By Stuart Grant, MB, ChB, FRCA, Gavin Martin, MB, ChB, FRCA, and Ellen Flanagan, MD – Oct 5, 2016

Each year, at least 250,000 older people—those 65 years and older—are hospitalized for hip fractures.
More than 95% of hip fractures are caused by falling, usually by falling sideways.
Women experience three quarters of all hip fractures.
Women more often have osteoporosis.
Fall prevention programs are
important.

When developing a plan to care for elderly patients with hip fractures, amassing a multidisciplinary team is the first step. With all stakeholders present charting the patient’s journey from arrival to discharge, a discussion of all areas of care and opportunities to reduce unwanted variability and improve care can take place.

As anesthesiologists working on the care improvement team, we had heard discussion about the severe pain many of these patients have to endure from arrival in the emergency room (ER) to continuation in other areas such as the X-ray suite, which we do not normally consider. As acute pain specialists with interests in regional anesthesia, we felt we could offer a better quality patient experience if we placed peripheral nerve catheters in these patients as soon as they arrived in the ER. In a previous review, Riddell et al^[1] examined the use of femoral nerve blocks in the ER. Both single-shot and catheter techniques have shown benefit by reducing pain scores and opioid consumption. Additionally, reductions in respiratory and cardiac side effects have been noted without any increase in any adverse events.

In collaboration with ER colleagues, we developed a plan to call anesthesiology as soon as a hip fracture was diagnosed. We used an electronic order set, which is triggered by the ER provider when the orthopedic surgeon is called.

The thought of taking on another off-service burden was something that was met with some resistance by a minority of colleagues. We all consider ourselves to be busy all the time, but when we analyzed the total number of patients with hip fractures who are admitted each year, we realized that this was not going to be an overwhelming burden for any individual provider and that it would be a huge benefit to individual patients. The calls would be taken by all providers who covered in-house calls within our institution. Colleagues not on the acute pain service expressed reservations about their ability to actually perform the blocks. To address this issue, we created an education program which was delivered repeatedly to colleagues through didactics and online education. Support was offered to ensure that everyone who might be called to provide this service could comfortably meet the expectations. One of the ways this was done was to provide direct clinical support during weekday calls for these catheters. An acute pain faculty member would accompany a generalist when he or she was placing femoral nerve catheters. In this way, the faculty member could answer questions and provide technical support for this procedure to improve the comfort level and expertise of all anesthesiologists in the department.

In addition, each day our anesthesia technicians ensured that all the equipment necessary was loaded into a bag stored beside the ultrasound machine. The bag contained our peripheral nerve catheter kits, ultrasound gel, consent form (for the nerve block and the surgery the next day), and a check list of all required equipment. Drugs cannot be stocked in the bag per regulations of the Centers for Medicare and Medicaid Services (CMS) and still have to be added from pharmacy before departure for the ER. The stocked bag and checklist minimized inconvenience to the patient as well as off-service providers who have to travel off-site and do not realize what equipment is missing until they arrive in the ER.

READ THE REST HERE

Monday, October 3, 2016 – Dept of Justice

Hospital Chain Will Pay over $513 Million for Defrauding the United States and Making Illegal Payments in Exchange for Patient Referrals; Two Subsidiaries Agree to Plead Guilty

A major U.S. hospital chain, Tenet Healthcare Corporation, and two of its Atlanta-area subsidiaries will pay over $513 million to resolve criminal charges and civil claims relating to a scheme to defraud the United States and to pay kickbacks in exchange for patient referrals.

Principal Deputy Assistant Attorney General David Bitkower of the Justice Department’s Criminal Division; U.S. Attorney John Horn of the Northern District of Georgia; Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division; U.S. Attorney G.F. Peterman III of the Middle District of Georgia; Georgia Attorney General Samuel S. Olens; Acting Special Agent in Charge George Crouch of the FBI’s Atlanta Field Office; and Special Agent in Charge Derrick L. Jackson of the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) in Atlanta made the announcement.

In addition, two Tenet subsidiaries, Atlanta Medical Center Inc. and North Fulton Medical Center Inc., have agreed to plead guilty to conspiracy to defraud the United States and to pay health care kickbacks and bribes in violation of the Anti-Kickback Statute (AKS). The plea agreements remain subject to acceptance by the court. Up until April 2016, Atlanta Medical Center Inc. and North Fulton Medical Center Inc. owned and operated acute-care hospitals located in the greater Atlanta metropolitan area.

Atlanta Medical Center Inc. and North Fulton Medical Center Inc. were charged in a criminal information filed today in federal court in Atlanta with conspiracy to defraud the United States by obstructing the lawful government functions of HHS and to violate the AKS, which, among other things, prohibits payments to induce the referral of patients for services paid for by federal health care programs. The two Tenet subsidiaries have agreed to plead guilty to the charges alleged in the criminal information and will forfeit over $145 million to the United States – which represents the amount paid to Atlanta Medical Center Inc. and North Fulton Medical Center Inc. by the Medicare and Georgia Medicaid programs for services provided to patients referred as part of the scheme.

Tenet HealthSystem Medical Inc. and its subsidiaries (collectively THSM) entered into a non-prosecution agreement (NPA) with the Criminal Division’s Fraud Section and the U.S. Attorney’s Office of the Northern District of Georgia related to the charges in the criminal information. THSM is the parent company of Atlanta Medical Center Inc., North Fulton Medical Center Inc., Spalding Regional Medical Center Inc. and Hilton Head Hospital, and employed their executives. THSM is a subsidiary of Tenet Healthcare Corporation. Under the terms of the NPA, THSM and Tenet will avoid prosecution if they, among other requirements, cooperate with the government’s ongoing investigation and enhance their compliance and ethics program and internal controls. Tenet has also agreed to retain an independent compliance monitor to address and reduce the risk of any recurrence of violations of the AKS by any entity owned in whole, or in part, by Tenet. The term of THSM’s and Tenet’s obligations under the NPA is three years, but the NPA may be extended for up to one year.

In the civil settlement, Tenet agreed to pay $368 million to the federal government, the state of Georgia and the state of South Carolina to resolve claims asserted in United States ex rel. Williams v. Health Mgmt. Assocs., Tenet Healthcare, et al., a lawsuit filed by Ralph D. Williams, a Georgia resident, in the Middle District of Georgia, under the federal and Georgia False Claims Acts. The acts permit whistleblowers to file suit for false claims against the government entities and to share in any recovery. The federal share of the civil settlement is $244,227,535.30, the state of Georgia will recover $122,880,339.70 and the state of South Carolina will recover $892,125. Mr. Williams’ share of the combined civil settlement amount is approximately $84.43 million.

“When pregnant women seek medical advice, they deserve to receive care untainted by bribes and illegal kickbacks,” said Principal Deputy Assistant Attorney General Bitkower. “The Tenet case is the first brought through the assistance of the Criminal Division’s corporate health care fraud strike force. This is one of more than a dozen active corporate investigations by the strike force, and we are committed to following evidence of health care fraud wherever it leads – whether it be individual physicians, pharmacy owners or corporate boardrooms.”

“Our Medicaid system is premised on a patient’s ability to make an informed choice about where to seek care without undue interference from those seeking to make a profit,” said U.S. Attorney Horn. “Tenet cheated the Medicaid system by paying bribes and kickbacks to a pre-natal clinic to unlawfully refer over 20,000 Medicaid patients to the hospitals. In so doing, they exploited some of the most vulnerable members of our community and took advantage of a payment system designed to ensure that underprivileged patients have choices in receiving care.”

“The Department of Justice continues to devote enormous resources to exposing and pursuing alleged misconduct of improper financial relationships between hospitals and referral sources,” said Principal Deputy Assistant Attorney General Mizer. “Such relationships exploit vulnerable populations and threaten to drive up the cost of healthcare for everyone. In addition to yielding a substantial recovery for taxpayers, this settlement reflects the department’s lack of tolerance for these types of abusive arrangements, and the negative effects they can have on our health care system.”

“The global resolution of this complex and sophisticated fraud scheme exemplifies what can be accomplished through the cooperation of federal and state investigative and prosecutorial authorities,” said U.S. Attorney Peterman. “I am particularly proud of the civil attorneys in the U.S. Attorney’s Office for the Middle District of Georgia, working hand in hand with investigators of the U.S. Department of Health and Human Services and attorneys in the Civil Division and the Medicaid Fraud Control Unit of the Office of the Attorney General of Georgia, whose combined efforts greatly contributed to this outstanding result on behalf of the American taxpayers.”

“Tenet took advantage of vulnerable pregnant women in clear violation of the law by paying kickbacks in order to bring their referrals to Tenet hospitals,” said Georgia Attorney General Olens. “Through this scheme, Tenet defrauded the Georgia Medicaid program, and reaped hundreds of millions of dollars. This is an unprecedented settlement for the state of Georgia, and reflects my office’s commitment to protecting Georgia taxpayers by uncovering Medicaid fraud and abuse.”

“The FBI continues to play a significant role in ensuring that federal laws related to the healthcare industry, to include the federally funded Medicare and Medicaid programs, are enforced,” said Acting Special Agent in Charge Crouch. “The settlement agreements announced today involving Tenet Healthcare Corporation, as well as related guilty pleas by two of its Atlanta-based hospitals, Atlanta Medical Center Inc., and North Fulton Medical Center Inc., are a clear example of those efforts. In addition, the FBI’s Major Provider Response Team (MPRT) assisted the Atlanta Field Office in the civil and criminal investigation of Tenet. The MPRT was created in 2011 in response to numerous healthcare related corporate-level schemes resulting in billions in losses to healthcare plans. The FBI, along with its MPRT, will continue to aggressively address the threat of large-scale corporate healthcare schemes significantly impacting both private and government healthcare benefit plans.”

“OIG continues to emphasize investigation of improper financial relationships between health care providers,” said Special Agent in Charge Jackson. “Using their positions of trust, health providers – after receiving payments from Tenet – sent expectant women specifically to Tenet hospitals. Patients were often directed to Tenet facilities miles and miles from their homes and on their journeys passed other hospitals that could have provided needed care. These women were thereby placed at increased risk during one of the most vulnerable points in their lives. HHS-OIG will continue to protect patients by exposing such illegal arrangements.”

As alleged in the criminal information as well as civil complaints filed by the department and the state of Georgia in 2014 and 2013, Atlanta Medical Center Inc., North Fulton Medical Center Inc., Spalding Regional Medical Center Inc. and Hilton Head Hospital paid bribes and kickbacks to the owners and operators of prenatal care clinics serving primarily undocumented Hispanic women in return for the referral of those patients for labor and delivery medical services at Tenet hospitals. These kickbacks and bribes allegedly helped Tenet obtain more than $145 million in Medicaid and Medicare funds based on the resulting patient referrals.

According to the criminal information, as part of the scheme, expectant mothers were in some cases told at the prenatal care clinics that Medicaid would cover the costs associated with their childbirth and the care of their newborn only if they delivered at one of the Tenet hospitals, and in other cases were simply told that they were required to deliver at one of the Tenet hospitals, leaving them with the false belief that they could not select the hospital of their choice. The criminal information alleges that as a result of these false and misleading statements and representations, many expectant mothers traveled long distances from their homes to deliver at the Tenet hospitals, placing their health and safety, and that of their newborn babies, at risk.

The criminal information also charges Atlanta Medical Center Inc. and North Fulton Medical Center Inc. with conspiring to defraud HHS in its administration and oversight of the Medicare and Medicaid Programs, including HHS-OIG’s enforcement of Tenet’s September 2006 corporate integrity agreement (the CIA). The criminal information and the civil complaint allege that many of the unlawful payments happened while Tenet was under the CIA. The criminal information further alleges that certain executives of Atlanta Medical Center Inc., North Fulton Medical Center Inc. and others concealed these unlawful payments from HHS-OIG during the pendency of the CIA by, among other things, falsely certifying compliance with the requirements of the CIA and failing to disclose reportable events relating to the unlawful relationship under the CIA.

* * *

Deputy Chief Joseph S. Beemsterboer, Assistant Chief Robert A. Zink and Trial Attorneys Sally B. Molloy, Antonio M. Pozos and A. Brendan Stewart of the Criminal Division’s Fraud Section and Chief Randy S. Chartash and Deputy Chief Stephen McClain of the Northern District of Georgia’s Economic Crime Section represented the government in the criminal prosecution. The U.S. Attorney’s Office of the Middle District of Georgia and the Civil Division’s Commercial Litigation Branch represented the federal government in the civil case. The HHS Office of Counsel to the Inspector General, the FBI and the Georgia and South Carolina Medicaid Fraud Control Units provided assistance in this matter.

The FBI’s Atlanta Field Office, HHS-OIG and the FBI Healthcare Fraud Unit MPRT investigated the case.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of HHS. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $30.9 billion through False Claims Act cases, with more than $18.6 billion of that amount recovered in cases involving fraud against federal health care programs.

If you believe you are a victim of this offense, please visit this website or call (888) 549-3945.

16-1144

Civil Division

Criminal Division

Criminal Fraud

USAO – Georgia, Middle

USAO – Georgia, Southern

Topic:

Healthcare Fraud

Download Tenet Civil Settlement Agreement

Download Tenet NPA and Attachments

Download Criminal Information for Atlanta Medical Center Inc. and North Fulton Medical Center Inc.

Updated Octo

10/01/2016 – By Blake Neff

Minnesota will let health insurers increase their rates by at least 50 percent next year to protect the state’s Obamacare health insurance individual market from “collapse,” the state announced Friday.

The announcement came from Minnesota commerce commissioner Mike Rothman, who explained bluntly that the state’s individual market was barely staying afloat.

“The Commerce Department pursued every option within its power to avert a collapse this year,” said Rothman. “We succeeded in saving the market for 2017, with only Blue Cross leaving. But the rates insurers are charging will increase significantly to address their expected costs and the loss of federal reinsurance support.”

The increase in premiums for next year will range between 50 percent and a staggering 67 percent. This comes on the heels of an increase of between 14 percent and 49 percent for 2016. After those increases, Rothman warns, the annual growth rate will be completely unsustainable, showing a desperate need for reform.

READ THE REST HERE

By Kathryn Doyle – September 28, 2016

(Reuters Health) – Two simple tests that can be done in a doctor’s office may be able to rule in or out a painful hip condition that is usually hard to diagnose without magnetic resonance imaging (MRI), according to a small study.

A common overuse injury, gluteal tendinopathy can be treated with rest and stretching. But hip pain can be hard to diagnose, and that may lead to inappropriate treatment or unnecessary surgery if gluteal tendinopathy is misdiagnosed as a lumbar spine issue or hip joint osteoarthritis, the authors write.

“It is important to identify the condition because this will help better target therapy and we believe this study has moved the field forward considerably in terms of our understanding of clinical tests that help us diagnose the condition,” said senior author Bill Vicenzino of the University of Queensland in Brisbane, Australia.

“We found more tests that when negative would rule out the likelihood of the condition being present and only one that strongly ruled in the condition if it was positive,” Vicenzino said.

The researchers studied 65 people, ages 35 to 70 years, with pain on the side of their hip. First clinicians palpated (felt with their hands) the painful hip and had participants perform a series of movements applying weight or pressure to the joint and tendons. Then participants had MRI scans of the painful hip, which were analyzed by a radiologist.

About half of the participants were diagnosed with gluteal tendinopathy based on clinical examination and tests, while more than three-quarters had gluteal tendinopathy based on MRIs, according to the results published in the British Journal of Sports Medicine.

Hip palpation had the lowest false-positive rate of the clinical tests, and was the best test for ruling out the presence of gluteal tendinopathy.

READ THE REST HERE

ALTSTAETTEN, Switzerland, September 29, 2016 /PRNewswire/ —

icotec AG, an innovative medical device company leading the industry in the development and manufacturing of non-metallic Carbon/PEEK composite medical devices, announces the brand name of BlackArmor^® for its Carbon/PEEK material, which boosts a 15 year and 20,000 implantation clinical track record in spinal and fracture surgical care.

BlackArmor is a combination of continuous, high-strength carbon fiber reinforced PEEK and the company’s composite flow moulding (CFM) process. The result is a medical device with an interwoven 3D fiber architecture that provides unmatched strength and endurance. icotec’s technology is an enabler for complex designs such as pedicle screws, vertebral body replacement devices or supplemental fixations devices, like anatomical bone plates. The combination of mechanical strength and non-metallic properties make BlackArmor also ideally suited for the treatment of spinal tumors.

In the case of spinal tumors, radiation therapy plays an important role in pain management and local tumor control after the surgical removal of the tumor and stabilization of the spinal column.

Before administering radiation therapy, the radiologist relies on accurate CT images to plan the radiation dose. However, the presence of metal spinal implants causes significant artifact on the planning images. This artifact makes it more difficult to delineate anatomic structures during radiation therapy planning and correctly calculate the proper dose distributions.

During radiation therapy, metal spinal implants may also shield tumor cells from the curing radiation. In addition, metal components induce scattering of the radiation beams into the surrounding soft tissue potentially causing side effects. In some cases, patients may not be candidates for proton radiation therapy because of the presence of metal implants.

BlackArmor is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts; a significant clinical benefit in the postoperative monitoring of anatomical structures. In addition, the non-metallic nature of the BlackArmor material minimizes the risk for patients where metal allergies are a potential concern.

Orthopedic implants manufactured from BlackArmor Carbon/PEEK material were approved for CE-mark in 2000 and received FDA clearance in 2005.

About icotec

Founded in 1999, icotec AG has become a worldwide leader in the design, development and manufacturing of Carbon/PEEK composite to create high strength implants for loadbearing musculoskeletal applications. The company is headquartered in Altstaetten, Switzerland.

For further information, please contact info@icotec.ch, +41-717570000 or visit the websitehttp://www.icotec.ch/en/innovation/carbon-peek/

SOURCE icotec

SANTA ROSA, Calif., Sept. 29, 2016 /PRNewswire/ — Osseon is pleased to announce the addition of medical device industry veterans Eric Gilbert as VP of Sales, and Paul Rogan as Area Sales Manager. Mr. Gilbert and Mr. Rogan will join the existing Sales Management team as the company continues to expand its market share.

In response to the company’s rapid growth, Osseon has also implemented cutting-edge cloud-based systems for both customer relationship management and product training. In addition, Osseon continues to partner with a number of physicians, both in the U.S. and abroad, to publish a series of best practices white papers related to the diagnosis and treatment options for Vertebral Compression Fractures.

Osseon will be exhibiting their complete line of Vertebral Compression Fracture treatment products at the North American Spine Society Annual Meeting (NASS) in Boston, October 26-29, 2016, Booth #725.

About Osseon:

Osseon^® LLC is a private medical device company located in Santa Rosa, CA. Osseon is driven by the needs of patients and the physicians and health care providers who treat them. The company designs, manufactures and distributes innovative products to improve the quality of life for patients with vertebral compression fractures (VCF). Vertebral compression fractures may result from osteoporosis, osteotraumatic injuries, myelomas or other degenerative bone diseases.

For more information, visit osseon.com. Osseon^® is a registered trademark of Osseon LLC.

SOURCE Osseon LLC

Related Links

http://www.osseon.com

September 29, 2016

GAINESVILLE, Fla.–(BUSINESS WIRE)–

Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder and spine, today announced positive surgeon feedback on first surgeries performed with the ExactechGPS® Guided Personalized Surgery system’s new Total Shoulder Application, which combines preoperative planning with intraoperative computer-assisted technology. Pierre-Henri Flurin, MD, a shoulder specialist at the Clinique du Sport in Bordeaux-Mérignac, France, performed both an anatomic and a reverse total shoulder replacement using Equinoxe® Shoulder System implants and instruments.

This Smart News Release features multimedia. View the full release here:http://www.businesswire.com/news/home/20160929006357/en/

“Our goal is to offer improved accuracy and precision in the placement and orientation of the Equinoxe implants,” said Dr. Flurin. “I was able to plan the case in advance through a virtual simulation and then execute that plan while visualizing the 3-D anatomy in real time, making adjustments based on assessments during surgery. Exactech’s design teams have developed innovative shoulder implants designed to preserve bone and overcome challenges; this new technology is the perfect complement to those implants.”

“In collaboration with our team of engineers located in Florida and France, Dr. Flurin and the rest of the design team brought brilliant expertise to our effort,” said Darin Johnson, Vice President of Marketing, Extremities. “Visualizing the glenoid vault in real time and adjusting the implant orientation to the unique anatomy of the patient should help surgeons improve patient outcomes, which is what we come to work every day to do.”

The shoulder application focuses on guiding the preparation of the glenoid in shoulder arthroplasty. There is wide variation in the position and orientation of glenoid implants because of limited exposure and poor operative landmarks, and studies show that inaccurate placement of the glenoid component has been linked with increased stresses in the implants¹, early loosening and poor outcomes.² The goal of the new ExactechGPS Total Shoulder Application is to allow surgeons to avoid those issues, ultimately providing longer implant survivorship.

Exactech worked closely with a design team of experienced upper extremity specialists to develop this system: Emilie Cheung, MD, Stanford University Department of Orthopaedics (Palo Alto, Calif.); Pierre-Henri Flurin, MD, Clinique du Sport (Bordeaux-Mérignac, France); Richard Jones, MD, Southeastern Sports Medicine (Asheville, N.C.); Moby Parsons, MD, Seacoast Orthopedics and Sports Medicine (Somersworth, N.H.); Paul Saadi, MD, Dallas Bone and Joint Clinic (Dallas, Texas); Thomas Wright, MD, University of Florida Department of Orthopaedics and Rehabilitation (Gainesville, Fla.); and Joseph Zuckerman, MD, NYU Hospital for Joint Diseases (New York, N.Y.).

The ExactechGPS Total Shoulder Application is being piloted in Europe and is currently undergoing premarket review by the FDA.*

About ExactechGPS

ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the implant in the optimal position. Exactech first introduced ExactechGPS to surgeons in the United States for knees, and has since broadened its reach by providing medical education and supporting surgeries in more than 11 countries. The technology has steadily gained market acceptance and worldwide reach.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

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BOSTON, MA (PRWEB) SEPTEMBER 29, 2016

AxioMed announced today it has received approval from the Therapeutic Goods Administration (TGA) of Australia to market and sell their cervical and lumbar Freedom Viscoelastic Disc Replacement. The approval, effective immediately, marks an important milestone for AxioMed as the company increases its presence both internationally and domestically in the USA in preparation for FDA approval. The AxioMed viscoelastic disc is a next-generation disc replacement that restores natural disc height, stability, and motion in the human spine.

In response to the TGA approval of the AxioMed discs, company President, Jake Lubinski will be traveling to Australia from October 7-12 to meet with surgeons in Brisbane, Sydney, and Melbourne to discuss the benefits of a viscoelastic disc replacement. “The evolution of total joint technology now enables restoration of joint motion with a high degree of patient satisfaction. AxioMed believes it can replicate this success in spine with their innovative and advanced viscoelastic total disc replacements” says Mr. Lubinski, “we’re excited to make our entrance into one of the most advanced markets globally in total disc replacement”

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.

IRVINE, Calif., Sept. 29, 2016 /PRNewswire/ — Phygen, LLC, a company focused on the development of devices used in the stabilization and repair of spinal disease and trauma, today announced that it has received a Notice of Allowance for its latest pedicle screw assembly utilizing the AutoLok technology. The unique design and its inherent resistance to back-out will provide a decided advantage to the Leucadia product line as the company continues to implement physician driven innovations in spinal health.

“We are pleased to receive this Notice of Allowance and plan to move forward rapidly on the regulatory and operational fronts with the Leucadia AutoLok system,” said Phygen CEO Thomas W. Gardner. “The clear advantages of this revolutionary feature will provide our clinical users with innovation developed through our clinical advisory members. We plan to quickly ramp up our regulatory and manufacturing efforts to get AutoLok technology back into the hands of clinicians as soon as possible. Our clinical advisory board considers this the most significant innovation in pedicle screws since pedicle screws became the gold standard in fusion.

AutoLok was initially introduced in 2011, and over 400 levels were implanted in spinal fusion cases, with no instances of backout and no revisions or field complaints of any kind. AutoLok was taken off the market after Phygen’s asset sale in 2012, and Phygen has now re-acquired full ownership of the technology.

About Phygen
Spinal disease is the leading cause of lost productivity and surgical intervention in the United States with an annual cost of more than $150 billion.

Phygen LLC is a medical device company focused on the development of surgeon-designed orthopedic spinal implants and instrumentation to address the stabilization and repair of spinal trauma and disease. Laguna, Lucadia, Coronado, La Costa, Del Mar and Cabo all represent Phygen products designed by spine surgeons for spine surgeons.

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

Forward-Looking Statements
This news release includes “forward-looking statements”. These statements are based upon the current beliefs and expectations of Phygen’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; significant fluctuations in expenses associated with product development, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the medical device industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Phygen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Phygen’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

BURLINGTON, Mass., Sept. 29, 2016 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc.(Nasdaq:FLXN) announced today that it has appointed John Magee as Vice President of Sales, the latest of several key appointments to the company’s leadership team.

Mr. Magee has more than 35 years of experience as a sales professional. Prior to joining Flexion, he was head of U.S. sales for the rare disease unit of Shire Pharmaceuticals, where he also served as U.S. sales director for its renal business. Previously, he held senior sales positions at Esprit Pharma and Bayer Corporation. He has a Bachelor’s degree in biology and anthropology from Hamilton College, and completed MBA courses at the Rochester Institute of Technology. Mr. Magee joins Flexion as the company prepares to submit a planned new drug application (NDA) in the fourth quarter of 2016 to the U.S. Food and Drug Administration (FDA) for its drug candidate Zilretta™ (also known as FX006), a potential treatment for patients with moderate to severe knee osteoarthritis (OA) pain.

Michael Clayman, MD, President and Chief Executive Officer of Flexion, stated, “John is another excellent addition to the Flexion team as we continue planning for Zilretta’s commercial launch. During his time in the rare disease unit of Shire, he helped to achieve revenue growth of more than $1 billion. John’s experience in successfully recruiting and managing pharmaceutical sales organizations will play a key role for us as we prepare for the potential launch and commercialization of our new investigational treatment in the marketplace in 2017.”

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive intra-articular (IA) injections for knee OA annually.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta[, including the expected timing of commercial launch for Zilretta]; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated regulatory filing dates and commercial launch plans for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

PR Contact
Danielle Lewis
Lazar Partners LTD
T: 212-843-0211
dlewis@lazarpartners.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

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Current Issues in Spine

Preoperative Continuous Peripheral Nerve Blocks in Hip Fracture Patients

Hospital Chain Will Pay over $513 Million for Defrauding the United States and Making Illegal Payments in Exchange for Patient Referrals; Two Subsidiaries Agree to Plead Guilty

Hospital Chain Will Pay over $513 Million for Defrauding the United States and Making Illegal Payments in Exchange for Patient Referrals; Two Subsidiaries Agree to Plead Guilty

Minnesota Hiking Obamacare Premiums At Least 50% To Avoid ‘Collapse’

In-office tests may detect hip tendon problems before MRI

icotec Brands BlackArmor® as an Alternative Material to Metal in Loadbearing Musculoskeletal Surgical Procedures

Osseon Invests in Leadership

Exactech Announces Successful First Surgeries with New ExactechGPS® Total Shoulder Application

AxioMed Cervical and Lumbar Viscoelastic Total Disc Replacement Technology Approved In Australia

Phygen, LLC Receives Notice of Allowance on AutoLok Fixation Screw Assembly Under U.S. Patent Application 13/274,243

Flexion Therapeutics Announces Appointment of John Magee as Vice President of Sales

STAR Ankle Joint Replacements Last Long Term and Provide Relief for Patients

Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

Spinal Stabilization Technologies Announces Start of LOPAIN 2 Clinical Trial in South America for Lumbar Degenerative Disc Disease

$250K Pediatric Device Competition Now Accepting Proposals

First Single-Use Rigid Endoscope to be Demonstrated at AAOS