State’s high court hears arguments in legal challenge to Medtronic-Covidien deal

By Star Tribune – October 5, 2016

Medical device maker Medtronic moved its legal headquarters to Ireland last year in a controversial $50 billion deal that forced about 20 percent of the people who owned its stock to shell out thousands of dollars each to cover capital gains taxes.

Now some shareholders want the company to cover those costs. First they will have to convince the Minnesota Supreme Court to agree with them that state law does not — or should not — prevent them from being able to bring their lawsuit at all. If they win at the high court, the plaintiffs would still have to prevail in a future trial or get a settlement to see any money.

In oral arguments Wednesday morning at the Supreme Court, the attorney representing Medtronic said the two-year-old class-action lawsuit should never have gotten to the state’s highest court. That is because long-standing Minnesota business law gives boards of directors legal protections so they can run a company without being second-guessed by litigious shareholders.

“The question before you this morning is whether you will abandon the rule of law that has been effectively applied for decades, and embrace a rule of law … that is inconsistent with your most recent statements of public policy,” said Medtronic’s attorney, Eric Magnuson, who was chief justice from 2008 to 2010.

The aggrieved shareholders, however, argue that long-standing rule of law doesn’t address unique situations that can arise during corporate inversions like Medtronic’s.

An inversion happens when a U.S.-based company relocates its headquarters to a lower-tax jurisdiction through a corporate acquisition. In January 2015, Medtronic acquired health care supplier Covidien for $49.9 billion in cash and stock in a deal that put the combined company in Covidien’s old headquarters building in Dublin, Ireland. CEO Omar Ishrak continues to run the company from offices in Minnesota.

Medtronic’s board members knew the inversion would impose taxes on the minority of shareholders whose stock was not protected in a tax-deferred account like an IRA. The board members also knew Medtronic’s management strongly favored of the deal — so much so that the company agreed to cover $69 million in special excise taxes on company officers imposed by Congress to discourage inversions.

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Spineology Interbody Devices Now FDA Approved with Allograft Bone

October 10, 2016

MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc. announced today that it has obtained FDA clearance for the use of allograft bone with its Rampart™ Interbody Fusion Devices.

“This approval and our recent partnership expansion with Musculoskeletal Transplant Foundation (MTF) provides us the ability to pair MTF allografts with the Rampart family of interbody devices,” says John Booth, CEO of Spineology. “In addition to reducing patient morbidity and enhancing surgical efficiency we expect this approval will provide Spineology with an excellent platform for delivery of our new Incite™ Cortical Fibers.”

Incite Cortical Fibers are a unique and versatile bone grafting solution. The fibers offer an osteoconductive and inductive matrix, excellent handling properties, in-situ expansion and placement options via a variety of delivery methods.

The Rampart Interbody fusion devices incorporate large graft windows to facilitate healing and a recently enhanced instrumentation system. Additionally, devices are now available sterile packed, eliminating the need for continual reprocessing, which reduces costs for our customers.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

SPINEOLOGY INC.

Release Summary

Spineology Inc. received FDA approval for Musculoskeletal Transplant Foundation allografts with Rampart Interbody Fusion Devices, which facilitates healing time and reduces costs for patients.

Release Versions

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall Public Relations
Dave Folkens, 651-286-6713
dave@risdall.com

K2M Expands 3D-Printed MIS CASCADIA™ Lateral Interbody System Featuring Lamellar 3D Titanium Technology™

LEESBURG, Va., Oct. 06, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand its CASCADIA Lateral Interbody System featuring Lamellar 3D Titanium Technology, the Company’s innovative technology that uses 3D printing with the goal of allowing for bony integration throughout an implant. The CASCADIA Lateral Interbody System line extension clearance strengthens K2M’s minimally invasive surgery (MIS) portfolio and the Company’s leadership in the 3D printing of spinal devices, as evidenced by its having the most comprehensive 3D-printed spinal portfolio available on the market.

“CASCADIA is an exciting innovation for lateral spine fusions,” stated Greg T. Poulter, MD, an orthopedic spine surgeon at OrthoIndy. “The unique engineering and 3D printing allows the implant to have the biocompatibility and ongrowth characteristics of titanium, while allowing a stiffness that more closely matches bone. The graft volume and surface area for fusion are generous and the new size options for lordosis allow me to address each patient’s individual sagittal plane requirements. CASCADIA has become my go-to implant for lateral interbody fusions.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CASCADIA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity.

Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the implant. K2M’s CASCADIA interbodies utilize this technology to create a 70% porous implant with an increased bone graft volume and similar stiffness when compared to K2M PEEK designs.

The CASCADIA Lateral Interbody System is part of the Company’s MIS portfolio, designed to promote less invasive access to the spine. The system functions as an invertebral body fusion device to provide support and stabilization of the lumbar segments of the spine. Its reverse hourglass implant design promotes increased endplate contact—compared to an ALEUTIAN® PEEK implant—without sacrificing internal bone graft volume. The system includes a full range of implant sizes and heights that are carefully designed to accommodate vertebral anatomy, and it is intended to work in conjunction with the RAVINE® Lateral Access System to offer a full line of instrumentation for the far lateral transpsoas approach.

“K2M is proud to strengthen our industry-leading portfolio of FDA-cleared, 3D-printed spinal solutions, thus reinforcing our market leadership and competitive advantage in this space,” stated K2M President and CEO Eric Major. “MIS procedures and 3D printing are core competencies for K2M, as indicated by the breadth and depth of our product offerings. We continue to be committed to our legacy of innovating the highest quality products with the ultimate goal of creating improved treatments for surgical patients around the globe who suffer from debilitating complex spinal deformities.”

The complete CASCADIA portfolio also includes the CASCADIA TL, AN, AN Lordotic Oblique, andCervical Interbody Systems. For more information on Lamellar 3D Titanium Technology, CASCADIA Interbody Systems, and K2M’s complete product portfolio, visit www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

Find K2M on Facebook: https://www.facebook.com/K2MInc

Follow K2M on Twitter: http://twitter.com/K2MInc

Watch K2M on YouTube: http://www.youtube.com/user/K2MInc

Forward-Looking Statements
This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies and techniques; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; the greater resources available to some of our competitors; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarters facility; our ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation including by the FDA; in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and FDA clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; our reliance on the performance of third parties who assist us in clinical trials and pre-clinical development; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; volatility in our common stock; our current plans not to pay dividends; potential dilution due to our issuance of common stock under our incentive plans, for acquisitions or otherwise; the amount of common stock held by our pre-IPO owners; the impact of anti-takeover provisions in our organizational documents and under Delaware law; our status as an emerging growth company, our ability to use our net operating loss carryforwards; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com  

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Amedica Provides Business Update

SALT LAKE CITY, UT — (Marketwired) — 10/06/16 — Amedica Corporation (NASDAQ: AMDA), a biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided a business update related to its business strategy and certain recent developments.

Briefly, the updates relate to the following items:

  • New patent directed to a threaded design in ceramic implants;
  • Participation at the annual International Society for Technology in Arthroplasty; and
  • Update related to completion of the company’s strategic workforce reduction.

Amedica Awarded Key Patent Protection for Threaded Implant Design Feature
Amedica was recently awarded a patent by the United States Patent and Trademark Office for “threading sinterable materials,” such as silicon nitride and other ceramic materials. U.S. Patent No. 9,399,309, covers methods for threading ceramic materials used for spinal fusion implants, or other biomedical implants. Threading technology is broadly applicable in a wide range of current medical devices made from PEEK or titanium, and this patent is the first for ceramic materials. Amedica’s ability to manufacture threaded biomedical implants made of silicon nitride and other ceramic materials reflects nearly five years of pioneering work by its R&D and engineering teams.

Amedica has implemented this new technology across its portfolio of Valeo® II spinal fusion devices. These fusion devices are made of micro-composite silicon nitride, which favors bone ingrowth and shows antibacterial properties, when compared to competitive PEEK and titanium implants. Valeo II silicon nitride interbody fusion devices are readily imaged on x-rays, CT, and MRI scans; a property unique to Amedica’s silicon nitride technology.

Amedica to Present Research Supporting Silicon Nitride at ISTA
Amedica announced that it will be presenting four papers at the International Society for Technology in Arthroplasty’s (ISTA) 29th Annual Congress occurring October 5-8, 2016 in Boston, Massachusetts. “These papers provide further evidence for the advantages of our proprietary silicon nitride composition in the spine, dental, and arthroplasty markets,” said Dr. Sonny Bal, Chairman and CEO of Amedica Corporation. “Our strength in manufacturing, research, and external collaborations is critical to creating long-term value, even as we reduce costs and address spine sales,” added Dr. Bal

Going Forward Following Strategic Reductions in Workforce
The company also confirmed that the previously-announced work force reduction has been completed, resulting in a leaner and more agile organization that is better positioned to extend its cash runway and execute on its strategic objectives.

Dr. B. Sonny Bal, chairman and chief executive officer of Amedica, stated, “despite the recent 38% reduction in force, the company continues to be in a strong position to timely and efficiently manufacture its silicon nitride products, further scientific research into the properties of our silicon nitride ceramic and how to enhance those properties, and to continue to support its external partnerships and product development opportunities.”

About Amedica Corporation

Amedica is focused on the development and application of interbody implants manufactured with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty as well as dental applications. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility and through its partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Kevin Ontiveros
801-839-3502
IR@amedica.com

Source: Amedica Corporation

 

Theranos closes its labs and wellness centers, lays off 340

By , , Contributor

 

Theranos is closing its labs and wellness centers, CEO Elizabeth Holmes announced today in a post on the company blog. And this isn’t a temporary closure: the “approximately” 340 employees running them are out of a job.

“After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission,” Holmes wrote.

The company pivoted away from working on its closely held “nanotainer” technology to a “miniLab” in August. The boxy device — unveiled at the American Association for Clinical Chemistry conference — collects small samples of blood and urine and then uploads them to a centralized system for further analysis.

And it’s a far cry from what the company, once valued at $9 billion, set out to do. According to several experts whom TechCrunch spoke to at the unveiling, it might not be very innovative, either. Although Theranos didn’t want its new device referred to as a “lab on a chip,” that’s essentially what these experts said the miniLab was. And that has been done.

The new device hinges largely on FDA approval — something Holmes said she’d hoped to fast-track under the emergency use authorization (EUA) for Zika detectors. That plan didn’t go so well, however. The FDA denied  Theranos approval after finding the company failed to use proper patient safety protocols.

 

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Trice Medical Receives FDA 510(K) Clearance for mi-eye 2

KING OF PRUSSIA, Pa., Oct. 6, 2016 — (Healthcare Sales & Marketing Network) — Trice Medical announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for mi-eye 2, a disposable needle with a fully integrated camera that enables physicians to use advanced diagnostic imaging to visualize joint injuries in their clinic. The mi-eye 2 is designed for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2 also provides physicians the ability to inject or aspirate under direct visualization.

The mi-eye 2 is Trice Medical’s second, next-generation FDA-cleared patented technology, which includes improvements that significantly enhance the mi-eye’s resolution, field of view, depth of field and overall visualization.

“Based on feedback we received from our surgeon advisory board, we promptly implemented and pursued FDA clearance for the next-generation mi-eye 2,” said Jeffrey O’Donnell, Sr., President and CEO at Trice Medical. “Our team made dramatic enhancements to the technology of the mi-eye, which reflects our continued commitment to patients by introducing our technology into a medical practice, and working to ensure that the mi-eye technology becomes the standard of care for providing an immediate real-time diagnosis. Our long-term goal is to eliminate the need for MRI exams and enable a quicker road to recovery.”

The Need for New Diagnostic Technology

Currently there are approximately 28,000 orthopedic surgeons seeing 20 million office visits annually for knee-related problems. In addition, there are 12 million visits annually related to shoulder pain. MRI’s are often inconclusive, or result in false readings, which has the potential to lengthen the timeline from diagnosis to recovery. In addition, not every patient is a candidate for MRI. The mi-eye 2 provides a diagnostic modality for every patient, and can provide time-savings to the patient by eliminating the multiple visits associated with an MRI. The mi-eye 2 is unlike any other in-office arthroscopy device on the market today, and provides unparalleled optics with the ease of use of a needle.

About Trice Medical

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, physician, and payor by providing instant, eyes-on, answers. Trice has pioneered and evolved, fully integrated camera-enabled technology that provides a clinical solution optimized for the physician’s office. Trice’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system. Trice Medical’s investors include Safeguard Scientifics (SFE), BioStar Ventures and HealthQuest Capital. For more information, visit www.tricemedical.com; follow us on Twitter, LinkedIn and Facebook; or call 844.643.9300.

Source: Trice Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain

October 04, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. approval of BurstDR™ stimulation, a physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior outcomes for patients with chronic pain over traditional SCS therapy. With FDA approval of BurstDR stimulation, which is exclusive to St. Jude Medical, the company aims to help patients find relief from their pain and suffering while also providing patients a better experience with their chronic pain therapy.

Chronic pain is a complex and challenging condition for physicians to manage, and a heavy burden for patients who find their lives profoundly limited by their pain. Many patients often move from treatment option to treatment option seeking pain relief, only to find a partial or incomplete response to therapy.

Fortunately, SCS therapy can transform quality of life for many people who are otherwise unable to find relief from chronic pain. BurstDR stimulation from St. Jude Medical has been clinically proven to improve upon traditional SCS by generating superior pain relief. With BurstDR stimulation, St. Jude Medical is also helping physicians address their patients’ physical and emotional responses to pain and reduce overall pain and suffering as measured by patients who reported their responses to therapy with BurstDR stimulation through visual analogue scale (VAS) scoring.

“As a physician, reducing the physical sensation of pain experienced by my patients is only part of my job; my ultimate goal is to help patients overcome both the physical pain and the suffering associated with their pain,” said Dr. Timothy R. Deer, president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia. “Now, with BurstDR stimulation, St. Jude Medical has armed physicians with a new therapy option that can reduce patients’ pain and suffering, reduce paresthesia and help us offer our patients a more complete pain management option.”

St. Jude Medical’s proprietary BurstDR stimulation works differently from other stimulation designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. While other companies have tried to mimic burst patterns, BurstDR stimulation from St. Jude Medical is the only approved form of burst stimulation to have been evaluated in a large scale, multicenter randomized controlled clinical trial.

The St. Jude Medical BurstDR stimulation was introduced after nearly a decade of research and study in collaboration with Prof. Dirk De Ridder, who filed the therapy’s initial patents in 2004. BurstDR stimulation was evaluated within the SUNBURST study, a prospective, randomized multicenter study which confirmed BurstDR stimulation offered superior pain relief over traditional SCS and that the therapy was preferred by most patients over traditional SCS therapy. In addition, BurstDR stimulation from St. Jude Medical has been studied in a large number of international real world studies that have helped the company assess the benefits of the therapy in patients worldwide.

“I am very excited that patients across the United States will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” said Prof. De Ridder, from the University of Otago in Dunedin, New Zealand. “When I developed BurstDR stimulation my goal was to introduce an entirely new therapy option, and one that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”

With FDA approval of BurstDR stimulation, patients receiving new implants of the St. Jude Medical Proclaim™ Elite and Prodigy MRI™ spinal cord stimulation systems will have immediate access to the new therapy. Combined, the Proclaim Elite SCS System and BurstDR stimulation offers patients the advantages of the St. Jude Medical Invisible Therapy™ portfolio and an entirely recharge free option, allowing patients to focus on their lives instead of their pain. In addition, patients previously implanted with upgradeable Protégé™ and Proclaim SCS systems will soon be able to upgrade their systems to deliver BurstDR stimulation without additional surgery.

“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With FDA approval of BurstDR stimulation, we are empowering physicians with a new therapy option in their fight against widespread chronic pain, and our goal is to continue to improve patient outcomes and get more patients the pain relief they deserve.”

About the St. Jude Medical Chronic Pain Portfolio

Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical is an international leader in the development of chronic pain therapy solutions and the only medical device manufacturer in the world to offer radiofrequency ablation (RFA) and spinal cord stimulation (SCS) therapy solutions including BurstDR stimulation and stimulation of the dorsal root ganglion (DRG) for the treatment of chronic pain.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer 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 has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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 July 2, 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.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Justin Paquette, 651-756-6293
Public Relations
jpaquette@sjm.com

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


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
Topic:
Healthcare Fraud
Updated Octo

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

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.

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

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.