Nanovis Announces Successful Completion of $5.5 Million Investment Round To Fund Technology-Driven Growth

Nanovis, an innovative and fast-growing technology company selling nano-technology enhanced spinal implants, announced today the successful completion of a $5.5 million funding round managed by Commenda Securities. Key investors include Elevate Ventures, 1st Source Capital Corporation, Purdue’s Foundry Investment Fund, Commenda Capital, and Ellipsis Ventures.

“Our investment in Nanovis is consistent with our mission to support the ongoing development and success of entrepreneurial businesses across Indiana. This latest round of funding will provide Nanovis the growth capital they need as a high-performing, high-growth business,” says Elevate Ventures CEO Chris LaMothe.

Nanovis will use the funds to meet increased working capital and sales needs from surging demand from surgeons and distributors for Nanovis’ nanotechnology enhanced spinal implants.

“Investors recognized that Nanovis’ technology portfolio offers interbodies with the best combination of a deeply porous bone interface scaffold with a tailored nanotube surface and bridging bone visualization. Nanovis’ nanotube surface is the only nanotechnology in the spine market with which scientists can customize and control the spacing of the nanofeatures,” says Nanovis CEO Matt Hedrick. “Appropriate nanofeature design and control is important in optimizing bone growth. As a result, our distribution partners are already seeing rapid sales growth and hospital approvals for Nanovis’ FortiCore interbodies. In addition, we are receiving strong interest from surgeons in participating in our nanotube enhanced FortiCore interbody launch.”

Nanovis invents, acquires, and commercializes technologies that offer meaningfully superior implants to reduce fixation and infection related complications. Surgeons seeking for the best outcomes for their patients by utilizing the leading-edge nanotechnology, now have the option with Nanovis implants.

Nanovis’ nanotube enhanced FortiCore interbodies have deeply porous interconnected titanium scaffolds enhanced with a carefully designed nanotube surface and intermolded with a PEEK core, giving surgeons the most advanced interbody fixation technology with very good bridging bone imaging.

For more information about how to help patients, or better serve surgeons with Nanovis’ nanotechnologies, please visit us during the North American Spine Society (NASS) 2018 meeting September 26-29 in Los Angeles at Booth #2260 or call 1-317-507-1058.

For more information about distribution opportunities, please contact Jeff Shepherd, Vice President of Sales, at jeff.shepherd@nanovistechnology.com.

About Elevate Ventures
Elevate Ventures is a private venture development organization that nurtures and develops emerging and existing high-growth businesses into high-performing, Indiana-based companies. Elevate Ventures accomplishes this by providing access to capital, rigorous business analysis and robust advisory services that connect companies with the right mix of resources businesses need to succeed long-term. Learn more about Elevate Ventures at http://www.elevateventures.com.

About 1st Source Capital Corp.
The venture capital arm of South Bend, IN-based 1st Source Bank, invests in growing companies that have the ability to impact our local communities. The Bank’s parent company, 1st Source Corporation, has assets of $5.2 billion and is the largest locally controlled financial institution in the northern Indiana-southwestern Michigan area. For more information, visit http://www.1stsource.com.

About Nanovis
Nanovis’ mission is to develop science-enhanced, life-improving technologies targeted at tissue fixation and infection. The Company maintains a technology portfolio intended to fuel 10 years of growth. Focused on aggressive, sustainable growth in the Spine market, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore® line of interbody fusion devices; an advanced nanotube-surface technology; and surface technologies with anti-colonization and bactericidal capabilities.

SI-BONE, Inc. Announces France’s National Healthcare System Establishes Exclusive Positive Coverage for the Triangular iFuse Implant System® for MIS SI Joint Fusion

SANTA CLARA, Calif.Aug. 27, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (“MIS”) treatment of the sacroiliac (“SI”) joint with the iFuse Implant System® (“iFuse”) announced that iFuse will be added to the List of Refundable Products and Services in France (Liste des Produits et Prestations Remboursables – LPPR), meaning that the French National Healthcare System will cover the iFuse ProcedureTM.  Reimbursement, which is exclusive to the iFuse ImplantTM, has been established following the favorable opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS), begins September 6, 2018 and is effective for an initial period of five years.

The CNEDIMTS concluded, in its opinion of December 5, 2017*, that the iFuse Procedure’s observed outcomes, including improvements in quality of life and work status, are sufficient to include iFuse on the list of Products and Services provided for in Article L.165-1 of the Social Security Code. The Commission recommends brand name registration for the iFuse Implant System with the following indications: second-line treatment of sacroiliac joint dysfunction caused by sacroiliac joint disruption or degenerative sacroiliitis in patients who fail to respond to conservative treatment. Before treatment with iFuse, a diagnosis of unilateral or bilateral SI joint dysfunction must have been confirmed with positive responses to at least three out of the five SI joint provocative maneuvers (iliac wing spacing test (distraction), iliac wings approximation test (compression), the vertical compression test of each SI joint (thigh thrust), the sacral test (Faber) and the shear test of the two supine SI joints (Gaenslen), and a positive response to palpation of the SI joint. Patients who meet the above criteria may experience relief from diagnostic injections with anesthetics and/or corticosteroid injections in the sacroiliac joint. If the clinical response to an anesthetic injection is significantly positive, the sacroiliac joint may be considered as the source of the pain, and treatment with iFuse is indicated absent any contraindications.

The commission recommends reserving the use of the iFuse Implant device to surgeons who are accustomed to using image-guided surgery and who have received specific training on the iFuse Procedure.

The iFuse Implant System® implant is included in the LPPR list under the code 3147413, the corresponding act is NEDB454 “Arthrodesis of the Sacro-iliac joint by transparietal way, with radiological guidance”.

*https://www.has-sante.fr/portail/upload/docs/application/pdf/2018-01/ifuse_5_decembre_2017_5386_avis.pdf

The iFuse ImplantTM, available in Europe since 2010, is the only SI joint fusion device believed to be supported by multiple prospective clinical studies, including two randomized controlled trials, showing that the device improves pain, patient function and quality of life. The body of peer-reviewed published clinical evidence, unique to the iFuse Implant, has enabled government and private payors to establish positive coverage exclusive to the iFuse triangular implant. There are over 55 peer-reviewed publications supporting the safety, effectiveness, biomechanical and economic benefits of the iFuse Implant. (www.si-bone.com/results).

About SI joint dysfunction

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating. SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes. SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test6, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by diagnostic injections to confirm the diagnosis. The SI joint is the largest of the eight major joints in the human body and is believed to be the last to have a proven surgical treatment.

About SI-BONE, Inc.

SI-BONE, Inc. (Santa Clara, California) is a leading medical device company that developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. In the United States, the iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10217.082718

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
  6. Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

Centinel Spine Announces Initial Cases with FLX™ Platform of 3D Printed All-Titanium Interbodies

NEW YORKAug. 23, 2018 /PRNewswire/ — Centinel Spine, LLC announced today that it has completed initial cases with three different implant portfolios within their FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices.  Centinel Spine is the largest privately-held spine company focused on anterior column reconstruction.

FLX devices are 3D-printed, all-titanium implants which feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve 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.  Centinel Spine received FDA-clearance for multiple cervical and lumbar interbody fusion device families in May of this year.

“FLX offers me another great material choice to add to my fusion armamentarium,” says Dr. Jason Garber, a Neurosurgeon with Las Vegas Neurosurgical Institute, implanting STALIF C FLX™ Cervical Integrated Interbody and STALIF M FLX™ Lumbar Integrated Interbody devices. “With STALIF® implants made from PEEK, titanium-surfaced PEEK, and now 3D-printed titanium, I have the unique opportunity to provide my patients with optimal care options for their individual and specific needs.”

STALIF FLX Integrated Interbody devices offer a unique advantage over other all-titanium implants—as they are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

Dr. Stelios Koutsoumbelis, Chief of Division of Orthopedic Surgery at South Nassau Communities Hospital, performing the first ACTILIF C FLX Cervical Interbody implantation comments, “The FLX implant offers an open bone graft window optimizing graft volume and allowing bone growth throughout the trabecular matrix structure.  The open configuration also allows for CT visualization post-operatively to assess fusion.”

“The initial implantations of these FLX products represent a significant milestone in the evolution of our interbody technologies and advanced material platforms.  Our FLX products merge the proven benefits of the STALIF design with a truly novel, all-titanium lattice technology.  This provides surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology,” says Centinel Spine Chairman & CEO, John Viscogliosi.

Centinel Spine—the pioneer of the No-Profile®, Integrated Interbody—has a 30-year global clinical history of success behind these devices for the treatment of degenerative disc disease.  The FDA clearance of the FLX platform is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.

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

SOURCE Centinel Spine, LLC

(PRNewsfoto/Centinel Spine, LLC)

Related Links

http://www.CentinelSpine.com

Amedica Announces Successful Completion of First Valeo® C+CSC with Lumen Interbody Fusion Surgery

SALT LAKE CITY, Aug. 21, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, is pleased to announce the successful completion of the first spine fusion surgery using the Valeo C+CSC with Lumen Interbody Fusion Device.

The first surgery was performed by Dr. Tarek Elalayli of Nashville, TN. “The implant, consisting of a novel combination of solid and porous silicon nitride, is well-designed, and the surgical implantation was straight forward. The benefits of this new device include the potential for bone in-growth as well as on-growth, while a central lumen gives the surgeon flexibility to add bone graft, if needed. The device and underlying technology are a step toward spine fusion without the need for bone graft additives; with the advantages of good radiographic visualization, and inherent antibacterial properties of silicon nitride. No other spinal fusion implant combines all these properties.” said Dr. Elalayli.

The Valeo C+CsC with Lumen is Amedica’s newest spinal implant that received FDA clearance earlier this year. The device is a composite silicon nitride implant that combines different densities of Amedica’s proprietary medical grade silicon nitride ceramic. A solid, outer shell of nanostructured silicon nitride is manufactured around an inner porous layer, called CsC (“cancellous structured ceramic). CsC is approved for clinical use in Europe, and published clinical data from the CASCADE clinical trial have shown that it achieves spinal fusion without added bone grafts or fillers, at rates similar to those achieved by bone autograft.

“Several of our published reports have challenged the existing dogma that the surface texture of a biomaterial alone affects bone healing. Instead, we have shown that surface microchemistry also plays a critically important role in promoting bone healing. In the case of silicon nitride, we can precisely engineer both the surface nanostructure, as well as the surface microchemistry of an implant in order to stimulate bone-forming cells, speed up bone fusion, and discourage bacterial adhesion. The Valeo C+CsC with Lumen device captures these advantages by manufacturing different material densities into one smart, bioactive implant that is already optimized for spinal fusion. In contrast, competing implants made of inert metal and plastic usually require enhancement with cost-added bone fillers, surface texturing, or related gimmicks” said Dr. Sonny Bal, Chairman of Amedica. “Unlike any other biomaterial available for spinal fusion today, silicon nitride is in a class by itself,” added Dr. Bal.

The Valeo C+CsC with Lumen Interbody Fusion Device is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. Additional information about Amedica’s complete line of products can be found at www.amedica.com.

About Amedica Corporation

Amedica is focused on the development and application of medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR 
801-839-3502
IR@amedica.com

Vericel Announces Appointment of Jonathan Hopper as Chief Medical Officer

CAMBRIDGE, Mass., Aug. 20, 2018 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the appointment of Jonathan Hopper as Chief Medical Officer.

Dr. Hopper formerly served as Senior Medical Director, Orthopedic Clinical Development for Ferring Pharmaceuticals, where he was responsible for establishing and executing the company’s strategy for Orthopedic clinical development.  Prior to joining Ferring Pharmaceuticals, he served in a number of senior medical roles including Vice President, Global Medical Director for Stryker Corporation.  Dr. Hopper also has significant medical device regulatory experience having served as a Senior Medical Officer for the UK Medicines and Healthcare products Regulatory Agency.  Dr. Hopper graduated with a M.B. Ch.B. from Birmingham University Medical School UK, is a Fellow of the Royal College of Surgeons, Edinburgh, and attained an M.B.A. at Keele University UK.

“Jon’s experience and expertise in orthopedics, wound care, and combination biologic device products are an ideal fit with Vericel’s current business and strategic focus,” said Nick Colangelo, president and chief executive officer of Vericel.  “Jon will play a key role in the execution of our life cycle management initiatives as well as our efforts to expand our product portfolio by accessing assets complementary to our existing business.”

About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  For more information, please visit the company’s website at www.vcel.com.

Epicel® and MACI® are registered trademarks of Vericel Corporation. © 2018 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding our efforts to expand our portfolio, the commercial potential of our products and growth in revenues, intended product development, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with business development activities, competitive developments, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2018, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

(vcel-corp)

Global Media Contacts:
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Russo Partners LLC
David.schull@russopartnersllc.com
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)

Karen Chase
Russo Partners LLC
Karen.chase@russopartnersllc.com
+1 646-942-5627 (office)
+1 917-547-0434 (mobile)

Investor Contacts:
Chad Rubin
Solebury Trout
crubin@troutgroup.com
+1 (646) 378-2947

Lee Stern
Solebury Trout
lstern@troutgroup.com
+1 (646) 378-2922

NuVasive Appoints Dale Wolf To Lead Ohio Manufacturing Facility

SAN DIEGOAug. 16, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the appointment of Dale Wolf as vice president, Manufacturing, who will oversee the Company’s West Carrollton, Ohio manufacturing facility.

Mr. Wolf will fill a newly created role emphasizing the importance of the company’s goal to become a world-class manufacturer. He will manage the 180,000 square foot manufacturing operations, and focus on optimizing output, advancing the insourcing strategy and streamlining processes, reporting directly to Steve Rozow, executive vice president, Global Process Transformation. With accelerated improvements over the second half of 2018, the manufacturing facility is expected to produce 70 percent of its spinal implant products by year-end. The NuVasive insourcing effort represents a tremendous opportunity to control costs and implant quality, along with overall positive margin expansion.

With nearly two decades at General Electric (GE), Mr. Wolf has extensive experience in medical device manufacturing operations. He has held various leadership roles managing GE Healthcare manufacturing facilities, streamlining new product introductions, implementing Lean Six Sigma processes, supporting high-performance work teams and operating with the philosophy of continuous improvement. Most recently, Mr. Wolf led GE Healthcare’s Florence, South Carolina plant producing magnetic resonance imaging (MRI) components for the past four years. There, he led a site of more than 400 employees, and directed all supply-chain operations supporting $1 billion in revenue and $60 million in inventory.

“Dale brings a dynamic pedigree of experience in medical device manufacturing to NuVasive that will be instrumental in scaling our insourcing output,” said Steve Rozow. “His knowledge and expertise of managing complex operations will be integral in driving growth for our business as our manufacturing efforts continue to expand. Dale is a proven leader who will be a great addition to the robust manufacturing talent we are cultivating at NuVasive.”

Mr. Wolf earned a bachelor of science in Mechanical Engineering from the University of Wisconsin-Madison, and holds a Six Sigma Green Belt certification.

About NuVasive 

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements 

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

HSS Ranked No. 1 in Orthopedics by U.S. News & World Report for Ninth Consecutive Year

NEW YORKAug. 14, 2018 /PRNewswire/ — For the ninth consecutive year, Hospital for Special Surgery (HSS) has been ranked the No. 1 hospital in the nation for orthopedics by U.S.News & World Report “Best Hospitals 2018-2019” survey. HSS was also recognized as a leader in the field of rheumatology, maintaining the No. 3 ranking in the country. This is the 27th consecutive year HSS has been among the top rated hospitals.

“We are fully committed to our singular focus on musculoskeletal health which allows us to not only provide the highest quality of care and value but also to be a leader in the field through innovation,” said Louis A. Shapiro, president and CEO of HSS. “We are invested in helping people move better so they can live better.”

For the 2018-19 rankings, U.S. News evaluated more than 4,500 medical centers nationwide in 25 specialties, procedures and conditions. In the 16 specialty areas, 158 hospitals were ranked in at least one specialty.

“Whether it’s a routine or complex case, our patients benefit from highly specialized physicians with the shared goal of delivering an unmatched level of personalized care to each patient,” said Todd J. Albert, MD, surgeon-in-chief and medical director of HSS. “It is truly an honor to be a part of such a dedicated, patient-centric medical staff.”

In 2017, HSS cared for over 135,000 pediatric and adult patients surgically and non-surgically for conditions including joint pain, trauma and sports injuries, osteoarthritis, rheumatoid arthritis, back pain and spinal disorders, and conditions of the hand and upper extremity, and foot and ankle.

“Rheumatic and autoimmune diseases often present as diagnostic puzzles, and medical management can be challenging,” said Mary K. Crow, MD, physician-in-chief and chief of the Division of Rheumatology. “The chronic nature of these disorders requires sustained attention and a personal approach to care. I am regularly impressed at the level of specialized expertise that our outstanding rheumatologists provide for these complex patients and the coordinated teamwork and commitment of our HSS staff that optimizes patient outcomes and quality of life.”

HSS also provides care to elite, professional and collegiate athletes and organizations around the world, including USABasketball, Fédération Internationale de Football Association (FIFA), UFC, the Brooklyn Nets, New York Giants, New York Knicks, New York Mets and New York Red Bulls, among others.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

Centinel Spine Announces that UnitedHealthcare Will Now Cover prodisc L Anterior Lumbar Total Disc Replacement

NEW YORKAug. 7, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that UnitedHealthcare®, the nation’s second largest commercial insurer, has issued a positive medical policy for Lumbar Total Disc Replacement (TDR).  This decision affects over 16 million patients covered through UnitedHealthcare, and means that three out of the four largest US commercial providers now have positive policies for the company’s prodisc® L Anterior Lumbar Total Disc Replacement system.

This is the second major policy change for Lumbar TDR since May 2018, and follows the recent TRICARE® policy change that added 9.5 million covered lives.  These combined decisions provide over 25 million additional patients with access to this life-changing technology.  This trend of positive coverage decisions is bolstered by the long-term clinical outcomes and economic value that TDR provides to both patients and the healthcare system.

prodisc is the most studied Total Disc Replacement technology in the world, with over 400 publications demonstrating its long-term effectiveness in over 125,000 patients.  This recent decision by UnitedHealthcare is the culmination of over 30 years of clinical evidence generated by Centinel Spine and its originators, multiple FDA studies, and long-term clinical success supporting the effectiveness of the prodisc technology. This recent coverage change further solidifies Centinel Spine as the worldwide leading company addressing spinal disease through anterior access to the spine.

“The impending positive coverage decision by UnitedHealthcare will soon allow millions of Americans access to lumbar disc replacement, a technology that has proven itself over the past 30+ years globally. High-level scientific evidence from FDA studies in the US have clearly shown the safety, effectiveness, decreased adjacent level degeneration, and durability of improvement when properly-selected patients are implanted with a lumbar disc replacement instead of having a fusion, ” stated spine surgeon Jack Zigler, M.D., Texas Back Institute, Plano, TX.

“We believe the recent TRICARE and UnitedHealthcare policy decisions further validate the clinical outcomes of lumbar total disc replacement.  These positive decisions provide millions of additional patients with access to a proven, life-changing technology.  Centinel Spine remains focused on providing surgeons and patients with the widest breadth of technology platforms to address spinal disease by an anterior approach.  To that end, we plan to continue to invest in motion-preserving solutions and expand the clinical body of evidence and global adoption of lumbar disc replacement,” stated John Viscogliosi, CEO of Centinel Spine.

About Centinel Spine

Centinel Spine, LLC is the largest privately-held spine company, focused on anterior column reconstruction. For more information on Centinel Spine products and technologies, please visit the Company’s web site 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 support 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

SOURCE Centinel Spine / (PRNewsfoto/Centinel Spine)

Related Links

http://www.centinelspine.com

SI-BONE, Inc. Announces 23 Commercial Health Insurance Plans Now “Exclusively” Cover Triangular iFuse Implant System®

SAN JOSE, Calif.Aug. 7, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint with the iFuse Implant System® (“iFuse”) announced that 23 commercial health plans have published exclusive positive coverage policies for the triangular iFuse Implant System.  These exclusive positive coverage policies provide access to MIS SI joint fusion using the iFuse Implant System for over 35 million health plan members in the following plans:

1.    BCBS Florida

13.  BCBS-Louisiana

2.    BCBS-Illinois (HCSC)

14.  BCBS-Massachusetts

3.    BCBS-New Mexico (HCSC)

15.  BCBS-Minnesota

4.    BCBS-Oklahoma (HCSC)

16.  BCBS-Mississippi

5.    BCBS-Texas (HCSC)

17.  BCBS-New Jersey (Horizon)

6.    BCBS-Montana (HCSC)

18.  BCBS-NY (HealthNow)

7.    BCBS-Idaho

19.  BCBS-Tennessee

8.    BCBS-Kansas City

20.  BCBS-Wyoming

9.    BCBS-Independence

21.  BCBS-Capital

10.  BCBS-Regence

22.  Select Health

11.  BCBS-South Carolina

23.  AmeriHealth

12.  BCBS-Kansas

In addition to the above exclusive iFuse coverage policies, in July, eviCore healthcare, which according to their web site manages over 100 million lives, published a positive recommendation for exclusive use of the triangular iFuse ImplantTM  that takes effect October 22, 2018.  Also, on January 1, 2018, Blue Cross Blue Shield Association (BCBSA), a national federation of 36 independent, community-based and locally-operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 106 million members across all 50 states, the District of Columbia and Puerto Rico, published their “triangular only” recommendation for MIS SI joint fusion.  And on May 16th, AIM Specialty Health, which is owned by Anthem, published their exclusive iFuse policy that became effective July 1, 2018.

“Payers continually tell us that long-term outcomes data from well-designed, well-executed randomized controlled trials are critically important when determining coverage for new procedures or technologies,” said Jeffrey Dunn, President, CEO and Chairman of SI-BONE.  “The threshold for positive coverage includes a reliable diagnostic algorithm combined with a broadly adoptable treatment that is safe and clinically effective with a low revision rate and is cost-effective.  The iFuse Implant, that’s been available in the U.S. since 2009,  has been the subject of 58 peer-reviewed publications demonstrating safety, effectiveness, biomechanical and economic benefits, including 2 randomized studies.1,2  Based on this extensive body of published evidence, many payers have concluded that the iFuse Implant is the only SI joint fusion device that meets the evidence threshold and have established exclusive coverage.  We remain committed to continued investments in education and clinical evidence development in order to further expand access to all those who can benefit from surgical treatment of SI joint disorders.”

About SI joint dysfunction

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain3-6, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.7  SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes.  SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test8, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by image-guided diagnostic injections to confirm the diagnosis.  The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment.

About iFuse

The iFuse Implant™, available since 2009, is the only SI joint fusion device known to be supported by multiple prospective clinical studies, including two randomized controlled trials, showing that the device improves pain, patient function and quality of life.  The extensive body of peer-reviewed published clinical evidence, unique to the iFuse Implant, has enabled government and private payors to establish positive coverage exclusive to the iFuse triangular implant.  There are over 55 peer-reviewed publications supporting the safety, effectiveness, biomechanical and economic benefits of this iFuse Implant. (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10218.080718

  1. Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. DOI: 10.14444/3028
  2. Dengler J, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, Van Eeckhoven E, Cher D, Sturesson B. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017;20:537-550.
  3. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
  4. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  5. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  6. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  7. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
  8. Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

RTI Surgical® and Aziyo® Biologics Announce Exclusive Agreement to Distribute ViBone® for Spine and Other Orthopedic Procedures

August 01, 2018

ALACHUA, Fla. & SILVER SPRING, Md.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, and Aziyo Biologics, Inc., a fully integrated regenerative medicine company, today announced the signing of an agreement under which Aziyo will provide ViBone to RTI Surgical for exclusive distribution in the U.S.

ViBone is a bone repair product designed to perform and handle more closely to autograft in a variety of orthopedic proceduresViBone is processed using a proprietary method optimized to protect and preserve the health of native bone cells to potentially enhance new bone formation.

“ViBone is a next generation bone graft product that meets the diverse needs of surgeons with high potential for improved outcomes for patients,” said Camille Farhat, President and CEO, RTI Surgical. “ViBone will join RTI’s existing biologic portfolio as another important option for surgeons.”

RTI’s company strategy centers on organic and acquisitive growth focused on differentiated products supported by clinical data. RTI’s commercial team will integrate ViBone into its sales and growth strategy in the U.S., effective immediately. Together, RTI and Aziyo will initiate new research on ViBone in the coming months to build on the characterization and other data currently available.

“We are excited to partner with RTI Surgical, a recognized leader in spine and tissue-based implants, to bring this innovative option to more surgeons, and to further investigate the value it provides to patients,” said Ron Lloyd, President and CEO, Aziyo Biologics. “This agreement provides a platform for RTI and Aziyo to mutually grow and expand in the spinal fusion and orthopedic markets in service to more patients.”

About ViBone

ViBone is a next generation viable bone matrix that was designed to perform and handle more like high quality autograft. Aziyo’s proprietary manufacturing process was designed to optimally protect the tissue environment with less disruption. ViBone is based on science that brings bone grafting closer to meeting the surgeon and patient’s needs and provides a better option for bone repair. To learn more about ViBone, visit www.Aziyo.com/ViBone/.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

About Aziyo Biologics, Inc.

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For more information, visit www.Aziyo.com.

Contacts

RTI Media Contact
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
RTI Investor Contact
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com
or
Aziyo Media Contact
Courtney Guyer, +1-510-730-7896
PR@aziyo.com