NuVasive to Resume XLIF Procedures in Japan in First Quarter 2017

Posted On December 30, 2016 By OrthoSpineNews In Spine /

SAN DIEGO, CA–(Marketwired – December 29, 2016) – NuVasive, Inc. (NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it received approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW).

Recent guidance from the MHLW requires dilators and associated components used in lateral access spine surgical procedures to be classified in Japan as Class III medical devices. NuVasive’s dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in August 2011 with additional sizes approved in January 2014. As previously disclosed, NuVasive submitted its dilator and associated components for reclassification as Class III medical devices, and surgeons had temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.

With this approval from the MHLW, XLIF procedures in Japan will resume in the first quarter of 2017. In connection with the MHLW approval, NuVasive has agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.

“We’ve worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan,” said Jason Hannon, NuVasive’s president and chief operating officer. “Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013. As the industry leader in lateral procedures, we take our leadership responsibility seriously and have worked diligently with the MHLW to make XLIF available in Japan again. We thank the MHLW and our surgeon partners in Japan for supporting our efforts in keeping industry-leading innovation available to patients in need.”

XLIF is a minimally invasive surgical (MIS) procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. There are over 350 peer-reviewed global journal articles reporting on the XLIF procedure over the last 11 years, which detail the positive outcomes and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.

The Company intends to provide preliminary guidance for 2017 revenue on January 9, 2017 at the J.P. Morgan Healthcare Conference.

About NuVasive

NuVasive, Inc. (NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. 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 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.

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.

READ THE REST HERE

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

Intrinsic Therapeutics announces the Filing of PMA Application for its Barricaid® Anular Closure Device for Lumbar Discectomy Patients.

Posted On December 22, 2016 By OrthoSpineNews In Regulatory, Spine /

BOSTON, Dec. 21, 2016 /PRNewswire/ — Intrinsic Therapeutics, Inc. announced today that the filing of its Pre-Market Approval (PMA) application with the Food & Drug Administration (FDA) for the Barricaid® Anular Closure device is complete. Barricaid has been shown to improve the outcomes of patients undergoing discectomy for herniated lumbar discs to relieve sciatica pain.

“Approximately 1 million discectomies are performed every year around the globe and 40% of these patients will leave the operating room after discectomy with a large hole remaining in the outer rim of the disc, the anulus,” said Professor Douglas Klassen, Chief of Neurosurgery at St. Bonifatius Hospital, Lingen, Germany. “By simply sealing these large defects, patient outcomes can be improved significantly.”

The Barricaid Anular Closure device, designed to prevent repeat disc herniations in patients undergoing back surgery to treat sciatica, is the first of its kind to be the subject of a prospective, randomized, superiority trial involving patients who are at higher risk for revision discectomy surgery to alleviate recurrent pain resulting from reherniation. The PMA submission was based on the 2-year outcomes of 554 trial participants. Inclusion criteria for the study ensured enrollment of only subjects with a high risk of reherniation, subsequent reoperation, and rehospitalization.

“Today, quality patient care and the utilization of healthcare resources are scrutinized more than ever,” said Dr. Matthew McGirt, a Neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, North Carolina. “Technologies that demonstrate fewer repeat surgeries when compared to traditional treatment will fit into the paradigm of improving outcomes and conserving healthcare resources.”

Further supported by the clinical success demonstrated in earlier single-arm studies, Barricaid today stands alone as a unique treatment device for patients wishing to minimize risk of reherniation and resultant reoperations. Additional benefits include reduction in serious adverse events, episodic pain events and early hospital readmissions (at 30, 60 and 90 days).

“We are thrilled to have reached this important milestone and move into the next phase with FDA,” said Cary Hagan, Intrinsic’s President and Chief Executive Officer. “Parallel to the PMA approval process, we continue to focus our efforts on market access including reimbursement pathways for this compelling new technology with a sharp focus on delivering a solid Health Economic proposal to payers and hospital systems.”

About Intrinsic Therapeutics

Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery. Intrinsic currently markets and sells the Barricaid in Europe, Australia, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device. See http://www.in-thera.com for more information.

Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.

This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the potential approval by the FDA of the Company’s PMA submissions for the Barricaid Anular Closure device and the success of the Company’s launch preparedness efforts. These forward-looking statements are based upon Intrinsic’s current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization and market acceptance of, and customer demand for, the Barricaid Anular Closure device; the uncertain and time-consuming regulatory process, including the risks that the Company may be required to complete additional clinical trials in order to obtain approval of its PMA submissions; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the Barricaid Anular Closure device or that the Company’s PMA submissions might not be approved by the FDA in a timely manner or at all; that the Company may not have the resources to support multiple regulatory submissions; adverse market and economic conditions; and other risks You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Intrinsic does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.

Contact:
Cary P. Hagan, CEO
Intrinsic Therapeutics, Inc.
clinical@in-thera.com
+1 781 932-0222

SOURCE Intrinsic Therapeutics, Inc.

Carevature’s Limited Market Launch in US Brings Promise of Less Trauma and Quicker Recovery to Spinal Decompression Surgery Patients

Posted On December 22, 2016 By OrthoSpineNews In Spine /

TEL AVIV, Israel, Dec. 20, 2016 /PRNewswire/ — Carevature announced today that its Dreal™ line of products has begun helping surgeons in the US achieve better outcomes in spinal decompression surgeries. Over 400 patients worldwide have been treated in clinical use, with outstanding safety and recovery results. Six centers in Massachusetts, New Hampshire, Connecticut and Texas, are currently taking part in Dreal™’s limited market release.

Traditional spinal decompression surgeries help patients with back or limb pain by removing the tissue (usually bone) that’s putting pressure on the spinal nerves. In order to access the problematic tissue, surrounding tissue often needs to be removed. This can compromise spinal stability, and may require a spinal fusion procedure to connect the treated vertebrae and restore stability.

Carevature’s Dreal™’s unique curved design enables orthopedic surgeons and neurosurgeons to perform better spinal decompression more quickly and with less trauma to the area. Preservation of the surrounding tissue may reduce the need for spinal fusion procedures or simplify these procedures when fusion cannot be avoided.

Use of Dreal™ reduces operating room time and hospitalization time for spinal decompression patients. Spinal decompression patients treated with Dreal™ can be released from the hospital much faster than those treated with standard surgical tools. Avoidance of spinal fusion procedures can save the healthcare system tens of thousands of dollars per patient.

“I am using the Dreal™ for all my decompression cases” said Richard Guyer, MD, spine surgeon, co-founder of the Texas Back Institute in Plano, TX and past president of the North American Spine Society.

“This is the only device that allows the surgeon to decompress severely stenotic neuroforamen from the inside out while still leaving the anatomy intact and eliminating the need for fusion. There have been other devices but none are as easy to use as this, as it requires no new skills. While hundreds of thousands of lumbar decompressions are performed in the US every year, I believe that this device has the potential of reducing the number of fusions in these patients.”

“This is a significant milestone for the entire Carevature team,” said Yosi Weitzman, Carevature Founder and CEO. “It is exciting to see our hard work and dedication, make a difference to patients’ lives and well-being. We look forward to introducing Dreal™ to more centers as part of our full commercial launch, planned for 2017.”

About Carevature

Carevature Medical Ltd. is a privately held medical device company, dedicated to the development of advanced orthopedic surgery solutions. Carevature Medical was founded in 2011 and is headquartered in Rehovot, Israel.

Carevature is now focused on its flagship line of products for spinal indications, Dreal™, the first and only curved device powerful enough to efficiently cut bone and small enough to be used in spine surgery and neurosurgery. www.carevature.com

Contact:
Shani Sarid
Shani@pearlcom.co.il
+972-523392383

SOURCE Carevature Medical Ltd.

Safe Orthopaedics Appoints Its Scientific Advisory Board Consisting of Key Opinion Leaders in the Field of Back Surgery

Posted On December 21, 2016 By OrthoSpineNews In Spine /

December 21, 2016

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments, announces the appointment of its Scientific Advisory Board (SAB), made up of four renowned European back surgeons. The SAB will provide high-level advisory support and its main tasks will be to:

Identify and assess trends in back surgery, particularly MIS, percutaneous, fast-track and ambulatory techniques;
Define the Safe Orthopaedics strategic technical plan and study program.

Pierre Dumouchel, Chief Executive Officer and Co-Founder of Safe Orthopaedics, commented: “With our technological leadership in single-use instruments for back surgery, Safe Orthopaedics has brought together some of Europe’s leading back surgeons to form its Scientific Advisory Board. This Scientific Advisory Board is another key milestone to accelerate the adoption of our innovations as part of the established surgical practice and to make back surgery safer and easier, particularly through minimally invasive techniques.”

“Each member of the committee has internationally acknowledged spinal know-how, and their skills complement each other well. Their vision and expertise will help us define our future programmes,” added Thomas Droulout, Chief Technical Officer and Co-Founder of Safe Orthopaedics. “It is vital to take into account the specific features of various countries when devising development plans suited to current trends. By working with internationally renowned experts, Safe Orthopaedics is also ensuring the relevance of its clinical trials in the next three years.”

The SAB will be meet several times each year, and its members are:

Dr Jörg Franke, orthopaedic surgeon at Klinikum Magdeburg in Germany;
Dr Antonio Faundez, orthopaedic surgeon at La Tour hospital in Geneva-Meyrin, Switzerland;
Dr Steven Van Gaalen, orthopaedic surgeon at Diakonessenhuis hospital in Utrecht, the Netherlands;
Prof Jean-Charles Le Huec, orthopaedic surgeon and head of the orthopaedics-spinal trauma unit at Bordeaux university hospital in France.

On behalf of the Scientific Committee, Prof Jean-Charles Le Huec said: “It is an honour to join the Scientific Advisory Board of Safe Orthopaedics, a company that, since it was founded, has constantly innovated and devised new, safer and more effective solutions for surgeons. Safe Orthopaedics’ model fits perfectly with the trend towards fast-track surgery, which involves major efforts to make the surgical process more efficient. The company also wants to revolutionise the treatment of spinal fractures using minimally invasive solutions, combined with single-use and always available instrumentation, to make patient care easier and reduce the risk of infection.”

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery. By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the SteriSpine™ Kits are CE-marked and FDA cleared. The company is based at Eragny-sur-Oise (France), and has 34 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
Thierry Lambert, Tél. : +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Investor Relations
Julien Perez / Valentine Brouchot
Media Relations
Nicolas Merigeau
Tél. : +33 (0)1 44 71 94 94
mailto: SafeOrtho@newcap.eu

Inaugural NASS Ultrasound and Fluoroscopic Guided Lumbar Procedures Workshop a success in Singapore

Posted On December 21, 2016 By OrthoSpineNews In Spine /

16th December 2016 – by Allen Chen, MD, MPH

Continuing its global educational efforts, NASS successfully produced the inaugural Ultrasound and Fluoroscopic Guided Lumbar Procedures Workshop at the Singapore General Hospital on October 29-30 2016. This was the first freestanding NASS workshop, which was held as an independent course prior to the World Congress on Low Back and Pelvic Girdle Pain. The course exceeded all expectations, with over 70 participants representing more than 15 countries, including Saudi Arabia, India, Singapore, Malaysia, Philippines, Australia, Poland, and Indonesia.

The Symposium was chaired by Board member Jeffrey C. Wang, MD, and Ho Kok Yuen, MBBS, MMed. The NASS faculty delegation included NASS Past President Heidi Prather, DO, Board Member David O’Brien, MD, David Fish, MD, Sanjog Pangarkar, MD, Allen Chen, MD, MPH, Bengt Sturesson, MD (Sweden), and Chang Ming Guo, MD (Singapore). The course was organized by Brad Repsold, NASS Associate Executive Director, who ensured that all lectures and labs ran smoothly.

The facilities at the Academia building at Singapore General Hospital proved to be ideal for morning lectures and afternoon labs. The didactics of the course included topics such as differentiation of lumbar spine disorders, the use of spinal injections for surgical planning, tools of the interventionalist, and ultrasound vs. fluoroscopic techniques.

READ THE REST HERE

Amedica Announces Positive Scientific Data and Re-files FDA Submission

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /

SALT LAKE CITY, UT — (Marketwired) — 12/19/16 — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company’s porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation. “We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future. The porous silicon nitride sample used in this study is the cancellous-structured ceramic (CsC) used in the center of our composite cervical implants that were the subject of recent FDA communications,” said Dr. B. Sonny Bal, CEO and President of Amedica Corporation.

Amedica has re-filed an application with the FDA, with a modified CsC-based cervical implant that is comparable to Amedica’s own commercially-available Valeo^®C cervical implants. “With this submission, the goal is to introduce our proprietary CsC technology platform into the U.S. market without further delay,” said Dr. Bal.

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and 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. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can 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 23, 2016, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

Source: Amedica Corporation

Released December 19, 2016

Safe Orthopaedics Receives CE Mark for a New Implant to Treat Vertebral Fractures

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /

December 16, 2016

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments, today announces that it has received CE Mark for a new version of its patented Oak screw used to treat thoracic vertebral fractures.

Previously, 7.5 mm, 6.5 mm and 5.5 mm diameter versions of the screw were available for lumbar (lower back) vertebral fractures. With its smaller diameter, the new 4.5 mm version caters more widely for thoracic (middle-back) vertebral fractures.

Oak is the only pedicle screw in the world to offer simultaneous correction and fixation of trauma-related vertebral fractures. It combines the advantages of a multi-axial screw, which eases insertion of the rod, with the benefits of a mono-axial screw in reducing the fracture without any additional instruments.

This Safe Orthopaedics-patented innovation is ideal for minimally invasive surgeries and is also compatible with conventional open approaches. SteriSpine modular kits can be used with either of these approaches, making it possible to switch from one to the other in mid-surgery should the need arise.

Combined with their sterile single-use instruments, Oak screws are also constantly ready for use, and so surgery can go ahead without any delay—a major advantage in trauma cases. Vertebral fractures, which are usually the result of accidents, require rapid emergency surgery.

Dr. Van Gaalen, orthopedic surgeon at the Utrecht Hospital, Netherland, commented: “The Oak screw is a major breakthrough for trauma surgery because it facilitates and enhances the treatment of vertebral fractures. The CE Mark of this latest 4.5 mm diameter version of the product, which previously catered largely to lumbar vertebral fractures, opens up new possibilities for the treatment of thoracic vertebral fractures. This means we can now offer the benefits of this technology to a larger number of patients.”

Dr. Vouaillat, orthopedic surgeon, Cedar Clinic, Echirolles, France, and co-inventor of the system added: “This unique system offers new possibilities in the management of trauma surgeries and also opens up new solutions for degenerative surgeries.”

Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics, concluded: “The CE Mark of this new version of the Oak screw further strengthens our position in the key trauma market. Our ground-breaking innovations are ideally suited for trauma treatment because surgical procedures become easier and can go ahead more rapidly. They also open the way for minimally-invasive approaches—still used all too rarely in emergency surgeries.”

About Safe Orthopaedics

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
Thierry Lambert
CFO
Tél. : +33 (0)1 34 21 50 00
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Predictive Technology Group, Inc. (PRED) Announces Notice of US Patent Allowance for Method for Treating Patients with Genetic Spinal Deformities and Syndromes

Posted On December 19, 2016 By OrthoSpineNews In Regulatory, Spine /

SALT LAKE CITY, UT–(Marketwired – December 16, 2016) – Predictive Technology Group, Inc. (OTC PINK: PRED), a life sciences technology holding company, announced today that the United States Patent and Trademark Office (USPTO) has allowed a fundamental patent application — US20160296671 -that covers the practice of administering “ANY” spine deformation therapeutics to a patient having a spine deformation altered risk associated biomarker.

“We are pleased to see this latest allowance that supports PRED’s novel approach to diagnosing spinal disorders and syndromes, “said Mike Schramm, PRED’s Director of Intellectual Property. “This allowed US patent application supports the commercial use of both our diagnostic and next-generation companion treatment products.”

The claims of the ‘671 application build on previously issued US patents 8,123,787, 8,641,738, and 9,370,431 to which ‘671 claims priority and further bolster Predictive Technology Group’s Intellectually Property position.

“We are gratified to see this latest application allowance, which covers the core technology underlying the Company’s molecular diagnostic test” said Bradley Robinson, President and Chief Executive Officer of Predictive Technology Group, Inc. “Furthermore, this fundamental patent covers not only spinal applications of our technology, but establishes a precedent for the other patent applications that have been submitted on the Company’s portfolio of next-generation diagnostic and companion treatment products.”

The allowance of this new application is a significant milestone for Predictive Technology Group. The patent establishes the foundation of key intellectual property (IP) covering ANY treatment options (drug, surgery, bracing, etc.) for patients having a specific spine deformity biomarker. This newly allowed application is additive to previously announced patents. Furthermore, the Company has additional US and International patent applications pending and will pursue such applications with the objective of receiving additional issued patents in additional disease states.

About Predictive Technology Group, Inc.

Predictive Technology Group, Inc. (PRED), through its wholly owned subsidiaries, revolutionizes the treatment of serious and debilitating diseases through the commercialization of novel therapeutics leveraged by proprietary gene-based companion diagnostics. The Company develops and/or acquires proprietary technologies that open windows into the origin of human disease and the role that genes and their related proteins play in diseases’ onsets and progressions. PRED’s subsidiaries use gene-based information as cornerstones in the development of new diagnostics that assess a person’s risk of disease and therapeutic products designed to effectively prevent and/or treat diseases, www.predictivetechnologygroup.com

For more information about PRED, contact Mr. Richard Kaiser, Investor Relations, YES INTERNATIONAL, 757-306-6090 and yes@yesinternational.com

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new vaccines and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment and other risks the Company may identify from time to time in the future.

Image Available: http://www.marketwire.com/library/MwGo/2016/12/16/11G125445/Images/predlogo-872a3d3903e49728b49b4214eae8dea8.jpg