AP5969450151211407512171.jpg

Predictive Technology Group, Inc. (PRED) Announces Notice of US Patent Allowance for Method for Treating Patients with Genetic Spinal Deformities and Syndromes

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /  

SALT LAKE CITY, UT–(Marketwired – December 16, 2016) – Predictive Technology Group, Inc. (OTC PINK: PRED), a life sciences technology holding company, announced today that the United States Patent and Trademark Office (USPTO) has allowed a fundamental patent application — US20160296671 -that covers the practice of administering “ANY” spine deformation therapeutics to a patient having a spine deformation altered risk associated biomarker.

“We are pleased to see this latest allowance that supports PRED’s novel approach to diagnosing spinal disorders and syndromes, “said Mike Schramm, PRED’s Director of Intellectual Property. “This allowed US patent application supports the commercial use of both our diagnostic and next-generation companion treatment products.”

The claims of the ‘671 application build on previously issued US patents 8,123,787, 8,641,738, and 9,370,431 to which ‘671 claims priority and further bolster Predictive Technology Group’s Intellectually Property position.

“We are gratified to see this latest application allowance, which covers the core technology underlying the Company’s molecular diagnostic test” said Bradley Robinson, President and Chief Executive Officer of Predictive Technology Group, Inc. “Furthermore, this fundamental patent covers not only spinal applications of our technology, but establishes a precedent for the other patent applications that have been submitted on the Company’s portfolio of next-generation diagnostic and companion treatment products.”

The allowance of this new application is a significant milestone for Predictive Technology Group. The patent establishes the foundation of key intellectual property (IP) covering ANY treatment options (drug, surgery, bracing, etc.) for patients having a specific spine deformity biomarker. This newly allowed application is additive to previously announced patents. Furthermore, the Company has additional US and International patent applications pending and will pursue such applications with the objective of receiving additional issued patents in additional disease states.

About Predictive Technology Group, Inc.

Predictive Technology Group, Inc. (PRED), through its wholly owned subsidiaries, revolutionizes the treatment of serious and debilitating diseases through the commercialization of novel therapeutics leveraged by proprietary gene-based companion diagnostics. The Company develops and/or acquires proprietary technologies that open windows into the origin of human disease and the role that genes and their related proteins play in diseases’ onsets and progressions. PRED’s subsidiaries use gene-based information as cornerstones in the development of new diagnostics that assess a person’s risk of disease and therapeutic products designed to effectively prevent and/or treat diseases, www.predictivetechnologygroup.com

For more information about PRED, contact Mr. Richard Kaiser, Investor Relations, YES INTERNATIONAL, 757-306-6090 and yes@yesinternational.com

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new vaccines and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment and other risks the Company may identify from time to time in the future.

Image Available: http://www.marketwire.com/library/MwGo/2016/12/16/11G125445/Images/predlogo-872a3d3903e49728b49b4214eae8dea8.jpg

Read More
fgdfhgdh.jpg

Vericel Corporation Prices $17 Million Public Offering of Common Stock

Posted On December 19, 2016 By OrthoSpineNews In Financial /  

CAMBRIDGE, Mass., Dec. 16, 2016 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced the pricing of its previously announced underwritten public offering of 6,200,000 shares of its common stock, offered at a price to the public of $2.75 per share. The gross proceeds to Vericel from this offering are expected to be approximately $17 million, before deducting the underwriting discount and other estimated offering expenses payable by Vericel. Vericel has granted the underwriter a 30-day option to purchase at the public offering price up to an aggregate of 930,000 additional shares of its common stock to cover over-allotments, if any. The offering is expected to close on or about December 21, 2016, subject to customary closing conditions. Vericel anticipates using the proceeds from the offering to support the commercialization of MACI, expand promotional efforts for Epicel, expand and optimize manufacturing and for other general corporate purposes.

Piper Jaffray & Co. is acting as the sole manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities Exchange Commission (SEC) on June 29, 2015 and declared effective by the SEC on July 15, 2015.  The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement has been filed with the SEC and a final prospectus supplement for the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924 or by email: prospectus@pjc.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

About Vericel Corporation
Vericel develops, manufactures, and markets expanded autologous cell therapies for the treatment of patients with serious diseases and conditions.  The company currently markets two cell therapy products in the United States.  Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  Vericel also plans to market MACI® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults, which was recently approved by the FDA.  Vericel is also developing ixmyelocel‑T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy.

Cautionary Statement on Forward-Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the proposed public offering of Vericel’s common stock. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ, including, the satisfaction of customary closing conditions related to the proposed public offering, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vericel’s Annual Report on Form 10-K for the year ended December 31, 2015 and Vericel’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Vericel’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Vericel’s results. There can be no assurance that the actual results or developments anticipated by Vericel will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on Vericel. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

CONTACT:
Chad Rubin
The Trout Group crubin@troutgroup.com 
(646) 378-2947
or
Lee Stern
The Trout Group lstern@troutgroup.com
(646) 378-2922
Read More
proudly-southafrica.png

New Medical Device Registration Requirements Issued in South Africa

Posted On December 16, 2016 By OrthoSpineNews In Regulatory /  

December 14, 2016 by Stewart Eisenhart

 

EMERGO SUMMARY OF KEY POINTS:

  • New South African registration requirements for medical devices and IVDs appear to have taken immediate effect from December 9, 2016.
  • Registration will initially be required only for devices participating in South Africa’s public tender system.
  • The Medicines Control Council (MCC) will continue requiring licensing of local manufacturers, distributors and importers in order to import devices into South Africa.

The South African Department of Health has issued new regulatory requirements covering both medical devices and in vitro diagnostic (IVD) devices, according to Emergo consultants in Cape Town.

The regulations are based heavily on guidance and principles of the International Medical Device Regulators Forum (IMDRF) and its predecessor organization, the Global Harmonization Task Force (GHTF); the new rules appear to take effect immediately, but Emergo offices in South Africa and the US are working to verify implementation and compliance details.

Based on an initial analysis of the new regulations, registration with the South African Medicines Control Council or MCC is for now required only for devices whose manufacturers and sponsors participate in the country’s public tender system. However, the MCC has the authority to impose registration requirements at its discretion for devices not participating in public tenders, as well.

 

READ THE REST HERE

 

Read More
download.png

Groundbreaking spinal surgery done at StoneCrest

Posted On December 16, 2016 By OrthoSpineNews In Spine /  

Michelle Willard – mwillard@dnj.com – December 16, 2016

Back pain sufferers will try anything to relieve the constant pain from therapy to medications to injections before going under the knife.

That was no different for one patient at TriStar StoneCrest Medical Center in Smyrna.

Daniel Gamber had done everything short of surgery to relieve his nerve pain originating in the neck, said Dr. James Fish, an orthopedic spine surgeon affiliated with Hughston Clinic.

“Every patient that enters our doors is different, which is why TriStar StoneCrest Medical Center continues bringing alternative spine surgery options to our community,” Fish said. “We have to be able to provide the best treatment, surgical or non-surgical, for each patient based on their pathology.”

In the case of Gamber, the best option was a ground-breaking procedure, the first two level cervical disk replacement in Rutherford County.

Fish performed the disk replacement at StoneCrest. This procedure is less invasive that other surgical procedures and reduces the likelihood of additional surgical needs, especially in young patients.

“Continuing to bring alternative spinal surgery to our suburban-based hospital is exciting for TriStar StoneCrest Medical Center and Rutherford County,” Fish said about the surgery that aims to remove a damaged disc in the spine that is causing pain and replace it with an artificial disc.

 

READ THE REST HERE

 

 

Read More
stem-cell-spinal_cord.jpg

Spinal Intervention: Markets for Surgical, Replacement & Neurostimulation Technologies – Research and Markets

Posted On December 16, 2016 By OrthoSpineNews In Financial, Neuro, Spine /  

December 16, 2016

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Spinal Intervention: Markets for Surgical, Replacement and Neurostimulation Technologies” report to their offering.

The global market for spinal and neurostimulation intervention products is expected to reach $15.8 billion by 2021 from $12.6 billion in 2016, rising at a compound annual growth rate (CAGR) of 4.5% from 2016 through 2021.

The report provides an analysis of the markets for spinal and neurostimulation products, including trends and sales to 2021. It analyzes the market in terms of key product and technology areas, major manufacturers and factors influencing market growth.

Manufacturers of neurostimulation and spinal technologies are discussed and analyzed based on product types, market share and key corporate activities, including a mergers and acquisitions, strategic alliances, and research and development. In addition to neurostimulation products used for the treatment of spinal conditions, the report looks at the wider neurostimulation industry in order to provide a more comprehensive analysis of the overall market and growth opportunities for companies operating in this field.

The report also includes an in-depth analysis of new products and technologies in development, as well as the development of new products that can address a growing number of therapeutic indications.

Companies Mentioned:

  • Alphatec Holdings
  • B. Braun/Aesculap
  • Boston Scientific
  • CVRX
  • Depuy Synthes
  • Globus Medical
  • K2M
  • Livanova
  • Medtronic
  • Medtronic
  • Neuropace
  • NEVRO
  • Nuvasive
  • Orthofix International
  • St. Jude Medical
  • Stryker
  • Zimmer Biomet

Key Topics Covered:

1: Introduction

2: Summary – Complimentary

3: Market Overview

4: Current Market Environment

5: Spinal Implant Products And Technologies

6: Neurostimulation Products And Technologies

7: Product And Technology Pipeline

8: Industry Developments

9: Company Profiles

For more information about this report visit http://www.researchandmarkets.com/research/mwb9t2/spinal

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Orthopedic Devices, Neurology Devices

Read More
health-data-breach.jpg

Health data breaches hit 2016 high in November

Posted On December 16, 2016 By OrthoSpineNews In Regulatory /  

By NEIL VERSEL

Just when you think the cybersecurity problem couldn’t get any worse in healthcare, along comes a report saying that there were more health data breaches disclosed in November than in any other month in 2016.

In a report released Thursday, Protenus, a startup focused on tracking and preventing healthcare data breaches, said there were 57 such incidents last month. That is 60 percent higher than the 35 in October, based on statistics compiled by DataBreaches.net.

Surprisingly, 31 of the data breaches in October, or 54 percent, were inside jobs, according to the monthly Protenus Breach Barometer, while just nine were traced to hackers. The Ponemon Institute said in May 2015 that criminal activity had become the top source of health data breaches.

“While insiders are always a major source of health data breaches and HIPAA violations in any given month, this month was particularly striking,” Protenus Cofounder and CEO Robert Lord said via email. “In November, there were insider breaches at a few business associates that resulted in a wide array of their clients submitting breach reports.”

At least three of the hacks involved ransomware; a fourth “mentioned ransom/extortion but not ransomware,” the Breach Barometer said.

 

READ THE REST HERE

Read More
BoneSupport.jpg

BONESUPPORT confirms election of Dr. Håkan Björklund as Chairman of the Board

Posted On December 16, 2016 By OrthoSpineNews In Biologics, Financial /  

Lund, Sweden, 16 December 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces, that Dr. Håkan Björklund has been confirmed as Chairman and that  Ms. Tone Kvåle has been elected as a  new Board Member. The appointments were made at an EGM held on 15 December 2016.

Dr. Björklund is Partner of Tellacq AB, a private investment firm. He joined the BONESUPPORT Board in September 2016 in conjunction with the Company’s $37 million (SEK 315 million) financing, which was led by Tellacq. Dr. Björklund has a long and successful track record in the healthcare industry, including as the former CEO of Nycomed, which he grew from a small Scandinavian company into a global business before its acquisition by Takeda in 2011. He is currently chairman of the board of Swedish Orphan Biovitrum AB and an Industry Executive at Avista Capital Partners.

Tone Kvåle joins as a Board Member and Head of the Audit Committee. She is currently Chief Financial Officer of Nordic Nanovector, an Oslo-listed biopharmaceutical company, and has more than 20 years’ biotech industry experience. Prior to joining Nordic Nanovector, she was CFO of NorDiag, Kavli Holding and Dynal Biotech, and has held senior management positions at Invitrogen, Life Technologies and ThermoFisher (US). Ms. Kvåle has a diploma in Finance & Administration from Harstad University College.

Richard Davies, CEO of BONESUPPORT, said: “I am extremely happy that Håkan has been elected Chairman and that Tone will be joining the Board. This is an exciting period for BONESUPPORT following our recent $37 million (SEK 315 million) financing. We are now focused on building further additional shareholder value by growing  sales of our current CERAMENT products, generating further data highlighting the clinical and health economic benefits these products deliver and progressing our pipeline. I am confident that Håkan’s and Tone’s experience will be valuable in helping us achieve our strategic goals.”

Dr. Björklund said: “I look forward to working with the management team and the Board to deliver BONESUPPORT’s potential to become a global leader in the management and treatment of bone disease based on the unique properties of its CERAMENT platform.” 

Notes to Editor

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at high risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark. 

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

 

 

Read More
Sanuwave.jpg

SANUWAVE Announces Cooperation with Ortho-Medico in Europe on a New 100 Subject Trial Treating Patients with Diabetic Foot Ulcers In-Home Care Using Dermapace

Posted On December 16, 2016 By OrthoSpineNews In Extremities /  

SUWANEE, GA / ACCESSWIRE / December 15, 2016 / SANUWAVE Health, Inc. (OTC QB: SNWV) is pleased to announce that the Company, in partnership with Ortho-Medico, a member of B&Co, Herzele, Belgium, is sponsoring continuing clinical investigation on diabetic foot ulcers (DFU). This trial is expected to begin in January 2017, and will be conducted by the VUB (Free University of Brussels) and UZ Brussel (University Hospital). Earlier work in 2015 at this hospital found that DFU patients, treated in-home with dermaPACE system, responded positively to the treatment. This trial will take the home-care procedures, used in a limited basis, and extend them to a randomized, controlled trial of 100 subjects. The intent of this trial is to compare the effectiveness of in-home treatment of diabetic foot ulcers (DFUs) using dermaPACE as compared to in-home treatment of DFUs using standard of care only. This trial will help to provide evidence that dermaPACE can be used outside the clinical setting and in essence increase the potential for expanded sales in Europe.

Ortho-Medico has long been SANUWAVE’s partner in the European Union. With their strength, experience, and knowledge of the orthopedics and wound care market, they are well positioned to help expand SANUWAVE’s market penetration via increased clinical presence and to continue to promote the Company’s core products, dermaPACE, and orthoPACE systems.

Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board, said, “We are very excited about this opportunity to investigate the use of dermaPACE in the home environment. We are equally excited that this opportunity is the first of many that SANUWAVE will partner with Ortho-Medico to help expand the clinical evidence associated with the use of dermaPACE system on diabetic foot ulcers.” Added Jo Schops, General Manager of Ortho-Medico, “Our company has long been a proponent of dermaPACE and orthoPACE and this clinical trial will help to show the strong efficacy exhibited by the use of dermaPACE on DFU’s. We are pleased to be partnering with SANUWAVE and the combined strength of our two companies will only help to expand market penetration in the European Union.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets, and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron®, and orthoPACE® devices in Europe, Asia, and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About Ortho-Medico

Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico’s final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico’s success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.

Read More
tmars-hero2-1.png

National Joint Registry Analysis Finds Zimmer Biomet Trabecular Metal™ Cups Associated with Significantly Lower Risk of Subsequent Revision Due to Infection in Revision Hip Procedures

Posted On December 16, 2016 By OrthoSpineNews In Recon /  

WARSAW, Ind., Dec. 14, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced positive outcomes associated with the use of its Trabecular Metal™ Cups in more than 9,500 patients undergoing revision hip arthroplasty.  The data, which stemmed from a new report by the National Joint Registry (NJR) for England, Wales, Northern Ireland and the Isle of Man, documented that Trabecular Metal Cups were associated with lower infection rates and a significant reduction in subsequent hip revision rates.

Specifically, the independent analysis conducted by NJR demonstrated the following*:

  • Trabecular Metal Cups used in revision total hip arthroplasty (THA) have been shown to be 21 percent less likely to be re-revised due to infection (statistically significant, p-value=0.036).1,2
  • For high risk patients with a first revision indication being infection, Trabecular Metal Cups appear to be 35 percent less likely to be re-revised for infection. Due to the limited sample size, this has not reached statistical significance (not statistically significant, p-value=0.108).3
  • Trabecular Metal Cups used in revision THA have been shown to be 11 percent less likely to be re-revised for any reason (statistically significant, p-value=0.015).1

NJR is a government-led registry that monitors the performance of joint replacement implants and the effectiveness of joint replacement procedures, with a focus on improving clinical standards.  The report retrospectively analyzed outcomes related to 9,573 revision procedures using cementless Trabecular Metal Cups and 30,452 revision procedures using non-Trabecular Metal cementless cups, from April 2003 through July 2015.  The complete NJR report can be found at www.zimmerbiomet.com/TM.

“Infection, implant loosening, pain and dislocation are the most common reasons for revision joint replacement surgery,” said Dan Williamson, Zimmer Biomet Group President of Joint Reconstruction. “Our Trabecular Metal acetabular devices are designed to meet the long-term performance needs of hip implant patients.  The NJR report reinforces their value in significantly reducing hip revision rates in a large clinical patient population and yielding better outcomes in comparison to traditional non-Trabecular Metal implants.”

Zimmer Biomet’s Trabecular Metal Material is a unique, highly porous biomaterial made from elemental tantalum with structural, functional and physiological properties similar to bone.  The material, which features a 100 percent open, engineered and interconnected pore structure to support bony in-growth and vascularization, has been used in a variety of orthopaedic applications for more than 19 years.4

“Infection after orthopaedic procedures has moved into center stage,” says Javad Parvizi, M.D., an orthopaedic surgeon at the Rothman Institute at Thomas Jefferson University Hospital in Philadelphia.  “Based on recent data from various sources, it appears that Trabecular Metal implants have unique properties that allow them to reduce the incidence of infection after revision total hip arthroplasty.  This finding is encouraging and should provide impetus for us to design studies that unravel the exact anti-infective properties of Trabecular Metal implants.”

*The statements have not been evaluated by the FDA for Zimmer Biomet Trabecular Metal Cups and do not alter the cleared indications for use.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

___________________________________
1 According to NJR data from 2003 to 2015 where 9,573 Trabecular Metal and 30,452 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (osteoarthritis/non-osteoarthritis).

2 NJR data shows a higher percentage of Trabecular Metal cups were used with antibiotic bone cement compared to all other non-Trabecular Metal cementless cups.

3 According to NJR data from 2003 to 2015 where 628 Trabecular Metal and 2,114 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (osteoarthritis/non-osteoarthritis).

4 Karageorgiou, V. and Kaplan, D. “Porosity of 3D Biomaterial Scaffolds and Osteogenesis.” Biomaterials, 26 (27): 5474-91, September 2005

 

SOURCE Zimmer Biomet Holdings, Inc.

Read More
si-bone-bg-01.jpg

Health Care Service Corporation (HCSC), the Fourth Largest Health Insurer in the United States, Establishes Exclusive Positive Coverage Policy for SI-BONE’s iFuse Implant System® for Minimally Invasive Sacroiliac Joint Fusion

Posted On December 16, 2016 By OrthoSpineNews In Spine /  

SAN JOSE, Calif., Dec. 15, 2016 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Health Care Service Corporation (HCSC), an independent licensee of the Blue Cross and Blue Shield Association (BCBSA), has issued a positive medical policy exclusively for iFuse for MIS SI joint fusion (SUR705.033).

HCSC is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, with approximately 15 million covered lives insured through Blue Cross and Blue Shield® (BCBS) Plans in Illinois, Montana, New Mexico, Oklahoma, and Texas. The positive coverage policy, which becomes effective January 1, 2017, covers MIS SI joint fusion exclusively using iFuse, based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse Implants™ for SI joint fusion.  HCSC joins SelectHealth of Utah and Geisinger in Pennsylvania to become the third private insurer to issue a positive coverage policy for MIS SI joint fusion exclusively using iFuse.  In addition, the five BCBS plans within HCSC join BCBS of Michigan and BCBS of Nebraska to provide iFuse coverage for BCBS members in seven states.

The policy calls out almost 3 dozen iFuse publications, including two randomized controlled trials (RCTs) comparing iFuse to non-operative care (INSITE and iMIA), long term results from a multicenter prospective single-arm trial (SIFI), as well as data from dozens of additional scientific publications addressing safety, durable effectiveness, biomechanics and cost effectiveness.  The policy summary states “based on professional societal organizations, literature reviews, in vitro studies, surveys, and cost-effective studies showing success and/or support for treating SIJ dysfunction with minimally invasive SIJ fusion, including a 2016 retrospective study group of patient surveys greater than 3 years, the evidence is sufficient to determine the effects of the technology on health outcomes.  Therefore, minimally invasive SIJ fusion or stabilization, using titanium triangular implants or devices, for the treatment of back pain presumed to originate from the SIJ may be considered medically necessary when meeting all of the specific criteria.”  iFuse is the only SI joint fusion device in the U.S. with peer-reviewed publications detailing evidence from prospective trials, and is the only SI joint fusion device with a FDA-cleared indication citing clinical studies that demonstrate improvements in pain, patient function and quality of life.

“The quality and quantity of clinical data supporting iFuse is compelling and was obviously a key element in enabling HCSC to establish exclusive coverage for iFuse,” said Frank Phillips, MD of Midwest Orthopaedics at Rush in Chicago, IL.  “Blue Cross Blue Shield patients make up a considerable part of my practice and now, those with SI joint pain caused by SI joint degeneration or disruption will have access to this clinically proven treatment.”

Ralph Rashbaum, MD of the Texas Back Institute in Plano, TX commented: “this is terrific news for Blue Cross Blue Shield patients throughout the state of Texas.  I frequently see BCBS patients in my practice who have SI joint pain and now, for those who are properly diagnosed and appropriate surgical candidates, I can offer them the iFuse procedure and eliminate the need for other costly procedures that fail to provide lasting relief of their SI joint symptoms.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotation of the sacrum relative to the illium.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth, facilitating long-term fusion of the joint.  iFuse is the only commercially available SI joint fusion system in the United States with published clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  It is the only SI joint fusion system with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

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.  Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.  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. ©2016 SI-BONE, Inc. All Rights Reserved. 9751.121516

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

Read More