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ORHub, Inc. Welcomes Internationally Recognized Spine Surgeon to its Advisory Board

Posted On October 11, 2017 By OrthoSpineNews In Spine, Top Stories /  

NEWPORT BEACH, CA–(Marketwired – Oct 6, 2017) – ORHub, Inc. (OTC: ORHB), an advanced medical software provider focused on real-time digital delivery of case-based data analytics, today announces the appointment of Dr. Choll Kim, an industry-leading physician and instructor in the technological automation of surgical procedures, to its advisory board.

As an internationally renowned expert in the field of computer-assisted, minimally invasive spine surgery, Dr. Kim has considerable insight into the intricate evolution of technology in the surgical sector, an invaluable resource that will strengthen ORHub’s grasp in the marketplace.

“In today’s health care environment, excellent clinical care must be delivered in a cost-effective manner. ORHub recognizes this industry demand, and provides a much-needed point-of-service system that allows both surgeons and hospitals to monitor the time and cost of the entire episode of surgical care. By providing reliable data in a manner that is useful to both surgeons and hospitals, a real collaborative effort can be pursued to optimize patient care. I am excited to be part of ORHub and the important efforts that will arise from improved information gathering and analysis. With this advisory role, I finally feel like I can be a meaningful participant in the ongoing effort to optimize health care efficiency while providing the highest level of care to my patients,” states Dr. Kim.

A leader in his field, Dr. Kim is the founder and past-president of the Society for Minimally Invasive Spine Surgery (SMISS), the founder of Minimally Invasive Spine Centers of Excellence (MIS-COE), the chair of the MIS Committee for the International Society for the Advancement of Spine Surgery (ISASS), the director of the Advanced Spine & Joint Institute at Alvarado Hospital, and an associate clinical professor at the University of California, San Diego.

He utilizes a broad range of minimally invasive treatments to effectively treat all aspects of complex spinal disorders, including herniated disks, spinal stenosis, adult scoliosis, spondylolisthesis, traumatic injuries, tumors, and infections throughout the entire spine — from the neck to the low back. Dr. Kim is one of only a handful of surgeons in the world to master laser endoscopic spine surgery (LESS), a state-of-the-art minimally invasive procedure that effectively treats herniated disks, radiculopathy and sciatica.

Dr. Kim graduated cum laude from Harvard Medical School and completed his fellowship training in complex spine surgery at the Mayo Clinic. He is double-board certified by the American Board of Orthopedic Surgeons and the American Board of Spine Surgery.

“Dr. Kim is a phenomenal addition to our team, as he has gained international recognition in his field, and has trained a new generation of surgeons and operating room personnel in technologically advanced operating systems. As a substantial contributor to the evolving industry, he has trained innumerable specialists throughout the country on the safe and effective application of state-of-the-art techniques using image guidance and navigation technologies. We believe that he will be an invaluable source of knowledge as we grow in the industry,” states ORHub CEO Colt Melby.

About ORHub, Inc.

ORHub is a medical software company focused on delivering case-based data analytics at the speed of surgery. The Company’s suite of products serves the needs of the health care industry, hospital, patient, government and the medical device vendor. ORHub provides a cloud-based software solution that captures information before, during and after surgery, filling a void in the current surgical information infrastructure and providing the first process to capture and measure the surgical process — evolving Big Data into Intelligent Digital Data.

ORHub’s software applications allow hospitals and medical device vendors to utilize any web-enabled device to create an anatomical graphic depiction of exactly what occurs during surgery. The application automatically translates the resulting schematic into an intelligent, electronic operative report that links every detail of surgery, including implant location, surgical techniques, product usage, and all clinical parameters to create a dynamically new source of comparative information.

As a result, hospitals and surgeons can make real-time, data driven decisions to improve business profitability and the quality of patient care. This innovative technology results in hospitals understanding costs and identifying areas of cost reductions, as well as results in increased accountability, automatic creation of comprehensive anatomic implant registries, real-time analytics, improved efficiencies, and compliance with existing government regulations. ORHub has offices in Phoenix, Arizona; Newport Beach, California; and Bellevue, Washington.

For more information, visit www.ORHub.com

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although the Company believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, it can give no assurances that its expectations will be attained. Such statements are inherently uncertain, and actual results and activities may differ materially from those estimated or projected. Certain factors that can affect the Company’s ability to achieve its anticipated results include, among others, uncertainties inherent in the development of a new software product business.

CONTACT INFORMATION

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DePuy Synthes Launches The First 3D Simulation Assisted Orthopaedic External Circular Fixation Device

Posted On October 11, 2017 By OrthoSpineNews In Extremities, Top Stories /  

WEST CHESTER, Pa., Oct. 11, 2017 /PRNewswire/ — DePuy Synthes* is launching the MAXFRAME™ Multi-Axial Correction System, an external circular fixation device used to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle. The MAXFRAME System’s unique 3D planning software helps improve accuracy of the deformity correction plan, which may reduce overall treatment time while potentially improving procedural efficiency and reducing costs. The device represents DePuy Synthes’ commitment to improving patient satisfaction, procedure efficiency and clinical outcomes in deformity correction.

Limb deformities can be congenital, developmental or acquired as the result of fracture, infection, arthritis or tumor. Left uncorrected, these deformities may lead to amputation and could have a potential cost burden of $500,000i per patient to the healthcare system. External circular fixation products currently on the market require precise X-rays and manual measurements by surgeons, and any inaccuracies can prolong treatment. Patients suffering from limb deformities may require an average of 37 outpatient visits over 12 months,ii iii and one in three patients will experience a residual deformity.iv

Unlike other computer-assisted external circular fixation systems, the MAXFRAME System’s 3D planning software creates accurate patient treatment plans using advanced algorithms, which eliminates the need for manual measurements and requires fewer inputs than any other system on the market. This can potentially lead to a reduction in the number of patient X-rays required, thus reducing procedural complexity, radiation exposure for both the patient and surgeon, and overall costs, while reducing treatment time for the patient.

Patients undergoing treatment with the MAXFRAME System are responsible for adjusting the struts on the device as per their custom treatment plan. These adjustments have been made easier with the system’s newly introduced ASSURE-STRUT™ Technology, wherein each time the patient adjusts the device, there is an audible click as the strut correctly locks into place.

“The MAXFRAME System incorporates three clinically important advantages that help provide great accuracy of correction for the patient and streamline the surgical phase of care,” said Dr. J. Spence Reid, MD, Professor and Chief of Trauma Division, Department of Orthopaedics and Rehabilitation. “The software eliminates significant sources of error inherent in earlier methods by removing the need to determine reference ring mounting parameters, as well as the requirement of ring orthogonality. The system also allows maximum flexibility in the location of strut attachment points on the ring which makes frame application easier, particularly in complex cases, and the ASSURE-STRUT™ Technology allows the patient to confidently make strut adjustments.”

MAXFRAME Patient Care Program
To support patients, DePuy Synthes has developed the MAXFRAME Patient Care Program, which includes a patient app featuring a character named “MAX,” and additional online content is available at www.maxframepatients.com. The program helps patients and their caregivers prepare for surgery, manage treatment and share their experiences through social media channels at the end of their treatment journey.

“There is a significant unmet need for treatment options that reduce both the burden to patients with limb deformities as well as surgical complexity,” said I.V. Hall, Worldwide Platform Leader, Trauma, CMF, Biomaterials and Veterinary Portfolios, DePuy Synthes. “With the launch of the MAXFRAME System, we are building on our long history of innovation, excellence in service and support for surgeons with unique 3D planning software and digital tools that help address these needs and enhance patient and surgeon satisfaction.”

Product Indications
The MAXFRAME System is indicated for the following treatments in adults and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed), pseudoarthrosis of long bones, limb lengthening (epiphyseal or metaphyseal distraction), joint arthrodesis, infected fractures or nonunions, correction of bony or soft tissue deformities, and correction of segmental defects.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies**, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com

i MacKenzie EJ, Jones AS, Bosse MJ, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. The Journal of bone and joint surgery. American volume. Aug 2007;89(8):1685-1692.
ii Lerner J, Holy CE, Menzie A. Cost of post-operative care after implantation of multiplanar stereotactic-assisted external fixation systems. Poster presented at: 21st Annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting, May 21-25, 2016; Washington, DC, USA.
iii Fenton P, Bose D. Patient-reported outcomes following treatment of tibial non-union with circular frames. Strat Traum Limb Recon. 2014;9(1):33-5.
iv Kucukkaya M, Karakoyun O, Armagan R, Kuzgun U. Calculating the mounting parameters for Taylor Spatial Frame correction using computed tomography. Journal of orthopaedic trauma. Jul 2011;25(7):449-452

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

DSUS/TRM/1017/1620

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

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French surgeons use robot & 3D printed model to fix 6-year-old’s spine in world-first surgery

Posted On October 11, 2017 By OrthoSpineNews In Spine, Top Stories /  

Oct 10, 2017 | By Tess

A team of surgeons from the Amiens-Picardie University Hospital in France has successfully performed a complex spinal surgery on a six-year-old boy with the help of a robot and a patient-specific 3D printed model. The procedure was the first of its kind.

 

 

The patient in question is a six-year-old boy who was suffering from a combination of severe progressive scoliosis and infantile spinal amyotrophy, a condition that causes weak muscles. The scoliosis had become so severe that the young boy could not even sit. Obviously, something had to be done.

The complex surgery, which took place on September 28, was the result of over a year of planning on the part of Dr. François Deroussen, a pediatric orthopedic surgeon; Professor Richard Gouron, head of the child surgery department at the hospital; and Dr. Michel Lefranc, a neurosurgeon.

To prepare for the operation, the doctors took a scan of the child to get a detailed visualization of the position and state of his spine. With the 3D scan, the doctors were able to take their planning one step further by 3D printing an accurate replica model of the patient’s spine.

 

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AlloSource President and CEO Thomas Cycyota Receives American Association of Tissue Banks Award

Posted On October 10, 2017 By OrthoSpineNews In Biologics, Top Stories /  

CENTENNIAL, Colo., Oct. 10, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced that its President and Chief Executive Officer, Thomas Cycyota, received the Jeanne C. Mowe Distinguished Service Award from the American Association of Tissue Banks (AATB).

The annual Jeanne C. Mowe Distinguished Service Award recognizes an individual who has made a significant contribution in tissue banking or transplantation, whether in research, education, or laboratory improvement, or who has served the Association or the field of tissue banking.

“I am humbled and honored to receive this award from the AATB. AlloSource’s success is possible because of our strong relationships with our donor community, as well as our dedicated, passionate employees,” said Cycyota. “Being involved in the tissue donation and transplantation community has been a sacred part of my life for the last 17 years. I am continually in awe and inspired by the possibilities tissue donors create for patients in need.”

Cycyota has served as the President and Chief Executive Officer of AlloSource since 2000, leading the organization in its ongoing dedication to honoring the gift of tissue donation. Under his leadership, the organization has grown into a leading provider of allografts for use in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care applications. AlloSource continues to identify new opportunities to create innovative products that advance patient healing.

The award was presented on October 4 at the AATB Annual Meeting held in Orlando, Florida.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact:
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org

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Globus Medical Announces First Spine Surgeries Using ExcelsiusGPS™

Posted On October 10, 2017 By OrthoSpineNews In Robotics, Spine, Top Stories /  

AUDUBON, Pa., Oct. 10, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the first spine surgeries using ExcelsiusGPS™, a revolutionary robotic guidance and navigation system. Surgeries using ExcelsiusGPS™ were performed last week at The Johns Hopkins Hospital in Baltimore, Maryland and St. Mark’s Hospital in Salt Lake City, Utah.  The surgical team at Johns Hopkins was led by neurosurgeons Dr. Nick Theodore and Dr. Ali Bydon, while orthopedic spine surgeon Dr. Kade Huntsman performed the surgeries at St. Marks.

“ExcelsiusGPS™ is the only robotic system that combines surgical navigation and robotic guidance for spinal surgery, which offers significant advantages to spine surgeons,” said Dr. Huntsman, “The system has been designed to take into account the typical surgical workflow to facilitate procedural efficiency.”

“ExcelsiusGPS™ is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation.  “We believe the ExcelsiusGPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”

ExcelsiusGPS™ supports minimally invasive and open screw placement procedures. It seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

Globus Medical expects its first revenues from the sale of ExcelsiusGPS™ systems to occur in the fourth quarter 2017, in alignment with current company guidance.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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Nuvasive Files Lawsuit Against Patrick S. Miles To Protect Corporate Assets And Stakeholders’ Interests

Posted On October 10, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

SAN DIEGO, Oct. 10, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has filed a lawsuit in the Delaware Chancery Court against Patrick S. Miles, former vice chairman of the Company and a member of NuVasive’s Board of Directors. The lawsuit asserts that before abruptly resigning from the Company to join Alphatec Holdings, Inc. (NASDAQ: ATEC), Mr. Miles engaged in a scheme for over a year to divert corporate opportunities and then announced he would join Alphatec in violation of his contractual obligations to NuVasive. In the lawsuit, NuVasive argues Mr. Miles’ divided loyalties constituted a clear breach of his fiduciary duties to NuVasive and its stakeholders, and that he violated his non-competition and non-solicitation obligations to the Company.

NuVasive issued the following statement:

This step was not taken lightly, particularly given Mr. Miles’ history with NuVasive. Yet it is this history and Mr. Miles’ intimate knowledge of the Company and our proprietary information that makes his breach of fiduciary duties and contractual obligations so egregious and this litigation necessary.

It is not the Company’s preference to proceed down a litigation path, but it would be contrary to our own responsibilities to ignore Mr. Miles’ actions. To be clear, Mr. Miles’ conduct has precipitated this lawsuit, which we believe is necessary to protect NuVasive’s rights and interests and the interests of our stakeholders. We will continue to take all appropriate steps in this regard.

As detailed in the complaint:

  • In January 2016, NuVasive was contacted by UBS Financial Services Inc. to explore NuVasive’s interest in acquiring Alphatec. Miles was NuVasive’s president and chief operating officer at the time. Miles advised NuVasive that pursuing such acquisition was “a waste of time,” and that Alphatec had an “aged, undifferentiated portfolio.” Consistent with Miles’ comments, NuVasive passed on the opportunity.
  • Then, on March 22, 2017, Miles secretly executed a securities purchase agreement to purchase $500,000 of Alphatec stock in a private placement. Miles and Alphatec concealed this investment by purchasing shares in Alphatec through an entity called “MOM” and failing to disclose that Miles was the beneficial owner of the shares. While still an employee and a member of the NuVasive Board, Miles negotiated an offer from Alphatec to serve as its executive chairman. As part of that offer, as an inducement to his employment, Alphatec granted Miles 1,000,000 Restricted Stock Units (a market value of $3,220,000 at Alphatec’s closing price as of October 2, 2017). Miles also agreed to purchase 1.3 million shares at $2.26 per share (a $2,938,000 investment) and is to be granted warrants to purchase up to an additional 1.3 million shares of Alphatec stock upon the closing of his purchase. Miles will own about 15% of the outstanding shares of Alphatec’s stock and, with the warrants he has been granted, could potentially own up to 23% of Alphatec’s outstanding stock.
  • On Sunday, October 1, 2017, Miles notified NuVasive that he was resigning his position as vice chairman and a member of the Board effective immediately. He planned to commence employment as Alphatec’s executive chairman the next day, and he did not intend to honor his contractual commitments to refrain from: 1) working for a competitor, 2) soliciting NuVasive’s customers and 3) recruiting NuVasive’s employees.

A full copy of the complaint will be available at NuVasive’s website.

NuVasive stated it is continuing to investigate and will file further claims if warranted.

DLA Piper is serving as legal counsel to NuVasive in connection with this matter.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.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 the 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.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Nextremity Solutions, Inc. Announces Limited Release of the Axi+Line™ Proximal Bunion Correction System

Posted On October 10, 2017 By OrthoSpineNews In Extremities, Top Stories /  

10 Oct 2017 – By Nextremity

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World” Warsaw, IN, is announcing the limited release of its newest product, the Axi+Line™ Proximal Bunion Correction System for the treatment of hallux valgus deformity, also known as a bunion. This announcement comes shortly after Nextremity Solutions announced the limited release of another new product, the PiroVue™ Gastrocnemius Recession System for the treatment of equinus deformities in patients.

According to a 2015 study in Foot & Ankle International® entitled, “A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal Rotation of the First Metatarsal in CT Scans”, patients with hallux valgus deformities (bunions) had a “more pronated first metatarsal than the control group”. The study showed that 87.3% of the patients sampled with hallux valgus deformity also had abnormal frontal plane rotation of the first ray.

Nextremity Solutions currently offers the Re+Line® Bunion Correction System, which specifically focuses on the treatment of hallux valgus deformities of lesser angles. However, the Axi+Line Proximal Bunion Correction System addresses treatment of deformities of larger angles and addresses correction in the frontal plane.

 

 

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Nanovis Spine Featured in Orthopedic Design and Technology

Posted On October 9, 2017 By OrthoSpineNews In Spine, Top Stories /  

Nanovis Spine CEO Matt Hedrick recently sat down to speak with ODT about our commitment to developing innovative products to improve patient care and outcomes (full article attached).

https://www.odtmag.com/issues/2017-10-01/view_features/distinguished-support-a-review-of-spinal-orthopedic-technologies/?sthash.APN1XgvK.mjjo

“With an approximately 10 percent rate of lumbar non-fusions, we feel this area is where we can do the most good. Nanovis’ deeply porous titanium scaffolded FortiCore implant systems provide high fixation strength in a short timespan compared to PEEK, plasma-sprayed PEEK, or allograft…” Hedrick said.

The advantages of FortiCore® include:

#deeply porous interconnected titanium scaffold

#intermolded PEEK-Optima® core by InVibio with benefits of modulus and imaging

#resistance to abrasion and delamination (rebar in concrete concept)

#published pre-clinical data showing statistically significant superiority vs. PEEK, Allograft, and Plasma Spray https://lnkd.in/eDjfMaR

“Our next technology upgrade for this market is a patented nanotube surface that offers the potential to further enhance the interface with bone that our entire line of spinal implants offers surgeons. Combining these technologies provides Nanovis and our distributor partners an entire portfolio of highly-advanced and highly-differentiated products.”

Nanovis is actively recruiting independent distributors to give more patients, physicians, and providers access to our science enhanced, meaningfully differentiated technology platforms.

To learn more, please contact jeff.shepherd@nanovistechnology.com, or visit us at Booth# 762 at the North American Spine Society meeting October 25-28, 2017 in Orlando.

 

 

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BONESUPPORT™ – First Patient Recruited in Study Evaluating CERAMENT® G and CERAMENT® V in Patients Undergoing Hip and Knee Arthroplasty Revisions

Posted On October 9, 2017 By OrthoSpineNews In Recon, Top Stories /  

Lund, Sweden, 08:00 CEST 9 October 2017 – BONESUPPORT™ an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform announces that the first patient has been recruited in a study evaluating CERAMENT® G and CERAMENT® V in patients undergoing hip and knee arthroplasty revisions. Professor Carlo Romanò is the Principal Investigator for the study, which will take place at 6 different clinical centers in Italy and is expected to recruit approximately 135 patients.

The investigator-led study is an open-label, prospective cohort, observational clinical trial designed to evaluate the effectiveness and safety of CERAMENT G or CERAMENT V when used to fill bone defects in the tibia and/or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for periprosthetic joint infections (PJIs).

The results from the study will be compared to a cohort of patients, at the same clinical centers, who were treated using current standard, of care.

The aim of the study is to show an improved clinical outcome and a lower infection rate for the CERAMENT G or CERAMENT V group compared to the retrospective control cohort where neither CERAMENT G or CERAMENT V were used.

One endpoint of the study will be the rate of PJIs according to the Musculoskeletal Infection Society (MSIS) criteria during the one year follow-up.

Professor Carlo Romanò, the study’s Principal Investigator, said: “PJIs remain one of the most feared complications after orthopedic surgery. The ability of microorganisms to adhere to the surface of an implant and to immediately produce a protective biofilm is currently considered as the main challenge in the treatment of implant-related infections. At present, there is no accepted approach for preventing recurring PJIs in patients undergoing revision arthroplasty. We have already conducted a pilot study that showed a beneficial outcome from using CERAMENT G and CERAMENT V in a small series of patients undergoing two-stage knee and hip arthroplasty revisions. The aim of the larger study which we are now conducting is to confirm these promising initial results in a larger cohort of patients and compare the results to a retrospective control.”  

Richard Davies, CEO of BONESUPPORT, commented: “The start of this study is a key step in our strategy to build a compelling data set to support the prophylactic use of both CERAMENT G and CERAMENT V in patients undergoing hip and knee arthroplasty revisions. We are confident that CERAMENT G and CERAMENT V’s ability to elute the antibiotics gentamicin and vancomycin respectively, while at the same time, remodeling to bone, will allow them to deliver a reduction in the rate of PJIs in this study.”

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

Citigate Dewe Rogerson

David Dible, Mark Swallow, Marine Perrier

+44 (0)20 7638 9571

bonesupport@citigatedr.co.uk

About BONESUPPORT™ 

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT®BONE VOID FILLER (BVF), CERAMENT®G and CERAMENT®V are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

 

This information was brought to you by Cision http://news.cision.com
http://news.cision.com/bonesupport-holding-ab/r/bonesupport—-first-patient-recruited-in-study-evaluating-cerament–g-and-cerament–v-in-patients-u,c2362136

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Xtant Medical Announces Consolidation of Fixation Operations to Montana and Closure of Dayton Facility

Posted On October 6, 2017 By OrthoSpineNews In Biologics, Top Stories /  

BELGRADE, Mont., Oct. 06, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the closure of its Dayton, Ohio facility and the transitioning of its fixation operations to the Company’s headquarters in Belgrade, Montana. This decision will allow the Company to align operations with the current and future needs of its customers, and recognize cost-savings by consolidating facilities and reducing duplicative resources.

“In an effort to maximize the benefit of the 2015 merger with X-Spine, and optimize synergies including efficiencies and cost savings, we made the difficult decision of transitioning operations to Montana and closing the Dayton facility,” said Carl O’Connell, CEO of the Company. “Hardware will continue to be an important aspect of our business, and is an area we intend to build on in the future. We remain excited about the new technologies in development. With the continued efforts in 2017 towards restructuring and reducing costs, we are looking to strategically invest in both our existing business and new market opportunities, for hardware and biologics in 2018. We will be working to make this transition as smooth as possible for our employees and our customers.”

The Dayton, Ohio facility employs approximately 55 employees in various quality assurance, regulatory, inventory management, finance, engineering, and distribution positions. Many of these functions will ultimately transition to our Montana facility. Once the transition is completed, annualized cost savings are anticipated to be in excess of $2 million, resulting from right-sizing the organization and reduction in facilities. The one-time cost for executing this change is estimated to be $1.5 million.

The Company will file the Worker Adjustment and Retaining Notification with the State of Ohio and the Department of Job and Family Services.

About Xtant Medical
Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements
This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

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