IMPLANET: Successful First Surgical Procedures with the New Jazz Lock® Implant

September 14, 2016

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces the successful results of the first surgical procedures using the Jazz Lock®.

Having obtained CE marking and 510K clearance, Jazz Lock has been used in select hospitals in France, Italy and the United States. Initial positive results in over 25 cases strengthen Implanet’s intention to carry out the wide-scale international launch of Jazz Lock by the end of the year.

The first component of an innovative range of band products designed for degenerative spine disorder surgery, Jazz Lock broadens the Jazz technological platform, allowing Implanet to expand its activity in a spine market estimated to be worth over $200 million worldwide1. Implanet offers surgeons a new implant with an optimized and reproducible surgical technique. Based on the polyester band platform, Jazz Lock simplifies the surgical procedure by replacing the locking screw and connecting rod with an innovative locking system.

Doctor Vincent Cunin, Deputy Chief of Service in the Spine Surgery department at Hospices Civils de Lyon (HCL), says: “As a spine surgeon, I have been using band implants for the last four years to correct spine deformities, with excellent post-operative clinical results. Jazz Lock’s arrival as part of the Implanet band range is a major breakthrough. This new implant’s ease of use during the first surgical procedures in Lyon, as well as the very encouraging initial post-operative clinical results, validate our choice. We will now follow these patients to confirm the long term results. In my opinion, Jazz Lock will quickly become an indispensable spine implant to surgeons across the globe.

Ludovic Lastennet, CEO of Implanet, adds: “As announced following the regulatory clearance, Jazz Lock® is the first component of an innovative range of band products designed for degenerative spine disorders that will rapidly be launched in accordance with our business plan. The positive results obtained in the first surgical procedures illustrate this implant’s potential for patients and surgeons alike. Jazz Lock® further expands the breadth of our product offering, with its launch is scheduled for upcoming major spine congresses: Eurospine in Berlin in early October and NASS in Boston (USA) in late October.

Next financial press release: results for the 1st half of 2016, on September 22, 2016, after market.

Upcoming congresses and conferences:

  • SRS in Prague, September 21 to 24, 2016
  • ICCC in São Paulo, September 30 to October 1, 2016
  • EUROSPINE in Berlin, October 6 to 8, 2016
  • NASS in Boston, October 26 to 28, 2016
  • SOFCOT in Paris, November 8 to 11, 2016

Reminder of recent press releases:

  • Green light for a new implant: Jazz Lock®, April 2016
  • Q1 2016 revenues: Strong increase in U.S. JAZZ sales: +106%, April 2016
  • Launch of the new Jazz Claw® implant, May 2016
  • Q2 2016 record revenue of €2.1 million with Spine sales growing by +68%, July 2016

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2015 sales of €6.7 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

1 Source: i-Data for 2010

Contacts

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

VEXIM Signs a Distribution Agreement with Creatori Health and Expands Its Market to South Africa

September 13, 2016

TOULOUSE, France–(BUSINESS WIRE)

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces the signing of a distribution agreement with Creatori Health for the distribution of its portfolio in South Africa.

The South African market, with its 53 million inhabitants, is a promising Spine trauma market with a potential of 20.000 vertebral fractures. This could lead to a market of €40 million, according to our estimates.

VEXIM’s portfolio already gained reimbursement from one of the leading medical health insurance in South Africa, which will benefit to the Creatori Health commercial team.

Creatori Health is a well-known medical device company established in South Africa since 2004 by the current MD, Dr. Jaco Van Der Walt. Supplying leading edge technology has been a core focus of the Company, and after 9 successful years namely in the Neurosurgery field, the company decided to expand its focus to Spine and Neurosurgery in 2014, streamlining the product portfolio to ensure the best possible servicing to their clients. SpineJack® is a natural extension of its current business and a great strategic fit.

“Creatori Health is looking forward to providing the South African medical industry with SpineJack® – a clinically sound device that is not only unique, but will definitely add value as a treatment option to both patients and surgeons. With the support of VEXIM, and the granted reimbursement from a leading funder for medical insurance, we feel positive about the contribution SpineJack® will bring to the medical industry in South Africa”, said Dr WJ Van Der Walt, CEO of Creatori Health.

“Thanks to our preparation activities in this market, and based on the strong clinical literature supporting SpineJack®, reimbursement has already been granted by one leading health insurer. That will for sure benefit to Creatori Health and allow for a fast penetration of the market”, said Vincent Gardès, CEO of VEXIM.

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital1 and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 62 employees, including its own sales teams in Europe and a network of international distributors.

VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® 2, a revolutionary implant for treating Vertebral Fractures

The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

MasterflowTM 2, a high-performance orthopedic cement delivery system

The MasterflowTM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the MasterflowTM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The MasterflowTM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

Name : VEXIM
ISIN code : FR0011072602
Ticker : ALVXM

1 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.

2 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, Tél. : +33 5 61 48 48 38
CEO
investisseur@vexim.com
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

NuVasive Names Jason M. Hannon President and Chief Operating Officer; Patrick S. Miles Assumes Role of Vice Chairman

SAN DIEGO, CA–(Marketwired – September 12, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Jason M. Hannon has been promoted to president and chief operating officer. Mr. Hannon will succeed Patrick S. Miles who has been appointed vice chairman of NuVasive, Inc. and will continue to serve as a member of the Company’s Board of Directors.

Jason Hannon Named President and Chief Operating Officer

In this newly expanded role, Mr. Hannon will be responsible for leading NuVasive’s global products and services, including product management and development, as well as operational duties, including manufacturing, customer fulfillment and quality engineering. Mr. Hannon will continue to oversee international operations working alongside NuVasive’s strong international leadership team. In his more than 11 years at NuVasive, Mr. Hannon has led key areas of the Company’s business, including strategy, corporate development, legal and regulatory. Since July 2015, Mr. Hannon has served as executive vice president, International.

“Jason has extensive knowledge about our business operations and the markets we serve, as well as strong relationships with our customers,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “Jason has demonstrated operational acumen as the leader of our international business where he spearheaded a successful revitalization in our global markets with a return to double-digit revenue growth. I am proud of our efforts to develop a deep bench of executive talent, along with a clear succession plan aligned to our long-term strategic goals.”

Patrick Miles Named Vice Chairman

In his new capacity as vice chairman, Mr. Miles will focus on enhancing NuVasive’s strategic plans for the future of spine surgery, supporting technology development and helping the Company become the ultimate partner to NuVasive customers and patients. He will continue to be actively engaged in supporting the Company’s next-generation spine solution research and development efforts.

“Pat is a valuable member of NuVasive’s leadership team and we are pleased that he will continue to advance the execution of the Company’s strategic priorities as vice chairman. With an experienced team in place and a spine business well positioned for continued profitability and growth, we welcome Pat into his new role to help guide NuVasive forward,” said Mr. Lucier.

“I am excited about the future of NuVasive as it continues to lead innovation in spine. I have great respect for the leadership team in place and look forward to partnering with Jason to carry NuVasive’s innovation and operational strategies forward,” said Mr. Miles.

2016 Financial Guidance

The Company is reiterating its 2016 full year financial guidance announced on July 26, 2016, which includes revenue of approximately $962.0 million, non-GAAP diluted earnings per share of approximately $1.64 and non-GAAP operating profit margin of approximately 16.0%. For additional information, refer to NuVasive’s earnings announcement for the quarter ended on June 30, 2016.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit 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. In addition, this news release contains projections for 2016 financial guidance, which represents current estimates, including initial estimates of the potential benefits, synergies and cost savings associated with acquisitions, which are subject to the risk of being inaccurate because of the preliminary nature of the forecasts, the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability. The potential risks and uncertainties that 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.

CONTACT INFORMATION

  • Investor Contact:
    Suzanne Hatcher
    NuVasive, Inc.
    858-458-2240
    Email contact

    Media Contact:
    Michael Farrington
    NuVasive, Inc.
    858-909-1940
    Email contact

Improving the Lives of Patients, Bioness’ StimRouter™ Neuromodulation System Currently Being Implanted to Manage Chronic Pain

VALENCIA, Calif., Sept. 7, 2016 /PRNewswire/ — Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced a series of successful StimRouter Neuromodulation System implantations to manage chronic pain conditions originating from varied peripheral neuralgias. As a minimally invasive device designed to reduce pain by specifically targeting the affected peripheral nerve, StimRouter is designed to be a cost-effective alternative to injections, ongoing medication regiments, and complex surgeries.

Nearly 100 million Americans suffer from debilitating chronic pain, which may be experienced across all areas of the body including the arm, torso and leg. Chronic pain is often secondary to a primary condition (e.g. stroke) and can also result from entrapment or compression syndromes, post-surgical complications or failed surgeries.

“For many years we have had limited solutions to help our patients manage their debilitating pain,” shared William Porter McRoberts, MD, a trained Physiatrist and Interventional Spine and Pain Management Specialist based in Fort Lauderdale, Florida. “As hard as it is to understand the impact of one’s pain, it is easy to see when relief is delivered. I’m very pleased with how well my patients are responding to the StimRouter and believe that the technology will be suitable for a greater range of patients in the future.”

StimRouter was the first FDA cleared non-drug, long-term, minimally invasive neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. The patient controlled device is an adjunct to other modes of therapy (e.g., medications) and is being well received by patients and clinicians alike.

The StimRouter is currently being implanted at prestigious clinical institutions across the country to treat chronic peripheral nerve pain, with specific focus on the following conditions or areas:

  • Axillary nerve (e.g. post-stroke shoulder pain)
  • Ulnar nerve (e.g. cubital tunnel syndrome)
  • Ilioinguinal (e.g. post-surgical hernia complication)
  • Superior Cluneal nerve (e.g. lower back neuralgia)

“As clinicians and patients continue to look for effective and sustainable ways to treat and manage pain, it is rewarding to see patients thrive with our StimRouter technology,” shared Todd Cushman, President and CEO of Bioness. “Pain is more than just a barrier to a comfortable life and pursing employment, it can be what prevents patients from being able to seek therapy to rehabilitate an injury or illness.”

For more information on the StimRouter as well as videos of real patients sharing their StimRouter experience, please visit www.stimrouter.com.

About StimRouter Neuromodulation System
StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the target nerve. StimRouter is programmed at the direction of the physician to meet patient requirements but is controlled by the patient to address the patients specific, changing pain management needs.

About Bioness Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include external and implantable functional electrical stimulation (FES) systems, robotic systems and software-based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com

Media Relations Contact Information
Next Step Communications
bioness@nextstepcomms.com
781.326.1741

StimRouter™ and Bioness® are trademarks of Bioness, Inc. | www.bioness.com | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com.

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/improving-the-lives-of-patients-bioness-stimrouter-neuromodulation-system-currently-being-implanted-to-manage-chronic-pain-300323378.html

Nevro touts 2-year data on Senza spinal cord stim

 By 

 

Nevro Corp. (NYSE:NVRO) today released 2-year results from Senza-RCT study of its HF10 spinal cord stimulation system, touting superior results over low-frequency SCS therapy treatments.

The Redwood City, Calif.-based company said results from the study were published in the journal Neurosurgery. Nevro said the trial is the largest prospective randomized trial of SCS systems and the 1st to evaluate the comparative effectiveness of spinal cord stimulation therapies.

The primary endpoint for the trial was a responder rate signifying a greater-than 50% reduction in back pain from the baseline at 3 months, with a secondary endpoint set at 12 months. Leg pain reductions and 24 month results from back pain reduction were also polled for secondary endpoints.

Patients treated with the company’s HF10 SCS reported significant improvements in superior back pain and leg pain 76.5% and 72.9% respectively, much higher than the 49.3% rates reported with traditional SCS for both back and leg pain.

Superior and durable pain relief results also indicated superiority for the HF10, with Visual Analog Scale scores for back and leg pain of 2.4 cm with HF10 versus 4.5 cm and 3.9 cm with traditional SCS, according to the study.

 

READ THE REST HERE

VTI Announces Partnership With BioMed. Tech. Intl. S.A. (BioMedical)™

MINNETONKA, MN (PRWEB) SEPTEMBER 09, 2016

VTI, Vertebral Technologies, Inc., announced a strategic partnership with BioMed. Tech. Intl. S.A. (BioMedical), the Mexico-based medical products distributor whose aim is to represent technology that helps people reclaim their lives.

BioMed Tech. Intl. will offer distribution of VTI’s patented InterFuse S™ and InterFuse T™ spinal fusion devices throughout Mexico.

BioMed Tech. Intl. President and CEO Marco Vega comments, “We are proud to work with the most important opinion leaders on MIS Spine Surgery in Mexico and Latin America. As a MIS Spine distributor leader we have the responsibility to increase the awareness of new and experienced physicians with the practice of MIS surgery”. Mr. Marco Vega also stated, “We decided to carry Interfuse in Mexico, because we are a Company who handles the most advanced Minimally Invasive Spine Products for our MIS Surgeons and Patients”.

The InterFuse™ System is a spinal implant able to achieve a large footprint through an intra-body modular assembly technique, using a minimally invasive posterior and or transformational approach. The InterFuse™ is currently being used by surgeons in over 20 countries, and VTI is pleased to be able to bring this state-of-the-art technology to more spine specialists in the country of Mexico.

“We have seen significant interest from Mexican surgeons at the various international congresses and we are looking forward to bringing the unique benefits of InterFuse™ to the Mexican Spine Surgeons and their Patients.” says VTI Vice President of International Sales, Ben Wasscher. He continues by stating, “Biomedical is a well-respected distributor in the Mexican spine market with great geographic coverage through its 6 offices and its large team of motivated sales people.”

This partnership will be formally announced at the AMCICO Spine Congress in Mexico City, September 13-17, 2016. This is the 17th Congress organized by AMCICO (Asociacion Mexicana de Cirujanos de Columna / Mexican Association of Spine Surgeons/ Spine Surgeons Association of Mexico), and both VTI and BioMed Tech. Intl. representatives will be in attendance.

About BioMedical Tech. Intl. (BioMedical).

Founded in 2004, BioMedical Tech. Intl., is a private held company who focuses on bringing high quality medical products and innovative technology to surgeons. Their Sales Operations Centers are located throughout Mexico, in Mexico City (headquarters), Guadalajara, Tijuana, Monterrey, Chihuahua, Merida, Villahermosa, Veracruz, Hermosillo and with a range of Subdistributors all around the country.. BioMedical’s mission is “To allow people to live more fully and healthier by seeking excellent quality in the products we manage, and to deliver unbeatable service at the appropriate time.” For more information for VTI products in Mexico, you can visit: http://http://www.biomedical.mx or contact Pedro Montero for sales at: +52 (55) 52638370.

About Vertebral Technologies, Inc.

Vertebral Technologies, Inc. (VTI) is a privately held company based in Minnetonka, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells its InterFuse modular interbody fusion devices worldwide to-date.

For more information visit, http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or +1.952-979-1811

Paralyzed Man Regains Use of Arms and Hands After Experimental Stem Cell Therapy at Keck Hospital of USC

LOS ANGELES, Sept. 7, 2016 /PRNewswire/ — Keck Medical Center of USC today announced that a team of doctors became the first in California to inject an experimental treatment made from stem cells, AST-OPC1, into the damaged cervical spine of a recently paralyzed 21-year-old man as part of a multi-center clinical trial.

On March 6, just shy of his 21st birthday, Kristopher (Kris) Boesen of Bakersfield suffered a traumatic injury to his cervical spine when his car fishtailed on a wet road, hit a tree and slammed into a telephone pole.

Parents Rodney and Annette Boesen were warned there was a good chance their son would be permanently paralyzed from the neck down. However, they also learned that Kris could possibly qualify for a clinical study that might help.

Leading the surgical team and working in collaboration with Rancho Los Amigos National Rehabilitation Center and Keck Medicine of USC, Charles Liu, MD, PhD, director of the USC Neurorestoration Center, injected an experimental dose of 10 million AST-OPC1 cells directly into Kris’ cervical spinal cord in early April.

“Typically, spinal cord injury patients undergo surgery that stabilizes the spine but generally does very little to restore motor or sensory function,” explains Liu. “With this study, we are testing a procedure that may improve neurological function, which could mean the difference between being permanently paralyzed and being able to use one’s arms and hands. Restoring that level of function could significantly improve the daily lives of patients with severe spinal injuries.”

Two weeks after surgery, Kris began to show signs of improvement. Three months later, he’s able to feed himself, use his cell phone, write his name, operate a motorized wheelchair and hug his friends and family. Improved sensation and movement in both arms and hands also makes it easier for Kris to care for himself, and to envision a life lived more independently.

“As of 90 days post-treatment, Kris has gained significant improvement in his motor function, up to two spinal cord levels,” said Dr. Liu.  “In Kris’ case, two spinal cord levels means the difference between using your hands to brush your teeth, operate a computer or do other things you wouldn’t otherwise be able to do, so having this level of functional independence cannot be overstated.”

Doctors are careful not to predict Kris’ future progress.

“All I’ve wanted from the beginning was a fighting chance,” said Kris, who has a passion for fixing up and driving sports cars and was studying to become a life insurance broker at the time of the accident.  “But if there’s a chance for me to walk again, then heck yeah! I want to do anything possible to do that.”

Qualifying for the Study

Because the window for performing the surgery was tight, everything needed to go according to schedule in order for Kris to qualify.

Once Kris made the decision to pursue enrollment in the study, dozens of doctors, nurses, rehabilitation specialists and others sprang into action. Because he would need to provide voice confirmation of his desire to participate in the study, Kris had to be able to breathe without a ventilator. Weaning a patient from assisted breathing generally is a three-week process. He did it in five days with the help of a respiratory care team. He signed the paperwork and began a week of assessments, scans and other pre-surgery tests.

In early April, a surgical team from Keck Hospital of USC carefully injected 10 million AST-OPC1 cells directly into Kris’ cervical spine. Nearly six weeks later, Kris was discharged and returned to Bakersfield to continue his rehabilitation. Doctors reviewed his progress at seven days, 30 days, 60 days and 90 days post-injection, and Kris can look forward to detailed assessments after 180 days, 270 days and one year.

Rodney and Annette Boesen say they are amazed at the level of collaboration and cooperation that enabled their son to participate in the study. “So many things had to happen, and there were so many things that could have put up a roadblock,” marvels Rodney. “The people at Keck Medical Center of USC and elsewhere moved heaven and earth to get things done. There was never a moment through all of this when we didn’t think our son was getting world class care.”

About the Study

The pioneering surgery is the latest example of how the emerging fields of neurorestoration and regenerative medicine may have the potential to improve the lives of thousands of patients who have suffered a severe spinal cord injury.

The stem cell procedure Kris received is part of a Phase 1/2a clinical trial that is evaluating the safety and efficacy of escalating doses of AST-OPC1 cells developed by Fremont, California-based Asterias Biotherapeutics. AST-OPC1 cells are made from embryonic stem cells by carefully converting them into oligodendrocyte progenitor cells (OPCs), which are cells found in the brain and spinal cord that support the healthy functioning of nerve cells. In previous laboratory studies, AST-OPC1 was shown to produce neurotrophic factors, stimulate vascularization and induce remyelination of denuded axons. All are critical factors in the survival, regrowth and conduction of nerve impulses through axons at the injury site, according to Edward D. Wirth III, MD, PhD, chief medical director of Asterias and lead investigator of the study, dubbed “SCiStar.”

“At the 10 million cell level, we’re now in a dose range that is the human equivalent of where we were when we saw efficacy in pre-clinical studies,” says Wirth. “While we continue to evaluate safety first and foremost, we are also now looking at how well treatment might help restore movement in these patients.”

To qualify for the clinical trial, enrollees must be between the age of 18 and 69, and their condition must be stable enough to receive an injection of AST-OPC1 between the fourteenth and thirtieth days following injury.

Keck is one of six sites in the U.S. authorized to enroll subjects and administer the clinical trial dosage.

The first early data results from a group of patients in this study will become available on September 14, 2016.

Photography and video assets can be downloaded at http://www.keckmedicine.org/stem-cell-patient-media-assets/

For more information, go to www.keckmedicine.org/beyond

Logo – http://photos.prnewswire.com/prnh/20160120/324215LOGO

 

SOURCE Keck Medicine of USC

Related Links

http://www.keckmedicine.org/

Global Market Study on Cervical Total Disc Replacement Device: Growth in Cervical Degenerative Diseases, a Catalyst for CTDR Devices Market

LONDON, Sept. 8, 2016 /PRNewswire/ — The cervical Total Disc Replacement (CTDR) device is used to treat patients suffering from Degenerative Disc Disorders (DDD). Neck pain is the major cause for the development of DDD in the cervical region of the spine. Cervical disc replacement surgery is performed for treatment of DDD, where the degenerated disc is removed surgically and an artificial disc is implanted in the vertebra. This is a Minimal Incision Surgery (MIS) and results in quick recovery post-surgery, short hospital stay, and low revision surgery rate.

Conventionally, DDD is treated through spinal fusion surgery, but due to the high rate of revision surgery and increasing the prevalence of adjacent segment disc degeneration post fusion surgery, doctors prefer cervical disc replacement over spinal fusion. Major players in the market are proactively providing training to spine surgeons, thus, ensuring efficient handling of their respective products.

Growing ageing population, low revision surgery rate, and increasing demand for advanced innovative CTDR devices for treatment of both class I and class II degenerative disc diseases, are major factors fueling demand for CTDR devices. Major trends witnessed in the CTDR device market include technological advancements, consistent investment in research and development activities, the and the surge in acquisitions and mergers.

The CTDR device market is segmented as follows:
CTDR device, by material type
CTDR device, by end user
CTDR device, by region
This report covers the global CTDR device market performance in terms of revenue contribution. This section also includes PMR’s analysis of key trends, drivers, restraints, and opportunities, which are influencing the growth of the global CTDR device market currently. Impact analysis of key drivers and restraints is included in this report to better equip clients with crystal clear decision-making insights. The report also provides regional company share analysis and product details in terms of marketing approvals.

By material type, the global CTDR device market is segmented into metal on a biocompatible material (M-o-B) and metal on metal (M-o-M). Of these, metal on biocompatible material segment holds majority market share currently and is expected to remain the leading segment in terms of volume and value during the forecast period. The metal on a metal segment is projected to grow in terms of value and volume, but at a relatively slower pace compared to the metal on the biocompatible material segment. The number of products in the metal on the biocompatible material segment is higher compared to the metal on a metal segment, which is a major driver for the growth of the metal on the biocompatible material segment. Various benefits offered by metal on biocompatible material products such as greater degree of rotation and flexible movement of a spine are expected to drive the growth of this segment during the forecast period.

On the basis of the end user, the global CTDR device market is segmented into hospitals and ASCs. The hospitals segment dominated the CTDR device market in 2014; however, the ASCs segment is projected to expand at a higher CAGR over the forecast period as compared to the hospital segment. This is attributed to the fact that cervical disc replacement is a minimally invasive surgery and can be performed in ASCs. Number of patients undergoing cervical disc replacement in ASCs is increasing substantially due to factors such as quick discharge and their cost effectiveness, which in turn is expected to fuel growth of CTDR device market in the ASCs segment.

By region, North America is expected to remain dominant in the CTDR device market mainly due to robust reimbursement policies and rise in the number of cervical disc replacement procedures performed in the region. Prevalence of neck pain is comparatively higher in Western Countries as compared to APAC. In terms of growth rate, the APAC market is projected to grow at a significant pace mainly due to the large population base in the region. Revenue contribution from the market in North America, followed by markets in APAC and Europe, is expected to expand at the highest CAGR during the forecast period. The market in the MEA remains untapped, thus offering potential opportunities to companies operating in this industry.

Some key market players included in this report are Medtronic, plc, Depuy Synthes (a Johnson & Johnson Company), Globus Medical, Inc., NuVasive, Inc., and LDR Holding Corporation. These companies have been profiled on the basis of various attributes such as company overview, recent developments, growth strategies, and financial overview.
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NuVasive’s MAGEC System Featured in Live Surgery Event at the Spine Hospital at NewYork-Presbyterian

SAN DIEGO, CA–(Marketwired – September 06, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced a key event in the Company’s advancement in the treatment of patients with deformity spinal conditions.

On Monday September 12, Dr. Michael G. Vitale, MD, MPH, Director of Pediatric Orthopedics at Columbia Orthopedics, will use the MAGEC® system to treat a seven-year-old Early Onset Scoliosis (EOS) patient with a progressive 45 degree curve and multiple cardiac comorbidities. The case will be featured in a live surgery event, in partnership with BroadWater’s Total Spine Series 2016, hosted by The Spine Hospital at NewYork-Presbyterian.

Dr. Michael Vitale commented, “I am honored to take part in this event to demonstrate the success of the MAGEC system in transforming the lives of pediatric patients requiring surgical treatment for EOS. The live surgery event will demonstrate that the surgical technique is no different from what surgeons have historically done. However, with the elimination of additional planned distraction surgeries, the MAGEC system helps simplify care for this patient population like no other technology.”

“NuVasive’s technology platform is quickly becoming the standard of care in pediatric deformity. The MAGEC rod can be extended non-invasively with a magnet, significantly reducing the number of planned distraction surgeries from up to 15 surgeries over several years, to a single surgery. By transforming the experience for these young patients, NuVasive is able to help minimize the risks associated with multiple surgeries, while also reducing the total cost of care. We will continue to partner with surgeons like Dr. Vitale to revolutionize deformity surgery with a comprehensive offering for pediatric, adolescent and adult deformity patients,” said Gregory T. Lucier, NuVasive’s Chairman and Chief Executive Officer.

The simultaneous live surgery broadcast will allow surgeons to observe a live feed, ask real-time Q&A with operating surgeons and take part in afternoon case discussions and lectures. In addition, the live surgery has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (AACME) through the joint sponsorship of Medical Education Resources (MER) and BroadWater, providing a maximum of up to 7 AMA PRA Category 1 credit(s)™. For more information and to register for the event, visit www.broad-water.com.

The MAGEC System

MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. Periodic lengthening of the rod is performed externally to distract the spine in an office setting, eliminating distraction surgeries and helping to simplify care.

Earlier this month, the U.S. Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for magnetically controlled growth rods. For a technology to qualify for an NTAP in the inpatient setting, the solution must demonstrate a substantial clinical improvement relative to available alternatives.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit 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.

Contact Information

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact

Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact

More than a third of adult spinal deformity patients experience at least one psychological disorder

6th September 2016

According to new research from the Hospital for Special Surgery in New York City, USA, 36.5% of patients undergoing surgical treatment for adult spinal deformity in the US Nationwide Inpatient Sample (NIS) has been coded with at least one psychological disorder catalogued in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders: 5th Edition (DSM-V). Adult spinal deformity patients displayed the highest prevalence of psychological impairment, when compared with three other disabling chronic diseases.

The research—which was presented at the International Meeting for Advanced Spine Techniques (IMAST; 13-16 July, Washington, DC, USA) by Bassel Diebo (Brooklyn, USA)—aimed to “investigate incidences of psychological disorders in adult spinal deformity patients undergoing surgical treatment.” The condition is a growing problem in the USA, according to the researchers, who attribute its increasing prevalence to the country’s ageing population. The disability associated with adult spinal deformity has been noted as “concerning” in the literature, “when compared to other self-reported chronic conditions.” Diebo explained that the psychological burden of the condition—a major factor in disability—“remains unclear” in comparison to many disabling diseases.

Diebo et al performed a retrospective review of NIS data from 2002 to 2012, using International Classification of Diseases, Ninth Revision coding to identify patients with adult spinal deformity undergoing more than four levels of fusion (n=17,536). The research team also searched for patients with cardiac diseases (n=2,675,767), type one and/or two diabetes (n=1,137,435), and lung cancer (n=363, 334). The total population included from the NIS database during this period was 4,194,073.
Using the DSM-5 manual, Diebo and colleagues identified incidences of depressive, anxiety, obsessive-compulsive, stress, somatic symptom, sexual dysfunction, substance abuse, delirium and personality disorders in patients within each chronic disease group.

Results showed that adult spinal deformity patients had “the highest prevalence of any psychological disorder” amongst the groups (p<0.001). Thirty-six point five per cent of these patients experienced at least one psychological disorder, followed by cardiac disease patients (33.3%), diabetic patients (28.3%) and lung cancer patients (24%).

When stratified according to age, researchers found that, amongst adult spinal deformity patients with psychological disorders, “61.7% were between 55 and 74 years old”. Six point two per cent were between 25 and 40 years old, with 12.2% over seventy-five years of age.

Amongst the patients, the most common disorders for 55-74 year olds were depressive, anxiety and sleep disorders. Amongst the younger age bracket of 41-54 years, however, the most common psychological disorders were substance abuse-based. Of the four most common psychological disorders amongst the population—depressive, sleep, anxiety and substance abuse—adult spinal deformity patients exhibited the highest percentage of the former three.

In conclusion, Diebo highlighted the prevalence of psychological disorders amongst this group, emphasising that “one in every three adult spinal deformity patients” was coded with at least one psychological disorder. Diebo recommended that “proper psychological screening, patient counselling and appropriate support” should be a part of adult spinal deformity treatment.