Monday, January 30, 2017

News - Device: DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screw Systems


VIPER® and EXPEDIUM® Fenestrated Screw Systems Designed for Enhanced Fixation in Patients with Advanced Stage Spinal Tumors



VIPER®
VIPER 2 System rod intro | DePuy Synthes Companies
VIPER®


RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ -- DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM® Fenestrated Screw Systems. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery. 
EXPEDIUM 5.5 System implant | DePuy Synthes Companies
EXPEDIUM®

EXPEDIUM 5.5 System instrument | DePuy Synthes Companies
EXPEDIUM®
Metastatic spine disease accounts for 10 percent to 30 percent of new cancer diagnoses annually.1 Surgical fixation with pedicle screws may be used as palliative care to stabilize the spine, help reduce pain and help keep the patient mobile.1 The VIPER and EXPEDIUM Fenestrated Screws are designed with a hollow shaft, or cannulation. This design along with holes called fenestrations above the screw tip enable controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement into the vertebra to provide immediate screw fixation.  

"Metastatic disease in the spine can be severely painful and limiting for patients who are really trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely," said William C. Horton, M.D., Vice President of Research & Development, DePuy Synthes Spine. "We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease."

The VIPER Fenestrated Screws are compatible with the VIPER and EXPEDIUM 5.5 Spine Systems and the EXPEDIUM Fenestrated Screws are compatible with the EXPEDIUM VERSE Spinal System. Both fenestrated screw systems are anticipated to be available in the United States in mid-2017.

Indications for Use

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

About DePuy Synthes Companies

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


*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. Medos International, SARL is the legal manufacturer of the VIPER and EXPEDIUM Fenestrated Screw Systems. DSUS/SPN/0117/1510 01/17

1 Dunning, E.C, et al. Complications in the management of metastatic spinal disease. World J Orthop. 2012 Aug 18; 3(8): 114–121. SOURCE DePuy Synthes

Published at PRNewsWire


News - Biologics: Aberdeen Uni spin out set for next multi-million investment round

A medical device company that spun out of the University of Aberdeen is on track to raise millions in a second round of funding from investors
Sirakoss, which has developed synthetic bone graft technology, is seeking to raise between £3.5million to £5million this year to take its products through regulatory approvals in its key US and European markets. These regions along with Japan make up around 80% of the growing $3billion (£2.4billion) global orthopaedic market the firm targets with its products.
The firm, which spun out of the university in 2011, raised $4.8million (£3.8million) from a syndicate of investors led by Epidarex Capital, which included the Scottish Investment Bank, in 2014.

The company’s name is a cognate of “si” for silicon – a key components of its technology, “rak” – which comes from the Greek for spine and “os” for bone.
Brian Butchart, chief executive of Sirakoss, said the company was now headquartered in Edinburgh but that its research & development (R&D) heart was placed firmly in Aberdeen.
He said: “There’s a team of four in Aberdeen. The team is quite small overall, we are nine in total.
“We continue to see Aberdeen will be the focus of our R&D activities.”
One of the founders of the firm is Iain Gibson professor of biomaterials and regenerative medicine at University of Aberdeen and research and development (R&D) director of Sirakoss. Jordan Conway, the company’s R&D manager, also works in Aberdeen and has been with the firm since its early proof-of-concept days.
Mr Butchart, who joined the firm in 2009 to oversee the company’s commercial growth, said its next fundraising effort was “challenging” but demographics were working in the company’s favour.
“Raising funding is always a challenge in the UK for medical devices.
“But where pharmaceuticals are tens of millions to get through to this stage, for devices it is less than that. But it is still significant and that is why we will continue to raise investment funding.
“We will look for investment funding for second product development ranges in the next six months.”
He added: “People are getting to an age and they have a degenerative disease in their spine – that is only going to increase with an aging population.
“People are no longer happy to sit by the fire and say that is all they can do now. They want to be out golfing, fishing, sailing.
“There is a positive social impact if people can stay active – and an economic impact.
“We are seeing a growth in these procedures worldwide.”
Published at The Press & Journal

Sunday, January 29, 2017

News: BioPoly® Granted Two Additional US Patents

January 26, 2017
Written by: BioPoly, LLC
FORT WAYNE, IN – BioPoly LLC has announced that two additional US patents have been granted which protect its unique material, orthopaedic devices, and methods of implantation. BioPoly’s patent portfolio totals 12 for this subject matter thus far. According to Company president, Herb Schwartz, PhD, “We’ve devoted a significant amount of resources and strategic planning toward intellectual property protection. With the patents and trademarks that have already been awarded, along with additional applications in the pipeline, we have extremely good coverage worldwide.”
BioPoly LLC is an orthopaedic company whose market advantage is based on its unique, proprietary material also called BioPoly®. Through an innovative combination of a lubricating molecule found in cartilage and an orthopaedic polymer, the BioPoly material behaves like a synthetic self-lubricating cartilage. With this material, the Company is able to provide implants that replace only the damaged portion of joints rather than replace entire (total) joints.
BioPoly® implants have been used clinically in Europe for over 5 years. Post market clinical data is being collected via registry studies and the results indicate that patients who receive these implants are experiencing very positive and life changing outcomes. BioPoly® implants for the knee, patella, and shoulder are approved for use in Europe through receipt of the CE mark.
BioPoly, LLC
Published at BioPoly

News: OsteoMed Acquires OT Medical’s InstaFix Shape Memory Staple

January 27, 2017: OsteoMed, LLC, a Colson Associates company, completed the acquisition of OT Medical’s InstaFix™ shape memory staple systems.  “We are very pleased to add OT Medical’s simple and effective staple line to our growing small bone orthopedic offering as we continue to support this important segment of our business,” says Walt Humann, President and CEO.

About OsteoMed: 

OsteoMed is a leading global innovator, developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments. OsteoMed’s mission is to be the premier, global, small bone implant company by striving to improve patient outcomes through offering high quality, innovative and cost effective surgical products and unmatched service. 

Contact:   Toby Miles, Vice President of Marketing. 972.677.4600

Published at Orthoworld

Tuesday, January 24, 2017

News: Histogenics Announces Publication of MRI Data From NeoCart® Phase 1 and Phase 2 Clinical Trials in the American Journal of Sports Medicine

  • Data demonstrate significant improvement in cartilage quality over first 24 months after treatment, with stabilization and maturation thereafter out to 60 months
  • Improvements in cartilage quality were accompanied by consistent and statistically significant improvements in patient reported clinical outcomes as early as 3 to 6 months after implantation
  • Data underscore potential to provide a faster and more durable recovery for patients with cartilage defects in the knee


WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the online publication in the January 2017 issue of the American Journal of Sports Medicine of a peer-reviewed publication entitled Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries.  The lead investigator is Dr. Dennis Crawford MD, PhD with support from other investigators including Devon E. Anderson, PhD, Riley J. Williams III, MD, Thomas M. DeBerardino, MD, Dean C. Taylor, MD, C. Benjamin Ma, MD, and Marie S. Kane, MS.  The publication analyzes magnetic resonance imaging (MRI) data through 60 months follow up from the Phase 1 and 2 clinical trials of NeoCart for the repair of articular cartilage injuries in the knee. 

29 patients with symptomatic full thickness cartilage lesions of the distal femoral condyle were treated with NeoCart in the Phase 1 and Phase 2 clinical trials and pooled for this analysis.  Safety and efficacy were evaluated prospectively by MRI and patient reported outcomes (PROs) through a 60-month follow-up period, with 21 patients evaluable at the final time point.  Qualitative MRI metrics were quantified according to modified magnetic resonance observation of cartilage repair tissue (MOCART) criteria, with an additional evaluation of repair tissue signal intensity.  The NeoCart patients were followed over 52 ± 15.5 (median=60) months.  

MOCART analyses indicated significant improvement (p<0.001) in the cartilage quality from 3 to 24 months, with stabilization and maturation from 24 to 60 months.  In addition, longitudinal MRI analysis demonstrated NeoCart repair tissue to be durable and evolve over time.  Changes in imaging measures over time corresponded with improvement in clinical measures, with maximum benefits experienced at 24-months.  Results from the two studies indicate that NeoCart is a safe and effective treatment for articular cartilage lesions through 5-year follow-up.  In addition, the Phase 1 and 2 NeoCart PROs when compared to baseline demonstrated statistically significant improvements on virtually all of the pain and functional endpoints, as early as 3 to 6 months, with sustained outcomes through 5 years.

“We are very pleased with the results of the clinical trials conducted to date and want to thank our investigators and patients for their participation.  We believe this is an area in need of a better alternative for patients who are seeking new options to repair cartilage defects that potentially offer both a more rapid recovery and durable response over time with fewer repeat surgeries,” stated Gloria Matthews, Chief Medical Officer of Histogenics.  “We believe the MRI data, while limited in the number of patients, provide additional confirmatory evidence of previously reported clinical efficacy outcomes, and demonstrate the potential benefits to patients with cartilage defects.  We are looking forward to the availability of additional data from the continuing development of this promising treatment alternative,” continued Dr. Matthews.

The demonstrated rapid maturation of cartilage as evidenced by the MRI data from the Phase 1 and Phase 2 clinical trials is consistent with biomechanical data recently presented by Histogenics and Cornell University that showed that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart exhibited mechanical properties prior to implantation that were similar to that of native cartilage.  These results suggest that the maturation of tissue-engineered cartilage implants, such as NeoCart, leads to improved mechanical properties prior to implantation and may result in a more rapid recovery and return to function for patients suffering from cartilage defects.
“We believe the data from these two clinical trials are compelling and provide further evidence that NeoCart implants may provide an improved alternative for patients with knee cartilage defects,” stated, Dr. Dennis Crawford, Department of Orthopaedics & Rehabilitation, Oregon Health & Science University.  “The NeoCart implants appear to improve knee function and quality of life two years after surgery with maintenance through five years,” continued Dr. Crawford.

The full publication is hosted on the Histogenics website and can be found at:  http://ir.histogenics.com/phoenix.zhtml?c=252477&p=irol-presentations.

About NeoCart
NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells.  The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells.  Before NeoCart is shipped to the surgeon for implantation, the cell and scaffold construct undergoes a bioengineering process that is designed to mimic a joint so that the implant, upon placement in the knee with a proprietary bioadhesive, is primed to begin functioning like healthy cartilage.  NeoCart is currently in a Phase 3 clinical trial that is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture.  Histogenics is conducting the trial under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) and expects to complete enrollment in this trial by the end of the second quarter of 2017.

About Histogenics Corporation

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

Forward-Looking Statements

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

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

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

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

Contact:
Investor Relations
Tel: +1 (781) 547-7909

Published at NasdaqGlobeNewsWire

News: XTNT Announces Preliminary Fourth Quarter and Full Year 2016 Revenue & Adjusted EBITDA

  • Record Fourth Quarter 2016 Revenue is estimated to be at least $24.5 million which represents 10.0% year on year growth
  • Full Year 2016 Revenue is estimated to be at least $90.0 million which represents 4.1% year on year growth
  • Fourth Quarter 2016 Adjusted EBITDA* is estimated to be at least $1.25 million versus a loss of $350,000 in the Fourth Quarter of 2015
  • Full Year 2016 Adjusted EBITDA* is estimated to be at least $2.2 million versus a pro forma loss of $33,000 for the Full Year 2015
  • Reiterated 2017 Revenue Guidance of between $98 million and $102 million
  • Reiterated 2017 Adjusted EBITDA* Guidance of between $7.7 million and $9.2 million

BELGRADE, Mont., Jan. 11, 2017 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, today has pre-announced that its Fourth Quarter 2016 record revenue is estimated to be at least $24.5 million, an increase of at least 10.0% as compared to revenues of $22.3 million reported in the fourth quarter of 2015. For the full year 2016, the Company has estimated that its sales will be at least $90.0 million, an increase of at least 4.1% as compared to pro-forma revenue of $86.5 million for the full year 2015.

The Company has also pre-announced that its Fourth Quarter Adjusted EBITDA* is estimated to be at least $1.25 million as compared to the prior year Fourth Quarter Adjusted EBITDA* Loss of $350,000. For the full year 2016, the Company estimates that Adjusted EBITDA* will be more than $2.2 million versus a full year 2015 pro forma Adjusted EBITDA* loss of $33,000. The Company defines earnings before interest, taxes, depreciation and amortization ("Adjusted EBITDA") as net income/loss from operations before depreciation, amortization, impairment charges, non-recurring expenses and non-cash stock-based compensation.

Both Revenue and Adjusted EBITDA* will be new records for the Company. The fourth quarter of 2016 is the fourth consecutive quarter of increasing Revenue and the third consecutive quarter of accelerating positive Adjusted EBITDA*.

Additionally, management reiterated 2017 guidance according to the following table:
 Full-Year 2017
($000's)Low-High
Revenue$98,000-$102,000
Adjusted     
EBITDA*$7,700-$9,200
The quarterly financial results included in this release were calculated prior to the completion of a review by the Company’s external auditors and are therefore subject to adjustment.

Use of Pro-Forma Financial Information

On July 31, 2015, Bacterin International Holdings, Inc. acquired all of the issued and outstanding stock of X-Spine Systems, Inc. and the combined company was renamed Xtant Medical Holdings, Inc. Except for the financial results for the three months ended June 30, 2016, the results presented are on a pro forma basis as if the two companies were combined for the periods shown. Certain pro forma adjustments have been made to reflect the impact of the purchase transaction, primarily consisting of amortization of intangible assets with determinable lives and interest expense on long-term debt. In addition, certain historical expenses, such as warrant expense and interest expense associated with debt that was immediately repaid, were eliminated from these pro forma results. The pro forma information does not necessarily reflect the actual results of operations had the acquisition been consummated at the beginning of the fiscal reporting period indicated nor is it indicative of future operating results. The pro forma information does not include any adjustment for potential revenue enhancements, cost synergies or other operating efficiencies that could result from the acquisition.

About Xtant Medical Holdings

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

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

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

Investor Contact
CG CAPITAL
877.889.1972
Rich Cockrell Company Contact Molly Mason
Xtant Medical Holdings, Inc.
Published at NasdaqGlobeNewsWire

Monday, January 23, 2017

News: Medovex Corporation Enters into International Distribution Agreement with AlfaMed s.r.l., Italy

Leading Supplier of Innovative Spine Surgery Equipment to Distribute the DenerveX™ System throughout Italy

ATLANTA, GA--(Marketwired - Jan 11, 2017) -  Medovex Corp. (NASDAQMDVX) ("Medovex" or "Company"), a developer of medical technology products, today announced that the Company has entered into an international distribution agreement with AlfaMed s.r.l., a supplier of innovative spine surgery equipment. The agreement covers the distribution of its DenerveX™ System throughout Italy.
Dennis Moon, Medovex Executive Vice President, stated, "AlfaMed s.r.l. serves as a perfect call point fit for our mission to provide a successful distribution, sales and marketing foundation for our entry of the DenerveX System in Italy, representing an important market in Europe."
"With AlfaMed s.r.l. as a specialized distributor offering complex and innovative spine products throughout Italy, we are closing a gap while showing a professional presence in a major market," added Manfred Sablowski, Senior Vice President Global Sales & Marketing. "Our goal is to continuously improve our international market presence by expanding our network of strong distributors with knowledgeable sales and support personnel, and in close proximity to our customers."
AlfaMed s.r.l. is expected to provide sales, marketing and distribution services for the launch of the DenerveX System.
The Company's patented DenerveX System, currently in final development and not yet commercially available, is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.
The DenerveX System consists of the DenerveX device, a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.
DenerveX is not yet CE marked or FDA cleared and is not yet commercially available.
About Medovex
MedovexMedovex 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.
About AlfaMed s.r.l.
AlfaMed s.r.l. boasts an experience of over twenty-five years in this business. It began as an authorized dealer in the regions of Marche, Abruzzo, Umbria and Molise. Since 2007 it is also structured as an importer and distributor for Italy of certain products for Spine, Pain Therapy, Obesity Surgery and Vascular Access. Commercially, it has positioned itself with innovative and exclusive hospital devices, qualitatively higher than the average. The experience gained over the years has led to the evolution and improvement of skills in the hospital field, leading, in addition, to a high degree of specialization and to the high quality standards of products.
To learn more visit http://www.alfamedsrl.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.
Contact -
Medovex Corp.
Jason Assad
470-505-9905

Published at MarketWired

Sunday, January 22, 2017

News: Spinal Simplicity Announces Six New Patents Granted in 2016

Company LogoSpinal Simplicity, a medical device company developing innovative solutions to treat complex surgical problems announces six new patents were granted to them in 2016, demonstrating the company’s ongoing commitment to innovation and leadership in the spinal and orthopedic medical device industry.
“2016 was a productive year for Spinal Simplicity’s intellectual property portfolio,” comments Douglas Snell, Director of Engineering for Spinal Simplicity. “Our portfolio now consists of fifty-two (52) U.S. and global patents covering more than seventeen unique inventions in the spinal and orthopedic arenas. Today we offer the Minuteman® interspinous process fusion implant, a truly innovative solution to the lumbar spine market. We intend to maintain this distinction in the industry by protecting the core design elements of our flagship product, the Minuteman®, along with our other core technologies and instrumentation for the spinal and orthopedic fusion markets. Spinal Simplicity has had a positive start to the new year having received a Notice of Allowance from the U.S. Patent & Trademark Office for another U.S. patent, which will raise our total number of granted U.S. patents to sixteen.”
The Minuteman® is a sterile packed, posterior, non-pedicle supplemental fusion and fixation device intended for use in the non-cervical spine (T1-S1). As an alternative to traditional pedicle screws, it is a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor. The device is available in the U.S. with or without hydroxyapatite coating. The Minuteman® is intended for use with bone graft material and is not intended for stand-alone use.
Todd Moseley, Co-Founder and CEO of Spinal Simplicity, added, “Spinal Simplicity continues to provide the spinal and orthopedic markets with new, differentiating technology that will increase the product offerings available to patients and physicians. Our Company’s innovative products are well-aligned with the spinal and orthopedic markets’ movements toward minimally invasive procedures. We are the only company in this space with an FDA clearance for an MIS lateral approach to the posterior aspect of the spine through an approximate one-inch incision.”
About Spinal Simplicity 
Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of simple solutions for the treatment of complex spinal disorders. Spinal Simplicity has regulatory clearance for the Minuteman system in the US, Europe and Canada. Our vision is to be the global leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com

Published at PRWeb

Tuesday, January 17, 2017

News: Globus Medical Reports Preliminary Fourth Quarter and Full Year Record Sales Results

AUDUBON, PA, January 6, 2016: Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced preliminary unaudited sales results for the fourth quarter and full year ending December 31, 2015, in advance of its annual national sales meeting being held later this week. The company anticipates fourth quarter 2015 sales of approximately $142.6 million, growing 10.7% as-reported or 11.5% in constant currency vs. fourth quarter 2014. Full year 2015 estimated sales are expected to be approximately $544.7 million, growing 14.8% as-reported or 16.0% in constant currency vs. the prior year, exceeding the company’s previous guidance of $539 million.
David Paul, Chairman and CEO, stated, “In 2015 we continued our focus on growing the business through expanding the sales force and launching innovative products. Our fourth quarter and full year results demonstrate the effective execution of our strategy, achieving strong sales growth and market share gains. We also continued to invest significantly in our Emerging Technologies platforms throughout the year for sustained, long-term growth potential. Looking to 2016, we are confident in our ability to continue to grow our business faster than the overall spine market.”
Image result for gmed google financeThe company established full year 2016 guidance of $583 million in sales and fully diluted earnings per share of $1.20. “2016 EPS guidance reflects an increase in net income in line with our expected sales growth, as well as a positive contribution from the recently-announced suspension of the Medical Device Tax. The full impact of the suspended Medical Device Tax is expected to be about $0.06 per share. We plan to redirect approximately 40% of this benefit into increased job creation initiatives in R&D and Manufacturing in 2016. Our 2016 guidance reflects approximately 7% growth in sales and 10% growth in EPS over our expected 2015 results”, said Dan Scavilla, CFO.
These preliminary results are unaudited and are based on management’s initial analysis of operations for the periods ended December 31, 2015, and are therefore subject to change. The company expects to announce its fourth quarter and full year 2015 financial and operating results in late February.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

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Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800


Published at Globus Medical Report