Arthrex Victorious in Patent Infringement Lawsuit Against Smith & Nephew

NAPLES, FL – December 12, 2016 – On Friday, December 9, 2016, a jury in the United States Eastern District of Texas upheld the importance of Arthrex Inc.’s innovation, issuing a verdict that Smith & Nephew, Inc. and Arthrocare, Corp. have been willfully infringing two of Arthrex’s patents on their knotless and cross-support technology. Today, a judgment was entered confirming this verdict and granting Arthrex Inc. more than $17 million in damages.

The jury found every variation and size of Smith & Nephew and Arthrocare’s HEALICOIL™ Suture Anchors, TWINFIX™ Ultra Suture Anchors, TWINFIX™ PK FT and SPYROMITE Suture Anchors, Titan Ti Suture Implants, SpeedFix Suture Implants, SPEEDSCREW™ Suture Implants, SPEEDLOCK™ Knotless Implants, SPEEDLOCK™ Hip Knotless Implants, Spartan Suture Anchors, BIORAPTOR Knotless Suture Anchors, FOOTPRINT PK Suture Anchors, FOOTPRINT Ultra, LabraLock™ P Knotless and MULTIFIX™ Knotless, all infringe an Arthrex Patent.

Arthrex will seek an injunction prohibiting Smith & Nephew and ArthroCare from further manufacturing or selling the infringing devices in the United States and will also seek enhanced damages and attorney fees as allowed by statute.

“Since its foundation, Arthrex has been committed to the mission of helping surgeons treat their patients better, and we are very appreciative for the extraordinary efforts of our trial team and the sound judgment of the jurors of East Texas which have helped Arthrex continue this mission and protect its innovative technology,” said John Schmieding, Senior Vice President, General Counsel at Arthrex.

The Arthrex patents involved are U.S. Patent No. 9,179,907, invented by Dr. Stephen S. Burkhart, Peter J. Dreyfuss and Dr. Neal S. ElAttrache and U.S. Patent No. 8,821,541, invented by Peter J. Dreyfuss and William C. Benavitz.

Arthrex, headquartered in Naples, FL, is a global leader in orthopaedic product development and medical education for orthopaedic surgeons. More than 10,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.arthrex.com.

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Category: Corporate Press Releases

Five ways Tom Price could change U.S. healthcare policy in a hurry

Dec 9, 2016 – By JULIE ROVNER

Prospective Health and Human Services Secretary Tom Price, currently the chairman of the House Budget Committee, brings a distinctive to-do list to the agency. And, if confirmed by the Senate, he will have tremendous independent power to get things done.

While he will report to the president, heads of major agencies like HHS — with a budget of more than $1 trillion for the current fiscal year — can interpret laws in different ways than their predecessors, and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” said Robert Moffit, a senior fellow at the conservative Heritage Foundation, in a statement.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said: “I don’t know if I want to brainstorm bad ideas for him to do.”

 

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21st Century Cures Act: Impacts on the US Medical Device Market

December 08, 2016 by

EMERGO SUMMARY OF KEY POINTS:

  • New legislation significantly impacting FDA oversight of US medical device and drug markets has passed Congress and is awaiting President Obama’s signature.
  • The 21st Century Cures Act would establish a priority review program for breakthrough devices, loosen some device clinical trial requirements and clarify how and whether to regulate medical software.
  • Critics of the new bill warn that efforts to streamline FDA regulations may end up allowing some devices into the US market without proper vetting, causing public health issues.

As legislation targeting a broad swath of US healthcare regulations awaits President Barack Obama’s signature after passage in the US Congress, effects of the pending law on registration and oversight of medical devices in the country will be significant.

The 21st Century Cures Act, which has garnered rare bipartisan support in Congress and is heavily backed by pharmaceutical and medical device industry lobbyists, would fast-track “breakthrough” and novel device registrations at the FDA, as well as alter clinical investigation requirements of manufacturers. Critics of the proposed legislation, however, warn of public health repercussions if FDA regulations of medical devices are made too lax.

Prioritizing “breakthrough” devices

Among the substantial changes to FDA medical device regulation included in the 21st Century Cures Act is a proposal to require the agency to set up a priority review program for “breakthrough” devices, or for devices targeting diseases for which no FDA-cleared or approved alternatives are available. The program would build upon a framework already in place at the agency for registration of such devices.

Under the program, a manufacturer or sponsor may request priority review designation before submitting its FDA registration application. The bill would authorize the Secretary of the US Department of Health and Human Services to develop and issue additional guidelines specifying parameters and requirements of the program.

 

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Bodycad Awarded Key US Patents for Improving Accuracy, Reproducibility and Speed for 3D Imaging in Orthopaedic Applications

QUEBEC CITY, Dec. 8, 2016 /PRNewswire/ — Bodycad announced it has been awarded two key US patents for improving the accuracy, reproducibility and speed for 3D constructs via MRI and CT images in long and small bone orthopaedic applications. These patents are critical to the company’s proprietary approach to creating personalized orthopaedic restorations based on each patient’s distinct anatomy.

To create personalized orthopaedic restorations, the company harnesses the world’s first suite of orthopaedic CAD/CAM software. This technology, along with individual patient imagery, is critical to Bodycad’s Personalized Restoration Evaluation Process (PREP).

“We are pleased to have the United States Patent and Trademark Office award these important and innovative patents to our library of intellectual property,” stated Jean Robichaud, Founder and President of Bodycad. “These patents are further evidence of our technology’s remarkable accuracy which is essential when creating a personalized orthopaedic restoration.”

Bodycad currently has numerous additional patents pending as well as an extensive collection of existing industrial design patents, copyrights and trademarks.

For more information, please visit www.bodycad.com.

ABOUT BODYCAD

Bodycad is developing personalized orthopaedic restorations to overcome the limitations of off-the-shelf, standardized implants. With its proprietary Personalized Restoration Evaluation Process (PREP), it enables surgeons to provide patient-specific solutions with a previously unavailable conformity to every patient’s distinct anatomy. This transformative approach will allow mainstream customization with the goal of optimizing fit, durability and comfort. The privately held company was founded in 2011 and is headquartered in Quebec City, Canada with offices in the United States. Investors include Beaudier, Inc. (Montreal, Canada). ROBIC is patent counsel to Bodycad.

CONTACT
Andrew McLeod
Chief Commercial Officer
andy@bodycad.com

Logo – http://photos.prnewswire.com/prnh/20160407/352645LOGO

SOURCE Bodycad

St. Jude Medical Receives CE Mark Approval for Full Body MR Conditional Labeling for the Proclaim Elite Spinal Cord Stimulation System

December 08, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim Elite Spinal Cord Stimulation (SCS) System. With the latest approval, patients who receive the Proclaim Elite SCS System can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters. The full-body MR conditional labeling is the second upgrade available to patients outside the United States implanted with the Proclaim Elite System, following a 2015 approval for MR Conditional labeling for head and extremity MRI scans.

With the latest approval, patients living with chronic pain who have been implanted with the Proclaim Elite SCS System may now undergo full-body MRI diagnostic scans within approved parameters while retaining access to the treatments they need, such as the St. Jude Medical BurstDR stimulation.

“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” said Dirk Rasche, M.D., functional neurosurgeon, University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”

The Proclaim Elite SCS System offers patients a combination of the convenience of a device that doesn’t require recharging while offering access to St. Jude Medical BurstDR stimulation technology. BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Unlike other stimulation designs, St. Jude Medical BurstDR stimulation works differently, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.

St. Jude Medical was the first company to provide patients suffering from chronic pain a single device featuring upgradeable and recharge-free therapy solutions. The company designed the Proclaim System with patient-centric solutions in mind. In addition, the Proclaim Elite SCS System’s Bluetooth® wireless technology allows clinicians to program and adjust their patient’s SCS therapy with an Apple iPad mini mobile digital device.

“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” said Dr. Allen W. Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Our new labeling for the Proclaim Elite SCS System ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.

Full body MR-conditional labeling for the Proclaim Elite System was also recently approved by the Food and Drug Administration in the United States.

Note: Apple and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Justin Paquette, 651-756-6293
jpaquette@sjm.com

curasan receives approval for orthopedic product in the strategically important US market

Kleinostheim, 7 December 2016 – curasan AG, a leading specialist for medical products in the field of orthobiologics, has received the market clearance of the Food and Drug Administration (FDA) and thus the authorization to market its synthetic bone regeneration material CERASORB Ortho FOAM in the United States.

The innovative product made of resorbable ceramic and porcine collagen can now be used for bone defect treatment in extremities and pelvis on the US market as well as in all other countries where the FDA certification is recognized.  curasan has been actively preparing the market launch of the product in recent months. Back in May, Shane Ray, an experienced orthopedic regenerative medicine sales and marketing executive, was appointed as the President of the US subsidiary curasan, Inc. “The FDA approval of CERASORB Ortho FOAM is an extremely important milestone for us in the re-orientation of our US business, which will open up a potential market worth more than US$ 900 million,” emphasized Michael Schlenk, CEO of curasan AG. “Even before the approval, major customers indicated during exploratory discussions that the flexible and mouldable version of CERASORB meets the demands of the US customers  perfectly, much more so than any of our other products.”

Ahead of the market launch of the product the American subsidiary also successfully completed its structural reorganization in the fourth quarter to align the ability to be successful in dental and orthopedics business within North America. Being able to report this important strategic milestone in the fourth quarter is due to the profound expertise of our internal approval department, which was optimally prepared for the dialogue with the FDA and could answer all of their questions quickly.  I’m very proud of our team!”  

Your contact at curasan AG:
Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@curasan.com 

Your contact at curasan Inc.:
Beth Lloyd
+001 (919) 941-9770

office@curasan.com 

About curasan AG:

curasan AG develops, manufactures and markets biomaterials and other medical products in the field of bone and tissue regeneration. A pioneer in its industry, curasan is specialized primarily on synthetic bone grafting ­materials for dental and orthopaedic applications. Numerous patents and a comprehensive list of scientific documentation prove the clinical success of the products and the highly innovative strength of curasan. Surgically active dentists, implantologists and oral, maxillary and dentofacial surgeons, as well as orthopaedics, traumatologists and spinal column surgeons worldwide benefit from the broad range of the premium quality and user-oriented portfolio offered by the technology leader. curasan maintains its own high-tech facilities for research, development and manufacturing in Frankfurt/Main, Germany, which are approved by the Food and Drug Administration (FDA) and other international authorities. In addition to its headquarters, the company has a subsidiary, curasan Inc., in the Research Triangle Park, near Raleigh, N.C., USA. The shares of curasan AG are listed in the General Standard at the Frankfurt Stock Exchange.

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

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.

Topic:
Healthcare Fraud
Updated December 1, 2016

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

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

FIREFLY Spinal Navigation Guides receive universal clearance from FDA

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.

 

JRI Orthopaedics strengthens Chinese links

30 Nov 2016 – By Aimee Robinson, Business Quarter

British healthcare company JRI Orthopaedics has strengthened its presence in China and the Far East after securing a new multi-million pound deal.

The company has secured regulatory approval to sell its hip product portfolio in China and has signed an exclusive distribution deal with China’s largest domestic orthopaedic producer, AK Medical.

The Chapeltown firm expects to sell a minimum of 10,000 hip implants in China over the next five years.

Keith Jackson, JRI Orthopaedics chief executive, said: “China has a population of 1.3 billion but currently only 250 million people have access to a hip replacement. The potential is huge and we see this as a significant market for the company.

“There is a really good appetite for high-quality, innovative British brands. Our proven, world class, precision manufacturing capabilities and efficiencies means we have defied convention to manufacture Chinese-designed products for the Chinese market here in Sheffield.

 

READ THE REST HERE