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Simplify Medical Closes Additional $23.25 Million in Second Tranche of Series B Financing Totaling $44.25 Million

Posted On February 9, 2018 By OrthoSpineNews In Financial, Spine /  

February 09, 2018

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced a second tranche of its Series B financing of $23.25 million, completing the oversubscribed round totaling $44.25 million.

The lead investor for the second tranche is LSP Health Economics Fund 2 (LSP HEF 2), with participation from existing venture investors LSP Fund V, MH Carnegie & Co., and Sectoral Asset Management. Series B funds will be used to complete two ongoing U.S. pivotal clinical trials of the Simplify Disc studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease, and for commercialization outside of the U.S.

“Having an oversubscribed Series B is a testament to the large opportunity presented by the Simplify Disc,” said Simplify Medical Chief Executive Officer David Hovda. “The Simplify Disc is designed to eliminate the need for CT scans post-surgery, reducing patient risk from associated radiation and solving a significant clinical problem in spine arthroplasty today.”

“We have great confidence in the Simplify Disc and the clinical outcomes achieved to date, and expect the U.S. clinical trials to demonstrate the same,” said Fouad Azzam, Ph.D, with LSP. “Risk mitigation is top of mind for hospitals, and products like the Simplify Disc that maximize patient safety are well aligned with their concerns. In addition, the Simplify Disc offers the lowest-profile device, opening up a broader patient population for the technology.”

“Simplify Medical has developed a very attractive cervical disc replacement system and the company has made tremendous progress on their multiple IDE studies and international commercialization. Our funding will allow them to accelerate these programs and expand access to the Simplify Disc to many more patients,” said Mark Carnegie, founding investor of Simplify Medical.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. 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. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The other pivotal trial is studying one-level cervical implantation of the device between C3 to C7 compared with one-level cervical fusion surgery. For information about eligibility or enrollment in either pivotal trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly 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/.

ABOUT LSP

LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. With over EUR1.3 billion (USD1.5 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s leading life sciences investors. In 2017, LSP launched LSP HEF 2 with a fund volume of EUR280 million targeting investment opportunities in private medical technology companies which offer products that can both improve the quality of patient care and lower healthcare spending. To learn more, visit www.lspvc.com.

ABOUT MH CARNEGIE & CO.

M.H. Carnegie & Co. is a leading Australian private equity and alternative asset manager with over AU$500M under management. Carnegie’s investment focus is on high value medical device technologies, with particular emphasis on opportunities that leverage the best innovations, development pathways, management teams and financing strategies. For more information, visit www.mhcarnegie.com.

ABOUT SECTORAL ASSET MANAGEMENT

Sectoral Asset Management is an established global healthcare specialist. Sectoral leverages its expertise and capabilities to capture significant value creation across both public and private companies. More information about the firm and its track record is available at www.sectoral.com.

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

Contacts

Chronic Communications Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

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Relievant Announces Publication of Positive Outcomes in 12-Month SMART Sham RCT

Posted On February 9, 2018 By OrthoSpineNews In Spine /  

SUNNYVALE, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain (CLBP), announced today the publication of the pivotal SMART Trial data in the European Spine Journal. The SMART Trial is a Level 1, randomized, sham-controlled, double-blind clinical trial for chronic low back pain whose rigor, size, and clinical outcomes are unprecedented in the field of spine care. The study included 225 patients, 147 in the treatment arm and 78 in the sham arm, across 15 sites in the United States (U.S.) and 3 in the European Union (E.U.)

The published results demonstrated a statistically significant difference between the per protocol Intracept treatment arm and the sham arm for the primary endpoint of comparative change in Oswestry Disability Index (ODI) from baseline to three months (p = 0.019).  Significant findings from the trial include:

  • The per protocol INTRACEPT treatment arm demonstrated a mean ODI improvement of 20.5 points or 48% decrease from baseline at 3 months
  • These patients also had a statistically significant decreases in pain at 6 and 12 months, as measured by Visual Analog Scale (VAS), with sustained 44% and 41% decrease in pain, respectively
  • Excellent safety profile with no device-related adverse events

“The SMART trial confirms that Intracept is an important, new solution for CLBP with the strong results demonstrated by the significant and durable ODI decreases in this highly rigorous sham controlled randomized trial,” said Jeffrey Fischgrund, M.D., chairman, Orthopedics, Beaumont Hospital, Royal Oak and the principal investigator of the study. “The significant improvement in pain and function demonstrated by the SMART trial provides clear proof of the efficacy of this treatment. We are honored to have these data published in the European Spine Journal and look forward to building upon these results.”

“The Intracept Procedure represents a novel, minimally invasive option for the over 5 million indicated patients in the U.S who are suffering from CLPB for whom today’s treatment options have proven ineffective,” stated Kevin Hykes, President and Chief Executive Officer of Relievant.  “Our ability to treat these patients early in the CLBP disease continuum can potentially avoid the later need for opioids, or more costly and invasive therapies.”

About Chronic Low Back Pain (CLBP)

Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the U.S., costing nearly $150 billion each year in medical treatment and lost productivity.   Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Conservative therapies fail to provide adequate pain relief for approximately 80 percent of CLPB patients. Surgery is often performed for eligible candidates to remedy structural defects in the spine in the hope that it will resolve a patient’s pain, but often with disappointing results.

About the Intracept Procedure

Relievant’s Intracept Procedure is a new, proven treatment option for the over 5 million indicated US patients who suffer from CLBP who have not responded to conservative therapies and who may not be candidates for surgery. The marketing clearance from FDA was supported by ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in generating low back pain from the vertebral body endplates. The procedure uses a transpedicular, minimally invasive approach to reach the BVN near the center of the vertebral body, and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine Surgeons and Interventional Pain Specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.

About Relievant Medsystems

Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.

FDA has cleared the Intracept System for the following Indications for Use:   The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact
Carrie Mendivil
Gilmartin Group
415-937-5405
investors@relievant.com

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John DeFord To Join NuVasive Board Of Directors

Posted On February 8, 2018 By OrthoSpineNews In Spine /  

SAN DIEGO, Feb. 8, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced the appointment of John A. DeFord, Ph.D. to the Company’s Board of Directors, effective upon the filing of the Company’s Form 10-K with the Securities and Exchange Commission.

Dr. DeFord has more than 25 years of experience in the medical device industry, with particular expertise overseeing clinical advancement through innovative R&D and technology-based initiatives. He currently serves as Senior Vice President, Research and Development, Interventional Segment for BD (Becton, Dickinson and Company). He joined BD following its December 2017 acquisition of C.R. Bard, Inc., where he had served as Senior Vice President, Science, Technology and Clinical Affairs since 2007. In that role, Dr. DeFord was responsible for R&D and clinical affairs functions across five global corporate divisions.

“We are pleased to welcome John to the NuVasive Board,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive, Inc. “We expect John’s experience driving innovative products and technology programs at other large medical device companies  will help inform our own strategic direction as we quicken the tempo of our product launches and expand our efforts toward software development and a focus on systematizing spine surgery.”

“I am thrilled to have the opportunity to support NuVasive’s leadership in spine,” said Dr. DeFord. “I have long admired NuVasive as an industry innovator and look forward to sharing my clinical and business perspectives as a member of the Board to help the Company deliver even greater value to its surgeon customers, patients and shareholders.”

As a result of Dr. DeFord’s appointment, the NuVasive Board of Directors consists of 10 directors, nine of whom are independent. Dr. DeFord will stand for reelection at the Company’s annual meeting where Mr. Lesley Howe and Dr. Peter Farrell will retire from the NuVasive Board when their current terms expire, pursuant to the Company’s director retirement age policy.

Prior to his 13-year tenure at C.R. Bard, Dr. DeFord held various executive positions including president and chief executive officer with Cook Incorporated, now a multi-billion dollar privately-held medical device manufacturer, and served as managing director at Early Stage Partners LP, a venture capital firm focused on advanced materials, medical/biotechnology and information technology companies.

Published in numerous scientific journals, Dr. DeFord is currently a member of the executive faculty at Purdue University’s Krannert School of Management and Weldon School of Biomedical Engineering. Dr. DeFord earned a B.S. and M.S. in electrical engineering and a Ph.D. in electrical/biomedical engineering from Purdue University. He holds numerous patents and multiple industry honors.

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 $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. 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.

Related Links

http://www.nuvasive.com

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joimax® Continues Strong Growth Trend in 2017 with Launch of Its MultiZYTE® Facet and SI Joint Treatment Set in the US

Posted On February 8, 2018 By OrthoSpineNews In Spine /  

Company also obtains full approval of its Endovapor® 2 system in China

February 08, 2018

KARLSRUHE, Germany–(BUSINESS WIRE)–the joimax® group announces very strong sales figures for 2017. The German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery shows a jump of almost 80% vs. 2016 in the U.S. Consolidated sales show a growth of nearly 30%, which reflects its CAGR of 35% since 2008.

“joimax® is in line with its top-line plans as well as with its EBIT growth projections,” states Rainer Schmitz, the long-standing CFO of joimax® GmbH. “The company is now active in 50 countries and enjoys a strong reputation in Europe, Asia and the U.S.”

Based on the inclusion of the newly created AMA CPT code 62380 for endoscopic decompression of the lumbar spine as of January 1st, 2017, and the worldwide increasing adoption rate of the joimax® procedures in general, the company is gaining a strong foothold throughout the U.S. The acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the patients and the surgeons are steadily growing worldwide.

The understanding and therapy of SI Joint is a rapidly growing new field worldwide. joimax® faces this growing area of unmet needs with its MultiZYTE® Facet and SI Joint Treatment Set in this market segment. The upcoming 3rd International Conference on Sacroiliac Joint Surgery (ICSJS, http://simeg-international.com/en/home/), taking place in Tampa, FL from Feb. 21 to 24, 2018 gives attendees the opportunity to further enhance the level of understanding of the sacroiliac joint and to participate in a cadaver workshop at CAMLS learning center.

Further success in Asia is a result of the recent approval of the joimax® Endovapor® 2 Multi Radio Frequency System also in China, where joimax® has already been successfully in the market for 10 years.

“With this latest approval we now can market all our systems in this important country, which is a great step towards more targeted patient care,” states Wolfgang Ries, Founder and CEO of joimax®.

The Endovapor® 2 generates electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations. The device is an all-in-one generator with specially integrated programs for spinal surgery with interdisciplinary application. It is equipped with two monopolar and two bipolar sockets and easy and intuitive touchpad technology. With arc control for safe application and easy neutral electrode monitoring, it combines a variety of electro-surgical modes and effects.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® (for facet and sacroiliac joint treatment) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press Contact USA:
joimax® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

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SAGICO Participating in the International Spinal Osteotomy Meeting in Europe with a Focus on Clinical Validation for Aria™ and Arion™ Interbody Devices

Posted On February 8, 2018 By OrthoSpineNews In Spine, Top Stories /  

Tampa, FL, USA, February 5, 2018: As part of the US commercial launch of Aria Surefit™ Lumbar Expandable Interbody and the first-to-market Arion™ Cervical Expandable interbody, representatives from SAGICO USA and SAGICO EU will be attending the 2018 International Spinal Osteotomy Meeting at Koç University Hospital on February 10, 2018. SAGICO will be meeting with several Key Opinion Leaders and discussing the preliminary data review of clinical research being conducted.

SAGICO anticipates releasing portions of the company’s new and ongoing clinical data efforts focusing on Aria™ and Arion™ which were recently cleared by the FDA.  James Gibson, CEO of SAGICO USA, explained, “with the recent release of our innovative interbody portfolio we are now focusing on the continuous cycle of clinical validation.  With over 4,000 surgical interbody cases completed, we have strong data that will differentiate our products in the North American market.”  He added, “the key to the introduction of our unique portfolio will be continued surgeon and clinical collaboration in both the US and abroad.”

The prestigious International Spinal Osteotomy Meeting is an annual event with scientific lectures and data being presented ranging from principles of thoracolumbar and sagittal balance and osteotomies in cervical and upper thoracic spine.

Koç University hospital is part of the Koç Healthcare group among with two other hospitals, American Hospital and MedAmerican Ambulatory Care Surgery Center. The Koç University Health Science Campus houses the university’s notable school of medicine.

Faculty members include surgeons from leading teaching facilities in the USA and Europe. The meeting’s faculty includes KOLs from Columbia University in New York, UCSF Spine Center in San Francisco, Switzerland, France, Belgium, Italy and the host nation of Turkey.  The multinational meeting is full of excellent lectures from prominent experts, clinical review of new procedures, case discussions, debate sessions, video demonstrations, and workshops from industry experts all designed to raise physician competence. 

MORE ABOUT SAGICO: Spinal Analytics & Geometrical Implant Co, (SAGICO) and its principals have many years of spinal industry success spanning multiple continents in more than 60 countries. SAGICO and its affiliates are privately held companies with global partners and shareholders and an aggressive pipeline that includes: novel artificial disk implants (TDR), Porous Titanium interbody technology, Expandable VBR options and unique Pedicle Screw Systems optimized for Complex & Pediatric surgery are just a few of the product lines SAGICO offers. SAGICO’s US corporate based operations are located in Tampa, Florida.

DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more.

Learn more @: www.SAGICO.co

To schedule an interview please contact SAGICO in the USA: Telephone: 813-830-3636

 

Limited USA and International Distributor Opportunities Remain

 

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Life Spine to Showcase Micro-Invasive Technologies at ICSJS, AAOS and the AANS/CNS Spine Summit

Posted On February 7, 2018 By OrthoSpineNews In Spine /  

February 07, 2018

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 its 2018 participation at ICSJS, AAOS and the AANS/CNS Spine Summit. The meetings are expected to have a combined attendance of over 13,000 medical attendees.

“These industry meetings are pivotal in that they provide the opportunity to share our newest technologies with surgeons and get direct feedback,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine “In the past two years we have launched over fifty products, we are more excited than ever to share our rapidly growing portfolio with the attendees. One key addition to our micro-invasive portfolio is SImpact Tri-Fin Sacroiliac Joint Fixation System which will be featured at the meetings this quarter.”

In February, Life Spine launched www.micro-invasive.com which features technologies focused on their growing suite of micro-invasive products including PROLIFT®, TIBOW™, LONGBOW®, SImpact™ and SImpact™ Tri-Fin.

Life Spine will be showcasing their Sacroiliac Joint fixation systems SImpact and SImpact TRI-FIN at ICSJS in Tampa Florida February 21-24 and featuring their full portfolio at AAOS in New Orleans March 6-10 at booth 714 and at booth 508 at the AANS/CNS Spine Summit in Orlando, FL March 14-17.

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.

Contacts

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

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7D Surgical Completes Significant Round of Financing

Posted On February 6, 2018 By OrthoSpineNews In Spine /  

TORONTO, Feb. 6, 2018 /PRNewswire/ — 7D Surgical is pleased to announce the completion of the largest round of financing secured by the company to date, providing the funding necessary to support the commercial launch of its FDA 510(k) approved Machine-vision Image Guided Surgery (MvIGS) system along with the development of an exciting pipeline of innovative and groundbreaking features for both spine and cranial surgical navigation.

“The latest investment into 7D Surgical will allow our team to aggressively scale our commercial footprint to meet the demand for our MvIGS technologies,” said Beau Standish, Chief Executive Officer at 7D Surgical. “We believe the hospital market will continue to adopt innovations that will lower costs while improving efficiency and safety.  The 7D Surgical system is perfectly positioned to fulfill each of these objectives.”

7D Surgical has integrated principles common in self-driving vehicles and facial recognition to create the first and only MvIGS platform.  7D Surgical’s Flash™ Registration and Flash™ Fix technology allows spine surgeons to perform spinal registration in just seconds, saving valuable operative time.  Clinicians can also update the patient registration with a simple foot pedal click at any time.  The system uses only visible light, eliminating the patient and staff exposure to intraoperative radiation which is common with older technologies.

“We have been thrilled by the response from clinicians who have implemented the MvIGS technology,” said Brian Stuart, Vice-President of Sales and Marketing at 7D Surgical. “The immediate and positive impact on surgical workflows, radiation reduction and sterile control of the technology has strongly resonated with surgeons and operating room staff.  These advantages, along with the significant cost savings over current options, makes MvIGS a win for everyone, including hospital administration.”

Demonstrations of the 7D Surgical System are available through a state-of-the-art audio-visual experience. Schedule a time to see our Flash™ Registration and Flash™ Fix technologies at contact@7Dsurgical.com. The company will also be presenting live demonstrations at the upcoming Texas Association of Neurological Surgeons Meeting in Houston from Feb 9-10, 2018 and at the Spine Summit Meeting in Orlando from March 15-16, 2018.

About 7D Surgical

7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada-approved MvIGS system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.  www.7Dsurgical.com

Flash™ Registration: https://7dsurgical.com/7d-surgical-system/spine-navigation/

Flash™ Fix: http://7dsurgical.com/7d-surgical-system/flash-technology/

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
189947@email4pr.com

SOURCE 7D Surgical

Related Links

http://www.7Dsurgical.com

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First Triojection cases in Germany were recently completed by Prof. Dr. Thomas Vogl MD.

Posted On February 2, 2018 By OrthoSpineNews In Spine /  

January 31, 2018

Minimus Spine Inc., manufacturer of the patented Triojection System, intended to produce ozone gas for spinal disc herniations, announced today that the first cases of Triojection in Germany were recently performed. The cases were done at the University of Frankfurt and performed by Prof. Dr. Thomas Vogl MD, Director of the Institute for Diagnostic and Interventional Radiology at the J.W. Goethe University Hospital Frankfurt am Main.

“I successfully completed 10 Triojection cases in December”, said Dr.Vogl. “It is an elegant design and simple to use. I particularly appreciate how Triojection is designed for safety and consistency. Triojection is unique in that it creates the ozone inside a sterile syringe and simultaneously measures the concentration of ozone within the syringe. This product advances the state of the art and gives me a new level of confidence in what is actually administered to the patient’s disc. Early results have been favorable and I intend to continue with Triojection in my practice.”

David Hooper Ph.D., Minimus Spine’s CEO, added “We are excited to have Dr. Vogl as one of our earliest adopters. He is a leader in his field and his support validates our belief that Triojection sets a new standard for spinal ozone injections.”

Dr. Vogl is a listed author on more than 500 peer reviewed articles related to interventional radiology and currently sits on the editorial boards for the journals European Radiology and Academic Radiology. The University of Frankfurt has been performing spinal ozone injections for more than 10 years. In 2012, Dr. Vogl and his colleagues published a key paper describing the reduction of disk volume following intradiscal ozone injection in 283 subjects with disc herniation.

About Minimus Spine Inc.: Established in 2006, Minimus Spine is a privately held medical device company dedicated to developing the Triojection technology the non-surgical treatment of herniated discs. Minimus Spine’s CEO and team largely stem from Spinal Concepts, another spinal startup that was sold to Abbott for $170M. The company is positioning itself for sale to one of several medical device strategics after achieving successful European adoption of its product. Minimus Spine maintains its headquarters in Austin, TX. For more information on Minimus Spine, please visit www.minimusspine.com or email info@minimusspine.com.

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US Spinal Implants and VCF Market Report Suite 2017-2023 – Motion Preservation Segment Will Be the Fastest Growing in the Market – ResearchAndMarkets.com

Posted On February 1, 2018 By OrthoSpineNews In Spine /  

February 01, 2018

DUBLIN–(BUSINESS WIRE)–The “Spinal Implants and Vertebral Compression Fracture (VCF) Market Report Suite for US 2017-2023 – MedSuite (Includes 10 Reports)” report has been added to ResearchAndMarkets.com’s offering.

Despite many challenges, growth is expected in many market segments, as the patient demographics in the U.S. maintain a steady demand for such procedures. Growth has slowed in the last few years as newer, minimally invasive innovations gradually cannibalized the traditional spine market. The motion preservation segment will be the fastest growing in the market, and will be continually driven by novel and emerging technologies.

The biggest limiting factor for the spinal fusion markets is the development of motion preservation technology. Lumbar artificial discs (LADs) have not been as successful at cannibalizing thoracolumbar fixation devices as previously anticipated due to a lack of reimbursement and unfavorable clinical results. Favorable reimbursement policies are expected for these devices as favorable clinical results involving newer devices emerge.

One of the key drivers for the interbody fusion market is the increase in the target population, which is composed of aging baby boomers. The majority of spinal fusion procedures are performed on those individuals over the age of 60. This age group is the fastest growing demographic in the United States.

Minimally invasive interbody options will continue to cannibalize areas of the standard interbody market, particularly traditional ALIF and PLIF approaches. However, other areas of the standard market will continue to experience growth.

General Report Contents

  • Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
  • Market Drivers & Limiters for each chapter segment
  • Competitive Analysis for each chapter segment
  • Section on recent mergers & acquisitions

Companies Mentioned

  • Medtronic
  • DePuy Synthes
  • Stryker
  • Zimmer Biomet
  • Globus Medical
  • NuVasive
  • Orthofix
  • K2M
  • Alphatec Spine
  • DJO
  • Aesculap
  • Atlas Spine
  • Benvenue Medical
  • Centinel Spine
  • Custom Spine
  • DFine
  • Exactech
  • Inion
  • Life Spine
  • Orthofix
  • Osseon
  • Paradigm BioDevices
  • Pioneer Surgical

Key Topics Covered:

  1. Executive Summary
  2. Research Methodology
  3. U.S. Spinal Implants and VCF Market Overview
  4. Procedure Numbers
  5. Cervical Fixation Market
  6. Thoracolumbar Fixation Market
  7. Interbody Device Market
  8. Motion Preservation Device Market
  9. Vertebral Compression Fracture Market
  10. Spinal Electrical Stimulation Device Market

For more information about this report visit https://www.researchandmarkets.com/research/tmsqnk/us_spinal?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
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SeaSpine Expands Ventura™ NanoMetalene® Implant Offering to Accommodate Larger Range of Posterior Procedures

Posted On February 1, 2018 By OrthoSpineNews In Spine /  

Carlsbad, Calif. / Jan. 31, 2018 – SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the portfolio expansion of the Ventura™ NanoMetalene® posterior interbody device. Ventura NanoMetalene, which has been commercially available since 2015, has expanded its size offerings to accommodate a larger range of posterior procedures and a wider variety of patient anatomies. These new sizes include additional lengths and oblique placement options with sagittally oriented lordosis.

The Ventura interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide implants a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.

Ali Chahlavi, MD, a neurosurgeon practicing in Jacksonville, FL and an early adopter of NanoMetalene, commented, “NanoMetalene has been an integral part of my fusion procedures. These implants deliver the same surface characteristics of titanium while maintaining PEEK’s radiolucency for clear assessment of fusion post-operatively, which has not always been my experience with a full titanium device.” With respect to the new lordotic options, he said, “the additional lordosis will improve my ability to restore better natural alignment to my patients.”

SeaSpine’s entire portfolio of posterior lumbar NanoMetalene interbody devices is cleared for use with both autograft and allograft. Having the additional indication allows surgeons more bone grafting options, including using Ventura NanoMetalene with SeaSpine’s new line of allograft demineralized bone fiber products.

“NanoMetalene is a differentiated product in a market that has become increasingly competitive,” stated Troy Woolley, Vice President of Marketing. “The expansion of this technology coupled with our advanced orthobiologics demonstrates our commitment to provide complementary, cost-effective procedural solutions to surgeons, hospitals and patients.”

About SeaSpine

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

Forward-Looking Statements

SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements may include, but are not limited to, statements relating to: the design and other benefits of the Ventura NanoMetalene portfolio; its ability to restore better natural alignment to patients; and the ability of the Ventura NanoMetalene product to provide complementary, cost-effective procedural solutions to surgeons, hospitals and patients. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of the expanded Ventura NanoMetalene portfolio to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

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