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SeaSpine to Participate in the 13th Annual Wells Fargo Securities Healthcare Conference (corrected time)

Posted On August 29, 2018 By OrthoSpineNews In Spine /  

CARLSBAD, Calif., Aug. 28, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today the Company plans to participate in the 13th Annual Wells Fargo Securities Healthcare Conference at the Westin Copley Place in Boston, Massachusetts on Wednesday, September 5th, 2018 at 9:05 am ET.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.seaspine.com. A replay will remain available on the website for 30 days after the webcast.

About SeaSpine

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

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

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Globus Medical to Exhibit Latest Advancements in MIS Spine Surgery at SMISS Annual Forum

Posted On August 29, 2018 By OrthoSpineNews In Spine /  

AUDUBON, Pa., Aug. 29, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, will feature its ExcelsiusGPS® revolutionary robotic guidance and navigation system along with its latest advancements in expandable interbody technology at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum being held September 6-8, 2018, in Las Vegas, Nevada.

As part of the Forum’s scientific agenda, two clinical studies will be presented highlighting Globus Medical’s expandable lateral interbody spacer technology designed to restore disc height, increase lordosis, and reduce subsidence compared to traditional static spacers. The company will also host an ExcelsiusGPS® workshop presented by Dr. Sabino D’Agostino, a neurosurgeon from South Carolina, who will discuss his transition to the ExcelsiusGPS® platform and the impact it has had on his minimally invasive spine surgery procedures.

“As leaders in the musculoskeletal device industry, we are committed to supporting research, education, and development of medical advancements through minimally invasive spine surgery,” said Andrew Iott, Senior Vice President, Global Product Development. “We are proud to be a sponsor of SMISS and are excited to showcase our state-of-the-art ExcelsiusGPS® robotic system and best-in-class platform of innovative expandable implants for MIS spine surgery.”

Globus welcomes SMISS attendees to clinical presentations and workshops on Friday, September 7.

7:30am: Pompeian III/IV
ExcelsiusGPS® First Clinical Experience
Sabino D’Agostino, MD; Charleston Brain and Spine, Charleston, SC

11:05am: Florentine Ballroom
A Clinical Study to Evaluate Static versus Expandable Lateral Lumbar Interbody Fusion Devices: With One-year Follow-up 
Richard Frisch, MD; Southeastern Spine Institute, Mount Pleasant, SC

11:17am: Florentine Ballroom
Do Expandable Cages Lead to a Higher Incidence of Subsidence? Two-year Follow-up of Lateral Lumbar Interbody Fusions
Dan Cohen, MD; Spine Care Institute of Miami Beach, Miami Beach, FL

Globus Medical invites meeting attendees to Booth# 201 to experience its most recent product innovations and discuss MIS advancements.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com

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

Posted On August 28, 2018 By OrthoSpineNews In Financial, Top Stories /  

CARMEL, IND. (PRWEB) AUGUST 28, 2018

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.

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Wright Medical Group N.V. Announces Pricing of Public Offering of Ordinary Shares

Posted On August 28, 2018 By OrthoSpineNews In Financial /  

AMSTERDAM, The Netherlands, Aug. 27, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced the pricing of its previously announced registered underwritten public offering of 18,248,932 of its ordinary shares at an initial price to the public of $24.60 per share.  The net proceeds to Wright from the offering, after deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be $423 million.  The offering is expected to close on or about August 30, 2018, subject to customary closing conditions.  J.P. Morgan is acting as sole underwriter for the offering.

Wright intends to use the net proceeds of the offering to fund the purchase price of the previously announced pending acquisition (Acquisition) of Cartiva, Inc., as well as costs and expenses related thereto.  The offering is not contingent on the closing of the Acquisition.  If for any reason the Acquisition does not close, Wright intends to use the net proceeds of the offering for general corporate purposes.

An automatic shelf registration statement relating to the ordinary shares offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on May 4, 2016 and was effective upon filing. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC and will be available on its website.  When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com.

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

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include those regarding our expectations related to the offering discussed in this press release. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. Applicable risks and uncertainties include, among others, the inability of the company to complete the anticipated sale of equity securities or the acquisition of Cartiva, Inc., or a delay in closing of the same.  These and other risks are described under the caption “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017, filed by Wright with the SEC on February 28, 2018, and subsequent SEC filings by Wright, including, without limitation, its Quarterly Reports on Form 10-Q for the quarters ended April 1, 2018 and July 1, 2018. Investors should not place undue reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements.

Investors & Media:

Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com

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Ceterix Orthopaedics Announces FDA Clearance of New Suture Cartridge, Providing Increased Flexibility and Enhanced Options for Surgeons

Posted On August 28, 2018 By OrthoSpineNews In Regulatory /  

August 28, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an added feature to the NovoStitch® Pro Meniscal Repair System – a size 0 suture cartridge – offering surgeons more options to repair meniscal tears.

The NovoStitch Pro system enables surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address meniscal tears which have not been amenable to repair in the past. With the addition of the NovoStitch Pro’s new 0 suture cartridge, surgeons have expanded options in suture size and are able to pass a complete stitch within the knee joint without having to remove the device to reload a suture, a common shortcoming among other systems.

More than 100,000 patients each year experience a common yet debilitating type of meniscal injury known as a meniscal root tear1. The availability of the 0 suture cartridge to the NovoStitch Pro system offers greater flexibility to physicians performing meniscal root and other complex repairs.

“The considerable strain placed on the knee’s meniscus during common physical activities makes it particularly prone to injury,” said Dr. David Flanigan, professor of orthopaedics and director of the Cartilage Restoration Program at The Ohio State University Wexner Medical Center. “Having access to a larger suture provides additional possibilities for meniscal repair.”

“Ceterix continues to bring advanced technology to orthopaedic surgeons who are looking for better ways to preserve the meniscus,” said John McCutcheon, Ceterix’s president and CEO. “This latest innovation will be especially beneficial to those surgeons who prefer an ‘all-inside, all-suture’ procedure with a stronger suture for the more-demanding meniscal root repairs.”

The meniscus is a crescent of soft cartilage that sits between the femur and tibia, providing stability and shock absorption to the knee. The meniscus attaches to the tibia at its root but is subject to tearing at this attachment point. Historically, this type of repair would have been treated with a meniscectomy (complete or partial removal of the meniscus) which has been shown in studies to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life.2

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats a damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.3,4

About Ceterix® Orthopaedics

Ceterix Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Pro Meniscal Repair System has received 510(k) clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures, and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter.

1Cinque, M. E., Chahla, J., Moatshe, G., Faucett, S. C., Krych, A. J., & LaPrade, R. F. (2018, July 01). Meniscal root tears: A silent epidemic. http://dx.doi.org/10.1136/bjsports-2017-098942
2Chung et.al. Arth 2015 Oct; 31(10):1941-50.
3Brinker MR, O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. J Bone Joint Surg Am. 2002 Nov; 84-A (11):1926-32.
4New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006.

Contacts

for Ceterix Orthopaedics, Inc.
Durae Hardy
Durae@healthandcommerce.com

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SpinalCyte, LLC Announces New U.S. Patent

Posted On August 28, 2018 By OrthoSpineNews In Regulatory /  

August 28, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts, today announced issuance of U.S. Patent No. 10,052,410, “Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor.”

The technology described in the patent involves an in vivobioreactor which acts as a delivery system to feed and grow cells, like fibroblasts, and induces cellular differentiation. Additionally, the device will also be subject to one or more growth factors which may enhance differentiation of the cells.

“Our patent portfolio uniquely positions us at the forefront of human dermal fibroblast cell therapy for spinal disc regeneration,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “As leaders in this field, we continue to expand our intellectual property protections.”

With this addition, SpinalCyte’s portfolio now includes 33 U.S. and foreign patents issued and 43 patents pending.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

Russo Partners LLC for SpinalCyte, LLC
David Schull, 858-717-2310
david.schull@russopartnersllc.com
or
Ned Berkowitz, 646-942-5629
ned.berkowitz@russopartnersllc.com

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Medicrea to Begin Trading on the OTCQX Market in the U.S.

Posted On August 27, 2018 By OrthoSpineNews In Financial, Spine /  

August 27, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the transformation of spinal surgeries through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD ASI™ technologies, announced today that the Company will begin trading on the OTCQX Best Market under the tickers “MRNTY” and “MRNTF” on Tuesday, the 28th of August, 2018.

“Being qualified to trade on the OTCQX Best Market in the U.S. is a great opportunity for Medicrea as well as for institutional and individual investors looking for a transformational medical device company. We believe that our proprietary patient-specific UNiD ASI™ (Adaptive Spine Intelligence) technology will become standard of care across the spine industry over the coming years and that it will replace the current approach, which requires manual implant manipulation and selection from a limited range that is not tailored to individual patients or surgeons,” stated Denys Sournac, Chief Executive Officer of Medicrea.

“The U.S. is an important market for Medicrea’s UNiD ASI™ platform as it represents the largest global market for spinal surgery and represents a key growth area with the Company’s largest subsidiary based in New York City. As we continue to drive Medicrea’s technology adoption in the U.S., we want U.S. investors to have a simple and efficient way to invest in Medicrea. Joining OTCQX will complement our European listing on EURONEXT Growth – Paris, providing additional opportunities for liquidity to the global investment community,” expanded Mr. Sournac.

The Company will trade under two separate tickers, MRNTY, which will represent the Company’s American Depository Receipts (“ADR”) and MRNTF, which will represent the Company’s ordinary shares. Each ADR represents one share of the Company’s ordinary shares. Investors will have the opportunity to purchase in dollars either ADR or ordinary shares.

“We are excited to welcome Medicrea to the OTCQX Best Market,” said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. “Trading on the OTCQX Market will give Medicrea the opportunity to increase visibility within the U.S. and grow its investor base. Historically, international companies who trade on OTCQX have both increased the number of U.S.-based investors and improved trading volume in their home market, providing a benefit for investors in the U.S. and in their domestic markets.”

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 200 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

About OTC Markets Group Inc.

OTC Markets Group Inc. (OTCQX: OTCM) operates the OTCQX® Best Market, the OTCQB® Venture Market and the Pink® Open Market for 10,000 U.S. and global securities. Through OTC Link® ATS and OTC Link ECN, OTC Markets Group connects a diverse network of broker-dealers that provide liquidity and execution services. OTC Markets Group enables investors to easily trade through the broker of their choice and empower companies to improve the quality of information available for investors.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Medicrea is traded on
OTCQX Best Market
Symbol: MNRTY & MRNTF

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

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Health insurers look for ways to cut costs with back surgery

Posted On August 27, 2018 By OrthoSpineNews In Spine /  

By JAY GREENE /August 26, 2018

  • Insurers adopt prior authorization programs to encourage alternative treatments, save money
  • Blue Cross, HAP and Priority Health have different approval criteria that continue to evolve
  • Back surgeons sometimes find it difficult to manage prior authorizations, but denial rates are low

Back surgery is one of the most overused types of surgery as well as the most common ailment that sends patients to doctors, chiropractors and physical therapists. More than $90 billion a year is spent on low-back pain alone.

On any given day, 31 million Americans experience low-back pain, and it is the leading cause of disability worldwide, according to the 2017 Global Burden of Disease study. Back pain also is one of the most common reasons for missed work.

Controlling costs is a major effort most health insurers are focusing on with patients who want back surgery. In Michigan, Blue Cross Blue Shield of Michigan, Blue Care Network, Priority Health and Health Alliance Plan have programs to ensure members have carefully weighed their options.

Nationally, more than 1.2 million spinal surgeries are performed each year, including spinal fusion and decompression, or discectomy, surgery, according to the National Center for Health Statistics. The fastest-growing types the past decade have been lumbar spinal fusion surgeries that range from $60,000 to $110,000 per procedure.

Some studies have shown that the back surgery failure rate, known as failed back syndrome, is as high as 50 percent. But most spine experts say one-third of patients will have successful outcomes, one-third will have no change and one-third will be worse off.

Since 2007, Priority Health has cut down on back surgery costs by requiring patients who have non-emergency surgery to consult with a rehabilitation doctor, or physiatrist, about treatment options before surgery, said John Fox, M.D., Priority’s medical director.

During the first year of the spine program, Priority had an $8 million reduction in costs. Surgery costs fell 24 percent and imaging 18 percent.

Over the past dozen years, health care costs have risen and the population Priority serves has nearly doubled, Fox said. “Our spine surgery rate was 4.1 per thousand in 2006 and today it’s 2.1 per thousand,” he said. “For the commercial population of just over 500,000, that translates into a cost savings of $36 million per year in avoided costs.”

 

READ THE REST HERE

 

Photo: Jay Greene/Crain’s Detroit Business

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

Posted On August 27, 2018 By OrthoSpineNews In Spine, Top Stories /  

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.

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MiMedx Announces Statistically Significant Results In New Multicenter Clinical Study Of Healing Of Diabetic Foot Ulcers Using EpiFix®

Posted On August 24, 2018 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., Aug. 24, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ : MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new study regarding the use of EpiFix® in the treatment of diabetic foot ulcers (DFUs) has been published in the peer-reviewed journal, International Wound Journal.

The paper is entitled “A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics.” The paper was authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M Caporusso, DPM; and Patrick S. Agnew, DPM. The electronic publication of the article in International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.12976.

This multi-center randomized and controlled trial was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for InterMountain Healthcare. Dr. Tettelbach is now Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

Clinical Study Design and Results

The objective of the study was to determine the safety and effectiveness of EpiFix as compared to standard of care (SOC) therapy for the treatment of non-healing DFUs. The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 110 patients meeting study inclusion and exclusion criteria were analyzed in the Intent-to-Treat (ITT) cohort. A total of 98 patients completed the study Per Protocol (Per-Protocol cohort).

ITT analysis requires patients to be included even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are counted towards the final results.

In the current study on an ITT basis, 70% of patients who received weekly EpiFix had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (EpiFix 70% vs. SOC 50%, p=0.0338).

For patients completing the study per protocol, 81% of those who received weekly EpiFix treatments achieved complete healing by 12 weeks. In comparison, 55% of patients had complete healing in 12 weeks after receiving weekly SOC alone (EpiFix + SOC 81% vs. SOC 55%, p=0.0093).

In the ITT cohort, adjusting for co-variates associated with healing, Cox regression analysis showed patients treated with EpiFix were more than twice as likely to heal completely within 12 weeks as those not receiving EpiFix  (HR: 2.15, 95% confidence interval 1.30-3.57, p=0.003).

Mechanism of Action     

EpiFix® is a tissue matrix allograft composed of dehydrated human amnion/chorion membrane (dHACM). The Company’s published scientific work indicates that MiMedx dHACM retains a diverse array of regulatory proteins including essential growth factors, cytokines and chemokines, which are regulators in inflammation, wound repair and tissue regeneration.

About MiMedx 

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Statements regarding the safety and efficacy of EpiFix are forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

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http://www.mimedx.com

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