Tuesday, September 27, 2016

News: joimax Announces Release of the First Endoscopic AMA CPT Code

IRVINE, Calif.--(BUSINESS WIRE)--
The AMA (American Medical Association) released the CPT 2017 Codebook (Current Procedural Terminology), now containing the first endoscopic spinal surgery code no. 62380. This new code covers endoscopic decompression of the spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar, and will be enforced as of January 1st, 2017. Under this code the specific transforaminal (TESSYS®) and/or interlaminar (iLESSYS®) procedures are fully covered in the USA herewith, which are already marketed by joimax® in 45 countries.
“The definition of this new code in the CPT codebook 2017 is a major milestone towards the acceptance of endoscopic minimally invasive spine surgery techniques and its benefits to both the surgeon and their patients,” states Wolfgang Ries, Founder and CEO of joimax®. Since 2012 joimax® had been driving this effort to obtain CPT codes as these procedures required submission to payors for reimbursement coverage which was granted only in single cases under temporary codes, so-called T-codes.
“joimax® has been instrumental in driving the effort to obtain full code coverage of endoscopic spinal surgery,” says Daniel Laich, DO, Swedish Convenant Hospital, Chicago, who had been participating and presenting in almost every AMA meeting over the last five years. Due to the high research and publication activities by key users like Albert Telfeian, MD, PhD, at Rhode Island Hospital at Brown University, and a group of users around him, strong evidence has been accepted by AMA authorities, justifying the release of this new CPT code.
Many papers and publications on joimax® products can now be downloaded from the newly released joimax® homepage. The completely redesigned website offers visitors richer insight into the company's innovative products and systems. A quick and easy access to essential information and features is available, including the latest workshop and education activities, which are essential in endoscopic minimally-invasive spinal surgery.
Meanwhile joimax® offers basic and advanced workshop training courses mainly in the USA, Germany and Austria, and oversees a participation population of almost 3,000 physicians. Independent training courses are also performed in China and Korea to support the fast growing Asian markets. Detailed information about those courses are updated regularly at www.joimax.com.
About joimax®
logoFounded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS®(cervical) for decompression procedures, Multiuse RT (e.g. for rhizotomy) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.
In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax®technologies to operate through small incisions - under local or full anesthetic - via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).
Published at Yahoo Finance

News: ulrich medical USA® Announces Product Line Extension, Releases uCerv® Titanium Cervical Interbody System

Continues with Spine Implant Portfolio Expansion for ACDF Spine Surgery
ST. LOUISSept. 26, 2016 /PRNewswire/ -- ulrich medical USA, Inc., a medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the U.S. market release of uCerv titanium spinal implants as an adjunct to its current uCerv PEEK OPTIMA® Interbody System which is an existing product used for anterior cervical discectomy and fusion (ACDF) surgical procedures.
"Spinal implants made from solid titanium alloy can support bone growth at the fusion site by providing proven and reliable structural integrity," said Ali A. Baaj, M.D., Assistant Professor of Neurological Surgery at Weill Cornell Medical College in New York. "I like the easy-to-use uCerv instrumentation which incorporates a slim designed inserter that allows for superior visualization and unimpeded work space at the surgical site."  Dr. Baaj went on to say, "This product line also features a beneficial large graft window which allows for the usage of maximum bone graft material and it is available in a wide variety of sizes."
ulrich medical USA(R) uCerv(R) Titanium Cervical Interbody System
ulrich medical USA(R) uCerv(R) Titanium Cervical Interbody System
The uCerv titanium implants have a roughened-surface design with a trapezoidal shape and are available in parallel or lordotic configurations of various heights in small, medium and large footprints. In addition, these implants feature optimal teeth patterns on the superior and inferior surfaces to limit migration.
For more information, please visit www.ulrichmedicalusa.com.
About ulrich medical USA, Inc.
Image result for ulrich medical USAulrich medical USA, Inc. is a privately-held subsidiary of ulrich medical®, an innovative medical technology company headquartered in Ulm, Germany which is celebrating 104 years in business in 2016.

Published at PRNewsWire

News: Spineology Inc. Expands Relationship with Nation's Leading Tissue Bank

Musculoskeletal Transplant Foundation and Spineology Inc. partner to provide high grade tissue products to customers and enhance anatomy conserving spinal surgery

MTF logoMINNEAPOLIS & ST. PAUL, Minn.--()--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.
“Our expanded relationship allows us to pass along that safety and quality to our customers.”
Tweet this
“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 LogoSpineology 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
or
Risdall Public Relations
Dave Folkens, 651-286-6713

Published at Businesswire

News: SPINEWAY : SPINEWAY SIGNS A PARTNERSHIP DEAL WITH TINAVI MEDICAL TECHNOLOGIES

                                                                                                                                         Ecully, September 22, 2016
TINAVI Medical Technologies signs a partnership deal with SPINEWAY
Exclusive distribution agreement
Reserved capital increase of up to €1.4m through the issue of shares with stock subscription warrants attached (BSA)
Image result for spinewaySPINEWAY, specialist in implants and surgical instruments for treating spinal column disorders, has just signed a 5-year partnership agreement with TINAVI Medical Technologies (China) for distributing the group's implant ranges. This partnership is linked to a planned strategic investment by the partner in SPINEWAY equity, starting November 2016.
TINAVI Medical Technologies is a Beijing-based group specializing in innovative medical devices. The company is a provider of avant-garde surgical systems and operating theatre solutions. Its third generation intelligent orthopedic robot, the TiRobot(TM), is the only surgical robot in the world capable of performing surgery on all areas of the spine (cervical, thoracic, lumbar, and sacral vertebrae). The company has been listed on Beijing's NEEQ Stock Market since November, 2015.
This agreement will, from 2016 onwards, enable TINAVI Medical Technologies to distribute SPINEWAY implant ranges that are registered in China.
In this context, before the end of 2016, SPINEWAY will propose a capital increase to its shareholders. The capital increase would be made by way of issuance of shares with stock subscription warrants attached (BSA) reserved entirely to TINAVI Medical Technologies, with shareholders pre emption rights waived, for an amount of 1.399.724.40 EUR (including share premium).
The transaction will involve the issue of 355,260 new shares at a price of 3.94 EUR each, giving TINAVI Medical Technologies 9.09% share of the capital and 5.04% of voting rights.
A stock subscription warrant will be attached to each of these newly issued shares, with 10 stock subscription warrants giving the right to subscribe to 11 additional new shares at a unit price of 4.09 EUR each, representing a total of 390,786 additional new ordinary shares, representing a further maximum subscription of 1,598,314.74 EUR (share premium included). These stock subscription warrants may be exercised from 1st June to 15thSeptember, 2017. After this second tranche, if the issue is taken up completely, TINAVI Medical Technologies' stake will account for 17.36% of the capital and 10.59% of voting rights.
The agreement also provides that TINAVI Medical Technologies be granted a priority right on any future financial transaction SPINEWAY might initiate, as well as the right to maintain its shareholding at the same level as provided for in the aforementioned capital increase transactions.
The agreement furthermore provides the appointment of TINAVI Medical Technologies or one of its representative as an observer to the board of directors, as the case may be, the appointment of TINAVI Medical Technologies or one of its representative as director in the event of the whole of the second investment tranche being taken up.
TINAVI Medical Technologies' subscription undertaking is subject to a certain number of usual conditions for such kind of transaction.
This operation enjoys the support of Messrs Le Roux and Laurito, key, long-standing shareholders of SPINEWAY, who hold together 87.03% of the company voting rights. They have committed to vote in favor of all the resolutions related to this transaction, which will be submitted to the next extraordinary shareholders' meeting.
For SPINEWAY CEO Stéphane Le Roux, "This new agreement opens up new prospects for SPINEWAY. I'd like to thank Mr. Zhang Songgen, whose group will become a key shareholder, for the confidence shown in our company and our know-how. Our Chinese deployment will now revolve around a front-stage actor, recognized worldwide for its innovation in the orthopedics field."
TINAVI CEO Mr. Zhang Songgen states, "We are delighted to announce a new strategic partnership between our company, TINAVI Medical Technologies, and SPINEWAY, which will bring new, additional therapies to the world of spinal surgery. By combining our expertise, we shall bring in innovations on a worldwide scale that will be decisive for surgeons specializing in problems and diseases of the vertebral column."

Contacts :          
   
Investor relations
David Siegrist - CFO
Tél : +33 (0)4 72 77 01 52
finance.dsg@spineway.com
 Financial communications
Jérôme Gacoin / Solène Kennis
Tel : +33 (0)1 75 77 54 68
skennis@aelium.fr

Published at GlobeNewswire

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

Occurring on the first night of the Congress of Neurological Surgeons (CNS) Annual Meeting in San Diego, the event will provide insight into the future of spine surgery. Subjects to be addressed include Axiomed LLC's viscoelastic cervical and lumbar Total Disc Replacements (TDRs) - a revolutionary new Less Exposure Surgery (LES) 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:
LES SocietyThe 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.
Published at PRWeb

Thursday, September 22, 2016

News: Inspired Spine study of new MIS direct thoracic interbody fusion yields positive results: 7 things to know

PubMed published results of Inspired Spine's study on minimally invasive direct thoracic interbody fusion.
Here are seven things to know:

1. MIS-DTIF is a surgery intended to reduce back pain in patients with degenerative disc disease or disc herniation.

Image result for inspired spine
2. The Inspired Spine study involved four patients, analyzing patient-reported pain, operation time and complications.


3. The patients receiving MIS-DTIF reported significant back pain reduction.

4. On a 10-point scale, the patients reported an 8.8 score prior to surgery. Patients reported an average of 3.5 out of 10 points at the first follow-up postoperation.

5. The study found surgery time lasted about one hour and patients experienced hospital stays of about two days.

6. MIS-DTIF also decreased complication risk, because the minimally invasive approach does not require opening of the chest. Surgeon used real time biplane fluoroscopy X-ray imaging.

7. The procedure was developed in Minnesota.

Published at Beckers Spine

News: K2M Expands MESA® Platform With FDA Clearance For Growing Spine Application

Clearance of Screw and Connector Components Enables Natural Spinal Growth in Pediatric Deformity Patients

MESA Deformity
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) 51 st 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."
Primary Logo
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. 



Published at thestreet.com