Spineology U.S. Clinical Trial for Interbody Fusion

Posted On October 1, 2018 By OrthoSpineNews In Spine /

October 01, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H., Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, presented 12-month outcomes data from Spineology’s SCOUT clinical trial at the recent annual meeting of the North American Spine Society (NASS) in Los Angeles, California.

The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

The fusion implant used in the SCOUT Study is Spineology’s porous graft containment mesh that deploys within the disc space as it is filled, permitting the packed bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients are skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion. Patients have been enrolled at ten participating study sites, and study enrollment is complete. Dr. Chi and his co-authors reported on 102 treated subjects, of whom 80 have completed 12-month postoperative follow-up and 27 have completed 24-month follow-up.

Statistically significant improvements were seen at six months, twelve months and 24 months in scores for low back pain and functional limitations, as recorded by Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) respectively. At the primary fusion endpoint of 12-months 65 of 70 (93%) with available films were fused, as read on CT by two independent radiologists. Eighty nine percent (89%) of subjects reported “Excellent” or “Good” patient satisfaction at 12 months (71 of 80) and 24 months (24 of 27). Safety was excellent. There were no unanticipated adverse events and no interbody device-related serious adverse events.

“We have found this innovative minimally invasive graft containment device to be a safe and effective option for lumbar interbody fusion procedures,” said Dr. Chi. “Patient- reported outcomes are very favorable, including improved function, reduced pain, and high satisfaction rates. Combined with excellent safety and radiographic fusion, the SCOUT study is demonstrating very favorable results.”

The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Spineology’s OptiMesh^® deployable implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data in support of a regulatory submission to FDA for expanded indications, allowing the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Spineology CEO John Booth said, “We are very pleased to know that SCOUT patients have reported these high satisfaction rates and good clinical improvements with their fusion success. We look forward to continuing patient follow-up and gaining the market clearance that will allow us to market this unique fusion device. We are grateful to Dr. Chi and all the SCOUT investigators for their commitment to this important clinical trial.”

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

Contacts

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

Medacta International Appoints Francesco Siccardi its Next Chief Executive Officer

Posted On October 1, 2018 By OrthoSpineNews In Recon /

October 01, 2018

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta^® International, the privately held, family-owned global leader in the design of innovative joint replacement and spinal surgery products, today announced that Francesco Siccardi, a noted biomedical engineer and current Executive Vice President of Medacta International, will become the company’s next chief executive officer on November 1, 2018. After nearly twenty years at the helm of the company, Medacta’s founder, Dr. Alberto Siccardi, will transition from his current CEO role and remain President of the company’s Board of Directors.

“It has been tremendously gratifying to see Medacta’s focus on medical education and sustainability resonate with surgeons and healthcare organizations around the world and to know that, together, we have changed orthopedics for tens of thousands of patients and their families,” said Dr. Alberto Siccardi, who founded Medacta following his own experience as a hip replacement surgery patient. “Medacta’s continued growth and prosperity make this an opportune time to transition to the next generation of the company’s leadership. With a deep understanding of both the technical and commercial sides of our business, Francesco is the right person to lead Medacta into the next phase of its evolution.”

Francesco Siccardi has served as Executive Vice President of Medacta International since 2010. A biomechanical engineer by training, he has been instrumental in the conception, development, and manufacture of many of Medacta’s leading products, including the AMIS® (Anterior Minimally Invasive Surgery) product line for total hip replacement, GMK® Sphere Total Knee System, MyKnee® Patient-Matched Technology, Efficiency Single Use Instruments, and the recently launched Medacta Shoulder System. Additionally, he was the driving force behind the creation of the Medacta Spine and Sports Medicine divisions. Francesco Siccardi joined Medacta in 2002 after studying Biomedical Engineering at the Politecnico of Milan.

“Medacta was borne out of my father’s experience as a patient, when he realized that orthopedic care should and could be better for both patient and surgeon alike. The company’s success is testament to that initial vision, and to the hard work behind it,” said Francesco Siccardi. “Over the past twenty years, Medacta has opened hundreds of surgeon learning centers, expanded into several new surgical disciplines, supported research efforts around the world, and changed the face of orthopedics in the process. The future is bright, and I am ecstatic to lead our talented Medacta team toward it.”

With Francesco Siccardi, the next generation of the Siccardi family will take over the operational responsibility of Medacta International. Francesco will be supported by the other two children of Dr. Alberto Siccardi: Alessandro Siccardi, a Board Member and head of the company’s supply chain, and Maria Luisa Siccardi, who also serves as a member of the company’s Board. Together with Medacta’s talented team of 930 employees, the organization strives to realize its mission to improve the patient experience emphasizing medical education, healthcare sustainability and responsible innovation.

About Medacta International

Medacta^® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

TransEnterix-files-a-FDA-510-k-for-Senhance-Ultrasonic-Instrument-System.jpeg

TransEnterix Receives CE Mark Approval for Senhance Ultrasonic Instrument System

Posted On October 1, 2018 By OrthoSpineNews In Regulatory /

October 01, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company received CE Mark approval for its Senhance Ultrasonic Instrument System.

Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures.

“Advanced energy devices are an important tool for laparoscopic surgeons because of their applicability within a wide range of procedures,” said Todd M. Pope, TransEnterix CEO. “We believe the addition of the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries that accept CE Mark around the world.”

“Ultrasonic energy devices are critical tools in managing complex surgeries while minimizing bleeding and trauma to surrounding tissue,” said Prof. Dietmar Stephan, M.D., Head of Minimally Invasive and Robotic Surgery at St. Marien Hospital in Siegen, Germany. “In certain procedures, use of such advanced energy has become standard of care. The addition of this capability to the Senhance Digital Laparoscopic platform is a significant expansion of clinical applicability.”

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical System and the Senhance Ultrasonic Instrument System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance™ Ultrasonic advanced energy capability will broaden the potential applicability of Senhance surgery in CE Mark countries, whether the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries around the world that accept CE Mark, and whether the addition of the ultrasonic energy device to the Senhance Digital Laparoscopic platform is a significant expansion of Senhance’s clinical applicability. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investor Relations:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Relations:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

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

Posted On September 28, 2018 By OrthoSpineNews In Financial /

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 30^th 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 30^th 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 VA^TM, 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

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

Posted On September 28, 2018 By OrthoSpineNews In Regulatory, Top Stories /

REDLANDS, Calif. and AUSTIN, Texas, Sept. 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.

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

Posted On September 27, 2018 By OrthoSpineNews In Spine /

LOS ANGELES, Sept. 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

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

Posted On September 27, 2018 By OrthoSpineNews In Regulatory, Spine /

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 26^th– 29^th, 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

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

Posted On September 27, 2018 By OrthoSpineNews In Regulatory /

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.

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

Posted On September 27, 2018 By OrthoSpineNews In Spine /

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.

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

Posted On September 27, 2018 By OrthoSpineNews In Regulatory, Top Stories /

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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