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Current Issues in Spine

February 2-4, 2017

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October 19, 2017 OrthoSpineNews

October 18, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, announced that it will introduce the NEXXT MATRIXX™ System, the company’s new 3D printed porous titanium interbodies and vertebral body replacement (VBR) devices, during the 2017 North American Spine Society (NASS) Annual Meeting in Orlando at Booth #1550.

The NEXXT MATIRXX™ implants which are now available nationwide have been successfully implanted as indicated for use as cervical intervertebral fusion devices and lumbar intervertebral fusion devices. To date, all surgeon feedback has been overwhelmingly positive.

The NEXXT MATRIXX™ System leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

“We are extremely excited to introduce the Nexxt generation technology with our 3D printed porous titanium devices along with our comprehensive product portfolio during the largest spine meeting and exhibition in the world,” said Andy Elsbury, Nexxt Spine’s President.

For more information about NEXXT MATRIXX™, visit www.nexxtspine.com.

Contacts

Nexxt Spine
Sarah Koch
Info@NexxtSpine.com


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October 19, 2017 OrthoSpineNews

October 18, 2017

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces its annual results for the 2016-17 financial year to June 30, 2017.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “20 years after Amplitude Surgical was founded, 2016-17 was another year with many key events and strong growth, with sales exceeding €90 million and an EBITDA margin of almost 17%. These results reflect the successful implementation of our development strategy, which is based on state-of-the-art R&D, major investments and staff eager to open up new markets and introduce new equipment to support medical practitioners and their patients. Beyond these solid foundations, the potential of the United States – the world’s largest market on which we are developing fast – and an innovative product portfolio that is continuously being enhanced will drive our growth, with our target of doubling the Group’s sales in 5 years to June 2021 reiterated.

Key 2016/17 events

At product level, Amplitude Surgical achieved the following:

  • in early March 2017, it obtained the CE Mark for the use in consultation of Kneemap®, a device for measuring knee kinematics to help surgeons assess all knee movements and refine their diagnosis and therapeutic strategy;
  • in early 2017, it received 510(k) regulatory clearance from the FDA (American Food and Drug Administration) for its Anatomic® posterior-stabilized knee prosthesis. After Europe in February 2013, Australia in August 2015 and South Africa in early 2016, this clearance provides access to the world’s largest lower-limb prosthetic reconstruction market. In the United States, this approval follows that obtained in late 2014 – early 2015 by the Novastep range for lower-limb (foot and ankle) surgery;
  • at the end of 2016, it obtained the CE Mark for its new ACLip® product, a fixation implant for anterior cruciate knee ligament transplants that provides surgeons with simplicity and replicability and rigid fixation that favors transplants in patients. After hips, knees and lower limbs, Amplitude Surgical’s offering thus now covers one of the most frequent knee pathologies and opens up this major market to the Group. The first transplants, over 600, undertaken in France during the final quarter of 2016-17 financial year bode well for the launch at the next SFA – French Society of Arthroscopy congress early December 2017.

At Group level, Amplitude Surgical carried out the following:

  • in February 2017, it settled the case pertaining to the acquisition of the remaining minority interests in Australia via a transactional agreement with Austofix, a minority shareholder in its Amplitude Australia Pty subsidiary. This agreement enabled the acquisition of the remaining 25% stake in this subsidiary and the payment of €8.8 million settlement compensation;
  • at the end of 2016, it finalized a €65 million bond issue, providing the Group with €30 million to continue its international development and €35 million towards the early repayment of its previous debt;
  • in mid-December 2016, it announced the acquisition of a 50% stake in SOFAB Orthopédie, a longstanding strategic industrial subcontractor. This transaction will provide a net positive contribution from 2017-18;
  • in July 2016, it finalized the acquisition of the remaining minority interests (40%) in its Brazilian subsidiary, Amplitude Latam, for €4.1 million.

Moreover, in France, Amplitude Surgical has recently signed Memoranda of Understanding with a view to acquiring two companies responsible for the direct management of key French regions, in the east of the country and the Paris region, thus intensifying its commercial presence on the domestic market.

Financial summary – (actual currency):

€ thousands – IFRS 2016-17 2015-16 Δ
Sales 93,356 80,788 +15.6%
Gross margin 70,519 62,213 +13.3%
as a % of sales 75.6% 77.0%
Sales & Marketing costs 38,626 32,115 +20.3%
General & Administrative costs 9,321 9,297
R&D costs 7,072 7,327 ‐3.5%
EBITDA 15,500 13,473 +15.0%
as a % of sales 16.6% 16.7%
Core Operating Profit 17 3,477
Non-core operating expenses 1,064 11,736
Operating Profit/Loss -1,046 -8,259
Financial profit/Loss -8,510 5,352
Attributable Net Profit/Loss -12,314 -174
Net financial debt 80,043 49,540
Net cash position 41,610 32,071

Improvement in the operating expenses / sales ratio; EBITDA margin of 17.6% excluding costs associated with the launch of the Japanese subsidiary

On the basis of annual sales of €93.3 million, up 15.6% in actual terms and 13.8% at constant currency, Amplitude Surgical recorded a gross margin of 75.6%, a decrease compared with 2015-16 mainly due to the distributor margin affected by the putting in place of substantial volumes of instruments.

The Group’s operating costs totaled €55.0 million, up 12.9%, with an improvement in the operating expenses / sales ratio of more than 150 bp, while EBITDA came to €15.5 million, up 15% compared with 2015-16. The EBITDA margin remained stable at a high level of close to 17%. Excluding the costs associated with the launch of the new Japanese subsidiary, i.e. €906 thousand, Amplitude Surgical recorded EBITDA of €16.4 million, up 21.5%, and a margin of 17.6%.

These changes reflect the human and commercial investments maintained by the Group in order to develop new territories and continue to increase its market share. At June 30, 2017, Amplitude Surgical had a workforce of 368 staff, of which 64 for SOFAB Orthopédie, vs. 297 at the end of June 2016. Moreover, the Group stabilized its R&D investments at more than €7 million, or 7.6% of sales.

The Core Operating Loss includes an increase in non-recurring provisions on inventory depreciations and legal disputes of €2.5 million. The Operating Loss was €1.0 million, compared with a loss of €8.3 million in 2015-16, as a result of:

  • the writing down, at June 30, 2017, of an additional provision of €2.6 million relating to the dispute with URSSAF (social security contribution collection authority) regarding tax on medical devices inherent to 2016-17 activity;
  • the settlement of the dispute with the Australian subsidiary’s minority shareholders, which resulted in a non-recurring profit of €1.5 million.

There was a financial loss of €8.5 million, which reflects the strengthening of the financial debt, but includes a €1.2 million non-recurring expense associated with the early repayment of a portion of the Group’s debt and a -€0.4 million currency impact essentially associated with the strengthening of the euro. The income tax level is a result of the tax rate on loss carryforwards being adjusted to 28%, contributing to a one-off expense of €2.3 million. The net loss was €12.3 million, including €7.2 million in non-recurring expenses and income, giving a core net loss of €5.1 million.

Substantial investments, notably in industrial and logistical integration

Over the 2016-17 financial year, Amplitude Surgical continued to implement an investment policy aimed at consolidating the foundations of its future growth, notably with:

  • a new logistic building for €4.0 million and a cutting-edge clean room for €2.5 million;
  • a 50% stake in SOFAB Orthopédie, an historical subcontractor, for €3.4 million;
  • the acquisition of the remaining minority interests in its Australian and Brazilian subsidiaries;
  • the installation, among new clients, of a large quantity of ancillary equipment, booked as tangible capital assets, for €6.3 million in France and €3.9 million abroad.

Reduction in WCR (substantial decrease in the WCR / sales ratio) and net cash of €42 million at end-June 2017

Amplitude Surgical has a solid financial structure, with Cash & Cash Equivalents of €41.6 million at end-June 2017.

The Group has reduced its working capital requirements, recording a working capital surplus of €6.3 million over the year. The WCR / sales ratio has seen a substantial 24-day improvement. Nevertheless, the high level of growth investments (€19.7 million during the year vs. €13.2 million in 2015-16) and the acquisition of the Australian minority interests increased Amplitude Surgical’s net financial debt to €80.0 million at the end of June 2017, vs. €49.5 million at June 30, 2016. The Group’s gearing (Net Financial Debt over Shareholders’ Equity) was thus 0.77, compared with 0.42 at the end of June 2016.

The Annual Financial Report can be found on Amplitude Surgical’s website: www.amplitude-surgical.com/fr/documentationold/documents-de-reference

Next financial press release: Q1 2017-18 sales, on Wednesday November 8, 2017, after market.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2017, Amplitude Surgical had a workforce of nearly 370 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
CFO
finances@amplitude-surgical.com
+33 (0)4 75 41 87 41
or
NewCap
Investor Relations
Marc Willaume
amplitude@newcap.eu
+33 (0)1 44 71 00 13
or
NewCap
Media Relations
Nicolas Merigeau
amplitude@newcap.eu
+33 (0)1 44 71 98 55


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October 19, 2017 OrthoSpineNews

October 18, 2017

LAKE FOREST, Calif.–(BUSINESS WIRE)–Tenex Health, Inc., a privately held provider of minimally invasive solutions for chronic tendon pain, announced today that its Board of Directors has appointed William “Bill” Maya as the Company’s President and Chief Executive Officer, effective October 9, 2017. Mr. Maya will replace Bernard Morrey, M.D., who will step down as interim Chief Executive Officer and resume his previously held role as Chief Medical Officer. The Company also announced today that Leslie “Les” Cross has been appointed to its Board of Directors.

Bill Maya Appointed CEO

Mr. Maya has spent more than three decades successfully leading, innovating and growing medical device and healthcare organizations. He has unique, demonstrated experience identifying and capitalizing on business opportunities, including guiding a number of companies through critical transformation periods. He has built long-term customer, physician and distributor relationships in the domestic and international markets and has a demonstrated track record of re-focusing organizations for growth and profitability. Throughout his career, Mr. Maya has built top performing leadership teams and instilled a winning culture focused on building long-term value for stakeholders.

Most recently Mr. Maya served as Chief Executive Officer at OrthAlign, Inc. During his six-year tenure, he productively first fixed and then successfully grew the organization globally, secured multiple millions of venture capital financing and led the commercialization efforts to support the launch of its next generation product. Prior to OrthAlign Inc., Mr. Maya spent over twenty years serving as Chief Executive Officer at such innovative companies as Vestara, LLC, DataLabs, Inc., Advanced Spine Fixation Systems, Inc., and Birtcher Medical Systems. Mr. Maya received a B.S. in Biology from Saint Joseph’s College. Mr. Maya currently also serves on the Board of Directors of three other companies.

Chuck Grant, Chairman of the Tenex Health Board of Directors, said, “Bill brings more than 35 years of strong operational and market growth experience, as well as sales and distribution expansion expertise to Tenex. His extensive leadership experience in the medical device industry, coupled with his strong track record of turn-arounds and delivering results, will be invaluable to Tenex. Bill is an excellent addition to Tenex and I look forward to working with him as we execute on our strategy for future growth.”

Mr. Grant added, “The Board would also like to thank Dr. Bernard Morrey for his leadership over the past year as interim CEO while we engaged in our executive search. We appreciate his guidance and dedication.”

Mr. Maya said, “I am honored with the appointment to lead Tenex as CEO. I have spent most of my career helping medical device companies transform their operations and realize their true potential. Tenex has pioneered a safe, minimally invasive solution for chronic tendon pain that is designed to provide relief to patients and ultimately, improve their lifestyles. With over 70,000 cases performed to date and proven clinical evidence, I believe there is significant opportunity ahead for Tenex. I am excited to work with the management team, Les and the Board of Directors, and our employees to capitalize on the opportunity and unlock stakeholder value.”

Les Cross Appointed to the Board of Directors

“We are extremely pleased to welcome Les to Tenex Health’s Board of Directors,” said Mr. Grant. “Les is an accomplished business leader and experienced board member in the medical device industry. We are confident that he will add great value to our Board of Directors and that Tenex will benefit from his insights and contributions as we execute on our strategy for long-term success.”

Mr. Cross said, “I am delighted to join the Tenex Board of Directors. With over 20 million Americans suffering from tendon pain, I believe that Tenex is well-positioned to become a compelling solution for physicians and make a real difference in patient’s lives. I look forward to working with Bill and the rest of the Board as he leads Tenex through this exciting new phase of growth for the Company.”

Mr. Cross brings more than 30 years of medical device and executive experience throughout his distinguished career to the Tenex Board. Previously, Mr. Cross served as the Chairman of the Board of Directors of Alphatec Spine from 2011 to 2017. From 2012 to 2014 he also served as Alphatec Spine’s Chief Executive of Officer. Prior to 2011, Mr. Cross served as President and Chief Executive Officer of DJO Global, Inc., where he held several principal executive roles since 1995. From 1990 and 1994, Mr. Cross held the position of Senior Vice-President of Marketing and Business Development of the Bracing and Support Systems division of Smith & Nephew. He was Managing Director of two different divisions of Smith & Nephew from 1982 to 1990. Mr. Cross earned a diploma in medical technology from Sydney Technical College in Sydney, Australia and studied business at the University of Cape Town in Cape Town, South Africa. Mr. Cross currently also serves on the Board of Directors of two other companies.

About Tenex Health, Inc.

Tenex Health, Inc. develops innovative surgical instruments for the treatment of tendon pain due to repetitive motion injuries. The Company’s proprietary technology is designed to cut and remove diseased soft tissue in a minimally invasive outpatient setting. Since the surrounding healthy tendon tissue is not disturbed, patients feel less discomfort and enjoy faster recovery times versus traditional open surgical procedures.

Additional information can be found at www.tenexhealth.com.

Contacts

Tenex Health, Inc.
Bill Maya
949.454.7500 / 855.2 TENDON
info@tenexhealth.com
www.tenexhealth.com


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October 19, 2017 OrthoSpineNews

SUNNYVALE, Calif, Oct. 18, 2017 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, today announced the appointment of Ray M. Baker, M.D., as Chief Medical Officer. Dr. Baker will report to Relievant’s Chief Executive Officer, Kevin Hykes.

“Ray is an internationally recognized, highly respected clinician bringing over 30 years of pain management expertise and industry leadership to Relievant,” said Kevin Hykes, President and Chief Executive Officer of Relievant Medsystems. “His deep experience as an interventional pain management specialist, and as past president of both the North American Spine Society and the Spine Intervention Society will be instrumental in shaping the commercial introduction of the Intracept® Procedure. We look forward to his contributions as the company enters its next phase of growth.”

As Chief Medical Officer, Dr. Baker will be an integral part of the executive team at Relievant, guiding technology development, clinical research strategy, and commercial initiatives. Prior to joining Relievant, Dr. Baker served as VP & Executive Medical Director at Evergreen Health in Kirkland, WA. He brings both academic and private practice experience to the position, having previously served as a Clinical Professor and Director of Interventional Pain Services at the University of Washington. In addition to presiding over the North American Spine Society and Spine Intervention Society, he has held a number of prominent board and leadership positions within the industry, including serving as the Founding Chairman of the CMS Multi-Society Pain Workgroup, and Chairman of the UnitedHealthcare National Spine Advisory Board.

“I have consulted for Relievant since the company’s inception – the depth, experience and talent of the executive leadership team are extraordinary, and I am thrilled to be on board,” said Dr. Baker. “Throughout my time as a practicing interventionalist, I have had the opportunity to be involved with the development of a number of novel technologies.  The FDA-cleared Intracept Procedure has been built on a foundation of level one evidence and clinical strength. I am acutely aware of how few options are open to these patients and am excited to be part of the team bringing this important new therapy to market.”

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 chronic low back pain. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the basivertebral nerve (BVN).  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for chronic low back pain.  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.

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.

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

Contact
Lynn Lewis or Carrie Mendivil
Gilmartin Group
415-937-5402
investors@relievant.com


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October 19, 2017 OrthoSpineNews

ARLINGTON, TENNESSEE, October 17, 2017 – MicroPort Orthopedics, a medical device company that develops and manufactures cutting-edge joint replacement implants and approaches, will host an industry symposium at the annual American Association of Hip and Knee Surgeons (AAHKS) meeting titled, “Tackling Your Toughest Cases in the Changing Healthcare Landscape” on Friday, November 3, 2017.

The symposium will feature four surgeon panelists, invited by MicroPort Orthopedics, who will discuss management of the toughest hip and knee replacement cases in an orthopedic landscape that faces evolving healthcare trends including new orthopedic technology and innovation, changing regulations and payment models, and the shift to outpatient care.

“Everyone in the medical device industry recognizes that the healthcare marketplace is evolving at breakneck speed, and we are constantly in pursuit of better and more efficient ways to adapt to these changes,” said Aurelio Sahagun, President, MicroPort Orthopedics. “We’re grateful to have not only a platform at AAHKS to discuss these innovations but also four renowned orthopedic surgeons who can speak to industry trends, best practices, and new approaches to their work.”

The symposium will be moderated by Stephen Murphy, MD, an orthopedic surgeon at New England Baptist Hospital, who will also be speaking about his experience in the Bundled Payments for Care Improvement (BPCI) Initiative. Joining Dr. Murphy will be, Judd Cummings, MD, Jimmy Chow, MD and Nicolas Noiseux, MD, MS, FRCSC. Dr. Cummings, an orthopedic surgeon at Specialty Orthopedic Surgery, will examine key considerations when taking on tough cases. Dr. Chow, a hip & knee specialist at Chow Hip and Knee, will discuss the importance of powerful surgical philosophy for Total Hip Arthroplasty. Dr. Noiseux, an associate professor in the department of Orthopedics and Rehabilitation at the University of Iowa Hospitals and Clinics, will be talking about anterior-posterior stability in complex primary cases. Following the discussion, the surgeons will answer questions asked by the audience.

About MicroPort Orthopedics

Established in January 2014, MicroPort Orthopedics Inc. is the fifth largest multinational producer of hip and knee implants and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative OrthoRecon products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japanese, Latin American and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/ or follow the company on Twitter at @MicroPortOrtho.

About MicroPort Scientific

MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements

Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

All rights reserved.

Copyright © 2017 MicroPort Scientific Corporation

 

Ryan Donovan | Assistant Account Executive

O: 617-374-8800 x102

M: 857-294-2561

Email:  rdonovan@lavoiehealthscience.com | Twitter: @lavoiegroup
LinkedIn: https://www.linkedin.com/company/lavoie-group

Website: http://www.lavoiehealthscience.com


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October 18, 2017 OrthoSpineNews

October 17, 2017 By 

DSM Biomedical has partnered with Cerapedics to create and manufacture the next generation of peptide-enhanced bone graft.

The partnerships allows for DSM’s regenerative materials capabilities to be used with Cerapedics’s proprietary synthetic small peptide (P-15) technology developed by Cerapedics.

Designed for fast and predictable remodeling in bone graft substitute applications, DSM’s newest bioceramic platform is make of a carbonated apatite matrix. The partnership states that DSM will provide collagen carrier, final packaging and full support throughout the product development process.

“The partnership combines the industry leading expertise and capabilities in bioceramic materials of DSM with Cerapedics’ innovative growth factor, delivering a new product solution to improve people’s lives,” David Yonce, VP and global head of innovation at DSM Biomedical, said. “Together, from concept to commercialization, we are at the leading edge of advanced healing solutions.”

 

READ THE REST HERE

 

 


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October 18, 2017 OrthoSpineNews

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October 18, 2017 OrthoSpineNews

October 18, 2017

NEW YORK: On August 2, 2017, an American surgical team conducted a surgery to replace the sternum and partial ribcage of a 20 year-old woman using a custom 3D-printed composite titanium/porous polyethylene implant. It is the first time this technology has been used in the United States and only the second time in the world that a 3D-printed composite sternum and ribcage has been implanted. 

The implant was designed and created for a patient named Penelope Heller by Anatomics, an Australian company that specializes in the manufacture of patient specific implants for surgeons around the world, and was made available to the patient via the United States Food & Drug Administration’s (FDA) Expanded Access (Compassionate Use) Program. Anatomics’ custom 3D printed implants do not have marketing approval in the US. The FDA’s Expanded Access Program provides a path to accessing devices for patients whom the treating physician believes may provide a benefit, but have not received FDA marketing approval.

The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardiothoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor after she was diagnosed with chondrosarcoma, a rare cancer affecting the bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal.

In the original resection surgery, the cancer was successfully removed and the previous surgeon created an implant for the patient, using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and Bone Cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve with time. Online research led the patient to a similar surgery performed in Spain using a custom implant also developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under the FDA’s Expanded Access program.

The custom implant was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient’s sternum and ribcage was created and a build code was sent to Australia’s Commonwealth Scientific & Industrial Research Organisation’s (CSIRO) 3D printing laboratory, Lab 22. The patient’s custom sternum implant is the second in the world to also use Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.

The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardiothoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor after she was diagnosed with chondrosarcoma, a rare cancer affecting the bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal.

In the original resection surgery, the cancer was successfully removed and the previous surgeon created an implant for the patient, using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and Bone Cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve with time. Online research led the patient to a similar surgery performed in Spain using a custom implant also developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under the FDA’s Expanded Access program.

The custom implant was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient’s sternum and ribcage was created and a build code was sent to Australia’s Commonwealth Scientific & Industrial Research Organisation’s (CSIRO) 3D printing laboratory, Lab 22. The patient’s custom sternum implant is the second in the world to also use Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.

“After my initial resection and reconstruction surgery, I continued to experience breathing issues and pain,” said Ms. Heller. “With a long, active life ahead of me, I wanted to participate in activities that I love fully and without pain. Electing to have this procedure was a big decision, and I’m coming forward to empower other people in the same position.”

Anatomics’ Executive Chairman Paul D’Urso, MBBS (Hons) Ph.D. FRACS said, “Anatomics is humbled by the strength of the thousands of patients we have helped over 25 years since inventing BioModeling technology. The patient’s story is one of many, but what makes it truly remarkable is how the patient and her family, Dr. Port and the staff at  NewYork-Presbyterian/Weill Cornell, Anatomics, and the FDA came together to make this story a reality. It was a group effort that began with the patient’s pursuit of information.”

About Anatomics

Anatomics is an Australian medical device company that has been manufacturing and marketing surgical products to surgeons locally and internationally since 1996. Anatomics pioneered CT scan derived surgical implant technology and was first to market with an innovative, quality product that assists surgeons to produce better surgical outcomes and reduce expensive operating time. For more information, visit http://www.anatomics.com and follow the company on twitter at https://twitter.com/anatomicsrx. 

 

For further information contact: 

(Media) Tiberend Strategic Advisors, Inc

Janine McCargo, Senior Vice President

Telephone: +1 (646) 604-5150

e-mail: jmccargo@tiberend.com

 

Anatomics United States

Dr. Dean Carson, Vice President US Operations

951 Mariners Island Blvd. San Mateo, CA 94404 (CSIRO Office)

Telephone: +1 (415) 806-2599

e-mail: dean.carson@anatomics.com

 

Anatomics Australia

Dr. Paul D’Urso, Executive Chairman

Suite 1, 23-27 Wellington Street, St Kilda, Victoria, 3182, Australia

Telephone: +61 3 9529-8088

e-mail: contact@anatomics.com


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October 18, 2017 OrthoSpineNews

October 18, 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 today announced the Alpha launch of the SENTRY ALIF Plating System.

SENTRY ALIF is a plating system designed to eliminate the need for posterior stabilization with anterior lumbar interbody fusion. The low profile plate design provides a rigidly stable construct without disturbing surrounding vasculature. An Anterior Lumbar Interbody Fusion prevents the need to disturb the muscles of the lower back potentially reducing post-operative pain and complications.

The SENTRY ALIF system incorporates a Cam style locking mechanism, which provides visual, tactical, and audible feedback to prevent screw back out. This innovative and proven feature allows for easy screw removal and repositioning of the plate for streamlined surgeon usage. SENTRY ALIF has an S1 anchor ledge feature to accommodate L5-S1 surgical procedures, which provides better guidance for proper positioning of the plate.

Mariusz Knap, Vice President of Global Marketing and Business Development noted, “We are thrilled to launch the SENTRY ALIF Plating System and add to our Anterior Lumbar solutions portfolio. We have had great success with predicate devices that incorporate the Cam style locking mechanism. It made perfect sense to add the same technology to an anterior lumbar plate. SENTRY ALIF’s low profile design and multiple plate options strengthen Life Spine’s commitment to providing differentiated products to surgeons and their patients.”

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


Medovex-Chronic-back-pain-relief-1.png

October 18, 2017 OrthoSpineNews

ATLANTA, GA — (Marketwired) — 10/18/17 — 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 the Company will be participating in NASS 2017, being held in Orlando, Florida, October 25-28, 2017.

The North American Spine Society (“NASS”) is a one of a kind annual meeting where spine care professionals from around the globe will share the latest information, innovative techniques and procedures, best practices, and new technologies.

A copy of the Company’s invitation to The Surgical Innovation Cadaver Lab may be found at the following link: Medovex Invitation

The lab will be led leading spine surgeons and key opinion leaders including Vik Kapoor, MD, Manchester, UK, Martin Deeg, MD, Stuttgart, Germany, Jan Spiller, MD, Stenum-Bremen, Germany, and Gabriel Davila, MD, Medellin, Columbia.

Manfred Sablowski, Medovex Sr. Vice President of Sales and Marketing, stated, “We are excited to again participate at NASS. We developed the DenerveX System to enhance a patient’s quality of life. The agony of pain associated with the Facet Joint can be life-altering, robbing people of even the simplest joys of daily life like bending over to hug a grandchild, taking a walk or gardening. Powerful painkillers often prescribed for severe back pain are fanning the flames of the nation’s opioid epidemic. The DenerveX System involves a simple, minimally invasive, ‘keyhole’ procedure that is designed to bring faster, longer-lasting relief.”

Videos of leading spine surgeon Dr. Vik Kapoor talking about FJS and the DenerveX Device may be viewed at the following links:

https://youtu.be/6Q7hpEsF2mg 

https://youtu.be/GIgPaIenXp4

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 CE marked and for sale in countries outside the US accepting the CE mark, but is not yet FDA cleared.

Please also follow us on Facebook at https://www.facebook.com/medovex/.

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

Jassad@medovex.com