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February 2-4, 2017

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March 20, 2017 OrthoSpineNews

March 20, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that the first procedures with its Lucent XP expandable interbody implant have been successfully completed.

The Lucent XP System is an interbody device that can expand in height and increase in lordotic angle after it has been surgically implanted. The height expansion helps restore the height of the spinal disc space and the lordotic angling helps correct the curvature of the spine. With the Lucent XP device, surgeons can achieve up to 15 degrees of lordotic angle, helping restore sagittal balance for the patient.

The Lucent XP system is made primary of polyetheretherketone (PEEK), a radiolucent material with a lower modulus of elasticity than titanium, the primary material of many competitive systems. The PEEK mechanical properties along with the design of the device allow for a more load-sharing construct. The radiolucency allows for post-operative evaluation of the fusion progression. Additionally, the device is coated with Spinal Elements’ Ti-Bond® porous titanium coating. Ti-Bond is a hydrophilic coating applied at the bone-contacting endplates of the implant.

Hyun Bae, MD, a leading spine surgeon who practices at The Spine Institute in Los Angeles, California, had this to say about his experience with the Lucent XP System: “The ease of use of this system and the ability of the device to expand in height and restore lordotic angle are exactly what I need to address the challenges spinal fusion surgery for my patients.

Paul Kim, MD, of the Spine Institute of San Diego, added, “The clinical importance of height restoration and spinal curvature cannot be understated. Spinal Elements’ system provides these features without making sacrifices relative to construct rigidity or post-operative ability to monitor the progress of a fusion. Furthermore, I was able deploy the system safely and efficiently with a minimally invasive surgical approach.”

Spinal Elements will be more widely launching the Lucent XP expandable interbody device in the summer of 2017. The company has seen over 20% growth of the past year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Follow us on Twitter @SpinalElements and on LinkedIn for continuous company updates.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760.450.7749
laurajohnsonpr@yahoo.com


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March 20, 2017 OrthoSpineNews

SAN DIEGO, March 20, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced updated guidance from the National Industry for Clinical Excellence (NICE) in the U.K. for lateral interbody fusion in the lumbar spine. NICE stated the evidence on efficacy for lateral interbody fusion is adequate in quality and quantity and the procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit. The majority of the evidence submitted to and reviewed by the panel was peer-reviewed journal articles describing the now 14-year experience with and outcomes following the Company’s eXtreme Lateral Interbody Fusion (XLIF®) procedure, the leading global lateral approach spine surgical technique.

“Our continued investment into clinical research and outcomes data from our XLIF procedure was supportive in NICE releasing updated guidance for this innovative surgical approach,” said Jason Hannon, NuVasive’s president and chief operating officer. “Our team has worked diligently with NICE since 2015 to gather, analyze and review the available evidence. The updated guidance further supports the clinical efficacy of XLIF and will help expand the availability of XLIF to back pain sufferers in the U.K. and around the world.”

With more than 150,000 successful surgeries around the world, XLIF is the leading global lateral approach procedure. First introduced in the U.S. in 2003, XLIF is a minimally invasive surgical procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies.

Initial NICE guidance for lateral interbody fusion was published in 2009 with additional special measures that impacted adoption of the procedure in the UK. In response to a request for input prior to a planned re-review of NICE guidance, NuVasive submitted a large body of evidence for the XLIF procedure, including data outlining safety profile, rate of fusion, and improvements in pain and disability. The updated guidance was supported by a systematic literature review of more than 200 previously published studies as a high-quality summary of the safety and efficacy of the XLIF procedure1. For more information on the updated NICE guidance for lateral interbody fusion, visit https://www.nice.org.uk/guidance/ipg574.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $956 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1 Lehmen JA et al. Eur Spine J 2015;24(Suppl 3):S287–S313

 

 

CONTACT:  Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com; or Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com


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March 20, 2017 OrthoSpineNews

ORLANDO, Fla., March 17, 2017 /PRNewswire/ — Mazor Robotics Ltd. is a global leader in the development and distribution of innovative surgical guidance systems for spine and brain surgery. Mazor Robotics Inc., the US subsidiary of Mazor Robotics LTD is recognized as one of largest players in the robotics and simulation industry in the State of Florida, their US headquarters are in downtown Orlando.  In nearby Celebration, The Florida Hospital Nicholson Center serves as the national training center for the new Mazor X™, a transformative platform for spine surgeries, having trained over 100 surgeons from all over the United States in 2016.

“As a pioneer and a leader in the field of surgical guidance systems, Mazor Robotics saw two significant milestones in 2016: the launch of our strategic partnership with Medtronic followed by the commercial release of the new Mazor X™. We are very excited to see what 2017 brings for our company,” says: Christopher Prentice, CEO Mazor Robotics, Inc.

Since signing the agreement in May 2016, Mazor and Medtronic have invested in co-marketing, promotion, and training efforts towards commercialization of Mazor X™, a transformative platform for spine procedures that launched in October at the North American Spine Society (NASS) Annual Meeting. Between the two companies, there are now hundreds of highly experienced capital and clinical specialists responsible for raising the awareness of, selling and supporting Mazor X.

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

SOURCE Mazor Robotics Ltd.

Related Links

http://www.mazorrobotics.com


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March 20, 2017 OrthoSpineNews

PUBLIC RELEASE: 

 

People with spinal deformity also requiring a total hip replacement are at greater risk for dislocation or follow-up revision surgery, suggesting that these higher-risk patients may benefit from a more personalized approach to their surgeries to reduce the risk of poorer outcomes.

A new study led by orthopaedic surgeons at NYU Langone Medical Center provides a greater understanding of exactly how spinal deformity interacts with the pelvis, potentially increasing risk despite implanting the artificial hip in what is traditionally considered a “safe zone” by surgeons.

“Surgeons should anticipate potential instability after performing a hip replacement in patients who have existing spinal deformity, and they should adjust their surgical plans accordingly,” says lead study author Aaron J. Buckland, MD, assistant professor of Orthopaedic Surgery in the division of Spine Surgery and director of spine research at NYU Langone.

The study was presented March 17, 2017 at the American Academy of Orthopaedic Surgeons (AAOS) 2017 Annual Meeting in San Diego, California. These findings also were published online December 27, 2016 in the Journal of Arthroplasty.

More than 310,000 hip replacements are performed in the U.S. each year, with rates dramatically increasing over the past two decades in younger adults 45 to 64 years of age who are active and living longer than ever before. An estimated 2.5 million Americans are currently living with hip replacements.

In a hip replacement, an artificial joint comprised of a ball and socket is implanted to replace the natural socket in the pelvis, enabling movement that is typical of the hip joint. For the past 40 years, surgeons have placed the socket (known as the acetabular cup) adjacent to the pelvic bone in a so-called “safe zone” — a position that is thought to reduce risk of dislocation. However, the new research suggests that placing the cup in the safe zone may not be enough to prevent dislocation in patients with spinal deformity.

Until now, no studies of the hip-spine relationship have focused on patients with sagittal spinal deformity, says Dr. Buckland. “Our research helps bridge any disconnect between surgeons who regularly treat spinal deformities and those who perform hip joint replacements, fostering more collaboration to improve patient outcomes,” he adds.

 

READ THE REST HERE

 


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March 20, 2017 OrthoSpineNews

Leading internationally renowned surgeons and their patients have hope that AxioMed’s first-of-its-kind viscoelastic disc replacement – which acts as a cushion between the vertebrae – will give hope to millions who suffer from back and neck pain and who are looking to maintain their normal activities post spine surgery.

Surgeons and patients who have experience with the AxioMed Freedom Disc have reacted overwhelmingly positively. “I have seen some of the postoperative X-rays noting that the AxioMed disc restores height, restores normal motion, and more patients are giving testimonials on getting back their quality of life,” says AxioMed President Jake Lubinski.

Dr. Kenneth Pettine, an experienced total disc replacement spine surgeon and part of the lumbar IDE study, calls it “the best artificial lumbar disc there is.” Dr. Robert Pflugmacher, spinal surgeon from Bonn, Germany, credits ease of use and positive results to AxioMed’s success in spinal disc rankings. The disc “imitates our nature, because our natural disc is viscoelastic,” explains Professor Dr. Burkhard Rischke.

Patient testimonials are life changing. Patient Kristen Lee, personal trainer and yoga instructor, explains, “I find that having undergone the Freedom Total Disc Replacement surgery, I have been given back my life. I was able to walk the next day without pain. I am more active now than I was pre-surgery.” Marathon runner and TDR patient Robert Ramsey credits the AxioMed disc immensely, stating, “The Freedom Disc has given me my life back.” Former American Gladiator winner Robin Coleman is back to her lifestyle and enjoying riding horses again.

Dr. Kingsley R. Chin points out the mechanics of the disc’s success, outlining, “When you look at this disc with its viscoelastic properties you now have a disc that truly mimics the human disc. The bond between the viscoelastic material and the Titanium endplates are very strong and its a single piece device no moving pieces. And so now, you are able to insert this disc easily. It’s going to be reliable for longevity. It’s a one piece device that does not have a keel. So putting this disc anteriorly in the lumbar spine or cervical spine is pretty easy. The ability for us to then put it in laterally in the lumbar spine, I think will be a game changer, and that’s what we’re going to do.”

View full video coverage here.


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March 17, 2017 OrthoSpineNews

Steve Collins, Contributor – CFO/COO Oska, Inc.

If you suffer from chronic pain, it’s likely you’ve chased rainbows, been let down by false marketing claims or – at worst – lost hope that anything will emerge to help manage your pain effectively. Additionally, you’ve probably spent considerable amounts purchasing items that just don’t perform as stated. Sadly, for those suffering, things are getting worse. Recent Centers for Disease Control policies have emphasized prescribing less opiate pain-killers and the Drug Enforcement Administration has announced it intends listing kratom, an herbal pain-relief supplement, as a “schedule I” substance. This means that whether you are currently using prescribed narcotic pain-killers, or an herbal substitute, you will have no choice but to identify and use other pain-relief options.

The human body is wondrous, and its capacity to heal itself is amazing. Think of a scraped knee, bruised heel or sprained ankle. The body’s own healing processes kick in automatically in response to injuries. Chronic pain, however, is more challenging to manage. Most times, because chronic pain exists in localized unstable body areas, the natural healing processes need a kick-start. TENs devices, creams, pharmaceuticals and even physical therapy tend to be effective, but only for short periods as they “interrupt” pain rather than actually addressing the source. Ask any doctor or physical therapist the key to recovery, and most will say “exercise”. But if you already experience pain, the mere thought of exercise may fill you with anxiety.

What if it was possible to exercise an injury without leaving your chair, touching your toes or wrestling with a physiotherapist? What if there was an alternative option to swallowing dangerous narcotic or analgesic pain-killers?

Have you ever heard of pulsed electromagnetic field therapy (PEMF)?

PEMF, as a science, has been used for over 60 years with no known adverse effects. NASA uses it as an effective means of countering bone-density loss and muscle atrophy in astronauts exposed to weightless environments for prolonged periods. In fact, it is so effective that the FDA has cleared PEMF to close bone fractures, for mitigating migraines and for orthodontic work. If you think an electromagnetic field sounds “wacky”, consider that Earth generates one and so does your body!

PEMF emits very low-frequency waves that are created many times each second. These waves push and pull on human cells causing them to squeeze and stretch. As a result, cells can breathe more easily, allowing important healing signals to be carried into the cell. These signals then activate its natural recovery response and cause it to exhale even more healing signals into the surrounding area, promoting intensive healing. An injured area is typically not functioning normally, and if the healing process is compromised, pain can become chronic. When PEMF is introduced into the injured area, it acts at the cellular level to kick-start the body’s natural healing process.

A PEMF device produces similar effects as physical exercise, but you won’t feel anything. Typically, PEMF devices deliver three things: reduced pain levels; reduced inflammation; and improved range of motion. Whereas a TENs unit merely interrupts a pain signal, PEMF actually works at the cellular level, allowing for natural healing. Significantly, a PEMF device does not cause the usual discomfort experienced via a TENs unit because it is noninvasive (lacking physical attachment requirements) and is portable (you can use it at home, at work, in the car).

PEMF is a lesser-known therapy amongst consumers, but it provides scientifically superior results. It seems miracles can happen! CDC: we are looking at you!

 

READ MORE ABOUT OSKA HERE

 

 


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March 17, 2017 OrthoSpineNews

March 16, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, LLC, a company that develops orthopedic implant solutions, today announced that it completed the first $10 million tranche of a $40 million Class D Units financing. The financing is to be comprised of $30 million from first-time investor LS Health Science Partners, L.P., with another $10 million to be contributed by existing investors.

“This investment reflects our enthusiasm for the NUsurface technology and its potential to fill a large unmet need in the market,” said Haynes Morris, managing partner for LS Health Science Partners. “We are pleased to participate in this new infusion of capital to help carry the company through this important phase of product development.”

An initial investment of $10 million has been received from LS Health Science Partners, with the remaining $30 million to be funded in tranches. The company intends to use the proceeds to continue funding two clinical trials of the NUsurface® Meniscus Implant – an investigational treatment for patients with persistent knee pain following medial meniscus surgery.

“Recruitment for the SUN and VENUS clinical trials for our NUsurface Meniscus Implant is going extremely well, and we expect to complete enrollment by the end of the year,” said Ted Davis, president and CEO of Active Implants. “This additional investment will allow us to continue our research and clinical development programs as we progress in and work toward bringing the first artificial meniscus to market.”

About Meniscus Injuries

A damaged meniscus has a very limited ability to heal itself, which can eventually lead to knee replacement surgery. It has been estimated that from 700,000 to over 1 million arthroscopic partial meniscectomies are performed annually in the U.S., with annual direct medical costs estimated at $4 billion. Active Implants estimates that in the U.S. alone, more than 130,000 meniscectomy patients per year would be appropriate candidates for the NUsurface Meniscus Implant.

About the NUsurface Meniscus Implant

The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant, which has been used in Europe under CE Mark since 2008 and in Israel since 2011.

About Active Implants

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com


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March 17, 2017 OrthoSpineNews

CARLSBAD, Calif., March 15, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today financial results for the fourth quarter and full year ended December 31, 2016.

  • Fourth quarter total net revenues of $27.1 million; revenue from the Company’s U.S. commercial business of $24.5 million.
  • Annual total net revenues of $120.2 million; revenue from the Company’s U.S. commercial business of $106.9 million.
  • Cash and cash equivalents of $19.6 million at the end of the fourth quarter.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2016

As a result of the sale of the Company’s international business in September 2016, the financial results and related assets and liabilities of such business have been excluded from continuing operations for all periods herein and reported as discontinued operations.

U.S. commercial revenues for the fourth quarter of 2016 were $24.5 million, down 16.9%, compared to $29.5 million reported for the fourth quarter of 2015.  For the full year ended December 31, 2016, U.S. commercial revenues were $106.9 million, representing a decrease of 6.7%, compared to $114.6 million reported for full year 2015.

For the fourth quarter 2016, U.S. commercial revenues decreased primarily as a result of a decrease in the Company’s stocking business, lower U.S. hospital unit volume and pricing declines.

For the full year 2016, U.S. commercial revenues decreased primarily as a result of a decrease in the Company’s stocking business and pricing declines, partially offset by higher hospital volumes.

U.S. gross profit and gross margin for the fourth quarter of 2016 were $15.2 million and 62.2%, respectively, compared to $21.4 million and 72.6%, respectively, for the fourth quarter of 2015. For the full year 2016, U.S. gross profit and gross margin were $71.7 million and 67.0%, respectively, compared to $79.5 million and 69.4%, respectively, for full year 2015.

For the fourth quarter and full year 2016, gross margins declined as compared to 2015, primarily as a result of: higher product costs driven by lower than planned sourcing volumes throughout 2016, obsolescence charges related to product portfolio management, and price declines, partially offset by the absence of one-time charges that occurred in 2015.

Total operating expenses for the fourth quarter of 2016 were $21.7 million, reflecting a decrease of $7.4 million, or approximately 25% improvement over the fourth quarter of 2015. For the full year 2016, total operating expenses were $91.5 million, reflecting a decrease of $172.4 million compared to the full year 2015, which included non-cash goodwill and intangible asset impairment charges totaling $164.3 million.

GAAP net loss for the fourth quarter of 2016 was $4.7 million or ($0.56) per share (basic and diluted), compared to a net loss of $9.9 million, or ($1.18) per share (basic and diluted) for the fourth quarter of 2015.  For the full year, 2016 GAAP net loss was $30.3 million or ($3.57) per share (basic and diluted), compared to a net loss of $178.7 million, or ($21.53) per share basic and diluted for full year 2015. GAAP net loss for full year 2015 was unfavorably impacted by $164.3 million of non-cash impairment charges.

Adjusted EBITDA in the fourth quarter of 2016 was $(2.2) million, compared to $3.4 million for the fourth quarter of 2015.  For the full year 2016, Adjusted EBITDA was $1.1 million, compared to $10.5 million for the full year 2015.  Please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures” that follows for more detailed information.

Total Current and Long-term debt, includes $34.8 million in term debt and $12.5 million outstanding under the Company’s revolving credit facility at December 31, 2016. This compares to $29.9 million in term debt and $12.2 million outstanding under the Company’s revolving credit facility at September 30, 2016.

Cash and cash equivalents were $19.6 million at December 31, 2016, compared to $25.6 million reported at September 30, 2016.

“Through our actions in 2016, we positioned the organization to be more responsive to today’s world-class spine surgeons, our employees and shareholders,” said Terry Rich, Chief Executive Officer of Alphatec.  “We look forward to providing you with a company update and more details on our plans in connection with the announcement of our first quarter 2017 results.”

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, in process research and development (IPR&D) expenses and other non-recurring income or expense items, such as impairments, restructuring expenses, severance expenses, litigation expenses, damages associated with ongoing litigation and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.   Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

About Alphatec Spine

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

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

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include the references to the optimization of the Company’s product portfolio through active product lifecycle management and the Company positioning itself to be more responsive to surgeons, employees and shareholders.  In addition, the unaudited financial results for the fourth quarter and year ended December 31, 2016 included in this press release are preliminary and represent the most current information available to management. 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:  adjustments to the unaudited financial results reported for the fourth quarter and year ended December 31, 2016 in connection with the completion of the Company’s final closing process and procedures, final adjustments, completion of the audit by the Company’s independent registered public accounting firm and other developments that may arise during the preparation of the Company’s Annual Report on Form 10-K; the uncertainty of success in developing new products or products currently in Alphatec Spine’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA clearance or approval or international regulatory approvals for new products, or unexpected or prolonged delays in the process; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Please refer to the risks detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited) 
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Revenues $ 27,090 $ 34,791 $ 120,248 $ 134,388
Cost of revenues 12,463 11,192 44,114 46,366
Gross profit 14,627 23,599 76,134 88,022
54.0 % 67.8 % 63.3 % 65.5 %
Operating expenses:
Research and development 2,449 8,077 9,248 17,615
In-process research and development 274
Sales and marketing 11,464 13,937 50,962 51,801
General and administrative 7,092 6,547 26,339 28,126
Amortization of intangible assets 172 304 934 1,200
Impairment of goodwill and intangibles 1,736 164,263
Restructuring expenses 514 246 2,292 597
Total operating expenses 21,691 29,111 91,511 263,876
Operating loss (7,064 ) (5,512 ) (15,377 ) (175,854 )
Interest and other income (expense), net (2,689 ) (769 ) (15,558 ) 3,455
Pretax loss (9,753 ) (6,281 ) (30,935 ) (172,399 )
Income tax provision (benefit) 474 182 (4,488 ) (1,146 )
Loss from continuing operations (10,227 ) (6,463 ) (26,447 ) (171,253 )
Income (loss) from discontinued operations 5,481 (3,440 ) (3,870 ) (7,423 )
Net loss $ (4,746 ) $ (9,903 ) $ (30,317 ) $ (178,676 )
Net loss per share continuing operations $ (1.21 ) $ (0.77 ) $ (3.11 ) $ (20.64 )
Net income (loss) per share discontinued operations 0.65 (0.41 ) (0.46 ) (0.89 )
Net loss per share  – basic and diluted $ (0.56 ) $ (1.18 ) $ (3.57 ) $ (21.53 )
Weighted-average shares – basic and diluted 8,465 8,376 8,495 8,298
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands – unaudited) 
December 31, December 31,
2016 2015
ASSETS
Current assets:
Cash and cash equivalents $ 19,593 $ 6,295
Restricted cash 2,350
Accounts receivable, net 18,512 26,870
Inventories, net 30,093 32,632
Prepaid expenses and other current assets 4,262 3,138
Current assets of discontinued operations 364 30,210
Total current assets 72,824 101,495
Property and equipment, net 15,076 16,067
Intangibles, net 5,711 8,806
Other assets 516 502
Noncurrent assets of discontinued operations 61 19,471
Total assets $ 94,188 $ 146,341
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 8,701 $ 13,542
Accrued expenses 27,981 21,175
Common stock warrant liabilities 687
Current portion of long-term debt 3,113 79,742
Current liabilities of discontinued operations 732 9,891
Total current liabilities 40,527 125,037
Total long-term liabilities 71,954 32,761
Long-term liabilities of discontinued operations 1,516
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (41,896 ) (36,576 )
Total liabilities and stockholders’ deficit $ 94,188 $ 146,341

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands, except per share amounts – unaudited) 
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Operating loss, as reported $  (7,064 ) $  (5,512 ) $ (15,377 ) $ (175,854 )
Add back:
Depreciation 1,735 3,310 7,387 10,802
Amortization of intangible assets 693 327 1,608 2,968
Total EBITDA (4,636 ) (1,875 ) (6,382 ) (162,084 )
Add back significant items:
Stock-based compensation 1,931 5,004 3,441 7,444
In-process research and development 274
Goodwill and intangible impairment 1,736 164,263
Restructuring and other charges 514 246 2,292 597
EBITDA, as adjusted for significant items $ (2,191 ) $ 3,375 $ 1,087 $ 10,494

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended
December 31, % Change
2016 2015
Revenues by source
U.S. commercial revenue $ 24,487 $ 29,479 -16.9 %
Other 2,603 5,312 -51.0 %
Total revenues $ 27,090 $ 34,791         -22.1 %
Gross profit by source
U.S. $ 15,243 $ 21,396
Other (616 ) 2,203
Total gross profit $ 14,627 $ 23,599
Gross profit margin by source
U.S. 62.2 % 72.6 %
Other -23.7 % 41.5 %
Total gross profit margin 54.0 % 67.8 %
Year Ended
December 31, % Change
2016 2015
Revenues by source
U.S. commercial revenue $ 106,932 $ 114,578 -6.7 %
Other 13,316 19,810 -32.8 %
Total revenues $   120,248 $   134,388 -10.5 %
Gross profit by source
U.S. $ 71,669 $ 79,501
Other 4,465 8,521
Total gross profit $ 76,134 $ 88,022
Gross profit margin by source
U.S. 67.0 % 69.4 %
Other 33.5 % 43.0 %
Total gross profit margin 63.3 % 65.5 %
CONTACT: Investor/Media Contact:

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

integra-lifesciences-office.jpg

March 17, 2017 OrthoSpineNews

PLAINSBORO, N.J., March 15, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation  (Nasdaq:IART), a leading global medical technology company, announced the launch of the Titan™ Press-Fit Reverse Shoulder for Fracture.

The use of the reverse shoulder to treat humeral fractures has increased in recent years. However, heat from cement used to secure the prosthesis can hinder healing of the bone, which negatively impacts patient outcomes.1 The Titan reverse is one of the few prostheses that does not require cement, due to its unique two-piece stem that achieves a direct implant-to-bone press-fit fixation below the fracture line in the humeral canal.

Stems that fixate in the humeral canal have a strong clinical heritage, with published literature showing comparable or better functional results in fracture scenarios compared to published studies of other stem designs.2

Matt Ramsey, MD, of the Rothman Institute said, “This product has revolutionized my treatment of proximal humeral fractures. The Titan Press-Fit Reverse allows me to reliably obtain a solid fit in the canal without having to wait for the cement to dry, and the ability to adjust height and version independent of the stem means no fiddling with a jig or making sacrifices on the fit.”

The Titan Press-Fit Reverse for Fracture was developed in conjunction with Matthew Ramsey, MD; William Geissler, MD; Sanford Kunkel, MD; Jean-Marc Glasson, MD; Phillip Duke, MBBS, FRACS, FA(ORTH)A; and Mark Ross, MBBS, FRACS, FA(ORTH)A.

“The Titan Press-Fit Reverse for Fracture is a cornerstone of our shoulder portfolio.  At Integra, we’re committed to creating products that enhance patient care and enrich the surgeon experience.  Our shoulder franchise is poised to redefine expectations in shoulder arthroplasty with this and other products we have in the pipeline,said Bob Davis, president of Integra’s Orthopedics & Tissue Technologies division.

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

For additional information on the release of the Titan™ Modular Shoulder System Press-Fit Reverse for Fracture, please contact PressFit.Fx@integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

1 Formaini, NT, Everding, NG, Levy, JC, Rosas, S. Tuberosity healing after reverse shoulder arthroplasty for acute proximal humerus fractures: the “black and tan” technique. J Shoulder Elbow Surg 2015 Nov;24(11):e299-306. doi: 10.1016/j.jse.2015.04.014. Epub 2015 Jul 2.

2 Ross, M, Hope, B, Stokes, A, Peters, SE, McLeod, I, Duke, PFR. Reverse Shoulder Arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg 2015 Feb;24(2):215-22. doi: 10.1016/j.jse.2014.05.022. Epub 2014 Aug 29.

CONTACT: Integra LifeSciences Holdings Company

Investors
Angela Steinway                                              
609-936-2268                                                                    
angela.steinway@integralife.com

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

Media
Laurene Isip
609-750-7984 
laurene.isip@integralife.com

Mitek_Sports_Medicine_Introduces_Comprehensive-4f951d673a40a9e48269bfd4e105c577-1.jpg

March 17, 2017 OrthoSpineNews

SAN DIEGO, March 16, 2017 /PRNewswire/ — DePuy Synthes Mitek Sports Medicine* has launched a new suite of knee arthroscopy solutions to help improve operating room efficiency, simplify ACL and meniscus repair, and make these surgeries more reproducible. The new platform expands the company’s leadership in products and instruments for knee arthroscopy by combining performance with an easy-to-use solution for every step of the procedure. The announcement was made here at the American Academy of Orthopaedic Surgeons Annual Meeting.

Meniscus and ACL surgery are two of the most common knee procedures performed worldwide. In 2016 580,000 meniscal repairs and more than 865,000 ACL surgeries were projected to be performed worldwide.1 With such a high-volume of surgeries, creating efficiency in the operating room through simple, versatile instruments and implants is critical for surgeons.

The new suite of products from Mitek Sports Medicine is designed to promote operating room efficiency and simplicity from the start to finish of the procedure, together with implants that may help promote stability:

  • The SPEEDTRAP™ Graft Prep System allows the surgeon to easily and quickly whipstitch, or suture, one tendon end without using a needle in about 20 seconds, which is at least 77 percent faster2 than traditional techniques and offers strong tension.
  • The TRUESPANTM Meniscal Repair System streamlines arthroscopic meniscal repair by offering a unique delivery system with an ergonomic handle, single trigger, and auto-reloading mechanism for quick, simple one-handed use. The TRUESPAN System also features the only 24-degree curved needle option on the market, which may provide better access to challenging tear locations.
  • The TWISTR™ Retrograde Reamer is used to drill the tunnels for graft placement during ACL reconstruction. The TWISTR Reamer can be set to drill 13 different tunnel diameters making it the only one-size-fits-all device of its kind on the market. The adjustable design simplifies inventory management by eliminating the need to stock multiple reamer sizes and help reduce cost during cases where more than one size reamer is needed. This product will be commercially available in the US in Q3 2017.
  • The RIGIDLOOP® Adjustable Cortical System, a titanium cortical button and adjustable loop implant, holds the graft in place in the femoral tunnel. The innovative design with adjustable loops eliminates need for multiple size implants. Simple one-handed tensioning technique allows surgeons to advance graft to completely fill the socket with stronger fixation and less graft displacement compared to similar adjustable loop devices.
  • The INTRAFIX® ADVANCE Tibial Fastener System provides rigid fixation of the graft in the tibial tunnel. The sheath and screw implant duo is designed to protect soft tissue grafts and promote integration with the surrounding bone to achieve a strong and stable fixation.

“The new products added to the Mitek Sports Medicine knee platform are well designed,” said Amir R. Moinfar, MD, orthopaedic surgeon at Elite Orthopaedic and Musculoskeletal Center in Glen Burnie, Md. “Either used individually or in concert with one another, their numerous features afford the opportunity to perform ACL reconstruction and meniscus repair safely, reproducibly and efficiently, ultimately assisting me in helping my patients.”

Matt Jewett, Platform Leader, Mitek Sports Medicine said, “We recognize that our customers need solutions for knee arthroscopy that deliver performance, reproducibility and operating room efficiency. We are very excited to be bringing these innovative knee products to our customers to address these needs at every step and help them treat patients with ACL and meniscal injuries.”

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
DSUS/MTK/0317/0939 03/17

1 Millennium Research Group Sports Medicine Device Market 2015 Analyses:  US, EMEA, ASPAC and LATAM Markets, September 2016.
2 DePuy Synthes Mitek Sports Medicine, Raynham, MA. Document 103304691 2016.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com