TiGenix Appoints Dr. June Almenoff to its Board of Directors

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


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.

SHS announces investment partnership with 3D printed medical device company EIT

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


G Surgical Announces FDA Clearance and Launch of the MARKSMAN MIS® Spine System


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

Global Sports Medicine Devices Market 2016: Hand-Wrist, Shoulders, Ankle-Foot, Knee, Back-Spine

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


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
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

By Application Area


By geography

North America
Asia Pacific

About Market Research Store

Market Research Store is a single destination for all the industry, company and country reports. We feature large repository of latest industry reports, leading and niche company profiles, and market statistics released by reputed private publishers and public organizations. Market Research Store is the comprehensive collection of market intelligence products and services available on air. We have market research reports from number of leading publishers and update our collection daily to provide our clients with the instant online access to our database. With access to this database, our clients will be able to benefit from expert insights on global industries, products, and market trends.

Contact Us:
Joel John
3422 SW 15 Street, Suite #8138,
Deerfield Beach, Florida 33442,
United States
Tel: 386-310-3803
GMT Tel: +49-322 210 92714
USA/Canada Toll Free No. 855-465-4651
Email: sales@marketresearchstore.com
Web: http://www.marketresearchstore.com/

LES Society to Sponsor Spine Surgeon Symposium Featuring Groundbreaking Innovations in Viscoelastic Total Disc Replacement Technology


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.

Zimmer Biomet Contributes Additional $100,000 in Funding to the Orthopaedic Research and Education Foundation

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



Osiris Provides Update Regarding NASDAQ Listing Status

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



Source: Osiris Therapeutics, Inc.

Medovex Corporation to Demonstrate Expanding EMEA Business During EuroSpine 2016, Berlin, Germany

ATLANTA, GA–(Marketwired – Sep 21, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the Company will exhibit during EuroSpine which is being held from October 5-7, 2016 in Berlin, Germany.

As part of the product exhibition, Medovex will highlight its innovative DenerveX™ System, a minimally invasive surgical (MIS) procedure pioneered by Medovex that was built around the combination of denervation and capsulectomy with reproducible results, “A potential paradigm shift in the treatment of Facet Joint pain.”

Medovex will exhibit at stand #B100 and will feature a number of work stations to demonstrate DenerveX™ treatment modality which uses Rotablation™ technology, high heat and rotational capsular tissue shaving, in a minimally invasive posterior capsulectomy procedure of the Facet Joint.

Medovex’s presence at EuroSpine is an extension of the Company’s continued investment in its strategic expansion throughout the EMEA market. EuroSpine is the union from the European Spine Society and the European Spinal Deformity Society. The Spine Society of Europe has experienced strong growth in membership, activities and participants at annual meetings, including participants from all over the world.

During EuroSpine 2016, Medovex also will announce the official opening of the Company’s European Distribution Center in Berlin.

The Center will serve as Medovex’s European distribution service headquarters and function as the commercial hub for all European distributors and end users, as well as other support functions. The international operations center in Atlanta, GA (USA) will remain the Company’s international operational headquarters.

Patrick Kullmann, President and COO for Medovex, stated, “Region specific events such as EuroSpine are important to our expansion efforts in Europe as we prepare for the future launch of the DenerveX System. The Berlin distribution service center will provide further infrastructure for Medovex to execute our future market development strategy across Western Europe and the entire EMEA region. Medovex is well-positioned to drive surgeon adoption of our new innovative DenerveX™ System across Europe.”

Manfred Sablowski, Senior Vice President of Global Sales & Marketing, added, “The opening of the European distribution service center is an important milestone for Medovex and a key inflection point for our Company’s strategy to grow our business in EMEA. In past months, we have additionally expanded our footprint to include all of Scandinavia and Israel. Our future goal is to increase our world-class EMEA distribution in other key countries. With the recent appointment of Juan Davila as Director Sales & Marketing for Latin America, having extensive experience in this market, we expect to continue to execute our go to market strategy.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.


    Jason Assad
    Email Contact

medi USA and Topical Gear Partner on Injury Prevention in the Sports Medicine Industry

WHITSETT, N.C., Sept. 20, 2016 /PRNewswire/ — medi USA, a global leader in compression therapy, orthopedics, spinal bracing, prosthetics and foot care with over 60 years of experience producing and distributing medical devices, has made a strategic investment in a sports medicine company, Topical Gear.

Topical Gear was formed in 2010 by a team of orthopedic sports medicine professionals who created performance wearables with T:25 Technology, which activates neuromuscular communication and targeted compression to enhance performance and keep patients stronger and healthier.

This new partnership challenges the traditional approach of addressing sports injury with an emphasis on prevention. A unique combination of compression technology is positioned to train muscles, increase proprioception and enhance performance to decrease the incidence of injury.

The union is a strong strategic fit, which leverages both companies’ respective strengths, including their diverse focus in the orthopedic and sports medicine industries.  By maximizing the product development talents and resources at both companies, the investment is expected to spark innovation and additional research and development, which will benefit club, college and professional sports channels alike.

For more information about the new partnership, please visit www.mediusa.com and www.topicalgear.com.

CONTACT: Jennifer Huber, 336-449-4440 ext. 129, jennifer.huber@mediusa.com


Related Links


K2M Expands MESA® Platform with FDA Clearance for Growing Spine Application

LEESBURG, Va., Sept. 21, 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 at the Scoliosis Research Society (SRS) 51st Annual Meeting & Course in Prague, Czech Republic that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for screw and connector components toward a growing spine application for its MESA® Spinal System. This clearance enables these screw and connector components to be used as a part of a growing rod construct designed to accommodate growth in patients under 10 years of age.

“We are excited to receive FDA clearance for a growing spine application, which will provide surgeons with a new treatment option for correcting spinal deformity among a specific subset of the pediatric spinal deformity population,” said Eric Major, K2M’s President and CEO.

K2M’s growing spine application features closed-head screws and previously-cleared axial connectors, providing a surgical solution for patients less than 10 years of age to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.

With this growing spine application, surgeons can utilize components from a traditional fusion construct for a growth-enabling construction, allowing implants to be surgically lengthened on a periodic basis as the patient grows. This growing spine application also offers a growth guidance option, combining standard instrumentation and placement of unlocked closed-head screws at non-fusion levels, to allow for rod passage as the patient grows.

K2M’s growth guidance implants may be used with any cleared K2M rod construct ranging in diameter from 4.5 mm to 6.35 mm. K2M’s growth rod conversion implants may be used with 4.5 mm and 5.5 mm rod constructs.

Major added, “This regulatory milestone, coupled with our recent data announcement of findings surrounding our motion-preserving scoliosis technology, reinforce our ongoing commitment to achieving the highest level of excellence in developing innovative technologies that provide enduring treatments for young patients suffering from complex spinal deformities, such as early-onset scoliosis and adolescent idiopathic scoliosis.”

In July, K2M announced findings from a multi-year study surrounding the Company’s recently-acquired motion-preserving scoliosis technology* from K-Spine. The study found that the innovative apical fusion technique achieved corrected deformity profiles in AIS patients and maintained mobility of non-fused segments with a lower implant density, sparing 52 percent of the spanned area from fusion.

For more information on K2M’s comprehensive product portfolio, visit www.K2M.com.

*This device is not available for sale within the United States.

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

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