NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures

Posted On October 16, 2017 By OrthoSpineNews In Regulatory, Spine /

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance introduces an expandable 20 degree cage and broader indications for use, including use with allogeneic bone graft and use in additional levels of the spine.

The TLX interbody system is a market-leading solution that is inserted through a conventional transforaminal lumbar interbody fusion (TLIF) approach. NuVasive developed a minimally invasive approach for the TLIF procedure, the MAS® TLIF or Maximum Access Surgery (MAS) TLIF. Designed to be used with a minimally invasive spine surgery approach, TLX implants can be placed seamlessly into the disc space due to their low profile, bulleted design. A proprietary inserter allows the surgeon to insert, expand and rapidly post pack the implant through the same instrument, optimizing surgical efficiency. The TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis and was designed to induce lordosis in an anatomical fashion, unique to what is currently on the market.

Prior to the expanded 510(k) clearance, TLX interbodies were available in 15 degree lordotic options and were only indicated for use with allograft. The recent clearance includes a 20 degree expandable interbody, and additional indications for use with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The new indications also include use in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. Use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis was also cleared. The TLX system’s size offerings provide multiple options for varying patient size and anatomic considerations.

“With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” said Matt Link, executive vice president of strategy, technology and corporate development of NuVasive. “This clearance highlights our persistant investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”

The TLX interbody system, coupled with the Company’s Integrated Global Alignment® (iGA) suite of software that allows surgeons to calculate, correct and confirm a patient’s pathology, has the ability to improve TLIF procedures overall. The software can calculate alignment parameters with the preoperative planning tools NuvaLine® and NuvaMap® and can intraoperatively correct using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.

“The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures,” said William Hunter, MD, neurosurgeon at The Spine Clinic at Neuroscience and Spine Center of the Carolinas. “The platform also allows me to confirm restoration of my patients’ lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients.”

NuVasive will showcase its market-leading, procedurally-integrated technologies, including the new TLX interbody system in NuVasive Booth #713 at the North American Spine Society Annual Meeting held October 25-28, 2017 in Orlando, Fla.

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 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.

Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®

Posted On October 16, 2017 By OrthoSpineNews In Recon, Regulatory, Robotics, Top Stories /

MAHWAH, N.J., Oct. 16, 2017 /PRNewswire/ — Stryker’s Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration.

Triathlon Tritanium combines the kinematics of Stryker’s market leading Triathlon knee implant with the latest in highly porous biologic fixation technology for a knee system like no other. The innovation of Tritanium’s tibial baseplate and metal-backed patella components are enabled by Stryker’s proprietary AMagine additive manufacturing technology and are SOMA-designed.

With cementless procedures rising in popularity and becoming a fast-growing trend¹, Mako Total Knee with Triathlon Tritanium expands the current robotics offering to provide a cementless solution for orthopaedic surgeons seeking a more predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.

“With the rise in demand for cementless knee technology, we believe this new offering can have a positive impact on procedural efficiency and patient outcomes,” said Stuart Simpson, President, Stryker’s Joint Replacement division. “We’re excited to continue to lead in robotic technology and combine two of our most advanced and differentiated products to provide surgeons with the ability to transform orthopaedic surgery.”

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

References:
1.	Table 54: Primary TKA Implant Market. US Markets for Large-Joint Reconstructive Implants 2013. Millennium Research Group. March 2013. Pg. 84

SOURCE Stryker

NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology

Posted On October 12, 2017 By OrthoSpineNews In Regulatory /

SAN DIEGO, Oct. 12, 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 received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s PRECICE® system from NuVasive Specialized Orthopedics™ (NSO) with expanded indications that now include open and closed fracture fixation, pseudoarthrosis, malunions, nonunions, and bone transport.

The PRECICE system is an innovative, market-leading solution to treat patients with limb length discrepancy, limb deformities and chronic nonunions. The platform consists of an intramedullary device that once implanted utilizes an external remote controller to non-invasively compress and distract long bones. The key to the PRECICE platform is the magnetic interaction between the PRECICE intramedullary nail and external remote control. The proprietary technology includes a complex internal gear system remotely activated and controlled by permanent magnets. This advancement in limb reconstruction allows for a precision controlled distraction phase with the ability to non-invasively customize treatment.

Prior to the expanded FDA clearance, the PRECICE system was indicated for limb lengthening of the femur and tibia. The system is now indicated for bone transport of long bones in addition to limb lengthening. Bone transport is a technique that allows for regeneration of bony tissue and is typically used to fill segmental bone loss due to trauma or infection, i.e. infected nonunions, segmental defect, and chronic bone infections. The expanded indications for use allows the Company to continue to build a platform for further growth in the limb reconstruction and trauma markets.

“This FDA 510(k) clearance of PRECICE for expanded indications, including bone transport, demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets,” said Massimo Calafiore, president of NSO. “NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures. This allows us to treat more patients suffering from debilitating segmental bone defects through the use of PRECICE in bone transport procedures.”

The Company has also created a patient and family online resource dedicated to providing information on limb length discrepancy with Reach Your Height. The digital resource center provides education on treatment options and shares patient success stories. To learn more, visit reachyourheight.com.

SOURCE NuVasive, Inc.

In Start to Unwinding the Health Law, Trump to Ease Insurance Rules

Posted On October 12, 2017 By OrthoSpineNews In Regulatory /

October 12, 2017/APhA

President Trump is expected to sign on Thursday an executive order that would initiate the unwinding of the Affordable Care Act (ACA). With the order, the president will direct federal agencies to take actions aimed at providing less expensive options and fostering competition in the individual insurance markets. According to two senior White House officials, the specific steps in the order will represent just the first moves in his White House’s effort to strike parts of the ACA. By increasing alternative insurance arrangements that would be exempt from some key ACA rules, the change would provide more choices for consumers. Health insurance experts note, however, that it could increase costs for sicker individuals by drawing together healthier, younger consumers to the alternative plans, which could be cheaper and provider fewer benefits. The executive order will seek to increase access to plans that allow small businesses and possibly individuals band together to purchase insurance. In addition, it will life limits on the sale of short-term insurance and will expand the ways in which workers use employer-funded accounts to purchase their own insurance policies. White House officials also noted Wednesday that the order would call on agencies to study and issue a report on federal and state policies that could contribute to increasing health costs, including, potentially, the effect of health care provider consolidation.

Wall Street Journal (10/11/17) By: Radnofsky, Louise; Armour, Stephanie; Mathews, Anna Wilde

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.

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: ZILRETTA^TM (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

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

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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ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device

Posted On October 4, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

KNOXVILLE, TN (PRWEB) OCTOBER 04, 2017

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device.

“Additive manufacturing techniques create intricate three-dimensional implants, layer by layer, allowing a freedom in design and surface unattainable through conventional machining,” explained Stephen Ainsworth, PhD, Vice President of Research & Development, ChoiceSpine. “It revolutionizes our approach to design and the benefits we can now offer to our spine surgeon customers and their patients.”

HAWKEYE Ti offers the same complete implant portfolio as the original PEEK HAWKEYE device with the added advantage of a 3D printed, open titanium structure optimized for bone in-growth. HAWKEYE Ti is the first of many 3D printed devices being developed and commercialized by ChoiceSpine.

The HAWKEYE Vertebral Body Replacement System was designed to stabilize and fuse the vertebral column with elegantly simple implants in a variety of shapes and sizes. The portfolio contains small and large footprints that range in size from 10 to 50 mm in height with either 0° or 6° lordosis. “The breadth of this portfolio married with the new 3D printed implants provides a wide variety of options to match varying patient anatomies and surgical needs,” said KC Gilbert, Vice President of Marketing & Professional Education, ChoiceSpine.

“The clearance of our first additively manufactured device is a great achievement for the ChoiceSpine R&D team and the company,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “HAWKEYE Ti allows us to meet the clinical demands of spine surgery in order to stay competitive in a dynamic market.”

About ChoiceSpine
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

Intellijoint Surgical Inc. Receives CE Mark Approval for Flagship Product intellijoint HIP®

Posted On October 4, 2017 By OrthoSpineNews In Recon, Regulatory /

WATERLOO, ON, Oct. 4, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for Total Hip Arthroplasty (THA). Requiring no pre-operative or intra-operative imaging, the system can be used with any implant manufacturer.

intellijoint HIP, the flagship product by Intellijoint Surgical is available for both an anterior approach as well as lateral and posterior approaches, regardless of incision size. The 3D Mini-Optical tracking by Intellijoint is the only one of its kind and serves as the core technology for THA’s and other orthopedic surgical applications in development.

“The CE mark supports our mission of making the intellijoint HIP technology accessible to every surgeon and every patient,” explained Intellijoint CEO Armen Bakirtzian. “Intellijoint Surgical has developed a global strategy for its product portfolio and our rapid expansion in the US market paired with our versatile business model has prepared us for global scale.”

Intellijoint Surgical plans to enter the European market in 2018 and expects approval for intellijoint HIP from the Australian Therapeutic Goods Administration (TGA) by November 2017. Intellijoint Surgical will be demonstrating the capabilities of the intellijoint HIP System at several orthopedic conferences this year including the American Association of Hip and Knee Surgeons (AAHKS) annual meeting in Dallas, Texas this fall.

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

SOURCE Intellijoint Surgical Inc.

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