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BiologicsRegulatoryTop Stories

MiMedx Agrees To Lawsuit Settlement With Halo Wound Solutions

November 1, 2017 OrthoSpineNews

MARIETTA, Ga., Nov. 1, 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 that the Company has agreed to a confidential settlement of the lawsuit the Company filed against BioResolutions LLC d/b/a Halo Wound Solutions (Halo) and one of the Halo executives.

MiMedx filed its lawsuit against Halo and its executive, Tracy Lucas, in January 2017. In its suit, MiMedx alleged that Lucas used MiMedx trade secrets and other confidential, proprietary business information to unlawfully solicit the sales of Halo’s medical products with the assistance of MiMedx employees, and tortiously interfered with MiMedx’s contracts with its employees. Mr. Lucas is a former employee of MiMedx. MiMedx alleged that during and after Mr. Lucas’ employment with MiMedx, Halo and Mr. Lucas engaged in wrongful conduct with MiMedx employees, knowing they were actively employed by MiMedx and knowing that MiMedx employees have contractual and legal obligations to the Company.

In addition to an undisclosed monetary settlement, other settlement terms were reached. Certain of these additional settlement terms include: for a period of two years Halo will not sell amniotic tissue products, human tissue/skin substitute products to MiMedx’ existing customers; and  for a two-year period, Halo will not solicit MiMedx employees to work for Halo in any fashion or to leave MiMedx’s employment. Luke Esslinger, President and CEO of Halo, stated, “I apologize that this situation arose. To our knowledge, MiMedx was not aware that its employees were selling third party products or services, including Halo products. We realize now that MiMedx firmly disapproves of its employees selling our products and that such a situation had the potential to create a conflict with the rightful obligations these employees had with their employer, MiMedx.”

Parker H. “Pete” Petit, MiMedx Chairman and CEO, said, “We are pleased to have another one of these lawsuits behind us. We have reached an amicable and favorable settlement with Halo. I applaud Halo for dealing with this in a professional manner and treating it as a learning experience for their future business activities.”

“We have been very effective in continuing our growth trajectory and sustaining our operational excellence, in spite of these corporate distractions. Our constant focus has been on growing our business for the benefit of our customers and their patients, employees and shareholders. I could not be more proud and complementary of our organization for its continued concentration on our business while these distractions are being resolved,” added Bill Taylor, MiMedx President and COO.

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 potential outcomes of legal actions.  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 different or additional facts may be discovered that change conclusions, and the risks of litigation.  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.

Related Links

http://www.mimedx.com

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RegulatorySpine

Pinnacle Spine Files with FDA for 510(k) Clearance to Market their InFill® Lateral Fusion System with PEEK-OPTIMA™ HA Enhanced Polymer

November 1, 2017 OrthoSpineNews

DALLAS & THORNTON CLEVELEYS, UK (PRWEB) OCTOBER 31, 2017

Pinnacle Spine Group, LLC, the pioneer of in situ graft delivery in spinal fusion, today announced it has filed an application with the Food and Drug Administration (FDA) seeking 510(k) clearance to market its lateral InFill® Lumbar Fusion Systems with PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial Solutions (Invibio).

Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. Invibio’s PEEK-OPTIMA HA Enhanced polymer is an implantable biomaterial grade that combines two clinically proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA and Hydroxyapatite (HA), a well-known osteoconductive material. PEEK-OPTIMA HA Enhanced encourages bone on-growth on all surfaces of a device while providing the strength, versatility and performance advantages of its proven predecessor, PEEK-OPTIMA Natural.

“We are excited about the possibility of combining the proven clinical benefits of Invibio’s PEEK-OPTIMA HA Enhanced with the benefits of Pinnacle Spine’s patented InFill technology,” said Zach Sowell, President of Pinnacle Spine Group. “Once cleared we believe the combination of these two technologies will provide surgeons with an ideal solution for improved outcomes in lumbar fusion, one of the more challenging approaches to achieve successful fusion.”

“Pinnacle Spine Group and Invibio share a passion for trying to improve the effectiveness of bone growth in the graft space,” said John Devine Medical Business Director, Invibio Biomaterial Solutions. “The combination of Pinnacle’s technology with our own pioneering materials feels like an obvious collaboration.”

Invibio´s PEEK-OPTIMA HA Enhanced biomaterial offers all the clinical advantages of PEEK-OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. Developed by Invibio, a leading provider of biomaterial solutions, this innovative high performance polymer for spinal fusion implants eliminates the extra processing time and expense of alternative bone on-growth technologies, such as coatings. Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both the US (FDA 510(k) clearance) and Europe (CE mark approval).

Pinnacle Spine Group was recently granted a new patent related to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies. In addition, Pinnacle was recently awarded a new patent related to the architecture of the lateral implant. These latest patents follow the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in Australia, Canada and Europe.

Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.

About Pinnacle Spine Group, LLC

Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-510(k) cleared InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.

About Invibio Biomaterial Solutions

Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. Further information is available on Invibio´s new website: https://invibio.com
INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

Contact:
Mr. Zach Sowell, President
Pinnacle Spine Group, LLC
214-466-1428

Contacts
Invibio Biomaterial Solutions
Barbara Pasciak, Marketing Communications Manager
barbara.pasciak(at)invibio(dot)com, Phone +1 484-342-6041

Victrex media contact
Beate Sauer, PR & Marketing Communications Manager
bsauer(at)victrex(dot)com, Phone +49 61 92 / 96 49 19

Victrex: Group media or Investor Relations enquiries
Andrew Hanson, Director of Investor Relations & Corporate Communications
ahanson(at)victrex(dot)com, Phone +44 12538 98121

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Regulatory

Medacta Receives FDA Clearance for Anatomic and Reverse Shoulder Systems

October 27, 2017 OrthoSpineNews

October 26, 2017

CHICAGO–(BUSINESS WIRE)–Medacta International, developer of innovative surgical techniques and products for the hip, knee, spine, and sports medicine disciplines, recently expanded its expertise to the world of shoulder surgery. The family-owned orthopedics leader today announced it has received FDA clearance for the Anatomic Shoulder and Reverse Shoulder components of its modular Medacta Shoulder System. The company also announced the successful completion of the first surgery in the United States utilizing the system, which was performed by Matthew D. Saltzman, M.D., Associate Professor of Orthopaedic Surgery at the Northwestern Memorial Hospital in Chicago, Illinois.

“The procedure went very well,” said Dr. Saltzman, who specializes in shoulder and elbow surgeries and has been practicing orthopedics for 14 years. “The Medacta Shoulder System’s instrumentation and implants allow for impressive anatomic restoration, resulting in an efficient surgery and, hopefully, improved patient outcomes.”

The Medacta Shoulder System, unveiled in February 2017 following its first ever surgery in Europe, is a modular solution that features a broad range of options, including wide-ranging sizes, adjustable offset, and innovative configurations. Developed by an international team of expert surgeons, the platform offers the modularity and compatibility demanded by today’s marketplace, while still respecting anatomic conversion from primary to reverse.

The Shoulder System is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute’s Clinical Excellence Program and is part of a multi-center, post-marketing, prospective, open clinical study that will collect clinical and radiological outcomes for the next ten years. The M.O.R.E. Institute provides continuous educational and developmental support to Medacta surgeons as they work towards discovering new technologies and supporting patients.

“The new Medacta Shoulder System is a continuation of our effort to improve orthopedic implant design and configurability for the benefit of both surgeons and their patients,” said Francesco Siccardi, Executive Vice President of Medacta International. “This latest surgery in the United States marks a milestone for Medacta in line with our company’s patient-centric vision and the same ambition that has helped us become a leader in knee, hip, and spine technology.”

Medacta will launch the Shoulder System for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting, which will be held in New Orleans in March 2018. For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta International

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

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BiologicsRegulatorySpine

Prosidyan Announces FDA Clearance and Commercial Launch of Its FIBERGRAFT BG MATRIX for Poster-Lateral Spinal Fusion

October 26, 2017 OrthoSpineNews
Warren, NJ, October 26, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today FDA 510(k) clearance and full commercial launch of FIBERGRAFT BG Matrix – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Matrix is the third generation product in the company’s FIBERGRAFT line of bioactive glass fiber based products. FIBERGRAFT BG Matrix leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary type I collagen based bioactive carrier.

FIBERGRAFT BG Matrix – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseaous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Here are some comments from the early users of FIBERGRAFT BG Matrix:
Dr. Paul Slosar MD of the San Francisco Spine Institute commented, “I have an interest in the growing scientific research focused on bone graft extenders and am impressed by the FiberGraft’s basic science data. I recently had the opportunity to use the Fibergraft Matrix in several cases where I needed to augment my posterior fusion, when we didn’t have enough autograft. The Fibergraft had excellent handling characteristics and interdigitated very nicely with the host bone. The Fibergraft provided me with an excellent option to reinforce my bone graft and, based on their scientific data, I anticipate excellent clinical fusion results.”

Dr. Adam Bruggeman MD of the Texas Spine Care Center commented, “Fibergraft Matrix from Prosidyan is an innovative update to their leading fiber based bioglass portfolio. Matrix is easy to manipulate, allowing for multiple applications. It is now my preferred graft for all biologic applications in the spine.”

Dr. Todd Allen, MD, PhD Associate Professor Orthopaedic Surgery UCSD commented, “The structural and handling features are dynamic and second to none with an innate ability to wrap around bony structures and wick needed blood and cells to the region. The structural and biologic capabilities of this unique synthetic are powerful, and make this a great product for the future of spine surgery, both in open and MIS applications.”

Prosidyan’s Founder & CEO Charanpreet Bagga informed that FIBERGRAFT BG Matrix was presented at the 2017 North American Spine Society Innovative Technology Presentations on October 25th by Dr. William Walsh PhD, of UNSW. There were only seven technologies selected for presentation at this forum and FIBERGRAFT is the only synthetic bone graft substitute selected for this prestigious forum.

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 9,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.
Contact Information
Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com
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Regulatory

FzioMed Receives FDA Approval for Small Confirmatory Study of Oxiplex® in Patients Undergoing Lumbar Surgery for Disc Herniation

October 24, 2017 OrthoSpineNews

October 23, 2017

SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc., a biomaterials company celebrating 21 years in business, has received approval from FDA to conduct a small confirmatory study of Oxiplex® in the United States.

Oxiplex® is an absorbable, synthetic viscoelastic gel that is applied following partial discectomy, with the intent to reduce postoperative leg pain, back pain and neurologic symptoms.

“We have been working with FDA for many years to bring this technology to the US,” said John Krelle, President and CEO of FzioMed, “and we are confident that a new level of cooperation with FDA will finally enable patients in this country to experience the benefits of Oxiplex following the large number of lumbar surgeries performed here.”

Multiple US and OUS studies have already demonstrated the benefits of Oxiplex® and this study will target patients with higher levels of back and leg pain who do not always experience the level of pain relief offered by surgery alone.

FzioMed is pleased to be working with Musculoskeletal Clinical Regulatory Advisers (MCRA) as both regulatory advisor and CRO on this study, which will be posted on Clinicaltrials.gov when open for enrollment.

About FzioMed, Inc.

FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable surgical biomaterials based on its patented scientific technology. For more information, please contact John Krelle at jkrelle@fziomed.com. You can also visit www.fziomed.com or contact investorrelations@fziomed.com.

FzioMed®, Oxiplex®,Oxiplex/AP®, Laresse® and Dynavisc® are registered trademarks of FzioMed, Inc.

Contacts

FzioMed, Inc.
John Krelle
jkrelle@fziomed.com

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RegulatorySpineTop Stories

Astura Medical Receives FDA 510(k) Clearance For BRIDALVEIL OCT Stabilization System

October 24, 2017 OrthoSpineNews

CARLSBAD, CA – October 19, 2017 – Astura Medical, a high growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System.

“The FDA 510(k) clearance of our BRIDALVEIL OCT System, demonstrates the power of our innovation engine at Astura Medical and represents our best system released to date. We are excited for the opportunity to provide our rapidly expanding group of surgeon partners the most complete OCT technology offering on the market today, to further enhance their ability to provide the best in patient care,” said Thomas Purcell, Vice President.

Designed with the most complex and demanding cases in mind, BRIDALVEIL OCT provides a comprehensive offering of screw options (single-lead, dual-lead, high-top, and smooth shank) ranging from 3.5mm to 5.5mm in diameter that are compatible with either a 3.5mm or 4.0mm rod in titanium or cobalt chrome. The system also provides an extensive line of connectors, transition rods, and instrumentation options to allow surgeons the ability to seamlessly transition across multiple segments of the spine.

The launch of BRIDALVEIL OCT represents the 11th system launched since the company was founded in 2014. The company anticipates high demand for BRIDALVEIL OCT in addition to the robust growth seen in its current line of products.

Astura Medical will be showcasing BRIDALVEIL OCT, along with the Company’s other systems at Exhibit 565 during the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, mulit-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

 

Media Contact:

Steve Haayen

Astura Medical

858.472.8825

steve@asturamedical.com

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RegulatorySpineTop Stories

Implanet Announces CE Mark Clearance for JAZZ® Passer

October 19, 2017 OrthoSpineNews

October 19, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY)(Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received European regulatory clearance through the CE Mark to market the new JAZZ® Passer.

Following 510(k) marketing clearance from the FDA in September for the US market, Implanet has just received the CE Mark for its new JAZZ® Passer product line.

This new milestone will allow Implanet to offer its latest technological development in the world’s second largest spine surgery market, worth an estimated $800 million1.

Ludovic Lastennet, CEO of Implanet, says: “This innovation will accelerate the adoption of JAZZ® technology by new European surgeons. This highly dynamic market is driven by France and Germany, regions where we are active, notably in the high potential adult degenerative bone disorder segment. At the recent Eurospine conference in Dublin, we saw enthusiasm for our solution from health professionals and surgeons. We were able to show, during a thematic evening with more than 50 participants and throughout this conference, how easy to use our latest innovations are.”

As a reminder, JAZZ® Passer is a compatible solution with the JAZZ® Platform, providing new options in terms of accessing and working around anatomical structures.

IMPLANET will participate in the following scientific conventions in Q4-2017
NASS in Orlando, October 25 to 28, 2017
SOFCOT in Paris, November 6 to 9, 2017
ICEOS in San Diego, November 15 to 17, 2017

Next financial press release: 2017 annual revenue, on January 16, 2018 (before market)

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

1 Source : Global Data

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

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RegulatoryTop Stories

Lamar Alexander and Patty Murray announce bipartisan Senate deal to prop up Obamacare

October 17, 2017 OrthoSpineNews

, USA TODAY/October 17, 2017

WASHINGTON — Democratic and Republican leaders in the Senate announced they have reached a bipartisan deal to shore up the Affordable Care Act health insurance markets for two years while Congress continues to grapple with GOP efforts to replace the law.

Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., the leaders of the Senate health committee, said Tuesday they have struck a deal for a two-year extension of subsidies for insurance companies to cover low-income clients — subsidies that President Trump canceled last week.

Alexander told reporters the deal would also expand authority for states to experiment with alternative standards for insurance plans that deviate from federal requirements, but it would not do away with the requirement to cover people with pre-existing conditions. The deal would also not eliminate so-called essential health benefits — such as mental health and maternity care — that insurance plans must cover.

Republican efforts to repeal Obamacare ran aground in part because of concerns of both Democrats and Republicans that these provisions would be eliminated.

The agreement would involve a two-year extension of federal payments to insurers that Trump halted last week. Unless the money is quickly restored, insurers and others say that will result in higher premiums for people buying individual policies and in some carriers leaving unprofitable markets.

“This agreement avoids chaos,” Alexander said. “Over the next two years, I think, Americans won’t have to worry about the price of health (insurance) and being able to buy insurance in the counties where they live.”

 

READ THE REST HERE

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BiologicsRegulatoryTop Stories

MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee

October 17, 2017 OrthoSpineNews

MARIETTA, Ga., Oct. 17, 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 been notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) Phase 2B clinical study for osteoarthritis of the knee may proceed.

The clinical study consists of a Phase 2B, prospective, double-blinded, randomized controlled trial of MiMedx’s AmnioFix® Injectable (micronized dehydrated Human Amnion Chorion Membrane), compared to saline placebo in the treatment of knee osteoarthritis. The trial will enroll approximately 318 patients and the Company expects patient enrollment to commence in the next quarter.

In the Company’s press release of September 19, 2017, MiMedx announced that it had filed for this IND Phase 2 to be initiated. In that press release, the Company indicated 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 osteoarthritis of the knee. The primary efficacy endpoints of this study will be the change in Visual Analog Scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group. The primary safety endpoint will be the proportion of product-related Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during 12 months following injection in the AmnioFix Injectable group versus the placebo-control group.

Parker H. “Pete” Petit, CEO, said, “This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix Injectable. We are pleased to receive the FDA’s notification that we can proceed with another IND study in the Orthopedic/Sports Medicine area. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities.”

Bill Taylor, President and COO, stated, “The first two ‘Biologics License Application (BLA) indications for use’ we are currently targeting for AmnioFix Injectable are General Tendonitis and Osteoarthritic Knee Pain, which represent approximately 80% of the more than 15 million injections done each year to treat musculoskeletal pain. We believe the results of our BLA clinical trials and safety profile will demand a price per dose of $1,000 or more. This expands the musculoskeletal degeneration market for our first two BLA products to more than a $12 billion U.S. market opportunity. We believe the non-degenerative aspect and potential reduction in opioid use due to our Amniotic Injectable product will drive significant adoption. We expect the study results to be compelling, and we look forward to the prospects of clinicians utilizing AmnioFix Injectable in the treatment of these debilitating conditions.”

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, expectations as to pricing and market opportunity, 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; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; reimbursement decisions by public and private payers may not occur as expected; and market opportunities may not materialize or may change in the future.  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.

Related Links

http://www.mimedx.com

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RegulatoryRoboticsTop Stories

TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System

October 16, 2017 OrthoSpineNews

October 13, 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 received FDA 510(k) clearance for the Senhance™ Surgical Robotic System.

“The clearance of the Senhance System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “Millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”

With this clearance, the Senhance becomes the first new market entrant into the field of abdominal surgical robotics since 2000. Using the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. The system builds on the foundation of laparoscopy and features the security of haptic feedback and eye-sensing camera control for the first time in a robotic surgery platform. Additionally, the Senhance utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. The system is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments.

“Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries,” said Dr. Steve Eubanks, a general surgeon and Executive Director of Academic Surgery at Florida Hospital. “The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”

TransEnterix will host a conference call on Tuesday, October 17, 2017 at 8:00 AM ET to discuss the FDA clearance of the Senhance. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, reference conference code 1546349. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

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 received FDA 510(k) clearance and has been granted a CE Mark. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to 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 and include whether the Senhance Surgical Robot will deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals, whether the Senhance System will maximize value for hospitals and whether the Senhance platform grants laparoscopic surgeons robotic precision, control of surgeon’s vision and haptic feedback while minimizing procedural costs. 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 filed on March 7, 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:
Mohan Nathan, +1-919-765-8400
media@transenterix.com

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