Regulatory – Page 22

September 20, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium^® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has received 510(k) clearance from the U.S. Food and Drug Administration.

The Tritanium C Anterior Cervical Cage is constructed from Stryker’s proprietary Tritanium In-Growth Technology,¹ a novel, highly porous titanium material designed for bone in-growth and biological fixation.¹ Tritanium material may be able to wick or retain fluid, in contrast to traditional titanium material.²

“We are excited to introduce the Tritanium C Anterior Cervical Cage following the successful launch last year of our Tritanium Posterior Lumbar Cage,” said Bradley Paddock, President of Stryker’s Spine division. “The benefits of additive manufacturing to create highly porous spinal implants that are ‘engineered for bone’ are becoming increasingly clear. Additive manufacturing allows us to push beyond conventional manufacturing techniques to address design complexity and achieve previously unmanufacturable geometries, while delivering the performance, reproducibility, and quality our customers have come to expect.”

The unique porous structure of the Tritanium material is designed to create a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study.³* It is inspired by the microstructure of cancellous bone⁴ and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

The Tritanium C Anterior Cervical Cage features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability,⁵ the cage has serrations on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges help to facilitate insertion and protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to adapt to a variety of patient anatomies. It will be available to surgeons in Q4 2017.

Intended Use (US)

The Tritanium C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. The cage is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. For the full indications for use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

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

PROJ43909: Tritanium technology claim support memo
RD0000050927: Tritanium material capillary evaluation
RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
PROJ44960: Coefficient of friction memo

Content ID TRICC-PR-1_15507

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com

Tether-Clamp-and-Implantation-System-Band-Lok-Patent.png

CHARLOTTE, NC (PRWEB) SEPTEMBER 19, 2017

Band-LOK, LLC, an orthopedic medical device innovation firm focusing on band technologies for surgical applications, announced today that two new patents have been allowed by the USPTO on the proprietary Tether Clamp and Implantation System.

Michael Albert, MD, Co-Founder of Band-LOK, said, “We continue to explore additional clinically-relevant designs for both the implants and the instrumentation. I am pleased to announce that I have personally implanted over 100 bands in more than 20 cases with highly successful results.”

The technology is a clamp housing assembly and method for providing stabilization as a bone anchor during an orthopedic surgical procedure. It includes a housing, a locking element, as well as a band.”

“We continue to strengthen our intellectual property assets and have done so with the support of Kapstone Medical,” said Randy Roof, Co-Founder and President of Band-LOK, LLC. “The two new patent allowances issued by the USPTO further protect our technology, and leads the way toward new advancements in surgical treatments benefitting from banding technologies.”

John Kapitan, Co-Founder of Band-LOK and CEO of Kapstone Medical said, “We are eager to leverage our core strengths in engineering, regulatory, quality and intellectual property creation in order to continue developing and protecting practical solutions for surgeons.”

Additional patent applications are pending.

About Band-LOK, LLC
Based in Waxhaw, NC, Band-LOK LLC is a team of surgeons, orthopedic medical device experts and engineers focused on providing quality medical device systems to hospitals, surgeons, and patients across the United States and Worldwide.

Contact Information
Randy Roof
Co-Founder and President, Band-LOK LLC
101 Waxhaw Professional Park Dr., Suite A – Waxhaw, NC 28173 – USA
phone: 704-839-1916
email: mrnuspine(at)me(dot)com

MARIETTA, Ga., Sept. 19, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 2 clinical trial for osteoarthritis of the knee.

The osteoarthritis clinical trial will study MiMedx’s AmnioFix® Injectable in a Phase 2, prospective, double-blinded, randomized controlled trial of the micronized dehydrated human amnion/chorion membrane (dHACM) injection as compared to saline placebo injection in the treatment of knee osteoarthritis. The Company expects patient enrollment to commence by the end of the year.

The trial will enroll approximately 318 study patients with a diagnosis of knee osteoarthritis defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. The IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of knee osteoarthritic pain.

The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90, expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group. The Western Ontario and McMaster Universities (WOMAC) scores will be one of the study’s secondary endpoints measured at 30, 60, 90 and 180 days.

Osteoarthritis of the knee is an extremely common occurrence in older patients, where it represents the biggest cause of disability and reduction of activity in patients over the age of 50. There are 14 million individuals in the U.S. who have symptomatic knee osteoarthritis and there were 7.8 million knee joint pain injections in the U.S. in 2015. Common medical treatment options include injectable medications such as corticosteroid; other injections such as hyaluronic acid (HA) and platelet rich plasma (PRP); and surgery, such as knee arthroscopy and knee replacement. Randomized trials have shown that corticosteroid injections may present short-term relief to patients with the condition, but unfortunately, the condition tends to recur, and complications may occur, such as systemic hyperglycemia, septic arthritis, and joint degradation. Clinicians generally agree that a lifetime limit of 2-3 corticosteroid injections is appropriate in unresponsive patients.

HA injections may provide temporary symptomatic relief and are widely used. However, their use is not without controversy and is currently not recommended by the American Academy of Orthopedic Surgeons in their treatment guidelines. PRP preparations have been popularly deployed in the treatment of knee osteoarthritis. However, concerns exist regarding this modality, since various methods of producing the material have differing bioactivity, and there is some debate in the literature about whether or not PRP is universally effective.

Bill Taylor, President and COO, stated, “With the variability of efficacy, cost, and side effects of current treatments for osteoarthritis, other treatment options are needed. This is particularly true when chronicity begins to develop and surgery is becoming the only remaining option. We believe our PURION® Processed AmnioFix® Injectable would be an ideal treatment alternative for osteoarthritis of the knee. Studies have confirmed that the natural characteristics of amniotic membrane may provide clinical benefits in the areas of enhanced soft tissue healing and inflammation modulation.”

The osteoarthritis study will be the fourth IND trial for MiMedx AmnioFix Injectable. The other three IND trials include the Plantar Fasciitis Phase 2B, Plantar Fasciitis Phase 3, and Achilles Tendonitis Phase 3 trials. MiMedx also plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company’s Plantar Fasciitis Phase 3 trial completes.

Over 80 clinical studies documenting the efficacy and effectiveness of MiMedx allografts have been published to date. The Company’s robust compendium of current clinical activity includes 28 ongoing clinical studies in various stages of development and execution, 123 clinical sites under management, and 175 physicians currently contracted for research activities. This vigorous agenda of clinical activities encompasses over 450 legal agreements and contracts for study involvement.

Parker H. “Pete” Petit, CEO, said, “There should not be any further concerns about MiMedx becoming a biopharma focused organization in an expedited fashion. We have accomplished rapid asset development in these areas over the years, and in March we disclosed to shareholders that our new strategic focus would be new therapeutic areas as a biopharma company. At that point, I did not think our level of expertise and accomplishments to date were fully appreciated. However, having two ongoing phase 3 trials and one phase 2 trial at a large number of centers will be quite an accomplishment. We have been able to very efficiently and effectively conduct our trials to this point without the assistance of a Clinical Research Organization (CRO). We expect to continue to build our staff as our demands increase. Along those lines, we will shortly announce additional very experienced biopharma executives to our staff. They will help continue our rapid development of the opportunities we have with our placenta based technology.”

“We are anxious to commence the Phase 2 clinical trial and we expect the study results to be compelling. We look forward to reporting the results to the medical and investment communities,” added Taylor.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee and expectations that study results will be compelling. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

DUBLIN – September 18, 2017 – Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the Intellis(TM) platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the Evolve^SM workflow^*, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients’ therapy needs.

Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device.

“Chronic pain is challenging to manage. Having real-time data can provide more information about patients’ quality of life changes,” said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. “This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse.”

Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.¹ Chronic pain can negatively impact all aspects of a person’s life – relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated.¹ Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, in addition to being a treatment option for patients interested in trying a non-drug alternative.^2-6

“Drawing upon our 40-year legacy in SCS, the launch of the Intellis platform isn’t just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief,” said Marshall Stanton, M.D., senior vice president and president of Medtronic’s Pain Therapies division, which is part of the Restorative Therapies Group. “Medtronic is committed to addressing patient needs, so the Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey – starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant.”

About the Intellis(TM) Platform
The Intellis platform can help optimize treatment and improve patient-physician communication by tracking and sharing daily activities, body positions and therapy usage and by giving physicians an objective look at mobility and progress. The Intellis platform also addresses a common patient complaint: battery recharge issues. With Medtronic’s proprietary Overdrive(TM) battery technology, the Intellis battery can be fully recharged from empty to full in approximately one hour and physicians can now estimate recharge intervals based on therapy settings.

Additional advances in the Intellis platform include secure wireless Samsung Galaxy Tab S2 programmers for physicians that enable faster delivery of evolving workflows and software upgrades. The Intellis implantable neurostimulator was designed for improved patient comfort and is the world’s smallest fully implantable SCS neurostimulator. The Intellis platform also includes both Medtronic’s proprietary SureScan(TM) MRI technology for the broadest access available to MRI diagnostic imaging and simple eligibility determination, which allows MRI scans anywhere on the body under certain conditions, as well as AdaptiveStim(TM) technology for automatic adjustments to deliver the right therapy dose to the right location, as the pain target shifts based on body position.

“We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform,” said Dr. Dave Rhew, chief medical officer and head of Healthcare and Fitness for Samsung Electronics America. “Samsung’s Galaxy tablets-secured by the HIPAA-ready Samsung Knox mobile security platform-will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions.”

About Spinal Cord Stimulation
Medtronic neurostimulation therapy for chronic intractable pain uses a medical device placed under a patient’s skin to deliver mild electrical impulses through a lead implanted in the epidural space to block pain signals from going to the brain. SCS is a non-opioid therapy that is clinically proven and cost-effective for treating chronic pain. Multiple randomized controlled trials have demonstrated that SCS provides more effective pain relief than both re-operation and conventional medical management.^{2-4, 7}


Medtonic’s Intellis(TM) Spinal Cord Stimulation Platform
Click the thumbnail above for a larger image.

About Medtronic Pain Therapies
Medtronic has the broadest portfolio of pain therapies, which have been in use for over 40 years and have benefited hundreds of thousands of patients worldwide. Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system, and continues to innovate and bring patient-centric advances.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

*A workflow is guidance only and physicians should use their medical judgement and product labeling to optimize therapy for individual patients, which may require discontinuation or modification of a workflow.

References:
1.   Mekhail N, Wentzel DL, Freeman R, Quadri H. Counting the costs: case management implications of spinal cord stimulation treatment for failed back surgery syndrome. Prof Case Manag. 2011;16(1):27-36.
2.   North RB., Kidd DH., Farrokhi F, et al. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurg; 56: 98-106 (2005).
3.   Kumar K., Taylor RS., Jacques L, et al., Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicenter randomised controlled trial in patients with failed back surgery syndrome. Pain; 132: 179-188. (2007).
4.   Kemler MA., De Vet HCW., Barendse GAM et al., The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow-up of the randomized controlled trial. Ann Neurol; 55: 13-18 (2004).
5.   Taylor RS, Spinal cord stimulation in Complex Regional Pain Syndrome and Refractory Neuropathic Back and Leg Pain/Failed Back Surgery Syndrome: results of a systematic review and meta-analysis. J Pain Symptom Manage; 31: S13-S19 (2006).
6.   Cameron T, Safety and efficacy of spinal cord stimulation for the treatment of chronic pain – a 20 year literature review. J Neurosurg Spine; 100: 254-267 (2004).
7.   Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-70.

Medtronic Photo

Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098

Ryan Weispfenning
Investor Relations
+1-763-505-4626

September 18, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has filed its response to the Food and Drug Administration’s (“FDA”) Additional Information (“AI”) request related to the Company’s Senhance Surgical Robotic System 510(k) submission.

“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to our second quarter 2017 results, the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, whether the Senhance 510(k) will achieve clearance in 2017, if at all. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2016, which was filed on March 6, 2017, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

WINNIPEG, Sept. 14, 2017 /PRNewswire/ – Precision ADM Inc. is pleased to announce that it is the first Canadian metal Additive and Subtractive manufacturing services company to receive ISO 13485:2016 Quality Management System certification. This industry standard represents the comprehensive set of requirements for the design and manufacture of medical devices.

Implementing this standard enables Precision ADM to manufacture medical devices, such as Orthopaedic Implants, using the latest digital manufacturing technologies. Using these technologies, Precision ADM can lower production costs by reducing waste and decreasing time to market by simplifying – or eliminating – tooling and equipment.

Additive Manufacturing also makes it possible to produce custom, patient-specific designs and devices with complex geometries, with potential lower cost than traditional manufacturing methods. Precision ADM is currently targeting additively manufactured medical devices produced in materials such as Titanium, Cobalt-Chrome, and stainless-steel alloys.

“Achieving ISO 13485 Registration and Certification using both metal Additive and Subtractive Manufacturing methods for Medical Devices is a first for any Canadian AM services company,” said Martin Petrak, CEO. “We are proud of our team’s accomplishment in achieving this significant milestone and are excited to work under this quality system with our existing and new clients.”

Dale Kellington, General Manager, added “The design and manufacturing controls this Certification demands gives our medical device customers the confidence they need that our manufacturing output will meet their stringent requirements. Our experience in product innovation and validation testing through our parent company, the Orthopaedic Innovation Centre, gives us a unique perspective on medical device manufacturing.”

“The expertise and experience our engineers possess give us the ability to solve the complex issues facing the medical field today,” said Derek VanDenDriessche, Director of Medical Sales.

For more information on manufacturing medical devices or other Additive Manufacturing solutions, please contact Precision ADM via email at: info@precisionadm.com or visit us online at: precisionadm.com

About Precision ADM
Precision ADM Inc. is a global engineering and manufacturing solutions provider that uses Additive Manufacturing, also known as 3D Printing, as a core technology, complimented by multi-axis machining to manufacture high value components and devices for the medical, aerospace, energy, and industrial sectors. Precision ADM has created a comprehensive Advanced Digital Manufacturing™ process which includes Design Support, Engineering, Manufacturing and Finishing. Precision ADM is ISO 13485:2016 certified and headquartered in Winnipeg, Manitoba, Canada.

SOURCE Precision ADM

sen-graham-cassidy-johnson-heller-gty-jef-170913_12x5_992-1.jpg

Robert Lowe – September 13, 2017

A group of Senate Republicans today introduced yet another bill that would largely repeal and replace the Affordable Care Act (ACA), this time around by giving block grants to states to enact their own healthcare reforms.

The money for the block grants would come from what the federal government now spends on the ACA.

The legislation goes by the names of its four sponsors ― Sen. Bill Cassidy, MD, (R-LA); Sen. Lindsey Graham (R-SC); Sen. Dean Heller (R-NV), and Sen. Ron Johnson (R-WI).

“If you believe repealing and replacing Obamacare is a good idea, this is your best and only hope,” said Graham at a press conference today. “Everything else has failed except this approach.”

Graham warned that if Republicans fail to pass his bill, a single-payer system like the kind proposed by Sen. Bernie Sanders (I-VT) and Democratic allies was inevitable.

The block grants under the Graham-Cassidy-Heller-Johnson bill would replace current ACA expenditures on Medicaid expansion, premium subsidies for health plans bought on insurance exchanges, cost-sharing subsidies, and the so-called Basic Health Program for low-income individuals that some states have adopted. States could use the block grants to contract with insurers to encourage their participation in the exchanges, subsidize premiums and out-of-pocket costs for individuals, pay physicians and hospitals, support their Medicaid programs, and create high-risk and reinsurance pools.

READ THE REST HERE

WASHINGTON, Sept. 13, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it has been chosen to lead three separate training sessions with the FDA. These three training sessions will take place during the months of September and November of 2017 and will be focused on the areas of clinical trials, reimbursement, and innovation.

The Experiential Learning Program (ELP) is a program designed to help all levels of FDA within the Center for Devices and Radiological Health (CDRH) better understand real-world experience as it relates to the design, manufacture and use of medical devices. The ELP program aims to collaboratively explore device technology and obtain the necessary knowledge to enhance the review process and support communication between sponsors and the CDRH review staff.

MCRA’s experts will provide insights and case studies on key strategic considerations in the important areas of technology development as it relates to industry, and the related impact of timing and cost in creating both value and mitigating risk. Additionally, as reimbursement and healthcare economics is becoming increasingly more important, MCRA will address how procedure labeling affects reimbursement coding and how Health Technology Assessment Groups and payers determine the increasing clinical evidence requirements that FDA regulates, which increases the investment required for successful commercialization of both new and existing technology.

Speaking on the impact of programs like ELP, MCRA’s General Manager, David Lown said, “MCRA is proud to be selected by FDA to participate in its ELP program. It confirms the value of our experience and the expertise our consultants deliver to over 500 medical device clients globally. Our hope is that FDA benefits from our CRO’s shared knowledge in the areas of regulatory affairs, reimbursement, quality assurance and compliance”

For more information on MCRA, please visit www.mcra.com.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and medical device industries. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves over 500 clients globally.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three additional size configurations for an expanded market opportunity, and importantly, for use with allograft. This clearance is the second received during this quarter, and continues to strengthen Xtant Medical’s focus in providing a more comprehensive portfolio focused on regenerative care for the patient.

Xtant Medical’s Irix-A is a standalone interbody device used in anterior lumber interbody fusions. The current product line offers a titanium and PEEK composite implant, with the additional option of a titanium plasma coating for improved osseointegration with the spinal endplate, all with 8° or 12° of lordosis for alignment with the curvature of the spine. This new 510k clearance adds three additional degrees of lordosis, specifically 16°, 20°, and 24°, providing the surgeon with a wider variety of choices to correct the patient’s loss of lordosis and to improve sagittal balance. The FDA clearance also expands the indications of use to include use with allograft, such as Xtant Medical’s patented OsteoSponge, proprietary 3Demin, or OsteoVive viable cell allograft.

“The clearance of the additional footprints, including hyperlordotic options, further enhances our lumbar product portfolio in response to our customer’s needs,” said Gregory Juda, Chief Scientific Officer. “We continue to execute on our focus of combining our hardware and biologics technologies, strengthening our position as a comprehensive supplier for spine surgeons and their patients.”

The Irix-A Lumbar Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer PEEK ring and three screws. It is intended for anterior spinal fusion procedures at one or two contiguous levels of the lumbosacral spine (L2-S1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.

Xtant Medical estimates the US market for standalone anterior lumbar interbody fusion market to be approximately $230 million and growing. The US market for Demineralized Bone Matrix (DBM) is estimated at $410M. The additional Irix-A interbody implants are intended to be available to customers later this year.

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

FT. LAUDERDALE, Fla., Sept. 7, 2017 /PRNewswire/ — Spinal Resources, Inc.^® (SRI) announced that it has received FDA 510(k) clearance for its Swedge™ Pedicle Screw System. This unique system offers multiple benefits, including CoCr and Titanium tulips; double lead and Cortical Cancellous Threads; Polyaxial, Monoaxial, Reduction, and Iliac screws; and MIS (minimally invasive spinal surgery) options. Currently, the Swedge system is cleared for a 5.5mm rod; 4.75mm and 5.0mm rods are pending clearance.

Since 2005, Spinal Resources, Inc. has been developing its groundbreaking technology, which accommodates multiple rods in a single-screw tulip with single-locking cap, and effectively locks the tulip’s angle without the presence of a rod. The FDA’s clearance of the Swedge™ Stabilization System marks the transition of Spinal Resources, Inc. from design and distribution experts into full manufacturers of innovative surgical enhancements. The Swedge system is the company’s first product development effort–and a seminal achievement: SRI’s system holds the tulip’s position while contouring rods in a multi-level scenario. The transition rod features a gradual taper between sections to minimize stress risers. Designed to improve efficiencies within the current and trending hospital environment by reducing inventory and increasing surgical procedure options, which may result in more affordable alternatives for patients, Spinal Resources, Inc.’s versatile, all-in-one Swedge implant system gives clinicians more surgical flexibility in degenerative, deformity, and midline approach surgeries, with a wider range of options to stabilize and conform to varying anatomies. Its MIS capabilities offer patients a smaller incision, with the added benefits of less tissue disturbance, reduced rehab/recovery time, and enhanced outcomes.

A report from GlobalData Healthcare, a UK-based company specializing in providing business data and analytics, indicated the 2017 global spinal fusion market is experiencing steady growth of about 3.4% CAGR (compound annual growth rate). The market is estimated to rise from $7.1 billion in 2016 to approximately $9 billion by 2023. The December 2016 report attributes the increase to degenerative spinal conditions caused by aging and the prevalence of technological advancements in surgeries. To learn more, see https://www.globaldata.com/spinal-fusion-market-approach-9-billion-2023-technology-improves-says-globaldata/.

According to President and Chief Executive Officer Bernard Bedor, no other screw on the market is quite like the Swedge System in capability. “We believe we’ve done something unique with our product,” he said. “We’ve taken three different rod sizes, put them into one effective tulip, and can lock them with a one-step locking cap. The Swedge System provides surgeons with greater versatility in the pre-planning and inter-operative stages, effectively reducing the surgical ‘fiddle factor’ thanks to its convenient standard and transition rods and screws in a variety of diameters and lengths. Our focus at SRI is to be problem-solvers for patients by supporting surgeons and hospitals in their important work with fewer instruments and a smarter system that shorten operating room time and lower costs.”

With the ownership of four (4) patents (and two more under consideration), this FDA clearance, and several other promising products in its pipeline, SRI is standing out as a strong contender in the design and manufacture of innovative solutions that enhance surgical procedures. The company is exploring full commercialization via strategic partnership, license, and/or private/corporate funding. For more information, contact our media and investors relations specialist: Ms. Melanie Raskin – melanie.raskin@aktaPD.com

Intended Use
The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion.

It is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: DDD (degenerative disc disease), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

About Spinal Resources, Inc.^® (SRI)
Founded in 2005, Spinal Resources, Inc.^®is a Ft. Lauderdale, Florida-based spinal medical device company that supports cost-effective patient care with innovative mechanical and biomechanical products to alleviate pain, shorten recovery time, restore health, and extend quality of life. SRI has engineered a unique line of patented spinal and cervical fixation systems with stem growth factors for the surgical repair and reconstruction of debilitating spinal conditions. For more information, visit spinalresourcesinc.com.

Media Contact:
Melanie Raskin
175102@email4pr.com

SOURCE Spinal Resources, Inc.(R)

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