SpinalCyte Announces Positive 12 Month Pain Data From Phase 1/Phase 2 Clinical Trial for Degenerative Disc Disease

Posted On October 25, 2018 By OrthoSpineNews In Spine, Top Stories /

October 25, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), today announced 12-month endpoint data from its Phase 1/Phase 2 clinical trial for treatment of degenerative disc disease (DDD). The analysis showed that patients who received intradiscal injections of the HDF product CybroCell™ had sustained improvement in pain relief and increased back mobility after 12 months. The sustained pain relief suggests that there is a regenerative process stimulated by its cell-based therapy, CybroCell. CybroCell is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.

The landmark Phase 1/Phase 2 clinical trial included 24 patients with chronic lower back pain caused by DDD. The patients’ pain levels were measured using the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS) at 6 and 12-months post-treatment. At the 12-month endpoint, more than 90% of the treatment group had over a 10-point reduction in ODI and 100% had improvement in VAS. On average, treatment group patients showed a 61% improvement over baseline ODI scores, compared to 29% improvement in the placebo group. Patients received intradiscal injections in one to three spinal discs and were randomly assigned to treatment groups which received: a saline injection, an injection of 10 million HDFs or an injection of 10 million HDFs in combination with platelet-rich plasma (PRP).

Previous MRI data from the 6-month endpoint demonstrated superior outcomes in the treatment versus the control group. Of the treatment group, 83% demonstrated increased disc height or no change in one or more discs compared to 66% of control patients. More than half 52% of CybroCell-treated discs showed either increased disc height or no change versus only 38% of control discs. Preclinical animal studies have demonstrated that an intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn regenerate the disc nucleus.

“We are encouraged by the significant pain reduction of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “CybroCell has demonstrated clinically relevant outcomes in the area of pain reduction for those patients who received treatment injections. The data suggests CybroCell possesses tangible pain reduction benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical improvement in the degenerated disc.”

“We are excited about the sustained pain reduction we witnessed in the treatment arm patients from 6 months to 12 months,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “This study provides evidence of long-term reduction in pain and quality of life improvement for treated patients. This will ultimately lead to a reduction or elimination in need for opioids for chronic back pain patients and address the critical opioid epidemic in the U.S.”

SpinalCyte’s Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts which would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

Russo Partners LLC
David Schull, 858-717-2310
david.schull@russopartnersllc.com
or
Ned Berkowitz, 646-942-5629
ned.berkowitz@russopartnersllc.com
or
SpinalCyte, LLC
info@spinalcyte.com

OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System

Posted On October 19, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis. The system represents the Company’s 26^th surgical system and is expected to launch in the fourth quarter of 2018.

The RESPONSE 4.5/5.0mm System was designed in collaboration with pediatric orthopedic surgeons focused on additional solutions for treating complex pediatric scoliosis patients. It expands the Company’s RESPONSE platform to treat smaller stature children and builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System. The RESPONSE 4.5/5.0mm System offers a hybrid implant technology allowing the option of either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome material, multiple implant connector options, and innovative, new instrumentation.

OrthoPediatrics’ Executive Vice President, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our 4.5/5.0mm system, which allows physicians to better treat smaller statures and patients at a younger age. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring their innovative vision to life with another surgical solution for treating complex pediatric scoliosis. The addition of the new system to our scoliosis platform continues to demonstrate OrthoPediatrics’ focus and commitment to providing solutions for children with complex spinal disorders.”

Scott Luhmann, M.D., Chief of Staff at Shriners Hospital for Children-St. Louis and Associate Professor in the Department of Orthopedic Surgery and Fellowship Director of Pediatric Orthopedic Surgery at Washington University School of Medicine, commented, “The new Response 4.5/5.0mm System brings OrthoPediatrics’ expertise and passion for musculoskeletal care of pediatric patients to the area of spinal deformity. This surgeon-centric system is focused on surgical efficacy and efficiency with an elegant rod reduction tool that significantly cuts down laborious task time in the effort to provide optimal patient outcome.”

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts a 5.5mm or 6.0mm rod in both cobalt chrome and titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

NuVasive Names J. Christopher Barry To Succeed Gregory T. Lucier As Chief Executive Officer; Lucier To Remain Chairman Of The Board

Posted On October 19, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Oct. 19, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced its Board of Directors has named J. Christopher Barry to succeed Gregory T. Lucier as chief executive officer (CEO) effective November 5, 2018. Mr. Barry will join the NuVasive Board of Directors; Mr. Lucier will continue to serve as chairman of the Board.

“On behalf of the Board of Directors, I want to thank Greg for his many contributions to NuVasive—first as a member of the Board, and then as our chairman and CEO. Greg quickly shaped NuVasive into a global spine systems innovator, delivering highly differentiated technologies and procedurally integrated solutions to the market, improving patient outcomes by enabling better clinical decision-making and execution. We look forward to continuing to work with Greg, leveraging his business leadership and industry expertise as chairman of the Board,” said Don Rosenberg, lead independent director of the NuVasive Board. “Succession planning is one of the most important responsibilities for a Board of Directors of a publicly traded company, and we take those responsibilities seriously. Through our comprehensive recruitment efforts, we were impressed with Chris’s expertise in the medical device industry, and feel his strong reputation as a skilled and strategic operator, along with his innate passion and business know-how, will enable him to continue NuVasive’s transformation of spine surgery, adding tremendous value as he leads NuVasive into the future.”

Mr. Barry brings to NuVasive extensive experience as an innovative global leader in the healthcare and medical device industry. Currently, he serves as senior vice president and president of Surgical Innovations, the second-largest business unit at Medtronic with $5.5 billion in annual revenue. In this role, Mr. Barry leads and provides strategic direction to more than 14,000 employees working in 78 countries, including 10 manufacturing sites and multiple R&D centers around the globe. He also is responsible for driving the core growth in Surgical Innovations while diversifying the business through acquisitions in near adjacencies and overseeing the development of Medtronic’s surgical robotics development initiative. He previously held commercial and leadership roles at Covidien.

“Chris has successfully led teams globally, managed complex R&D programs, driven commercial initiatives and executed strategic acquisitions. He has built a stellar reputation for driving employee engagement and operational excellence,” said Gregory T. Lucier, chairman and CEO of NuVasive. “Through my personal and professional interactions with Chris, it is clear to me his leadership will benefit our surgeon partners, employees and shareholders. As a Board member and shareholder, I have every confidence in Chris’s ability to take NuVasive to its next level of growth.”

NuVasive also announced today that Matt Link, currently executive vice president, Strategy, Technology and Corporate Development, is promoted to president. Since joining NuVasive in 2006, Mr. Link has held various roles with increasing scope within the organization, particularly around building the U.S. Commercial organization and most recently bringing his spine and leadership expertise to the product and systems engineering, surgeon education and corporate development functions.

Mr. Lucier commented, “The combination of Chris and Matt at the helm of NuVasive creates the most dynamic leadership team in the industry.”

Mr. Lucier will remain involved with the strategic direction of the company as the chairman of the Board. His focus will also be on supporting Mr. Barry and Mr. Link in this leadership transition. Mr. Lucier has been with NuVasive since December 2013, first joining as a member of the Board of Directors, and then stepping in as chairman and CEO in May 2015.

The Company will further discuss the management transition plan on its third quarter 2018 earnings call scheduled for October 30, 2018, at 4:30 p.m. ET/1:30 p.m. PT.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Simplify Medical Appoints IP Attorney Veteran to VP, General Counsel

Posted On October 18, 2018 By OrthoSpineNews In Spine /

SUNNYVALE, Calif., Oct. 18, 2018 (GLOBE NEWSWIRE) — Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced that it has appointed Cindy Lynch to Vice President, General Counsel. Ms. Lynch has nearly 15 years of experience providing strategic legal and intellectual property advice to medical device startups.

Ms. Lynch’s appointment comes at a time when Simplify is expanding commercial efforts in Europe and nearing completion of its two-level U.S. IDE clinical trial for the implantation of its cervical artificial disc. The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018.

David Hovda, Chief Executive Officer of Simplify Medical, commented, “Cindy has led our intellectual property program for years, and we are very excited she has joined our team as General Counsel. While continuing to lead our IP program, which we believe is the largest and most impactful portfolio in cervical spine motion preservation, she will lead our overall legal strategy and continue to ensure our technology remains fully protected.”

Ms. Lynch specializes in intellectual property law and business venture advising. Prior to consulting for companies including Simplify Medical as in-house Counsel, she worked as the VP of Intellectual Property at Elixir Medical Corporation, Moximed, Inc., SpinalMotion, Inc., Conor Medsystems, Inc., and as a partner at Burns, Doane, Swecker & Mathis, LLP. Lynch will complete her M.B.A. from San Francisco State University in 2018 and earned her J.D. from George Mason University School of Law in 1995.

“I am thrilled to be part of the Simplify Medical team,” Cindy Lynch, J.D., said. “This is an exciting time to be working with Simplify as we near completion of the two-level Simplify Disc IDE trial enrollment and work toward the highly-anticipated commercial launch of the Simplify Disc, which will provide patients an innovative option for cervical disc replacement. As we continue to expand our commercial efforts, the protection of Simplify’s legal and IP interests is critical, and I look forward to working closely with the management team in these efforts.”

About Simplify Disc
Simplify^® Disc is a motion preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, and better match patients’ anatomies and kinematics. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI and may eliminate the need for CT/Myelogram and CT imaging in order to minimize patient exposure to radiation. The Simplify Disc is anatomically designed, offering a broader range of disc heights including low height implant options to better fit patients’ anatomies. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Simplify Medical Contacts:

Investor Contact:
Brian Johnston, The Ruth Group
Tel: +1 646-536-7028
Email: bjohnston@theruthgroup.com

Media Contact:
Kirsten Thomas, The Ruth Group
Tel: +1 508-280-6592
Email: kthomas@theruthgroup.com

SPINEWAY : Marketing of new Mont-Blanc Evo product line authorized in the United States

Posted On October 17, 2018 By OrthoSpineNews In Spine /

Ecully, October 17 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), completed all the regulatory steps and can market its Mont-Blanc Evo product line (presented at the Eurospine conference) in the United States.

This development of the flagship Mont-Blanc line that is already distributed on territory provides surgeons with an implant that can be screwed twice as fast, and with more efficient insertion tools. There will be a standard version (non-sterile) and a “ready-to-use” sterile version, a differenciating feature which is to become popular with US surgeons.

Spineway has already begun production of these new implants and instruments, and should be able to record its first US sales during the first quarter of 2019. In addition, the EC label should be granted in 2019 for distribution throughout Europe and the rest of the world.

Spineway has thus taken its first step toward reconquering the US market and will be accelerating the reorganization of its US subsidiary as per its strategic plan.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication: Half-year results for 2018 – 24 October 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent award (2015). ISIN: FR0011398874 – ALSPW

Contacts :


*Spineway* *Investor relations* David Siegrist – CFO finance.dsg@spineway.com		*Aelium* *Financial communication* Jérôme Gacoin / Solène Kennis skennis@aelium.fr

Attachment

SPW_MB_EVO_GB.pdf

Implanet Opens Another Direct Market in Europe with the First Surgery Jazz® in Belgium

Posted On October 16, 2018 By OrthoSpineNews In Spine /

October 16, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, is today announcing its first surgery Jazz® in Belgium, at the UZ Brussels University Hospital. A further illustration of its direct sales strategy that has proven effective in France and USA.

After the opening of Implanet UK, which along with its Jazz® platform has recently been approved by the UK’s National Health Service, and the opening of Implanet GmbH in Germany, this first surgery in Belgium demonstrates that Implanet is continuing to roll out its products directly in European markets.

“Jazz® technology is an excellent solution to be used in addition to screw fixation for preventing pullout in treating degenerative spine disease in adults. In pediatrics Jazz® can also be a replacement for screws in complex spinal deformities. The clinical benefit of Jazz® is undeniable, providing patients with additional safety. I am delighted to have access to the entire Jazz® product range at the University Hospital UZ Brussel, Belgium” says Dr David Van Schaik, orthopedic spine surgeon.

Ludovic Lastennet, CEO of Implanet, said: “This first surgery, which took place only shortly after we announced the opening of Implanet UK and Implanet GmbH in Germany, accelerates the roll-out of our direct sales strategy. We are confident that this model is the right one and will positively impact our earnings going forward.”

Implanet will be attending the following scientific conferences during Q4 2018:

SOFCOT in Paris from November 12 to November 15, 2018, stand F07
BSS (British Scoliosis Society) in Belfast from November 29 to November 30, 2018, stand 9
DWG in Wiesbaden (Germany) from December 6 to December 8, 2018, stand 102

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

Xtant Medical Announces Appointment of Interim CEO

Posted On October 15, 2018 By OrthoSpineNews In Spine /

BELGRADE, MT, Oct. 15, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today the appointment of Michael Mainelli to serve as Interim Chief Executive Officer, replacing Carl O’Connell effective October 12, 2018.

Mr. Mainelli joined the Board of Directors in February 2018 and will remain a member of the Board of Directors while serving as Interim Chief Executive Officer. The Company intends to commence a process to recruit a permanent Chief Executive Officer that will include both internal and external candidates.

Mr. Mainelli commented, “I am excited to continue working with our Board and with our management team in my new role. Xtant has great products, strong business partners, and dedicated, talented employees. We will be working hard to drive superior execution.”

Mr. Jeff Peters, Chairman of the Board, stated that “Mike is a proven leader with over 25 years of successful business leadership in the medical technology industry. He has led businesses at both public and private medical technology companies resulting in growth, operational improvement, and enhanced shareholder value. His unique experience in the global orthopaedic and spinal markets will be particularly valuable, and we are pleased to have him in this interim role.”

Mr. Mainelli succeeds Carl O’Connell, who served as Xtant’s Chief Executive Officer since October 2016. Mr. Peters added, “On behalf of the Board, I want to thank Carl O’Connell for his dedication and contributions, notably guiding the company through the recent restructuring process. We wish Carl all the best.”

About Xtant Medical Holdings, Inc.
Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.

™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Important Cautions Regarding Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ “continue,” “future,” ‘‘will,’’ “can,” similar expressions or the negative thereof, and the use of future dates. The Company cautions that its forward-looking statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s future operating results and financial performance; the ability to increase revenue; the ability to remain competitive; the ability to innovate and develop new products; the effect of management changes and the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subject; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 8, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

COMPANY CONTACT
Kathie Lenzen, Chief Financial Officer
406.388.0480
klenzen@xtantmedical.com

SpineEX® Announces FDA Clearance of Sagittae® Lateral Lumbar Interbody Fusion Devices

Posted On October 10, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

FREMONT, Calif., Oct. 10, 2018 /PRNewswire/ — SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sagittae lateral lumbar interbody fusion (LLIF) device.

The LLIF procedure uses minimally invasive techniques that approach the spine from the side of the patient, allowing for a larger implant footprint, and less disruption to lower back muscles as compared to other approaches, which results in less blood loss and faster recovery.

Sagittae is a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It is designed for up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment. The large single graft chamber can be filled with bone graft material after insertion and adjustment to ensure even contact with both vertebral endplates.

The ability to personalize the device to each patient’s needs provides restorative independent height and lordotic angle with proper anatomical fit. Available in five sizes, all with independent parallel height or lordotic profiles, Sagittae provides several options for surgeons to address optimal sagittal balance, while minimizing burdensome implant inventory traditionally required for each procedure.

“Sagittae is a personalized, expandable spinal implant with intra-operative adjustability ability for any height and any lordotic angle needed in a patient’s specific anatomy. This new lateral cage minimizes the need to forcefully impact the cage into the disc space,” said Roy Chin, Executive Chairman and CEO of SpineEX.

Indications for Use
The SpineEX Sagittae Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

About SpineEX, Inc.
SpineEX is a medical device company that is focused on providing minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries.

SOURCE SpineEX

First Endoscopic Minimally Invasive Spinal Procedure at Reston Hospital Center is Performed by Surgeons at Virginia Spine Institute

Posted On October 10, 2018 By OrthoSpineNews In Spine, Top Stories /

RESTON, Va., Oct. 10, 2018 (GLOBE NEWSWIRE) — Dr. Colin Haines, assisted by Dr. Christopher Good, Spine Surgeons at Virginia Spine Institute, is the first physician to perform endoscopic spine surgery at Reston Hospital Center. Through a micro incision (less than 1cm), Dr. Haines and Dr. Good utilized the magnification of an HD-endoscope to perform a microdiscectomy. This surgical method allowed safer and more efficient removal of a disc herniation.

Minimally invasive procedures are now commonplace in spinal surgery, but endoscopic spine surgery utilizes ultra-minimally invasive technology that enhances traditional surgical technique. The advantage of a smaller incision (less than 1cm) and the introduction of a high-resolution camera minimizes tissue disruption and reduces post-operative pain for the patient. Typically performed as an outpatient procedure, patients undergo less anesthesia and experience improved recovery times.

A wide-reaching innovation, endoscopic spine surgery has promise to transform the lives of patients with degenerative disc disease, disc herniations, and spinal stenosis. This milestone is an essential breakthrough for future spinal procedures as the specialists at Virginia Spine Institute work to advance endoscopic technology for spinal fusions and spinal decompressions.

“Endoscopic spine surgery has unleashed new potential for faster, safer, and more effective surgical recoveries,” says Dr. Colin Haines, Spine Surgeon and Director of Research at Virginia Spine Institute. “I’m proud to dramatically improve the lives of patients suffering from back pain by pioneering treatment solutions like this that get them back to their active lifestyles faster.”

Dr. Colin Haines is an expert in minimally invasive surgical techniques that improve patient safety and reduce recovery time. These techniques include ultrasonic spine surgery, endoscopic spine surgery, and robot-guided spine surgery.

Dr. Christopher Good, Spine Surgeon and President of Virginia Spine Institute, specializes in the treatment of complex spinal conditions and is considered a world expert in the field of robotic spine surgery.

About Virginia Spine Institute: Virginia Spine Institute is an award-winning specialty medical practice in the Washington, DC metro area solely dedicated to spinal health care. For over 25 years they have improved the lives of over 85,000 patients suffering from back or neck pain conditions. This comprehensive spine center provides convenience of specialty care with the top experts from multiple specialties of spinal health care under one roof. Custom treatment options include non operative care, pain management, physical therapy, and when necessary surgical intervention, including minimally invasive, laser and robot-guided procedures. For more information about Virginia Spine Institute visit SpineMD.com.

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Contact: Communications Director
Virginia Spine Institute
Tel: 703.709.1114 x 180
Email: 
SpineMD.com

NuVasive Announces Strategic Partnership With Biedermann Technologies To Access Intellectual Property And Co-Develop State-of-the-Art Complex Spine Solution

Posted On October 9, 2018 By OrthoSpineNews In Spine /

SAN DIEGO and DONAUESCHINGEN, GERMANY, Oct. 9, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has entered into a strategic partnership with Biedermann Technologies GmbH & Co. KG, a company that holds a broad and extensive patent and technology portfolio in the fields of spinal and extremity surgery, based in Donaueschingen, Germany.

Biedermann Technologies is well regarded for its world-class design expertise within many medical device industries and holds one of the most comprehensive and innovative patent portfolios in the field of spinal surgery. Within the terms of the license and services agreement, Biedermann Technologies has granted NuVasive licenses to intellectual property relating to its spinal technology portfolio.

Specifically, certain Biedermann Technologies’ proprietary screw innovations will be integrated into the NuVasive RELINE^® portfolio, offering surgeons a superior solution to treat complex spinal pathologies in both the adult and pediatric populations for open, as well as minimally invasive surgery, with customized screw placement and ability to facilitate various corrective maneuvers based on the clinical needs of the patient. NuVasive’s RELINE system is the only technology on the market to offer a single tulip that accepts three posterior fixation rods of different diameters and is integrated into its proprietary Integrated Global Alignment (iGA^®) platform designed to achieve global alignment across spinal procedures. This combination of Biedermann Technologies’ propriety screw technology and NuVasive’s RELINE system is expected to be commercially available to surgeons in the first half of 2019.

Biedermann Technologies will also provide services to NuVasive in connection with the development of its next-generation RELINE complex spine system to support three foundational clinical pillars: surgical efficiency, operative reliability and procedural versatility.

“Partnering with Biedermann Technologies —a highly innovative medical device design powerhouse—coupled with NuVasive’s best-in-class engineering teams and innovation prowess—will accelerate the development and time-to-market to put the most advanced posterior fixation solutions in the hands of our surgeon partners,” said Matt Link, executive vice president, Strategy, Technology and Corporate Development of NuVasive. “This partnership will help create better, more reproducible clinical outcomes in some of the hardest to treat spine pathologies, and further demonstrates our commitment to R&D investments to create the future of leading complex spinal innovation.”

“Significant challenges demand smart collaborations,” said Lutz Biedermann, founder and president of Biedermann Technologies. “And reconstructive spine surgery of complex deformities and instabilities of all age groups is still such a significant clinical challenge. With this in mind, I welcome the opportunity to work with NuVasive’s very talented and skilled organization to offer clinically meaningful solutions to the global spine community.”

NuVasive will showcase the upcoming RELINE system featuring Biedermann Technologies’ innovations at the Scoliosis Research Society Annual Meeting held October 10-13, 2018 in Bologna, Italy.

About Biedermann Technologies
Biedermann Technologies GmbH & Co. KG is a privately held company based in the South of Germany and is the owner and guardian of a substantial patent and technology portfolio for specialized orthopedic markets. For the last 25 years, Biedermann Technologies has successfully licensed numerous patents and related technologies to several key players in the orthopedic and neurosurgical field.

SOURCE NuVasive, Inc.

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