Thursday, March 31, 2016

News: USMD Hospital at Arlington is First Hospital in the World to Utilize Arena-C® HA Enhanced Cervical Intervertebral Body Fusion Device in a Patient

Jacob Rosenstein, M.D., Performed Surgery on March 11, 2015

IRVING, Texas--()--USMD Holdings, Inc. (NASDAQ: USMD), a physician-led integrated healthcare system, announced today that Jacob Rosenstein, M.D., an active staff member of USMD Hospital at Arlington, became the first surgeon in the world to implant an Arena-C® HA with PEEK-OPTIMA® HA Enhanced. This cervical spinal implant is designed to provide mechanical stability and quicker healing for patients who need spine surgery. Dr. Rosenstein completed the surgery on March 11, 2015, at USMD Hospital at Arlington.
“This is just one more example of the excellence of the physicians and staff working at USMD Hospital at Arlington.”
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The Arena-C HA with PEEK-OPTIMA HA Enhanced, which is manufactured by SpineFrontier®, is a spinal implant device that is produced with a revolutionary new biomaterial to enhance spinal fusion technology. Dr. Rosenstein utilized the implant in an anterior cervical discectomy and fusion procedure to treat a patient who was suffering from spinal cord compression and myelopathy as a result of degenerative disc disease that was producing severe cervical stenosis.
I'm incredibly proud that SpineFrontier and our surgeons are leading the way in this PEEK Optima HA Enhanced technology and scholarship.PEEK-OPTIMA HA Enhanced shares all of the properties of PEEK-OPTIMA Natural, which aids in stabilizing the cervical spine, but it has been compounded with hydroxyapatite (HA), a naturally occurring compound in bony structures. HA promotes the formation of a direct interface between the implant and bone, without intervening soft tissue. This is the first implant to be made with HA, and was approved for use by the FDA in October 2014.
“The Arena-C HA with PEEK-OPTIMA is a potential game changer for spinal fusion procedures,” said Jacob Rosenstein, M.D. “By incorporating HA, a naturally occurring compound in bony structures, into the PEEK Cage, fusion rate will improve, as HA promotes direct attachment of the implant to the bone, thus providing added stability and quicker healing. The device also has a tapered design for easier insertion, a large bone graft pocket to promote bone fusion and aggressive teeth to prevent expulsion. This is a great benefit to patients, who will heal faster and more predictably and return to normal activity sooner.”
“USMD is honored to be the first hospital in the world in which one of our staff physicians conducted a surgery that utilizes the new Arena-C HA spinal implant in a patient,” said John House, M.D., chairman of the board and chief executive officer of USMD Holdings. “This is just one more example of the excellence of the physicians and staff working at USMD Hospital at Arlington.”
Dr. Rosenstein is a board-certified neurosurgeon who specializes in treating disorders of the spine. He earned his B.A. in Human Biology from Johns Hopkins University. He completed his medical degree from the Johns Hopkins University School of Medicine and his residency in Neurological Surgery at U.T. Southwestern Medical Center and Parkland Hospital in Dallas, where he served as Chief Resident of Neurological Surgery. He completed his fellowship in Neurological Surgery at the Gough-Cooper Department of Neurology and Neurosurgery at the National Hospital for Nervous Diseases in London, England. He has more than 30 years of experience caring for patients. Dr. Rosenstein serves as a member of the USMD Hospital at Arlington Board of Directors and was one of the hospital’s founding physicians.
About USMD Holdings, Inc.
USMD is a publicly held (NASDAQ: USMD), physician-led, integrated health system committed to exemplary patient care. Headquartered in Irving, Texas, USMD serves the Dallas-Fort Worth metropolitan area with more than 250 physicians and associate practitioners, and provides healthcare services to patients in just under 20 different specialties at its two hospitals, six cancer treatment centers and nearly 70 physician clinics, many of which are multi-specialty. All 29 of USMD’s primary care clinics have been accredited by the Patient-Centered Medical Home Program, a recognition program that is part of the National Committee for Quality Assurance. This recognition means that USMD’s primary care clinics successfully display and utilize evidence-based, patient-centered processes that focus on highly coordinated patient care and long-term patient relationships. For more information about USMD, visit www.usmd.com.
About USMD Hospital at Arlington
USMD Hospital at Arlington is a physician-owned hospital where clinical and surgical excellence are the everyday standards. With nine oversized state-of-the-art operating rooms and two procedural rooms, USMD Hospital at Arlington is equipped for a wide variety of cases. The extensive surgical experience and expertise with three da Vinci Systems has made USMD Hospital at Arlington a leader in the DFW Metroplex, and one of the top ten robotic surgery programs in the world. If an overnight stay is required, the hospital offers 34 private inpatient suites complete with WiFi, a small refrigerator, TV and an additional bed for an attending family visitor. What further differentiates this hospital from its competitors is its 1:5 nurse to patient ratio versus the national average of 1:8.
About SpineFrontier
Image result for spinefrontierSpineFrontier Inc. is a growing medical device company that designs, develops and markets implants and instruments used in spine surgery. The SpineFrontier team focuses on developing innovative and disruptive technologies and techniques for spinal surgery based on the Less Exposure Surgery (LES) philosophy. These technologies allow for same day outpatient surgery with minimal disruption of the tissues. The company was founded in 2006, released its first products in 2008, and is headquartered in Malden, MA.

Contacts

USMD Holdings, Inc.

Megan Vincent, 214-493-4024

Published at BusinessWire

Wednesday, March 30, 2016

News: Dr. F. Paul DeGenova Successfully Performs Procedure Using SpineFrontier’s Less Exposure Surgery Technology: Inspan Spinous Process Plate System

Dr. DeGenova performs successful procedure using SpineFrontier's LES Technology: Inspan.

SportsMedicine Grant & Orthopaedic Associates announced today that Dr. DeGenova performed a Less Exposure Surgery technique using Inspan, SpineFrontier’s spinous process plate system. Inspan is the next generation design in interspinous fixation systems.
The operation took place on January 3, 2013 at Fairfield Medical Center in Lancaster, OH. The surgery was a decompression L2-3 on a female patient with severe stenosis.
The Inspan Spinous Process Plate System is a posterior, non-pedicle, supplemental fixation system intended for use in the non-cervical spine and for plate fixation or attachment to the spinous process. Its low profile design minimizes the footprint of the implant within the patient. Made of titanium, the Inspan implant provides superior strength and fixation while its dual interlocking hub with dual set screws provides an exceptionally rigid design.

Dr. DeGenova describes Inspan’s surgical advantages, “Inspan’s dual locks make it a very secure and stable device to use. Its spike design also enhances fixation.” Dr. DeGenova also uses other SpineFrontier medical technology, including the Invue Inset, DBM Pure Micro, Dorado T-LIFT and PedFuse REset for lumbar fusion.
Dr. DeGenova is a board-certified orthopaedic surgeon who specializes in reconstructive spine surgery at the SportsMedicine Grant & Orthopaedic Associates in Columbus, OH. He has been practicing medicine for over 25 years. Dr. DeGenova received his doctor of osteopathy degree from Ohio University College of Osteopathic Medicine. He completed an orthopaedic residency at Dallas/Fort Worth Medical Center and a foot and ankle fellowship at the University of Texas Southwestern Medical Center at Dallas Parkland Medical Center. He also completed a spine surgery fellowship at Spine Surgery in Louisville, Kentucky. Among other honors, Dr. DeGenova has been awarded the “Excellence in Orthopedics” Harold E. Clyborne Award. Dr. DeGenova is a registered member of the Less Exposure Surgery Society (http://www.les-society.org).
Dr. DeGenova describes his philosophy of surgery, “First and foremost is patient care. I treat my patients as individuals, and for all of them, I want to decrease blood loss, recovery time, and incision scar.” As part of his commitment to excellent care, Dr. DeGenova prioritizes individual needs when choosing medical devices for his patients’ procedures.
About SpineFrontier
SpineFrontier Inc. (http://www.spinefrontier.com) is a growing medical device company that designs, develops and markets implants and instruments used in spine surgery. The SpineFrontier team focuses on developing innovative and disruptive technologies and techniques for spinal surgery based on the Less Exposure Surgery (LES) philosophy. These technologies allow for same day outpatient surgery with minimal disruption of the tissues. The company was founded in 2006, released its first products in 2008, and is headquartered in Beverly, MA.
Published at PRWeb

News: Amedica First to 3D Print Silicon Nitride for Medical Applications

Company Plans to Use 3D Printing Technology for Its Proprietary Silicon Nitride Devices


SALT LAKE CITY, UT -- (Marketwired) -- 03/23/16 -- Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce its first fabrication of complex, three-dimensional structures by a 3D printing process called robotic deposition, or robocasting. The final products have been examined under scanning electron microscopy to confirm the integrity and validity of the 3D printing method, and have been shown to achieve similar theoretical density and microstructure attributes to the traditionally manufactured silicon nitride fusion devices currently in use.

AMEDICA"This innovation speaks to the unique art and science related to our manufacturing strength," said Dr. Sonny Bal, Chairman and Chief Executive Officer. "3D printing of a complex ceramic material opens future doors, especially in terms of cost advantages, and addressing a variety of OEM partner needs. Custom additive manufacturing is a modern advancement, and we are proud to lead the way in 3D printing of our silicon nitride formulation, with its advantages in bone fusion, antibacterial behavior, and superior strength."

Robocasting is a freeform fabrication technique for dense ceramics and composites that is based on layered deposition of highly colloidal slurries. The process is essentially binder-less and a device can be completely sintered in less than 24 hours. With this advancement, Amedica can now progress toward commercializing 3D printed silicon nitride implants, with controllable porosity levels to address specific clinical needs. This unique manufacturing method is promising for the production of anatomically relevant shaped silicon nitride implants, while also allowing custom fabrication of bone scaffolds suited for cellular differentiation and neovascularization.


About Amedica Corporation
Amedica is focused on the development and application of interbody implants manufactured with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty as well as dental applications. The Company's products are manufactured in its ISO 13485 certified manufacturing facility and through its partnership with Kyocera, one of the world's largest ceramic manufacturers. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM and private label partnerships.


For more information on Amedica or its silicon nitride material platform, please visit  www.amedica.com.


Forward-Looking Statements 
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, the intent, belief or current expectations of Amedica and members of its management team with respect to Amedica's future performance, business operations and acceptance of its technology platform. Statements relating to Amedica's expectation that scientific results may result in innovative solutions, increased market opportunities, growth, future products, market acceptance of its products, sales and financial results and similar statements are subject to risks and uncertainties such as the timing and success of new product introductions, physician acceptance, endorsement, and use of Amedica's products, regulatory matters, competitor activities, changes in and adoption of reimbursement rates, potential product recalls, effects of global economic conditions and changes in foreign currency exchange rates. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2015, and in Amedica's other filings with theSECAmedica disclaims any obligation to update any forward-looking statements.



Contacts:
Mike Houston
VP, Commercialization 
801-839-3534

Robert Haag
Managing Director
IRTH Communications
866-976-4784



News Provided by Acquire Media

News: OrthoPediatrics Announces Partnership with SpineGuard for PediGuard Spine Probes

OrthoPediatrics is pleased to announce an exclusive partnership with SpineGuard, an innovative company that designs, develops and markets disposable medical devices intended to make spine surgery safer.

OrthoPediatrics is pleased to announce an exclusive partnership with SpineGuard, an innovative company that designs, develops and markets disposable medical devices intended to make spine surgery safer. OrthoPediatrics will serve as a stocking distributor for the commercialization of the SpineGuard’s PediGuard probes to pediatric institutions in the US. Specifically, PediGuard will complement OrthoPediatrics’ RESPONSE™ Spine System, which was designed with Pediatric Orthopedic Surgeons for pediatric spinal deformity patients. The system boasts low profile screws, simple rod reduction and de-rotation instrumentation and helps with OR efficiency.
Mark Throdahl, President and CEO of OrthoPediatrics, said, “OrthoPediatrics’ goal is to advance the field of pediatric orthopedics with the broadest and most innovative product line in our industry. PediGuard probes are a valuable addition to our complex spine offering, addressing the safety needs of both patients and surgeons. We are pleased to partner with SpineGuard on the application of this innovative technology to pediatric orthopedic surgery.”
Pierre Jérôme, CEO and Co-founder of SpineGuard, shared his thoughts on the partnership, saying “We are delighted to partner with OrthoPediatrics for the distribution of our smart drilling devices. I have been very impressed with the quality of their management team and their commitment to the cause of improving the lives of children with orthopedic conditions. This partnership will enhance our exposure into US pediatric institutions where we believe our Dynamic Surgical Guidance technology can bring great clinical value.”
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About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market in order to improve the lives of children with orthopedic conditions. OP currently markets 17 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine, and ACL reconstruction procedures. OP also has the only global sales organization focused exclusively on pediatric orthopedics and distributes its products to 29 countries outside the USA. For more information, contact Mallory Trusty at 574-267-0825.

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About SpineGuard® 
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, initially for safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 40,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris and is listed on Alternext Euronext in Paris. For further information, visithttp://www.spineguard.com

Published at PRWeb