Scientists develop grapheme nanoribbons to help knit together severed and damaged spinal cords

Posted On December 7, 2016 By OrthoSpineNews In Biologics, Neuro /

December 2, 2016

The combination of graphene nanoribbons made with a process developed at Rice University and a common polymer could someday be of critical importance to healing damaged spinal cords in people, according to Rice chemist James Tour.

The Tour lab has spent a decade working with graphene nanoribbons, starting with the discovery of a chemical process to ‘unzip’ them from multiwalled carbon nanotubes, as featured in a Nature article in 2009. Since then, the researchers have used them to enhance materials for the likes of deicers for airplane wings, better batteries and less-permeable containers for natural gas storage.

Now their work to develop nanoribbons for medical applications has resulted in a material, dubbed Texas-PEG, that may help knit damaged or even severed spinal cords.

Graphene nanoribbons customised for medical use by William Sikkema, a Rice graduate student and co-lead author of the paper, are highly soluble in polyethylene glycol (PEG), a biocompatible polymer gel used in surgeries, pharmaceutical products and in other biological applications. When the biocompatible nanoribbons have their edges functionalised with PEG chains and are then further mixed with PEG, they form an electrically active network that helps the severed ends of a spinal cord reconnect.

“Neurons grow nicely on graphene because it’s a conductive surface and it stimulates neuronal growth,” said Tour.

In experiments at Rice and elsewhere, neurons have been observed growing along graphene.

“We’re not the only lab that has demonstrated neurons growing on graphene in a petri dish,” said Tour. “The difference is other labs are commonly experimenting with water-soluble graphene oxide, which is far less conductive than graphene, or non-ribbonised structures of graphene.

“We’ve developed a way to add water-solubilising polymer chains to the edges of our nanoribbons that preserves their conductivity while rendering them soluble, and we’re just now starting to see the potential for this in biomedical applications,” he said. He added that ribbonised graphene structures allow for much smaller amounts to be used while preserving a conductive pathway that bridges the damaged spinal cords.

Tour said only one per cent of Texas-PEG consists of nanoribbons, but that’s enough to form a conductive scaffold through which the spinal cord can reconnect.

Texas-PEG succeeded in restoring function in a rodent with a severed spinal cord in a procedure performed at Konkuk University in South Korea by co-authors Bae Hwan Lee and C-Yoon Kim. Tour said the material reliably allowed motor and sensory neuronal signals to cross the gap 24 hours after complete transection of the spinal cord and almost perfect motor control recovery after two weeks.

“This is a major advance over previous work with PEG alone, which gave no recovery of sensory neuronal signals over the same period of time and only 10 per cent motor control over four weeks,” Tour said.

Executives, Surgeons, Physicians, and Others Affiliated with Forest Park Medical Center (FPMC) in Dallas Indicted in Massive Conspiracy

Posted On December 6, 2016 By OrthoSpineNews In Financial, Regulatory /

December 1, 2016

DALLAS — Founders and investors of the physician-owned Forest Park Medical Center (FPMC) in Dallas, other executives at the hospital, and physicians, surgeons, and others affiliated with the hospital, have been charged in a federal indictment, returned by a grand jury in Dallas last month and unsealed today, with various felony offenses stemming from their payment and/or receipt of approximately $40 million in bribes and kickbacks for referring certain patients to FPMC. The announcement was made this afternoon by U.S. Attorney John Parker of the Northern District of Texas.

FPMC was an out-of-network hospital. According to the indictment, the referred patients were primarily ones with high reimbursing out-of-network private insurance benefits or benefits under certain federally-funded programs. FPMC’s owners, managers, and employees also attempted to sell patients with lower reimbursing insurance coverage, namely unwitting Medicare and Medicaid beneficiaries, to other facilities in exchange for cash. As a result of the bribes, kickbacks, and other inducements, from 2009 to 2013, FPMC billed such patients’ insurance plans and programs well over half of a billion dollars and collected over $200 million in paid claims.

The below-listed defendants are charged in the indictment:

Alan Andrew Beauchamp, 64, of Dallas
Richard Ferdinand Toussaint, Jr., 58, of Dallas
Wade Neal Barker, 51, of Dallas
Wilton McPherson Burt, 61, of Costa Rica
Andrea Kay Smith, 37, of Rockwall, Texas
Carli Adele Hempel, 40, of Plano, Texas
Kelly Wade Loter, 48, of Dallas
Jackson Jacob, 53, of Murphy, Texas
Douglas Sung Won, 45, of Dallas
Michael Bassem Rimlawi, 45, of Dallas
David Daesung Kim, 54, of Southlake, Texas
William Daniel Nicholson IV, 46, of Dallas
Shawn Mark Henry, 46, of Fort Worth, Texas
Mrugeshkumar Kumar Shah, 42, of Garland, Texas
Gerald Peter Foox, 69, of Tyler, Texas
Frank Gonzales Jr., 41, of Midland, Texas
Israel Ortiz, 49, of Dallas
Iris Kathleen Forrest, 56, of Dallas
Andrew Jonathan Hillman, 40, of Dallas
Semyon Narosov, 51, of Dallas
Royce Vaughn Bicklein, 44, of San Antonio, Texas

“Medical providers who enrich themselves through bribes and kickbacks are not only perverting our critical health care system, but they are committing a serious crime,” said U.S. Attorney John Parker. “Massive, multi-faceted schemes such as this one, built on illegal financial relationships, drive up the cost of healthcare for everyone and must be stopped.”

“The charges announced today show that the government will not tolerate corrupt practices by medical providers motivated by greed,” said Dallas FBI Special Agent in Charge Thomas M. Class, Sr. “The FBI will continue to work with our law enforcement partners to identify those who manipulate and defraud our healthcare system and to seek their prosecution.”

“The Defense Criminal Investigative Service (DCIS), in partnership with our federal law enforcement partners, will continue to aggressively investigate those who defraud the federal government, and ultimately the American taxpayers, in order to protect the integrity of federal health care programs,” said Special Agent in Charge Janice M. Flores of the DCIS Southwest Field Office. “Fraud and abuse by healthcare providers poses a significant threat to the viability of government health care programs, and today’s arrests demonstrate the commitment of DCIS and it partners in rooting out health care fraud and to hold those accountable for their actions.”

“I would like to acknowledge and thank our OIG criminal investigators, and their law enforcement partners, for their tireless efforts in pursuing this case,” said Deputy Inspector General Norbert E. Vint. “Their fine work protects the Federal Employees Health Benefits Program from those who would manipulate the health care system in order to steal taxpayer dollars.”

“An important mission of the Office of Inspector General is to investigate allegations relating to fraud involving the Federal Employees’ Compensation Act. We will continue to work with our law enforcement partners to investigate these types of allegations,” stated Steven Grell, Special Agent-in-Charge of the Dallas Regional Office of the United States Department of Labor, Office of Inspector General.

“The allegations against the defendants in this indictment indicate that patient trust was broken by the payments of kickbacks and bribes used to induce surgeons to use their hospital to perform services,” said Special Agent in Charge Tamera Cantu. “IRS Criminal Investigation, along with our law enforcement partners, will vigorously pursue corporate owners and managers that use their company to violate laws, including healthcare regulations.”

FPMC was founded by Beauchamp, Toussaint, Barker, Burt, and others as an out-of-network hospital; as such, it was free to set its own prices for services and was generally reimbursed at substantially higher rates than in-network providers. FPMC’s strategy was to maximize profit for physician investors by refusing to join the networks of insurance plans for a period of time after its formation, allowing its owners and managers to enrich themselves through out-of-network billing and reimbursement.

Toussaint and Barker co-owned FPMC; Beauchamp and Burt managed it. Beauchamp was FPMC’s Chief Operating Officer and was an investor in FPMC. Toussaint, an anesthesiologist, was the President of FPMC’s board of directors. Barker, a bariatric surgeon, was on FPMC’s board of directors. Burt was a Managing Partner of FPMC and was also an investor in FPMC.

FPMC’s referral coordinator, Smith, owned a shell entity known as Unique Healthcare that the coconspirators created to funnel bribe and kickback payments to surgeons in exchange for those individuals referring patients to FPMC. Smith tracked surgeries and referrals so surgeons and referral sources could receive “credit.” Another FPMC employee, Hempel, was FPMC’s Director of Bariatric Services; she led efforts to sell Medicare and Medicaid referrals from certain coconspirators to a non-FPMC facility.

Jacob owned a shell entity known as Adelaide Business Solutions that he and others used to funnel bribe and kickback payments to surgeons, primary care physicians, chiropractors, lawyers, worker’s compensation preauthorization specialists, and others in exchange for those individuals referring patients to FPMC or to surgeons who used the hospital’s facilities to perform certain medical procedures, including surgeries. Another company, Entity A, co-owned by Toussaint and Barker, was a commercial real estate group that provided commercial real estate services to FPMC and was used by the coconspirators as a conduit for bribe and kickback payments. Loter owned an advertising agency that received bribe and kickback payments on behalf of physicians.

According to the indictment, two bariatric surgeons, Kim and Nicholson, investors in FPMC, received $4,595,000 and $3,400,000, respectively, in bribe and kickback payments in exchange for referring their patients to FPMC. Three spinal surgeons, Won, Rimlawi, and Henry, also received bribe and kickback payments in exchange for referring their patients to FPMC. The indictment alleges that Won received $7,000,000 and Rimlawi received $3,800,000 in bribe and kickback payments. Henry was also an investor in FPMC. The surgeons spent the vast majority of the bribe payments marketing their personal medical practices, which benefitted them financially, or on personal expenses, such as cars, diamonds, and payments to family members.

Other physicians who received bribe and kickback payments in exchange for referring patients to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital include Shah, a pain management doctor; Gonzales, a chiropractor who received approximately $385,000 in bribes and kickbacks; and Foox, who owned an orthopedic clinic in Tyler, Texas, and received approximately $500,000 in bribes and kickbacks.

Forrest, a worker’s compensation preauthorization specialist, received approximately $450,000 in bribe and kickback payments in exchange for referring patients, including those she was preauthorizing, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital. Bicklein was a worker’s compensation lawyer who received approximately $100,000 in bribe and kickback payments in exchange for referring patients, including his clients, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.

Ortiz owned a clinic that received approximately $1,100,000 in bribe and kickback payments for referring its patients to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital,

Collectively, Hillman and Narosov controlled a hospital consulting company, and they received approximately $190,000 in bribe and kickback payments in exchange for referring patient to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.

According to the indictment, as part of the conspiracy, certain coconspirators also paid bribes and kickbacks of $500 per month to approximately 40 primary care physicians and practices to refer patients to the hospital or to surgeons associated with the hospital. In addition to paying surgeons and primary care physicians, certain coconspirators also paid a host of others, including FECA beneficiaries, workers’ compensation preauthorization specialists, lawyers, businesses, runners, and chiropractors. Certain coconspirators also “rented” space in doctors’ and chiropractors’ offices in outlying cities, including Foox’s clinic in Tyler, and clinics in Midland and Odessa, Texas, in exchange for patients being referred to FPMC or to surgeons who performed medical procedures at the hospital.

The bribes and kickbacks resulted in victim plans and programs being billed well over half of a billion dollars, including more than $10 million to the Department of Defense healthcare program TRICARE, more than $25 million to the Department of Labor FECA healthcare program, and more than $60 million to the federal employees’ and retirees’ FEHBP healthcare program, and FPMC collecting more than $200 million in tainted and unlawful claims.

Each of the 21 defendants is charged with one count of conspiracy to pay and receive health care bribes and kickbacks; the maximum statutory penalty upon conviction is five years in federal prison and a $250,000 fine.

Beauchamp is charged with 10 counts of offering or paying and soliciting or receiving illegal remuneration, in violation of the federal Anti-Kickback Statute, and aiding and abetting. Toussaint, Barker, and Burt are each charged with five counts of this offense. Jacob is charged with eight, Shah with three, Rimlawi with two, and Won, Kim, Nicholson, Gonzales, and Forrest each with one count of this offense. The maximum statutory penalty upon conviction is five years in federal prison and a $25,000 fine.

Beauchamp is also charged with seven counts of violating the federal Travel Act and aiding and abetting. Jacob is also charged with six counts of this offense; Toussaint, Barker, Burt, and Jacob are also each charged with four counts of this offense; Foox is also charged with two counts of this offense; and Won, Kim, Nicholson, Henry, and Gonzales are also each charged with one count. The maximum statutory penalty upon conviction is five years in federal prison and a $250,000 fine.

Beauchamp, Toussaint, Barker, and Burt are also each charged with two counts of conspiracy to commit money laundering. Jacob and Henry are also each charged with one count of this offense. The maximum statutory penalty upon conviction is 20 years in federal prison and a $250,000 fine.

The indictment also includes a forfeiture allegation that would require the defendants, upon conviction, to forfeit to the U.S. any property, real or personal, which constitutes or is derived from proceeds traceable to the offenses. Restitution could also be ordered.

An indictment is an accusation by a federal grand jury, and a defendant is entitled to the presumption of innocence unless proven guilty.

The case was investigated by the FBI, the U.S. Department of Labor Office of Inspector General, the U.S. Department of Labor Employee Benefits Security Administration, the U.S. Department of Defense – Defense Criminal Investigative Service, the U.S. Office of Personnel Management Office of Inspector General, and Internal Revenue Service Criminal Investigation, with assistance from the Food and Drug Administration and the U.S. Postal Inspection Service.

Assistant U.S. Attorneys Andrew Wirmani, Kate Pfeifle and Mark Tindall are prosecuting the case.

USAO – Texas, Northern

Topic:

Healthcare Fraud

Updated December 1, 2016

Implanet Presents JAZZ Band Clinical Results in Hypokyphotic Idiopathic Scoliosis Patients

Posted On December 6, 2016 By OrthoSpineNews In Spine /

December 06, 2016

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the publication of a new White Paper entitled “Correction of Adolescent Idiopathic Scoliosis in hypokyphotic patients using JAZZ sublaminar bands: preliminary results of a multricentric study using 3D reconstruction”, which presents clinical results from a group of adolescents suffering from hypokyphotic thoracic scoliosis treated with JAZZ sublaminar implants.

This study, co-authored by the Departments of Pediatric Orthopedic Surgery at the Robert Debré (Paris), La Timone (Marseille) and Purpan (Toulouse) hospitals in France, represents a key stage in the JAZZ system’s clinical validation and confirms both safety and efficacy in the treatment of hypokyphotic idiopathic scoliosis. The study followed a 35 patient consecutive series for an average of 34-months.

“These results confirm the efficacy of combining the posteromedial translation technique with rigid chrome-cobalt rods, enabling sagittal alignment to be restored in hypokyphotic patients suffering from idiopathic scoliosis”, says Prof. Brice Ilharreborde, MD, PhD, adding: “The use of JAZZ sublaminar bands should be considered for these patients to reduce complication rates and, in particular, the risk of intra-operative failure of the concave screws as a result of pulling from the bone. Furthermore, the reduced number of implants used to adequately treat these deformities allows the cost of surgery and the risk of medullary complication to be reduced.”

Ludovic Lastennet, CEO of Implanet, adds: “The results of this major study confirm that the JAZZ implant offers surgeons a safe and efficient alternative to traditional techniques, with excellent clinical results documented an average of 34 months postoperatively, in patients suffering from complex hypokyphotic thoracic scoliosis.”

Although many surgeons still advocate using constructs consisting entirely of screws for this type of patient, the results of this study show that the JAZZ system should be a recommended front line treatment, in particular when treating hypokyphotic pathologies.

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

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

Contacts

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

Osiris Provides Update Regarding NASDAQ Listing Matters

Posted On December 6, 2016 By OrthoSpineNews In Financial /

COLUMBIA, Md., Dec. 02, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) (the “Company”) today provided an update regarding the status of its compliance with the Listing Rules of the NASDAQ Stock Market (“NASDAQ”).

As previously disclosed, the Company participated in a hearing before the NASDAQ Hearings Panel (the “Hearings Panel”) on November 10, 2016 in connection with the Company’s late filings and the Company’s anticipated financial restatement relating to prior periods. At the hearing, the Company requested that the Hearings Panel grant the Company additional time to file its delinquent reports with the Securities and Exchange Commission (the “SEC”) and regain compliance with NASDAQ’s continued listing requirements.

On December 1, 2016, the Company received a decision letter from NASDAQ’s Office of General Counsel stating that the Hearings Panel has granted the Company’s request and, accordingly, the Company’s common stock will continue to trade on the NASDAQ Stock Market provided that the Company becomes current in its periodic filings with the SEC on or before March 10, 2017. The letter stated that March 10, 2017 represents the full extent of the Hearing Panel’s discretion to grant continued listing while the Company is non-compliant.

The Company is continuing to work diligently to complete its previously announced accounting reviews, restatement of prior period financial statements, transition to a new independent registered public accounting firm and 2015 audit so that it will be in a position to file its delinquent periodic reports with the SEC as soon as possible. However, there can be no assurance that the Company will be able to complete all of this work and become current in its SEC filings by March 10, 2017. If the Company is not able to file all of its delinquent periodic reports with the SEC by March 10, 2017, then the Hearings Panel will issue a final delist determination and the Company will be suspended from trading on the NASDAQ Stock Market. 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.

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^4®, 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^4® 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 delisting process; the ability of the Company to successfully maintain its NASDAQ listing; the outcome of the restatement, 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 Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the SEC. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact:



Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Integra LifeSciences Announces Key Executive Appointments

Posted On December 6, 2016 By OrthoSpineNews In Extremities, Neuro /

PLAINSBORO, N.J., Dec. 05, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced key executive appointments effective December 1, 2016.

Robert T. Davis, Jr., corporate vice president and president, Specialty Surgical Solutions (SSS), has been named corporate vice president and president, Orthopedics and Tissue Technologies.
Dan Reuvers, corporate vice president and president, International, will assume the role of corporate vice president and president, SSS.
Glenn Coleman, corporate vice president, chief financial officer and principal accounting officer, in addition to his current responsibilities, will assume oversight of the international business. A leader for the international business will be later named reporting into Mr. Coleman.

All three executives will continue to be members of the Integra executive leadership team, reporting to Peter Arduini, Integra president and chief executive officer.

“These key leadership appointments reflect the depth and strength of our management team, enabling us to promote executives from within the company,” said Peter Arduini. “Bob, Dan and Glenn are proven leaders who have demonstrated exemplary management capabilities over the years and a track record of accomplishments that have contributed to our strong business performance.”

Robert T. Davis, Jr. brings more than 25 years of executive management experience in the global healthcare industry. He joined Integra in 2012 as president of the global neurosurgery business and was appointed corporate vice president in December 2012 and president of the SSS division in 2014.

Dan Reuvers has more than 25 years of experience in the medical technology field, including holding various executive level positions in sales, marketing and general management. Mr. Reuvers joined Integra in 2008 as vice president of marketing and product development for Integra’s surgical business. He was promoted to president of the acute surgical business in 2010 and appointed president of the instruments business in 2011. Mr. Reuvers was named corporate vice president in 2012 and became president of the international business in 2013.

Glenn Coleman joined Integra as corporate vice president, chief financial officer and principal accounting officer in 2014, bringing 25 years of experience in financial management with leading global corporations. Mr. Coleman has been a certified public accountant in New Jersey for more than 20 years.

About Integra

Integra LifeSciences Holdings Corporation, a world leader in medical technology, is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984
laurene.isip@integralife.com

KYOCERA Medical Corporation Receives FDA 510(k) Clearance for Initia® Total Hip System, Featuring BIOCERAM AZUL® Ceramic Femoral Head

Posted On December 6, 2016 By OrthoSpineNews In Recon, Regulatory /

December 05, 2016

SAN DIEGO–(BUSINESS WIRE)–Kyocera Medical Corporation, a leading manufacturer of implantable systems and advanced ceramic components, today announced it has received the U.S. Food and Drug Administration’s 510(k) clearance for its Initia^® Total Hip System.

Developed in collaboration with leading U.S. surgeons, the Initia Total Hip System features Kyocera Medical Corporation’s core technologies — including its own BIOCERAM AZUL^® (blue) zirconia-toughened alumina (ZTA) ceramic femoral heads. Initia is also available with cobalt chrome (CoCr) femoral heads, giving surgeons the option of ceramic or metal heads matched to highly cross-linked polyethylene acetabular liners. Designed for a global patient population, the Initia system includes a total of 16 tapered-wedge stem sizes, 12 of which are available in the U.S., with both standard and high femoral offsets.

Kyocera has manufactured artificial hips, knees and other implantable systems since 1982, and is now one of Japan’s leading suppliers of surgical orthopedic products. Kyocera also manufactures a wide range of implantable ceramic components, including alumina and ZTA ceramic femoral heads, hip liners and shoulder liners, available to original equipment manufacturers (OEMs) in the U.S. and Europe.

In addition to the Initia Total Hip System, Kyocera Medical Corporation’s BIOCERAM AZUL ceramic material is available to medical device OEMs who demand a durable, high-quality, biocompatible solution for implantable components.

The Initia Hip System, along with BIOCERAM AZUL components, will be the highlight of Kyocera Medical Corporation’s technology presentation at the AAOS Annual Meeting, March 15-17, 2017 – booth #4908.

ABOUT KYOCERA

Kyocera International, Inc., headquartered in San Diego, California, serves as the U.S. sales and marketing arm for Kyocera Medical Corporation. Both companies are wholly-owned subsidiaries of Kyoto, Japan-based Kyocera Corporation.

Kyocera Medical Corporation, headquartered in Osaka, Japan, is a producer of ceramic and metal orthopedic systems and components, dental systems and components, and cardiovascular devices.

Kyocera Corporation (NYSE:KYO) (TOKYO: 6971), the parent and global headquarters of the Kyocera Group, was founded in 1959 as a producer of fine ceramics (also known as “advanced ceramics”). Kyocera specializes in combining these engineered materials with other technologies to create medical orthopedic implants and implantable ceramic components, ceramic cutlery and cookware, cutting tools, industrial components, electronic devices, semiconductor packages, solar power generating systems, printers, copiers and mobile phones. During the year ended March 31, 2016, Kyocera Corporation’s consolidated net sales totaled $13.1 billion.

© 2016 KYOCERA Corporation. All rights reserved. Kyocera is a registered trademark of Kyocera Corporation. Initia and BIOCERAM AZUL are registered trademarks of Kyocera Medical Corporation. All other marks are properties of their respective owners.

Photos available by request.

Contacts

Kyocera Medical Corporation
Ken Kaneko, (908) 227-4376
Ken.Kaneko@kyocera.com

Aurora Spine Launches Mobile App

Posted On December 6, 2016 By OrthoSpineNews In Spine /

CARLSBAD, CALIFORNIA–(Marketwired – Dec 5, 2016) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today the launch of its new Aurora Spine Mobile App, designed to bring information regarding the new and exciting products being offered by Aurora Spine straight to your mobile device. The App is currently available for Apple, Android, and iPad devices.

“We’re very excited to be entering into a new era for the company in how we get information to our customers. Anyone interested in our products or anyone interested in connecting with us through social media can now do so through our App,” said Nick Feretich, 3D Graphic Artist and Marketing Advisor for Aurora Spine.

“We really want to stress how important it is to us that we are able to educate those who work with, or distribute our products, and our new App is the perfect way to do that. Our entire product line, as well as accompanying surgical technique guides, is available in its entirety on your mobile device,” said Feretich.

The Aurora Spine mobile App currently offers detailed 3D models, surgical technique guides, and comprehensive sets of features regarding each individual implant. The user can also check up on Aurora through Facebook, Twitter, and YouTube. With this new App, Aurora Spine looks to continue its trend of bringing new and innovative products to the medical industry as well as educating those involved on all it has to offer.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

AxioMed Continues International Push with Visit to German Surgeons to Discuss Viscoelastic Total Disc Replacement Technology

Posted On December 5, 2016 By OrthoSpineNews In Spine /

(PRWEB) DECEMBER 05, 2016

In anticipation of AxioMed’s exclusive cleanroom manufacturing facility in Woburn, MA to soon resume cervical and lumbar disc production, company President, Jake Lubinski will be traveling to Germany on December 6th. Mr. Lubinski will meet with surgeons who are implanting the AxioMed disc in Cologne and Karlsruhe to discuss the benefits of a viscoelastic total disc replacement.

AxioMed received its CE mark in 2009 and is the only truly viscoelastic next-generation disc replacement to restore height, cushioning, stability, and lordosis.

Mr. Lubinski will be meeting with Dr Pflugmacher, who has implanted the AxioMed disc in several patients. Dr. Pflugmacher has commented on AxioMed’s disc, saying “This prosthesis is the best prosthesis, it is easy to use and I get excellent results, it’s a very straightforward disc.”

About AxioMed
Founded in 2001, AxioMed (http://www.axiomed.com/) began its journey of exhaustively proving the Freedom® Disc through clinical studies in the USA and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology

Design Evolution of EXOGEN® Enhances Patient Compliance

Posted On December 5, 2016 By OrthoSpineNews In Biologics /

December 05, 2016

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced that a published study reveals its latest generation EXOGEN Ultrasound Bone Healing System improves patient compliance by 10% and overall compliance never fell below 76%. EXOGEN uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.¹The findings are published in the November 30, 2016 issue of Medical Devices: Evidence and Research available here.

The next generation EXOGEN device launched in 2014 and features a compliance calendar. The study found that among 12,984 patient data files analyzed, the patient compliance was 84%, while compliance with the previous generation EXOGEN device was 74%. In addition, incorporation of the calendar feature resulted in compliance never decreasing below 76% over the 6-month analysis period.

The researchers also analyzed 12 clinical trials on LIPUS where compliance was recorded. In eight of these clinical studies, where they met their end point, compliance was 88%. If the primary end point was unmet, compliance averaged 54%.

“This study clearly shows a correlation between clinical effectiveness and compliance rates of more than 70%,” said Neill Pounder, Director – Project Management, Bioventus. “The work also revealed that use of the next generation EXOGEN device resulted in a measurable improvement in patient adherence, which may help to optimize clinical outcomes and fracture healing. LIPUS technology can make a difference if it used as directed.”

Authors of this study are N.M. Pounder, J.T Jones and K.J. Tanis of Bioventus.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.

Contacts

Media:
Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

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FIREFLY Spinal Navigation Guides receive universal clearance from FDA

Posted On December 5, 2016 By OrthoSpineNews In Regulatory, Spine /

December 3, 2016 – George Frey

Mighty Oak Medical is a medical device incubator that continues to focus on novel surgical solutions to solve problems for patients and surgeons. Our goal is to make spinal surgery safer, faster, and more efficient, by offering more intuitive solutions to the existing challenges surgeons face every day. While navigation is gradually becoming a standard of care in spinal surgery, it remains very burdensome with its cost and complexity. Adoption has been slow. FIREFLY Navigational Guides represent a cutting edge alternative to the complex and costly existing forms of intraoperative navigation in spinal surgery. FIREFLY Technology is a patented platform joining pre-surgical planning with the accuracy and patient specificity of additive manufacturing to offer improved solutions for navigating spinal procedures. FIREFLY Guides are 3D printed, patient specific and anatomically matched drill guides created by our technicians to implant pedicle screws in the spine with far greater accuracy, speed, and safety than conventional forms of navigation.

Mighty Oak Medical announces that FIREFLY Guides have now been FDA cleared for universal use with any compatible pedicle screw system, and within their cleared indications.

This universal clearance allows FIREFLY to expand its growing alignment with many well known and successful pedicle screw systems currently available to surgeons worldwide.

Month: December 2016

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