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Synaptive Medical Unveils Next Generation of Surgical Robotics with Groundbreaking Optics Platform

Posted On October 9, 2017 By OrthoSpineNews In Robotics /  

October 9, 2017

TORONTO–(BUSINESS WIRE)–Synaptive Medical Inc., a medical device and technology company, today released Modus V™. This second-generation, high-powered digital microscope with a surgical robotic arm is derived from Canadarm technology used on the International Space Station. Designed with feedback from Synaptive’s clinical partners, Modus V is the new cornerstone of its integrated BrightMatter™ platform.

Modus V sets the new standard for robot-assisted neurosurgery with the most powerful optics available on the market that give unprecedented views of patient anatomy and may allow surgeons to perform less invasive procedures with more precision. For patients, less invasive procedures may lead to faster recovery times, reduced complications and, in some cases, may render an inoperable diagnosis operable.

For surgeons, Modus V’s advanced instrument tracking with auto-focus, combined with a highly flexible arm, also allows for increased surgical efficiency through hands-free control, better ergonomics during procedures and greater versatility in the operating room. These innovations feed developments in precision medicine by creating more opportunity to capture, analyze and draw trends from patient data and build better decision-making tools for physicians, researchers and hospital administrators.

“This product release marks a major milestone in our evolution as a company,” says Peter Wehrly, Synaptive’s CEO. “Modus V is an integral part of our overall BrightMatter surgical solution. Conceptualized for the digital era as a fully integrated set of devices, our solution collects and delivers data—be it imaging, tractography or other patient information—when and where it’s most needed to drive surgical decision making. It’s part of our ongoing commitment to give surgeons the most advanced tools with which to treat their patients.”

Modus V is part of the BrightMatter product suite, which transforms surgical planning, patient data collection and intraoperative vision from disjointed analog methods to a fully integrated platform with navigation, robotic automation, digital microscopy and data analytics.

As the successor to BrightMatter Drive, Synaptive’s first generation robotic digital microscope, Modus V’s improved design was created to meet the complex needs of cutting-edge surgery, including:

  • The most powerful optics platform on the market fully integrated with the robotic arm, providing superior visualization of anatomy and allowing for better decision making when it matters most
  • Enhanced hands-free tracking of surgical instruments with auto-focus and programmable motions gives surgeons more control without disrupting workflow
  • Increased arm flexibility covers a larger volume of space, permitting more versatile positioning around the patient and ergonomic alignments of optics for the surgeon
  • Smaller unit footprint allows for greater maneuverability in the OR and enables faster deployment

“Collaboration is hardwired into Synaptive’s culture. Modus V’s improvements are grounded in the collaboration and extensive feedback from neurosurgeons in our customer community on both Modus V prototypes and BrightMatter Drive,” says Cameron Piron, Synaptive’s president and chief strategy officer. “We’re grateful for their support, and look forward to deeper commentary from the surgical community as Modus V enters the market.”

About Synaptive Medical | Synaptive Medical Inc., a Toronto-based medical device and technology company, collaborates with leading clinicians and healthcare systems to revolutionize products and services that cross traditional barriers to enable continuous improvement in care delivery in and beyond the operating room. Synaptive’s integrated BrightMatter™ solutions—including surgical planning, navigation and visualization, and an informatics platform—are designed to give clinicians the right information they need to ensure the best possible outcomes for patients.

Contacts

Synaptive Medical
Elizabeth Monier-Williams, 647-299-6429
Director, Marketing Communications
elizabeth.monierwilliams@synaptivemedical.com

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SI-BONE, Inc. Announces Utah’s PEHP Coverage for the iFuse Procedure™ for MIS SI Joint Fusion

Posted On October 9, 2017 By OrthoSpineNews In Spine /  

SAN JOSE, Calif., Oct. 9, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that PEHP Health & Benefits of Utah, a nonprofit trust providing health benefits to Utah’s public sector employees and their families, has issued a positive coverage policy for MIS SI joint fusion with iFuse.  The policy specifies positive coverage for MIS SI joint fusion using iFuse with prior authorization for CPT (current procedural terminology) code 27279 and considers open SI joint fusion with CPT 27280 experimental and investigational.  In addition, the policy considers percutaneous radiofrequency ablation/denervation of the SI joint, including pulsed, non-pulsed and cooled, experimental and investigational.

“Minimally invasive SI joint fusion using the iFuse Implant has become the method of choice to treat patients who suffer from chronic pain resulting from degenerative sacroiliitis or sacroiliac joint disruption.  With over 28,000 procedures performed and 54 peer-reviewed publications that include two Level 1 randomized controlled trials as well as numerous long-term studies including a 6-year study published in Neurosurgery, the iFuse Implant is the benchmark for SI joint fusion,” said Jeffrey Dunn, President, Chairman and CEO at SI-BONE.  “It’s very encouraging to see health plans such as PEHP of Utah provide access to the iFuse Procedure™ for its health plan members who are suffering from chronic SI joint pain who’ve failed conservative care.”

About SI joint dysfunction

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse Implant and iFuse Procedure are trademarks of SI-BONE, Inc.  ©2017 SI-BONE, Inc. All Rights Reserved. 10004.100917

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

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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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Flexion Therapeutics Announces FDA Approval of Zilretta™ for Osteoarthritis (OA) Knee Pain

Posted On October 6, 2017 By OrthoSpineNews In Regulatory /  

BURLINGTON, Mass., Oct. 06, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain relief over 12 weeks.

“The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “It comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition.” Dr. Clayman added, “We believe that Zilretta has the potential to be a transformative medicine for the more than five million patients who receive an intra-articular injection for OA knee pain each year.”

The FDA approval of Zilretta is based upon data from Flexion’s pivotal Phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide.

Commenting on the approval, Andrew Spitzer, M.D., Co-Director, Joint Replacement Program, Cedars-Sinai Orthopaedic Center, said, “OA knee pain presents a host of challenges for patients and clinicians alike, and there has been very little innovation in this area in recent years. Zilretta is a groundbreaking new therapy, providing clinically meaningful pain relief with a safety profile that is similar to saline.”

Sometimes called degenerative joint disease or “wear and tear” arthritis, OA is a progressive and incurable condition and the most common form of arthritis. Its effects may range from intermittent discomfort to the loss of function and severe chronic pain associated with irreversible structural damage.

“As OA progresses, many patients experience intractable joint pain, which can ultimately lead to the need for a total joint replacement,” said John Richmond, M.D., Medical Director for Network Development, New England Baptist Hospital. “As a result, healthcare providers are eager for new, non-opioid therapies that may help patients manage their OA pain for extended periods of time. Zilretta gives us an important new non-surgical intervention.”

Zilretta’s label also includes the results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with type 2 diabetes.

Steven Russell, M.D., Ph.D., Assistant Professor of Medicine, Massachusetts General Hospital Diabetes Research Center, commented, “Our trial demonstrated that Zilretta may avoid the disruptive blood glucose spikes that can be seen with corticosteroid use in patients coping with both knee OA and type 2 diabetes. As a practicing diabetologist, I believe the availability of Zilretta will make intra-articular injection of glucocorticoid an attractive option for these patients.”

The pain from OA of the knee can have a profound impact on the people it afflicts, often resulting in a cascade of consequences, which patient advocates warn is only expected to grow.

According to Seth Ginsberg, President and Co-Founder of CreakyJoints®, a national patient advocacy organization for people with all forms of arthritis, “Despite common misperceptions, OA is not a disease that is limited to the elderly. In fact, the average age of knee OA diagnosis has decreased while the number of people diagnosed with OA of the knee has been steadily rising. That’s why our community advocates for and welcomes new therapeutic options for people to consider in consultation with their doctor.”

Flexion expects Zilretta will be available in the U.S. by the end of October. For more information, visit www.Zilretta.com or call 1-844-FLEXION.

Conference Call Details

Flexion’s management will host a conference call Monday, October 9, 2017, at 8:00 a.m. ET. The dial-in number for the conference call is 855-770-0022 for domestic participants and 908-982-4677 for international participants, with Conference ID # 92539488. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website, and a replay will be available online after the call.

About Zilretta
Zilretta is the first and only FDA-approved extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. Zilretta employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.

Indication and Important Safety Information
Indication: ZILRETTATM (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.

Limitations of Use: ZILRETTA is not intended for repeat administration.*

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions

  • Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal or subcutaneous routes. Serious events have been reported with epidural and intrathecal administration of corticosteroids and none are approved for this use. ZILRETTA should not be considered safe for epidural or intrathecal administration.
  • Hypersensitivity Reactions: Rare instances of anaphylaxis, including serious cases, have occurred in patients with hypersensitivity to corticosteroids.
  • Joint Infection and Damage: A marked increase in pain accompanied by local swelling, restriction of joint motion, fever and malaise are suggestive of septic arthritis. Examine joint fluid to exclude a septic process. If diagnosis is confirmed, institute appropriate antimicrobial therapy. Avoid injecting corticosteroids into a previously infected or unstable joint. Intra-articular administration may result in damage to joint tissues.
  • Increased Risk of Infections: Infection with any pathogen in any location of the body may be associated with corticosteroid use. Corticosteroids may increase the susceptibility to new infection and decrease resistance and the ability to localize infection.
  • Alterations in Endocrine Function: Corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression, with potential for adrenal insufficiency after withdrawal of treatment, which may persist for months. In situations of stress during that period, institute corticosteroid replacement therapy.
  • Cardiovascular and Renal Effects: Corticosteroids can cause blood pressure elevation, salt and water retention and increased potassium excretion. Monitor patients with congestive heart failure, hypertension and renal insufficiency for edema, weight gain and electrolyte imbalance. Dietary salt restriction and potassium supplementation may be needed.  
  • Increased Intraocular Pressure: Corticosteroid use may be associated with increased intraocular pressure. Monitor patients with elevated intraocular pressure for potential treatment adjustment.
  • Gastrointestinal Perforation: Corticosteroid administration may increase risk of gastrointestinal perforation in patients with certain GI disorders and fresh intestinal anastomoses. Avoid corticosteroids in these patients.
  • Alterations in Bone Density: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients with or at increased risk of osteoporosis prior to treatment.
  • Behavior and Mood Disturbances: Corticosteroids may cause adverse psychiatric reactions. Prior to treatment, special consideration should be given to patients with previous or current emotional instability or psychiatric illness. Advise patients to immediately report any behavior or mood disturbances.

Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough and contusions.

Please see the full Prescribing Information at www.ZILRETTAlabel.com.

* The efficacy and safety of repeat administration of ZILRETTA have not been evaluated.

About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.

About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, a type of degenerative arthritis. The company’s core values are focus, ingenuity, tenacity, transparency and fun. Flexion was named one of the Boston Business Journal’s 2017 Best Places to Work.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; timing for the expected commercial availability of Zilretta; our plans to commercialize Zilretta and its market potential; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of launching a new pharmaceutical product in the United States; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; the risk that we may not be able to successfully hire, train and maintain an effective sales force to commercialize Zilretta; the risk that Zilretta may not be successfully commercialized, including as a result of limitations in Zilretta’s label and package insert information; risks regarding our ability to obtain adequate reimbursement from payors for Zilretta; risks related to the manufacture and distribution of Zilretta, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Corporate Contact:
Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com

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Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device

Posted On October 6, 2017 By OrthoSpineNews In Regulatory /  

CONCORD, Calif., Oct. 6, 2017 /PRNewswire/ — The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.

Since the company was founded in 1997, Game Ready’s cold and compression system has become the treatment system of choice globally for thousands of leading healthcare professionals. Game Ready’s customers are Surgeons, Sports Medicine Physicians, Physical Therapists and Athletic Trainers, who rely on Game Ready for its award-winning technology to improve clinical outcomes and care for their patients. Over a million people worldwide have experienced a better, faster recovery by using the company’s products.

Built upon Game Ready’s patented technology, the Med4 Elite is a powerful rehabilitation tool. Controlled by an intuitive touchscreen computer interface, the system delivers iceless cold therapy, heat therapy, rapid contrast (alternating heat and cold) therapy and intermittent pneumatic compression therapy, providing healthcare practitioners with flexible treatment options for different patients, procedures, injuries and stages of rehabilitation.

“The future of orthopedic recovery has arrived,” said Craig Grabell, CEO & President. “With the launch of the Med4 Elite we are changing the post-operative and post-injury landscape. This is a landmark moment for Game Ready and our customers. The Med4 Elite features Game Ready’s proprietary Rapid Changeover Technology™ for contrast therapy, which allows for a groundbreaking switch from heat at 113 degrees Fahrenheit to cold at 38 degrees Fahrenheit in less than one minute. We are excited to build on the success of our GRPro 2.1, and add additional therapies that will help providers get all their patients back to being their best. Game Ready is not just for world-class athletes. Elite technology for everyone is what Game Ready is all about.”

Current methods of rapid contrast therapy require multiple cumbersome devices and a large amount of space. The Med4 Elite provides a greatly improved application of therapy due to it’s compact but powerful footprint. A wide portfolio of patented, anatomically designed Game Ready Wraps delivers the Med4 Elite therapy for a more effective and comfortable recovery experience.

Game Ready also received a CE Mark for the Med4 Elite in August of 2017 and began international sales, with first systems shipped to Spain, France and the United Kingdom.

The company attributes its on-going success to adoption by thousands of medical and physical therapy centers, and its expanding international footprint, as well as being prescribed by the most elite surgeons and physicians. Game Ready’s clinically effective devices provide the power to accelerate the body’s natural repair mechanisms as well as treat symptoms.

About Game Ready 
Game Ready® (CoolSystems, Inc.) manufactures best-in-class orthopedic and sports medicine devices that help healthcare providers improve outcomes and the quality of the recovery experience for their patients. Technology innovation, meticulous testing and development, and a laser focus on customer and patient satisfaction put Game Ready in a class of its own.

 

SOURCE Game Ready

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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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Tangible Solutions Inc., Achieves ISO 13485:2016 and 9001:2015 Certification

Posted On October 6, 2017 By OrthoSpineNews In Regulatory /  

September 29, 2017

Fairborn, Oh – September, 2017, Tangible Solutions, Inc., Contract Manufacturer of 3D Printed Implants operates a quality management system and has received full certification in compliance with ISO 13485:2016 and 9001:2015. Tangible Solutions was independently audited and verified by Eagle Certification Group to conform to the specific requirements necessary to achieve this distinction.

A quality management system (QMS) is a set of integrated policies, processes and procedures that ensure an organization’s services are reliable and meet their customer’s expectations. ISO 13485: 2016 and 9001:2015 are examples of Quality Management Systems and a standard that outlines the requirements an organization must have in order to maintain their QMS certification.

Tangible Solutions’ ISO 13485: 2016 and 9001:2015 registration adds yet another level of credibility, expertise, and distinction.

Tangible Solutions is pioneering the field of additive manufacturing to provide large-scale, cutting-edge contract manufacturing solutions within the medical field. End-to-end lifecycle management of product lines provides solutions and support from prototype through production and sustainment.

 

About Tangible Solutions

Tangible Solutions specializes in innovative trabecular and complex lattice features that allow integrated device structures to mimic the human body and potentially provide better results for the patient. Tangible Solutions manages the entire lifecycle of your orthopedic products from the micro to the macro. From build plate orientation through supply chain management, we are here to help.

www.tangiblesolutions3d.com | aclark@tangiblesolutions3d.com | 937-912-4603

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Sports Medicine Market to Grow 7.4% CAGR by 2022

Posted On October 6, 2017 By OrthoSpineNews In Sports Medicine /  

PUNE, India, October 6, 2017 /PRNewswire/ —

The global sports medicine market will reach $8.24 billion by 2022 from $5.78 billion in 2017 at a CAGR of 7.4% during (2017-2022) driven by increasing incidences of sports injuries, continuous influx of new products and treatment modalities, and development in the field of regenerative medicine, while in 2017, North America accounted largest share of the said market followed by Europe, APAC and RoW according to RnRMarketResearch.

Browse 103 Market Data Tables and 32 Figures spread through 169 Pages and in-depth TOC on “Sports Medicine Market by Product (Implants, Arthroscopy, Prosthetic, Orthobiologics, Braces, Compression Clothing, Physiotherapy (Thermal, Ultrasound), Bandages & Tapes), Application (Knee, Shoulder, Elbow) – Global Forecast to 2022“ http://www.rnrmarketresearch.com/sports-medicine-devices-market-by-products-application-2012-2017-bone-cartilage-ligament-tendon-reconstruction-repair-braces-hot-cold-therapy-topical-pain-relief-compression-clothing-market-report.html .

The key players in the global sports medicine market are Arthrex, (US), Smith & Nephew (UK), DePuy Synthes (US), Stryker (US), CONMED (US), Zimmer Biomet (US), Breg (US), DJO Global (US), Mueller Sports (US), Wright Medical Group (US), Medtronic (Ireland), RTI Surgical (US), and Performance Health International (US).

Based on application, the sports medicine market is segmented into shoulder injuries, foot and ankle injuries, elbow and wrist injuries, back and spine injuries, hip and groin injuries, knee injuries, and other injuries (head, face, and finger injuries). The elbow and wrist injuries segment is expected grow at the highest CAGR during the forecast period. This growth can be attributed to the increasing number of injuries in sports like rowing, racquet sports, and golf, where there is a repetitive overuse of elbow and wrists.

Make an Inquiry on Sports Medicine Market – Global Forecast to 2022 research report at http://www.rnrmarketresearch.com/contacts/inquire-before-buying?rname=80170 .

On the basis of product, the sports medicine market is segmented into body reconstruction products, body support & recovery products and accessories. In 2017, the body reconstruction products segment is expected to account for the largest share of the market. The large share of this segment can primarily be attributed to the wide usage of implants and arthroscopy devices by sports medicine surgeons and orthopedic surgeons for sports-related injuries. The body reconstruction products segment is further segmented into implants, fracture & ligament repair devices, arthroscopy devices, prosthetics, and orthobiologics.

Asia Pacific is expected to witness the highest sports medicine market growth during 2017 to 2022. The influx of international players, government initiatives to promote sports medicine, and collaborations for sports medicine research are the key factors responsible for the growth of this market in the APAC region.

Inquire for Discount on “Sports Medicine Market – Global Forecast to 2022“ research report at http://www.rnrmarketresearch.com/contacts/discount?rname=80170 .

The report analyzes the sports medicine market and aims at estimating market size and future growth potential of this market based on various segments such as product, application, and region. In 2017, the fracture & ligament repair devices segment is expected to account for the largest share of the market. The high incidence of fractures and ligament tears in sports is expected to drive the market for fracture and ligament repair devices. The orthobiologics segment is expected to register the highest CAGR during the forecast period. The recent developments in regenerative medicine, allografts, and stem cell therapy to treat broken bones are expected to drive the growth of the orthobiologics market.

Break of primary participants was as mentioned below:

  • By Company Type: Tier 1-55%, Tier 2-25% and Tier 3-20%
  • By Designation: C-level-43%, Director Level-32%, Others-25%
  • By Region: North America-38%, Europe-23%, Asia Pacific-29%, RoW-10%

Another research titled Orthobiologics Market Global Forecast to 2022 says, the global orthobiologics market is projected to reach $6.06 billion by 2022 from $4.66 billion in 2017, at a CAGR of 5.4%. The PRP segment is expected to grow at the highest rate during the forecast period. The spinal fusion segment is expected to grow at the highest CAGR. Hospitals, orthopedic clinics, and ambulatory care centres are expected to be the fastest-growing segment. Asia Pacificis expected to register the highest growth rate in the orthobiologics market. Companies such as DePuy Synthes, Medtronic, Stryker, Zimmer Biomet, Harvest Technologies, Globus Medical have been profiled in this 159 pages research report available athttp://www.rnrmarketresearch.com/orthobiologics-market-by-product-viscosupplementation-synthetic-orthobiologics-dbm-bmp-prp-bmac-allograft-application-fracture-recovery-osteoarthritis-spinal-fusion-soft-tissue-end-user-hospitals-as-st-to-2022-market-report.html .

Explore more reports on Medical Devices Market athttp://www.rnrmarketresearch.com/reports/life-sciences/medical-devices .

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SOURCE RnRMarketResearch

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Zimmer Biomet, Wright Medical Lead US Market for Elbow Repair Devices Fueled by Cases of Arthritis and Use of New Anatomic Plates

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

Vancouver, BC — (ReleaseWire) — 10/05/2017 –According to a new series of reports on the U.S. market for orthopedic small bone and joint devices by iData Research (www.idataresearch.com), elbow open reduction internal fixation (ORIF) is growing due to the use of anatomic plates which are low profile designed specifically for the olecranon, coronoid and distal humerus. The fastest growing procedure of the elbow is complete replacement which is prescribed in cases of arthritis, fractures which cannot be managed using other techniques and for revision of the elbow. The elbow repair market is segmented by primary elbow and radial head implants with a combined market value in the U.S. of just under $50 million in 2016.

“Radial head implants are primarily used for traumatic fixation, as degeneration of radial head articulation is not a frequent occurrence,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “Fractures of the radial head typically result from falls on outstretched hands; therefore, the demand for these products increases as the population ages.”

The primary elbow implant market is sub-segmented into semi-constrained and unconstrained devices. The majority of unit sales are semi-constrained due to greater durability and the higher complication rate of unconstrained devices. Only Wright Medical’s Latitude™ EV Total Elbow Prosthesis can be installed unconstrained and, of those devices, just under half are done this way. The radial head market meanwhile, is the fastest growing segment with both units sold and ASP expected to grow over the next several years.

Zimmer Biomet is the leading competitor in the U.S. elbow repair market. They have experienced strong growth in the past few years and offer a full range of products for the orthopedic elbow surgeon. Zimmer Biomet’s Coonrad-Morrey total elbow product has a long history in the market with over 25 years of clinical use, set the standard for primary elbow replacement. The Coonrad-Morrey is the most popular primary elbow joint replacement in the world and is designated for rheumatoid arthritis, osteoarthritis and fractures.

 

READ THE REST HERE

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OMNIlife science™, Inc. Surpasses 17,000 Procedures Milestone for OMNIBotics® Robotic-Assisted Total Knee Replacements

Posted On October 5, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /  

RAYNHAM, Mass., Oct. 5, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), an established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that surgeons have completed more than 17,000 total knee replacements worldwide using the OMNIBotics robotic-assisted total knee replacement technology platform. The OMNIBotics system enables optimized implant placement using robotics driven by OMNI’s proprietary ART™ software. Surgeons can efficiently plan a procedure that is specific to each patient using a patented intra-operative 3-D modeling technique that eliminates the need for preoperative CT scans or x-rays. This results in a more precise alignment of the knee implant that many surgeons believe can lead to more rapid recovery and a more natural feeling knee replacement.

In addition to the clinical benefits, the OMNIBotics system provides proven savings per episode of care through a reduced learning curve for the surgeon and O.R. staff as well as a fast case-to-case turnaround and a compact physical footprint which improves efficiency. There is no capital investment cost for the hospital and no annual maintenance or software upgrade fees. This makes the OMNIBotics system a more cost-effective way for healthcare providers to offer robotic-assisted total knee replacement surgery to their patients.

“As one of the first surgeons to adopt OMNIBotics and having performed more than 1500 procedures, this significant milestone validates my experience with the technology,” said Ronald LaButti, DO, FAOAO, orthopedic surgeon with Advanced Orthopedics of Oklahoma and Oklahoma Surgical Hospital in Tulsa, OK. “I am committed to providing orthopedic care that is second to none and find that the precision of the OMNIBotics patient-specific procedure enables my patients to recover more quickly and results in excellent clinical outcomes as well as very satisfied patients.”

Market research estimates that in the next 5 years, more than 20% of total knee replacement procedures will be performed using robotic-assistance. OMNI has anticipated this demand and is focused on designing breakthrough complementary technologies like their recently FDA cleared Active Spacer which, for the first time, provides the surgeon with a quantitative tool to actively manage the tension on ligaments and pressures in the knee joint itself  with dynamic real-time feedback.

“OMNI has been at the forefront of robotic-assisted total knee replacement technology since the initial introduction of our first robotic total knee systems in 2010 and passing this 17,000 robotic- assisted TKA procedure milestone shows that we are still going strong,” stated Carl Knobloch, OMNI’s Vice President of Marketing.  “We continue to see increased interest in our latest OMNIBotics technology from surgeons, patients and hospitals.  With the pending addition to the OMNIBotics platform of our recently FDA cleared Active Spacer robotic soft tissue balancing technology, we expect the rate of adoption and case volumes to increase significantly in the coming year.

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT
Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444 
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com

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