Mayo Clinic finds surprising results on first-ever test of stem cell therapy to treat arthritis

Posted On December 28, 2016 By OrthoSpineNews In Biologics, Sports Medicine /

By Kevin Punsky – December 6, 2016

JACKSONVILLE, Fla. — Researchers at Mayo Clinic’s campus in Florida have conducted the world’s first prospective, blinded and placebo-controlled clinical study to test the benefit of using bone marrow stem cells, a regenerative medicine therapy, to reduce arthritic pain and disability in knees.

The researchers say such testing is needed because there are at least 600 stem cell clinics in the U.S. offering one form of stem cell therapy or another to an estimated 100,000-plus patients, who pay thousands of dollars, out of pocket, for the treatment, which has not undergone demanding clinical study.

The findings in The American Journal of Sports Medicine include an anomalous finding — patients not only had a dramatic improvement in the knee that received stem cells, but also in their other knee, which also had painful arthritis but received only a saline control injection. Each of the 25 patients enrolled in the study had two bad knees, but did not know which knee received the stem cells.

Given that the stem cell-treated knee was no better than the control-treated knee — both were significantly better than before the study began — the researchers say the stem cells’ effectiveness remains somewhat uninterpretable. They are only able to conclude the procedure is safe to undergo as an option for knee pain, but they cannot yet recommend it for routine arthritis care.

“Our findings can be interpreted in ways that we now need to test — one of which is that bone marrow stem cell injection in one ailing knee can relieve pain in both affected knees in a systemic or whole-body fashion,” says the study’s lead author, Shane Shapiro, M.D., a Mayo Clinic orthopedic physician.

“One hypothesis is that the stem cells we tested can home to areas of injury where they are needed, which makes sense, given that stem cells injected intravenously in cancer treatments end up in the patients’ bone marrow where they need to go,” he says. “This is just a theory that can explain our results, so it needs further testing.”

Another explanation is that merely injecting any substance into a knee offered relief from pain.

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MiMedx Announces Preliminary Investigation Findings

Posted On December 28, 2016 By OrthoSpineNews In Regulatory /

MARIETTA, Ga., Dec. 27, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that the Audit Committee of its Board of Directors has reported preliminary findings of its investigation to the Board of Directors regarding allegations made by two former employees against the Company.

As previously disclosed in its December 15, 2016 press release, the Company terminated two employees when it was discovered that the employees were selling products for other companies, some of which were competitive, in violation of their contractual and common law duties to MiMedx. Following their terminations, the Company filed suit against the employees for these breaches, and the employees in turn filed suit against the Company alleging that the Company engaged in certain fraudulent business practices, including practices that allegedly would affect the Company’s revenue recognition policy. As the Company has previously stated publicly, management believes the claims made in the lawsuit brought by these former employees, including claims made about the Company’s sales practices, are without merit, and the Company does not anticipate any material effect on the Company’s financial statements resulting from these allegations.

The Audit Committee is working closely with independent counsel and its external auditors to conduct an extensive internal investigation into the claims alleged in the lawsuit. The Audit Committee has provided preliminary findings to the Board of Directors and Company management, but the investigation into the claims is ongoing. The Audit Committee has advised the Company’s management and the Board of Directors that it has found no credible evidence to indicate that any changes to previously issued financial statements are necessary in light of these allegations.

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement

SOURCE MiMedx Group, Inc.

Titan Spine’s new medical devices could set it apart

Posted On December 28, 2016 By OrthoSpineNews In Spine /

Guy Boulton , Milwaukee Journal Sentinel – December 25, 2016

The day after his first call to Barbara Boyan, Kevin Gemas was on a plane to meet her in Atlanta.

Gemas’ company, Mequon-based Titan Spine, was selling titanium medical devices used in back surgery to shore up injured or deteriorating vertebrae.

The devices seemed to work better than the plastic materials that were commonly used for spinal fusions at the time, but Gemas and his Titan Spine co-founder, Neenah spine surgeon Peter Ullrich Jr., didn’t know why.

Boyan did. A cell biologist at Emory University, she had spent decades studying how bones heal.

“There is more here than meets the eye, and more than you guys probably realize,” she said at the time, according to Gemas.

The result of that 2009 meeting was the development of a second generation of devices with a more precisely roughened surface that resembles that of bone and that theoretically triggers the cellular reaction needed to encourage beneficial bone growth.

For people with debilitating back pain, this may lead to reduced inflammation, quicker healing and better outcomes.

Following Gemas’ meeting with Boyan, Titan Spine developed a manufacturing process that creates pits in its devices on a scale of one to three micrometers. By comparison, a cell is 10 micrometers.

The approach is “biomimetic,” or designed to mimic nature, said William Murphy, a professor of biomedical engineering and orthopedics at the University of Wisconsin-Madison.

“There’s a lot of potential in that strategy,” said Murphy, who is co-director of the university’s Stem Cell and Regenerative Medicine Center.

Titan Spine’s first generation of devices gave the company a solid foundation. The company — which employs some 84 people and has a manufacturing and inspection plant in Brown Deer — is on track for revenue of $43 million this year.

The new devices have the potential of setting it apart in a large and lucrative market. About 650,000 to 675,000 spinal fusions are done a year, said Charles Whelan, a senior analyst who follows the medical-device industry for Frost & Sullivan, a research and consulting company.

The market for metal and plastic medical devices for spine surgery is estimated at $1.6 billion a year. And despite criticisms that spinal fusions are done too often, the market continues to grow at 4% to 5% a year.

Titan Spine is the only company with clearance from the Food and Drug Administration for medical devices with a nano-textured surface — distinguishing them from devices made of plastic or bone from cadavers as well as other devices made of titanium.

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FUSE MEDICAL, INC. Announces $720,000 Capital Investment and New Leadership

Posted On December 28, 2016 By OrthoSpineNews In Financial /

FORT WORTH, Texas, Dec. 22, 2016 /PRNewswire/ — Fuse Medical, Inc. (OTC: FZMD) (“Fuse” or the “Company”) announced today that it closed on a capital investment from local healthcare executives Mark W. Brooks and Christopher C. Reeg. Messrs. Brooks and Reeg bring over 50 years of combined experience in the ancillary healthcare market and have partnered in the formation and operation of multiple high-growth healthcare ventures. Mr. Reeg currently serves as the President and Founder of Maxim Surgical, a manufacturer and distributor of spinal and orthopedic implants. Mr. Brooks currently serves as Chief Executive Officer of CPM Medical Consultants, LLC, a privately-owned national distributor of medical devices and regenerative tissue.

Mr. Brooks acquired 5,000,000 shares of the Company’s common stock for a purchase price of $400,000, and Mr. Reeg acquired 4,000,000 shares of the Company’s common stock for a purchase price of $320,000. The 9,000,000 shares acquired by Messrs. Brooks and Reeg represent in the aggregate approximately 57% of the Company’s outstanding common stock after the closing.

In connection with the closing of the investment, effective December 19, 2016, the Company’s Board of Directors has appointed Mr. Brooks as Chairman of the Board and Mr. Reeg as Chief Executive Officer of the Company. Christopher C. Pratt, D.O. resigned from his position as Chief Executive Officer, and Robert H. Donehew resigned from his positions as Chairman of the Board and Chief Operating Officer.

Also in connection with the closing, Mr. Brooks, Mr. Reeg, Dr. Pratt and Mr. Donehew entered into a Voting Agreement with the Company pursuant which they have agreed to cause the size of the Company’s Board of Directors to be increased to five members and, for a period of six months, to cause three persons designated by Mr. Brooks and Mr. Reeg and two persons designated by Dr. Pratt and Mr. Donehew to be elected as directors of the Company. Mr. Brooks and Mr. Reeg have designated themselves and William E. McLaughlin, III for election, and each of them has been elected as a director effective December 19, 2016, and Dr. Pratt and Mr. Donehew will continue to serve as directors. Rusty Shelton and Randall Dei have resigned from the Company’s Board of Directors.

Mr. McLaughlin is a Certified Public Accountant licensed in the State of Texas and has over 25 years of experience in accounting and financial reporting positions for private and large public companies traded on the NYSE and NASDAQ, in addition to “Big-Four” public accounting. Mr. McLaughlin currently serves as Chief Financial Officer of CPM Medical Consultants, LLC. Mr. McLaughlin will not be employed by the Company and satisfies the requirements for independent directors and audit committee financial experts, and he will lead the Company’s efforts to establish an Audit Committee.

Dr. Pratt commented, “We are thrilled Mark and Chris have selected Fuse as their long-term strategic platform. They bring added healthcare and financial expertise to our Board of Directors and management team. This is a relationship that will drive success and longevity for Fuse. The Company’s Board of Directors view their significant investment in Fuse as a vote of confidence in our business and our long-term growth prospects, and we look forward to working together to grow and shape our product distribution portfolio.”

“Although the Fuse Board will miss Rusty Shelton and Randall Dei, they have been an instrumental part of developing the Fuse story and we are grateful for their fine contributions,” Mr. Donehew added.

About Fuse Medical, Inc.
Fuse is a national distributor and provider of surgical implants and regenerative tissue for the orthopedic and spine markets and offers a full-line product portfolio. The Company is committed to delivering the highest quality and most cost efficient products to hospitals, surgical centers, physicians and other medical providers across a broad continuum of care. For more information about Fuse, please visit: www.fusemedical.com.

Forward Looking Statements
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. Forward-looking statements are based on current beliefs and expectations and involve certain assumptions or estimates that involve various risks and uncertainties, such as financial market conditions and the other risks discussed in detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 and other subsequent filings with the Securities and Exchange Commission. Readers should not place undue reliance on any such forward-looking statements, which are made only as of the date hereof. Fuse has no duty, and assumes no obligation, to update forward-looking statements as a result of new information, future events or changes in the Company’s expectations.

Contact:
Fuse Medical, Inc.
1300 Summit Avenue, Suite 670
Fort Worth, Texas 76102
(817) 439-7025 Office

SOURCE Fuse Medical, Inc.

Latest Hospital Injury Penalties Include Crackdown On Antibiotic Resistant Germs

Posted On December 28, 2016 By OrthoSpineNews In Financial, Regulatory /

By Jordan Rau – December 21, 2016

The federal government has cut payments to 769 hospitals with high rates of patient injuries, for the first time counting the spread of antibiotic-resistant germs in assessing penalties.

The punishments come in the third year of Medicare penalties for hospitals with patients most frequently suffering from potentially avoidable complications, including various types of infections, blood clots, bed sores and falls. This year the government also examined the prevalence of two types of bacteria resistant to drugs.

Based on rates of all these complications, the hospitals identified by federal officials this week will lose 1 percent of all Medicare payments for a year — with that time frame beginning this past October. While the government did not release the dollar amount of the penalties, they will exceed a million dollars for many larger hospitals. In total, hospitals will lose about $430 million, 18 percent more than they lost last year, according to an estimate from the Association of American Medical Colleges.

The reductions apply not only to patient stays but also will reduce the amount of money hospitals get to teach medical residents and care for low-income people.

Forty percent of the hospitals penalized this year escaped punishment in the first two years of the program, a Kaiser Health News analysis shows. Those 306 hospitals include the University of Miami Hospital in Florida, Cambridge Health Alliance in Massachusetts, the University of Michigan Health System in Ann Arbor and Mount Sinai Hospital in New York City.

Nationally, hospital-acquired conditions declined by 21 percent between 2010 and 2015, according to the federal Agency for Healthcare Research and Quality, or AHRQ. The biggest reductions were for bad reactions to medicines, catheter infections and post-surgical blood clots.

Still, hospital harm remains a threat. AHRQ estimates there were 3.8 million hospital injuries last year, which translates to 115 injuries during every 1,000 patient hospital stays during that period.

Each year, at least 2 million people become infected with bacteria that are resistant to antibiotics, including nearly a quarter million cases in hospitals. The Centers for Disease Control and Prevention estimates 23,000 people die from them.

Infection experts fear that soon patients may face new strains of germs that are resistant to all existing antibiotics. Between 20 and 50 percent of all antibiotics prescribed in hospitals are either not needed or inappropriate, studies have found. Their proliferation — inside the hospital, in doctor’s prescriptions and in farm animals sold for food — have hastened new strains of bacteria that are resistant to many drugs.

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MiMedx EpiFix Receives Coverage From Aetna

Posted On December 27, 2016 By OrthoSpineNews In Biologics /

MARIETTA, Ga., Dec. 27, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, today announced that the Company’s EpiFix^® product has received coverage from insurer Aetna Inc. effective December 23, 2016.

With this coverage decision, the approximately 17.5 million Aetna commercial members now have coverage for EpiFix. Aetna considers EpiFix medically necessary for treatment of partial and full-thickness neuropathic diabetic foot ulcers (DFUs) that are greater than six weeks in duration with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.

Parker H. “Pete” Petit, Chairman and CEO said, “We are very pleased to have received coverage from Aetna and with the significant progress we have made in gaining coverage for our allografts from both the commercial, as well as the federal and state payers. We believe we have substantial opportunities ahead as we continue to grow our advanced wound care products and broaden the other therapies and market sectors we serve with our allografts. Gaining coverage from all commercial payers has been a critical strategy for MiMedx. From our viewpoint, attainment of EpiFix coverage for the vast majority of the commercial covered lives has been a significant contributor to the success we have experienced in achieving and exceeding our growth projections.”

Bill Taylor, President and COO, stated, “The clinical efficacy and cost effectiveness of tissues and products are heavily scrutinized by the commercial health plans. It is clear to us that the evidence demonstrating that our allografts benefit their members clinically, as well as provide more cost effective care, has been a significant factor in our success in attaining coverage awards from insurers. We know the positive clinical and economic impact our allografts have on their covered populations, and we are always pleased when health plans come to this same conclusion.”

“Including Aetna, we now have over 200 commercial health plans representing more than 198 million covered lives providing insurance coverage. Within the more than 200 commercial health plans, Blue Cross/Blue Shield plans encompassing 47 states plus the District of Columbia also provide insurance coverage for their members. In addition to the commercial health plans, 40.3 million Medicare and 55.4 million Medicaid beneficiaries have insurance coverage for our allografts,” concluded Petit.

About MiMedx

MiMedx^® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human amniotic membrane utilizing our proprietary PURION^® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the belief that there are substantial opportunities ahead for the Company, attainment of EpiFix coverage for the vast majority of commercial covered lives has been a significant contributor to the Company’s success in achieving and exceeding growth projections, and the Company’s belief that a significant factor in its success with attaining coverage awards from insurers is that its allografts benefit members of health plans clinically as well as provide more cost effective care. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include opportunities for growth may not materialize as expected, provider usage may change due to multiple factors, insurance coverage for EpiFix may not be a significant contributor to the Company’s success in achieving and exceeding growth projections or may have no impact at all, reimbursement is always subject to change and may therefore impact cost effectiveness of care, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015, and its most recent Form 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Precision Spine® Announces 510(k) Clearance of the AccuFit® Lateral Plating System

Posted On December 27, 2016 By OrthoSpineNews In Regulatory, Spine /

December 27, 2016

PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announced today that it recently received 510(k) clearance of its AccuFit^®Lateral Plating System.

The AccuFit Plate represents a significant addition to the Precision Spine lateral product portfolio and joins the recently introduced MD Vue™ Lateral Access Retractor. The AccuFit Plate is designed to provide optimal stabilization with a low profile, titanium plating system that features four points of fixation for enhanced biomechanical rigidity and load sharing. AccuFit features five sizes that are matched to the heights of Precision’s ShurFit^® LLIF Interbody cages. The system also includes insertion instrumentation to ensure proper anatomical plate alignment with minimal retraction.

“As a system that utilizes a lateral approach, AccuFit helps bring about a full range of operative and postoperative benefits designed to optimize patient outcomes,” said Andrew Cappuccino, MD, who worked closely with Precision Spine design engineers in the development of the system.

“The AccuFit Lateral Plate System is an important addition to our growing portfolio of devices for use in the lateral approach to spine surgery and is designed to be used in conjunction with our MD-Vue Lateral Access System,” said Chris DeNicola, Chief Operating Officer of Precision Spine. “The MD-Vue System is the only lateral retractor that offers a unique and patented nested 3-blade design, which prevents blade creep during insertion. Together, these lateral devices provide surgeons with a safe, reproducible approach designed to decrease OR time, shorten costly hospital stays and achieve efficient, positive patient outcomes.”

The AccuFit Lateral Plate System consists of non-sterile, single use rigid plates that attach to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5) by means of bone screws of varying sizes and lengths. The system is indicated for use via a lateral or anterolateral surgical approach, above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbarsacral (L1-S1) spine instability. The system is intended as a temporary fixation device until fusion is achieved.

About Precision Spine

Precision Spine, Inc. is a privately held company headquartered in Parsippany, NJ with manufacturing facilities in Pearl, MS. Precision Spine is dedicated to providing innovative, quality spine products that are made in the USA and designed to help treat serious orthopedic medical conditions in a cost effective manner. For more information, visit www.precisionspineinc.com.

Contacts

Precision Spine, Inc.
Chris DeNicola
Chief Operating Officer
chris.denicola@precisionspineinc.com

RUNNING LOWERS INFLAMMATION IN KNEE JOINTS!

Posted On December 27, 2016 By OrthoSpineNews In Extremities /

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, December 16th, 2016

Lace up! New research from Brigham Young University (BYU) has found that running can protect knees. Matt Seeley, Ph.D., A.T.C., is associate professor of exercise science at BYU. He and BYU colleagues Sarah Ridge, Ph.D., and Ty Hopkins, Ph.D., have found that running reduces inflammation in the joint.

“It flies in the face of intuition,” said Dr. Seeley, associate professor of exercise science at BYU, in the December 8, 2016 news release. “This idea that long-distance running is bad for your knees might be a myth.”

Their study, published in the December 2016 edition of European Journal of Applied Physiology, also involved Dr. Eric Robinson from Intermountain Healthcare. The scientists measured inflammation markers in the knee joint fluid of several healthy men and women aged 18-35, both before and after running.

“The researchers found that the specific markers they were looking for in the extracted synovial fluid—two cytokines named GM-CSF and IL-15—decreased in concentration in the subjects after 30 minutes of running. When the same fluids were extracted before and after a non-running condition, the inflammation markers stayed at similar levels.”

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Surgical Navigation Systems in the US Driven by the Increasing Adoption of Ambulatory Surgical Centers: Technavio

Posted On December 27, 2016 By OrthoSpineNews In Financial /

December 23, 2016

LONDON–(BUSINESS WIRE)–According to the latest market study released by Technavio, the surgical navigation systems market in the US is expected to grow at a CAGR of almost 6% during the forecast period.

This research report titled ‘Surgical Navigation Systems Market in the US 2016-2020’ provides an in-depth analysis of the market in terms of revenue and emerging market trends. This market research report also includes up to date analysis and forecasts for various market segments and all geographical regions.

One of the most important factors driving this market is the expansion of outpatient settings. Studies have proved computer-assisted surgeries to be more precise and less risky, resulting in improved quality of life for the patient. The procedures are pre-programmed into a surgical navigation system, and can be carried out in outpatient settings with the assistance of an experienced surgeon. This has resulted in an increased number of ambulatory surgical centers (ASCs) where even the most complex spinal surgeries can be performed in a safe and sterilized setting.

Other key drivers for this market are the growing popularity of minimally invasive surgeries, ever broadening applications of surgical navigation systems, and innovative marketing strategies used by vendors. Due to the increasing demand for surgical navigation systems, manufacturers are focusing on developing portable and lightweight systems equipped with the latest, cutting-edge software capabilities.

Request a sample report: http://www.technavio.com/request-a-sample?report=55087

Technavio’s sample reports are free of charge and contain multiple sections of the report including the market size and forecast, drivers, challenges, trends, and more.

Based on application, the report categorizes the surgical navigation systems market in the US into the following segments:

Neurosurgical navigation systems
Orthopedic surgical navigation systems
ENT surgical navigation systems
Spine surgical navigation systems

Neurosurgical navigation systems

“The neurosurgical navigation systems market represents the largest segment of the surgical navigation systems market in the US. This system is ideal for surgeries related to cranial tumors and neurological disorders. There has been an increase in the use of frameless stereotaxy and MRI image-guided navigation for obtaining brain biopsies and in tumor resurrection procedures. This has clearly demonstrated improved surgical outcomes for complex spinal surgeries,” says Barath Palada, one of the lead analysts at Technavio for medical devices research.

With the increase in the volume of neurosurgical procedures across the US and high adoption of minimally invasive surgeries, the demand for neurosurgical navigation systems is on the rise. These systems have also shown to lessen the extent of neurological functioning when compared to traditional surgeries. This is mainly due to the availability exact mapping for a variety of cortical functions like sensory, motoric, speech, and language functions, and for visualizing subcortical pathways for both benign and malignant brain tumors.

Orthopedic surgical navigation systems

The orthopedic surgical navigation market represents the second largest surgical navigation systems in the US. Statistics show that the number of people suffering from musculoskeletal diseases is growing. The American Academy of Orthopedic Surgeons (AAOS), hospital discharge data has shown that an increasing number of patients are undergoing knee replacements and this rate has jumped up by 120% over a 10-year period, and overall hip replacement cases have also doubled in the past decade.

In this scenario, with a growing number of orthopedic surgeries, the surgical navigation system will be ideal for several procedures including joint arthroplasties, total hip arthroplasty, total shoulder arthroplasty, limb-salvage techniques and fracture surgeries. Computer-assisted orthopedic surgery (CAOS) system comprises of 3D image-guided and non-image based navigation systems, intraoperative fluoroscopic navigation, robotic-assistance tools, and intraoperative visualization devices.

ENT surgical navigation systems

“The ENT surgical navigation market represents the newest and fastest growing segment in the surgical navigation systems market in the US. With the rising number of ASCs, the outpatient setting of the surgical navigation system is establishing itself as a popular option for most patients opting for ENT. In 2015, 92% of the ear and 87% of the nasal surgeries were performed in ASCs in an outpatient setting,” says Barath.

ENT navigation systems are especially beneficial as these surgeries include working with delicate anatomies, such as optic nerves, blood vessels, eyes, and the nasal region, which are beyond the view of the endoscope. These systems help in precise navigation of surgical instruments through complex sinus passages without causing any damage to the surrounding anatomy.

Spine surgical navigation systems

Spinal fusion surgeries are performed to relieve pain arising due to injury, degenerative disc disease, spinal curvatures or arthritis. This surgery is most commonly carried out through surgical navigation systems in the US. Additionally, extremely precise placement of implants like pedicle screws is assured by computer assisted navigation when compared to other conventional surgeries. This is especially true during treatment of spinal instability caused by degenerative disc disease, spinal stenosis, spondylolisthesis, deformity, fractures, tumors, and infection. Usage of CT-guided or 3D fluoroscopy-based navigation systems has clearly demonstrated an increase in the accuracy up to 98% and lessen the need for re-operating.

The top vendors highlighted by Technavio’s research analysts in this report are:

B. Braun Melsungen
Brainlab
GE Healthcare
Medtronic
Stryker

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About Technavio

Technavio is a leading global technology research and advisory company. The company develops over 2000 pieces of research every year, covering more than 500 technologies across 80 countries. Technavio has about 300 analysts globally who specialize in customized consulting and business research assignments across the latest leading edge technologies.

Technavio analysts employ primary as well as secondary research techniques to ascertain the size and vendor landscape in a range of markets. Analysts obtain information using a combination of bottom-up and top-down approaches, besides using in-house market modeling tools and proprietary databases. They corroborate this data with the data obtained from various market participants and stakeholders across the value chain, including vendors, service providers, distributors, re-sellers, and end-users.

If you are interested in more information, please contact our media team at media@technavio.com.

Contacts

Technavio Research
Jesse Maida
Media & Marketing Executive
US: +1 630 333 9501
UK: +44 208 123 1770
www.technavio.com

Vivex Biomedical, Inc. Receives Level II HCPCS Q-Code for Cygnus™, a Human Amniotic Tissue Allograft

Posted On December 27, 2016 By OrthoSpineNews In Regulatory /

ATLANTA Dec. 20, 2016 /PRNewswire

Vivex Biomedical, Inc. (Vivex) is a biomaterials developer focused on creating treatment options and creative solutions to advance clinical, surgical and therapeutic patient care. It has made significant progress in a short time, bringing together the brightest minds in the scientific community and from the orthopaedic and material science industries. With its focus on continued innovation in next-generation biomaterials, Vivex is creating a new standard in patient care and delivering groundbreaking health products to meet the needs of a diverse, rapidly expanding market.

“Vivex is very excited to receive this unique Level II HCPCS Q-Code for Cygnus, one of our premiere amniotic tissue allografts,” commented Michele Pablos, Vice President of Sales and Marketing. “Our goal is to make our products more affordable based on the operating needs of all payers, and this is a huge step in making that goal a reality.”

“Cygnus, an amniotic tissue matrix with innate regenerative capability to support healing, is a product that is available in multiple sizes for multiple uses. Cygnus’ amnion patch is an immune-privileged tissue with proven clinical success in regenerative healing, and we look forward to providing more payers with the opportunity to use it.”

This Q-code set is available for use by an array of payers, and is maintained by the Centers for Medicare and Medicaid Services (CMS).

About Vivex Biomedical, Inc., Powered by UMTB:

Vivex Biomedical, Inc. is a regenerative biologics company, dedicated to creating new standards in patient care. Since 2014, Vivex and UMTB (founded 1970) have strived for methods to translate creative collaborations into treatments for real problems.

In collaboration with multiple partners, Vivex is on the cutting edge of scientific development. Translating innovation into treatments for real problems further expands surgical options. All research and development is focused on making strides in the field of musculoskeletal regenerative medicine, with major areas of investigation including: cartilage, bone, and skin. Innovative vision provides a platform that assists in the regeneration of all these tissue types in a personalized but scalable transplantation model.

Vivex is constantly working closely with services that support the advancement of allograft transplantation, specifically services that are committed to providing care and compassion to donor families while inspiring communities to share life by donating. Partnering with others ensures that families are offered the appropriate options and support for donation, including Life Alliance, the Lions Eye Bank, Brain Bank, and Medical Examiners.

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Contacts

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, December 16th, 2016

Contacts