Johnson & Johnson Innovation Announces New Collaboration with Texas Medical Center to Spur Development of Breakthrough Medical Device Technologies

Posted On October 20, 2016 By OrthoSpineNews In Financial /

HOUSTON, Oct. 18, 2016 /PRNewswire/ — Johnson & Johnson Innovation LLC (JJI) today announced the creation of the Center for Device Innovation at Texas Medical Center (CDI @ TMC), a broad, new collaboration between JJI and TMC that aims to accelerate end-to-end development of breakthrough medical devices. This expands on JJI’s collaboration with TMC established earlier this year with the opening of JLABS @ TMC, combining the resources of the world’s largest medical complex with the capabilities of the Johnson & Johnson Medical Devices Companies*, to advance the health and well-being of people around the globe.

William E. “Billy” Cohn, M.D., an internationally renowned cardiac surgeon and serial medical device entrepreneur will lead the CDI @ TMC. Dr. Cohn recently joined the Johnson & Johnson Medical Devices Companies from the Baylor College of Medicine and the Texas Heart Institute (THI), where he was the Director of THI’s Center for Technology and Innovation and the Cullen Cardiovascular Research Laboratory. In his role as Director of the CDI @ TMC, Dr. Cohn will work on cutting-edge internal research and development projects for the Johnson & Johnson Medical Devices Companies and with external entrepreneurs and innovators.

“By creating a nexus for innovation, where scientists and engineers of the Johnson & Johnson Family of Companies can collaborate with academicians, expert clinicians, and external entrepreneurs to leverage the unique size, scope, and capabilities of TMC’s member institutions, we are confident that we can dramatically enhance health care around the world,” said Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.

The CDI @ TMC will include multiple components that will accelerate the development of new medical technologies from concept through commercialization, including a new medical device engineering studio housed at the TMC Innovation Institute. This state-of-the-art “maker space” will be home to R&D staff of the Johnson & Johnson Medical Devices Companies and will be used to accelerate both select internal projects and strategically aligned ventures of JJI partner companies. The facility will allow rapid prototyping and “fast failure” for early and mid-stage development. Through a series of collaborative agreements, the CDI @ TMC will also have broad access to the preclinical facilities of Baylor College of Medicine, Houston Methodist Research Institute, and THI that will permit the testing of novel devices for any organ system or disease-based application.

“We are eager for the opportunity to expand our collaboration with Johnson & Johnson Innovation,” said Robert C. Robbins, M.D., President and CEO, TMC. “Working together, we are creating a globally competitive innovation ecosystem here, and the new Center for Device Innovation @ TMC will enable us to expeditiously bring discovery and innovation to fruition, directly improving the health of patients.”

In addition to investing in a world-class innovation facility, JJI’s partnership is expanding innovation collaborations among several TMC member institutions. The alliance with Baylor College of Medicine will foster scientific discovery and promote the commercialization of medical devices using an open innovation model. The collaboration with Houston Methodist Research Institute will facilitate translational research activities in the anticipation of rapidly moving into human clinical trials. To this end, R&D staff and JJI partner companies will also have the use of the Methodist Institute for Technology, Innovation, and Education (MITIE^SM), a virtual hospital and hands-on clinical training facility, which develops strategies to optimize the introduction of novel device technologies into clinical practice. The relationship with Texas Heart Institute will deepen the scope of research currently devoted to surgical medical devices used to treat patients, helping to make more options commercially available. JJI will join forces with the TMC Clinical Trials Institute to develop and test new paradigms for accelerated medical device clinical trials. Lastly, the CDI @ TMC will have an affiliation with TMC Biodesign, a one-year innovation fellowship program, where Dr. Cohn will continue in his role as a faculty member.

* Comprising the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

About Johnson & Johnson Innovation LLC

Johnson & Johnson Innovation LLC focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson’s global healthcare businesses. Johnson & Johnson Innovation LLC provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical devices and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, JLABS, JLINX, Johnson & Johnson Innovation – JJDC, Inc. and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs for patients. For more information please visit: www.jnjinnovation.com.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to a new collaboration and product research and development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Innovation, LLC, the Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges inherent in new product research and development, including the uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov,www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson Innovation, LLC, the Johnson & Johnson Medical Devices Companies and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media Contact
Ryan Flinn
Johnson & Johnson Innovation
+1 510-207-7616
rflinn1@its.jnj.com

Stryker Spine to demonstrate its 3D printed Tritanium® Posterior Lumbar Cage at NASS 2016

Posted On October 20, 2016 By OrthoSpineNews In Spine /

Allendale, N.J.—Oct. 20, 2016—Stryker’s Spine division will demonstrate its 3D-printed Tritanium Posterior Lumbar (PL) Cage, an interbody fusion device designed to aid in lumbar spinal fixation for patients with degenerative disc disease, including up to Grade 1 spondylolisthesis, and degenerative scoliosis, at the North American Spine Society (NASS) Annual Meeting, Oct. 26-29, 2016, in Boston (booth No. 1415).

As part of the exhibit, Stryker’s proprietary Tritanium In-Growth Technology will be featured in a virtual reality “tour,” providing surgeons with a unique perspective on how 3D printing, also known as additive manufacturing, allows Stryker to produce highly porous implants that would be difficult or impossible to create using traditional manufacturing techniques.

Stryker’s Tritanium Technology, which reflects years of extensive research and development, allows for the creation of porous structures designed to mimic cancellous bone, a type of spongy bone tissue, with the goal of bone in-growth.¹

“We are excited to showcase the Tritanium PL Cage and unveil our new 3D virtual reality experience to surgeons during the NASS conference,” said Bradley Paddock, president of Stryker’s Spine division. “Oculus headsets will take surgeons on a journey through the evolution of Stryker’s pioneering additive manufacturing technology. They will then ‘travel’ to Stryker’s state-of-the-art additive manufacturing facility in Ireland for an up-close view of Tritanium and explore how our highly porous Tritanium implants may benefit their patients.”

Also at NASS, results will be presented from a pre-clinical animal study, titled, “Biomechanical and Histologic Comparison of a Novel 3D-Printed Porous Titanium Interbody Cage to PEEK,” that evaluated the biomechanical performance and bone in-growth potential of various lumbar interbody fusion implants utilizing different materials, including the Tritanium PL Cage.

The Tritanium Posterior Lumbar Cage features fully interconnected pores that span endplate to endplate. It is available in a variety of widths, lengths, heights, and lordotic angles that can adapt to a variety of patient anatomies. Its large lateral windows and open architecture allow visualization of fusion on CT and X-ray,² and its solid-tipped, precisely angled serrations are designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Media Contact
Barbara Sullivan, Sullivan & Associates
bsullivan@sullivanpr.com, 714/374-6174

Editor’s note: For images, video footage, or animation of the Tritanium PL Cage and Stryker’s 3D additive manufacturing process, contact Barbara Sullivan at 714/374-6174 or bsullivan@sullivanpr.com. A media backgrounder about Tritanium and the Tritanium PL Cage also is available at www.stryker.com/builttofuse.

References

Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
Abbushi A, Cabraja M, Ulrich-Wilhelm T, Woiciechowsky C, Kroppenstedt S. The influence of cage positioning and cage type on cage migration and fusion rates in patients with monosegmental posterior lumbar interbody fusion and posterior fixation. Eur Spine J. 2009;18: 1621–1628.

Content ID TRITA-PR-5_11874

If you would rather not receive future communications from Sullivan & Assoc, please go to https://optout.cision.com/en/2vVUvJiyZuPYBCQUEj9vDbXHtboNTZq4mSnUfHHiU6L1o6vU199Pj71nU2SaPbT6R47bUsaQmGSs67mzVf7yfB2N5xbRE48mDyZL1Hwhqgco3m.
Sullivan & Assoc, 419 Main Street, Suite 149, Huntington Beach, 92648 California, United States

Isto and Arteriocyte join forces to form leading biologics player, Isto Biologics

Posted On October 19, 2016 By OrthoSpineNews In Biologics, Financial /

ST. LOUIS, Oct. 19, 2016 /PRNewswire/ — Isto Holdings, the parent company of St. Louis-based Isto Technologies – a leader in bone-regeneration technologies and cell-based therapy – has acquired medical-device company Arteriocyte Medical Systems Inc. ofHopkinton, Massachusetts, with plans to integrate the companies under the name Isto Biologics. Isto Biologics will be focused on offering evidence-based solutions to expand its spine, orthopedics, and functional-medicine product portfolios. Isto Biologics will be headquartered in St. Louis, while maintaining operations in Massachusetts.

“We’re excited to bring together two great organizations under the Isto umbrella and build upon their leading biologics platforms,” saidAnthony Chambers, Director at Thompson Street Capital Partners, which provided capital for the transaction. “Both Isto and Arteriocyte have achieved remarkable success by developing innovative, clinically-proven product offerings that help improve patient outcomes. The integrated product portfolio, combined with the expanded sales force and broader distribution network, will allow Isto Biologics to extend its reach within the spine, orthopedics, and functional-medicine markets.”

George Dunbar, current CEO of Isto Technologies, will serve as CEO of Isto Biologics. “We are grateful for the support of Thompson Street Capital Partners and excited to lead Isto Biologics into the future,” said Mr. Dunbar. “The integration of Isto and Arteriocyte presents an opportunity to leverage our combined expertise to establish a strong position in an ever-changing market and better serve our physician partners, as they work to grow their practice and meet the demands of value-based healthcare.”

Isto Biologics’ expanded, best-in-class product portfolio will feature Arteriocyte’s market-leading MAGELLAN® Autologous Platelet Separator and Isto’s bone-growth and cell-therapy products, including InQu® Bone Graft Extender & Substitute; Influx®, a natural bone-graft material; and CellPoint®, a concentrated bone marrow aspirate system.

About Isto Biologics

Isto Biologics was formed in 2016 when St. Louis-based Isto Technologies and Arteriocyte Medical Systems Inc. of Hopkinton, Massachusetts, integrated under the Isto Holdings umbrella. Isto Biologics is focused on offering evidence-based solutions for bone regeneration and cell therapy to help improve patient outcomes. The company’s best-in-class product offerings include Arteriocyte’s market-leading MAGELLAN® Autologous Platelet Separator and Isto’s bone-growth and cell-therapy products including InQu® Bone Graft Extender & Substitute; Influx®, a natural bone-graft material; and CellPoint®, a concentrated bone marrow aspirate system.

For more information, visit istobiologics.com.

Media Contact:
Jenny Reid
Director of Marketing
314-262-8039
JReid@istotech.com

Logo – http://photos.prnewswire.com/prnh/20161019/430449LOGO

SOURCE Isto Biologics

CollPlant Receives CE Mark for Vergenix™STR for Treatment of Tendinopathy

Posted On October 19, 2016 By OrthoSpineNews In Regulatory /

NESS ZIONA, Israel, October 19, 2016 /PRNewswire/ —

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human collagen) technology for tissue repair products, today announced that it has achieved a significant milestone with the receipt of the CE Mark for Vergenix™STR, a soft tissue repair matrix for the treatment of tendinopathy. Sales in Europe are expected to commence in the coming months.

Yehiel Tal, Chief Executive Officer of CollPlant: “The CE Mark for Vergenix^™STR denotes an additional and key milestone achieved by CollPlant. In the past few months, we have shown that treatment with our product provides for substantially superior results when compared to published steroid treatment results, the current standard of care for tendinopathy. We are presently in dialogue with potential distributers for product marketing in Europe and expect initial sales within the coming months. Of note, this is the second CE Mark the company received this year, with the first granted at the beginning of the year, to its VergenixFG product, indicated for the treatment of chronic and surgical wounds. These accomplishments advance the company’s strategic plan to position plant-bad human collagen technology, and its medical byproducts, as the gold standard in regenerative medicine.”

Vergenix^™STR primarily made of cross linked rhCollagen intended to be combined with platelet-rich plasma (PRP), a concentrated blood plasma derived from the patient’s own blood, that contains high levels of platelets, which are critical to the healing process. Platelets contain growth factors are responsible for stimulating tissue generation and repair, including soft tissue repair, bone regeneration, development of new blood vessels, and stimulation of the healing process. Upon administration, CollPlant’s Vergenix^™STR serves as a scaffold to support cell adhesion and proliferation involved in the tendon healing while maintaining growth factor containing PRP in the vicinity of the injury. After injection into the affected area, the product forms a viscous gel matrix, holding the platelet concentrate in place. The matrix formed then has the ability to release growth factors in a controlled manner and with controlled biodegradation time, thereby enabling tissue repair.

About CollPlant:

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based rhCollagen technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary recombinant human collagen (rhCollagen), among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix^™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; Vergenix^™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; Vergenix^™BVF (Bone Void Filler), for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacturing of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacturing and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant
Eran Rotem
Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC
Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@RxIR.com

SOURCE CollPlant

Feb 23, 2016, 02:33 ET

Preview: CollPlant Receives CE Mark for Vergenix™FG Wound Filler

SpineGuard® expands “PediGuard®” franchise, will launch “PediGuard Threaded” drilling device at North American Spine Society (NASS) annual meeting

Posted On October 19, 2016 By OrthoSpineNews In Spine /

October 19, 2016

PARIS & SAN FRANCISCO–(BUSINESS WIRE) – SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD) announced today that it will launch its next-generation PediGuard “Threaded” device enabled by DSG™ (Dynamic Surgical Guidance) technology at next week’s 31^st annual meeting of the North American Spine Society (NASS) in Boston on October 26-29.

The innovative PediGuard Threaded device with DSG is a drilling instrument with a threaded shaft design available in various sizes. It may be used to streamline surgical steps while maintaining the accuracy of pedicle preparation for screw placement. Additionally, it may reduce the use of intraoperative imaging in standard and MIS procedures.

“The PediGuard Threaded device is a transformative product in spine surgery. It combines the need to make a pilot hole and do a tap into one-step. As it is threaded, surgeons can get a very nice controlled advancement of the tip down through the pedicle, which gives steady feedback regarding the positioning of the pedicle screw pilot hole,” said Ciaran Bolger, MD, PhD, Professor of Clinical Neuroscience, Beaumont Hospital, Dublin, Ireland.

“Because we can be confident in our guided placement, we have been able to reduce the amount of fluoroscopy used during minimally invasive procedures. I estimate that, at our spine center, we have reduced the number of fluoroscopy images by about 50%,” said Larry T. Khoo, MD, The Spine Clinic of Los Angeles, California. “My practice is 90-100% minimally invasive, so I routinely use the PediGuard Threaded device in the vast majority of my cases. I use it in everything from routine lumbar to thoracic screw cannulations.”

“I have used the PediGuard Threaded device for CBT (cortical bone trajectory),” added Richard A. Hynes, MD, FACS, President of The B.A.C.K. Center in Melbourne, Florida. “Due to the significant cortical bone in this pedicle screw method, tapping of the bone is recommended. With the PediGuard Threaded device, I am able to benefit from a prospective warning of breaching the bone while performing the tapping step simultaneously. This may result in improved safety, efficiency and accuracy while consistently facilitating the longest possible screw lengths.”

Stéphane Bette, CTO and Co-Founder of SpineGuard, concluded, “Learning now on 50,000 surgeries secured with DSG™ technology,SpineGuard continues to enhance the value offered to surgeons and hospitals with the US launch of our new, finely designed PediGuard Threaded range, further demonstrating how our DSG technology can be integrated within pedicle screw instrumentation for additional clinical benefits and efficiencies.”

SpineGuard reports 50,000 spine procedures performed using its family of PediGuard devices for accurate pedicle screw placement. The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated, and now, PediGuard Threaded.

Find more information on the PediGuard Threaded device with DSG technology and product information.

Recent events:

The DSG™ screw was presented in a symposium on October 5 at the EUROSPINE Annual meeting in Berlin, Germany. The US-FDA clearance is progressing well with the company submission of the 510k on October 14.

Latest news release: SpineGuard reports €1.7M revenue for 3Q 2016, and 9 months growth of 15%

Next financial press release: 2016 full year revenue, January 5, 2017

SpineGuard will participate at Actionaria retail investor show on November 18 and 19 in Paris.

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. 50,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris.

For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Orthocell Receives Approval for Human Nerve Regeneration Study Using CelGro®

Posted On October 19, 2016 By OrthoSpineNews In Biologics, Neuro /

October 17, 2016

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell has been granted ethics approval for a human study examining the effectiveness of its CelGro® collagen medical device, to guide and promote nerve regeneration in severed peripheral nerves of the hand and upper limb.

The primary objective of this study is to demonstrate the safety, tolerability and effectiveness of CelGro® when used as a conduit in the surgical repair of peripheral nerve injuries. The study will involve 20 patients who have suffered injury to one or more peripheral nerves and will be undertaken at St John of God Hospital beginning in the fourth quarter of calendar 2016.

Peripheral nerve injury is most commonly caused by accidents or other trauma and in the US alone, over 20 million people are affected each year, at a cost of approximately $150 billion in annual health care dollars.

Principal investigator, orthopaedic surgeon Dr Alex O’Beirne said: “This is an exciting development that has the potential to improve patient outcomes by allowing for a suture-less repair to the damaged nerve, to guide nerve regeneration and accelerate the healing process.”

CelGro® is a biological medical device used as a scaffold for a variety of orthopaedic and general reconstructive surgical applications. Orthocell is also undertaking clinical studies using CelGro® to augment repair of the rotator cuff tendon within the shoulder, as an augment to guide and promote bone regeneration, as well as an augment to cartilage repair within the hip joint.

Orthocell Managing Director Paul Anderson said, “This is an exciting new phase in the development of CelGro® and its use as an augment to improve nerve repair. It further validates CelGro as a unique platform technology for soft tissue repair.”

Orthocell has submitted CelGro® for first regulatory approval in Europe and expects to receive notice of approval of its CE Mark application in 2016. Receipt of this approval will enable sales of CelGro® to commence in Europe, and trigger applications for other regulatory approvals in the United States, Australia and Japan in 2017.

About Orthocell Limited

Orthocell is a commercial-stage, regenerative medicine company focused on regenerating mobility for patients and our ageing population by developing products for a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-approved stem cell therapies Autologous Tenocyte Implantation (Ortho-ATI™) and Autologous Chondrocyte Implantation (Ortho-ACI™), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is CelGro™, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.

Contacts

Orthocell Limited
General enquiries
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

Precision Spine® to introduce the MD-Vue™ Lateral Access System at the North American Spine Society’s 31st Annual Meeting in Boston

Posted On October 19, 2016 By OrthoSpineNews In Spine /

October 19, 2016

PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, will introduce its MD-Vue™ Lateral Access System at the North American Spine Society (NASS) Annual Meeting October 26-29 in Boston, MA. The strong, lightweight MD-Vue System was designed in collaboration with prominent lateral approach spine surgeons and is the only lateral retractor that offers a unique and patented nested 3-blade design for preventing blade creep during insertion. An adjunct 4^th Blade Anterior Retraction option enables surgeons to increase the retraction field if necessary. MD-Vue features infinite resolution retraction, multiple fixation options and integrated LED lighting. The system will sell into a $1.2B worldwide market and is one of several innovative systems in the Precision Spine product development pipeline the company expects to become significant growth drivers during the next phase of its aggressive growth.

“The MD-Vue Lateral Access System’s patented, nested 3-blade design is an innovative feature that enables surgeons to prevent blade creep in lateral procedures. It incorporates a large blade diameter for increased surface area contact, which minimizes the pressure on neural structures during retraction. And the system’s radiolucent retractor increases visibility of critical anatomical structures during intraoperative C-Arm use,” said Faheem Sandhu, M.D. Director of Spine Surgery at MedStar Georgetown University Hospital, a key member of the MD-Vue design team.

Andrew G. Cappuccino, M.D., another key member of the MD-Vue design team, remarked, “The system features Infinite Cranial/Caudal Resolution, which is designed to prevent unwanted nerve pressure by permitting the surgeon to dial in precisely the desired amount of retraction, in contrast to other systems which only permit traditional incremental step retraction. In addition, the system features an industry leading integrated, adjustable dual light source, as well as an improved rotary retraction mechanism that provides surgeons with better control and tactile feel during retraction.”

“With its many unique features, MD-Vue is a noteworthy advancement over existing lateral access systems and an outstanding platform from which we can continue to expand our presence in the lateral market,” said Jim Pastena, Precision Spine’s Chief Executive Officer and Chairman of the Board. “It’s a landmark addition to our portfolio and represents another example of how Precision Spine is working with spine surgeons to develop next generation products designed to help improve efficiency and achieve positive patient outcomes.”

About Precision Spine

Precision Spine, Inc. is a privately held company headquartered in Parsippany, NJ with manufacturing facilities in Pearl, MS. Precision Spine is dedicated to providing innovative, quality spine products that are made in the USA and designed to help treat serious orthopedic medical conditions in a cost effective manner. For more information, visit www.precisionspineinc.com.

Contacts

Precision Spine, Inc.
Chris DeNicola
Chief Operating Officer
chris.denicola@precisionspineinc.com

InVivo Therapeutics Announces Foothills Medical Centre in Calgary, Alberta as New Canadian Site for INSPIRE Study

Posted On October 19, 2016 By OrthoSpineNews In Biologics, Neuro /

October 19, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Foothills Medical Centre in Calgary, Alberta has been added as a Canadian clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of theNeuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. The Foothills Medical Centre is the largest hospital in Alberta and is one of the most recognized medical facilities in Canada, providing advanced healthcare services to over two million people from Calgary and southern Alberta, the northwestern United States, southeastern British Columbia, and southern Saskatchewan.

“InVivo’s Neuro-Spinal Scaffold is one of the more innovative approaches to treating acute spinal cord injury in recent history and we look forward to being a part of the INSPIRE study,” said Steven Casha, M.D., Ph.D., Assistant Professor of Neurosurgery in the Department of Clinical Neurosciences and Principal Investigator at the study site.

Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Casha and his team at the Foothills Medical Centre to the INSPIRE study. We will continue to expand our footprint in both the US and Canada.”

A new CEO’s Perspective discussing the current status of the INSPIRE study can be found on the InVivo Therapeutics website:http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

There are now 24 clinical sites participating in the clinical study:

Banner University Medical Center, Tucson, AZ
Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, MO
Ben Taub Hospital/Baylor College of Medicine, Houston, TX
Barrow Neurological Institute – St. Joseph’s Hospital and Medical Center, Phoenix, AZ
Carolina Neurosurgery and Spine Associates/Carolinas Rehabilitation, Charlotte, NC
Cooper Neurological Institute, Camden, NJ
Foothills Medical Centre, Calgary, Alberta, Canada
Goodman Campbell Brain and Spine/Indiana University Health Neuroscience Center, Indianapolis, IN
Hospital of the University of Pennsylvania, Philadelphia, PA
Keck Hospital of University of Southern California, Los Angeles, CA
Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
Mount Sinai Hospital, New York, NY
Northwestern Medicine, Chicago, IL
Oregon Health & Science University, Portland, OR
Rutgers New Jersey Medical School, Newark, NJ
Thomas Jefferson University Hospital, Philadelphia, PA
Toronto Western Hospital, Toronto, ON, Canada
University of California, Davis Medical Center, Sacramento, CA
University of California, San Diego Medical Center, San Diego, CA
University of Kansas Medical Center, Kansas City, KS
University of Louisville Hospital, Louisville, KY
University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
University of Virginia Health System, Charlottesville, VA
Vidant Medical Center, Greenville, NC

For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

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 www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release or the CEO Perspective referred to herein 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, the expected timing of full enrollment in the INSPIRE study, the timing of the submission of the Humanitarian Device Exemption (HDE), the timing for opening of the pilot cervical SCI study, and the company’s anticipated cash balance. 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 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.

Contacts

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

Ekso Bionics to Exhibit Ekso GT Robotic Exoskeleton at AAPM&R and AMRPA Annual Meetings

Posted On October 19, 2016 By OrthoSpineNews In Robotics /

RICHMOND, Calif., Oct. 18, 2016 (GLOBE NEWSWIRE) — Ekso Bionics Holdings, Inc. (EKSO), a robotic exoskeleton company, today announced that the company and its collaborators will exhibit their Ekso GT robotic exoskeleton in New Orleans at both the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly taking place October 20-23, 2016 and the American Medical Rehabilitation Providers Association (AMRPA) Annual Educational Conference taking place October 24-26, 2016.

Ekso Bionics will host a symposium in conjunction with AAPM&R on Friday, October 21 from 4:45 – 6:00 pm at the New Orleans Downtown Marriott Convention Center. During this symposium, Dr. Jeffrey Oken, Chief Medical Officer at Marianjoy Rehabilitation Hospital and Dr. Christina Kwasnica, Medical Director of Neuro-rehabilitation at Barrow Neurological Institute will discuss their research on the use of Ekso GT. In addition, Leslie VanHiel, DPT and Clinical Training Specialist at Ekso Bionics will review the most recent studies involving the Ekso GT device. A demonstration and Q&A will follow the symposium.

There are four educational sessions at AAPM&R dedicated to robotic therapy:

Session 401. Integrating Advanced Rehabilitation Technology and Robotics into Clinical Practice

7:30 AM–9:00 AM Oct 20, 2016; Convention Center, Meeting Room R08-09, Level 2

Erin Eggebrecht, PT, DPT, NCS

Deborah Gaebler-Spira, MD, McGaw Medical Center of Northwestern University (RIC) PM&R Program

Joshua Vova, MD

Session W204. Incorporating Exoskeletal Robots Into Practice

2:00 PM–3:30 PM Oct 20, 2016; Convention Center, Meeting Room 217, Level 2

Lauri Bishop, PT, DPT

Alberto Esquenazi, MD, Chmn Dept of PMR and Chief Med Off at Moss Rehab Hosp

Kristen Hohl, MD

Casey Kandilakis, PT, DPT, NCS

Donald Leslie, MD, Shepherd Ctr

Joel Stein, MD, Chair at Columbia Univ Med Ctr

Session 223. Frontiers in Rehabilitation Robotics

2:30 PM–4:00 PM Oct 22, 2016; Convention Center, Great Hall B, Level 1

Sunil Agrawal, PhD

Ethan Rand, MD, Assistant Professor at New York Prebyterian – Weill Cornell Medicine

Joel Stein, MD,Chair at Columbia Univ Med Ctr

Session 225. Robotics in Rehabilitation: Optimizing Treatment Delivery

4:15 PM–5:45 PM Oct 22, 2016; Convention Center, Great Hall B, Level 1

Alberto Esquenazi, MD, Chmn Dept of PMR and Chief Med Off at Moss Rehab Hosp

Matthew Vnenchak, PT

The following educational session will be offered at AMRPA:

Robotics in Neurorehabilitation: A Way to Improve Care Intensity and Efficiency

4:50 PM-5:50 PM Oct. 24, 2016; Royal Sonesta Hotel, Royal Conti Room

Alberto Esquenazi, MD, Chmn Dept of PMR and Chief Med Off at Moss Rehab Hosp

Ekso Bionics will be exhibiting at booth numbers 201 for AAPM&R and 18 for AMRPA.

About Ekso Bionics^®
Ekso Bionics is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical, industrial and defense applications. Founded in 2005, the company continues to build upon its unparalleled expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe, to providing research for the advancement of R&D projects intended to benefit U.S. defense capabilities. The company is headquartered in the Bay Area and is listed on the Nasdaq Capital Market under the symbol EKSO. For more information, visit: www.eksobionics.com.

About Ekso™ GT
Ekso™ GT is the first FDA cleared exoskeleton cleared for use with stroke and spinal cord injuries from L5 to C7. The Ekso GT with smart Variable Assist™ (marketed as SmartAssist outside the U.S.) software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of the patient’s body, challenging the patient as they progress through their continuum of care. The suit’s patented technology provides the ability to mobilize patients earlier, more frequently and with a greater number of high intensity steps. To date, this device has helped patients take more than 55 million steps in over 120 rehabilitation institutions around the world.

Michigan Technological University Joins Nanovation Partners in a Commercialization Agreement on Nanotube Processes

Posted On October 19, 2016 By OrthoSpineNews In Financial /

ORLANDO, FL (PRWEB) OCTOBER 19, 2016

Nanovation Partners, LLC and Michigan Technological University today announced a partnership agreement for commercialization of processes to nano-texturize medical implants. These advanced processes can simultaneously increase bone ingrowth and provide an antimicrobial barrier. The collaboration agreement extends Nanovation Partner’s leadership in commercialization of nano-texturing technology.

Craig Friedrich, PhD, Director of Michigan Tech’s Multi-scale Technologies Institute, commented, “What we’re developing is a surface treatment that’s more straightforward and economical than other processes. It speeds healing and is applicable to a broad range of implants. With this process, in conjunction with the technologies developed at other leading nano-technology universities and companies already in partnership with Nanovation Partners, we can fight infection and reduce inflammation. Our partnership with Nanovation Partners will speed and broaden the transfer of this technology to provide a clinical benefit for a broad range of patients.”

With this latest collaboration, Nanovation Partners has aligned with another well-published, recognized leader in the development of titanium dioxide (TiO2) nanotubes for modifying the surfaces of medical implants. It builds on Nanovation Partners’ growing list of partnerships with academic researchers at the University of California San Diego (UCSD), Washington State University (WSU), and University of Central Florida (UCF), and further broadens the company’s portfolio of five Issued and over 20 pending U.S. and international patents for nanotexturing processes and structures.

Researchers at Michigan Technological University and Washington State University have been issued separate U.S. patents for nanotexturing processes and structures that improve bone growth and provide anti-microbial properties, addressing both initial and long-term infections following implantation. The agreements with these institutions give Nanovation Partners, in part, exclusive rights to license the technologies to medical device companies in all medical areas.

“The partnership with Michigan Tech builds on Nanovation Partners’ strategic collaborations with leaders in nanotexturing technology,” said Dan Justin, President and CEO of Nanovation Partners. “We are first licensing technologies focused on nanotexturing existing implant surfaces, then, when applicable, licensing nanotechnologies that further enhance the textured surface. Our licenses with the four universities extend into all areas of medicine including orthopedics, cardiovascular, and neurovascular. Having demonstrated superior properties to other nanotextured and traditional implant surfaces in numerous in vivo and in vitro studies, our nanotube structure addresses all three major deficiencies of traditional implant material surfaces, by increasing hydrophilicity, enhancing osseointegration and by providing a surface that is unfriendly to pathogenic microbes. The agreement with Michigan Tech extends Nanovation Partners lead in developing nanotexturing technology for clinical use.”

Mr. Justin continued, “In addition to the first generation of nanotechnologies that enhance implants by nanotexturing their surfaces, the next generation of licensed technologies from our four research institution partners can be used as drug and antimicrobial delivery systems. For example, Michigan Tech’s technology has demonstrated extended release of the anti-inflammatory drug sodium naproxen after implant surgery in a study published in the journal RSC Advances. The technology may also be used on a variety of implants to reduce inflammation and promote healing. All of these technologies are now available for further development and licensing, and Nanovation Partners is actively seeking medical device partners who are interested in bringing this innovative approach to patients.”

Nanovation Partners has also recently partnered with N2 Biomedical of Bedford, Massachusetts, a leading ISO-13485 certified surface treatment provider, who can perform the nanotexturing process on a service basis for interested device manufacturers.

Discover Nanotechnology at NASS (Booth #1837) in Boston, MA where Nanovation Partners will be exhibiting, October 26th through October 29th.

For more information, please contact Dan Justin (info(at)nanovationpartners.com), President and CEO of Nanovation Partners, LLC.

Michigan Technological University is a leading public research university developing new technologies and preparing students to create the future for a prosperous and sustainable world. Michigan Tech offers more than 120 undergraduate and graduate degree programs in engineering; forest resources; computing; technology; business; economics; natural, physical and environmental sciences; arts; humanities; and social sciences.

Nanovation Partners LLC sponsored early research at the University of California at San Diego (UCSD) in the lab of Sungho Jin, PhD. This research showed enhanced osseointegration and reduced implant surface infection by forming tiny rows of metal oxide nanotubes on the implant surfaces. A comprehensive patent portfolio has since begun issuing with claims that cover a wide range of processes and structures. Nanovation Partners has also licensed Intellectual Property from Washington State University (WSU) related to antimicrobials with silver nano-particles on nanotubes and other nanostructures, the University of Central Florida (UCF) and Michigan Technological University related to nanotube processing.

Month: October 2016

Contacts

Contacts

Contacts

Contacts