Tissue Regenix Group plc – DermaPure secures GPO agreement with Premier, Inc.

Posted On December 12, 2016 By OrthoSpineNews In Biologics /

Leeds, 06 December 2016 – Tissue Regenix Group (AIM:TRX) (“Tissue Regenix” or “The Group”) the regenerative medical devices company today announces Tissue Regenix Wound Care, Inc. has secured a Group Purchasing Organisation (GPO) contract with Premier Inc., a leading healthcare improvement company.

DermaPure has been awarded this contract under a ‘Breakthrough Technology Agreement’, which is awarded by the GPO after a thorough four step review process is completed and it is determined that the technology offers unique attributes to the other available treatment options.

The Premier alliance is comprised of approximately 3,600 U.S. based hospitals and 120,000 other healthcare providers which will now have contracted access to DermaPure®.

Antony Odell, CEO, Tissue Regenix Group plc commented: “Approval under Premier’s Breakthrough Technology Agreement marks a significant milestone for DermaPure®. This confirms the unique characteristics of our patented dCELL® Technology, the powerful clinical evidence we have collected, and the remarkable outcomes it achieves in real world clinical situations.”

For more Information:

Tissue Regenix Group plc Caitlin Pearson Corporate Communications Officer	Tel: 0330 430 3073
Jefferies International Ltd Simon Hardy / Harry Nicholas	Tel: 020 7029 8000

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL®’) technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, as part of its commercialisation strategy for its dCELL® technology platform.

William Rhoda Joins SeaSpine as General Manager of Process Innovation and Development

Posted On December 12, 2016 By OrthoSpineNews In Spine /

CARLSBAD, Calif., Dec. 08, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that William Rhoda has joined the Company as General Manager of Process Innovation and Development.

In this newly created position, Mr. Rhoda will establish and lead a small, focused office in eastern Pennsylvania that will provide additional product development and process improvement resources and bring even more focus to surgeon and patient needs. This office will also serve as a local training and education site for surgeons and distributors in the Eastern United States. Mr. Rhoda will report directly to Keith Valentine, President and Chief Executive Officer.

Mr. Rhoda has more than 20 years of experience in the spinal implant market. He started his career in orthopedics with Synthes Spine and later became a founding member of Globus Medical, where he served as the Vice President of Product Development. While at Globus, he conceived and implemented a rapid product development process that dramatically shortened the time from concept to market introduction of new products.

“SeaSpine is a dynamic organization that has dramatically improved its product development process through both quality and output during the past year,” said Mr. Rhoda. “I am excited to join the team and leverage my experience to further reduce the time to market as we continue to drive innovation and put SeaSpine firmly on the map of innovators in the spine market.”

“I am excited to welcome Bill to our leadership team and look forward to his contributions to drive faster innovation at SeaSpine,” said Keith Valentine. “I am confident that he will be instrumental in adding energy and responsiveness to our engineering effort and keeping us laser-focused on the needs of the surgeon and our sales team.”

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

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: Mr. Rhoda’s ability to shorten time-to-market, drive faster innovation and position SeaSpine as an innovator in the spine market. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: Mr. Rhoda’s ability to transition in a timely manner, if at all, and to integrate into SeaSpine’s existing infrastructure, including his ability to collaborate successfully with SeaSpine’s existing product development team; Mr. Rhoda’s ability to conceive and implement a rapid product development process at SeaSpine and his ability to shorten the time from concept to market introduction of new products; surgeons’ willingness to adopt new products resulting from such process, including as a result of failure to demonstrate adequate safety or efficacy, whether as a result of rapid development or otherwise; unexpected expense associated with the new Pennsylvania office; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

Tiny HD Cameras Have Revolutionized Knee Surgery, Doctors Claim

Posted On December 12, 2016 By OrthoSpineNews In Sports Medicine /

December 9, 2016 – Filed Under: Dr. Max Gomez, Knee Surgery, MRI, Mt. Sinai Health System

NEW YORK (CBSNewYork) — Tiny hi-def cameras have been changing everything from home videos to selfies, but new technology has legitimately revolutionized medical procedures.

As CBS2’s Dr. Max Gomez explained, a new camera may actually replace MRIs and even some surgeries, especially in the knees.

If you’ve ever injured your knee it can be hard to tell exactly what’s causing the pain, so the doctor usually send you for an expensive MRI and maybe an arthroscopy in the O.R. to take a look inside. But what if you could do a scope in the doctor’s office cheaper and safer.

Lemouchi Soufinae injured his knee in a car accident two years ago. Since then he hasn’t been able to play his beloved soccer, because of the pain in his knee.

“Can’t walk more than three blocks, have to lay down, have trouble sleeping at night, lot of strong pain,” he said.

Two MRIs later, it still wasn’t completely clear what was causing his knee pain.

Like Lemouchi, Liz Meris has been having severe knee pain.

“Couldn’t kneel or straighten without pain, can’t get out of car, swelling in back of knee, hurts to walk, feels unstable,” she said.

Worse yet, Liz is claustrophobic in an MRI

“Hate em, I’m claustrophobic. I’m out, I’m in, I’m out again,” she said.

The next is usually a trip into the operation room to look around by sticking a scope in the knee. It’s expensive and requires anesthesia.

Why not do that in the office, under a local anesthesia?

Thanks to a tiny scope with a hi-def camera on the tip, doctors can do in the office what once took a trip to the O.R.

READ THE REST HERE

New Orthopedic Device Technology Moves From Lab Toward Operating Room With Help From Philadelphia-Based Start-Up OrthoMend Research, Inc.

Posted On December 9, 2016 By OrthoSpineNews In Extremities, Financial /

PHILADELPHIA, Dec. 9, 2016 /PRNewswire-USNewswire/ — A platform of orthopedic device technologies developed by researchers from Temple University are moving one step closer to becoming viable options for repairing broken bones and orthopedic applications. OrthoMend Research, Inc., a start-up company from Philadelphia, PA., recently acquired the exclusive license for these novel absorbable bone fixation and regenerative repair technologies and plans to develop them for commercial use. The company has leased space within the University City Science Center.

“OrthoMend Research, Inc. has licensed exclusive commercial rights from Temple University for Nano-Diamond technology in bone fixation which has the potential to evolve current therapies to fix, repair and regenerate bones and orthopedic “drug delivery applications,” OrthoMend Research, Inc. CEO Joseph P. Connell said. “It is our desire to commercialize the technology to improve clinical outcomes, reduce costs and alleviate pain and suffering for our patients.”

“OrthoMend Research represents the important role startups have in our commercialization process by bringing together the inventors, technology and business leadership to advance this orthopedic device to patients in need,” said Stephen Nappi, associate vice president for technology commercialization and business development at Temple.

“We are very excited to begin our next phase by manufacturing and testing the devices. We plan to make considerable contributions to clinical outcomes and improve patient’s lives by repairing broken bones without leaving hardware behind in a patient’s body.” said Connell.

Peter Lelkes, chair of bioengineering and director of the Institute for Regenerative Medicine and Engineering at Temple is equally enthusiastic about the licensing agreement and the potential for collaborative research and development opportunities.

“The licensing of our invention to OrthoMend Research is an important milestone in our efforts to translate our basic research from the bench to the bedside and will, without a doubt, result in commercial products that will benefit patients around the globe,” Lelkes said.

About OrthoMend Research: OrthoMend Research, Inc. is an emerging Regenerative Orthopedic Device Company pioneering new technologies intended to revolutionize bone fixation after orthopedic, surgical and trauma situations. OrthoMend Research, Inc. is involved with commercializing technologies licensed from Temple University for an absorbable suite of bone fixation and drug delivery devices. We will develop, test and launch absorbable screws, pins and possibly plates to repair the millions of broken bones occurring each year. We are steadfast to be the leader in orthopedic devices delivering real-world technologies to impact the lives of those in need. For more information, visit www.orthomend.com

About Temple University’s Department of Bioengineering: Founded in January 2012, the Dept. of Bioengineering in the College of Engineering has grown significantly in the past four years to about 300 undergraduate students, nearly 50 graduate students, 11 core faculty members and two dozen affiliated faculty from across the entire university. The Department is the home of a first-rate, nationally and internationally recognized bioengineering research enterprise that is supported by extramural funds from NIH, NSF, DoD and others. Its newly renovated, state-of-the-art research facilities (ca. 20,000 square feet) attract graduate students, postdocs, visiting scientists and scores of undergraduate students who pursue exciting basic and translational bioengineering research.

News media contacts:
Joseph P. Connell, CEO, OrthoMend Research, Inc., 910-233-0806, jpconnell1@gmail.com

SOURCE Temple University

Biomatlante invests in innovative solutions for active healing through orthobiologics

Posted On December 9, 2016 By OrthoSpineNews In Biologics /

NANTES, FRANCE (PRWEB) DECEMBER 09, 2016

Coordinated by INSERM (Institut National de la Santé et de la Recherche Médicale) and with the support of the E.U., the REBORNE Program sought to establish the feasibility, relevance and efficacy of the association of MBCP+™*, a synthetic bone graft manufactured by Biomatlante made from MBCP™ Technology, and Mesenchymal Stem Cells (MSCs)1.

REBORNE was a 12 multi-center clinical trials conducted over 8 European countries using advanced biomaterials and cells from autologous sources, as human mesenchymal stem cells from bone marrow, offering great potential for active bone regeneration. Biomatlante successfully went through a stringent selection process, after three years of experiences with the support of ANR (Agence Nationale de la Recherche)², prior to becoming the partner of choice of the European consortium as supplier of the bone graft matrix. A large consortium of 24 participants, with world class laboratories and GMP-cells manufacturing facilities and hospitals, collaborated to reach these ambitious clinical goals.

This program demonstrated the efficacy of expanded MSCs combined with the osteogenic matrix MBCP™ technology for bone tissue engineering in bone regeneration, both from a regulatory, scientific and clinical standpoint. The Reborne project demonstrated the osteogenic and osteoinductive properties of the association of MSCs and MBCP™ Technology3,4,5,6,7 with a high rate of clinical success, particularly in the treatment of long bone non-unions (92%).

Building on these successes, Reborne has now been extended to attempt to provide the same clinical excellence at an affordable price by combining the same MBCP™ Technology matrix with autologous concentrated bone marrow aspirate. Clinical trials are expected to begin in the next few months.

About BIOMATLANTE, Experts in Bone Regeneration
Based near Nantes, France, Biomatlante specializes in synthetic biomaterials for bone regeneration and is a world leader in bone graft technologies, selling its products in over 50 countries. Biomatlante’s products are routinely used in orthopedics and trauma surgery, in spine and dental surgery. BIOMATLANTE strives to integrate a strategy of strong innovation and product development required to meet and exceed the needs of today’s market. Our R&D collaborates closely with universities and research centers across the world, bringing together competences in innovation, technological transfers of new biomaterials, surgical technologies and providing the intellectual protection required to foster long-term projects.

About MBCP™ Technology*, Worldwide Reference in Synthetic Bone Graft
The unique 3-step manufacturing process developed by BIOMATLANTE confers its core MBCP biphasic HA/ ß-TCP technology unique properties for hard tissue regeneration. Its micro-macroporous structure mimics that of human bone and provides an ideal osteogenic matrix for bone regeneration in general and tissue engineering in particular.

About REBORNE, Regenerating Bone Defects Using New Biomedical Engineering Approaches
The objective of REBORNE is to develop new biomaterials that stimulate bone tissue formation with a view to correcting bone regeneration defects in orthopedic and maxillofacial surgery. Biomaterials, combined with the use of stem cells, are interesting alternatives to biological grafts.

About INSERM, French National Institute of Health and Medical Research
Founded in 1964, INSERM is a public scientific and technological institute that operates under the joint authority of the French Ministry of Health and French Ministry of Research. Its researchers are tasked with studying all diseases, from the most common to the most rare, through their work in biological, medical and public health research.

1.    Reborne: HEALTH 20091.4.2-241879 (Regenerating Bone Defects using new biomedical engineering approaches)
2.    Daculsi et al, Association of cells and biomaterials for bone reconstruction, IRBM 32 (2011) 76-79
3.    Brennan MÁ, Renaud A, Amiaud J, Rojewski MT, Schrezenmeier H, Heymann D, Trichet V, Layrolle P. Pre-clinical studies of bone regeneration with human bone marrow stromal cells and biphasic calcium phosphate. Stem Cell Res Ther. 2014 Oct 13;5(5):114. doi: 10.1186/scrt504.
4.    Gómez-Barrena E, Rosset P, Muller I, Giordano R, Bunu C, Layrolle P, Konttinen YT, Luyten FT. Bone regeneration: stem cell therapies and clinical studies in Orthopaedics and traumatology. J Cell Mol Med. 2011 Jun; 15(6):1266-1286.
5.    Gomez-Barrena E, Rosset P, Lozano D, Stanovic J, Ermthaller C, Gebhard F. Bone fracture healing: cell therapy in delayed unions and non-unions. Bone. 2015 Jan; 70C:93-101
6.    Gomez-Barrena et al. Non-unions in tibia, femur and humerus safely healed with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric trial. 2016 (in press).
7.    Miramond, T., Corre, P., Borget, P., Moreau, F., Guicheux, J., Daculsi, G., & Weiss, P. (2014). Osteoinduction of biphasic calcium phosphate scaffolds in a nude mouse model. J Biomater Appl. 2014 Oct; 29(4):595-604

For further information about BIOMATLANTE and its technologies, please visit http://www.biomatlante.com

This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use

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21st Century Cures Act: Impacts on the US Medical Device Market

Posted On December 9, 2016 By OrthoSpineNews In Regulatory /

December 08, 2016 by Stewart Eisenhart

EMERGO SUMMARY OF KEY POINTS:

New legislation significantly impacting FDA oversight of US medical device and drug markets has passed Congress and is awaiting President Obama’s signature.
The 21^st Century Cures Act would establish a priority review program for breakthrough devices, loosen some device clinical trial requirements and clarify how and whether to regulate medical software.
Critics of the new bill warn that efforts to streamline FDA regulations may end up allowing some devices into the US market without proper vetting, causing public health issues.

As legislation targeting a broad swath of US healthcare regulations awaits President Barack Obama’s signature after passage in the US Congress, effects of the pending law on registration and oversight of medical devices in the country will be significant.

The 21^st Century Cures Act, which has garnered rare bipartisan support in Congress and is heavily backed by pharmaceutical and medical device industry lobbyists, would fast-track “breakthrough” and novel device registrations at the FDA, as well as alter clinical investigation requirements of manufacturers. Critics of the proposed legislation, however, warn of public health repercussions if FDA regulations of medical devices are made too lax.

Prioritizing “breakthrough” devices

Among the substantial changes to FDA medical device regulation included in the 21^st Century Cures Act is a proposal to require the agency to set up a priority review program for “breakthrough” devices, or for devices targeting diseases for which no FDA-cleared or approved alternatives are available. The program would build upon a framework already in place at the agency for registration of such devices.

Under the program, a manufacturer or sponsor may request priority review designation before submitting its FDA registration application. The bill would authorize the Secretary of the US Department of Health and Human Services to develop and issue additional guidelines specifying parameters and requirements of the program.

READ THE REST HERE

Bodycad Awarded Key US Patents for Improving Accuracy, Reproducibility and Speed for 3D Imaging in Orthopaedic Applications

Posted On December 9, 2016 By OrthoSpineNews In Regulatory /

QUEBEC CITY, Dec. 8, 2016 /PRNewswire/ — Bodycad announced it has been awarded two key US patents for improving the accuracy, reproducibility and speed for 3D constructs via MRI and CT images in long and small bone orthopaedic applications. These patents are critical to the company’s proprietary approach to creating personalized orthopaedic restorations based on each patient’s distinct anatomy.

To create personalized orthopaedic restorations, the company harnesses the world’s first suite of orthopaedic CAD/CAM software. This technology, along with individual patient imagery, is critical to Bodycad’s Personalized Restoration Evaluation Process (PREP).

“We are pleased to have the United States Patent and Trademark Office award these important and innovative patents to our library of intellectual property,” stated Jean Robichaud, Founder and President of Bodycad. “These patents are further evidence of our technology’s remarkable accuracy which is essential when creating a personalized orthopaedic restoration.”

Bodycad currently has numerous additional patents pending as well as an extensive collection of existing industrial design patents, copyrights and trademarks.

For more information, please visit www.bodycad.com.

ABOUT BODYCAD

Bodycad is developing personalized orthopaedic restorations to overcome the limitations of off-the-shelf, standardized implants. With its proprietary Personalized Restoration Evaluation Process (PREP), it enables surgeons to provide patient-specific solutions with a previously unavailable conformity to every patient’s distinct anatomy. This transformative approach will allow mainstream customization with the goal of optimizing fit, durability and comfort. The privately held company was founded in 2011 and is headquartered in Quebec City, Canada with offices in the United States. Investors include Beaudier, Inc. (Montreal, Canada). ROBIC is patent counsel to Bodycad.

CONTACT
Andrew McLeod
Chief Commercial Officer
andy@bodycad.com

Logo – http://photos.prnewswire.com/prnh/20160407/352645LOGO

SOURCE Bodycad

Medicrea to Host Key Opinion Leader Breakfast in New York City for Investors Focused on Advances in the Personalized Spine Market

Posted On December 8, 2016 By OrthoSpineNews In Spine /

December 08, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced that it will host a Key Opinion Leader breakfast in New York City for investors focused on advances in the personalized spine market at 8:00 am Eastern Time on Thursday, December 15, 2016.

The meeting will feature keynote presentations by spine surgeon KOLs Nicholas Qandah, DO, from the Mohawk Valley Health System, and Themistocles Protopsaltis, MD, from NYU Langone Medical Center, Bellevue Hospital, who will provide an overview of the complex spine market and discuss current and novel approaches to treating complex spinal conditions.

Members of the Medicrea management team will provide an overview of the Company’s UNiD™ personalized spinal technology platform of analytical services and patient-specific implants for the complex spine market, which received the first ever FDA Clearance for a personalized spinal treatment modality.

Dr. Nicholas Qandah is a complex spine specialist and the Director of Neurosurgery at the Mohawk Valley Health System in New Hartford, NY. Dr. Qandah was previously the Director of the Complex Spine Program for Neurosurgery and an Assistant Professor of Neurosurgery for the Residency Program at Virginia Tech Carilion Clinic in Roanoke, VA. In addition to general neurosurgery, Dr. Qandah treats patients with back and neck pain, degenerative disc disease, spinal stenosis, and herniated discs. He has special interest and expertise in minimally invasive spine surgery, complex spine surgery, and surgery for scoliosis. Dr. Qandah is a Fellow of the American College of Osteopathic Surgeons and a member of the Association for Collaborative Spine Research. Dr. Qandah completed his Neurosurgical Residency training at the Virginia Tech Carilion Clinic and was subsequently awarded the AO Complex Spine Fellowship in Orthopedics and Neurosurgery at the prestigious Harborview Medical Center at the University of Washington in Seattle, WA.

Dr. Themistocles Protopsaltis is an orthopedic spine surgeon at NYU Langone Medical Center and the Hospital for Joint Diseases. He serves as Director of Adult Spinal Deformity Surgery and Director of the Orthopaedic Spine Service at Bellevue Hospital Center in New York, NY. He is also an Assistant Professor in the Department of Orthopedic Surgery at NYU School of Medicine. Dr. Protopsaltis is board certified in orthopedic surgery and is actively involved in many research areas. Some of his interests include cervical and thoracolumbar spinal deformity, cervical spondylotic myelopathy surgical outcomes, and proximal junctional kyphosis avoidance in adult scoliosis patients. He is a member of the International Spine Study Group, comprised of leading physicians from multiple academic centers studying cervical and thoracolumbar spinal deformity surgery. He is also a fellow of the American Academy of Orthopaedic Surgeons. Dr. Protopsaltis earned his medical degree at the Columbia University College of Physicians and Surgeons and completed his orthopedic surgery residency at New York Presbyterian Hospital. He has completed a spine surgery fellowship at NYU Langone Hospital for Joint Diseases.

The event is intended for investors, analysts, investment bankers, and business development professionals only. If you would like to attend in person, please contact Mac MacDonald at 212-915-2567 or via e-mail at Mac@LifeSciAdvisors.com to reserve a place.

A live webcast of the event, with slides, will be available at http://lifesci.rampard.com/20161215/reg.jsp and within the Investors section of the Company’s website at www.medicrea.com.

About MEDICREA (www.medicrea.com)

MEDICREA specializes in bringing pre-operative digital planning and pre and post-operative analytical services to the world of complex spine. Through the lens of predictive medicine, MEDICREA leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, MEDICREA is an SME with 150 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient- specific implants.

By leveraging its proprietary software analysis tools with big data and deep learning technologies supported by an expansive collection of clinical and scientific data, MEDICREA is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: medicrea.com.

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

MEDICREA is listed on ALTERNEXT Paris ISIN: FR 0004178572 – Ticker: ALMED

Contacts

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

St. Jude Medical Receives CE Mark Approval for Full Body MR Conditional Labeling for the Proclaim Elite Spinal Cord Stimulation System

Posted On December 8, 2016 By OrthoSpineNews In Neuro, Regulatory /

December 08, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim^™ Elite Spinal Cord Stimulation (SCS) System. With the latest approval, patients who receive the Proclaim Elite SCS System can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters. The full-body MR conditional labeling is the second upgrade available to patients outside the United States implanted with the Proclaim Elite System, following a 2015 approval for MR Conditional labeling for head and extremity MRI scans.

With the latest approval, patients living with chronic pain who have been implanted with the Proclaim Elite SCS System may now undergo full-body MRI diagnostic scans within approved parameters while retaining access to the treatments they need, such as the St. Jude Medical BurstDR^™ stimulation.

“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” said Dirk Rasche, M.D., functional neurosurgeon, University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”

The Proclaim Elite SCS System offers patients a combination of the convenience of a device that doesn’t require recharging while offering access to St. Jude Medical BurstDR stimulation technology. BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Unlike other stimulation designs, St. Jude Medical BurstDR stimulation works differently, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.

St. Jude Medical was the first company to provide patients suffering from chronic pain a single device featuring upgradeable and recharge-free therapy solutions. The company designed the Proclaim System with patient-centric solutions in mind. In addition, the Proclaim Elite SCS System’s Bluetooth^® wireless technology allows clinicians to program and adjust their patient’s SCS therapy with an Apple^™ iPad mini^™ mobile digital device.

“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” said Dr. Allen W. Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “Our new labeling for the Proclaim Elite SCS System ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.

Full body MR-conditional labeling for the Proclaim Elite System was also recently approved by the Food and Drug Administration in the United States.

Note: Apple and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Justin Paquette, 651-756-6293
jpaquette@sjm.com

InVivo Therapeutics Appoints Melanie Morel-Ferris, C.P.A. as Interim CFO, Replacing Steven McAllister in Role

Posted On December 8, 2016 By OrthoSpineNews In Biologics, Neuro /

December 08, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the resignation of Steven McAllister from the position of Chief Financial Officer effective December 31, 2016. He has indicated he will be transitioning to a new opportunity at a privately-held medical device company.

In connection with his departure, the Company has appointed Melanie Morel-Ferris, C.P.A. to assume the responsibilities and title of interim Chief Financial Officer, effective January 1, 2016. In this capacity, she will serve the role of the Company’s Principal Financial Officer and Principal Accounting Officer.

Ms. Morel-Ferris has served as the Company’s Controller since May, 2016. Prior to joining InVivo, Ms. Morel-Ferris served as the Corporate Controller of Astrodyne TDI, an electrical manufacturing company from July 2014 to May 2016. Prior to that, Ms. Morel-Ferris served as the Associate Director of Corporate Accounting of ARIAD Pharmaceuticals, Inc., a drug development company, from January 2014 to July 2014, and as a Senior Accounting Manager at ARIAD from January 2011 to December 2013. Ms. Morel-Ferris, who began her career at Deloitte, received a B.A. from Assumption College and is a Certified Public Accountant.

“We thank Steve for his significant contributions to InVivo over the last several years and wish him the best in his future endeavors,” Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said. “We also would like to congratulate Melanie on her promotion to interim Chief Financial Officer. The Board of Directors conducts regular succession planning exercises, and Melanie had been identified as a potential successor if and when the opportunity presented itself. She brings a wealth of financial experience to the position and will be a valuable addition to the executive team.”

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 Scaffold^TM received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

Author: OrthoSpineNews

Contacts

Contacts

Contacts