Archive for : September 28, 2018

28 Sep

Safe Orthopaedics’ Continues to Improve Results over the First Six Months of 2018

September 28, 2018

ERAGNY-SUR-OISE, France--(BUSINESS WIRE)--Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), Safe Orthopaedics (FR0012452746 – SAFOR), a company specialized in the development and marketing of implants and single-use instruments that improve the minimally invasive treatment of spinal fracture conditions, today announced its revenue for the six-month period ending on the 30th June 2018. Safe Orthopaedics’ 2018 six-month financial report will be available on the company’s website (www.SafeOrtho.com) via Investors > Documentation > Regulatory information, from the 25th September 2018.
Thousands of euros - IFRS Standards 30/06/2018 30/06/2017
Revenue - France 904 803
Revenue - Rest of world 756 841

Total Adjusted Revenue

1 660 1 644
Revenue from discontinued operations 0 0
Total Revenue 1 660 1 644
Purchases and inventory change (844) (839)
External expenses (1 525) (1 221)
Payroll (1 726) (1 659)
Other operational expenses (321) (406)
Ordinary operating income (2 756) (2 481)
Other revenue and operational expenses (154) (49)
Operating income (2 910) (2530)
Financial result 200 (716)
Net Income (2 710) (3 245)
  In the first six months of 2018, turnover remained stable (+1% at €1.66 million) despite a drop in export sales of 11%. This decreasing resulted from a slow down in sales in the United Kingdom (that coincided with the purchase of British sales force), in Middle Eastern and southern European. These issues known on this period led to corrective actions being taken to revitalise those areas. The strengthening of our sales force in France, the purchase of a British sales force and the establishment of a partnership with a Japanese group, all constituted major investments in the first six months of 2018, and were all undertaken while maintaining cost control. Consequently, ordinary operating income dropped by €275,000 over the period (-€2.75 million compared with -€2.48 million in the first six months of 2017). However, after taking into consideration the positive financial result of €200,000, linked to the impact of exchange rates on the intra-group balance sheet (US subsidiary), net income rose by €0.54 million to - €2.7 million compared to -€3.2 million the previous year. On the 30th of June 2018, Safe Orthopaedics’ cash position was €474,000 compared with €3.74 million at the end of June 2017. However, this amount does not include the €6.95 million fund raised at the beginning of July, in order to boost the development of new minimally invasive technologies; create new strategic partnerships similar to the one established in Japan; launch SteriSpine VATM, a new range dedicated to vertebral augmentation that opens up a new market in 2018 worth €72 million; and, strengthen its direct sales force in France, Germany and the United Kingdom. “Safe Orthopaedics’ strategy of leading the spinal fracture treatment field has been boosted by our broader product portfolio as well as by the deployment of a direct sales force in France, Germany and the United Kingdom,” said Pierre Dumouchel, CEO and co-founder of Safe Orthopaedics. “The major developments in the first six months of 2018 and our successful fund-raising from institutional investors of reference at the beginning of July both aim to improve Safe Orthopaedics’ financial performance over the six-month periods to come.” Safe Orthopaedics has also enhanced the expertise of its Executive Board with the appointment of Anne Reiser. Anne Reiser was a member of Mondial RedMed’s board in which she was President of the Emea-Apac-Japan region from 2014 to 2017, having previously been President of the European area. Her entire career has been spent in the medical device field with sector leaders such as Medtronic, Hollister, Zimmer, American Home Product and Mölnlycke. At Zimmer, Anne Reiser managed a traumatology, arthroscopy and spine portfolio. She has lived in France and Germany and is currently based in Dubaï. “I am very excited to join Safe Orthopaedics’ Executive board and I am looking forward to bringing my sectoral and geographic experience.” At the same time, Kurma partners, an early stage investor in Safe Orthopaedics, has resigned from its position on the board. “Kurma partners may be resigning from the board but we continue to have full confidence in the strategy adopted by Safe Orthopaedics following the appointment of Pierre Dumouchel and his management team.” said Thierry Laugel, president of the board and founder of Kurma Partners. Forthcoming financial publication: turnover for the 3rd quarter of 2018 on Monday 8th October (after market close). About Safe Orthopaedics Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to offer the safest technologies for treating spinal fracture. Delivered sterile, all implants and single-use instruments are available to surgeons anytime, anywhere. These technologies facilitate minimally invasive methods which reduce the risk of cross-contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits have CE marking and are FDA cleared. The company is based at Eragny-Sur-Oise (France) and has 37 employees. For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics François-Henri Reynaud, Tel.: +33 (0)1 34 21 50 00 CFO investors@safeorthopaedics.com or NewCap Valentine Brouchot Investor Relations or Nicolas Merigeau Press Relations Tel.: +33 (0)1 44 71 94 94 SafeOrtho@newcap.eu or Ulysse Communication Bruno Arabian, +33 (0)6 87 88 47 26 barabian@ulysse-communication.com or Nicolas Daniels, +33 (0)6 63 66 59 22 ndaniels@ulysse-communication.com

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28 Sep

Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System

REDLANDS, Calif. and AUSTIN, TexasSept. 26, 2018 /PRNewswire/ -- Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System. Tesera X is the latest product to utilize Renovis' proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone. A 550-micron average pore size and 68% porosity combined with micro-surface roughness within the structure makes for an ideal environment for bone ongrowth and ingrowth. Tesera X completes Renovis' 3D-printed titanium interbody product portfolio, which also includes implants for ALIF, TLIF, PLIF, ACDF, and standalones. The company is hoping to take advantage of the recent consolidations in the spine market. For more information on the Tesera porous structure, visit www.teseratrabeculartechnology.com, or visit the company website to learn about our systems for spine, total joint replacement and trauma applications at www.renovis-surgical.com. About Renovis Surgical Renovis Surgical Technologies, Inc. was founded in 2009 with the mission to be a leading manufacturer of advanced medical devices, striving to continuously exceed customer expectations in service, quality, reliability, and value. The company is headquartered in Redlands, California, with engineering & manufacturing operations in Austin, Texas. For additional information on the Company, please visit www.renovis-surgical.com. Media Contact: sales@renovis-surgical.com, 1 (800) RENOVIS SOURCE Renovis Surgical Technologies, Inc.

Related Links

http://www.renovis-surgical.com

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27 Sep

4WEB Medical, TeDan Surgical Innovations and Lattus Spine Announce Exclusive Partnership To Provide Best In Class Total Lateral Solution

LOS ANGELESSept. 26, 2018 /PRNewswire/ -- 4WEB Medical, the industry leader in 3D printed implant technology, announced today at the North American Spine Society (NASS) Annual Meeting that the company has entered into an exclusive partnership with both TeDan Surgical Innovations and Lattus Spine, LLC to market a turnkey, best in class, Total Lateral Solution. "Today is a truly exciting day for 4WEB as we establish a premier market position with these game changing partnerships," said Jessee Hunt, 4WEB Medical President and CEO.  "The combination of our Truss Implant Technology and the Extreme Lateral access solution offered by TeDan and Lattus, address two major components of a Total Lateral Solution that is poised to make a meaningful impact on lateral spine clinical outcomes." The Extreme Lateral (XL) Access platform was developed to be the most user-friendly retractor system on the market. This was accomplished by integrating proprietary design elements that mitigate performance characteristics that surgeons find problematic in competitive retractors.  While TeDan will continue to market other surgical systems and fulfill contractual obligations to its existing customers, the company will no longer manufacture & distribute its flagship XL3 retractor.  Going forward, the company's primary focus will be the advancement of 4WEB's Lateral Spine Truss System™ through the continued development of the Lattus XL15 retractor. "The optimized ergonomics of the XL platform allows the surgeon to focus on implant technology rather than the access portion of the procedure," said Danny Fishman, President of TeDan.  "After analyzing the lateral market, we believe 4WEB's Truss Implant Technology provides the best in class implant offering necessary to be competitive with the market leaders in lateral surgery.  We are thrilled to be exclusive partners with 4WEB in our common goal to provide an industry leading Total Lateral Solution." 4WEB's proprietary Truss Implant Technology™ mitigates the chance of subsidence and leverages mechanobiology to stimulate an osteogenic response that facilitates the healing process in spine fusion procedures. The 4WEB Total Lateral Solution combines the most innovative implant design and access solution to successfully compete with well-established leaders in the lateral spine market. The transaction is subject to customary closing conditions. 4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical's proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures. For more information about 4WEB Medical, 4WEB's Truss Implant Technology™, and the Spine Truss Systems™, please visit www.4WEBMedical.com. SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

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27 Sep

Stryker announces 510(k) clearance of SpineJack® Implantable Fracture Reduction System

KALAMAZOO, Michigan, USA, Sept. 26, 2018 /PRNewswire/ -- Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.  The SpineJack system is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. In the SAKOS clinical study, the SpineJack system demonstrated superiority to balloon kyphoplasty (BKP) for the endpoints of freedom from adjacent level fracture and midline vertebral height restoration.  The SpineJack system also showed substantial and sustained improvement in both pain (VAS) and function (Oswestry Disability Index) over BKP. Available in three sizes to accommodate different vertebral body sizes, the SpineJack titanium implant is inserted and expanded, and PMMA bone cement is injected at low pressure to stabilize the restored vertebral body. The SpineJack system has been commercially available in Europe since 2008 and over 70,000 units have been implanted worldwide.  The company plans to execute a limited launch of the device for the remainder of 2018. For more information, please visit Stryker's booth #1401 at the annual meeting of the North American Spine Society in Los Angeles September 26th- 29th, or at www.stryker.com. About Stryker
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Media contact
Jennifer Lentner 
jennifer.lentner@stryker.com SOURCE Stryker

Related Links

http://www.stryker.com

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27 Sep

Histogenics to Meet With FDA to Discuss NeoCart Phase 3 Clinical Trial Data and Potential Regulatory Pathway

WALTHAM, Mass., Sept. 26, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss the top-line results from the NeoCart Phase 3 clinical trial and Histogenics’ planned Biologics License Application submission. Histogenics submitted its briefing materials regarding the top-line data of the NeoCart Phase 3 clinical trial to the FDA in mid-September 2018, and has been working closely with the FDA to schedule the meeting. Histogenics expects to provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018.  During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock in at-the-market offerings pursuant to Histogenics’ equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72 million after deducting sales agent fees and expenses. Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018.

About Histogenics Corporation

Histogenics (Nasdaq:  HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, 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 Histogenics’ forward-looking statements include, among others:  expectations regarding the timing and success of discussions with the FDA regarding the submission of a biologics license application for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital 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, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, 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.  Histogenics cautions 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.

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27 Sep

Kuros Reports First Patient Treated in Randomized Controlled Trial of MagnetOs in Spinal Fusion

SCHLIEREN (ZURICH), Switzerland, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Kuros Biosciences (SIX: KURN) today announced that the first patient has been treated in an investigator-led multicenter randomized controlled study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The University Medical Center Utrecht (UMCU) in the Netherlands is the principal investigating site for the study, which is entitled "A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion". UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “It is gratifying to see this important trial get underway in spinal fusion, as this area of great medical need is the focus of our commercial activities. The study is expected to generate important data that can help further differentiate MagnetOs and improve outcomes for patients.”

The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “It is a privilege to be leading this investigation of MagnetOs. MagnetOs is supported by some fantastic scientific evidence and is a treatment which has the potential to significantly improve patients’ lives. Patients own bone remains the gold standard against which all other grafts should be measured, yet very few studies have investigated synthetic alternatives side by side with autograft in a clinical setting. This study is poised to provide a level of definitive clinical evidence that surgeons have been crying out for.”

About the study The study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will enrolled in this study. Primary endpoint is posterior spinal fusion rate after one year based on CT-scans.

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:
Kuros Biosciences AG Media & Investors
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors
Tel +41 44 733 47 47 +41 79 598 7149
michael.grau@kurosbio.com hherklots@lifesciadvisors.com

About MagnetOs MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

About Kuros Biosciences AG  Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements  This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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27 Sep

North Carolina Physicians’ Whistleblower Lawsuit Leads to Second Multi-Million-Dollar Recovery in Ground-Breaking Emergency Room Fraud Case

September 27, 2018

CHARLOTTE, N.C.--(BUSINESS WIRE)--The United States Department of Justice and the United States Attorney’s Office for the Western District of North Carolina announced that HEALTH MANAGEMENT ASSOCIATES, INC. (“HMA”), now known as Health Management Associates, LLC, and its parent, will pay over $260 million to resolve false hospital billing and kickback allegations. This settlement includes civil payments by HMA of more than $74 million plus interest to the federal government and participating Medicaid states to settle six whistleblower lawsuits filed under federal and state False Claims Acts (FCAs) related to HMA’s emergency room fraud. One of these cases, filed by Drs. Thomas Mason and Steven Folstad, and their emergency medicine practice, Mid-Atlantic Emergency Medical Associates, PA (“MEMA”)(“collectively, “the MEMA Relators”), alleges a nationwide scheme by HMA’s corporate, division, and hospital executives to defraud federal and state healthcare programs by submitting false claims related to patients treated in HMA’s emergency rooms. MEMA alleged that HMA’s fraud caused two types of false claims to be submitted. First, HMA caused patients to be admitted from their emergency room without regard for medical necessity. In other words, patients were hospitalized when they did not need to be. Second, when HMA did bill for outpatient emergency room care, they padded the charges by manipulating the acuity points used to justify their billing. The MEMA Relators also allege that HMA and its affiliates acted in concert with a national emergency physician staffing company, Emergency Medical Services Corporation, Inc. (“EmCare”), and its affiliated entities, to defraud government healthcare programs and retaliate against MEMA for refusing to participate in the HMA and EmCare defendants’ emergency room fraud. The settlement includes false claims HMA submitted for both unnecessary admissions (false inpatient charges) and inflated patient acuity to support upcoded outpatient emergency room charges. Drs. Mason and Folstad and MEMA have been represented for longer than eight years by Marc S. Raspanti, Pamela Coyle Brecht, and Michael A. Morse of the Pennsylvania law firm, Pietragallo Gordon Alfano Bosick & Raspanti, LLP. They pursued this case on behalf of the MEMA Relators and the American taxpayers with co-counsel, James F. Wyatt, III and Robert Blake of the Charlotte, North Carolina law firm Wyatt & Blake, LLP. “After 24 years of practicing emergency room medicine at the highest level, it saddens me that we needed to file a federal lawsuit with all the effort that it has taken to stop these fraudulent practices. It is my hope that our efforts over these many years will make a difference for emergency room patients all over the United States,” said Thomas L. Mason, M.D., FACEP, Senior Member –Mid-Atlantic Emergency Medical Associates. “Our efforts should embolden other emergency medicine practitioners to stand up against corporate pressure to put profits before patient care. Perhaps others will not have to resort to taking the extraordinary measures that our group was forced to do to stop this type of illegal behavior,” said Steven G. Folstad, M.D., FACEP, Senior Member, Mid-Atlantic Emergency Medical Associates. Marc S. Raspanti, of Pietragallo Gordon Alfano Bosick & Raspanti, LLP, lead counsel said, “It has been a privilege to represent our clients through this long and stressful ordeal. They remain true healthcare professionals who chose to place their patients before corporate pressures. At the end of the day, only sick patients should be hospitalized. Billing for unnecessary hospital stays wastes precious government funds and endangers the viability of the Medicare Trust Fund.” Pamela Coyle Brecht, a partner with Pietragallo Gordon Alfano Bosick & Raspanti, LLP, who has also represented the MEMA Relators since 2010, added, “As a result of the fortitude of Drs. Mason and Folstad and their practice, and their willingness to stand up for their patients against two national behemoths, unsuspecting emergency room patients are no longer subject to this fraud. The taxpayers – both federal and state - have recovered tens of millions of dollars through the MEMA Relators’ efforts. “In recognition of the harsh reality that those who stand up against fraud often suffer retaliation and all of its related harm, the federal False Claims Act and the laws of North Carolina provide remedies for persons who, like the MEMA Relators, have been victimized by fraudsters,” said James F. Wyatt, III, the whistleblowers’ Charlotte-based counsel. The lawsuit is captioned United States et. al. ex rel. Mason, Folstad and MEMA v. Health Management Associates, Inc., et. al., No. 3:10CV472 (W.D.N.C.). The matter is assigned to the Honorable Graham C. Mullen. The plaintiffs’ private causes of action, which are still pending against HMA and EmCare, will be remanded to the U.S. District Court for the Western District of North Carolina for litigation on the Whistleblowers’ private causes of action. About Pietragallo Gordon Alfano Bosick & Raspanti LLP Pietragallo Gordon Alfano Bosick & Raspanti, LLP, a litigation and business law firm with a national client base, is one of the largest and most experienced whistleblower law firms in the United States. Lawyers in its nationwide whistleblower practice have served for 30 years as lead counsel in qui tam cases that have recovered over $2 billion for federal and state taxpayers. In addition to its Pittsburgh and Philadelphia offices, the firm has offices in Sharon, Pennsylvania; Steubenville, Ohio; and Weirton, West Virginia. For more information, visit our website at www.PIETRAGALLO.com.

Contacts

Pietragallo Gordon Alfano Bosick & Raspanti, LLP Pamela Coyle Brecht, Esquire PCB@Pietragallo.com or Marc S. Raspanti, Esquire MSR@Pietragallo.com or Micaela A. Famiglietti Public Relations Coordinator MAF@Pietragallo.com (215) 320-6200

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27 Sep

Centinel Spine Announces STALIF C® Integrated Interbody™ Milestone Usage in Australia

New York, NY, September 26, 2018 –Centinel Spine, LLC announced today that Dr. Arvind Dubey, MD, FRACS, Neurosurgeon and Spine Surgeon at Hobart Brain and Spine Centre in Hobart, Tasmania, Australia, performed a milestone procedure implanting his 1,000th level of the STALIF C-Ti™ Anterior Cervical Integrated Interbody®device.  The procedure was a 2-level ACDF and took place at the Royal Hobart Hospital.  Centinel Spine is the largest privately-held spine company focused on anterior column reconstruction and remains a leading provider of Integrated Interbody solutions, with over 30 years of clinical history and over 50,000 devices implanted. After implanting his momentous 1000th STALIF® level, Dr. Arvind Dubey commented, “The STALIF C® system offers me a very simple yet clinically effective system for treating my patients with degenerative disc disease.  The STALIF® design and lag screws provide constant compressive fixation between the endplates and graft material.  The compressive fixation coupled with the titanium surface give me the best opportunity to achieve fusion and has resulted in great outcomes for my patients.” STALIF Interbody devices are currently offered in three material options: PEEK, titanium-surfaced PEEK, and the recently launched 3D-printed, all-titanium FLX™ technology.  FLX implants feature a combination of solid and porous radiolucent titanium sections developed with the goal of reducing mechanical stiffness and improving visibility, as compared to solid titanium implants.  The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.  Furthermore, all three materials options are utilized with a single, streamlined instrument set. “We are proud to announce Dr. Dubey reaching 1,000 STALIF levels implanted and congratulate him on this significant achievement.  This milestone further exemplifies Centinel Spine’s mission in partnering with surgeons throughout the world to become the world-wide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms,” says Centinel Spine Chairman & CEO, John Viscogliosi. Centinel Spine will highlight the Company’s latest anterior column reconstruction technologies at the North American Spine Society (NASS) Annual Meeting−­held September 26-29, 2018 in Los Angeles, California at the Los Angeles Convention Center.  At the annual meeting, the company will demonstrate its commitment to advancing technology platforms for both fusion and motion preservation.  In Booth #2123, the company will showcase its recently acquired prodisc® Total Disc Replacement portfolio−the most extensive total disc replacement portfolio in the world−as well as its recently launched proprietary FLX 3D-printed, all-titanium devices for both cervical and lumbar fusion.  Additionally, Centinel Spine technologies will be highlighted in multiple podium presentations and hosted industry events. About Centinel Spine, LLC. Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc®Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use.  For more information on Centinel Spine products and technologies, please visit the company’s website at www.CentinelSpine.com. The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica, LLC and Surgicraft, LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies, and continues its corporate mission of becoming the leading anterior column reconstruction spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes. Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device. For more information, please contact: Varun Gandhi SVP, Corporate Finance & Strategic Planning Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 Phone: 484-887-8871 Email: v.gandhi@centinelspine.com Wendy F. DiCicco Chief Operating and Chief Financial Officer Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 Phone: 484-887-8837 Email: w.dicicco@centinelspine.com

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26 Sep

Alphatec Advances Clinical Distinction With OsseoScrew® Clearance

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) -- Alphatec Holdings, Inc.  (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its OsseoScrew® System, making it available for clinical use for the first time in the United States.

"I am exceptionally pleased that OsseoScrew has been cleared for the U.S. market,” said Pat Miles, Chairman and Chief Executive Officer. “The system will create new market opportunities for ATEC by uniquely addressing an unmet need for an underserved patient population.  We are building an organic innovation machine and today’s announcement represents another significant step toward creating a clinically distinguished portfolio.”

The OsseoScrew System

OsseoScrew is a next-generation expandable pedicle screw system, intended to restore the integrity of the spinal column in elderly patients with advanced stage tumors involving the thoracic and lumbar spine. It is designed to be implanted into the pedicle, then expanded after implantation to achieve increased screw fixation and reduced post-operative pullout in bone with poor density.  OsseoScrew has been clinically proven to increase pullout and holding strength, improving fixation in the bone-implant interface by 29%, as compared to conventional pedicle screws.  It performs comparably to cemented fenestrated screws without the risk associated with cement leakage.

Alphatec will display OsseoScrew this week at the North American Spine Society (NASS) 2018 Annual Meeting, which is being held from September 26-29 at the Los Angeles Convention Center.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company that designs, develops, and markets technology for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company's mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Alphatec, Alphatec Spine, the Alphatec logo, SafeOp Surgical and OsseoScrew are trademarks or registered trademarks of Alphatec Holdings, Inc., its affiliates and/or subsidiary companies. All other marks are the property of their owners. Additional information can be found at www.atecspine.com.

Forward-Looking Statements

This press release contains "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. The Company 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 the references to the Company’s strategy in significantly repositioning the ATEC brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including OsseoScrew, Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company's most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. ATEC 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: Tina Jacobsen Investor Relations tjacobsen@moreeffectiveir.com

Company Contact: Jeff Black Executive Vice President and Chief Financial Officer Alphatec Holdings, Inc. ir@atecspine.com

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26 Sep

SeaSpine Announces Launch of Regatta™ Lateral System

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of the Regatta™ Lateral System, featuring NanoMetalene® technology.

Regatta is a comprehensive, minimally invasive lateral interbody fusion system designed to efficiently and reproducibly treat the spine through indirect decompression and the restoration of sagittal alignment. Regatta offers a wide variety of implants to accommodate the patient’s anatomy, including 10 and 15 degree lordotic options for sagittal alignment and 18 and 23mm wide implants for complete endplate coverage. The Regatta lateral retractor and the EMG nerve detection dilators allow for customizable access with minimal tissue disruption through the psoas, while also providing the visualization necessary to effectively perform the procedure. The addition of new streamlined disc preparation and angled instruments to access challenging disc spaces combine to deliver the complete procedural solution.

“We are excited to provide this comprehensive lateral system to surgeons who perform less-invasive interbody fusion procedures that minimize the tissue disruption that typically accompanies traditional spinal fusion surgery. By optimizing each procedural element, from access to fusion, the surgeon can efficiently and effectively treat each patient’s unique spinal condition,” said Keith Valentine, President and Chief Executive Officer.

The Regatta interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene is a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide implants a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.

“The Regatta system offers a variety of sizes and angles of interbody implants to address the majority of patient anatomy requirements and my surgical correction goals. Additionally, the implant’s novel NanoMetalene titanium surface technology may allow for more rapid and reliable fusion healing, and allows me to consider a wider variety of graft materials, potentially reducing the cost of care,” stated Dr. James Bruffey, Orthopedic Spine Surgeon, Scripps Health - San Diego, CA.

SeaSpine will be conducting initial cases through a limited launch over the coming months and expects a full commercial launch of the Regatta Lateral System in the first half of 2019.

About SeaSpine SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design of the Regatta Lateral System to efficiently and reproducibly treat the spine, to provide customizable access with minimal tissue disruption while providing necessary visualization, and to access challenging disc spaces; the ability of the Regatta Lateral System to deliver a complete procedural solution and efficiently and effectively treat each patient’s unique spinal condition; and the timing of initial cases and full commercial launch of the Regatta Lateral System. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; unexpected delay, including as a result of developing and supporting the launch of new products, including the fact that newly launched products may require substantial additional development activities, which could introduce further delay, or as a result of obtaining regulatory clearances; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact Lynn Pieper (415) 937-5402 ir@seaspine.com

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