our combined product portfolio with leading spine surgeons.”

NASS’s annual meeting is the ideal setting to share the latest information, innovative techniques and best practices with renowned spine care professionals from around the world. The meeting delivers dynamic and challenging educational programs, outstanding exhibitions and the chance to network and build relationships with celebrated spine professionals. NASS 2016 is being held Oct. 26–29 in Boston at the Boston Convention and Exhibition Center.

About Isto Biologics

Isto Biologics was formed in 2016 when St. Louis-based Isto Technologies and Arteriocyte Medical Systems Inc. of Hopkinton, Massachusetts, combined under the Isto Holdings umbrella. Isto Biologics is focused on offering evidence-based solutions for bone regeneration and cell therapy to help improve patient outcomes. The company’s best-in-class product offerings include Arteriocyte’s market-leading MAGELLAN® Autologous Platelet Separator System and Isto’s bone-growth and cell-therapy products including InQu® Bone Graft Extender & Substitute; Influx®, a natural bone-graft material; and CellPoint®, a concentrated bone marrow aspirate system.

For more information, visit www.istobiologics.com

Media Contact:
Jenny Reid
Director of Marketing
314-262-8039
JReid@istotech.com

Logo – http://photos.prnewswire.com/prnh/20161019/430449LOGO

 

SOURCE Isto Biologics

Related Links

http://www.istobiologics.com

RTI Surgical® Announces 2016 Third Quarter Results

October 25, 2016

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, reported operating results for the third quarter of 2016 as follows:

Quarterly Summary:

  • Achieved worldwide revenues of $66.5 million, comparable to third quarter of 2015.
  • Achieved worldwide direct revenues of $38.1 million, a 14 percent increase over the third quarter of 2015.
  • Achieved global commercial and other revenues of $28.5 million, a 14 percent decrease compared to the third quarter of 2015.
  • Expanded nanOss® Bioactive bone void filler into Australia and Europe with regulatory clearance from the Australian Therapeutic Goods Administration (TGA) for nanOss Bioactive bone void filler and CE Mark from BSI for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe.
  • Continued comprehensive strategic review of RTI’s business lines and operations and continued to pursue search for a new chief executive officer to succeed Brian K. Hutchison who announced his intent to retire on August 15, 2016.

Worldwide revenues were $66.5 million for the third quarter of 2016, which were comparable to revenues for the third quarter of 2015. Domestic revenues were $61 million for the third quarter of 2016, which were also comparable to revenues for the third quarter of 2015. International revenues were $5.6 million for the third quarter of 2016, a slight increase compared to revenues of $5.5 million for the third quarter of 2015. On a constant currency basis, international revenues for the third quarter of 2016 increased 2 percent compared to the third quarter of 2015. Direct revenues of $38.1 million increased 14 percent for the third quarter of 2016 compared to $33.2 million for the third quarter of 2015. Commercial and other revenues of $28.5 million decreased 14 percent for the third quarter of 2016 compared to $33.3 million for the third quarter of 2015.

“Our direct business continued to show strong performance in the third quarter, highlighted by our U.S. spine, cardiothoracic and surgical specialties businesses,” said Brian K. Hutchison, president and chief executive officer. “Our direct spine business has become one of the fastest-growing spine companies in the market according to published data, with growth driven by both hardware and biologics. Despite the strong performance in our domestic direct business, our commercial business continues to perform below expectations.”

For the third quarter of 2016, the company reported net loss applicable to common shares of $4.5 million and net loss per fully diluted common share of $0.08, based on 58.4 million fully diluted shares outstanding, compared to net income applicable to common shares of $2.7 million and net income per fully diluted common share of $0.05 for the third quarter of 2015, based on 58.9 million fully diluted shares outstanding. On an adjusted basis, excluding pre-tax other charges of $5.1 million, as detailed in the reconciliation provided later in this release, and a foreign net operating loss valuation reserve of $1.2 million, adjusted net income applicable to common shares was $0.0 million and adjusted net income per fully diluted common share was $0.00, based on 58.4 million fully diluted shares outstanding.

Adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA), as detailed in the reconciliation provided later in this release, was $8.1 million for the third quarter of 2016 (12 percent of third quarter 2016 revenues) compared to $10.7 million for the third quarter of 2015 (16 percent of third quarter 2015 revenues). The decline was principally a result of higher variable compensation and distributor commission expenses on direct revenue distributions and the development of our international direct sales network.

Fiscal 2016 Outlook

As previously announced, RTI continues to progress on its strategic business review and CEO search. RTI’s board of directors and management remain focused on achieving sustainable top- and bottom-line growth and identifying opportunities that can generate the most value for RTI’s customers, employees and shareholders.

Based on the outlook for the remainder of the year, the company now expects that full year revenue for 2016 will range from $268 million to $270 million, as compared to prior guidance of $274 million to $280 million. The company expects full year direct revenue to grow in the range of 13 percent to 15 percent as compared to the previous range of 16 percent to 17 percent. The reduced outlook is primarily due to delays associated with transition of an international distributor. The company expects full year commercial and other revenue to decline in the range of 21 percent to 23 percent as compared to the previous range of 18 percent to 21 percent. The reduced outlook is primarily due to continued softness in commercial orders.

As a result of the lower revenue guidance, the other charges, and the foreign net operating loss valuation, the company now expects that full year net loss per fully diluted common share for 2016 will range from $0.11 to $0.13 based on 58.3 million fully diluted shares outstanding, as compared to prior guidance of net income per fully diluted common share of $0.03 to $0.06. Excluding the other charges and foreign operating loss valuation reserve, adjusted full year 2016 net income per fully diluted common share is expected to range from $0.01 to $0.03, based on 58.3 million fully diluted common shares outstanding as compared to prior guidance of adjusted full year 2016 net income per fully diluted common share of $0.09 to $0.12, based on 58.5 million fully diluted common shares outstanding.

Conference Call

RTI will host a conference call and simultaneous audio webcast to discuss the third quarter results at 8:30 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419. The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on the RTI website following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2016 2015 2016 2015
Revenues $ 66,547 $ 66,529 $ 201,518 $ 206,172
Costs of processing and distribution 32,273 31,296 97,270 96,737
Gross profit 34,274 35,233 104,248 109,435
Expenses:
Marketing, general and administrative 28,724 25,464 84,678 80,088
Research and development 3,789 3,793 12,034 11,492
Restructuring charges 1,107
Strategic review costs 650 650
CEO Retirement and transition costs 4,107 4,107
Contested proxy expenses 2,680
Severance costs 328 1,039
Total operating expenses 37,598 29,257 106,295 91,580
Operating (loss) income (3,324 ) 5,976 (2,047 ) 17,855
Total other expense – net (374 ) (405 ) (1,112 ) (986 )
(Loss) income before income tax provision (3,698 ) 5,571 (3,159 ) 16,869
Income tax benefit (provision) 92 (2,069 ) (338 ) (6,120 )
Net (loss) income (3,606 ) 3,502 (3,497 ) 10,749
Convertible preferred dividend (883 ) (832 ) (2,611 ) (2,460 )
Net (loss) income applicable to common shares $ (4,489 ) $ 2,670 $ (6,108 ) $ 8,289
Net (loss) income per common share – basic $ (0.08 ) $ 0.05 $ (0.10 ) $ 0.14
Net (loss) income per common share – diluted $ (0.08 ) $ 0.05 $ (0.10 ) $ 0.14
Weighted average shares outstanding – basic 58,353,110 57,701,810 58,173,580 57,492,606
Weighted average shares outstanding – diluted 58,353,110 58,922,423 58,173,580 58,591,303
RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net (Loss) Income Applicable to Commons Shares to Adjusted EBITDA
(Unaudited, in thousands)
For the Three Months For the Nine Months
Ended September 30, Ended September 30,
2016 2015 2016 2015
Net (loss) income $ (4,489 ) $ 2,670 $ (6,108 ) $ 8,289
Interest expense, net 307 336 1,053 978
(Benefit) provision for income taxes (92 ) 2,069 338 6,120
Depreciation 3,459 3,011 10,295 9,212
Amortization of intangible assets 934 1,100 2,792 3,245
EBITDA 119 9,186 8,370 27,844
Reconciling items for Adjusted EBITDA
Preferred dividend 883 832 2,611 2,460
Non-cash stock based compensation 1,975 662 3,075 1,915
Foreign exchange loss 67 69 59 8
Other reconciling items(1)
Restructuring charges 1,107
Strategic review costs 650 650
CEO Retirement and transition costs 4,107 4,107
Contested proxy expenses 2,680
Severance costs 328 1,039
Adjusted EBITDA $ 8,129 $ 10,749 $ 23,698 $ 32,227
Adjusted EBITDA as a percent of revenues 12 % 16 % 12 % 16 %
(1) See explanations in Use of Non-GAAP Financial Measures section later in this release.
RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net (Loss) Income Applicable to Common Shares and Net (Loss) Income Per Diluted Share to
Adjusted Net Income Applicable to Common Shares and Adjusted Net Income Per Diluted Share
(Unaudited, in thousands, except per share data)
For the Three Months Ended
September 30, 2016 September 30, 2015
Net Net
Income Amount Income Amount
Applicable to per Diluted Applicable to per Diluted
Common Shares Share Common Shares Share
As reported $ (4,489 ) $ (0.08 ) $ 2,670 $ 0.05
Severance charges, net of tax effect (1) 202 $ 0.00
Strategic review costs, net of tax effect (2) 401 $ 0.01
CEO retirement and transition costs, net of tax effect (3) 2,709 $ 0.05
European net operating loss valuation reserve 1,224 $ 0.02
Adjusted $ 47 $ 0.00 $ 2,670 $ 0.05
For the Nine Months Ended
September 30, 2016 September 30, 2015
Net Net
Income Amount Income Amount
Applicable to per Diluted Applicable to per Diluted
Common Shares Share Common Shares Share
As reported $ (6,108 ) $ (0.10 ) $ 8,289 $ 0.14
Restructuring charges, net of tax effect (4) 1,050 0.02
Contested proxy expenses, net of tax effect (5) 1,654 0.03
Severance charges, net of tax effect (6) 641 0.01
Strategic review costs , net of tax effect (2) 401 0.01
CEO retirement and transition costs, net of tax effect (3) 2,709 0.05
European net operating loss valuation reserve 1,224 0.02
Adjusted $ 1,571 $ 0.03 $ 8,289 $ 0.14
Note: Amounts may not foot due to rounding.

Footnotes:

2016
(1) Severance charges, net of tax effect, as follows:
Severance charges $ 328
Tax effect on Severance charges (126 )
Severance charges, net of tax effect $ 202
(2) Strategic review costs, net of tax effect, as follows:
Strategic review costs $ 650
Tax effect on Strategic review costs (249 )
Strategic review costs, net of tax effect $ 401
(3) CEO Retirement and transition costs, net of tax effect, as follows:
CEO Retirement and transition costs $ 4,107
Tax effect on CEO Retirement and transition costs (1,398 )
CEO retirement and transition costs, net of tax effect $ 2,709
(4) Restructuring charges, net of tax effect, as follows:
Restructuring charges $ 1,107
Tax effect on Restructuring charges (57 )
Restructuring charges, net of tax effect $ 1,050
(5) Contested proxy expenses, net of tax effect, as follows:
Contested proxy expenses $ 2,680
Tax effect on contested proxy expenses (1,026 )
Contested proxy expenses, net of tax effect $ 1,654
(6) Severance charges, net of tax effect, as follows:
Severance charges $ 1,039
Tax effect on Severance charges (398 )
Severance charges, net of tax effect $ 641

Fiscal 2016 Outlook

Full year net loss per fully diluted common share is expected to be in the range of $0.11 to $0.013, based on 58.4 million fully diluted shares outstanding. Excluding the contested proxy expenses, restructuring charges, severance charges, strategic review costs, CEO retirement and transition costs and foreign operating loss valuation reserve taken in 2016, full year net income per fully diluted common share is expected to be in the range of $0.01 to $0.03.

RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP Guidance Net Loss Per Common Share – Diluted to
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted
(Unaudited)
Twelve Months Ended
December 31, 2016
$ Amount
per Common
Share – Diluted
GAAP Guidance net loss per common share – diluted $ (0.13) – (0.11)
Restructuring charges, net of tax effect (1) 0.02
Contested proxy expenses, net of tax effect (2) 0.03
Severance charges, net of tax effect (3) 0.01
Strategic review costs , net of tax effect (4) 0.01
CEO retirement and transition costs, net of tax effect (5) 0.05
European net operating loss valuation reserve 0.02
Adjusted non-GAAP guidance net income per common share – diluted $ 0.01 – 0.03

Use of Non-GAAP Financial Measures

To supplement the Company’s unaudited condensed consolidated financial statements presented on a GAAP basis, the Company discloses certain non-GAAP financial measures that exclude certain amounts, including non-GAAP net income applicable to common shares, adjusted. The calculation of the tax effect on the adjustments between GAAP net (loss) income applicable to common shares and non-GAAP net income applicable to common shares is based upon our estimated annual GAAP tax rate, adjusted to account for items excluded from GAAP net (loss) income applicable to common shares in calculating non-GAAP net income applicable to common shares. A reconciliation of the non-GAAP financial measure to the corresponding GAAP measure is included in the table above.

The following is an explanation of the adjustment that management excluded as part of adjusted measures for the three and nine month periods ended September 30, 2016 as well as the reason for excluding the individual items:

(1) Restructuring charges – This adjustment represents the closure of our French distribution and tissue procurement office. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

(2) Contested proxy expenses – This adjustment represent charges relating to contested proxy expenses. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

(3) Severance charges – This adjustment represents charges relating to the termination of former employees. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

(4) Strategic review costs – This adjustment represents charges relating to a comprehensive strategic review of the Company’s business lines and operations to leverage the Company’s expertise, technology and products and identify opportunities to increase stockholder value. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

(5) CEO Retirement and transition costs – This adjustment represents charges relating to the retirement of our Chief Executive Officer, Brian K. Hutchison, pursuant to the Executive Transition Agreement dated August 29, 2012. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

Adjusted EBITDA should not be considered in isolation, or as a replacement for GAAP measures.

Usefulness of Non-GAAP Financial Measures to Investors

The Company utilizes certain financial measures that are not calculated based on GAAP. Certain of these financial measures are considered “non-GAAP” financial measures within the meaning of Item 10 of Regulation S-K promulgated by the U.S. Securities and Exchange Commission (“SEC”). The Company believes that non-GAAP financial measures reflect an additional way of viewing aspects of its operations that, when viewed with the GAAP results, provide a more complete understanding of the Company’s results of operations and the factors and trends affecting the Company’s business. These non-GAAP financial measures are also used by the Company’s management to evaluate financial results and to plan and forecast future periods. However, non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Non-GAAP financial measures used by the Company may differ from the non-GAAP measures used by other companies, including the Company’s competitors.

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Revenues
(Unaudited, in thousands)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2016 2015 2016 2015
Revenues:
Spine $ 17,775 $ 13,674 $ 52,514 $ 42,375
Sports medicine and orthopedics 11,874 11,882 36,956 37,654
Surgical specialties 1,168 670 2,985 2,004
Cardiothoracic 2,893 2,225 8,332 6,403
International 4,352 4,793 15,532 13,938
Subtotal direct 38,062 33,244 116,319 102,374
Global commercial 25,297 30,182 75,396 93,061
Other revenues 3,188 3,103 9,803 10,737
Total revenues $ 66,547 $ 66,529 $ 201,518 $ 206,172
Domestic revenues 60,959 61,046 183,192 189,751
International revenues 5,588 5,483 18,326 16,421
Total revenues $ 66,547 $ 66,529 $ 201,518 $ 206,172
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
September 30, December 31,
2016 2015
Assets
Cash and cash equivalents $ 11,624 $ 12,614
Accounts receivable – net 38,512 47,243
Inventories – net 125,175 118,673
Prepaid and other current assets 7,512 13,184
Total current assets 182,823 191,714
Property, plant and equipment – net 89,856 84,992
Goodwill 54,887 54,887
Other assets – net 46,844 49,069
Total assets $ 374,410 $ 380,662
Liabilities and Stockholders’ Equity
Accounts payable $ 23,287 $ 20,446
Accrued expenses and other current liabilities 22,153 33,474
Current portion of long-term obligations 4,689 5,853
Total current liabilities 50,129 59,773
Deferred revenue 7,754 9,354
Long-term liabilities 79,115 73,856
Total liabilities 136,998 142,983
Preferred stock, including accrued dividends 59,073 56,323
Stockholders’ equity:
Common stock and additional paid-in capital 417,670 417,337
Accumulated other comprehensive loss (6,895 ) (7,042 )
Accumulated deficit (232,436 ) (228,939 )
Total stockholders’ equity 178,339 181,356
Total liabilities and stockholders’ equity $ 374,410 $ 380,662
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
For the Three Months For the Nine Months
Ended September 30, Ended September 30,
2016 2015 2016 2015
Cash flows from operating activities:
Net (loss) income $ (3,606 ) $ 3,502 $ (3,497 ) $ 10,749
Adjustments to reconcile net (loss) income to net cash
(used in) provided by operating activities:
Depreciation and amortization expense 4,393 4,111 13,087 12,457
Stock-based compensation 1,975 662 3,075 1,915
Amortization of deferred revenue (1,216 ) (1,160 ) (3,650 ) (5,065 )
Other items to reconcile to net cash
provided by operating activities (4,721 ) (11,409 ) 1,019 (17,633 )
Net cash (used in) provided by operating activities (3,175 ) (4,294 ) 10,034 2,423
Cash flows from investing activities:
Purchases of property, plant and equipment (3,371 ) (4,392 ) (12,774 ) (12,969 )
Patent and acquired intangible asset costs (804 ) (133 ) (2,195 ) (249 )
Net cash used in investing activities (4,175 ) (4,525 ) (14,969 ) (13,218 )
Cash flows from financing activities:
Proceeds from long-term obligations 8,000 6,750 15,000 6,750
Net proceeds (payments) from short-term obligations (662 ) 160 (1,511 ) 508
Payments on long-term obligations (1,125 ) (1,135 ) (9,424 ) (4,161 )
Other financing activities 612 (94 ) 2,308
Net cash provided by financing activities 6,213 6,387 3,971 5,405
Effect of exchange rate changes on cash and cash equivalents 7 41 (26 ) (5 )
Net decrease in cash and cash equivalents (1,130 ) (2,391 ) (990 ) (5,395 )
Cash and cash equivalents, beginning of period 12,754 12,699 12,614 15,703
Cash and cash equivalents, end of period $ 11,624 $ 10,308 $ 11,624 $ 10,308

Contacts

RTI Surgical Inc.
Robert Jordheim
Executive Vice President,
Chief Financial Officer
rjordheim@rtix.com
or
Wendy Crites Wacker, APR, 386-418-8888
Vice President, Global Communications
wwacker@rtix.com

Aurora Spine Participating at North American Spine Society Annual Meeting

CARLSBAD, CALIFORNIA–(Marketwired – Oct. 25, 2016) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it will be participating at the 2016 North American Spine Society (“NASS”) Annual Meeting, October 26 – 28, 2016 at the Boston Convention and Exhibition Center Boston, Massachusetts at Booth 1302. The North American Spine Society is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, value and evidence based spine care.

Aurora Spine will be showcasing its Screwless Procedure™ and highlighting its latest fusion technologies, including the recently patented ZIP® MIS Interspinous fusion systems. The Screwless Procedure product portfolio consists of the innovative ZIP® ISP Product Line, TiNano® Interbody cages, Biologics, and Surgical Tools. All Aurora Spine products are pre-packaged sterile to provide the best products possible for both surgeons and patients alike.

“Aurora’s modern spine technology is changing spine surgery for the benefit of patients worldwide,” said Trent J. Northcutt, President and CEO of Aurora Spine. “We are excited to demonstrate the Screwless Procedure™ featuring our TiNano® MIS titanium coated interbody cages, our recently patented innovative ZIP® MIS Interspinous fusion systems, and the Compass 4D™ retractor system, all designed to improve spine patient outcomes, drive continued surgeon interests and provide benefits that deliver value to hospitals and patients. We look forward to demonstrating our cutting-edge portfolio to spine surgeons and distributors attending the world’s largest spine exhibition in Boston, Massachusetts.”

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

CONTACT INFORMATION
  • Aurora Spine Corporation
    Trent Northcutt
    President and Chief Executive Officer
    (760) 424-2004

    Aurora Spine Corporation
    Eric Fronk
    Chief Financial Officer
    (760) 424-2004
    www.aurora-spine.com

Zimmer Biomet’s Mobi-C® Cervical Disc Becomes Most Widely Covered Intervertebral Disc Prosthesis for Cervical Disc Replacement

WARSAW, Ind., Oct. 25, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Mobi-C® Cervical Disc Prosthesis is now the most widely covered device for one- and two-level cervical disc replacement by commercial health insurers in the United States.  Mobi-C, acquired as part of Zimmer Biomet’s combination with LDR Holding Corporation in July, is now accessible to more than 200 million insured patients with one-level disc disease and more than 150 million patients with two-level disc disease across more than 90 commercial insurance plans.  Zimmer Biomet achieved this significant milestone when Anthem (formerly WellPoint), which reports nearly 40 million enrollees in its health plans, added Mobi-C to the list of covered devices for one-level disc replacement and as the sole cervical total disc prosthesis covered for two-level surgery.

“The widespread coverage of Mobi-C is a testament to payers accepting the peer-reviewed clinical data and real-world evidence from 40,000 procedures, as validation for the significant advantages Mobi-C offers over invasive spinal fusion for patients in need of cervical disc replacement,” said Adam Johnson, Group President, Spine, Dental, CMF and Thoracic.  “As the most widely insured cervical intervertebral disc prosthesis, Mobi-C is poised to become the standard of care for total cervical disc replacement, which is welcome news for the millions of patients who are looking for a safe and effective option for the treatment of one level or two contiguous levels in the cervical spine.”

Mobi-C was the first cervical disc prosthesis approved by the U.S. Food and Drug Administration for reconstruction of the cervical disc at both one and two levels to treat arm pain and/or neurological deficit caused by various spine disorders or injuries.  Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels.  Unlike cervical fusion, the current standard of care, which immobilizes the targeted vertebrae, Mobi-C features patented mobile-bearing technology designed to allow the prosthetic disc to self-adjust to facilitate motion similar to that of the natural cervical spine.  To learn more about Mobi-C, visit www.cervicaldisc.com.

“Expanding payer coverage for the Mobi-C Cervical Disc prosthesis has been a critically important priority and solidifies Zimmer Biomet’s foothold as a market leader in cervical disc replacement,” said David Dvorak, President and CEO of Zimmer Biomet. “The Mobi-C Cervical Disc, coupled with our differentiated and comprehensive Spine portfolio of innovative surgical solutions, strengthens Zimmer Biomet’s position for sustainable growth.”

At the annual meeting of the North American Spine Society (NASS) this week, the Company plans to present data from a seven-year study confirming the statistical superiority of two-level cervical disc arthroplasty with Mobi-C over two-level anterior cervical discectomy and fusion (ACDF).

For more information about Zimmer Biomet and its musculoskeletal health offerings, please visit the Company online at www.zimmerbiomet.com.

Dynamic Scoliosis Brace wins AdvaMed Innovation Competition

MINNEAPOLIS, MN. (October 19, 2016) –AdvaMed 2016: The MedTech Conference, the leading event for medical technology professionals in North America and MedTech Innovator today named Green Sun Medical the first place winner of the global competition and awarded the company a $200,000 cash prize.

Held in partnership with AdvaMed Accel, MedTech Innovator is the medtech industry’s global competition and virtual accelerator that identifies and accelerates the development of transformative innovations. Green Sun Medical’s tech-­‐enabled spinal brace for Adolescent Idiopathic Scoliosis patients applies reduction forces dynamically, both allowing the patient to move and generate the constant corrective forces necessary to reverse deformity.

“Green Sun Medical’s tech-­‐enabled spinal brace is an amazing innovation that addresses an unmet need in today’s healthcare space, and I am thrilled that our judges and the live audience vote selected the company to win our $200,000 grand prize,” said Paul Grand, CEO, MedTech Innovator. “MedTech Innovator 2016 has been an amazing opportunity to showcase the wide range of early-­‐stage medical technology companies across the globe, from our more than 500 applicants to our 20 semi-finalists and four finalists and our big winner, Green Sun Medical.”

Held during the Wednesday morning plenary session at AdvaMed 2016, the final round of the MedTech Innovator competition featured four finalists presenting their innovations before a panel of judges including Daniel Estes, vice chair, Mayo Clinic Ventures; Jennifer Kozak, vice president, new business development, Johnson & Johnson; Albert Lauritano, director, strategic technology partnerships, BD; and Tamara St.Claire, chief innovation officer, Xerox Healthcare. The winners were then determined by a real-­‐time live audience vote, with cash prizes of $200,000 for first place winner Green Sun Medical and $50,000 for second place winner Adient Medical.

“My experience working in the spinal business tells me that Green Sun Medical’s technology will have a tremendous impact on the young patients who have limited options to treat scoliosis,” said Ashley Wittorf, executive director, AdvaMed Accel. “I congratulate Green Sun Medical’s recognition as MedTech Innovator 2016, and look forward to seeing their product reach the market.”

Several other emerging growth companies were awarded cash prizes during the session, including $25,000 Johnson & Johnson Innovation JLABS Awards for Green Sun Medical and Intuitap.

“This year’s MedTech Innovator winner, Green Sun Medical, is addressing an important unmet need that will improve patient care and well-­‐being,” said Albert Lauritano, director, strategic technology partnerships, BD. “It’s been great to witness their progress over the course of the program and I strongly support their selection!”

MedTech Innovator is supported by Johnson & Johnson, the Cottrell Foundation, BD (Becton, Dickinson and Company), Enterprise Ireland, IDA and RCT Ventures.

“As a founding sponsor of MedTech Innovator, we congratulate Green Sun Medical,” said Susan Morano, vice president, business development, Johnson & Johnson Medical Devices Companies. “This company has demonstrated the passion for developing unique and meaningful innovation to address critical needs for patients around the world.”

For more information on MedTech Innovator 2016 and AdvaMed 2016, visit www.medtechinnovator.org or www.advamed2016.com

 

About AdvaMed 2016: The MedTech Conference

AdvaMed 2016: The MedTech Conference is the leading gathering in North America of global MedTech executives with regulatory, reimbursement, business development, legal, IP, marketing, quality, compliance, HR and other key responsibilities. Along with industry leaders, the international conference attracts business development professionals, investors, policy-makers, members of the media, legal experts, consultants, distributors and other important stakeholders.

More than 2,500 attendees will network, conduct business, gain access to capital and share insights in Minneapolis from Oct. 17-19. The conference also features world-class plenary speakers, networking and business development opportunities.

 

 

Pinnacle Spine Group Announces Launch of InFill® V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

DALLAS, Oct. 25, 2016 /PRNewswire/ — Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain disc height and facilitates the formation of a robust fusion column.

The V2 Lateral implants, the most recent update to Pinnacle’s patented flagship line of InFill Interbody Fusion Systems, features an expanded size matrix and wide range of lordotic options.

“Science has shown that in many unilateral posterior lumbar interbody fusion procedures, less than 50 percent of the disc area is actually grafted,” said Zach Sowell, President of Pinnacle Spine Group. “Creating a greater opportunity to fill the biologic void is exactly why we developed the only patented Interbody Fusion System designed to deliver optimized graft-to-endplate contact. We are excited to add the V2 Lateral device to our growing line of patented fusion systems.”

Features of the V2 Lateral device include:

  • Unique access port to secure the implant to the inserter, ensuring controlled device placement and allowing in situ delivery of optimal bone graft volume
  • A larger graft chamber to allow greater volume of bone graft material, promoting a more robust fusion column
  • A larger load-bearing surface area to help maintain disc height and reduce chances of subsidence
  • Bulleted nose to ease insertion and ensure precise placement for challenging disc conditions
  • Implant size matrix to address unique patient anatomy with lengths ranging from 30mm to 60mm, heights ranging from 8mm to 14mm, widths of 18mm, 21mm and 24mm, and lordotic angles of 0°, 7°, 10° and 13°
  • Comprehensive instrumentation, including angled instruments and a variety of handles
  • Multiple retractor options

Pinnacle Spine Group has pioneered the novel concept for filling the biologic void by placing bone graft material into an implanted device in situ for optimal bone graft volume and contact with vertebral endplates – a critical element for a successful spine fusion outcome.

Pinnacle Spine’s InFill Fusion Systems include a full line of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting chamber and compatibility with the InFill® Graft Delivery System. The backbone of the technology is based on controlled and precise in situ placement of bone graft material.

Pinnacle recently announced its first international patent, a Chinese patent, which followed receipt of three U.S. patents on the InFill Fusion System. For more information on Pinnacle Spine Group’s unparalleled innovation, please visit PinnacleSpineGroup.com.

About Pinnacle Spine Group, LLC

Pinnacle Spine Group was founded with the focused goal of developing innovative medical devices, conceived in the operating room, for surgical procedures of the spine. The objective for every device and instrument we develop is a better outcome for the patient, and a better experience for the surgeon and operating room staff. Backed by the pioneering private equity firm Sowell & Co., Pinnacle is dedicated to developing advanced technologies that offer greater opportunities for positive patient outcomes. The team applies innovative thinking to deliver implants and instrumentation that simplify and enhance the surgical procedure.

SOURCE Pinnacle Spine Group, LLC

Related Links

http://PinnacleSpineGroup.com

Genesys Spine to Debut Cortical Spinal System at NASS 2016 Conference

WEST LAKE HILLS, Texas, Oct. 25, 2016 /PRNewswire/ — Genesys Spine is pleased to announce the release of our latest product line, the TiLock Cortical Spinal System.

The system will be featured at our cadaveric lab being performed during the NASS 2016 Conference at the Boston BioSkills Lab on Thursday, October 27, 2016.

TiLock Cortical Spinal System offers midline screw placement with a medial/ lateral trajectory to provide a substantial anatomy-conserving alternative to traditional pedicular fixation. Its unique tapered, self drilling/tapping feature facilitates an easy start that transitions into a Corticocancellous thread form for maximum fixation in bone. The reduced tulip head profile allows for efficient screw placement with nominal bony removal helping to mitigate the risk of adjacent facet encroachment.

Dr. Matthew Philips, Director of the Brain and Spine Center at SouthCoast Health in Massachusetts and board certified neurosurgeon says, “The Genesys Spine Cortical Screw System is a low profile screw system that requires less dissection and provides superior fixation compared to traditional pedicle screws. The low profile combined with unique thread geometry proved for insertional ease with maximal purchase.”

“Genesys Spine is proud to introduce our latest product offering during the NASS 2016 Conference in Boston,” says Josh Kaufmann, Principal at Genesys Spine. “We feel that this product continues our goal at Genesys of creating products with an eye towards maximizing efficacy while reducing patient risk and morbidity.”

About Genesys Spine:

Founded in 2009, Genesys Spine is a privately held company focused on the design, development and marketing of an array of medical implants and instruments with novel characteristics. These devices, with their award winning proprietary features, all remain within existing parameters for today’s current reimbursement codes.

Media inquiries please contact:
Noelle Corcoran noelle.corcoran@genesysspine.com

www.genesysspine.com
www.nassannualmeeting.org
http://bostonbioskills.com/

This press release was issued through 24-7PressRelease.com. For further information, visit http://www.24-7pressrelease.com.