ROCKLAND, Mass.–(BUSINESS WIRE)–Paradigm BioDevices, Inc. announced today that it completed its 25,000th case with its proprietary MIS bone grafting system. The QuickDraw MIS Bone Harvester is a percutaneous and/or MIS access system for obtaining autogenous iliac crest bone graft for fusion procedures.

“Cancellous autograft remains the gold standard because it contains osteoconductive architecture, osteogenic stem cells and osteoinductive signaling factors.” said Michael O’Neill, President & CEO of Paradigm. “Not all autografts or bone graft materials meet this high standard. Iliac crest graft is widely accepted as the best bone graft available for fusion and we are able to obtain it through a minimal incision which is driving our success.”

An independent study with the QuickDraw MIS Bone Harvester found that 67% of patients could not tell they had a bone graft harvest, of the remaining only 14% of those were confident. The clinicians concluded, “(we) describe a minimally-invasive procedure to harvest iliac crest bone graft. Pain at the site was either non-existent or mild enough that patients were unable to accurately define their graft site.”

Paradigm BioDevices will be launching a new single use sterile kit version of the system at the North American Spine Society next week in Boston. The company expects CE clearance later this year and will expand its marketing and distribution efforts for sale of products outside the US.

About Paradigm BioDevices
Paradigm BioDevices, Inc. is an ISO 13485-2012 certified manufacturer of minimally-invasive orthopedic and spinal instrumentation and a master US national distributor of spinal fusion technologies. The company is a Boston-based privately-held organization founded in 1997.

For more information, visit http://www.paradigmbiodevices.com.

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has doubled its sales management team with the addition of nine new members to meet the growing demand for its Endoskeleton® line of titanium interbody fusion devices and to support the recent full launch of its next-generation nanoLOCK^® surface technology.

Steve Cichy, Vice President of Sales for Titan Spine, commented, “The addition of nine new sales managers, all of which bring a tremendous amount of spine sales experience and success, was required to meet accelerating demand for our surface technology offerings. They will play a critical role in working closely with our distribution network partners across the United States to further drive surgeon adoption, to support the recent full launch of nanoLOCK^®, and to capitalize on the dramatically increased access to surgeons and hospital systems our recently-awarded Section X new technology code from CMS affords us. Our sales expansion initiative is ongoing and is made possible, in large part, from proceeds from our recent substantial round of financing with investor Southlake Equity Group.”

Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary nanoLOCK^® surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^1,2 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary roughened surfaces in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

² Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced key presentations and company events featuring the Luna^® 3D Multi-Expandable Interbody Fusion System and Kiva^® VCF Treatment System at the North American Spine Society (NASS) 31^st Annual Meeting taking place Oct. 26-29 in Boston.

Benvenue is one of eight companies selected to present in the Innovative Technology Presentations Session. Dr. Jeffrey Coe of the Silicon Valley Spine Institute (Campbell, California) will provide an overview of the Luna 3D system and discuss early clinical results in the presentation, “Multiexpandable Cage for Minimally Invasive Posterior Lumbar Interbody Fusion,” on Oct. 26 at 8:30 a.m. in room 209.

“The Luna 3D System further advances minimally invasive lumbar fusion surgical techniques,” said Dr. Coe. “An important advantage of Luna’s multi-expandable cage for fusion is that it allows us to restore disc height using a well-established posterior surgical approach while providing stable fixation via a larger construct that is more often achieved using an anterior approach. Early experience with the Luna interbody cage is demonstrating encouraging outcomes, including restoration of disc height, segmental lordosis and foraminal height, along with lack of subsidence and maintenance of sagittal correction. Importantly, these results are being achieved without nerve retraction injuries, which are which are a risk of posterior lumbar fusion.”

Data Presentations

• “Incidence of Serious Adverse Events Associated with Readmissions after Vertebral Augmentation Using an Expandable Implant: Follow-Up Analysis of KAST” (presentation #10) will be presented by Dr. Douglas Beall of Clinical Radiology of Oklahoma (Edmond, Oklahoma) on Oct. 26 at 10:47 a.m. in room 205A. The podium presentation will review serious adverse events requiring unplanned re-admission for patients who had vertebral augmentation using the Kiva VCF Treatment System as compared to balloon kyphoplasty.
• “Community Practice Experience with Subsequent Vertebral Compression Fractures During the Year after Vertebral Augmentation Using an Expandable Implant” (presentation #88) will be presented by Dr. Arthur McCain of Vascular and Interventional Radiology Associates of Central Georgia (Macon, Georgia) on Oct. 27 at 3:10 p.m. in The Learning Place, Green Theater Technical Exhibition, booth #1900. The poster reviews the rate of subsequent vertebral compression fractures in the year following vertebral augmentation with the Kiva VCF Treatment System.
• “Biomechanics of Expandable Lumbar Interbody Fusion Cage Deployed Through Transforaminal Approach” (ePoster #11) will be moderated by Dr. Avinash Patwardhan of Loyola University Medical Center Department of Orthopaedic Surgery (Maywood, Illinois). The poster highlights a novel posterior minimally invasive approach to safely access the lumbar disc without intrusion into the spinal canal by use of the Luna 3D interbody cage to restore disc height as a means to achieve indirect canal and foraminal decompression.

Benvenue is exhibiting at booth #1451, where it is hosting “Meet the Experts” sessions throughout the day on Oct. 26 and Oct. 27. The company is also sponsoring the following product demonstration labs in The Learning Place on the Convention Floor:

• “Luna 3D, the MULTI-Expandable Interbody Implant” on Oct. 26 at 2 p.m.
• “Luna 3D Expandable Interbody Fusion System Surgeon Training Lab” on Oct. 27 at 5 p.m.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is designed to provide one of the largest yet least invasive devices for posterior lumbar interbody spinal fusion. Cleared by the U.S. Food and Drug Administration in November 2014, the Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint and secondarily in height, allowing surgeons to effectively restore height via a posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height with the insertion of a middle section. When the cannula is removed, bone graft is placed in the middle of the implant and the implant is locked in place with a locking wire.

About the Kiva VCF Treatment System

The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. Kiva was recently launched in the U.S. and it is commercially available in Europe. Kiva has been shown, in at least three comparative studies with a total of more than 500 patients, to meet or exceed the performance of balloon kyphoplasty, the standard of care. Kiva is indicated for the reduction and treatment of spine fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by DeNovo Ventures, Domain Associates, Esquilime Partners, InterWest Partners, Technology Partners and Versant Ventures. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

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.

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.