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February 2-4, 2017

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July 13, 2017 OrthoSpineNews

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces successful 12-month clinical data utilizing its Total Hip Arthroplasty (THA) system. Paxeon has partnered with some of the top Orthopedic Surgeons in the country and the results of the follow-up has shown Paxeon products to be easy to use and effective.

In today’s orthopedic environment, companies must not only provide quality products but also financially beneficial products. With that in mind, Paxeon Reconstruction has created a unique Value Solutions Program that has provided hospitals over $1.3m in savings through its first 12-months of clinical use. Physicians utilizing Paxeon’s THA system save on average $1,315.00 per case.

Dr. Kevin Pugh (Pikeville, KY) says “I have been using Paxeon Reconstruction’s Origin hip system for the past 14 months.  During that time, I have successfully completed nearly 200 Total Hip Arthroplasties with the Origin stem and Logical acetabular cup with no implant failures or repeat operations.  These implants have provided excellent outcomes for my patients.  The instrumentation is very user friendly and easy for my staff to learn.  My hospital is pleased with the excellent service provided by Paxeon, as well as the tremendous savings that Paxeon has provided on the implants.  As a company Paxeon has been very good to work with, as they have been very receptive to my individual needs as a surgeon.  I am extremely happy with their products and am excited to watch them grow as a world leader in total joint reconstruction innovation.”

Dr. Chris Christensen (Lexington, KY) added “I am continually impressed with the ease of insertion of the origin stem. Broaching is much less physically demanding than other bone removal broaching systems. Patient comfort postop is excellent. At one year and 300 stems, the hip has performed essentially perfectly.”

Due largely to the success of their product portfolio, Paxeon Reconstruction is advancing through high quality implants and a unique value proposition that offers unparalleled advantages for both the surgeons and their hospitals. Kyle Sineath, President of Paxeon Reconstruction says “It’s proof that improved clinical outcomes are available at a savings to physicians and facilities. By providing showing clinical outcomes and significant savings, Paxeon is positioned as the true leader in the valued solutions market.”

 

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.


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July 13, 2017 OrthoSpineNews

DALLASJuly 12, 2017 /PRNewswire/ — Pinnacle Spine Group, LLC, the pioneer of in-situ graft delivery technology, today announced that the company has been granted a U.S. patent that meaningfully reinforces its exclusivity position with respect to its in situ graft delivery technology. Patent No. 9,649,203, titled Methods of Post-Filling an Intervertebral Implant, like previously issued patents of the company, relates to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies.

Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. This latest patent follows the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in AustraliaCanada and Europe.

“Years ago, we identified a problem with traditional interbody fusion systems – that a biologic void remained between an implant and its two adjacent vertebrae,” says Zach Sowell, President of Pinnacle Spine Group. “We developed a highly effective solution and are thrilled to now have even stronger patent protection related to in situ graft delivery directly to an implant, a technique whose value is being recognized and appreciated by the spinal fusion industry. This recognition is a testament to the technology’s usefulness and benefits, and we look forward to working with companies that are interested in adopting and using implant designs that require delivery of bone graft material in situ.”

Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.

For more information on Pinnacle Spine Group’s unparalleled innovation, or to become a part of the Pinnacle team, please visit www.PinnacleSpineGroup.com, or contact us at info@pinnaclespinegroup.com.

About Pinnacle Spine Group, LLC

Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-approved InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.

 

SOURCE Pinnacle Spine Group, LLC


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July 12, 2017 OrthoSpineNews

AMSTERDAM, The Netherlands , July 12, 2017 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it will highlight new innovations at the American Orthopaedic Foot and Ankle Society (AOFAS) 2017 Annual Meeting taking place at the Washington State Convention Center in Seattle, Washington from July 12-15, 2017.

Wright will feature its full range of lower extremities and biologics products at exhibit booth #801 and will showcase, for the first time, three important additions to its foot and ankle portfolio:

INVISION™ Total Ankle Revision System – The first and only system developed specifically for total ankle revision arthroplasty, the INVISION Total Ankle Revision System provides a unique solution for even the most difficult revision procedures.  Whether leveraged as a standalone construct or in conjunction with INFINITY and INBONETM components, the INVISION Total Ankle Revision System is an important addition to the continuum of care from total ankle replacement through any necessary revisions.  The INVISION Total Ankle Revision System helps surgeons re-build bone lost through previous surgeries and provides modularity to help restore natural joint height.

ORTHOLOC™ 3Di Ankle Fracture Low Profile System – The ORTHOLOC 3Di Ankle Fracture Low Profile System features a complete range of ankle fracture plates designed specifically for the foot and ankle surgeon.  The system features low-profile, anatomic plate designs and ORTHOLOC 3Di polyaxial locking screw technology, providing an innovative fracture solution that addresses a primary need for one of the foot and ankle’s largest market segments.

MICA™ Minimally-Invasive Foot & Ankle System – As the first minimally invasive solution specifically designed for foot and ankle surgery, the MICA Minimally-Invasive Foot & Ankle System provides a minimally disruptive, procedurally integrated solution that features specifically designed implants and instrumentation for percutaneous surgery of the foot.  The MICA Minimally-Invasive Foot & Ankle System can be used to treat multiple pathologies including one of the most common, Hallux Valgus, commonly known as bunions.  Compared to a traditional open surgery, the MICA Minimally-Invasive Foot & Ankle System has been shown to provide less pain, shorter operative times and improved cosmesis.

Robert Palmisano, president and chief executive officer, commented, “We have continued to expand our best-in-class foot and ankle product portfolio to meet the needs of orthopaedic physicians and patients and further extend our leadership position in the fast growing lower extremities and biologics markets.  The launch of our unique INVISION Total Ankle Revision System will expand our leadership in total ankle technology and highlights our ability to address the total ankle replacement continuum of care.  In addition, the ORTHOLOC 3Di Ankle Fracture Low Profile System and MICA Minimally-Invasive Foot & Ankle System further enhances our offering in the foot and ankle market space and allows for an improved surgical experience.”

Wright is also conducting medical education and training courses during the AOFAS annual meeting in its mobile training lab.  These courses will address total ankle arthroplasty, Charcot reconstruction and limb salvage, and ankle and hindfoot fusion using Augment®.  More information on Wright Medical’s products can be found at www.wright.com.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates,  registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements  

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:  Julie D. Tracy                                                                                                           Sr. Vice President, Chief Communications Officer Wright Medical Group N.V. (901) 290-5817 julie.tracy@wright.com


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July 12, 2017 OrthoSpineNews

BILLERICA, Mass., July 11, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that Dan Krupp has joined the Company as its Senior Vice President of U.S. Sales, effective July 3, 2017.

“The addition of Dan to our leadership team is another example of our commitment to developing additional expertise and support that will help us execute our commercial strategy,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “We are very excited to have Dan join us. His extensive experience in leading top-ranked sales organizations in startup, turnaround, volatile, and growth markets will be a tremendous asset for ConforMIS.”

Mr. Krupp has more than 20 years of sales and marketing experience in medical devices and total joint arthroplasty. From 2002-2014, he held positions of increasing responsibility at DePuy Synthes, developing and executing sales strategies and managing multiple new product launches.  Most recently, he was Vice President, Sales and Marketing, at JACE Medical, where he successfully managed the development and execution of a range of corporate and product branding initiatives.

“I am very pleased to be joining the outstanding team at ConforMIS and to play a role in reshaping the future of arthroplasty with the company’s disruptive technology platform,” said Mr. Krupp. “I look forward to leading the U.S. sales force during what we believe will be a transformative period in orthopedics.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

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

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS’s commercial strategy, future results, and orthopedic and arthroplasty markets, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/75f70387-ab76-48cd-bf98-27c3569e87df.

The photo is also available via AP PhotoExpress.

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

Media Contact:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

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July 12, 2017 OrthoSpineNews

July 12, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced the appointments of orthopedic and sports medicine industry veterans Charles W. Federico and Gary D. Henley to its board of managers.

“Both Charlie and Gary are respected leaders with long-term success in medical and orthopedic device industries, and they bring a wealth of strategic and operational experience to our board,” said Ted Davis, president and chief executive officer of Active Implants. “We believe their diverse leadership experience will strengthen our board, and their insights will be invaluable as we continue to develop the NUsurface Meniscus Implant and fulfill a significant unmet need in the orthopedic market here in the U.S. and worldwide.”

Federico has 44 years of experience in the medical device industry, with significant focus in the sports medicine segment while president and chief executive officer of Orthofix International N.V. and president of Smith & Nephew Endoscopy. Additionally, he has held senior management and sales and marketing positions with Dyonics, General Foods Air Products Corporation, Puritan Bennett Corporation and LSE Corporation. Federico has extensive board experience, including chairman of the board and lead director of MAKO Surgical Corp, sold to Stryker; and a board member at Biomimetic Therapeutics, sold to Wright Medical Group.

Henley has more than 35 years of experience in the orthopedic device industry, including president, chief executive officer and board member of United Orthopedic Group, which was sold to Breg. Previously, he was president and chief executive officer of Wright Medical Group, Inc.; president of Orthofix International N.V.’s Americas Division; president of Smith & Nephew’s Endoscopy Video Division; and president and chief executive officer of Cecorp, Inc. Henley is an experienced board member and industry consultant, most recently serving as executive chairman of the board of directors at OrthAlign, Inc. and a director at Orchid Orthopedic Solutions.

With the appointment of Federico and Henley, Active Implants’ board consists of eight members: Henry Klyce, chairman of the board; Ted Davis, Active Implants CEO; James D. Lackie; William T. Mays, Jr.; Haynes Morris; and Spence Wilson, Jr.

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. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Active Implants LLC

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 Haarlem, 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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July 12, 2017 OrthoSpineNews

July 12, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting and fixed-driver surgical instruments and procedural kits for the medical industry and surgeons worldwide, has designed and produced sterile-packed, surgery ready disposable instrument kits for a wide range of trauma and extremity implants used by surgeons for fracture and joint degeneration repair.

Tailored to implant manufacturer specifications these kits are being rapidly adopted across the marketplace to reduce cost, eliminate reprocessing, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

The fully disposable kits include the full complement of instruments needed by surgeons and OR teams including cannulated fixed drivers, torque limiters, cannulated countersinks and depth gauge instrument, drill guides, guide wires and drill bits. The cannulated instrument design permits minimally invasive surgery (MIS), which reduces OR time, blood loss and patient recovery times. All the instruments are packaged in sterile pack and fully disposable trays.

“We recently launched the industry’s first sterile-packed instrument set for securing cannulated titanium screws and also have deployed sterile pack kits and instruments for hand and wrist repair as well as joint arthroplasty and spine implant product lines,” said James Schultz, ECA’s executive vice president, sales & marketing. 

ECA Medical Instruments Disposable Instrument Kits   

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity orthopaedic surgeries in both the hospital and outpatient setting,” he said. “We’re excited to partner with major OEMs in the ortho and spine industry and bring these new instrument kits to market.

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA.  ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 32 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2012 by the Pacific Coast Business Times. www.ecamedical.com


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July 12, 2017 OrthoSpineNews

July 11, 2017

PARSIPPANY, N.J.–(BUSINESS WIRE)–Fidia Farmaceutici S.p.A., a world leader in the research, development and manufacturing of hyaluronan (HA)-based products, and its wholly owned subsidiary, FIDIA PHARMA USA Inc., are projecting continued growth in 2017. The global viscosupplementation market is anticipated to increase to over $2.64 billion by 2021, according to a research study by RnR Market Research1.

Fidia Farmaceutici S.p.A. now leads the orthopedic biomaterials market in Europe after increasing its market share over the past few years. The largest segment of the biomaterials market internationally is HA viscosupplementation, to inject lubricating fluid into a joint. The company’s strong presence in the HA viscosupplementation market, with its product HYALGAN®, and Fidia’s entrance into the German market have contributed to the expansion.

“Fidia is building upon its structure and experience to expand its business and strengthen its presence in the U.S. and globally,” said Aldo Donati, president, FIDIA PHARMA USA. “Fidia Farmaceutici has invested in research and development of hyaluronic acid-based products for more than 70 years. Today, Fidia is growing its product portfolio with new, innovative solutions to meet challenges in the field of osteoarthritis using science, our legacy and our drive.”

In the United States, FIDIA PHARMA USA Inc. offers HYMOVIS® and HYALGAN®, which are viscoelastic hyaluronan injection treatments for osteoarthritis (OA) knee pain that may help to delay total knee replacements2.

More than 20 million Americans suffer from knee OA. By 2030, 20 percent of Americans over the age of 65 will be at risk for developing OA, according to the U.S. National Library of Medicine. The rise in OA of the knee diagnoses is reported to be attributed to an increase in life expectancy, obesity and sedentary behavior3.

The United States continues to hold the largest market share in the global viscosupplementation market. Growth is anticipated to be based off of the latest health care infrastructure, well-established reimbursement, aggressive marketing efforts on supply, and trends toward early intervention and demand for nonsurgical OA treatment.

HYMOVIS® is a breakthrough in HA-based intra-articular (IA) therapy for the treatment of OA knee pain. Specifically engineered to fulfill a need of having a true viscoelastic hydrogel that is non-crosslinked and naturally derived from non-avian sources, HYMOVIS®maintains enhanced properties of improved lubrication to decrease friction, exhibits greater elasticity in recovering its original structure even after repeated mechanical stresses, and demonstrates increased residence time in the knee joint*. HYMOVIS® is delivered as an IA injection in a convenient two-dose regimen, with each injection given one week apart.

HYALGAN® is a solution that contains a natural substance called hyaluronate, which is normally found in the fluid that lubricates and cushions the knee joint. HYALGAN® is injected into the knee to relieve pain due to osteoarthritis. It is a five-injection regimen given at weekly intervals that provides long-lasting pain relief for up to six months. Some patients get benefits with three injections given at weekly intervals as reported in the published literature in which patients were followed for 60 days.

About FIDIA PHARMA USA Inc.

FIDIA PHARMA USA Inc. is a wholly owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment. FIDIA PHARMA USA Inc. is focused on expanding Fidia’s position in the U.S. and Canadian market, while upholding the company’s mission to provide consumers with innovative products that offer quality, safety and performance. FIDIA PHARMA USA Inc. is headquartered in Parsippany, N.J. For more information, please visit www.fidiapharma.us.

About Fidia Farmaceutici S.p.A.

Fidia Farmaceutici Fidia Farmaceutici is an Italian company founded in 1946 with proven expertise in Neuroscience, acquired over the years thanks to an activity of Research and Development unique in the Italian pharmaceutical scenario. It is also a top leading company in marketing products based on hyaluronic acid, which have many applications in the biomedical field, in areas such as rheumatology, orthopaedics, wound care, tissue repair and dermo-aesthetics, with worldwide leadership in viscosupplementation. Fidia Farmaceutici is part of the Milanese P&R Holding group. The company is well established in Italy, with R&D activities carried out both in Abano (where the company’s headquarter is located) and at the Research Unit in Noto (Sicily, Italy). The turnover will amount over 300 million Euros in 2017, of which 70% generated in international markets. Fidia Farmaceutici’s products are marketed in over 100 countries, through wholly-owned subsidiaries – in USA, Kazakhstan, Germany, Spain, Russia and the Middle East – and a comprehensive network of international partners and distributors. Thanks to its investment in R&D, it has managed to create a time-honored legacy of products, with over 900 patents to its name.

Indications: HYALGAN® and HYMOVIS® are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).

Important Safety Information: HYALGAN® and HYMOVIS® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins (HYMOVIS® only) or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hyalgan.comand www.Hymovis.com. Rx Only

HYMOVIS® and HYALGAN® are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2017 FIDIA PHARMA USA Inc., Parsippany, NJ, a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID523-06.2017

*Data on file – Preclinical studies may not be indicative of human clinical outcomes.

Rx Only

1 http://www.rnrmarketresearch.com/medipoint-viscosupplementation-global-analysis-and-market-forecasts-market-report.html

2 Turajane T, Tanavaree A, Labpiboonpong V, Maungsiri, S. Outcomes of intra-articular injection of sodium hyaluronate for the treatment of osteoarthritis of the knee. J Med Assoc Thai. 2007;90(9):1845-1852.

3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612336/

Contacts

FIDIA PHARMA USA Inc.
Carolyn Kong, 1-973-507-5120
ckong@fidiapharma.us


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July 12, 2017 OrthoSpineNews

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July 12, 2017 OrthoSpineNews

CARLSBAD, Calif., July 11, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended June 30, 2017.

Preliminary revenue for second quarter 2017 is expected to be in the range of $34.0 to $34.2 million, an increase of approximately 3% compared to the prior year period.  Based on this preliminary estimate, spinal instrumentation revenue is expected to be approximately $16.6 million and orthobiologics revenue is expected to be approximately $17.6 million. U.S. revenue for the second quarter 2017 is expected to increase approximately 1%, to approximately $30.4 million, with US spinal instrumentation revenue expected to decrease approximately 5% and orthobiologics revenue expected to increase approximately 7.5% over the prior year period.

At June 30, 2017, cash and cash equivalents are expected to be approximately $12.3 million and outstanding borrowings under the Company’s credit facility are expected to be approximately $4.0 million. SeaSpine realized $4.6 million in net proceeds in the second quarter 2017 through the sale of approximately 477,000 shares of its common stock under its “at the market” equity offering program.

“We are executing on our strategy to deliver mid-single digit revenue growth in 2017 while simultaneously focusing on cash conservation,” said Keith Valentine, President and Chief Executive Officer. “We continue to focus on our strengthening distributor base and expanding product portfolio.”

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal instrumentation solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal instrumentation portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: delivering mid-single digit revenue growth in 2017 while simultaneously conserving cash; and continuing to strengthen the Company’s distributor base and expand its product portfolio.  In addition, this release contains preliminary financial results for the second quarter 2017.  Preliminary results are provided prior to completion of all internal and external review procedures and therefore are subject to adjustment.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact Lynn Pieper Lewis (415) 937-5402 ir@seaspine.com


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July 12, 2017 OrthoSpineNews

LEESBURG, Va., July 10, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced the signing of a new, long-term, exclusive agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. and a prominent supplier of medical devices in Japan, for the distribution of K2M’s innovative spinal technologies.

Pursuant to the agreement, Japan Medicalnext is the exclusive distributor of K2M’s spine products in Japan. The terms of the agreement include a long-term partnership of up to seven years. With more than 250 employees—including 50 orthopedic sales professionals—in seven offices located throughout the country, Japan Medicalnext has significant experience in medical device distribution, including the Japanese spinal surgery market.

“We are pleased to announce a new, long-term exclusive distribution agreement with Japan Medicalnext and look forward to this partnership enhancing our potential to increase our market share beyond our existing relationships in Japan’s estimated $300 million spine market,” said K2M President and CEO Eric Major. “We are excited that the management of Japan Medicalnext has a wealth of spine experience within Japan and are applying their market expertise with their established infrastructure to help grow our business in this region.”

In April, K2M secured registrations from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for several of its innovative products, including its MESA® and EVEREST® Spinal Systems, and will continue to seek additional product registrations over the next year.

For more information about K2M, visit www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS™, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on FacebookTwitterInstagramLinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations;  our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com