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Current Issues in Spine

February 2-4, 2017

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September 23, 2016 OrthoSpineNews

September 22, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Paris: ALMED) (Alternext Paris: FR0004178572 – ALMED), pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, announced 2016 half-year results to June 30, approved by the Board of Directors on September 19, 2016.

€ millions H1 2015 H1 2016
Revenue 13.8 14.8
Gross margin as a % of sales 79 % 81 %
Operating profit before amortization and provisions 0.5 0.6
Operating profit before share-based payments (1.0 ) (1.5 )
Other non-recurring expenses (0.1 ) (1.2 )
Current pre-tax profit (1.1 ) (2.9 )
Net profit (1.0 ) (2.7 )

The variations in exchange rate had no significant impact on results

H1 2016 revenue rose by 1 million euros, up 7% compared to the same period of 2015, driven by growth of +20% in France, the Group’s historic market, and +13% in the US, a priority market that represents over 60% of sales.

Gross margin improved by 2 points compared to the first half of 2015 to reach €12 million, or 81% of revenues. This evolution of the gross margin reflects both the relevance of the industrial strategy and modernization of production means, in which Medicrea has invested heavily since 2014, as well as the growing importance of the US market in sales revenues. To further control the gross margin, the Group is gradually changing its international distribution strategy to favor a direct market presence by opening new subsidiaries and signing cooperative agreements with its distributors.

“We are continuing our investment policy and increasingly intensifying our research and development efforts to promote our UNiD™ personalized spinal technology and services in the US and worldwide. The sales and marketing teams have been expanded notably with the establishment of our subsidiary in Germany, whose contribution to Group revenue will not be seen substantially until 2017. Despite these significant costs, our operating income before depreciation and amortization remains positive, a slight increase over last year to 0.6 million euros,” stated Denys Sournac, President and CEO.

In the first half of the year, an exceptional expense of €1.2 million was generated by the collective costs relating to the relocation of the production unit from La Rochelle to Lyon, France. The new facilities, which will group the production teams with research and development, sales and administrative support, will be operational in the 4th quarter of 2016.

In August, Medicrea raised €20 million in financing, which consisted of €15 million in convertible bonds, held by Athyrium Capital Management, a US investor strongly regarded as a specialist in the sector, and €5 million in equity through a private placement, in which Denys Sournac, President and CEO, and Richard Kienzle, co-founder of Globus who joined the Medicrea Group at this time, participated.

“The appointment of Richard Kienzle, as Chief Commercial and Business Development Officer, highlights his confidence in Medicrea’s unique opportunity in the marketplace and marks a new milestone in the Group’s history. The proven industry experience that Richard Kienzle brings, combined with the significant resources provided as part of the fundraising, enables Medicrea to secure our position as a pioneer and worldwide leader in personalized spine and to become a key player in the complex spine market,” continued Denys Sournac.

The milestone of 1,000 UNiD™ surgeries is expected in the 4th quarter, with nearly half of those surgeries to take place in the United States where the technology’s adoption has accelerated markedly in recent months.

Next publication: Sales for the 3rd quarter of 2016 published October 6, 2016, 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

Medicrea is listed on ALTERNEXT Paris ISIN : FR 0004178572 – Ticker : ALMED

Contacts

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


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September 23, 2016 OrthoSpineNews

September 23, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today it has expanded its relationship with Musculoskeletal Transplant Foundation (MTF), the nation’s leading tissue bank. MTF will now be the sole tissue provider for Spineology’s allograft product lines, including the newly launched Incite™ Cortical Fibers, a unique and versatile bone grafting solution.

“MTF has a long track record of delivering safe, high quality tissue products using the most stringent standards in the industry,” said John Booth, CEO of Spineology Inc. “Our expanded relationship allows us to pass along that safety and quality to our customers.”

Incite Cortical Fibers are ultra-thin, entangled cortical bone fibers which provide a significant surface area of exposed growth factors to stimulate bone growth, and an osteoconductive matrix for cellular attachment and proliferation. The fibers also offer excellent handling properties, in-situ expansion and placement through a variety of delivery methods.

“The Incite Cortical Fibers give me great intra-operative flexibility because of the handling properties and versatility of the product,” said Charles C. Park, M.D., Ph.D., Director of the Minimally Invasive Brain and Spine Center at Mercy Medical Center in Baltimore, Maryland.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com


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September 23, 2016 OrthoSpineNews

September 23, 2016

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–

IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible) (IMPL.PA) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its financial results for the 1st half of the year to June 30, 2016, as approved by the Board at its meeting of September 20, 2016.

In € thousands – IFRS H1 2016 H1 2015
Revenue 4,094 3,307
Cost of products sold -1,943 -2,173
Gross margin 2,152 1,134
Gross margin (%) 52.5% 34.3%
Research & Development -532 -483
Regulatory matters, Quality control -510 -472
Sales, distribution and marketing costs -2,606 -2,283
Operating costs -526 -398
General costs -1,534 -1,773
Operating Profit/Loss -3,556 -4,275
Net Profit/Loss -3,802 -4,299

Revenue: further ramping up of Jazz in the United States and France

Over the 1st half of 2016, the Group recorded revenue of €4.094 thousand, up 24% compared with the 1st half of 2015, notably due to a further increase in Spine activity (+38% compared with H1 2015). This growth momentum was a direct result of Implanet’s growth in the United States and France, markets in which Implanet markets its Jazz technological platform directly and where sales increased by 101% and 40% respectively. Close to 800 surgical interventions were carried out using the Jazz technological platform in the 1st half of 2016, taking the total number of patients treated via this technology to more than 2,800 since its launch in 2013 (with more than 15,000 implants in total).

The substantial acceleration in the number of surgical operations carried out reflects the growing adoption of Jazz technology by surgeons around the world (111 surgeons as of June 30, 2016), notably due to the excellent clinical results obtained by Jazz in adults and adolescents and the growing use of Jazz technology on the degenerative bone disorder segment, the largest market segment.

Knee activity recorded a 12% increase in sales to €2.1 million over the first six months of the year. As anticipated, this increase was driven by the particularly buoyant growth of over 50% on the French market, which now accounts for over 70% of this division’s revenue.

Strong increase in the gross margin, tight control of the operational structure

In the 1st half of 2016, the gross margin came to 52.5% of revenue, a substantial improvement of 18.2 percentage points. This is a direct result of the increase of Jazz sales in the United States, the market with favorable unit sale prices and an excellent overall product and geographic mix.

The €302 thousand increase in operating expenses compared with the 1st half of 2015 was mainly due to the €323 thousand increase in sales and marketing costs that accompanied the buoyant growth in activity, in particular in the United States (including €184 thousand in personnel costs following the strengthening of the sales team and the appointment of Brian T. Ennis to head the US subsidiary, as well as a €173 thousand in sales commissions paid to sales agents).

Other operating costs remained stable compared with the 1st half of 2015, reflecting tight control over expenses.

Taking all these factors into account, Implanet recorded a 17% improvement in its operating result to -€3,556 thousand in the 1st half of 2016 (vs. -€4,275 thousand in H1 2015) and a 12% improvement in its net loss to -€3,802 thousand (vs. -€4,299 thousand in H1 2015).

Cash, cash equivalents and financial investments

As of June 30, 2016, Implanet had cash and cash equivalents of €2.0 million and financial investments of €1.9 million, i.e. a total of €3.9 million. Operating cash burn was €3.5 million in the first half of 2016, versus €4.6 million in the first half of 2015 (giving a 24% reduction in cash burn).

Implanet also has the possibility to request, under certain conditions, the subscription of 340 convertible bonds coupled with equity warrants (OCABSA) with L1 EUROPEAN HEALTHCARE OPPORTUNITIES FUND for a total amount of €3.4 million, and recently obtained an interest-free innovation loan of €0.8 million from Bpifrance Aquitaine.

Ludovic Lastennet, CEO of Implanet, says: “Over the first half of this year, we have successfully continued to implement our growth strategy in our direct markets: France and the United States. This strategy prioritizes the following development routes: continue our expansion via the contribution of the new Jazz Claw implant for major deformities and Jazz Lock implant for degenerative bone disorders, demonstrate Jazz’s clinical efficacy through major clinical studies and continue improving our financial performance through the ramping up in the United States and tight control over our spending.


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September 23, 2016 OrthoSpineNews

LEUVEN, Belgium, Sept. 22, 2016 (GLOBE NEWSWIRE) — TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has appointed June Almenoff, M.D., Ph.D., as a member of its Board of Directors in replacement of Dirk Reyn.

“Her background is a perfect fit for TiGenix, and the projects we have under development. She has a strong clinical development record, and has successfully led the process toward FDA approval for a GI product; experience with early-stage development, scientific licensing and business development; an expertise in infectious diseases, and a clear focus on the US market,” said Eduardo Bravo, CEO, TiGenix. “With Cx601 close to start its second pivotal Phase III study towards BLA filing and the rest of the assets moving into mid to late stage clinical development, June is a great complement to our outstanding Board of Directors.”

“I am very excited to be joining the Board of TiGenix,” said Dr. June Almenoff. “TiGenix currently has the most advanced cell therapy pipeline in Europe, with positive pivotal Phase III data and European filing of their lead product candidate, Cx601, announced earlier this year. The product has then been licensed ex-US to Takeda. These are remarkable accomplishments. As a Board member, I look forward to leveraging my clinical development and regulatory experience with the FDA to move Cx601 along the pathway toward approval in the US, as well as to advance the company’s pipeline initiatives in acute myocardial infarction and severe sepsis.”

Dr. Almenoff is replacing Dirk Reyn (R&S Consulting BVBA), who is stepping down. “I regretfully leave my position at TiGenix due to my increasing commitment to eTheRNA immunotherapies, where I am CEO,” said Dirk Reyn. “During my five-year tenure as a Board member at TiGenix, together with the Management Team, we have transformed the company, secured funding from marquee investors and achieved the first ever positive pivotal trial with an allogeneic cell therapy product that led to the very successful licensing agreement with Takeda. I am very proud of the work we have done together.”

“We have made tremendous progress during Dirk’s tenure. We sincerely owe him our gratitude for his help getting us to where we are today” said Jean Stéphenne, Chairman of the Board of Directors of TiGenix. “As we march toward approval of Cx601 in the US and we advance our pipeline in new and exciting indications I am confident that Dr. June Almenoff, given her clinical development background and experience working with the FDA, is the ideal person for our Board going forward.”

June S. Almenoff MD, PhD, is an accomplished pharmaceutical executive with close to 20 years of industry experience. She has extensive expertise in clinical development, translational medicine and business development. Dr. Almenoff recently served as President, Principal Executive Officer and Chief Medical Officer of Furiex Pharmaceuticals, a publicly held biopharma company.  During her 4-year tenure, the company’s valuation increased ~10-fold, culminating in its acquisition by Actavis plc (now Allergan) for ~$1.2B in 2014. Furiex’s lead product, eluxadoline (Viberzi TM), a novel gastrointestinal drug, received FDA approval in 2015.  Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK), where she held positions of increasing responsibility.   During her 12 years at GSK, she was a Vice President in the R&D organization, chaired a PhRMA-FDA working group and also worked in the area of scientific licensing. Dr. Almenoff led the development of pioneering systems for minimizing risk in early- and late-stage drug development which are now widely used by pharmaceutical companies and regulatory agencies. Dr. Almenoff is currently an independent biopharma consultant and Board Director: she is the Executive Chair of RDD Pharma and a member of the Boards of Ohr Pharmaceuticals (Nasdaq: OHRP) and Valanbio. She also serves on the investment advisory board of the Harrington Discovery Institute (Case Western Univ.) and the advisory boards of Redhill Biopharma (Nasdaq: RDHL) and numerous private companies. Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center (Internal Medicine, Infectious Diseases) and served on the faculty of Duke University School of Medicine. She is an adjunct Professor at Duke and a Fellow of the American College of Physicians.

The appointment of June Almenoff is effective immediately subject to final appointment by the next shareholders’ meeting.

For more information

Claudia D’Augusta Chief Financial Officer

T: +34 91 804 92 64

claudia.daugusta@tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com.

Forward-looking information

This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company’s control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.


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September 23, 2016 OrthoSpineNews

September 22, 2016

German 3D printed orthopedic device manufacturer Emerging Implant Technologies (EIT) has just announced that it has received a significant investment from German private equity company SHS mbH. With the new funds, EIT, a pioneer in making 3D printed medical orthopedic devices, will seek to both expand its international presence, notably within the United States, and continue developing its range of innovative products.

Emerging Implant Technologies was founded in 2014 in Tuttlingen, Germany and has established itself as a reliable manufacturer of 3D printed orthopedic medical devices and implants. Using Selective Laser Melting (SLM) technologies, the young company has developed its own EIT Cellular Titanium(R) structures, which have properties such as 80% porosity and diamond pores the size of roughly 650 μm, which in mimicking trabecular bone structure, help to promote natural bone growth.

The company also offers patient specific implants, and a complete spinal fusion cage portfolio, including a Cervical Cage implant, PLIF cage, TLIF cage, and a soon to be released ALIF cage. Guntmar Eisen, founder and CEO of EIT, explains: “Our EIT Cellular Titanium implants provide the answer to current challenges in implant design and choice of materials as well the extreme cost pressure in medical technology. The additive manufacturing technology allows us to tackle existing problems with new solutions. Thus we can improve the benefits for patients without increasing costs, which is a clear competitive advantage.”

EIT’s new investment, which comes from SHS’s fourth fund generation (itself worth a total of 125 million euro), will facilitate the expansion of the 3D printed medical device manufacturer into other countries such as the United States and will allow them to develop more innovative and useful additively manufactured implants for the medical industry.

As Dr. Bernhard Schirmers, Managing Partner at SHS Gesellschaftfür Beteiligungsmanagement, explains, “EIT’s 3D-printed spine implants have already proven their superior functionality many times in practical applications, thus promoting EIT’s growth. EIT Emerging Implant Technologies’ management team is experienced and successful in the field of spine surgery. As a medical technology investor, we look forward to supporting them on their path to increased growth.”

SHS, which invests primarily in medical technology and life-science companies, is planning on making more investments and even acquisitions within the industry in the coming months. According to a press release, these additional investments will be for companies in Germany, Austria, and Switzerland. SHS’s investments are usually focused on “expansion financing, changes in shareholder structures, and successor situations.”

 

 

Posted in 3D Printer Company

 


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September 22, 2016 OrthoSpineNews

 

G Surgical, a privately held medical device company offering innovative spinal implants, announced that it has received 510(k) clearance from the United States Food and Drug Administration to market their MARKSMAN MIS® Spine System.

Don Grafton, President and CEO of G Surgical, comments, “We are excited to strengthen our portfolio by introducing the MARKSMAN MIS® Pedicle Screw Spine System. G Surgical has led the way in providing surgeons with the highest quality surgical solutions while maintaining cost effectiveness for cervical and lumbar fusions.”

G Surgical was founded in G Surgical was founded in 2009 by Don Grafton. G Surgical provides world class spinal products with headquarters in the United States and with offices in Thailand and Malaysia. G Surgical’s culture and experienced team allows us to respond swiftly to customer needs and places G Surgical in the forefront to strategically compete in a changing market environment.  More information can be found at www.gsurgical.com.

For Additional Information:

Company Contact: James Thomas, Director of Sales and Marketing for G Surgical (512) 968-5000 jthomas@gsurgical.com

©2016 G Surgical LLC, All Rights Reserved


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September 22, 2016 OrthoSpineNews

Deerfield Beach, FL — (SBWIRE) — 09/22/2016 — Sports medicine is a branch of medicine that deals with the prevention and treatment of injuries incurred during sports activities, exercises or physical fitness training.Sports medicine devices therefore, include a wide range of products utilized for the prevention, recovery and cure of injuries related to the above physical activities. These injuries consist of fractures, sprains, soft tissue damage, joint dislocation, strain and musculoskeletal injuries. The increased global adoption of western sports has given rise to injuries that drive the market for sports medicine devices. Additionally, the growing demand for outpatient, minimally invasive surgeries, the growing awareness regarding the maintenance of an active lifestyle and the changing reimbursement landscape for innovative surgical technologies are key factors contributing to the growth of the sports medicine devices market.

On the other hand, the lack of trained professionals for sports medicine and the exorbitant price of certain devices and products serve to hinder market growth. Nevertheless, a general apprehension of the benefits of sports medicine devices- made possible through training programs and market penetration, and expansion in emerging countries of the Asia-Pacific region present key opportunities for the growth of this market. Technological advancements and the discovery of novel technologies are principle strategies followed by major players in this market. The key companies profiled in this report are Arthrocare Corporation, Biomet, Inc., Arthrex, Inc., Cayenne Medical Inc, Breg Inc., Zimmer Inc., Wright Medical Group Inc., Smith & Nephew Inc., Mueller Sports Medicine, Inc., and FH Orthopedics Inc. amongst others.

Get Free Sample Report Of Sports Medicine Devices Market :http://www.marketresearchstore.com/report/world-sports-medicine-devices-market-opportunities-and-68583#RequestSample

The global sports medicine market is segmented into product type, application area and geography. On the basis of product type the market is segmented into orthopedic and support and recovery products. Orthopedic products include arthroscopy devices, fracture repair devices, artificial joint implants, orthobiologics and prosthesis. Support and recovery products include surgical equipment, compression clothing, support devices, tapes, bandages and others. Arthroscopy devices dominate the market due to their joint-related issues. Fracture repair devices and artificial joint implants are also gaining ground due to the rising incidence of fractures and growing demand for joint replacements.

On the basis of application, the market is segmented into Hand-wrist, Shoulders, Ankle-foot, Arm-elbow, Knee, Back-spine and Hip-groin. Shoulder and Knee treatment generated the highest revenue as most sports injuries are knee-related. Furthermore, the increasing number of age-related complications caused by diseases such as rheumatoid arthritis is also fueling market growth.

Do Inquiry Before Purchasing Report:http://www.marketresearchstore.com/report/world-sports-medicine-devices-market-opportunities-and-68583#InquiryForBuying

KEY BENEFITS

Extensive analyses of the factors that drive and limit the growth of the global sports medicine market are provided.

Deep dive analysis of segments such as product type and applications provide insights that would enable companies to gain competitive edge.

In-depth analysis of various regions would enable an understanding of the trends in various regions so that companies can make region specific plans.

The competitive landscape section lists the market shares of major leaders within the global sports medicine market along with the key strategies adopted by them to achieve high monetary value.

Key deliverables

The sports medicine market is segmented according to product type, application and geography as follows:

By Product type

Orthopedic Products
Arthroscopy Devices
Fracture Repair Devices
Artificial Joint Implants
Orthobiologics
Prosthesis
Support and Recovery Products
Body Recovery and Support
Thermal Therapy (Cold/Hot Therapy)
Support Devices and Braces
Compression Clothing
Analgesics (Topical Pain Relief)
Body Repair and Reconstruction
Surgical Equipment
Bone/Cartilage Repair and Reconstruction
Soft Tissue Repair (Tendon and Ligament Repair)
Body Evaluation and Monitoring
Respiratory
Hemodynamic
Cardiac
Musculoskeletal
Accessories
Tapes
Bandages
Disinfectants
Wraps

By Application Area

Hand-wrist
Shoulders
Ankle-foot
Arm-elbow
Knee
Back-spine
Hip-groin

By geography

North America
Europe
Asia Pacific
LAMEA

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September 22, 2016 OrthoSpineNews

SAN DIEGO, CA (PRWEB) SEPTEMBER 22, 2016 

During the 2016 Congress of Neurological Surgeons Annual Meeting, surgeons will gather to discuss less invasive surgery techniques and technologies for moving elective spine surgeries from hospitals to outpatient surgery centers with a focus on Axiomed LLC’s revolutionary cervical and lumbar viscoelastic total disc replacements. This discussion will compare newer spine surgery techniques to fusion.

The the Symposium will be centered around a new philosophy of less invasive surgery entitled Less Exposure Surgery (LES). Minimally invasive surgery is focused on smaller incisions. LES improves on minimally invasive surgery to achieve less tissue disruption and a faster recovery. It uses more fluoroscopy to achieve indirect visualization. Open surgery uses maximum exposure to improve ease and accuracy of the techniques.

Less exposure surgery utilizes the fundamental principles and goals of open surgery techniques but achieves the same results using smaller incisions and greater precision under direct visualization instead of relying on fluoroscopy, so there is higher degree of safety. LES surgical techniques are also more straight forward. Many companies are continuing to develop improvements to LES technology.

The LES Society has sponsored a growing body of peer reviewed and published research studies demonstrating that patients can safely undergo spine surgery using LES fusion techniques and technologies in outpatient surgery centers and go home the same day to recover rapidly. With this summer’s completion of the IDE study of the Axiomed Freedom viscoelastic lumbar total disc replacement and the completion of the European pre-clinical trial of the Freedom Cervical viscoelastic total disc replacement, surgeons will have access to spine technology that most closely emulates the human disc. This could have revolutionary effects on spine surgery, as it allows for a much less invasive technique than fusion and better, faster outcomes.

Surgeons will discuss topics such as comparing anterior cervical fusion using plates and screws, standalone cages with screws and total disc replacement. Featured speakers include neurosurgeons, Dr. Fassil Mesfin and Dr. Juan Valdivia and moderator, professor Dr. Kingsley Chin, an orthopedic surgeon and the founder of the LES Society. The event will take place on September 24, 2016, from 5:00-7:00 pm.

“The LES Society consistently provides education and training concerning Less Exposure Surgery techniques and technologies in annual meeting forums such as CNS and locally in cities via journal clubs where surgeons get to share their experiences and cases as well as network around business and innovation,” said Jessica Morgan, program director of the LES Society. “There is a growing movement towards LES and companies like SpineFrontier Inc and Axiomed Inc are pioneering the technologies with surgeon inventors who want to safely move surgeries to same day outpatient recovery centers.”

Dr. Mesfin is the director of complex spine and spine oncology and an assistant professor at the University of Missouri School of Medicine in Columbia, Missouri. Dr. Valdivia specializes in reconstructive spine surgery, and is a member of the medical staff of the Baycare Medical Group in Tampa, Florida. He spent over 5 years at the University of Michigan teaching as an academic neurosurgeon.

CNS Annual Meeting attendees are invited to enjoy a wine and cheese tasting during the Symposium at the award winning San Diego restaurant, BiCE. Hor d’oeuvres will also be served at the event. To RSVP for the event or to get more information, email the LES Society program director, Jessica Morgan, at jessicamorgan(at)lessociety(dot)org.

About Less Exposure Surgery Society:

The Less Exposure Surgery Society is a non-profit organization, which aims to advance research, technology and education for minimal invasive surgery. Using smaller incisions and new technology, the surgeon exposes only the areas that need to be treated. The technique has improved recovery and outcomes for patients. The society is expanding its membership in order to provide education and networking for medical professionals globally. The LES Society is seeking experienced members in order to expand its board and administration.

Visit https://www.lessociety.org/about.html to learn more.


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September 22, 2016 OrthoSpineNews

ROSEMONT, Ill. and WARSAW, Ind., Sept. 22, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today pledged to donate up to $100,000 in matching funds to the Orthopaedic Research and Education Foundation (OREF).  According to the agreement, Zimmer Biomet will help underwrite OREF’s grant administration costs by donating 10 cents for every dollar given to OREF by individual donors.

Since 2010, Zimmer Biomet has donated more than $6 million toward advancing OREF’s mission by funding programs, awards and grants including OREF’s Career Development Award, Clinician Development Program, Young Investigator Grants, New Investigator Grants, Resident Research Symposia and Collaborative Research Agenda in Hip/Knee and Trauma.

“Zimmer Biomet and the Orthopaedic Research and Education Foundation share a commitment to advancing the treatment of musculoskeletal disorders and injuries, and we’re pleased this funding will help to defray administration costs and enable the Foundation to invest more financial resources toward its research grants,” said David C. Dvorak, President and CEO of Zimmer Biomet.

The partnership between Zimmer Biomet and OREF will increase the dollars that are available to orthopaedic investigators through OREF’s grant programs and will encourage other donors to support OREF’s mission. Richard F. Santore, MD, OREF Trustee and Chair of the Individual Development Committee, stated, “this support from Zimmer Biomet for peer reviewed research sends an incredibly positive message to current and prospective OREF donors about the value of the work OREF is doing. It allows OREF to keep administrative overhead for grants extremely low.”

According to the U.S. Bone and Joint Initiative, musculoskeletal disorders are the most common causes of long-term pain and disability worldwide, and account for half of all chronic conditions in the elderly. “OREF and Zimmer Biomet share a long history of supporting the best orthopaedic research. This exciting new chapter in our relationship demonstrates Zimmer Biomet’s ongoing commitment to both OREF and the orthopaedic community,” said David G. Lewallen, MD, President of the OREF Board of Trustees.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

About the Orthopaedic Research and Education Foundation
The Orthopaedic Research and Education Foundation is a charitable 501(c)(3) organization committed to improving lives by supporting excellence in orthopaedic research. OREF is dedicated to supporting new investigators and is the premiere orthopaedic organization funding research across all specialties. A list of research and funding priorities is available at oref.org/grants or follow @oreftoday on Twitter.

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

 

 

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

 


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September 22, 2016 OrthoSpineNews

COLUMBIA, Md., Sept. 16, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) (the “Company”) provided today an update concerning the status of its compliance with the Listing Rules of the NASDAQ Stock Market (“NASDAQ”).

As previously disclosed, the Company is working diligently to complete its previously announced restatements of prior period financial statements and transition to a new independent registered public accounting firm for the 2015 audit so that it is in a position to bring its SEC filings up to date.

The Audit Committee of the Board of Directors has completed an independent review of the accounting matters with the assistance of outside professionals.   The Company, under the direction of the Audit Committee, is working diligently with its former independent registered accounting firm to complete the restatement of its 2014 audited and interim financial statements as soon as possible.   Once that process is complete, the Company expects to transition to a new independent registered accounting firm and begin work on the 2015 financial statements.

As a result of these matters, the Company has delayed the filing of its Annual Report on Form 10-K for the year ended December 31, 2015 (“2015 Form 10-K”), its Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2016 (“Q1 2016 Form 10-Q”), and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (“Q2 2016 Form 10-Q”).  As a result, the Company is currently out of compliance with NASDAQ Stock Market Listing Rule 5250(c)(1).

As previously disclosed, the Company submitted to the NASDAQ listing qualifications staff (the “Staff”) a plan to regain compliance with NASDAQ’s continued listing requirements.  On May 24, 2016, NASDAQ granted an exemption to the NASDAQ Listing Rule, extending the deadline until September 12, 2016 for the Company to file all delinquent reports with the SEC, including the 2015 Form 10-K, Q1 2016 Form 10-Q, and Q2 2016 Form 10-Q.  Although the Company is working diligently to finalize these reports, the Company was unable to bring its SEC filings up to date by the September 12, 2016 deadline.

Consequently, on September 14, 2016, the Company received an anticipated letter from NASDAQ, stating that unless the Company requests a hearing before a NASDAQ Listing Qualifications Panel (a “Hearings Panel”) bySeptember 21, 2016, the Company’s common stock will be delisted. Under NASDAQ’s rules and procedures, in general, a company’s request for such a hearing automatically stays any delisting for 15 calendar days from the deadline to request a hearing.  The Company will file a hearing request on or prior to September 21, 2016 and request a further stay. The letter states that the hearing would be expected to occur 30-45 days from the date of the hearing request.

If the Hearings Panel grants the Company’s request for a further stay (which is discretionary on the part of the Hearings Panel and therefore not assured), any final delisting will be stayed until further Hearings Panelproceedings.  The NASDAQ Rules also permit the Company to appeal decisions from the Hearings Department to the NASDAQ Listing Council.

While the Company is continuing to work diligently to complete its previously announced restatements of prior period financial statements and bring its SEC filings up to date, there can be no assurance regarding the timing or ultimate outcome of this process or the ability of the Company to successfully maintain its NASDAQ listing.

The Company is making this announcement in compliance with NASDAQ Listing Rule 5810(b), which requires prompt disclosure of receipt of a noncompliance letter.

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 BIO, Cartiform®, Grafix®, TruSkin ™ and Stravix™.

Osiris, Grafix, and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc.  BIO 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.