Spine – Page 54 – Selby Spine

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August 22, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today the first cases performed with multiple methods of in-situ expansion.

“Surgical intervention for the degenerative spine is a multi-dimensional challenge and by utilizing two methods of expansion, Life Spine allowed for me to cater to my patient’s unique pathologies,” said Dr. Thomas Scully of Tucson, AZ. “At one level, my goal was to provide the patient with restoration of significant disc height and sagittal alignment, while minimizing the need for excessive boney decompression and multiple passes by important neural structures. After reviewing intra-operative images this was accomplished with Life Spine’s PROLIFT^® Lordotic system. Adjacent level pathology and patient bone quality dictated increased endplate coverage for stability and the ability to post-pack graft material to increase the chance of fusion, so TiBOW™ was the best choice.”

ProLift Expandable PLIF/TLIF Spacer System and TiBOW Expandable TLIF Spacer System highlight Life Spine’s Micro Invasive Expandable portfolio. ProLift and TiBOW feature OSSEO-LOC^™ Surface Treatment Technology, which is a proprietary surface treatment that creates a unique osteophylic surface architecture for potential bone on-growth¹.

“It is very exciting to be part of an organization that is able to provide physicians with innovative surgical solutions to accommodate patient’s distinct and challenging pathologies, especially where bone quality and disc access can be compromised. Each patient is unique and their treatment should be as well,” said Mariusz Knap, Vice President of Marketing for Life Spine.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

¹K.Kieswetter, Z. Schwartz, T. W. Hummert, D. L. Cochran, J. Simpson and B. D. Boyan
“Surface roughness modulates the local production of growth factors by osteoblast-like MG-62 cells” The Journal of Biomedical Materials Research (1996): Web

Contacts

Life Spine
Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal applications by utilizing additive manufacturing (“3D-Printing”), today announced the acquisition of a full patent portfolio of 22 issued and pending patents for 3D printed expandable spinal fusion cages based on living hinges from Morgan P. Lorio, MD. These patents cover the United States, Europe and many other global markets and provide EIT the option to offer a complete product range of fully 3D printed cages for both vertical and lateral expansion.

Dr. Morgan Lorio is triple board certified in spine, orthopaedic and hand surgery. Since recovering from a significant spinal injury, he has become a renowned advocate for patients with spinal injuries, an expert in spine policy, and a notable pioneer in spinal technology. He has special interests in cervical spine pathology affecting the upper extremity, artificial discs, motion preservation, and minimally invasive spinal surgery, as well as in issues particular to the female spine, such as sacroiliac joint disease and vertebral augmentation. Dr. Lorio practices at Hughston Clinic Orthopaedics in Nashville,TN.

Guntmar Eisen, CEO of EIT says “This IP is our platform to take fully 3D printed fusion cages to the next level by adding functionality to our EIT cellular titanium® cages. This will give the surgeon more options intraoperatively, reduce inventory and support MIS techniques – and at the same time reduce cost of expandable cages.”

Morgan Lorio, MD believes that “The combination of 3D printed cellular structures with functionality is disruptive game changing technology. It will give me better tools to restore my patients´ spinal balance and enlarge the cage footprints for better endplate coverage while experiencing faster spinal fusion. I am thrilled that these technologies will be advanced by the German engineering team of EIT.”

The first functional spinal fusion cages based on the patent acquisition will be launched in 2018.

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of SMART Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment.

In July 2017 EIT has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.

EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen. Since then more than 10.000 EIT cases have been performed in over 15 markets globally.

ATLANTA, GA — (Marketwired) — 08/21/17 — Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company“), the developer of the DenerveX™ System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today announced it has appointed Jesse Crowne as Director and Executive Co-Chairman of the Board.

Jesse Crowne has been acting as a Vice President of Business Development for the Company since January 2015. Mr. Crowne has been a Managing Partner at Gorlin Companies; a healthcare focused single family office specializing in founding and funding early ventures since July 2015. Crowne replaces Steve Gorlin who will remain with the Company in a consultancy role.

Between August 2015 and January 2017, Mr. Crowne was the President of Vavotar Life Sciences, a private clinical stage biotechnology company developing antibody directed oncology products. Since 2016, Mr. Crowne has served as an Adjunct Professor at Westminster College teaching a course on financing new ventures to MBA students. From October 2013 to March 2014, he was the Co-Founder of Virtual Clinic Trials, LLC, a cloud based document management solution for clinical trials until it was sold to Global Deal Market in 2014. From 2010 to June 2014, he was an associate at White Pine Medical, a subsidiary of Essex Woodlands, which was a private equity investment fund seeking late stage medical device opportunities.

Steve Gorlin, Medovex Co-founder, stated, “I’m pleased to have accomplished my initial goal of seeing Medovex successfully progress from the development stage to the commercialization phase. I’m also extremely proud of our entire management team and their collective effort in getting us to the opportunistic place we find ourselves today. At no point in the Company’s history have I ever been more confident in its future. Over the years, I’ve been intimately involved in many small healthcare related companies which eventually went on to experience sizeable value creation, but few were as personal as Medovex. My continuing commitment to the company can be no better evidenced than by my Form 4 filing made Wednesday memorializing my open market purchase of an additional 200,000 shares of our stock.”

Gorlin continued, “I’ve worked closely with Jesse Crowne at my own company for some time now and I handpicked him based on a steadfast confidence in his ability to finish what we’ve started. I view him as the ideal person to assist in taking Medovex to the next level and I look forward to continuing to work closely with him, the board and management as we together seek to accomplish my ultimate goal of maximizing shareholder value.”

The Company’s DenerveX System recently received CE Mark approval and clearance for commercialization in the European countries and offers a unique way to perform a Facet Joint Syndrome treatment.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

ATLANTA, GA–(Marketwired – Aug 17, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), the developer of the DenerveX™ System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today reported it has named Charlie Farrahar as its Chief Financial Officer.

Charlie Farrahar is a Certified Public Accountant with over 30 years of managerial finance, administration, human resource and risk management experience in the public, private and non-profit sectors. Mr. Farrahar was the first Chief Financial officer of the Company from its inception through IPO. He remained with the Company as its Secretary only from January 2015 until August 2017, when he agreed to resume the CFO role.

Mr. Farrahar currently serves as Chief Financial Officer for several small private biotech companies in the research and development stage. In 2003 he joined a private governmental assistance startup as it’s CFO and Director of Human Resources, helping with the sale of that company to a private entity in 2011 after it had grown to a multi-state operation with over 400 employees. In the late 1990’s he was CFO of Credit Depot Corp. (Nasdaq).

At its August 16, 2017 quarterly Board meeting, the Board asked Charlie Farrahar, Company Secretary, to become Chief Financial Officer, a role he held from the inception of the Company through its initial public offering. Jeffery Wright, the former CFO, agreed to become the Company’s first Controller.

Jarrett Gorlin, Medovex Chief Executive Officer, stated, “We’re excited by the enthusiastic reception we’ve seen thus far to the Denervex product and realize that we have to properly support sustained revenue growth. One area affected by this growth is the financial/accounting function. With the addition of overseas sales and all the administration that entails, we were no longer able to have just one full-time person in the finance area.”

Gorlin continued, “We asked Charlie Farrahar to become CFO so Jeff Wright could focus on assisting our sales and distribution efforts as we expand sales into multiple countries. They have complementary skill sets and work well together. Their combined experience should allow us to properly steward anticipated growth associated with the launch of a successful new product targeting a broad audience.”

The Company’s DenerveX System recently received CE Mark approval and clearance for commercialization in the European countries and offers a unique way to perform a Facet Joint Syndrome treatment.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

August 16, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Serrato™ Pedicle Screw, intended for use in the non-cervical spine as part of the company’s successful Xia^® 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration.

Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.^1,2 The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

“Pedicle screws have been used for decades with very few changes to their design,” said Bradley Paddock, President of Stryker’s Spine division. “The design innovations incorporated into Serrato reinforce our commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies that our surgeon customers have come to expect.”

Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopaedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization, or corrective action through the application of force.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

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.

References

1. Stryker Patent #6,074,391
2. Stryker Design History File DHF0000016688

Content ID TLSER-PR-1_14675

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com

SAN DIEGO, Aug. 15, 2017 /PRNewswire/ — NuVasive, Inc. (Nasdaq: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the appointment of Rajesh (Raj) J. Asarpota as the Company’s new executive vice president and chief financial officer (CFO), effective September 1, 2017.

As a member of NuVasive’s global executive team, Mr. Asarpota will be responsible for the Company’s global finance functions including accounting, FP&A, treasury and tax. He joins NuVasive with nearly 25 years of experience in financial and executive leadership roles across the healthcare industry.

Mr. Asarpota began his career at General Electric (GE) in the GE Financial Management program, including finance roles in commercial operations, plant and manufacturing analysis, sourcing and R&D analysis. He then joined the GE Corporate Audit Staff program and from there moved to GE Healthcare where he held a variety of key finance operating roles. In the last 15 years, he has accumulated critical experience in both public and private enterprises, highlighted by his decade-long tenure at Life Technologies where he helped drive the growth from a small biotech company to a $4 billion life sciences leader. More recently, Mr. Asarpota was the CFO of publicly-traded Questcor Pharmaceuticals and supported the sale of that company, and then worked in private equity-backed healthcare companies for the last several years in executive financial and operational roles.

“Raj brings a strong financial and operational background to the NuVasive leadership team as we continue to focus on driving revenue growth and expanding profitability,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “I have worked closely with Raj at multiple companies where we were successful at expanding market share and transforming operations. He’s a proven leader who will drive significant shareholder value.”

Mr. Asarpota earned a bachelor’s degree from the University of Bombay in Bombay, India and an MBA from Marquette University in Milwaukee, Wisconsin.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 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. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. 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.

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Current Issues in Spine

Life Spine Announces First Cases Performed with Multiple Methods of In-situ Expansion

Contacts

EIT Emerging Implant Technologies Acquires 22 Patents for 3D Printed Expandable Cage Technology Based on Living Hinges from Dr. Morgan Lorio

Medovex Corporation Appoints Gorlin Companies Managing Partner Jesse Crowne Director and Executive Co-Chairman of the Board

Medovex Corporation Names Charlie Farrahar Chief Financial Officer

CONTACT INFORMATION

Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw

Contacts

NuVasive Appoints Rajesh J. Asarpota As Chief Financial Officer

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