Birmingham surgeon pioneers new rotator cuff surgery

Posted On September 16, 2016 By OrthoSpineNews In Sports Medicine /

Sep 9, 2016 – By Tim Steere, Birmingham Business Journal

Birmingham physician Kenneth Bramlett recently became the first in Alabama to offer a new form of rotator cuff surgery that is making waves throughout the medical community.

Bramlett is now using rotation medical rotator cuff bioinductive implants, a technology that significantly cuts down on recovery time by facilitating faster tissue growth in the rotator cuff tendon group.

The implant is placed on the bursal side of the supraspinatus tendon and attached first to the tendon with proprietary tendon staples and then to the humeral head using proprietary bone staples.

“Rotator cuff disease is the most frequently observed orthopedic condition in my sports medicine practice here in Alabama and in Dubai for patients over 45 years of age,” Bramlett said. “The ability to reinforce a direct rotator cuff tear or an early abrasional tear is a strong step forward in the healing process. It’s been a bit of a surprise to observe how little pain is associated with the Rotation Medical hybrid repairs and the ease of the early rehabilitation cycles.”

Rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports. The risk of injury increases with age.

The implant, manufactured by Rotation Medical, is suitable for a large segment of rotator cuff disease, from small partial tears to large full-thickness tears.

California Democrats trying to circumvent Obamacare ban on illegal immigrants

Posted On September 16, 2016 By OrthoSpineNews In Financial /

By Tom Howell Jr. – The Washington Times – Thursday, September 15, 2016

California Democrats are testing the bounds of Obamacare’s “innovation” waiver, pushing to bypass the 2010 law’s ban on illegal immigrants’ participation by letting them purchase insurance on the state’s health care exchange.

Capitol Hill Democrats, who created the ban over fear that allowing illegals to enroll would be too politically charged, now sense a shift in their favor. They say it’s time to let those in the country without authorization buy into Obamacare as long as they cover all the costs themselves.

The California plan is poised to be the first major test for President Obama and his waiver authority. The White House is not tipping its hand, saying it will wait to see an official proposal.

Waivers were written into Section 1332 of the Affordable Care Act as a way to let states experiment on whether they could provide the same level of coverage without having to follow all of the law’s strict rules.

The waivers don’t take effect until next year because the law’s authors wanted to force states to play by the rules at first.

Vermont and Hawaii are the only states to submit waiver requests so far and have requested modest changes to how Obamacare’s small-business exchanges are implemented.

Other states see California as a test.

If California succeeds, “that may signal to some states, ‘Hey, there’s an openness here to thinking a little bit more broadly,’ and we may see then some states moving forward,” said Jennifer Tolbert, director of state health care reform at the nonpartisan Kaiser Family Foundation.

READ THE REST HERE

MiMedx Urges FDA To Reconsider Draft Guidances During Hearing

Posted On September 16, 2016 By OrthoSpineNews In Regulatory /

MARIETTA, Ga., Sept. 15, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), 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, announced today that the Company urged the Food and Drug Administration (“FDA”) to reconsider its Draft Guidances on Minimal Manipulation and Homologous Use of Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) during hearings conducted on September 12 and 13, 2016.

Parker H. Petit, Chairman and CEO of MiMedx, said, “I am encouraged that the FDA agreed to hear input from industry, academia, healthcare practitioners and patients. As expected, the almost universal sentiment from industry and the scientific community was that the Draft Guidances should be amended significantly or withdrawn in their entirety. Many presenters also noted that some provisions of the Draft Guidances are outside the scope of FDA’s authority to regulate HCT/Ps.”

Summary of the Majority of Industry, Clinical and Scientific Sentiments Expressed During the Hearing:

Draft Guidances introduced new concepts or proposed changes to the current regulatory scheme, which is inappropriate for guidance. Therefore, Draft Guidances cannot be lawfully adopted in their current form.
Many of the principles in the Draft Guidances are scientifically unsound. Specifically, most presenters objected to the characterization of tissue as either structural or nonstructural, noting that many tissues have multiple functions, both structural and nonstructural.
Multiple objections to the concept that each tissue type has a single “main function.”
Draft Guidances should be amended significantly or withdrawn in their entirety;
If FDA wants to change the way tissue products are regulated, it must do so through a formal notice and comment rulemaking process.
For tissues that don’t currently qualify for regulation under Section 361, many presenters advocated for a new, abbreviated regulatory pathway that would take into account the unparalleled safety record of tissue products and the needs of patients for new and improved products.
Many physicians and patients testified as to the safety and efficacy of HCT/Ps.

An overwhelming majority of the parties who testified at the hearing, including the American Association of Tissue Banks (“AATB”), called for notice and comment rulemaking or stated that the Draft Guidances constitute major changes to the current regulatory scheme. A small minority of presenters called for greater restrictions on the use of HCT/Ps. This minority was roughly a dozen individuals, at least eight of whom were Organogenesis’ current or former associates, including its Senior Vice President of Regulatory & Government Affairs, its former President and CEO, one of its Tissue Bank Directors, its former Clinical Program Manager, three members of its speakers bureau, and a consultant that was formerly its Director of Technology Implementation.

Petit commented, “Organogenesis continues to attempt to discredit human tissue allografts, and in particular, amniotic membrane allografts. The basis for their position is that almost 20 years ago their Apligraf® product went through the Premarket Approval (“PMA”) regulatory pathway whereas human tissue allografts are subject to a different regulatory pathway, namely Section 361 of the Public Health Service Act, which they deem to be inferior. This argument is baseless, and it reflects negatively on the FDA’s regulatory history and expertise. Also, this concept has been previously rejected by the Centers for Medicare and Medicaid (“CMS”), the Department of Veterans Affairs (“VA”), and many thousands of physicians.”

Draft Guidances Cannot Lawfully be Adopted in Their Current Form

MiMedx does not believe the FDA lawfully can adopt the Draft Guidances on minimal manipulation and homologous use in their current form because the FDA cannot reverse its well-established practice and effectively amend existing substantive regulations via informal guidance.

Petit stated, “Simply put, the issuance of these Draft Guidances in their existing form requires notice-and-comment rule making with Congressional oversight and possible Office of Management and Budget (“OMB”) review. Similarly, the majority who testified at the hearings alleged that the Draft Guidances introduce new concepts that are contrary to the existing regulations and/or FDA’s prior positions.”

During the Monday, September 12, 2016 session, Frank Wilton, President & CEO of the AATB, called upon the FDA to formally withdraw the Draft Minimal Manipulation Guidance document. Further, he asserted that if the FDA wished to proceed with their new “main function concept,” then the FDA must do so via the formal rulemaking process. Mr. Wilton also pointed out numerous ways in which the provisions in the Draft Guidance on Homologous Use deviated from positions taken previously by the FDA.

Many of the Principles that Underlie the Guidance Documents are Scientifically Unsound

Bill Taylor, President and COO of MiMedx, commented, “We also believe that many of the principles that underlie the Draft Guidances are scientifically unsound. For example, the Draft Guidance on Minimal Manipulation postulates that HCT/Ps must be intended for the HCT/P’s ‘main function’ in order to qualify for regulation under Section 361 of the Public Health Service Act (“PHSA”). This new concept is not based on science. It ignores the fact that many HCT/Ps have more than one important function, and can have both structural and non-structural functionality in the donor. An overwhelming number of the parties who commented on the Draft Guidance on Minimal Manipulation during the initial comment period, as well as the parties that testified throughout the course of the hearings, criticized this aspect of the Draft Guidance.”

“Specifically with respect to amniotic membrane, both the Draft Guidance on Manipulation and the Draft Guidance on Homologous Use characterize amniotic membrane as a purely structural tissue with limited, purely structural functions, which is not correct,” added Petit.

During the Tuesday, September 13, 2016 session, Dr. Rebecca Baergen, a leading expert in placental pathology, author of Manual of Bernirschke and Kaufmann’s Pathology of the Human Placenta (2005, 2011) and co-author of Pathology of the Human Placenta (2006, 2012), which generally is recognized as the most comprehensive and authoritative text in the field, testified to the myriad functions of amniotic membrane in the donor, both structural and nonstructural, none of which is more important than another.

Petit stated, “Another instance of the Draft Guidances not comporting with science is one of the examples included in the Draft Guidance on Minimal Manipulation that characterizes amniotic membrane powder as being more than minimally manipulated because it ‘alters the tissue’s physical integrity, tensile strength, and elasticity that allow it to serve as a membranous barrier.’ This example is problematic for a number of reasons, including that it gives no consideration whatsoever to the labeled indication of the product. Suppose, for example, the product was labeled for homologous uses as an anti-scarring and anti-inflammatory agent, and it was not intended to serve as a membrane barrier. These are explicit non-structural functions the FDA has already acknowledged.”

“But more significantly, the FDA does not present any scientific evidence to support its contention that micronization of amniotic membrane reduces its tensile strength and elasticity,” noted Taylor. “In fact, two years ago, MiMedx presented the FDA with three sets of test results from independent laboratories demonstrating that micronizing its allograft products does not reduce their tensile strength and modulus of elasticity. The FDA has never refuted or even acknowledged receipt of those test results.”

During the Monday, September 12, 2016 session, Lisa A. Ferrara, Ph.D., President and CEO of OrthoKinetic Testing Technologies, LLC, which is one of the independent laboratories that performed these tests, explained that tensile strength and elasticity are material properties of amniotic membrane and, as such, do not vary with the size of the sample. Dr. Ferrara also presented the results of her lab’s testing of MiMedx’s micronized product, as well as the results of the testing by the other two independent laboratories, all of which confirmed that processing amniotic membrane into smaller pieces does not alter its tensile strength and elasticity.

“In summary, we believe this and other scientific evidence presented at the hearing is irrefutable and should preclude adoption of these Draft Guidance documents in their current form,” said Petit.

Guidance Documents are Non-Binding

The Company reported that even if the Draft Guidances were finalized in their current form, they are non-binding on the FDA or industry. Page one of each of the Draft Guidance documents provides as follows: “This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

In his remarks at the FDA workshop held on Thursday, September 8, 2016, Stephen Bauer, PhD, Chief of the Cellular and Tissue Therapy Branch (CTTB), U.S. Food and Drug Administration, likewise characterized guidance as “non-binding advice.”

Taylor noted, “MiMedx continues to believe that its marketing of its products as Section 361 HCT/Ps is consistent with the applicable statutes and regulations.”

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 birth tissues 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. The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ and AmnioFill™ brands; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix, EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft; EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.

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 Company’s position that different regulatory pathways are neither inferior nor superior to each other, that the issuance of the Draft Guidance documents in their existing form would constitute a substantive rulemaking that could only be properly completed through notice-and-comment rulemaking, that many of the principles underlying the draft guidance documents are scientifically unsound, and that the scientific evidence presented at the hearing is irrefutable and should preclude adoption of the draft guidance documents in their current form. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that regulators such as the FDA may determine that certain regulatory pathways are superior or grant certain privileges over other pathways used to bring products to market, that it could be determined that the draft guidances in their existing form do not constitute a substantive rulemaking or that the draft guidance documents are finalized even though they do constitute a substantive rulemaking and/or are scientifically unsound, 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 endedDecember 31, 2015 and its most recent 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.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Spinal fusion operations may be needlessly crippling patients: expert

Posted On September 16, 2016 By OrthoSpineNews In Spine /

By GRANT McATHUR, HEALTH EDITOR, Herald Sun – September 15, 2016

SURGEONS are being warned to stop routinely undertaking spine fusing operations over fears too many patients are being left needlessly crippled.

A gathering of Australian pain specialists will this weekend be told to scale back their reliance on common lumber fusion operations by visiting US expert Dr Gary Franklin.

It comes as the appropriateness of all spinal surgeries are being reviewed for and clinical relevance by the spinal surgery clinical committee as part of the Medicare Benefits Schedule Review Taskforce.

In the past five years Australian surgeons have performed more than 34,000 stand procedures to fire two or more vertebrae together to prevent any movement between them, a well as thousands of other fusions as part of other spinal operations.

While the operation was designed as a last resort for patients with significant measurable instability in their spinal bones, Dr Franklin will tell The annual gathering of the Faculty of Pain Medicine that most disc-related cases now undertaken in Australia and the US could be better treated with less invasive measures.

“I cannot think of another surgical procedure that has such terrible outcomes,” Dr Franklin said.

“A lot of people have back pain and we just need to learn to use (other) methods of treating it.”

READ THE REST HERE

Alphatec Holdings Announces Company Updates

Posted On September 15, 2016 By OrthoSpineNews In Financial, Spine /

CARLSBAD, Calif., Sept. 15, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced changes to the Company’s executive leadership team and an update on its compliance with Nasdaq’s listing requirements.

The Company’s Board of Directors has appointed Leslie H. Cross, Chairman of Alphatec’s board, to the role of Chief Executive Officer on an interim basis, effective September 16, 2016. Mr. Cross, who previously served as Alphatec’s CEO between 2012 and 2014, succeeds James Corbett, who resigned his role as President and CEO and as a Director, effective September 12, 2016. Mr. Cross will continue his role as Chairman of the Board. As a result of Mr. Cross serving as both Chairman and CEO, the Company anticipates naming a Lead Independent Director in the near future.

Leslie Cross, Chairman of the Board of Directors, said, “Over the past few years, Alphatec has made significant progress under Jim’s leadership on its strategic journey to reshape the organization, including the successful sale of our international business to Globus Medical. We have strengthened our product development pipeline and as a result our commercial product portfolio has never been stronger. Similarly, we made significant progress on streamlining our cost structure through the outsourcing of manufacturing operations and improvements to our supply chain management processes through our partnership with outside suppliers. With a robust product suite that is attractive to surgeons, an improved balance sheet and a singular focus on the U.S. market, Alphatec is now well-positioned to undertake the next stage of transformation – improving commercial execution and accelerating revenue growth. The leadership changes we are announcing today are designed to fast track this vision to reality. We appreciate Jim’s contributions and wish him the best in his future endeavors.”

Other Executive Appointments

As part of today’s announcement, Michael J. Plunkett, the Company’s current Chief Operating Officer, COO, has been promoted to President and COO. Mike has served as the Company’s COO since January 2014. He originally joined Alphatec Spine in March 2012 as Vice President of Operations. During his time with the Company, Mike has been instrumental to the development of the Company’s strategy to accelerate growth and improve profitability, including the development of the Company’s product portfolio, streamlining supply chain management and partnering with external suppliers to successfully outsource the Company’s manufacturing operations.

The Company also announced today that Craig Hunsaker has accepted a newly created position at Alphatec as its Executive Vice President of People and Culture. In this role, Craig will be responsible for all aspects of employee recruitment, development, engagement and corporate culture. Craig’s professional career includes 16 years practicing law at some of the world’s largest technology focused law firms, advising and defending companies and management with respect to their people decisions, while holding various leadership positions. Craig left full-time legal practice in 2009, when he joined NuVasive, Inc., a publicly traded spinal implant company, first to serve as Vice President, Legal Affairs, then from late-2009 through March 2014 as Senior Vice President, Global Human Resources. Since April 2014, Craig has engaged in consulting in the areas of Employment Law and Human Resources, including most recently (since April 2016) as Senior Advisor, Human Resources at San Diego-based General Atomics. He received a B.S. in International Business & Finance from Brigham Young University and a J.D. from Columbia University School of Law.

In addition, the Company announced today that Jeff Rydin has agreed to serve in the role of Special Advisor to the Board, Commercial, and will advise the Board with respect to sales, marketing and revenue acceleration. Jeff most recently served as Chief Sales Officer with Ellipse Technologies, Inc., before its purchase by NuVasive in February 2016. He was previously at NuVasive, for over seven years, where he held various senior sales roles, including serving as President of Global Sales from October 2011 through March 2013. Prior to joining NuVasive, from January 2004 to December 2005 Jeff was Area Vice President of Orthobiologics for DePuy Spine, where he was responsible for the DePuy sales team in the Southeastern U.S. He also served in various executive and leadership sales roles at Orquest, Inc. (acquired by Johnson & Johnson), Symphonic Devices, Inc., General Surgical Innovations, Inc. (acquired by Tyco International Ltd), Baxter Healthcare, US Surgical and Xerox. Jeff received a Bachelor of Arts in Social Ecology from the University of California, Irvine.

Mr. Cross added, “This leadership transition is the next step in connecting surgeons and patients in the U.S. with Alphatec’s new and robust products. As part of this transition, the Board, the executive team and I will be focused on the next phase of the Company’s transformation – accelerating U.S. revenue growth and superior performance for Alphatec. I am pleased to expand the breadth and experience of the executive team with the expansion of Mike Plunkett’s role and the addition of Craig Hunsaker. In addition, we are fortunate to engage the counsel of Jeff as we transform our U.S. commercial execution and drive future revenue growth. I look forward to all of their contributions and have tremendous confidence in this leadership team and the dedicated employees we have at Alphatec.”

Nasdaq Listing Compliance

Today the Company also announced that it has received formal notification from the Listing Qualifications Department of The NASDAQ Stock Market (“NASDAQ”) notifying Alphatec that it has regained compliance with Listing Rule 5450(a)(1), the minimum bid price requirement for continued listing on The NASDAQ Stock Market, and that the matter is now closed. Alphatec’s common stock will continue to be listed on The NASDAQ Global Select Market.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a global medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. and internationally via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include references to the Company’s: product development pipeline and product portfolio; ability to streamline its cost structure; ability to improve its balance sheet; and ability to accelerate its revenue growth or grow its revenues at all. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:
Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services

Posted On September 15, 2016 By OrthoSpineNews In Financial /

Dublin – September 15, 2016 – Medtronic (NYSE: MDT) today announced the appointment of Mark Ploof as Senior Vice President, Global Operations and Business Services effective October 31, 2016. He will serve on the company’s Executive Committee and be responsible for leading Medtronic’s Global Operations, Information Technology, Facilities & Real Estate and Medtronic Business Services functions, which include the company’s ongoing Covidien acquisition integration efforts.

Ploof succeeds Gary Ellis who previously announced plans to retire from the company later this fiscal year after a 27-year Medtronic career. As part of a planned succession, Ellis will remain on the Medtronic Executive Committee and work with Ploof to ensure a smooth transition.

“Mark brings a diverse range of experiences to the Medtronic leadership team as well as a relentless focus on creating operational excellence, value creation and business growth,” said Omar Ishrak, Medtronic Chairman and CEO. “It is an exciting and transformational time for Medtronic, and I am confident in Mark’s ability to help us deliver against our strategic business priorities. From his broad knowledge of operations to his expertise in assessing and identifying opportunities to operate at scale and generate margin expansion, Mark’s vast experiences in a multitude of industries will bring fresh thinking and leadership to our organization.”

“I’m excited for this opportunity with Medtronic and to play such a vital role in helping the company achieve its Mission around the world,” said Ploof. “I am particularly pleased to join the men and women of Medtronic in these functional areas who are driving world class business performance and efficiencies in their work, and I know that we will play an instrumental part in helping Medtronic realize its operational and financial goals in the coming years.”

Ploof worked with Cerberus Capital Management portfolio companies to drive margin expansion, efficiency and value creation efforts in a variety of operations, industries and roles. He brings a track record of assessing, diagnosing and remediating opportunities to capture value and institute new operational and service delivery models to operate efficiently at scale. His business development background at GE and Cerberus companies included creating and executing company integration plans and programs, including facility and supply chain consolidations, shared services and centers of excellence creation and organizational development and alignment efforts.

Ploof joins Medtronic from YP, LLC where he most recently served as the Chief Customer Experience Officer. As a member of YP’s Operating Leadership Team, Ploof oversaw centralized and field service management, quality and operational enablement, and business intelligence. He also served as the company’s Chief Restructuring Officer, focused on YP’s spin-off from AT&T. Under his leadership, YP established and drove significant shareholder returns and significantly improved customer engagement and satisfaction scores.

Ploof has also held senior leadership roles in finance, supply chain, business development and sourcing in Cerberus portfolio companies and at General Electric, where he established a track record of establishing large scale operating models that generated meaningful efficiencies and value creation. Ploof holds a bachelor of business administration degree in Management from Pace University.

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

-end-

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Episurf Medical obtains its first granted patent in Australia

Posted On September 15, 2016 By OrthoSpineNews In Regulatory /

September 15, 2016 04:15 ET | Source: Episurf Medical AB

The patent covers a surgical drilling guide with a functionality for depth adjustments. This guide constitutes a component of Episurf’s toolkit for implantation of patient specific joint implants.

“To look forward and secure intellectual property protection in new markets is an important field for an expanding company”, comments Rosemary Cunningham Thomas, CEO of Episurf Medical.

For more information, please contact:

Rosemary Cunningham Thomas, CEO, Episurf Medical

Tel: +46 (0) 70-7655892

Tel: +44 (0) 7803-753603

Email: rosemary@episurf.com

About Episurf Medical
Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 10.15 CET on 15 September 2016.

Misonix Files for Extension of Time for Annual Report on Form 10-K; Appoints Interim CFO

Posted On September 15, 2016 By OrthoSpineNews In Financial /

FARMINGDALE, N.Y., Sept. 14, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, announced that it filed a Form 12b-25 (the “Filing”) today with the Securities and Exchange Commission indicating that Misonix likely will not be in a position to file its Annual Report on Form 10-K for the fiscal year ended June 30, 2016 within the 15-day extension period provided in Rule 12b-25(b) under the Securities Exchange Act of 1934.

The Filing stated that the Audit Committee of the Company has determined that deficiencies existed in the Company’s internal control over financial reporting at June 30, 2016. The Audit Committee is still considering whether or not the deficiencies constitute one or more material weaknesses in the Company’s internal control over financial reporting at such date. Notwithstanding its determination, the Audit Committee has no current information to suggest that the Company’s previously reported financial statements and results are incorrect in any material respect. The filing of the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016 will be delayed pending completion of an investigation relating to these deficiencies being overseen by the Audit Committee. The filing may also be delayed as a result of the appointment effectiveSeptember 13, 2016 by the Board of Directors of the Company of Joseph Dwyer as interim Chief Financial Officer. Richard A. Zaremba, Senior Vice President and Chief Financial Officer through September 13, 2016, has been appointed Senior Vice President, Finance. The Company is working diligently to resolve these matters and intends to file its Annual Report on Form 10-K as promptly as reasonably practicable.

Preliminary results for the fiscal year ended June 30, 2016 are net sales of $23.1 million and a net loss ranging from $(1.0) million to $(1.3) million for the fiscal year ended June 30, 2016 as compared to net sales of $22.2 million and net income of $5.6 million for the fiscal year ended June 30, 2015, which included a $2.9 million reversal of the valuation allowance previously recorded against deferred tax assets. On a per share basis, such preliminary results represent a net loss per share – basic ranging from $(0.13) to $(0.17) and a net loss per share – diluted ranging from $(0.13) to $(0.17) for the fiscal year ended June 30, 2016 as compared to net income per share – basic of $0.74 and net income per share – diluted of $0.69. The preliminary net loss for the fiscal year ended June 30, 2016 is attributable to higher operating expenses, including higher sales and marketing expense.

About Misonix

Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the completion of the investigation related to identified deficiencies in internal control over financial reporting, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact	Investor Contact
Misonix Contact:	Joe Diaz
Richard Zaremba	Lytham Partners
631-694-9555	602-889-9700
invest@misonix.com	info@misonix.com

Logo – http://photos.prnewswire.com/prnh/20160201/328020LOGO

SOURCE Misonix, Inc.

Related Links

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Phoenix VA Health Care System Deploys Germ-Zapping Robots to Enhance Veteran Safety; Xenex Robots Destroy Pathogens that Pose a Risk to Patients, Staff & Family Members

Posted On September 15, 2016 By OrthoSpineNews In Robotics /

September 15, 2016 11:44 AM Eastern Daylight Time

PHOENIX–(BUSINESS WIRE)–The Phoenix Veterans Affairs (VA) Health Care System is the first hospital in Arizona to deploy Xenex LightStrike™ Germ-Zapping Robots™ to destroy deadly germs and bacteria lurking on hospital surfaces that can cause hospital acquired infections (HAI). The portable room disinfection system utilizes pulsed xenon ultraviolet (UV) light and is effective against even the most dangerous superbugs and multi-drug resistant organisms (MDRO), including methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile (C.diff), VRE, norovirus and influenza. Additionally, the Xenex Germ-Zapping Robot has been proven effective against both the Ebola virus and Anthrax, and can easily be incorporated into a facility’s disease containment and biodefense strategy.

Pulsed xenon UV disinfection is an environmentally-friendly technology and exceeds both Presidential Executive Orders and VA Directives regarding sustainability and green procurement. Prior to implementing Xenex, the Phoenix VA used a mercury UV disinfection system (mercury is toxic) and as a result, the facility’s OR experienced a degradation of materials including the cracking and yellowing of plastics. The materials damage associated with continuous mercury UV is a newly identified problem associated with mercury UV technology and the Phoenix VA was among the first in the nation to identify this issue.

To date, 20 peer-reviewed studies showing the effectiveness of pulsed xenon UV in reducing pathogens from the environment have been published, including eight studies that reported a decrease in patient infection rates when the pulsed xenon UV technology was used. Five of the environmental studies were accomplished by VA researchers including Dr. Chetan Jinadatha, Chief of Infectious Disease, Central Texas Veterans Health Care System, who found manual cleaning plus pulsed xenon UV light disinfection was far more effective than traditional cleaning methods at eliminating MRSA bacteria and was 23 percent faster when integrated into the room cleaning process. More importantly, numerous healthcare organizations using Xenex LightStrike robots have reported significant reductions in C.diff, MRSA, VRE and Surgical Site Infection (SSI) rates. This is evidenced in multiple published peer-reviewed outcome studies showing 50-100 percent reductions in HAI rates.

In addition to being the first hospital in Arizona, the Phoenix VA is the first VA facility in the Southwest Health Care Network (VISN 18) to deploy this innovative, leading-edge patient safety technology. The Phoenix VA joins 40 VA facilities and over 350 hospitals across the nation who have added the Xenex LightStrike robot to their disinfection arsenals. During the implementation, as a tribute to the military, the Phoenix VA named its six LightStrike robots after the Commander-in-Chief and five sister services: Chief, Army, Navy, Air Force, Marines, and Coast Guard.

“We want to do everything possible to provide a clean environment and enhance patient safety at our facility to reduce the risk of hospital acquired infections,” said Kenneth Carter, Chief of Environmental Management Services, Phoenix VA. “One infection is one too many, so enlisting the help of the Xenex robots will help us achieve our goal of zero infections. This investment in a proven technology is important and underscores our commitment to patient care and the veterans we serve.”

The Xenex Germ-Zapping Robots are an adjunctive step in the hospital’s cleaning process. Operated by the hospital’s EVS team, they are brought into a room after traditional cleaning has taken place to destroy microscopic germs and bacteria that may be lurking on high touch surfaces, such as bed rails, tray tables, door knobs and remote controls. The portable Xenex system can disinfect a typical patient or procedure room in four or five minute cycles (depending on robot model) without warm-up or cool-down times. It can be used in any department and in any unit within a healthcare facility, including isolation rooms, operating rooms, general patient care rooms, contact precaution areas, emergency rooms, bathrooms and public spaces.

Xenex Disinfection Services

Xenex’s patented Full Spectrum^TM pulsed xenon UV room disinfection system is used for the advanced disinfection of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. Xenex’s mission is to save lives and reduce suffering by eliminating the deadly microorganisms that cause hospital acquired infections (HAIs). The company is backed by well-known investors that include Malin Corporation, Battery Ventures, Targeted Technology Fund II and RK Ventures. For more information, visit Xenex.com.

Contacts

Phoenix VA Health Care System
Paul Coupaud, 602-200-6036
Paul.coupaud@va.gov
or
Xenex
Melinda Hart, 210-240-4669
melinda.hart@xenex.com

Complication risk of minimally invasive sacroiliac joint fusion surgery may be higher than previously reported

Posted On September 15, 2016 By OrthoSpineNews In Spine /

Minimally invasive sacroiliac joint fusion surgery has been shown to be an effective treatment and potentially cost-saving for sacroiliac joint pain, with low adverse event and reoperation rates, as compared to open surgery. According to the study authors, “possibly as a result of this combination of factors,” the procedure has become a commonly-used technique. Current literature reports over 87% of sacroiliac joint arthrodesis as performed minimally invasively. This “has created the need for reliable data addressing the safety of the procedure,” the authors from Los Angeles, USA, state, noting that “existing literature has largely failed to…address this issue.” Because of the relative novelty of the procedure, the authors speculate that “acquiring a large sample population” has been difficult, with most current literature addressing outcome results via case series.

The Pearl Driver database—cataloguing patient records from US insurer, Humana Incorporated—holds data on 18,620,198 patients “from every major geographic region of the country.” The research team searched the database using International Classification of Disease, Ninth Revision and Current Procedural Terminology codes to distinguish patients who had undergone the minimally invasive procedure. The team specified their search parameters in order to account for changing terminology and pathologies indicated for open procedures, narrowing a population of 508 sacroiliac fusion patients down to 469, once exclusions had been made for neoplasms, pelvic ring trauma and reoperations. Of this patient population, 164 patients were male and 305 were female.

The corresponding records data were evaluated for novel postoperative complications in six categories; postoperative infection, nervous system, pain, urinary tract infection, osteomyelitis and joint derangement. Complication rates were investigated at 90 days and six months postprocedure, with a 30-day point used to evaluate infection rates. Novel lumbar pathology was also investigated as an outcome.

The researchers observed an incidence of 62 complications within the first 90 days (13.2%), and 77 (16.4%) within six months of the procedure. An infection rate of 4.1% (19) was observed within six months. Novel lumbar pathology was found in 3.6% of patients (n=17) at 90 days following the procedure, and in 5.3% (25) at six months, with a 9.1% (15) prevalence among on the male population at this time point.

“The results of our study show higher overall complication rates for minimally invasive sacroiliac joint fusion than have been previously reported,” write the authors. Whilst the team note that their population size is not particularly large, “it is nonetheless significantly bigger than nearly all previously published studies, and as a result has the statistical power that these smaller case series lack.” Whilst the team report that one study (Smith et al, Ann Surg Innov Res, 2013) has previously reported a higher overall complication rate of 18% (114, n=5319), others have reported rates as low as 3.5% (Miller et al, Med Devices (Auckl), 2013).

The observed infection rate, which was comparable to other results in the literature, was highlighted as notably higher than is associated with other minimally invasive procedures. “Minimally invasive sacroiliac joint fusion surgery potentially carries a relatively high risk of postoperative infection,” the authors of this study report. Furthermore, the study “for the first time also demonstrated substantial rates of postoperative complications involving the nervous systems, pain, and urinary tract infections,” with respective rates of 6.2%, 4.1% and 4.9% found for each subtype at six months.

Speculating on reasons for the novel lumbar pathology reported, the authors comment, “previous studies suggest that lumbar fusion can lead to sacroiliac joint degeneration in up to 75% of cases within five years.” “One potential limitation of this finding,” they report, “is that lumbar and sacroiliac joint pains are often difficult to distinguish.” Misdiagnosis, they suggest, may account for some of these findings.

As well as observing higher complication rates, the team observed a stark increase in the incidence of minimally invasive sacroiliac joint fusion procedures performed, particularly in the latter three years of the study data. This spike corresponds with a notable increase in studies of the procedure around this time, as well as “the US Food and Drug Administration approval of multiple minimally invasive sacroiliac fusion devices” at the beginning of 2008. “this notion is further supported”, they state, “by data which show that 92% of the original patient population remained after excluding patients with…indications for open sacroiliac fusion.”

Noting limitations including the potential for missing data as a result of changing billing codes, as well as “some degree of misclassification bias and unmeasured confounding,” the authors conclude that their study was “able to provide a unique analysis of minimally invasive sacroiliac joint fusion complications.” “As more data become available in the long term,” they comment, “adverse events need to be analysed to gain a better understanding of the procedures’ safety.”

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