Inspired Spine Presents Research at Society for Minimally Invasive Spine Surgery Annual Meeting

Las Vegas, Nevada (PRWEB) November 07, 2016

Inspired Spine recently presented its groundbreaking research at the Society for Minimally Invasive Spine Surgery in Las Vegas, Nevada. The study focused on the cost savings to hospitals with its innovative spinal implant – the Oblique Lateral Lumbar Interbody fusion (OLLIF).

The research was presented by renowned spine surgeon and main author Hamid Abbasi MD, who has performed hundreds of OLLIF procedures. The study compared 69 OLLIF procedures to 55 of the TLIF procedures, which is short for transforaminal lumbar interbody fusion.

The study showed significant differences between the procedures. Lumbar fusion procedures with the OLLIF implant entailed one tenth the blood loss as the TLIF procedure, much less time in the OR, and 40% reduced hospital length of stay. Incisions are smaller, pain is less, with the main outcome in the study being thousands of dollars saved per case to a hospital.

Between the reduced surgical time and hospital stay, average cost savings compared to TLIF ranged from 30 to 50% and over $10,000 per case. In addition, the reduced time per case with the OLLIF implants can lead to a greater throughput per operating room and patient bed for hospitals under constraints.

The conclusion of the study is that the OLLIF procedure makes it an appealing alternative to the traditional open fusions. Along with presenting at the SMISS conference, the paper has also been published in the peer-reviewed journal Cureus and is indexed in PubMed.

Christopher Murphy, President of Inspired Spine, said, “I’m excited every time an Inspired Spine study is given the opportunity to provide an oral presentation. Audience and industry reception has been fantastic, and it shows in our ever increasing number of physician partnerships.”

For more information on the OLLIF implant, visit and call Inspired Spine at (888) 378-2828.

For the original version on PRWeb visit:

Novastep Launches biofit™ Allograft Bone Wedge System

Orangeburg, New York, Nov. 07, 2016 (GLOBE NEWSWIRE) — Novastep, Inc., and its affiliates (“Novastep” or the “Company”), a global medical technologies company specializing in the foot and ankle, today announced the release of their biofit™ Wedge System, which consists of a variety of size-specific, pre-shaped allograft bone wedges for both Evans and Cotton osteotomies and a dedicated trials instrumentation module.  The trials are designed to provide a method of assessing osteotomy spaces to assist in the selection of appropriate biofit™ allograft wedge implants.

Osteotomies are procedures in which bone is cut and then re-aligned, often with bone graft placed as a wedge to secure the new position. The Cotton osteotomy involves the medial cuneiform and is used to correct rotational deformities of the forefoot. The Evans osteotomy is a lengthening procedure for the calcaneus (heel bone), used most commonly for treating flatfeet. The company’s newly released biofit™ Wedge System allows for more efficient procedures by eliminating some of the measuring and shaping of the graft material that are frequently required. The biofit™ wedge implants are aseptically processed from human cancellous bone by means of the bioSTART® Tissue Process to provide an osteoconductive scaffolding matrix that permits bony in-growth.  The allografts are stored at ambient temperatures with a five-year shelf-life.

“The biofit™ Wedge System instrument trials and allograft implants are engineered specifically for Evans and Cotton osteotomy surgeries, permitting decreased O.R. time and eliminating significant harvest site morbidity and other possible complications that may result from autograft specimen removal at the donor site” said Wayne A. Hurst, DPM, FACFAS, owner and founder Foot Specialists of Cedar Park & Georgetown in Austin, Texas. Hurst added that “Choosing the correct size is greatly simplified because each implant has a corresponding trial that may be used prior to actual insertion of the implant at the osteotomy site.”  The trials are arranged in a compactly organized, ergonomically designed module.

Nick Zelensky, Novastep’s Vice President of Marketing further commented that “The biofit™ instrument module is fully compatible with all Novastep cleanSTART® instrumentation trays and may be easily interchanged with other instrument modules or added to them within the trays.”  The cleanSTART® trays feature intuitive layouts, interchangeable modules, light weight construction and space saving designs that eliminate the need for multiple, bulky containers.

The biofit™ Wedge System, and other key elements of Novastep’s portfolio will be featured at the upcoming 2016 Global Foot and Ankle Symposium in New York City on December 2 – 3, 2016.

About Novastep

Novastep is a global medical device company specializing in the design, development and commercialization of advanced technologies that treat conditions affecting the foot and ankle. The Company is focused on optimizing clinical efficiencies, inventory management and healthcare economics by transforming the way foot and ankle products are deployed and utilized in the surgical environment. Novastep has allied itself with a strategic network of key international opinion leaders to deliver breakthrough technologies, innovative services and compelling medical education programs to the foot and ankle community. Novastep’s portfolio, services and distribution platforms are uniquely positioned to address foot and ankle trauma, deformity corrections and Charcot fracture management.

For further information concerning this announcement and/or Novastep, Inc., send all inquiries to or call 877.287.0795.

EOS imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software for Total Knee Arthroplasty

November 07, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that the Company has received a 510(k) clearance from the Food and Drug Administration (FDA) to market kneeEOS software in the United States. The kneeEOS online 3D planning software utilizes weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for Total Knee Arthroplasty. The software makes an initial automatic proposal for the size selection and position of the implant components to facilitate surgical preparation and optimize the alignment in 3D while displaying relevant clinical parameters in real time.

The clearance of kneeEOS completes the Company’s current portfolio of EOSapps dedicated to the most common orthopedic surgeries. The EOSapps are based on a patient’s 2D images and 3D digital anatomical dataset obtained from an EOS exam. EOS exams are performed at each step of the patient care continuum including diagnosis, pre-operative planning, post-operative assessment and follow-up.

Marie Meynadier, CEO of EOS imaging, said, “The kneeEOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market. It will support the growing adoption of EOS images, 3D models and patient-specific datasets at each step of the care continuum, helping healthcare providers bring the value of personalized treatments to their patients without the high dose and cost of CT imaging.”

For more information, please visit

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.


EOS imaging
Anne Renevot
Ph: +33 (0)1 55 25 61 24
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
Ph: +33 (0)1 44 71 94 96
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006

Providence Medical Technology Announces the Launch of CAVUX™ Cervical Cage-L and DTRAX® Spinal System-L

WALNUT CREEK, Calif., Nov. 7, 2016 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing cervical fusion technology, today announced the commercial launch of its new CAVUX Cervical Cage-L and DTRAX Spinal System-L.

The CAVUX Cervical Cage-L is an intervertebral cage made of solid titanium alloy with a large graft window and proprietary subtractive surface treatment technology. It is packaged sterile and supplied pre-loaded on a disposable delivery instrument. The DTRAX Spinal System-L is a single-use, disposable set of surgical instruments designed for cervical fusion and compatible with CAVUX Cervical Cage-L.

“I found the delivery of this new cage to be easier and more efficient than other options currently available for anterior cervical discectomy and fusion (ACDF),” said Dr. Kris Siemionow of the University of Illinois at Chicago after performing the first commercial use of the device. “The instruments in the new DTRAX Spinal System-L allowed me to deliver the device with fewer steps and in less time than the typical ACDF [procedure],” he added.

CAVUX Cervical Cage-L is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

Providence’s family of products for cervical spine surgery now includes DTRAX Spinal Systems, CAVUX Cervical Cages, BIOLOGIX™ Allograft Bone, and ALLY™ Bone Screws.

“The launch of CAVUX Cervical Cage-L and DTRAX Spinal System-L represents an important step in broadening our platform of innovative, single-use instruments and implants for cervical fusion,” commented Jeff Smith, Chief Executive Officer of Providence Medical Technology. “We are committed to continuing to fill critical gaps in the continuum of traditional cervical spine care.”

About Providence Medical Technology, Inc.

Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company is focused on commercializing the DTRAX platform of single-use, tissue-sparing instruments and CAVUX implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients. For more information, visit

DTRAX, CAVUX, BIOLOGIX, and ALLY are trademarks of Providence Medical Technology, Inc.

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SOURCE Providence Medical Technology, Inc.

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Inaugural Lumbar Total Disc Replacement Summit Yields Surgeon Consensus on Lumbar TDR as a Standard of Care for Lumbar DDD

CENTER VALLEY, PA–(Marketwired – November 03, 2016) – Prior to the 31st Annual North American Spine Society (NASS) meeting in Boston, MA last week, a group of leading spine surgeons came together at the inaugural Lumbar Total Disc Replacement Summit. The goal of the Summit was to drive consensus on Lumbar Total Disc Replacement (TDR) as a standard of care for lumbar DDD in the active patient subpopulation and to ultimately influence payers to expand coverage of the procedure. The surgeons recognized motion-preserving TDR as a well-studied surgical treatment alternative to spinal fusion and collaborated on a review of the long-term evidence in support of lumbar TDR.

The 19-surgeon panel developed a general consensus on the patient groups who, based on the published long-term evidence, should have access to this procedure through their insurance companies. The panel cited lumbar TDR as the most studied spinal procedure with outcomes exceeding those of fusion, which is currently treated as the standard of care for this patient population.

Despite significant evidence available on the procedure, many insurance carriers have shown reluctance to adding lumbar TDR to their covered benefits. “There is a general lack of understanding by the payers of how well lumbar TDR has been studied and how positive the outcomes have been,” said Lynn Miller, MD, a neurosurgeon whose practice is focused on motion preservation in the Twin Cities. “Our panel group agreed that lumbar TDR does not add cost to the payer. We don’t understand why they are so reluctant to cover something where the patient benefit has been thoroughly demonstrated.”

The surgeon panel plans to publish the outcome of their discussion and share with payers in their regions to demonstrate how surgeons would responsibly utilize TDR as a treatment alternative to fusion.

Plans for the second Lumbar TDR Summit are underway for Spring 2017. The panel is looking for additional surgeons to join the movement and increase momentum of this procedure aimed at improving quality of life for chronic low back pain patients. The inaugural Lumbar TDR Summit was funded in part by Aesculap Implant Systems, LLC. The company is currently closing out a seven-year IDE study on its lumbar TDR device, activL® Artificial Disc.

Cornerstone Research Group was commissioned to employ a modified-Delphi process to reach consensus on the responsible use of TDR. The firm is currently pooling the existing five-year evidence on lumbar TDR from six randomized controlled trials into a meta-analysis.

Patients suffering from debilitating low back pain who have exhausted their non-surgical treatment options without finding relief for their pain often seek surgical procedures to stabilize their low back, thereby reducing pain and getting them back to a favorable quality of life. While the vast majority of spine surgeons first offer a spinal fusion to address this problem, long-term evidence demonstrates that for some patients, TDR is a better option because it comes closer to maintaining the natural physiologic movement of the healthy human back. In five-year studies, total disc replacement has demonstrated a threefold reduction from fusion in the rate of further degenerative disease at other motion segments in the spine.

About Aesculap Implant Systems, LLC

Aesculap Implant Systems, LLC, part of the B. Braun group of companies, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit


  • Senior Project Manager, Corporate Communications
    Aesculap Implant Systems, LLC
    office: 610-984-9242

InVivo Therapeutics Reports 2016 Third Quarter Financial Results and Business Update

November 04, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the quarter ended September 30, 2016.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the third quarter, we continued to make fundamental progress at InVivo. One of the most notable achievements was the expansion of the INSPIRE study to allow for twenty evaluable patients. Just a few weeks later, we had a fifth patient improve from complete to incomplete paralysis making our current conversion rate approximately four times the rate in natural history databases (62.5% vs. 16%). Due in large part to the encouraging clinical outcomes achieved to date, we appointed Pam Stahl as Chief Commercial Officer to lead pre-commercialization efforts in preparation for establishing a commercial organization. We expanded the INSPIRE footprint when we received Investigational Testing Authorization from Health Canada and added our first ex-U.S. investigator and site: Dr. Fehlings at Toronto Western Hospital. We also added Northwestern Medicine and Ben Taub Hospital/Baylor College of Medicine. We had one of our most active quarters in terms of domestic and international speaking engagements: for the investment audience, we presented at annual conferences for Cantor Fitzgerald, Rodman & Renshaw, and Ladenburg Thalmann; for the medical audience, we presented at the International Spinal Cord Society Annual Scientific Meeting and had multiple presentations at the 2016 Congress of Neurological Surgeons Annual Meeting, including a late-breaking oral presentation; and for the scientific audience, we presented at the Cell & Gene Meeting on the Mesa. We ended the quarter in a strong financial position and believe our funds will last us through the end of 2017.”

Financial Results

For the quarter ended September 30, 2016, the Company reported a net loss of approximately $6,196,000, or $.19 per diluted share, compared to a net loss of $2,308,000, or $.09 per diluted share, for the quarter ended September 30, 2015. The Company’s results for the three months ended September 30, 2016 were unfavorably impacted by a loss on the Company’s derivative warrant liability (a non-cash item) of $336,000, driven by an increase in the fair market value of the Company’s warrants. The results for the three months ended September 30, 2015 were favorably impacted by a gain on the Company’s derivative warrant liability of $3,591,000 driven by a decrease in the fair market value of the Company’s warrants. Excluding these charges, for the quarters ended September 30, 2016 and September 30, 2015, adjusted net loss per diluted share was $.18 and $.22, respectively.

The Company ended the quarter with $37,665,000 of cash and cash equivalents.

For the nine months ended September 30, 2016, the Company reported a net loss of approximately $18,004,000, or $.59 per diluted share, compared to a net loss of $28,581,000, or $1.09 per diluted share, for the nine months ended September 30, 2015. The Company’s results for the nine months ended September 30, 2016 were adversely impacted by a loss on the derivative warrant liability of $788,000, reflecting increases in the fair market value of the warrants. The results for the nine months ended September 30, 2015 were adversely impacted by a loss on the derivative warrant liability of $11,349,000. Excluding these charges, for the nine months ended September 30, 2016 and September 30, 2015, adjusted net loss per diluted share was $.56 and $.66, respectively.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the items noted. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors, enabling them to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding these identified items.

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit

Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the Company’s beliefs regarding its cash position. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to complete the INSPIRE study and submit an HDE; the Company’s ability to receive regulatory approval for the Neuro-Spinal Scaffold; the Company’s ability to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
(In thousands, except share and per share data)
As of
September 30,

December 31,

Current assets:
Cash and cash equivalents 37,665 20,194
Restricted cash 361 361
Prepaid expenses and other current assets 413 184
Total current assets 38,439 20,739
Property, equipment and leasehold improvements, net 630 938
Other assets 411 115
Total assets 39,480 21,792
Current liabilities:
Accounts payable 556 521
Loan payable, current portion 416 395
Derivative warrant liability 2,695 1,907
Deferred rent, current portion 134 115
Accrued expenses 1,704 374
Total current liabilities 5,505 3,312
Loan payable, net of current portion 960 1,275
Deferred rent, net of current portion 175 276
Total liabilities 6,640 4,863
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares, issued and
outstanding 32,033,094 at September 30, 2016; and authorized 50,000,000 shares, issued
and outstanding 27,555,948 shares at December 31, 2015 1 1
Additional paid-in capital 184,411 150,497
Accumulated deficit (151,572 ) (133,569 )
Total stockholders’ equity 32,840 16,929
Total liabilities and stockholders’ equity 39,480 21,792
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2016 2015 2016 2015
Operating expenses:
Research and development 3,294 2,432 8,659 7,280
General and administrative 2,584 3,437 8,573 9,861
Total operating expenses 5,878 5,869 17,232 17,141
Operating loss (5,878 ) (5,869 ) (17,232 ) (17,141 )
Other income (expense):
Interest income 50 2 133 6
Interest expense (32 ) (32 ) (117 ) (97 )
Derivatives (loss) gain (336 ) 3,591 (788 ) (11,349 )
Other income (expense), net (318 ) 3,561 (772 ) (11,440 )
Net loss (6,196 ) (2,308 ) (18,004 ) (28,581 )
Net loss per share, basic and diluted (0.19 ) (0.09 ) (0.59 ) (1.09 )
Weighted average number of
common shares outstanding,
basic and diluted 31,968,357 27,010,444 30,687,263 26,150,525
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2016 2015 2016 2015
Reported GAAP net income (loss) (6,196 ) (2,308 ) (18,004 ) (28,581 )
Derivative (gain)/ loss 336 (3,591 ) 788 11,349
Adjusted net loss (5,860 ) (5,899 ) (17,216 ) (17,232 )
Reported GAAP net loss per diluted share (0.19 ) (0.09 ) (0.59 ) (1.09 )
Derivative loss per diluted share 0.01 (0.13 ) 0.03 0.43
Adjusted net loss per diluted share (0.18 ) (0.22 ) (0.56 ) (0.66 )


InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations

Bioventus Appoints Andrew McCartney Managing Director, International for EMEA


Bioventus, a global leader in orthobiologic solutions, today announced the appointment of Andrew McCartney as Managing Director, International for Europe, Middle East and Africa (EMEA). McCartney, who will be responsible for leading the company’s EMEA business and growing the Bioventus Active Healing Therapies portfolio within the region, will also have responsibility for the international headquarters office in Hoofddorp, The Netherlands.

This Smart News Release features multimedia. View the full release here:

“We are very pleased Andrew is joining us to lead our growing business in EMEA,” said Tony Bihl, CEO of Bioventus. “His broad and deep experience of the European healthcare market, business management and marketing will help us accelerate our growth in key international markets.”

McCartney joins Bioventus from Stryker, where for the past 10 years he progressively grew through leadership roles in Sales, Marketing and Business Unit Management positions. He most recently served as Vice President and General Manager of the Surgical Division of Stryker Europe and previously was General Manager, MedSurg, Stryker UK & Ireland. He began his nearly 20-year career in the medical device industry with UK based distributors gaining experience in multiple segments including wound care, patient monitoring and diagnostic cardiology in both primary and acute healthcare settings.

McCartney has a Bachelor of Accountancy from the University of Glasgow.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit and follow the company on Twitter @Bioventusglobal.

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

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Lawsuit against Medtronic questions the company’s handling of spinal device

November 05, 2016 – By

Medtronic faces a federal false claims and misbranding lawsuit that accuses the company of designing products for one purpose but tricking the U.S. Food and Drug Administration (FDA) into approving them for another to avoid expensive and time-consuming safety testing.

The suit, by a former Medtronic sales representative, alleges that the company designed a family of spinal devices for the neck but told the FDA they were to be used only in the chest and lower spine, where they were almost always too small to work.

In court documents, Medtronic denied the allegations, saying it developed the product in different sizes to accommodate patients’ anatomical differences. The company has asked a federal judge to dismiss the suit.

Medtronic recently settled a suit making many of the same charges in a California state court. The company admitted no wrongdoing. The settlement amount was undisclosed.

Like the state case, the federal suit raises questions about the FDA approval process, which lets device makers sell products if the FDA deems them “substantially equivalent” to devices the government has already approved for sale. The suit also raises questions about the ability of device makers to market products for non-FDA approved uses, a practice known as off-label promotion.

Doctors are allowed to use medical devices in any way they think will help patients, but federal law prohibits misbranding and some kinds of off-label promotion. Balancing patient safety with free speech has grown so contentious that the FDA will conduct two days of hearings this week to consider “manufacturer communications” about “unapproved uses” of products.

Brian Shapiro, a former Medtronic salesman, brought the federal suit as a whistleblower on behalf of himself and the United States, 31 states, including Minnesota, and the District of Columbia. The federal False Claims Act lets private citizens who believe they have proof of fraud against the government sue and collect a portion of any settlement, even if they have not been injured.

The U.S. government has “declined to intervene in the case at present,” but “remains a party for service, must be notified of all filings and discovery in the case, and reserves the right to intervene at any point in the future,” John Parker, one of Shapiro’s lawyers, said.



BONESUPPORT™ Announces Key Corporate Appointment To Drive Growth in North America

Lund, Sweden, 7 November, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone graft substitutes to treat bone voids caused by trauma, infection, disease or related surgery, is pleased to announce the appointment of Patrick O’Donnell as General Manager and Executive Vice President, North American Commercialization to its leadership team.  Mr O’Donnell will lead the relationship with the company’s partner, Zimmer Biomet, to drive revenue growth of BONESUPPORT’s CERAMENT™ BONE VOID FILLER (BVF). He will also set the strategy for the introduction of CERAMENT™ G, a novel gentamicin eluting bone graft substitute, to the U.S. market pending a positive outcome of the planned FORTIFY PMA trial and subject to FDA approval.

Mr O’Donnell joins BONESUPPORT after serving as CEO of three companies focused on innovative orthopaedic regenerative technologies.  Following his role as CEO of Histogenics Corporation, he was most recently the Co-Founder and CEO of ProteoThera Inc., based in Cambridge, MA.  His experience includes being head of Global Marketing of Confluent Surgical, where he launched and built the DuraSeal™ brand of surgical dural sealant products, currently owned by Integra LifeSciences In addition, he spent 13 years in sales, sales management and marketing in orthobiologics and medical devices at Johnson & Johnson’s DePuy Spine Division.

Mr O’Donnell said: “I am very pleased about the opportunity and quite fortunate to be joining BONESUPPORT at a very important and exciting tipping point stage for the Company. I look forward to working with the BONESUPPORT team to optimize the significant potential of CERAMENT BVF and in time CERAMENT G in North America.”

Richard Davies, CEO of BONESUPPORT, said: “We are excited to welcome Patrick to the BONESUPPORT team, particularly after completing the recent financing, which will be crucial to executing our strategy.  Patrick brings with him a great breadth of experience ranging from start-ups to small and large companies.  He has an in-depth of knowledge of the orthobiologics space and appreciation of the significant potential of our unique CERAMENT drug eluting osteoconductive bioceramic platform to develop a pipeline of novel products for a broad range of bone diseases.   The clinical value proposition of our products is expected to become increasingly relevant to the U.S. healthcare market which is undergoing a sea change to value based care.”


Osteoarthritis: New blood test detects early stages, study finds

There is currently no blood test for early-stage osteoarthritis, a degenerative joint disease where the cartilage that eases and cushions movement breaks down, causing pain, swelling, and problems moving the joint. Now, researchers at Warwick University in the United Kingdom have developed a blood test that can provide an early diagnosis of osteoarthritis and distinguish it from rheumatoid arthritis and other inflammatory joint diseases.

The researchers, led by Dr. Naila Rabbani of Warwick Medical School, report how they developed the new blood test in the journal Arthritis Research & Therapy.

The test could be available within 2 years, say the researchers. The earlier that arthritis is diagnosed – before physical and irreversible symptoms set in – the better the chances that treatment can focus on how to The researchers, led by Dr. Naila Rabbani of Warwick Medical School, report how they developed the prevent the problem, for instance with lifestyle changes.

The new blood test looks for chemical signatures in fragments of joint proteins (amino acids) that have been damaged, as Dr. Rabbani explains:

The combination of changes in oxidized, nitrated and sugar-modified amino acids in blood enabled early stage detection and classification of arthritis – osteoarthritis, rheumatoid arthritis or other self-resolving inflammatory joint disease.”

Dr. Rabbani notes that scientists have known for a while that proteins in the arthritic joint get damaged, but this is the first time they have looked at them from the point of view of early disease diagnosis.

“For the first time we measured small fragments from damaged proteins that leak from the joint into blood,” she adds.