VEXIM Announces the Registration of Its Products SpineJack® and Masterflow™ For the Treatment of Vertebral Fractures in Australia

September 06, 2016

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces it has received the regulatory approval from the Therapeutic Goods Administration (TGA) in order to commercialize the SpineJack® and the cement delivery system MasterflowTM in Australia.

This success opens a new market opportunity for VEXIM in Australia which represents a potential market of €30 million in the treatment of vertebral compression fractures according to VEXIM’s estimations.

The company keeps expanding its international presence whilst preparing new products’ development.

Vincent Gardès, VEXIM’s CEO, concludes: “This registration will enable us to have a substantial increase of our global activities. The company considers launching the exportation in Australia by the end of 2016.”

 

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.

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

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.

St. Teresa Medical, Inc. Announces Appointment of Richard Guyer, M.D. to Scientific Advisory Board

ST. PAUL, Minn., Sept. 6, 2016 /PRNewswire-USNewswire/ — St. Teresa Medical, Inc. today announced the appointment of Richard Guyer M.D. to its scientific advisory board.  Dr. Guyer is a board certified orthopedic spine surgeon and one of the founders of Texas Back Institute and serves as its President.  He also serves as the Chairman of the Board of Directors for the Texas Back Institute Research Foundation and has been Director of the Spine Surgery Fellowship program since its inception in 1986.

Dr. Guyer did his medical school and residency training at the University of Pennsylvania School of Medicine and completed two spine fellowships, one at Case Western Reserve University with Henry Bohlman, M.D. in Cleveland, Ohio and the other with Leon Wiltse, M.D. in Long Beach, California.  He holds many patents in spine surgery and has published over 100 peer-reviewed articles and 45 chapters presenting his research at national and international spine conferences.  While the majority of the research work has dealt with the diagnosis and treatment of painful degenerative spinal conditions, he is also one of the pioneers in minimally invasive surgery and lumbar and cervical disc replacement.   In the early 1980s he worked with his former mentor Parviz Kambin who pioneered endoscopic discectomy.   In 2000 he performed one of the first disc lumbar disc replacements in the USA and has been an investigator in nearly a dozen U.S. IDE studies of both cervical and lumbar disc replacements.  He continues to research and publish in this area as well as in motion preservation and minimally invasive treatments.

Dr. Guyer has been very active with various spine societies including North American Spine Society (NASS), Cervical Spine Research Society (SSRS), International Society for the Study of the Lumbar Spine (ISSLS), and International Society for the Advancement of Spine Surgery (ISASS) serving as President of NASS during the 2006-2007 year and various committees of the ISASS.  He was recently appointed to the board of directors of the American Board of Spinal Surgery.

Philip Messina, President and CEO said, “We are very pleased to welcome Dr. Guyer to our Scientific Advisory Board.  He is considered to be among the top spine surgeons in the world.  We could not be more pleased to have him on board. “

  1. Timothy Floyd, MD, Chief Scientific Officer and Chair of the Scientific Advisory Board said, “Dr. Guyer is a world leader in cutting edge spine surgery and techniques.  His counsel, as we move into our global clinical trial on SURGICLOT will be important.”

About St. Teresa

St. Teresa Medical, Inc.®, based in St. Paul, MN., is a medical-device company developing SURGICLOT®, a new unique dissolvable hemostatic dressing for use during orthopedic surgery.  SURGICLOT® is uniquely fabricated from nanoscale electro-spun dextran fibers infused with fibrinogen and thrombin.  SURGICLOT® works by supplementing and enhancing the body’s natural clotting mechanism.  SURGICLOT® utilizes thrombin and fibrinogen obtained from human sources.

For more information, see www.StTeresaMedical.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/st-teresa-medical-inc-announces-appointment-of-richard-guyer-md-to-scientific-advisory-board-300322887.html

SOURCE St. Teresa Medical, Inc.

The single protein injection which could replace the need for knee surgery for osteoarthritis sufferers

By SARA MALM – September 3, 2016

A single injection of protein harvested from a patient’s own blood may replace the need for knee surgery for osteoarthritis sufferers.

The new 20-minute procedure sees blood drawn from the patient’s arm, separated in a centrifuge, after which part of the fluid is then injected into the arthritic knee.

The surgeon who brought the treatment to the UK believes it can stop the need for keyhole surgery for osteoarthritis of the knee altogether.

Osteoarthritis is the most common type of arthritis, particularly affecting people aged 65 and over.

The degenerative condition affects the cartilage – the joint’s connective tissue – causing pain, stiffness and inflammation.

A trial study in the Netherlands published earlier this year showed that 85 per cent of patients had little to no pain in their knee six months after new procedure, which is called the NStride Autologous protein injection.

A further, larger, study based on work in Italy, Austria, Belgium and Norway, which has seen similarly positive results, is due to be published later this month.

About 55ml of blood is taken from a vein in the patient’s arm, mixed with an anticoagulant and centrifuged at high speed for 15 minutes, causing the blood to separate into three layers – a yellow blood plasma; a red blood cell concentration; and a ‘platelet-rich plasma’, a solution comprising platelet cells and some white blood cells.

READ THE REST HERE

3-D graphene has promise for bio applications, Scientists weld nanoscale sheets to form tough, porous material

September 2, 2016 – Ajayan Group/Rice University

The Rice lab of materials scientist Pulickel Ajayan and colleagues in Texas, Brazil and India used spark plasma sintering to weld flakes of graphene oxide into porous solids that compare favorably with the mechanical properties and biocompatibility of titanium, a standard bone-replacement material.

The discovery is the subject of a paper in Advanced Materials.

The researchers believe their technique will give them the ability to create highly complex shapes out of graphene in minutes using graphite molds, which they believe would be easier to process than specialty metals.

“We started thinking about this for bone implants because graphene is one of the most intriguing materials with many possibilities and it’s generally biocompatible,” said Rice postdoctoral research associate Chandra Sekhar Tiwary, co-lead author of the paper with Dibyendu Chakravarty of the International Advanced Research Center for Powder Metallurgy and New Materials in Hyderabad, India. “Four things are important: its mechanical properties, density, porosity and biocompatibility.”

Tiwary said spark plasma sintering is being used in industry to make complex parts, generally with ceramics. “The technique uses a high pulse current that welds the flakes together instantly. You only need high voltage, not high pressure or temperatures,” he said. The material they made is nearly 50 percent porous, with a density half that of graphite and a quarter of titanium metal. But it has enough compressive strength — 40 megapascals — to qualify it for bone implants, he said. The strength of the bonds between sheets keeps it from disintegrating in water.

The researchers controlled the density of the material by altering the voltage that delivers the highly localized blast of heat that makes the nanoscale welds. Though the experiments were carried out at room temperature, the researchers made graphene solids of various density by raising these sintering temperatures from 200 to 400 degrees Celsius. Samples made at local temperatures of 300 C proved best, Tiwary said. “The nice thing about two-dimensional materials is that they give you a lot of surface area to connect. With graphene, you just need to overcome a small activation barrier to make very strong welds,” he said.

 

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Attila Poka, MD, Joins CoNextions Medical as Chief Medical Officer

SANDY, Utah, Sept. 2, 2016 /PRNewswire/ — CoNextions Medical (www.conextionsmed.com) has announced that Attila Poka, one of the most experienced and internationally known surgeons in Orthopaedic Trauma, has joined CoNextions Medical as CoNextions Medical’s Chief Medical Officer beginning September 1st, 2016.  Dr. Poka was previously Chief of Orthopaedic Trauma at Grant Medical Center in Columbus, Ohio and Clinical Professor of Orthopaedic Trauma of Ohio University.  Prior to moving to Columbus, Ohio in 1993, Dr. Poka held numerous appointments while at Shock Trauma Center/MIEMSS, in Baltimore, Maryland.  Dr. Poka has a very strong background in educating health care providers both as faculty at universities and as a consultant to multiple international medical companies.  Dr. Poka has given hundreds of educational presentations at medical conferences worldwide, hundreds of book chapters and peer reviewed journal articles, and is widely regarded as a legend in orthopaedic surgery and at Shock Trauma.

In his role as Chief Medical Officer, Dr. Poka will lead CoNextions Medical in its development and practice of clinical education and training for physicians and distributors, oversee clinical research collaboration and educational grants, work with physical therapists in recovery protocols, support sales and marketing programs, and help guide product development initiatives to further improve and expand CoNextions Medical’s products.

“We are honored to announce the hiring of Dr. Poka, who I know will bring his focus and passion for excellence in patient care to CoNextions Medical above all else.  Dr. Poka is an intensely disciplined, yet caring physician who demands the best in quality and will ensure that the focus of CoNextions Medical will continuously remain on providing the best care and outcomes for patients,” said Dan Gruppo, Executive Vice President of Global Sales and Marketing.

Richard J Linder, Chairman and Chief Executive Officer and Co-Founder of CoNextions Medical, said, “Dr. Poka brings us the critical perspective of a tremendous health care provider and patient advocate.”  Mr. Linder further stated, “Dr. Poka’s first-hand experience in caring for injured patients will be invaluable as we maintain our focus on the achievement of our mission to dramatically improve patient outcomes, reduce surgical complications, improve the quality of life for patients, and improve the health economics of tendon repair worldwide.”

Dr. Poka said, “I am honored to move into the next chapter of my career where I have the opportunity to participate in the development, marketing, and sales of a pioneer product which we hope will provide a better means to repair tendons and provide reliable and more consistent patient outcomes.”

About CoNextions Medical

Founded in 2011, CoNextions Medical is a privately-held company located in Sandy, Utah. They are an innovation-based medical device company dedicated to achieving safer, stronger, and more durable tendon repairs worldwide marked by faster rehabilitation, fewer complications, and lower long-term costs.

SOURCE CoNextions Medical

Related Links

http://www.conextionsmed.com

Interventional Orthopedics Foundation Announces Fellowship Grants

BROOMFIELD, Colo., Sept. 2, 2016 /PRNewswire/ — As part of its commitment to furthering the quality of education in the field of interventional orthopedics, the Interventional Orthopedics Foundation is proud to announce that it has awarded two prestigious universities and medical centers in the United States for the 2016-2017 academic year. The grants were awarded through the Foundation and provided a total of $75,000 to recipients for the placement of clinical PM&R Fellows.

Award recipients are Emory University Department of Orthopedics and Sports Medicine in Atlanta, Georgia and Stanford University PM&R Sports Medicine Fellowship in Redwood City, California.

These programs demonstrate a comprehensive curriculum that fits well with the IOF’s mission to expand the reach of regenerative interventional orthopedics. Fellows in these programs have the opportunity to acquire significant hands-on spine and peripheral joint ultrasound and fluoroscopy training focused on Interventional Orthopedics—by utilizing more invasive and technically advanced stem cell therapies.” said Nancy Ho, Executive Director for Interventional Orthopedics Foundation.

About the Interventional Orthopedics Foundation

The Interventional Orthopedics Foundation (www.interventionalorthopedics.org) was created as a not-for-profit (501)C(3) organization on January 27, 2015.  The Foundation’s primary function is to educate and serve as a resource to physicians and the public who seek to understand the growing field of interventional orthopedics, which includes the development and availability of regenerative medicine therapies. 

Each application is reviewed by IOF’s Grant Review Committee. Two nationally recognized universities and medical centers were selected to receive one of the 2016 PM&R Clinical Fellowship grants based on a comprehensive application process, focusing on each institution’s specific clinical and research programs that target the specific needs of the local community.

Media contact:  
Dave Klein  
Email  
303-800-6467

SOURCE Interventional Orthopedics Foundation

Related Links

http://www.interventionalorthopedics.org

Should your ASC bundle? Dr. Randolph Bishop on navigating a spine program

Bundled payment programs are receiving a lot of buzz in the value-based arena, but developing a bundled product is no straightforward task.

Before surging ahead into a bundled payment program, ambulatory surgery centers should first decide whether its surgeons and facility can perform the desired service at a competitive market price. Consider whether the ASC has the ability to operate the business with the margin generated by government payers.

Once an ASC understands its capabilities, it can build a bundled spine surgery product by calculating an accurate facility cost combined with the surgeon payment.

“The goal would be for the facility and surgeon to assume the risk of the episode of care and therefore should cover all aspects of the surgery with the exception of indirect complications,” says Randolph Bishop, MD, MBA, a neurosurgeon at Neurological Institute of Savannah (Ga.).

Certain ASCs pose as superb candidates for bundled payment programs. Surgeon-owned centers and centers specializing in spine are especially groomed for bundled payments.

 

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Stem cell company paid $443,500 to former head of state agency that funds research

By DAVID JENSEN – September 1, 2016

The former president of the $3 billion California stem cell agency received $443,500 in total compensation from the Bay Area stem cell company that appointed him to its board of directors only seven days after he left his state post.

The stock and cash were provided over a two-year period to Alan Trounson by Newark-based StemCells Inc., a firm that was awarded more than $40 million in funding while Trounson headed the California Institute for Regenerative Medicine, as the state stem cell agency is formally known.

In 2014, when Trounson served less than six months on the StemCells Inc. board, his total compensation was more than double that of any other board member.

The surprise appointment of Trounson almost immediately after he left CIRM in 2014 generated allegations of conflict of interest. The size of Trounson’s total compensation, however, was not available at that time.

Conflict-of-interest allegations have dogged the agency since it was created in 2004 by California voters to use state bond proceeds to finance stem cell research.

In 2008, the respected scientific journal Nature warned about “cronyism” at the agency. In 2012, the Institute of Medicine, a division of the National Academies of Sciences, recommended in a $700,000 study commissioned by CIRM that the stem cell agency make sweeping changes to reduce the possibility of such conflicts.

Speaking about the agency’s board, Harold Shapiro, chairman of the Institute of Medicine team, told the Los Angeles Times, “They make proposals to themselves, essentially, regarding what should be funded.”

The agency made some changes to deal with conflict questions but resisted the institute’s far-reaching proposals.

The latest news prompted John Simpson, who has followed the stem cell agency for Consumer Watchdog of Santa Monica, to say in an email, “Trounson’s joining the StemCells Inc. board a mere seven days after quitting as CIRM’s president at the time smacked of being a payback for a job well done on behalf of the company when he should have been looking out for the taxpayers’ money and interests. It was a blatant conflict that undermined the agency’s credibility. Now we know his price tag.”

In 2014, the stem cell agency said its “limited” investigation showed that no violation of law occurred. At the time, CIRM Chairman Jonathan Thomas described the issue as a “perception” problem.

 

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Medtronic, Zimmer Biomet Enter 2-level Cervical Disc and Robotic Markets

September 1, 2016 – By  Carolyn LaWell

Disc Replacement

Zimmer Biomet’s $1 billion acquisition of LDR and its Mobi-C cervical disc assets and Medtronic’s FDA Premarket Approval for the Prestige LP 2-level application changed the game in the U.S. 2-level cervical disc replacement arena.

Mobi-C had been the only 2-level disc approved on the U.S. market. Prior to Zimmer Biomet’s purchase of the technology, LDR was able to expand reimbursement coverage, update label claims and publish peer-reviewed papers that resulted in Mobi-C’s sales growth, which increased 80% in 2015 vs. 2014.

Further, in April 2016, LDR reported that Mobi-C had surpassed $100 million in cumulative U.S. revenue since its 2013 launch. Half of the Mobi-C units sold address 1-level indications and half are for 2-level indications.

The acquisition of LDR allows Zimmer Biomet to increase its share of the worldwide spine market from 4% to 5%, according to ORTHOWORLD estimates. While the purchase also expands Zimmer Biomet’s traditional cervical and lumbar offerings, Mobi-C is presumably the technology that attracted Zimmer Biomet to LDR, primarily.

Medtronic’s entry into the 2-level market is expected to put competitive pressure on Zimmer Biomet’s purchase. The 2-level discs will be sold in a small market that faces a lack of reimbursement, compared to 1-level discs and fusion. To dive into specifics, >50 million lives are covered for Mobi-C’s 2-level procedure. The total artificial disc market is expected to reach ~$275 million in 2016, according to estimates in the ORTHOWORLD report, Cervical and Lumbar Artificial Disc Profiles.

 

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