News – Page 149 – Selby Spine

CANTON, Mass., Sept. 19, 2017 /PRNewswire/ — Organogenesis Inc., a commercial leader in the field of regenerative medicine with a portfolio of advanced and next-generation bioactive and acellular biomaterials products in the advanced wound care and surgical biologics markets, has elevated two industry veterans and longtime company employees, Brian Grow and Patrick Bilbo, to Chief Commercial Officer and Chief Operating Officer, respectively.

“Both Patrick and Brian have shown tremendous leadership at Organogenesis over the years, and we are proud to welcome them to these key positions,” said Gary S. Gillheeney, Sr., President and CEO of Organogenesis. “Both gentlemen bring decades of combined experience in regenerative medicine and advanced wound care, and have contributed greatly to Organogenesis’ success. Their guidance and expertise will help us as we expand into new markets.”

As Chief Commercial Officer, Grow will oversee Sales and Marketing for the company, leading the wound care sales forces, as well as the planned expansion of Organogenesis’ product portfolio into the burn and surgical markets. Grow previously served as Director of Commercial Operations for Organogenesis and has been with the company since 2004.

Mr. Grow has more than 15 years of experience in the regenerative medicine, tissue-engineering and advanced wound care markets. A founding member of the original Apligraf sales team in 2000, Grow has since held various leadership positions with the company in sales, sales management and marketing, and was instrumental in the launch of the PuraPly™ and PuraPly™ Antimicrobial product lines. PuraPly Antimicrobial was recently named one of the “Top 10 Innovations in Podiatry” by Podiatry Today for the product’s impact on reducing bioburden in wounds.

“I’m honored to lead this dynamic and talented commercial team, and look forward to helping the company expand in the years ahead,” said Grow. “And now with the recent acquisition of NuTech Medical, we’re more excited than ever to be launching what we believe is the world’s most robust skin substitute portfolio.”

As Chief Operating Officer, Mr. Bilbo will oversee daily operations and execution of business strategy across departments, including the expansion of Organogenesis’ leading product portfolio and manufacturing operations to support the company’s planned growth. Bilbo previously served as Senior Vice President of Regulatory Affairs, Government Relations and Administration for Organogenesis, and has been with the company in a wide variety of roles for more than 20 years.

During his time at Organogenesis, Bilbo has focused on successfully overcoming the unique challenges of developing living cell-based and novel collagen biomaterial products for large scale commercialization and patient use.

Mr. Bilbo has extensive experience in the medical products industry, with a broad range of expertise in the commercialization of transformational devices, combination products and regenerative medicine therapies. Early in the company’s founding days, Bilbo worked on the Organogenesis research and product development team that developed the pioneering product Apligraf®, a cell-based product with approximately one million patient applications to date. He then advanced in various leadership positions in the company, including product development, clinical research, regulatory affairs and government relations. Bilbo led the successful development of the company’s novel PuraPly and PuraPly Antimicrobial product lines.

“This is an exciting time – both for Organogenesis and for the future of advanced wound care and regenerative medicine,” said Bilbo. “I’m thrilled to serve in this expanded capacity and look forward to helping the company capitalize on our leading cell, biomaterial and allograft therapies, as well as expanding our regenerative wound healing and surgical product portfolio to serve clinicians and patients with unmet medical needs.”

Already this year, the company acquired NuTech Medical and launched the company’s amniotic wound care line and its new surgical division. Earlier in 2017, the company also announced that it had secured approximately $45 million in additional financing for the expansion of its commercial operations and product portfolio.

About Organogenesis
Originally founded as a spin-off from technology developed at MIT in 1985, Massachusetts-based Organogenesis Inc. offers a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

Contact:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

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 and patent-protected processes for multiple sectors of healthcare, announced today it will be hosting a webcast on Thursday, September 21, 2017 beginning at 10:30 a.m. Eastern Time to discuss numerous strategic initiatives and provide in-depth information on other key topics requested by shareholders.

The Company reported that “Pete” Petit, Chairman and CEO; Bill Taylor, President and COO; Chris Cashman, EVP and Chief Commercialization Officer; and Debbie Dean, Executive Vice President, will be presenting during the September 21st call.

The Company expects the planned presentation to last approximately 45 minutes. After the planned presentation, the call will be open for questions and answers. The subject matter, topics and updates to be covered during the formal presentation include:

Short Selling Matters and Proactive Remedies
Patent and Intellectual Property Matters
IND and BLA Clinical Studies
Biopharma Market Valuations and Revenue Opportunities
Additional Revenue Opportunity from VLU Clinical Study

A listen-only simulcast of this MiMedx shareholder call and presentation slides will be available on-line at the Company’s website at www.mimedx.com beginning at 10:30 a.m. eastern time, September 21, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company’s website at www.mimedx.com.

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.

SOURCE MiMedx Group, Inc.

Dublin, Ireland — (SBWIRE) — 09/18/2017 — Low back pain is becoming a very common health problem across the globe. Affecting people of all ages from children to elderly, low back pain can be acute or chronic. The prevalence of spine disease is also on a rise due to increasing aging population, changing lifestyle, constant stress, acute or repetitive injuries and various other conditions. There has been a drastic change in spine surgery, with the robotic spine surgery currently being offered by few healthcare providers, giving patients improved outcome than the traditional surgical procedure. Manufacturers are also focusing on developing minimally invasive devices. As the less invasive procedure can result in lower pain score and lead to quick recovery time. Surgeons around the world are also focusing on endoscopic techniques leading to less invasive spine care, hence, new technologies are being developed to simplify technically complex procedures.

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Spine device manufacturers are also working towards offering better spinal imaging technology for sharper images. Effective in chronic pain conditions, spinal cord stimulation therapy is on a rise, hence, manufacturers are developing spinal cord stimulator devices that can reduce the risk of thermal tissue damage and are compatible with MRI. Companies are also working on stem cell technology and its use in the spine.

According to the latest report by Fact.MR, the global spine devices market is expected to witness massive growth, registering 7.1% CAGR during the forecast period, 2017 to 2022. Owing to an aging population, occupational posture, obesity, etc., spinal diseases are growing rapidly. Hence, spine surgery has also undergone a significant change, with new spine devices being developed to decompress and stabilize the spine. Following insights show how the global spine devices market will perform in the next five years.

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4 Forecast Highlights on Global Spine Devices Market

North America is projected to remain dominant in the global spine devices market throughout the forecast period from 2017 to 2022. The market is anticipated to witness the robust growth, reaching close to US$ 2,900 million revenues by the end of 2022. Owing to the availability of healthcare infrastructure and increase in investment by the government to improve healthcare across the region, North America is expected to emerge as the biggest market for spine devices.

Asia Pacific Excluding Japan (APEJ) spine devices market is expected to experience impressive growth through 2022. The rise in a number of accidents resulting in spine injury, improving lifestyle and an aging population are some of the factors boosting the growth of APEJ spine devices market.

Spinal plates will emerge as one of the most-preferred spine devices. Towards the end of 2017, Spinal plates are projected to gain nearly one-fourth of the revenue share. Meanwhile, spinal screws will also witness healthy growth, reaching nearly US$ 1,500 million revenue by 2022 end.

Compared to orthopedic clinics as the end user of spine devices, hospitals will emerge as the biggest users of spine devices. Towards the end of 2022, Hospitals as the end user are projected to surpass US$ 5,600 million revenue. Hospitals are also expected to account for more than two-third revenue share on global revenues by the end of 2017.

The report has also profiled leading players in the global market for spine devices, which will remain active through 2022. These include companies such as NuVasive, Inc., Exactech, Inc., DePuy Synthes, Braun Melsungen AG., Amedica Corporation, Arthrocare, K2M Group Holding, Inc., Medtronic Plc., Zimmer Biomet Holdings, Inc., and Stryker Corporation.

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About Fact.MR
Fact.MR is a fast-growing market research firm that offers the most comprehensive suite of syndicated and customized market research reports. We believe transformative intelligence can educate and inspire businesses to make smarter decisions. We know the limitations of the one-size-fits-all approach; that’s why we publish multi-industry global, regional, and country-specific research reports.

Posted Monday, September 18, 2017 at 10:55 PM CDT – Permalink

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.

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.

September 18, 2017/Roxane Wergin, Director, Corporate Communications

ALACHUA, Fla. (September 18, 2017) – RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today three new appointments to its senior leadership team to accelerate the Company’s strategic growth initiatives. They include Jonathon Singer, a member of RTI’s board of directors, as Chief Financial and Administrative Officer, effective October 2, 2017. Outgoing CFO Robert Jordheim will leave the company to pursue new endeavors following a successful transition. RTI also appointed Olivier Visa, formerly Vice President of Global Compounding for Baxter, and Julius Aviza, past Vice President of Global Quality at American Medical Systems, to lead its OEM, Donor Services, Sports business and quality assurance function, respectively.

The new management additions demonstrate another important step toward positioning RTI for continued progress in executing its strategic transformation plan. The augmented leadership team has decades of highly specialized functional and industry expertise, along with a diverse skill set that is aligned to build on RTI’s recent strong performance and to advance its progress toward returning RTI to long-term sustainable growth and profitability. Each leader will play a critical role in further developing their respective functional excellence, streamlining RTI’s businesses, upgrading its processes and reinforcing a culture that is laser focused on the customer.

New Chief Financial and Administrative Officer

Mr. Singer, an RTI board member since May 2016, will resign from the board to focus on his new role, which includes managing the company’s financial operations and overseeing RTI’s information technology, legal and business development functions. He will report to RTI Chief Executive Officer Camille Farhat.

“As we continue to implement our long-term growth strategy, we need the right team to accelerate and solidify our progress,” said Mr. Farhat. “I am particularly proud to welcome Jonathon who already has been a valuable contributor to RTI’s progress as one of our board members. His intricate knowledge of RTI combined with his broad business experience and deep background in strategic planning, finance, operations, IT, investor communications and business development will bring a new dimension to his role and help us accomplish the significant work ahead of us.”

Mr. Singer has more than 30 years of leadership experience at publicly-traded health care and pharmaceutical organizations. Previously, he was Executive Vice President and Chief Financial Officer at Sagent Pharmaceuticals, a producer of generic injectable products that won numerous awards for growth and innovation during his tenure. Mr. Singer also served as CFO of Landauer, a radiation safety products and services provider, and as Vice President for Global Finance and CFO of the Medical Segment at specialty medical device company, Teleflex. A certified public accountant, he has held finance, accounting and operations roles at Cardinal Health, R.R. Donnelley & Sons and KPMG.

“I would like to extend my appreciation and gratitude to Rob Jordheim for his service as CFO and interim CEO,” said Mr. Farhat. “His commitment to RTI’s mission has contributed to putting us back on the path toward growth. We all wish Rob the best in his future endeavors.”

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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

CAMPBELL, Calif. & COLUMBUS, Ohio–(BUSINESS WIRE)–ZipLine Medical, Inc. today announced results from an economic study that showed that Zip Surgical Skin Closure reduced post-discharge costs for total knee arthroplasty (TKA) when compared to staples. Results were presented Friday at the Knee Society Members Meeting by Roger Emerson, MD, of the Texas Center for Joint Replacement, Plano, Texas.

“In the study, we saw that staples and the Zip are both fast to apply in the operating room, but in the post-discharge environment, staple-related issues, such as patient phone calls, emergency department visits, infection concerns and removal create extra work and extra cost in the long run,” said Dr. Emerson. “In addition, patients were apprehensive about staple removal and concerned when they saw redness around their staples, which in some cases triggered antibiotic prescriptions to avoid possible infection.”

The study encompassed 130 consecutive TKA patients, with half of subjects closed with staples and half closed with Zip Surgical Skin Closure. All surgeries were performed at the Texas Center for Joint Replacement by the same surgeon using the same approach and implant, and were closed by the same surgical physician’s assistant. Patients were followed from surgery to first clinic post-operative visit (day 21-28) for assessment.

The study findings showed that the Zip reduced all of the following measures when compared to staples:

46 percent reduction in incision-related actual clinic costs
60 percent reduction in incision-related phone calls
60 percent reduction in incision-related clinic visits
75 percent reduction in incision-related antibiotics prescribed

In addition, patients found the resulting scar from the Zip to be cosmetically more appealing, and the Zip device less painful to remove, than staples.

”In addition to actual emergency room, clinic and wound-related care costs, which can be considered ‘bundle-busters’ in a bundled care setting, there are opportunity costs to consider, where unreimbursed time responding to patient calls, concerns and staple removal results in less time spent on billable activities,” said Omar Alnachoukati, director of clinical research at the Texas Center for Joint Replacement. “In the study, we found a five times higher opportunity cost in the staple group.”

He continued, “Total joint arthroplasty is the largest expense for a single condition among Medicare beneficiaries, totaling $7 billion annually. With staples currently one of the primary methods currently used for TKA closure, this study suggests that replacing staples with the non-invasive Zip device has the potential to offer significant savings to the healthcare system.”

The Zip is a non-invasive and easy to use skin closure device that replaces sutures, staples, and glue for surgical incisions and lacerations. Clinical studies have demonstrated significant time savings, fewer wound complications and the ability to reduce post discharge healthcare costs. A patented force distribution design results in secure wound closure, excellent scar quality and high patient satisfaction. Unlike staples or sutures, there are no skin punctures with the Zip that can create pathways for bacteria. Benefits of the Zip have been demonstrated in clinical studies in orthopedic total joint arthroplasty, foot and ankle, pediatric cardiothoracic, electrophysiology, dermatology, and plastic and reconstructive surgery.

ABOUT ZIPLINE MEDICAL

ZipLine Medical is an innovator in cost-effective, non-invasive surgical skin closure devices that deliver high patient satisfaction and surgeon efficiency. Zip Surgical Skin Closure devices have been used in more than 100,000 cases and in over 30 countries worldwide. ZipLine Medical was founded by Amir Belson, M.D. and is headquartered in Campbell, CA. For more information, visit www.ziplinemedical.com.

Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received the CE Mark and CFDA approval.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 310.902.1274
michelle@chronic-comm.com

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BRISBANE, AUSTRALIA (PRWEB) SEPTEMBER 14, 2017

AxioMed is pleased to announce the success of the first viscoelastic Freedom Lumbar Disc case in Australia. Dr. Steven Yang completed the procedure on a 35-year-old female patient suffering from degenerative disc disease with radiating pain as a result of a degenerative lumbar disc at level L5-S1. The patient failed conservative treatments prior to undergoing surgery.

Dr. Yang spoke to the advantages of the AxioMed Disc after the operation, stating, “The Freedom Lumbar Disc is a great implant. It’s a very easy system to use and the compressible viscoelastic core restores the natural motion in the lumbar spine. My patient was pain free and out of the hospital in two days.”

AxioMed President Jake Lubinski personally met with Dr. Yang months before the surgery. “Dr. Yang’s disc replacement expertise led him to deciding the AxioMed Disc is the best treatment for his patients because it restores natural motion in the spine which ball-and-socket disc replacement cannot do.” Lubinski added, “With the addition of the viscoelastic lateral lumbar technique, we expect AxioMed to be the worldwide leader in disc replacement surgery.”

Dr. Yang is an orthopedic spinal surgeon specializing in complex spine reconstruction and vertebral tumor surgery, as well as all aspects of adult and pediatric spine surgery. Prior to joining his current practice – BrizBrain & Spine – in 2013, Dr. Yang was director of orthopedic surgery and director of spine surgery fellowship at the Royal Brisbane and Women’s Hospital.

View motion footage of the AxioMed Freedom Lumbar Disc here.

About AxioMed
Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom® Disc through clinical studies in the U.S. and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.

CHARLOTTE, N.C., Sept. 18, 2017 (GLOBE NEWSWIRE) — Two Charlotte, N.C.-based orthopedic hand surgeons are pioneering new amputee surgeries that are offering patients unparalleled use of their upper extremities. OrthoCarolina hand surgeons Glenn Gaston and Bryan Loeffler are performing and developing multiple new surgical techniques for upper extremity amputees, including Targeted Muscle Reinnervation (TMR), which transplants nerves and allows them to reinnervate, or grow into, another muscle. TMR surgery enables nerve signals that have been transferred into a new muscle to control prostheses as a normal human arm would, using nerve impulses sent directly from the brain.

One of Dr. Gaston and Loeffler’s most recent and notable TMR patients is 32-year old mother of three Tiffany Johnson who lost her right arm when she was bitten by a shark while snorkeling off the coast of the Bahamas in June. The surgeons amputated Johnson’s arm just below the elbow joint. With badly damaged muscles and skin, the surgeons’ challenge was to keep the amputation below the elbow to ensure functional and sustained use of the limb. They transferred nerves that controlled the hand from the severed limb to another part of the arm, reinserting those nerves into another muscle. In their new location Johnson’s nerves can function as they would have previously. She is in the process of learning to use her new myoelectric hand, which is controlled by signals from her brain.

“Reassigning nerves to another part of the limb allows a patient easier control of their prosthesis and can also significantly reduce the phantom pain often felt by amputees,” said Dr. Gaston. “Even when a limb is gone, nerves are still available for the body to use.”

Drs. Loeffler and Gaston are developing other innovative forms of TMR by adapting the principles to other parts of the body including the forearms and legs. They also completed the first surgery for the prosthetic hand with individual finger control in 2016.

Beyond TMR, the doctors are leading experts in other advanced nerve reconstruction surgeries for adults and children with spinal cord injuries as well as brachial plexus injuries. They lead the the OrthoCarolina Reconstructive Center for Lost Limbs, a multidisciplinary clinic intended to help upper extremity amputees by offering patients the latest surgical innovations and technology to help them restore maximum limb performance and live life to the fullest. Cutting-edge techniques and surgeries include targeted muscle reinnervation, the STARFISH procedure (developed by the OrthoCarolina Hand Center), and flexion osteotomies to improve prosthetic fit and control. The Clinic coordinates with local and regional prosthetists and utilizes the most advanced myoelectric prostheses available.

“By coming to the clinic individuals who have amputations can meet with multiple healthcare providers and address variety of daily challenges that affect their lives, including general health and wellness, mobility, independence and more,“ said Dr. Loeffler. “It is also a chance for patients to meet others who have their same injuries or who have had similar surgeries, which goes a long way in dealing with the emotional part of their injury.”

Drs. Gaston and Loeffler have recently received awards from the American Academy of Orthopaedic Surgeons (AAOS) and have spoken at numerous international meetings about their work in the field of upper extremity reconstruction for amputees. Read more at orthocarolina.com.

About OrthoCarolina
With expert physicians and care providers in locations throughout our region, OrthoCarolina is one of the nation’s leading orthopedic practices and your destination for comprehensive orthopedic care. Our expertise in the areas of foot and ankle, hand, hip and knee, shoulder and elbow, spine, sports medicine and pediatrics to offer a continuum of care unmatched in our region — and throughout the country.

OrthoCarolina. You. Improved.

Connect with OrthoCarolina at orthocarolina.com or on Facebook, Twitter and YouTube.

Contact:
Logan Stewart
704.323.2486
logan.stewart@orthocarolina.com

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

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