Smith & Nephew retains membership of World Dow Jones Sustainability Indices for fourteenth consecutive year

Posted On September 16, 2016 By OrthoSpineNews In Financial /

16 September 2016

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, is proud to announce that it has retained its position as an index component on the Dow Jones Sustainability Indices (DJSI).

Since 1999, the DJSI tracks the financial performance of the leading sustainability-driven companies worldwide based on an analysis of financially relevant economic, environmental, and social factors. Smith & Nephew is included in both the 2016 DJSI World and DJSI Europe Indices. Smith & Nephew has now been a member of DJSI World since 2002 and a member of DJSI Europe since 2001.

In the Healthcare Equipment and Supplies sector, Smith & Nephew is one of only seven members of the DJSI World Index and one of just three members for DJSI Europe. Smith & Nephew scored highly in Climate Strategy, Occupational Health and Safety, Social Reporting and was awarded a perfect score in the Environmental Reporting category, illustrating the company’s continued excellence in sustainable operations.

Olivier Bohuon, Chief Executive Officer of Smith & Nephew, said:

“We are firmly committed to making a meaningful contribution across all three pillars of sustainability – social, environmental and economic. Our emphasis is on delivering positive outcomes that advance the long-term prospects for our business everywhere we operate. We will continue to strive to be a responsible business that sets an example for others. ”

Media

Charles Reynolds, Corporate Communications
Smith & Nephew
+44 (0)20 7401 7646

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management,Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

_{Forward-looking Statements}

_{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}

Histogenics Corporation Announces $30.0 Million Private Placement

Posted On September 16, 2016 By OrthoSpineNews In Financial /

WALTHAM, Mass., Sept. 16, 2016 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has entered into a definitive securities purchase agreement to raise approximately $30.0 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock. The private placement is being led by new healthcare dedicated institutional investors, with participation by certain existing investors.

Histogenics expects to use the net proceeds from the private placement to support the development of NeoCart^®, its novel cartilage repair therapy, including the completion of the ongoing Phase 3 clinical trial, and for general corporate and working capital purposes. Upon the closing of the private placement, Histogenics expects the proceeds raised in the offering along with its existing cash resources to last through the middle of 2018. Based on Histogenics’ current plans, enrollment in the NeoCart Phase 3 clinical trial will be completed in the second quarter of 2017, with topline data on its 1-year primary efficacy endpoint available by the middle of 2018.

Pursuant to the terms of the securities purchase agreement, Histogenics has agreed to sell 2,653,553 shares of common stock at a price of $2.25 per share and 24,158.8688 shares of newly created Series A Convertible Preferred Stock, which shares of preferred stock are convertible into approximately 10,679,781 shares of common stock. Purchasers will receive warrants to purchase up to approximately 13,333,334 shares of common stock at an exercise price of $2.25 per share. The warrants will be exercisable following approval of the private placement byHistogenics stockholders and will expire 5 years from the date of such stockholder approval. The closing of the offering is subject to the satisfaction of customary closing conditions.

Affiliates of certain members of Histogenics’ Board of Directors agreed to purchase an aggregate of 283,045 shares of common stock and 2,563.1451 shares of Series A Convertible Preferred Stock in the private placement and will receive warrants to purchase up to 1,422,221 shares of Histogenics’ common stock at an exercise price of $2.25 per share.

H.C. Wainwright & Co., LLC served as the sole placement agent in connection with this offering.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United Statesabsent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Histogenics has agreed to file one or more registration statements with the SECregistering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series A Convertible Preferred Stock.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development. NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells. Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options. For more information, please visit www.histogenics.com.

Forward –Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others: the expected closing and closing date of the offering and the use of proceeds of the offering and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenicscautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Investor Relations

Tel: +1 (781) 547-7909

InvestorRelations@histogenics.com

Histogenics Corporation

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

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SOURCE Misonix, Inc.

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Month: September 2016

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