Written by Ayla Ellison – February 06, 2017

Dallas-based Tenet Healthcare agreed to pay approximately $514 million last October to resolve allegations the company paid kickbacks in exchange for patient referrals. Although Tenet settled the lawsuit, the federal government attached a name to the case last week when a former Tenet executive was charged for his alleged involvement in the scheme.

In an indictment filed Jan. 24, John Holland, who previously served as senior vice president of operations for Tenet’s Southern States Region and as CEO of North Fulton Medical Center in Roswell, Ga., is charged with one count of healthcare fraud and two counts of major fraud against the United States.

According to the Department of Justice, Mr. Holland and his co-conspirators circumvented Tenet’s internal accounting controls to pay illegal kickbacks and bribes to a clinic that referred undocumented pregnant patients to Tenet hospitals for Medicaid-covered deliveries. Federal prosecutors allege the illegal scheme helped Tenet bill the Georgia and South Carolina Medicaid programs for more than $400 million.

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PARIS & SAN FRANCISCO–(BUSINESS WIRE)–

SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today it has been granted a patent by the US Patent Office for the application of its Dynamic Surgical Guidance technology for a new application: bone quality measurement.

“Because of population aging, orthopedists and neurosurgeons are treating an increasing number of osteoporotic patients, and they are expressing the need to precisely measure the bone quality. A widely shared opinion amongst surgeons is that the existing standard of care – known as a DEXA scan – only brings an uncertain (unreliable) answer to this growing need. This grant from the US Patent Office follows previous patent grants in China and Japan. It confirms the potential of SpineGuard’s DSG™ technology for this very promising new application,” said Pierre Jérôme, CEO and Co-founder of SpineGuard.

“We believe that the DSG™ technology can allow surgeons facing these skeletal pathologies to evaluate the bone density of their patients intraoperatively in a much more precise anatomical area and in doing so, to fine-tune their surgical strategy. For spine surgeries, this will ease the choice of the implants, their size, their diameter, their location and if cement should be used or not,” concluded Stéphane Bette, Co-founder, CTO and US General Manager of SpineGuard.

Osteoporosis represents a serious and growing healthcare issue due to population aging. Most patients with a fragility fracture are neither evaluated, nor treated for osteoporosis. For patients being diagnosed with osteoporosis, several complications are associated with spine surgeries, and the quality of the purchase of the pedicle screws is directly linked with the bone mineral density.

Sources :

• Bouxsein ML, Kaufman J, Tosi L, Cummings S, Lane J, Johnell O. Recommendations for optimal care of the fragility fracture patient to reduce the risk of future fracture. J Am Acad Orthop Surg. 2004 Nov-Dec;12(6):385-95.
• Lehman RA Jr, Kang DG, Wagner SC. Management of osteoporosis in spine surgery. J Am Acad Orthop Surg. 2015 Apr.23 (4):253-63. doi: 10.5435/JAAOS-D-14-00042.

More information on the DSG™ technology, its new applications and surgeons’ testimonials here.

Latest news release: FDA clearance to market DSG module for making pedicle screws smart, January 16, 2017

Next financial press release: 2016 full year financial results, March 23, 2017

SpineGuard will attend the 2017 Musculoskeletal Conference organized by Canaccord Genuity on March 14, 2017, at the occasion of the AAOS annual congress (American Association of Orthopedic Surgeons) in San Diego USA. SpineGuard’s CEO presentation will be broadcasted live and a replay will be available.

About SpineGuard^®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170206005999/en/

MARIETTA, Ga., Feb. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. MDXG 2.31%, the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, commented today regarding the Food and Drug Administration’s (“FDA’s”) recently published 2017 calendar year guidance agenda. The tissue-related Guidances to be finalized in calendar year 2017 do not include Guidances on Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps), including minimal manipulation and homologous use of HCT/Ps.

Parker H. Petit, Chairman and CEO, said, “Last September when the FDA convened its hearing on the proposed Draft Guidances on minimal manipulation and homologous use of HCT/Ps, there was an overwhelming response and considerable input given to the FDA by industry, academia, healthcare practitioners and patients. The almost universal sentiment from industry and the scientific community was that these Draft Guidances should be amended significantly or withdrawn in their entirety. Certain presenters at the September 2016 hearings also noted that some provisions of the Draft Guidances were outside the scope of FDA’s authority to regulate HCT/Ps and thus would require notice and comment rulemaking.”

Petit added, “I am encouraged that the FDA has not included these Draft Guidances in their 2017 calendar of those to be finalized. The massive amount of input that the FDA received during the hearing was certainly impactful, and it seems as if the Agency is not in a position to finalize Guidances in 2017 regarding the key HCT/P guidance documents related to homologous use and minimal manipulation.”

Bill Taylor, President and COO, commented, “There was a tremendous amount of data and scientific evidence presented to the FDA at last year’s hearings on HCT/Ps. The absence of any planned finalized Guidances on the key HCT/P guidance related documents is encouraging. Their absence on this year’s calendar gives us confidence that, when eventually finalized, these Guidances will have taken into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community.”

About MiMedx
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone.  “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement
This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the  input from the hearings in 2016 impacted the decision not to finalize the HCT/P guidances in 2017,  the delay in finalizing the HCT/P guidances is a positive,  and the absence of the HCT/P guidances on this year’s calendar gives confidence that when eventually finalized, the guidances will have taken into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that other factors may be impacting the timing of the finalization of the HCT/P guidances, the final guidances may not necessarily take into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community, the delay could have a negative impact rather than a positive one, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015, and its most recent Form 10Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

OVERLAND PARK, KANSAS (PRWEB) FEBRUARY 03, 2017

Spinal Simplicity, a medical device company developing innovative solutions to treat complex surgical problems, has received its third 510(k) clearance from FDA for the Minuteman G3-R spinal implant, part of the Minuteman family of supplemental fusion and fixation devices. The Minuteman G3-R may be implanted via a minimally invasive lateral approach and will have a lower profile upon placement of the device.

“The lower profile of the Minuteman G3-R provides an aesthetic enhancement while maintaining the key elements of strength of the device and its minimally invasive nature. The interest that surgeons have expressed in this new product has been outstanding,” says Todd Moseley, Co-Founder and CEO of Spinal Simplicity. “Spinal Simplicity continues to raise the bar in the industry as we bolster our product portfolio and provide physicians with diverse options for patient treatments that utilize minimally invasive technologies”.

The Minuteman® G3-R is a sterile packed, posterior, non-pedicle supplemental fusion and fixation device for use in the non-cervical spine (T1-S1). As an alternative to traditional pedicle screws, it is a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor. The device is available in the U.S. with hydroxyapatite coating and a removable 12mm portion of the implant body. The Minuteman® is intended for use with bone graft material and is not intended for stand-alone use.

About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of simple solutions for the treatment of complex spinal disorders. Spinal Simplicity has regulatory clearance for the Minuteman system in the US, Europe and Canada. Our vision is to be the global leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com

February 01, 2017 – Medscape Medical News – Robert Lowes

The Senate Finance Committee today approved the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS) and serve as President Donald Trump’s point person in repealing and replacing the Affordable Care Act (ACA).

The 14 to 0 vote reflected the partisan tumult engulfing the nation’s capital during Trump’s first few weeks in office. All the votes came from Republican members of the committee because, for a second day in a row, the 12 Democratic members boycotted executive sessions to confirm both Dr Price and Steven Mnuchin, the president’s nominee for Treasury secretary. Ranking member Sen. Ron Wyden (D-Ore) said the committee should not move forward on the nominations until it addresses “unanswered questions and misleading statements” by both men. Democrats contend that Dr Price has not come clean about alleged conflicts of interest regarding his investments in healthcare companies, which he has denied.

The committee normally needs at least one member from each party present to fulfill its quorum requirement, but Republicans suspended that rule so they could proceed to a vote.

Dr Price’s nomination now goes before the full Republican-controlled Senate for a vote. Because the Senate changed its rules when Democrats were in power to exempt cabinet-level appointments from a filibuster, Dr Price needs only a simple majority, or 51 votes, for confirmation. Republicans hold 52 seats.

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Walter Eisner – Wed, February 1st, 2017

Zimmer Biomet Holdings, Inc. has a lot of ‘splaining to do to the FDA after an inspection of the company’s Warsaw, Indiana, plant resulted in one the “longest and most serious” 483s ever encountered by a legal expert quoted by Wells Fargo Analyst, Larry Biegelsen.

FDA 483s are “Inspectional Observations,” used by the FDA to document and communicate concerns discovered during inspections. They do not represent a final determination regarding a company’s compliance.

Over the course of three one-week blocks, the agency conducted an inspection at the company and issued a 60-page heavily redacted Form 483 in November.

North Campus Concerns

Prior to the FDA inspection the company completed internal audits of its North Campus in the first half of 2016. According to a January 30, 2017 analyst report by RBC’s Glenn Novarro, these audits identified several compliance-related issues, and a remediation program was established in July 2016. This program identified 7 of the 14 Form-483 observations and 6 of the 15 discussion points prior to the start of the FDA’s inspection.

Biegelsen wrote in mid-December that the 60 heavily redacted pages of the 483 appears to be “severe”, but is unlikely to have a material impact on the business in the near-term because the issues found by the FDA do not impact product approvals and are unlikely to lead to an injunction.

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February 02, 2017

WARSAW, Ind., Feb. 1, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded 26-week efficacy claim for its single-injection viscosupplement Gel-One^® Cross-linked Hyaluronate for the treatment of knee pain associated with osteoarthritis. Gel-One Cross-linked Hyaluronate may be administered in the physician office setting and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen¹.

“Gel-One Hyaluronate is a vital component in the continuum of treatments for knee osteoarthritis, offering millions of patients the potential for up to six months of pain relief with a single injection,” said David Nolan, Zimmer Biomet Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. “The expanded efficacy claim not only strengthens our competitive positioning, but reinforces our commitment to alleviating pain and restoring mobility for patients at every stage in the continuum of musculoskeletal care, including conservative and non-surgical options.”

Gel-One Cross-Linked Hyaluronate is the first low-volume viscosupplement available in a single-injection formulation for the treatment of osteoarthritis of the knee. Hyaluronic acid (HA) products such as Gel-One Cross-linked Hyaluronate may supplement the natural HA of the knee, which provides cushioning and lubrication to the joint. Gel-One Cross-linked Hyaluronate requires only a single 3 mL injection to complete the treatment course.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation.  Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries.  For more information, visit zimmerbiomet.com or follow Zimmer Biomet on Twitter at twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

¹Important Safety Information

Important Safety Information

Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry. Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given. Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA. Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or prolonged weight-bearing activities after treatment. The effectiveness of repeat treatment cycles of Gel-One Hyaluronate has not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate in the clinical trial were knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Other conditions, including but not limited to skin redness and rash, knee stiffness, knee muscular weakness and dizziness, were also reported. If any of these symptoms or signs appear after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor.  Ask your surgeon if you are a candidate and discuss potential risks.  For additional information, call 1-800-348-2759, or visit www.zimmerbiomet.com.

This material is intended for US patients and US Health Care Professionals.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/zimmer-biomet-announces-fda-approval-of-expanded-26-week-efficacy-claim-for-gel-one-cross-linked-hyaluronate-for-treatment-of-pain-associated-with-knee-osteoarthritis-300399479.html

SOURCE Zimmer Biomet Holdings, Inc.

News Provided by Acquire Media

Todd Hixon ,  CONTRIBUTOR

Donald Trump’s election combined with continued Republican control of Congress creates uncertainty for the U.S. health care economy that has no recent parallel. Digital health companies and digital health investors are undeterred. Many push forward by focusing on long-standing patient needs and efficiency challenges that any administration will need to tackle.

Healthcare is highly regulated, the federal government pays for half of it, and were are in the midst of a major reform launched by President Obama and a Democrat-controlled Congress in 2010. Now new hands are on the tiller, and they promise a sharp turn to starboard, but as of yet they not have plotted a comprehensive and coherent course. The Kaiser Family Foundation, IMHO one of the best resources for understanding U.S. healthcare, posted a distillation of President-elect Trump’s declared positions on healthcare after the election. What does he intend to do beyond repealing the ACA and replacing it with something “much better”? KFF distills Trump’s declared intentions into six points, summarized below:

•  Health insurance: Trump would completely repeal the ACA including the mandate for individuals to have insurance coverage and for insurers to cover them regardless of pre-existing conditions. Instead, he would create high risk pools for individuals with expensive pre-existing conditions, and, in lieu of premium tax credits, Trump would provide a tax deduction for the purchase of individual health insurance.  He would seek to keep individuals’ costs down by allowing insurers to sell plans across state lines, increasing competition which should reduce premiums, and by increasing use of tax-advantaged Health Savings Accounts (HSAs) which incent consumers to shop for the best prices for healthcare.

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