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October 10, 2016 OrthoSpineNews

October 10, 2016

BORDEAUX, France & BOSTON–(BUSINESS WIRE)

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its sales for the third quarter and first nine months to September 30, 2016.

Ludovic Lastennet, CEO of Implanet, says:

This was the Company’s second most successful quarter in Spine activity. On the adult degenerative bone disorder segment, which is acyclic and has substantial potential given the large number of annual procedures, we generated growth of +145% over 3rd quarter 2015 and +140% over the first 9 months of the year. Furthermore, the JAZZ platform’s adoption by prominent surgeons and hospitals, both in France and in the United States, is continuing to increase, establishing Implanet as a leader in sublaminar technology in spine surgery.

Sales (in € thousands – IFRS) 2016 2015 Change
1st quarter 1,988 1,599 +24%
2nd quarter 2,107 1,707 +23%
Spine (JAZZ) 848 790 +7%
Knee + Arthroscopy 633 903 -30%
Total 3rd quarter 1,481 1,693 -12%
Spine (JAZZ) 2,860 2,245 +27%
Knee + Arthroscopy 2,715 2,754 -1%
9-month 5,576 4,999 +12%

Implanet recorded total sales of €5,576 thousand over the 9 months of the year to September 30, 2016, up +12% (vs. €4,999 thousand), and recorded solid performances in its priority markets, with sales up +37% to €2,856 thousand in France and +53% to €1,550 thousand in the United States, in spite of a 4% slight decrease in JAZZ sales on this market.

Over the first 9 months of the year, Spine activity grew by +27%, with sales totaling €2,860 thousand (compared with €2,245 thousand last year).

As of September 30, 2016, Implanet had 116 surgeon users in its direct markets (vs. 72 as of September 30, 2015), 66 in the United States (vs. 36) and 51 in France (vs. 36).

Over the first 9 months to September 30, 2016, sales from Knee activity slipped 1% to €2,715 thousand (vs. €2,754 thousand), despite solid sales momentum in France where revenue increased by +43% to €1,930 thousand.

In Q3 2016, Implanet recorded sales of €1,481 thousand, down 12% (vs. €1,693 thousand), mainly due to the temporary postponement of knee implant deliveries (totaling €254 thousand) in Brazil due to the credit insurance ceiling having been reached in this country.

Spine activity saw sales increase to €848 thousand in the 3rd quarter of 2016 (vs. €790 thousand a year earlier). Over the quarter, Implanet sold 824 JAZZ units in France, 340 in the United States and 341 in the rest of the world, giving a total of 1,505 units and growth by volume of +22%.

IMPLANET will participate in the following scientific congresses and conferences in Q4-2016
NASS in Boston, October 26 to 28, 2016
SOFCOT in Paris, November 8 to 11, 2016

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2015 sales of €6.7 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net


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October 7, 2016 OrthoSpineNews

CARLSBAD, Calif., Oct. 05, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced changes to the Company’s executive leadership team, a reduction in the Company’s workforce and an inducement award granted to Craig Hunsaker, the Company’s newly appointed Executive Vice President, People & Culture.

Changes to the Executive Leadership Team and Reduction in Workforce

Michael O’Neill, Alphatec’s Chief Financial Officer and Treasurer, has resigned effective October 5, 2016.  Dennis Nelson, the Company’s Vice President of Finance and Corporate Controller, a position he has held since 2011, will serve as the interim principal financial and accounting officer for filings under the Securities Act of 1933 and the Securities Exchange Act of 1934, while the Company executes its search for a Chief Financial Officer.

In addition, today the Company reduced its workforce by approximately 20%.  This reduction in force is a significant part of a broader plan, which the Company has previously outlined, to reduce operating expenses by $20 million following the sale of its international business to Globus Medical and to more appropriately size the Company’s resources to better reflect the needs of a U.S.-focused organization.

“I would like to thank Mike for all of his contributions to Alphatec over the past six years,” said Leslie H. Cross, interim Chief Executive Officer of Alphatec Spine. “Today we have a stronger financial foundation — a much improved balance sheet and enhanced liquidity – that positions us to build to a high quality U.S.-focused business in the future.” Mr. Cross continued, “Dennis is a talented and experienced financial leader. Given his intimate knowledge of Alphatec and our financials, we are confident that Dennis will do an excellent job as we engage in our search for a CFO. We wish Mike all the best in his future endeavors.  I would also like to express my appreciation to each of the employees affected by today’s announcement for their dedication and many contributions to Alphatec over the years.”

Inducement Award Granted

The Company has granted restricted stock units (RSUs) and performance stock-based awards (PSAs) to Craig Hunsaker, Alphatec’s newly appointed Executive Vice President, People & Culture. These inducement awards were approved by the Compensation Committee of the Alphatec Board of Directors on October 4, 2016, with an effective date of October 5, 2016, and granted as an inducement material to Mr. Hunsaker entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”).  The Plan was approved by Alphatec’s board of directors on October 4, 2016 and has a share reserve of 350,000 shares.

Effective October 5, 2016, Alphatec granted Mr. Hunsaker 173,322 RSUs and $750,000 (at target) of PSAs. The RSUs will vest in equal installments on each of the first three anniversaries of September 14, 2016, subject to Mr. Hunsaker’s continued service with Alphatec through the applicable vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec. The PSAs will vest in a dollar amount representing between 0% to 250% of the target value upon the earlier of September 14, 2019 or a change in control of Alphatec, subject to Mr. Hunsaker’s continued service with Alphatec through the applicable vesting date. The actual payout amount will be based on the Company’s market capitalization on the vesting date and the fair-market value of the Company’s common stock on such vesting date and will be paid in shares of Alphatec common stock.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

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 and its affiliates market products in the U.S. via a direct sales force and independent distributors.

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 Spine 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 references to the Company’s: product development pipeline and product portfolio; ability to streamline its cost structure; ability to improve its balance sheet and liquidity; and ability to accelerate its revenue growth or grow its revenues at all.   Please refer to the risks detailed from time to time in Alphatec Spine’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, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine 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.

CONTACT: Investor/Media Contact:

Christine Zedelmayer

Investor Relations

Alphatec Spine, Inc.

(760) 494-6610

czedelmayer@alphatecspine.com


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October 7, 2016 OrthoSpineNews

COLUMBIA, Md., Oct. 06, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) today announced that it has appointed R. Alberto Avendano, M.D., as the Company’s Chief Medical Officer.

Dr. Avendano brings to Osiris his expertise in medical education and communication, academic and industry clinical research, pharmacovigilance and regulatory affairs.  In his role as Chief Medical Officer, Dr. Avendano will manage and oversee the continued growth of the Company’s Medical Affairs and Clinical Operations, act as the Company’s medical spokesperson, and participate in development of clinical programs for the Company’s products and technologies.

“Alberto brings a wealth of managerial and life sciences expertise to Osiris during an important time in our company’s growth,” said David A. Dresner, Interim CEO of Osiris.  “Alberto will bridge our research and development team to our marketing team, furthering our commitment to help patients both today and into the future, as we continue to launch innovative therapies into the regenerative medicine space.”

Dr. Avendano received his license to practice medicine almost 30 years ago.  From June 2013 until joining Osiris, Dr. Avendano served as the Medical Director for Indivior Inc. (previously Reckitt Benckisser Pharmaceuticals).  Prior to joining Indivior, Dr. Avendano served in a variety of medical director and research positions, most recently as Associate Medical Director at EMD Serono, Inc.

Osiris welcomes Dr. Avendano as the newest member of the team.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4®, Cartiform®, Grafix® , TruSkinTM and StravixTM. Osiris, Grafix, and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc. BIO4® is a trademark of Howmedica Osteonics Corp. More information can be found on the company’s website, www.Osiris.com. (OSIR-G).

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: the outcome of the NASDAQ listing qualification deficiency process, including the ability of the Company to successfully maintain its NASDAQ listing; the outcome of the restatements, including the materiality, significance, nature, subject matter, timing or quantitative effects of the Company’s restated financial statements; the timing of the transition to a new independent registered public accounting firm; the completion of the audit of the Company’s 2015 financial statements; and the timing of the filing of the Company’s 2015 Form 10-K, Q1 2016 Form 10-Q and Q2 2016 Form 10-Q. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with?the SEC. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact:

Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

 

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media


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October 7, 2016 OrthoSpineNews

October 5, 2016

Alpharetta, Georgia – Solvay’s medical grade KetaSpire polyetheretherketone (PEEK) and AvaSpire polyaryletherketone (PAEK) polymers enabled medical device pioneer, Shanghai Reach Medical Instrument Co., to develop a lighter, more ergonomic and highly cost-effective kit of reusable instruments for spinal surgeries.

“For decades, metal was the material of choice for medical instruments because conventional plastics could not deliver metal’s combination of high modulus, strong chemical resistance and compatibility with stringent sterilization methods,” says Xiaomin Huang, general manager of Shanghai Reach. “Today, Solvay’s broad range of specialty polymers is changing that reality – not only by offering metal-like performance, but by also enabling the fabrication of more complex and integrated parts through cost-effective injection molding.”

Shanghai Reach’s innovative kit includes six reusable instruments:  one rod bender, two pairs of distraction and compression pliers, and three awls. For the rod bender, the medical device-maker specified KetaSpire KT-880 CF 30 PEEK, a 30% carbon fiber-reinforced resin that delivers the high strength and stiffness necessary to bend implantable 5.5mm to 6.0mm titanium rods. For the pliers and awls, Shanghai Reach chose AvaSpire AV 651 GF 50 PAEK, a 50% glass fiber-reinforced resin offering a cost-effective balance of strength, stiffness and dimensional stability.

Typically, these parts would be made from stainless steel. But Shanghai Reach’s goal was to reduce instrument weight by up to 70% for improved ergonomics, yet not compromise on mechanical properties or sterilizability. In addition to lightweight strength and stiffness, Solvay’s two biocompatible polymers offer strong resistance to fatigue and are compatible with sterilization methods based on stringent chemicals, steam and even gamma radiation.

“Shanghai Reach’s innovative new kit highlights the ground-breaking value that Solvay’s advanced polymers are injecting into a healthcare market once dominated by metal,” states Jeff Hrivnak, global business development manager for healthcare at Solvay’s Specialty Polymers Business Unit. “We expect this trend to continue as we team with industry pioneers like Shanghai Reach to explore new possibilities for replacing metal medical instruments with more cost-effective, ergonomic instruments made from high-performance polymers.”

Solvay Specialty Polymers’ experience as a reliable materials supplier in the healthcare field spans more than 25 years. The company is a leading manufacturer of healthcare plastics, offering a broad range of high-performance, medical-grade plastics for orthopedics, sterilization cases and trays, medical and dental devices, as well as filtration media and housings for hemodialysis and water purification membranes. Solvay also offers a family of Solviva Biomaterials for use in a range of implantable devices.

Source: Solvay Specialty Polymers

 


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October 7, 2016 OrthoSpineNews

By Jim Dryden

Osteoarthritis is a debilitating condition that affects at least 27 million people in the United States, and at least 12 percent of osteoarthritis cases stem from earlier injuries. Over-the-counter painkillers, such as anti-inflammatory drugs, help reduce pain but do not stop unrelenting cartilage destruction. Consequently, pain related to the condition only gets worse.

Now, researchers at Washington University School of Medicine in St. Louis have shown in mice that they can inject nanoparticles into an injured joint and suppress inflammation immediately following an injury, reducing the destruction of cartilage.

The findings are reported online Sept. 26 in the early edition of the Proceedings of the National Academy of Sciences.

“I see a lot of patients with osteoarthritis, and there’s really no treatment,” said senior author Christine Pham, MD, an associate professor of medicine. “We try to treat their symptoms, but even when we inject steroids into an arthritic joint, the drug only remains for up to a few hours, and then it’s cleared. These nanoparticles remain in the joint longer and help prevent cartilage degeneration.”

Frequently, an osteoarthritis patient has suffered an earlier injury — a torn meniscus or ACL injury in the knee, a fall, car accident or other trauma. The body naturally responds to such injuries in the joints with robust inflammation. Patients typically take drugs such as acetaminophen and ibuprofen, and as pain gets worse, injections of steroids also can provide pain relief, but their effects are short-lived.

 

READ THE REST HERE


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October 7, 2016 OrthoSpineNews

October 06, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, announced its sales for the 3rd quarter ending September 30, 2016.

€ millions 2015 2016 Δ

Half-year 1

13.8

14.8

+7

%

3rd quarter

7.1

6.8

-3

%

9-month total at September 30 20.9 21.6 +3 %

Movements in exchange rates had no significant impact on the evolution of turnover.

Sales reached a total of €6.8 million over the third quarter, down 3% compared to the same quarter of 2015, due to a temporary decrease in activity in Europe.

Year-to-date 2016, Medicrea sales have increased by 3% thanks to its priority markets, the United States (+9%) and France (+13%) where the adoption of UNiDpatient-specific technology is continuing with more than 100 surgeons utilizing this service and the significant 1,000 UNiD™ surgery milestone anticipated within the next month.

Outlook:

Medicrea is currently participating in the Eurospine congress in Berlin from the 5th to the 7th of October and will be present at the world’s largest convention for spine specialists organized by the NASS (North American Spine Society) in Boston from the 26th to the 29th of October. During this event, the company is expected to announce a major development related to the UNiD™ services and personalized treatment modalities.

From early September, the Group has undertaken the relocation of production facilities and office headquarters to its new site near Lyon, gathering all the activities in a single infrastructure to improve productivity and optimize collaboration between the various support teams.

Next publication: 2016 annual sales published January 12, 2017, after market.

About Medicrea (www.medicrea.com)

Medicrea specializes in the design, manufacture, and distribution of innovative proprietary technologies devoted exclusively to spinal surgery. Operating in a $10 billion market, Medicrea operates with 150 employees, including 40 at its Medicrea USA Corp. subsidiary based in New York City.

Medicrea is the only company to offer personalized value-based healthcare solutions to the global complex spine market. The Company has driven innovation in Spine by focusing development on market-disrupting technologies focused on patient outcomes, including the growing UNiD™ Technology Platform of Patient-Specific Implants and Analytical Services, which received the first-ever FDA Clearance in November 2014 for a personalized spinal treatment modality.

Medicrea has uniquely positioned itself outside of the traditional implant manufacturer’s role in order to engage with each market player as a collaborator, offering customized implants to patients, personalized services to doctors and immediate cost-savings to providers. By leveraging its proprietary software analysis tools with big data technologies, Medicrea is well-placed to improve the efficacy of spinal care efficiency for all stakeholders in this market.

Connect with Medicrea:

FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Contacts

Medicrea
Denys Sournac, Founder, Chairman and CEO
+33 (0)4 72 01 87 87
dsournac@medicrea.com
or
Fabrice Kilfiger, Chief Financial Officer
+33 (0)4 72 01 87 87
fkilfiger@medicrea.com


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October 7, 2016 OrthoSpineNews

FRANKLIN, Mass., Oct. 6, 2016 /PRNewswire/ — Arthrosurface® announced today that at the September 27, 2016 American Society for Podiatric Surgery (ASPS) meeting in Baltimore, Maryland, the new CheckMATE® 3.0 Fusion Plate was launched for end stage toe arthritis. One study showed that 35%-60% of the population over 65 years old has osteoarthritis of the big toe, making this a common problem. The CheckMATE® plate was designed to offer advantages over existing systems by including features to make the plate low-profile, yet strong, rigid, and faster to implant, reducing surgical time and improving patient comfort. These features may also provide cost savings to the healthcare system and other clinical benefits to the patient. Arthrosurface is advancing patient care in the extremities market with a special focus in foot and ankle applications. Using evidence based designs that reference scientific literature, combined with clinical input from expert surgeon design teams, the Arthrosurface® extremities portfolio has expanded significantly over the past several years to provide innovative options for both surgeons and patients.

The CheckMATE® 3.0 complements the Arthrosurface® forefoot portfolio allowing surgeons to address the full spectrum of forefoot arthritis. With rising costs associated with valuable operating room time, shorter procedures become increasingly important. Various speed elements were built into the plate to reduce implantation time while still maintaining a state of the art forefoot fusion surgery. The CheckMATE® 3.0 plate is designed to minimize post-operative irritation and the need for secondary surgery for hardware removal, again providing a significant cost savings to the system and a potential improvement in patient comfort.

Dr. Patrick DeHeer, surgeon pioneer for the CheckMATE® plate commented, “The goal was to design a plate that is low-profile, but strong and rigid, providing the best of both internal and external fixation. This could allow patients to bear weight on their forefoot earlier, and to minimize secondary surgery and hardware irritation. This new plate has incorporated all these elements, making it a very attractive option for surgeons who perform first MTP fusions.”

“From a design perspective, our goal is to provide surgeons with complete and innovative solutions that improve upon the standard of care for patients experiencing forefoot arthritis. We want to challenge the status quo and use insights from the clinical data and our developers to make products that are anatomic, joint preserving and quick to implant,” said Steve Ek, Founder & CEO. “Arthrosurface is focused on bringing new products to the market that may enhance patient outcomes and potentially provide better options for both surgeons and patients in the extremities market,” commented Joseph Darling, Executive Chairman at Arthrosurface, Inc.

About Arthrosurface
Arthrosurface, Inc. is a leader in the design and distribution of orthopedic devices for joint preservation, restoration and resurfacing. The HemiCAP® system is a unique, less invasive technology that can be used to treat a wide variety of joint conditions caused by trauma, injury and disease. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world.

Logo – http://photos.prnewswire.com/prnh/20131118/NE19554LOGO

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com


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October 7, 2016 OrthoSpineNews

WALTHAM, Mass., Oct. 06, 2016 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced today the addition of Professor Lawrence Bonassar to its Scientific Advisory Board (SAB).  The SAB’s mission is to provide strategic scientific and technical oversight as Histogenics brings NeoCart through its ongoing Phase 3 clinical trial, and seeks to expand its pipeline with additional indications and next generation cartilage therapies by leveraging its biomaterials manufacturing experience and cell therapy technology platform.

Dr. Bonassar is a Professor at Cornell University in the Meinig School of Biomedical Engineering and the Sibley School of Mechanical and Aerospace Engineering.  His research focuses on cartilage biomechanics and tissue engineering, with a goal of understanding structure-property relationships in cartilage to elucidate mechanisms of disease and inform design of tissue replacements. He has authored more than 160 peer reviewed manuscripts, is an inventor on 11 patents and won several national and international awards including the Hansjorg Wyss ResearchAward at the World Forum for Spine Research. Prior to joining the faculty at Cornell, Dr. Bonassar was an Assistant Professor in the Center for Tissue Engineering at the University of Massachusetts Medical School. He received his bachelor’s degree from the Departments of Biomedical Engineering and Materials Science and Engineering from the Johns Hopkins University and received both his masters and doctoral degrees from the Department of Materials Science and Engineering at MIT. Dr. Bonassar also completed postdoctoral training in the Department of Orthopaedic Surgery at Massachusetts General Hospital.

“We are pleased to have Dr. Bonassar join our distinguished team of scientific advisors. Our Sponsored Research Agreement with his lab at Cornell has been highly successful in demonstrating the biomechanical competence of cartilage tissue engineered using our NeoCart manufacturing technology.  The work we have done together has resulted in two presentations to date, the first at the Orthopedic Research Society annual meeting in March 2016 and a more recent presentation at the Biomedical Engineering Society Annual Meeting in October 2016,” stated Stephen Kennedy, Chief Technology Officer of Histogenics.  “Dr. Bonassar’s expertise in biomechanics and tissue engineering will be invaluable to Histogenics as we advance NeoCart through our ongoing Phase 3 clinical trial and prepare to file a biologics license application with the FDA,” continued Mr. Kennedy.

Dr. Bonassar joins current SAB members Dr. Kyriacos A. Athanasiou, PhD, Professor of Biomedical Engineering and Orthopaedic Surgery, University of California Davis; Dr. Charles Cooney, PhD, Professor Emeritus, Massachusetts Institute of Technology; Dr. Jennifer Elisseeff, PhD, Professor Biomedical Engineering, Johns Hopkins University; Dr. Shuichi Mizuno, PhD, Assistant Professor, Orthopedic Surgery, Harvard Medical School and co-founder of Histogenics; Dr. Lonnie Shea, PhD, Professor Biomedical Engineering, University of Michigan; and Dr. R. Lane Smith, PhD, Professor of Orthopedic Surgery, Stanford University School of Medicine.

About NeoCart

NeoCart is a cartilage-like, tissue-engineered implant created from a patient’s own cartilage cells that is currently in Phase 3 clinical development.  The ongoing 245 patient clinical trial is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture.  Histogenics is conducting the trial under a Special Protocol Assessment with the U.S. Food and Drug Administration and expects enrollment to be between 190 and 200 patients at the end of 2016 and to be complete by the end of the second quarter of 2017.  Histogenics designed and manufactures NeoCart using a proprietary, ex vivo bioengineering process so that each NeoCart implant is primed to begin functioning like healthy cartilage upon implantation in the knee.  Histogenics believes that these attributes may offer patients a more rapid recovery and a more durable treatment option, if approved, than other products and procedures, either on the market or in development.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year.  NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms; Histogenics’ ability to attract or retain key personnel; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon is based; the additional expenses that Histogenics will incur in connection with its exclusive channel collaboration agreement with Intrexon Corporation and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016 and June 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ending September 30, 2016, to be filed with the SEC in the fourth quarter of 2016.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

 

Investor Relations

Tel: +1 (781) 547-7909

InvestorRelations@histogenics.com


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October 7, 2016 OrthoSpineNews

BELGRADE, Mont., Oct. 06, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the appointment of Carl O’Connell as President, reporting to the CEO effective October 6, 2016.

Mr. O’Connell will lead all commercial efforts by providing the vision, leadership, strategy and management skills necessary to continue and further develop Xtant Medical’s successful commercial business. He has worked to transform and grow companies into market leaders in Orthopedics, Neurosurgery, Ophthalmology, ENT and Dentistry. His extensive leadership experience in both U.S. and global medical device markets will be an asset to Xtant Medical.

“We are pleased to have an executive of Carl’s stature and experience as a leader for Xtant Medical,” said Dan Goldberger, Chief Executive Officer of Xtant Medical. “He brings a wealth of knowledge and a vast network of strong relationships within the medical device market, and has been directly responsible for creating growth strategies, opportunities and leadership platforms in his prior positions. I share the excitement of the Company in welcoming Carl to the team.”

“I am honored and excited for the opportunity to be a part of this Company,” states Carl O’Connell, President of Xtant Medical. “Xtant Medical is an organization that has been focused on delivering quality products to its customers, and has taken great pride and responsibility as stewards of the gift of donation. My goal is to continue and build upon the positive momentum that Xtant Medical has achieved, and to work closely with the talented team to drive value for our customers, employees, and stakeholders.”

Carl O’Connell has over 30 years of experience in the healthcare and medical device arena. He most recently worked as Global Vice President of Marketing for Wright Medical as the leader for the Foot and Ankle division, the fastest growing segment in Orthopedics. He has also served as President for the U.S. healthcare division of the Japanese conglomerate, ITOCHU Corporation, and previously as Global Vice President for Stryker Spine, and President for Carl Zeiss Surgical, Inc. Mr. O’Connell’s responsibilities have spanned from global marketing, sales, manufacturing, leadership development, regulatory affairs, corporate quality systems, research, product and business development functions. Carl received a bachelor’s degree in Psychology and an M.B.A. from Mount St. Mary’s College, Maryland.

About Xtant Medical Holdings

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

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October 6, 2016 OrthoSpineNews

LEESBURG, Va., Oct. 06, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand its CASCADIA Lateral Interbody System featuring Lamellar 3D Titanium Technology, the Company’s innovative technology that uses 3D printing with the goal of allowing for bony integration throughout an implant. The CASCADIA Lateral Interbody System line extension clearance strengthens K2M’s minimally invasive surgery (MIS) portfolio and the Company’s leadership in the 3D printing of spinal devices, as evidenced by its having the most comprehensive 3D-printed spinal portfolio available on the market.

“CASCADIA is an exciting innovation for lateral spine fusions,” stated Greg T. Poulter, MD, an orthopedic spine surgeon at OrthoIndy. “The unique engineering and 3D printing allows the implant to have the biocompatibility and ongrowth characteristics of titanium, while allowing a stiffness that more closely matches bone. The graft volume and surface area for fusion are generous and the new size options for lordosis allow me to address each patient’s individual sagittal plane requirements. CASCADIA has become my go-to implant for lateral interbody fusions.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CASCADIA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity.

Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the implant. K2M’s CASCADIA interbodies utilize this technology to create a 70% porous implant with an increased bone graft volume and similar stiffness when compared to K2M PEEK designs.

The CASCADIA Lateral Interbody System is part of the Company’s MIS portfolio, designed to promote less invasive access to the spine. The system functions as an invertebral body fusion device to provide support and stabilization of the lumbar segments of the spine. Its reverse hourglass implant design promotes increased endplate contact—compared to an ALEUTIAN® PEEK implant—without sacrificing internal bone graft volume. The system includes a full range of implant sizes and heights that are carefully designed to accommodate vertebral anatomy, and it is intended to work in conjunction with the RAVINE® Lateral Access System to offer a full line of instrumentation for the far lateral transpsoas approach.

“K2M is proud to strengthen our industry-leading portfolio of FDA-cleared, 3D-printed spinal solutions, thus reinforcing our market leadership and competitive advantage in this space,” stated K2M President and CEO Eric Major. “MIS procedures and 3D printing are core competencies for K2M, as indicated by the breadth and depth of our product offerings. We continue to be committed to our legacy of innovating the highest quality products with the ultimate goal of creating improved treatments for surgical patients around the globe who suffer from debilitating complex spinal deformities.”

The complete CASCADIA portfolio also includes the CASCADIA TL, AN, AN Lordotic Oblique, andCervical Interbody Systems. For more information on Lamellar 3D Titanium Technology, CASCADIA Interbody Systems, and K2M’s complete product portfolio, visit www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

Find K2M on Facebook: https://www.facebook.com/K2MInc

Follow K2M on Twitter: http://twitter.com/K2MInc

Watch K2M on YouTube: http://www.youtube.com/user/K2MInc

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, including with respect to our international distribution partners in Australia and Japan. 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; our ability to successfully demonstrate the merits of our technologies and techniques; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; the greater resources available to some of our competitors; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our 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 our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarters facility; our ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation including by the FDA; in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and FDA clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; our reliance on the performance of third parties who assist us in clinical trials and pre-clinical development; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; volatility in our common stock; our current plans not to pay dividends; potential dilution due to our issuance of common stock under our incentive plans, for acquisitions or otherwise; the amount of common stock held by our pre-IPO owners; the impact of anti-takeover provisions in our organizational documents and under Delaware law; our status as an emerging growth company, our ability to use our net operating loss carryforwards; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; 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.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com  

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