Global Cartilage Repair/Regeneration Market Will Reach USD 6.5 Billion By 2024: Zion Market Research

New York, NY, Aug. 20, 2018 (GLOBE NEWSWIRE) — Zion Market Research has published a new report titled “Cartilage Repair/Regeneration Market by Treatment Modality (Cell-Based and Non-Cell Based), by Treatment (Cartilage Replacement and Cartilage Repair), by Type (Fibro Cartilage, Hyaline Cartilage, and Elastic Cartilage), and by End-Use (Ambulatory Surgical Centers, Hospitals & Clinics, Surgical Centers, and Others): Global Industry Perspective, Comprehensive Analysis & Forecast, 2017 – 2024”. According to the report, global cartilage repair/regeneration market was valued at approximately USD 4.3 billion in 2017 and is expected to generate revenue of around USD 6.5 billion by end of 2024, growing at a CAGR of around 5.8% between 2018 and 2024.

The primary factor driving the global cartilage repair/regeneration market is the growing prevalence of joints & bones disorders all across the globe. Increasing obese and geriatric population base all across the globe are the prominent factors driving the cartilage repair/regeneration market. According to the World Health Organization, by 2050 the number of people of age 60 or above will get doubled and is estimated to reach a value of 2.1 billion globally, from 962 million in 2017 globally.

Browse through 71 Tables & 29 Figures spread over 110 Pages and in-depth TOC on “Global Cartilage Repair/Regeneration Market Size, Share, Trends and Forecast, 2017 – 2024”.

Request Free Sample Report of Global Cartilage Repair/Regeneration Market Report @ https://www.zionmarketresearch.com/sample/cartilage-repair-cartilage-regeneration-market

According to the NIH (National Institute of Health), one-third of the adults in America aged above 45, generally suffer from cartilage damage issue. However, the high cost of treatment is acting as a hurdle for the cartilage repair/regeneration market and may affect its growth in the long term. Nonetheless, a significant investment by the government for the development of the process & therapies used for the treatment of cartilage damage along with the growing awareness are likely to disclose the new avenues for the market.

The cartilage repair/regeneration market is divided by treatment modality, type, treatment, and end-use.
Based on treatment modality, the cartilage repair/regeneration market has been segmented into cell-based and non-cell based. The cell-based segment is sub-segmented into growth factor technology, chondrocyte transplantation, and stem cells and the non-cell based segment is sub-segmented into cell-free composites, tissue scaffolds, and stem cells. By treatment modality, the cell-based treatment is estimated to hold the largest market value share attributed to the fact of long-term & effective results.

Download Free PDF Report Brochure: https://www.zionmarketresearch.com/requestbrochure/cartilage-repair-cartilage-regeneration-market

On the basis of treatment, cartilage repair/regeneration market has been segmented into cartilage replacement and cartilage repair. The cartilage replacement segment is sub-segmented into autologous chondrocyte implantation and osteochondral transplant and the cartilage repair segment is sub-segmented into cell-based cartilage resurfacing, microfracture, and non-surgical treatment.

By type segment, the cartilage repair/regeneration market is categorized into fibrocartilage, hyaline cartilage, and elastic cartilage.

Based on end use, the cartilage repair/regeneration market is classified into ambulatory surgical centers, surgical centers, hospital & clinics, and others. Hospital & clinics segment holds the maximum share and is expected to boost the market over the forecast period.

Browse the full Cartilage Repair/Regeneration Market by Treatment Modality (Cell-Based and Non-Cell Based), by Treatment (Cartilage Replacement and Cartilage Repair), by Type (Fibro Cartilage, Hyaline Cartilage, and Elastic Cartilage), and by End-Use (Ambulatory Surgical Centers, Hospitals & Clinics, Surgical Centers, and Others): Global Industry Perspective, Comprehensive Analysis & Forecast, 2017 – 2024  report at https://www.zionmarketresearch.com/report/cartilage-repair-cartilage-regeneration-market

In the cartilage repair/regeneration market, North America is anticipated to cover the prominent market value share over the estimated time. The U.S. is by far the leading cartilage repair/regeneration market by country in North America. The U.S. market is anticipated to grow with significant CAGR over the near future. Increasing number of cases of cartilage damage due to the active involvement in sports along with the significant investments by the government for the in therapies & procedures adopted for the treatment is supporting the growth of cartilage repair/regeneration market in North America. According to research data by the American Orthopedic Society for Sports Medicine, over 3.5 million athletes receive medical treatment due to sports injuries each year.

North America is anticipated to be followed by Europe and is expected to show a significant growth in the near future. This growth of cartilage repair/regeneration market is mainly supported by high per capita income which allows the population base to afford costly treatments of cartilage damage in this region.

 

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Xtant Medical Announces Appointment of Chief Financial Officer

BELGRADE, MT, Aug. 20, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development and commercialization of regenerative medicine products and medical devices, today announced the appointment of Kathie Lenzen as chief financial officer, effective August 20, 2018. Ms. Lenzen will report to Carl O’Connell, Xtant’s chief executive officer.

“Ms. Lenzen is an accomplished healthcare executive with significant financial expertise and we are pleased that she is joining our executive management team,” said Carl O’Connell. “In addition to the financial leadership she will provide to the organization, she is a strong strategic, cross-functional leader. Her appointment continues our commitment to building a highly skilled management team.”

Kathie Lenzen brings over 36 years of financial experience to Xtant. Most recently, Ms. Lenzen served as the senior vice president and general manager of Astora Women’s Health division. Prior to being in this position, she was the vice president of finance for American Medical Systems and drove financial performance to ensure EBITDA growth consistently outpaced revenue growth. She is versed in cross-departmental collaboration from a financial perspective, knowledgeable about information systems, restructuring for profitability, and merger and acquisition activities.

“I am excited to join the Xtant team and contribute to the Company’s growth strategy,” said Kathie Lenzen. “Xtant has made considerable progress over the past year, and I look forward to helping the Company continue to transform its business and drive shareholder value.”

About Xtant Medical

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘continue,’’ ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘strategy,’’ ‘‘will,’’ “can” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. The Company cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to increase revenue; the ability to achieve expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

SOURCE: Xtant Medical Holdings, Inc.

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com
Xtant Medical Holdings, Inc.

AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

17 August 2018 | By Ana Mulero 

In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.

The five-pronged action plan—revealed in April—consists of establishing a medical device safety net, exploring regulatory options for postmarket mitigations, spurring innovation towards safer devices and further strengthening cybersecurity.

It also involves plans for a major structural reorganization at FDA’s Center for Devices and Radiological Health (CDRH), which is expected to have an impact on the regulatory reviews, approvals and clearances of devices, to better support the total product life cycle.

The trade association expressed concerns with implying that devices cleared via the expanded abbreviated 510(k) program are safer compared to the traditional 510(k) pathway, whereas Johnson & Johnson expressed support for expanding the alternative to more moderate-risk devices.

The company also further stressed the trade association’s concerns around FDA’s statement that “the marketplace…does not provide strong incentives to make an established device safer in the absence of a new or greater-than-previously-understood safety concern.

“FDA should identify and overcome whatever internal obstacles prevent efficient practice,” said AdvaMed associate VP for technology and regulatory affairs Zachary Rothstein. “We note that at the time of this submission, our members’ experience indicates that FDA’s current use of emerging signals is subjective and, at times, lacks appropriate input from the manufacturer.”

But CDRH’s reorganization plans and advancing the use of RWE in support of regulatory decision-making were both endorsed by AdvaMed. The center’s RWE efforts, as well as those around advancing cybersecurity, are centered on developing the National Evaluation System for Health Technology, which is run by the nonprofit Medical Device Innovation Consortium (MDIC).

 

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Avista Healthcare Public Acquisition Corp. To Combine With Organogenesis Inc.

NEW YORK and CANTON, Mass.Aug. 17, 2018 /PRNewswire/ — Avista Healthcare Public Acquisition Corp. (NASDAQ :AHPA ) (“AHPAC”), a publicly traded special purpose acquisition company, and Organogenesis Inc. (“Organogenesis” or the “Company”), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care, Surgical and Sports Medicine markets, today announced that they have entered into a definitive merger agreement, under which Organogenesis will become a wholly owned subsidiary of AHPAC.  Affiliates of Avista Capital Partners (“Avista”), a leading private equity firm, have agreed to invest $92 million in the combined company in conjunction with the transaction.  Following the closing of the transaction, Organogenesis will be listed on the Nasdaq Stock Exchange under the ticker symbol “ORGO.”  The combined company will have an anticipated initial enterprise value of approximately $673 million.

Organogenesis’ mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients, while lowering the overall cost of care.  Organogenesis’ versatile product portfolio is designed to treat a variety of patients with repair and regenerative needs across the continuum of care.  Today, Organogenesis has over 600 employees worldwide and is led by a management team of talented individuals with more than 75 years of collective regenerative medicine experience.

“We are delighted to be partnering with Organogenesis, as the Company is well-positioned to benefit from secular tailwinds driving growth in the Advanced Wound Care, Surgical and Sports Medicine sectors,” said Thompson Dean, Executive Chairman of AHPAC.  “Organogenesis represents an ideal partner for AHPAC given its leading position in the large and attractive regenerative medicine sector, numerous growth opportunities and demonstrated ability to execute on product development and commercialization capabilities.”

Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis, said, “This is an important day in the history of Organogenesis.  We look forward to working with Tom Dean, AHPAC and Avista Capital Partners to continue building a successful enterprise.  This transaction will provide Organogenesis with capital that we will use to accelerate our growth plan for both our existing product portfolio and R&D pipeline.”

Additional Transaction Terms and Conditions

This transaction will be funded through a combination of cash, stock, and rollover debt financing.  Organogenesis’ key existing shareholders will remain committed long-term partners by rolling over their equity into the combined company.

The boards of directors of AHPAC and the Company have unanimously approved the proposed transaction and shareholders of the Company representing approximately 89% of the outstanding stock of the Company have agreed to support approval of the proposed transaction in any consent solicitation or shareholders’ meeting in connection with the transaction. Completion of the proposed transaction, which is expected before the end of the year, is subject to customary and other closing conditions, including regulatory approvals and receipt of approvals from AHPAC’s shareholders.

Credit Suisse Securities (USA) LLC is acting as financial advisor to AHPAC.  Weil, Gotshal & Manges LLP is acting as legal advisor to AHPAC.  Foley Hoag LLP is acting as legal advisor to Organogenesis.

Investor Presentation Information

AHPAC and Organogenesis are simultaneously releasing a slide presentation with information on the proposed transaction; this presentation will be filed with the Securities and Exchange Commission (SEC) as an exhibit to AHPAC’s Form 8-K, which will be filed to report its entry into the merger agreement, and can be viewed on the SEC website at www.sec.gov.  Investors are encouraged to review these materials.

About Organogenesis Inc.

Organogenesis Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopaedics and spine.  Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs.  For more information, visit www.organogenesis.com.

About Avista Healthcare Public Acquisition Corp.

AHPAC is a special purpose acquisition company that completed its initial public offering in October 2016.  AHPAC was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or business combination with one or more businesses.  AHPAC is sponsored by Avista Acquisition Corp., which was formed for the express purpose of acting as the sponsor for AHPAC.  Avista Acquisition Corp. is an affiliate of Avista Capital Holdings, L.P.  For more information, visit www.avistapac.com/ahpac.

About Avista Capital Partners

Founded in 2005, Avista is a leading New York-based private equity firm with over $6 billion invested in more than 30 growth-oriented healthcare businesses.  Avista targets businesses with strong management teams, stable cash flows and robust growth prospects and utilizes a proactive, hands-on approach to create value in our portfolio companies.  Avista’s Operating Executives and Advisors are an integral part of the team, providing strategic insight, operational oversight and senior counsel, that help drive growth and performance to create long-term value and sustainable businesses.  For more information, visit www.avistacap.com.

Contacts:

Kekst (for AHPAC and Avista Capital Partners)

Daniel Yunger

212-521-4800

Daniel.Yunger@kekst.com  

Organogenesis

Angelyn Lowe

781-774-9364

alowe@organo.com

Forward Looking Statements

This communication includes “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995.  Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters.  Such forward looking statements include estimated financial information.  Such forward looking statements with respect to revenues, earnings, performance, strategies, prospects and other aspects of the businesses of Avista, Organogenesis or the combined company after completion of the business combination are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward looking statements.  These factors include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the Agreement and Plan of Merger between AHPAC and Organogenesis (the “Merger Agreement”) and the proposed business combination contemplated therein; (2) the inability to complete the transactions contemplated by the Merger Agreement due to the failure to obtain the approval of the shareholders of AHPAC or the failure to satisfy the other conditions to closing in the Merger Agreement; (3) the ability of AHPAC to continue to meet applicable Nasdaq listing standards; (4) the risk that the proposed business combination disrupts current plans and operations of Organogenesis as a result of the announcement and consummation of the transactions described herein; (5) the ability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees; (6) costs related to the proposed business combination; (7) changes in applicable laws or regulations; (8) the possibility that Organogenesis may be adversely affected by other economic, business, and/or competitive factors; and (9) other risks and uncertainties indicated from time to time in the definitive registration statement of AHPAC filed in connection with the proposed business combination and the joint proxy/consent solicitation statement/prospectus contained therein, including those under “Risk Factors” therein, and other documents filed or to be filed with the Securities and Exchange Commission (“SEC”) by AHPAC.  Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made.  AHPAC and Organogenesis undertake no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.  Anyone using the presentation does so at their own risk and no responsibility is accepted for any losses which may result from such use directly or indirectly.  Investors should carry out their own due diligence in connection with the assumptions contained herein.  The forward-looking statements in this communication speak as of the date of this communication.  Although AHPAC may from time to time voluntarily update its prior forward-looking statements, it disclaims any commitment to do so whether as a result of new information, future events, changes in assumptions or otherwise except as required by applicable securities laws.

Disclaimer

This communication shall neither constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.  This communication relates to a proposed business combination between AHPAC and Organogenesis.

Additional Information and Where to Find It

In connection with the proposed business combination between Organogenesis and AHPAC, AHPAC intends to file with the SEC a registration statement on Form S-4 and joint proxy/consent solicitation statement/prospectus forming a part thereof (the “Registration Statement”).  This communication does not contain all the information that should be considered concerning the proposed business combination.  This communication is not a substitute for the Registration Statement that AHPAC will file with the SEC or any other documents that AHPAC may file with the SEC or that AHPAC or Organogenesis may send to stockholders in connection with the proposed business combination.  It is not intended to form the basis of any investment decision or any other decision in respect to the proposed business combination.  AHPAC’s shareholders and other interested persons are advised to read, when available, the preliminary and definitive Registration Statement, and documents incorporated by reference therein, as these materials will contain important information about AHPAC, Organogenesis and the business combination.  The proxy statement and the prospectus contained in the Registration Statement will be mailed to AHPAC’s shareholders as of a record date to be established for voting on the proposed business combination.

AHPAC Shareholders will also be able to obtain a copy of the Registration Statement once it is available, and other documents containing important information about AHPAC and Organogenesis once such documents are filed with the SEC, without charge, at the SEC’s website at http://sec.gov or by directing a request to: Avista Healthcare Public Acquisition Corp., 65 East 55th Street, 18th Floor, New York, NY 10022.

Participants in the Solicitation

AHPAC and its directors, executive officers and other members of its management and employees and Organogenesis and its directors and management may be deemed to be participants in the solicitation of proxies from AHPAC’s shareholders in connection with the proposed business combination.  Shareholders are urged to carefully read the Registration Statement regarding the proposed business combination when it becomes available, because it will contain important information.  Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of AHPAC’s shareholders in connection with the proposed business combination will be set forth in the Registration Statement when it is filed with the SEC.  Information about AHPAC’s executive officers and directors and Organogenesis’s management and directors also will be set forth in the Registration Statement relating to the proposed business combination when it becomes available.

SOURCE Avista Capital Partners

KFx Medical, LLC. Sues Stryker, Inc. for Patent Infringement

August 16, 2018

SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC. announced it has sued Stryker, Inc. (NYSE: SYK) for its continued infringement of US Patent number 7,585,311 and related patents for knotless double row rotator cuff repair.

In 2015, when KFx successfully defended these patents versus Arthrex, Inc., Arthrex paid in excess of $35m in damages and interest for its infringement of these same KFx Knotless Double Row Fixation patents and fought KFx through the appellate court and was ultimately denied any further review by the Supreme Court of the United States.

KFx Medical, LLC has 5 agreements that license the same patents to other medical device companies, giving them the right to promote the use of products and techniques for knotless double row rotator cuff repair as claimed in US Patent number 7,585,311 and related patents and applications for the life of those patents.

About KFx Medical, LLC

KFx Medical LLC was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine. The company is privately held. Investors include Alloy VenturesCharter Life SciencesArboretum VenturesMontreux Equity Partners, and MB Venture Partners.

Contacts

KFx Medical, LLC
Tate Scott
President and Chief Executive Officer
Tate.Scott@kfxmed.com
619-742-2010
www.kfxmedical.com

CoreLink, LLC Announces 510(k) Clearance for Foundation™ 3D Anterior Lumbar (ALIF)

August 16, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market The FoundationTM 3D Anterior Lumbar (ALIF) Interbody device. This marks the launch of the latest addition to CoreLink’s Foundation 3D Interbody Cage family.

Jay Bartling, CEO, said, “The Foundation 3D ALIF demonstrates our increasing capabilities with 3D printing titanium alloy. We’re proud to have the largest ALIF cage footprint on the market, which will allow surgeons to maximize endplate contact area and hold up to 8cc’s of graft.”

Prior to the newly 510(k) cleared ALIF device, CoreLink released 3 other sterile-packaged Foundation 3D interbody cages: Cervical, Straight Lumbar, and Curved Lumbar.

“I have been very pleased since converting to Foundation 3D Cervical last year. I am excited about the Mimetic Metal technology and have had great clinical outcomes with very happy patients.” said Todd Stewart, MD.

Foundation 3D ALIF leverages CoreLink’s proprietary Mimetic Metal™ technology that mimics key characteristics of natural bone – 100% open-pore architecture and micro roughened porosity with significant hydro-wicking properties. The new ALIF design also features patent pending StrutSure™ technology which creates a combination of load-sharing support structure and interconnected lattice designed to provide optimal balance between strength, stiffness, and stability. This unique structure minimizes implant material density, providing good imaging characteristics. Foundation 3D devices have a low modulus that may reduce stress shielding and enable the benefits of Wolff’s Law.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where the portfolio of Foundation 3D Products will be featured.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

(Photo: Business Wire) Foundation 3D

www.corelinksurgical.com

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808

BONESUPPORT – CERAMENT® G Approved by Health Canada

Lund, Sweden, 18:00 CET, 16 August 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, announces that its antibiotic-eluting product CERAMENT G has been approved by Health Canada.

CERAMENT G is the first and only CE-marked gentamicin-eluting injectable ceramic bone graft substitute on the market.  CERAMENT G sales have been growing strongly based on the clinical benefits it delivers when used for indications where infection may be present or of concern.

BONESUPPORT is currently conducting the FORTIFY trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial  include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G   in the US, where the product is expected to be launched in 2021. 

Emil Billbäck, CEO of BONESUPPORT said: “We are looking forward to commercializing CERAMENT G in Canada following its approval by Health Canada. CERAMENT G will be the first injectable antibiotic eluting ceramic bone graft substitute to be launched on the Canadian market. We are currently in dialogue with potential distributors to assist us in bringing this novel product to orthopedic surgeons managing bone voids where infection is present or an important risk.”

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 16 August 2018.

 

Pip Batty

Account Manager

 

3 London Wall Buildings

London Wall

London EC2M 5SY

Tel: +44 (0)20 7282 1022

Mob: +44 (0)7808 642 922

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 Extends Network to Aspen

NEW YORKAug. 14, 2018 /PRNewswire/ — HSS, the New York-based health system that includes Hospital for Special Surgery, is forming a strategic co-management partnership with Aspen Valley Hospital (AVH) and its OrthoAspen specialist group, to provide the world’s most advanced orthopedic care to Aspen community members and visitors. Following months of development, the relationship was endorsed by a vote on August 13 among the AVH Board of Directors.

Hospital for Special Surgery has been ranked the No. 1 orthopedic hospital in the nation for the past nine consecutive years by U.S. News & World Report ‘Best Hospitals’ (2018-19). AVH, Colorado’s only five-star rated critical access hospital by the Centers for Medicare and Medicaid Services, will adopt HSS best practices standards and leverage its orthopedic resources and capabilities. HSS will provide AVH with services including clinical knowledge transfer, medical staff development, professional education, research and academic programming, and practice quality enhancement.

“This partnership is a great example of our different approach to transforming healthcare,” said Louis A. Shapiro, president and CEO of HSS. “Innovative collaboration amongst two organizations committed to excellence in a focused specialty offers an alternative source of value to the trend of mass consolidation and commoditization in healthcare.”

“Embedding HSS’s knowledge, expertise, and best practices in AVH, enables world-class care to be more accessible and more individuals to live life to the fullest,” he added.

“We are thrilled to partner with Aspen Valley Hospital, an exceptional institution in its own right,” said HSS Surgeon-in-Chief and Medical Director Dr. Todd J. Albert. “Together we will provide an even higher standard of quality to a community with an especially strong appreciation for the value that will come from that.”

“This is a unique opportunity to advance the excellence of OrthoAspen and assure the most discerning consumers of world-class orthopedic care right here in Aspen,” said Dave Ressler, CEO, Aspen Valley Hospital. “This transformative partnership is very exciting for both AVH and HSS because it clearly demonstrates our shared commitment to delivering the best possible orthopedic outcomes.”

“It will also enable us to better control costs and deliver value to the Aspen community,” added Mr. Ressler.

Both nonprofit hospitals have long histories serving their respective communities – HSS was founded in 1863 and AVH has been serving Aspen for 127 years.

ABOUT ASPEN VALLEY HOSPITAL

Founded in 1891, Aspen Valley Hospital (AVH) is one of the most sophisticated rural hospitals in the U.S. With twenty-five beds, AVH is designated as a critical access hospital and level III trauma center, meeting the needs of the Aspen and Roaring Fork Valley communities, plus thousands of visitors from around the world every year. Combining the warmth and friendliness of a small town with the technical expertise of a major medical center, AVH has been recognized with numerous awards, including a Five-Star Rating from the Centers for Medicare and Medicaid; “Hospital of Choice” award (based on Hospital Consumer Assessment of Healthcare Providers and Systems results); and a “Top 20 Best Practice in Financial Stability” designation from the National Rural Health Association for critical access hospitals in the U.S., among others. AVH offers a full range of services with board-certified specialists in 25 fields of medicine, with expanded expertise in orthopedics and sports medicine. For over 125 years, Aspen Valley Hospital has been working to deliver extraordinary healthcare in an environment of excellence, compassion and trust. Learn more at aspenhospital.org or 970-925-1120.

ABOUT ORTHOASPEN

The OrthoAspen team of physicians is dedicated to improving and restoring the health of recreational and competitive athletes, adults, seniors and children. OrthoAspen has earned worldwide acclaim for its expertise in orthopedic care, providing the latest technologies and comprehensive services for its patients. Utilizing diagnostic imaging technology, minimally-invasive techniques, and the Mako surgical robot for total and partial joint replacements, OrthoAspen brings state-of-the-art orthopedic care to Aspen and surrounding communities. OrthoAspen’s research findings have been reported in major medical journals and at academic conferences throughout the world. Learn more at orthoaspen.org or 970-544-1289.

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

Related Links

http://www.hss.edu

China: Innovative Hybrid PEEK-titanium Expandable Cage for DLIF and OLIF Procedures Demonstrated

The growing interest in PEEK-OPTIMA™ spinal implants in China received further impetus at the 11th Congress of the Chinese Association of Orthopaedic Surgeons (CAOS) held in partnership with the North American Spine Society (NASS). At this event, Fule Science & Technology Development, Beijing, and Invibio Biomaterial Solutions partnered to demonstrate the new Uplifter® Expandable Anterior Lumbar Interbody Fusion Device in a hands-on workshop in Shanghai.

The Uplifter is the first domestic expandable hybrid cage, whose constituent materials are Invibio’s PEEK-OPTIMA™ Natural polymer and titanium. Indications for use of the Uplifter comprise Degenerative Disc Disease (DDD) of L2-L5, nerve root-canal stenosis, and lumbar spondylolisthesis.

During the live demonstration on a cadaver using the Uplifter, Dr Patrick C. Hsieh, from the USC Spine Center in Los Angeles, demonstrated the Direct-Lateral Lumbar Interbody Fusion (DLIF) procedure and device specifics: “The benefits of using PEEK1 for spinal implants include radiolucency that assists in accurate fusion assessment as well as having a track record of excellent long-term clinical results and radiographic fusion rates. Invibio PEEK-OPTIMA polymer combined with the features of Fule’s expandable cage allows 3-5mm of expansion, supporting the restoration of disc height and lordosis with more optimal foraminal height.”

Further clinical features of this hybrid implant include according to Fule:

  • Minimized impaction contributing to preservation of endplate integrity
  • Controlled expansion and anatomical fit helping to maximize indirect decompression through disc height restoration
  • Continuous expansion that can maintain stability by optimizing the fit

Professor Renfu Quan, a faculty member at Hangzhou Xiaoshan TCM hospital responsible for on-site cadaver workshops, explained the standard surgical techniques for OLIF and demonstrated the procedures for the surgeons present in a lab setting. Using Fule’s retractors and instruments, he showed how to implant their expandable ”Poster“ cage.

This live demo was available to surgeons who attended the workshop in Shanghai and was also broadcast directly to the CAOS/NASS congress in Hangzhou. The demo has also been published through the CAOS online education platform, being available to more than 10,000 participants in the CAOS congress.

Radiolucent biomaterial allows better fusion assessment
“PEEK has been used for interbody fusion devices for many years. Both, the literature and my personal experience indicate that PEEK provides better clinical outcomes compared with titanium-only approaches in spinal fusion. There is a higher fusion rate and lower subsidence”, Dr. Xifeng Zhang, from Beijing 301 Hospital, emphasized in his ‘Review of Clinical Applications and results associated with Direct-Lateral Lumbar Interbody Fusion (DLIF). Indeed, the potential benefits of PEEK-OPTIMA Natural in conventional spinal cages may translate to expandable cages. They include radiolucency, with no artifacts present, allowing better fusion assessment by CT and MRI and a modulus of elasticity close to that of bone, reducing stress shielding, which may otherwise contribute to implant subsidence.“

Guoping Fan, Technology Director at Fule Science & Technology Development Company commented: “To drive advances in orthopedics we partner with a variety of experts ranging from material and technology experts to orthopedic surgeons treating patients. The in-depth technical cooperation with Invibio for example allowed the development and introduction of this first hybrid PEEK-titanium expandable cage in China for DLIF and OLIF procedures. Now we are working full speed to develop the spinal fusion devices with PEEK-OPTIMA HA Enhanced.”

In China, Invibio´s enhanced PEEK is a relatively new thermoplastic biomaterial offering all of the clinical advantages of the unfilled “PEEK-OPTIMA Natural” polymer. In addition, it has been shown to improve bone apposition compared to unfilled PEEK-OPTIMA Natural in a pre-clinical ovine model at 4 weeks and 12 weeks (2), and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at 6 and 12 weeks. (2) In PEEK-OPTIMA HA Enhanced, Hydroxyapatite (HA), a well-known osteoconductive material, is fully integrated into the polymer matrix, and not simply coated on the surface. Early clinical results for cervical and lumbar spinal fusion reveal potential patient benefits and specific improvements for the enhanced biomaterial including solid fusions as early as 6 months, beneficial clinical outcomes at early time points, improvements in overall pain and neurological function. (3)

With China’s accelerating interest in innovative materials such as PEEK-OPTIMA from Invibio for spinal implants, it is expected that more and more patients can potentially benefit from implants using the high performance polymer. Today, more than 140 devices in China have been approved by the CFDA [China Food and Drug Administration, aka SFDA (State Food Drug Administration) ], with over 10 years of accumulated clinical history in China. (4)

The 11th CAOS/NASS congress in May marks the second time Invibio has partnered with a medical-device manufacturer in China to support surgeon education. The company´s PEEK-OPTIMA implants now have over 15 years of clinical history and approximately nine million PEEK-OPTIMA devices have been implanted worldwide. (5)

References:
(1) PEEK” is the abbreviation for polyetheretherketone, a high-performance polymer from the PAEK (polyaryletherketone) family.
(2) Walsh WR, Pelletier MH, Bertollo N, Christou C, Tan C. Does PEEK/HA Enhance Bone Formation Compared With PEEK in a Sheep Cervical Fusion Model? Clin Orthop Relat Res. 2016 Nov; 474(11):2364-2372.
(3) Testimonials presented have been provided by practicing orthopaedic surgeons. Their view and experience are their own and do not necessarily reflect those of others. “Invibio” disclaims any liabilities or loss in connection with the information herein.
(4) Data on file at Invibio Biomaterial Solutions.
(5) Data on file at Invibio Biomaterial Solutions.
Further information is available on https://invibio.com

About Fule Science & Technology Development 
Established in 1994, Beijing Fule Science & Technology Development Co. Ltd is a manufacturer and trader specialized in the research, development and production of Orthopaedic products including spinal products, trauma products, multi-functional external fixator, knee meniscus suturing device, rehabilitation instrument and related instruments. The company’s products have been widely used by thousands of large and medium-sized hospitals and achieved a good report, winning a high reputation from many orthopedic experts. Further information is available on http://www.fulekeji.com/en/index.php

About Invibio Biomaterial Solutions 
Invibio, part of the Victrex plc group of companies, is a global leader in providing high-performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic and dental medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in approximately 9 million implanted devices worldwide. Find out more at https://invibio.com/