Bioventus Receives US FDA Approval for DUROLANE®

Posted On September 5, 2017 By OrthoSpineNews In Biologics, Regulatory /

September 05, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has received US FDA approval for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Hyaluronic acid is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues within the knee.

“More than 20 million Americans are afflicted with knee osteoarthritis and there is no cure, but the associated pain can be managed,” said Tony Bihl, CEO of Bioventus. “DUROLANE has been a proven knee OA pain reliever for more than 15 years, improving the lives of more than one million people worldwide. It will join our current offerings to provide even more efficacious treatment options for US patients, physicians and payers.”

DUROLANE will complement the company’s OA portfolio which includes three-injection HA GELSYN-3™ and the five-injection HA SUPARTZ FX™. Bioventus markets and sells DUROLANE in more than 25 countries including Canada, Mexico, Australia, and throughout much of Europe. It plans to launch DUROLANE the US market in early 2018.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^®Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3, is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corporation.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Mainstay Medical Announces CEO Leadership Transition

Posted On September 5, 2017 By OrthoSpineNews In Neuro, Spine /

Dublin – Ireland, 5 September 2017 – Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8^®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that Mr. Jason Hannon will succeed Mr. Peter Crosby as Chief Executive Officer with effect from October 9, 2017. Mr. Hannon’s appointment results from the Company’s succession planning associated with the retirement of Mr. Crosby at the end of October, 2017. Mr. Hannon will also be appointed as a Director with effect from October 9, 2017.

Mr. Hannon most recently served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions. His prior roles at NuVasive, Inc. include Executive Vice President of International, Executive Vice President of Business Development and Strategy, and General Counsel. During his 12 year tenure at NuVasive, the company’s commercial presence was expanded globally to more than 40 countries and revenue grew from $61M to $962M.

Dr. Oern Stuge, Chairman of Mainstay commented: “Mainstay has made tremendous progress since the founding of the Company in 2008 under Mr. Crosby’s leadership, and as we move forward to the next phase we are delighted that Jason is joining as our new CEO. Jason’s broad medical device experience has spanned areas critical to the future success of Mainstay: commercialization of new products, penetration of new markets, product innovation, strategic and financial planning, raising capital, regulatory and clinical management and the building of a high-performance culture that will attract the most talented people to our company.”

Mr. Hannon said: “Mainstay has developed a strong foundation in its scientific, clinical and regulatory accomplishments to date. The dedicated team has done the pioneering work to establish a new market – ReActiv8 seeks to help the body repair itself rather than merely masking pain. This has created the potential of bringing an entirely new option to people suffering from chronic back pain. I am impressed by the work done to get to this point, and I look forward to working with the entire team to advance the mission.”

In the period up to his retirement date, Mr. Crosby will act as Special Adviser to the new CEO, and will continue to work with the Company as a consultant up to the end of 2020. He will also continue to act as a Director until the conclusion of the Company’s Annual General Meeting to be held on Friday, 22 September 2017, when he will retire as a Director.

Mr. Crosby led Mainstay in its development of ReActiv8 from concept to commercialization. He was recruited as the Company’s first CEO in 2009 to build the Company and its team and to develop ReActiv8. Mr. Crosby led Mainstay through its Series A and Series B fundraisings to its IPO on Euronext Paris and the ESM of the Irish Stock Exchange in 2014, and its subsequent debt and equity fundraisings. In addition to fundraising, Mr. Crosby was a driving force in the development of ReActiv8 from concept stage through multiple clinical trials to CE Mark approval in 2016, start of the ReActiv8-B clinical trial to gather data for US approval, and first commercialization in Germany and Ireland in 2017. Mr. Crosby said: “I am proud of what we have achieved as a team, and I am confident that the Company will be in good hands under Jason’s leadership. I look forward to remaining involved with the Company into the future, to ensure continuity with our employees, consultants and investigators.”

Dr. Stuge concluded: “On behalf of Mainstay’s Board, management team and staff, I would like to thank Peter for his substantial contribution to the Company’s growth over the last eight years. Peter’s tireless efforts in building the Company from start-up stage through multiple fundraisings, product development and clinical trials to initial commercialization has positioned the Company well for the future. We look forward to continuing to work with Peter into the future.”

ADDITIONAL INFORMATION:

Mr Hannon holds no interest in ordinary shares of Mainstay, and, other than as set out below, there is no further information to be disclosed under schedule 2(g) and Rule 17 of the ESM Rules in respect of Mr Hannon’s appointment to the board of Mainstay.

Mr Jason Marshall Hannon (aged 45) is, or has been, a director of the following companies during the previous five years:

Previous Directorships:

Nemaris, Inc.

This announcement contains inside information within the meaning of the EU Market Abuse Regulation 596/2014

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8^®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-B Clinical Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay‑medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:

Consilium Strategic Communications (international strategic communications – business and trade media)

Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys

Tel: +44 203 709 5700 / +44 7921 697 654

Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)

Jonathan Neilan
Tel: +353 1 765 0886

Email: jonathan.neilan@fticonsulting.com

NewCap (for France)

Louis-Victor Delouvrier

Tel: +: +33 1 44 71 98 53

Email: lvdelouvrier@newcap.fr

AndreasBohne.Com/Kötting Consulting (for Germany)

Andreas Bohne

Tel : +49 2102 1485368

Email : abo@andreasbohne.com

Investor Relations:

LifeSci Advisors, LLC

Brian Ritchie

Tel: +1 (212) 915-2578

Email: britchie@lifesciadvisors.com

ESM Advisers:

Davy

Fergal Meegan or Barry Murphy

Tel: +353 1 679 6363

Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8^®, the progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

ApiFix Signs Distribution Agreement in Canada; Completes First Cases in North America at IWK Health Centre Hospital, Halifax

Posted On September 5, 2017 By OrthoSpineNews In Spine, Top Stories /

ApiFix has invented and developed a non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). The implant system is inserted in a minimally invasive surgical procedure. The ApiFix system aims to improve the quality of life of patients who undergo scoliosis surgery, save hospitalization and OR time, and substantially reduce costs and recovery time associated with standard scoliosis surgery. In contrast to standard scoliosis surgery, the ApiFix system represents a game-changer in the market, with a spinal implant system, inserted in a short procedure, followed by a brief recovery period, and maintains spine flexibility.

“With our vast experience in the spine surgical field, we instantly understood the significance of the device for scoliosis patients and its market potential. We are delighted to join forces with ApiFix and exclusively distribute their products in Canada,” stated Joint Solution Alliance President, Alan Tanner.

ApiFix CEO Eran Feldhay, M.D. remarked: “We are excited to begin our penetration in the North American markets with Canadian patients. We are convinced that together with JSA we’ll succeed in delivering the ApiFix solution to more patients around the world.”

About ApiFix

ApiFix is an innovation-driven medical device company focused on providing less invasive solutions for scoliosis patients. ApiFix’s leading product for non-fusion treatment of adolescent idiopathic scoliosis (AIS) is used today in Europe. ApiFix is led by a team of highly-regarded spine surgeons and veteran spine specialists. The company has CE clearance and is marketed in Germany, Italy, Greece, The Netherlands, Spain, Australia and Israel.

ApiFix Principals will be available to discuss the ApiFix system, clinical cases and their follow-up to potential spine surgeons from all over the world during the annual meeting of the Scoliosis Research Society, (SRS) in Philadelphia, USA on September 5-8.

Contact:
Saar Wollach,
ApiFix Sales & Marketing Manager,
+972-54-4511512,
saar@apifix.com

SOURCE ApiFix

MediPoint: Partial Knee Replacement – South America Analysis and Market Forecasts

Posted On September 1, 2017 By OrthoSpineNews In Recon /

NEW YORK, Aug. 31, 2017 /PRNewswire/ — MediPoint: Partial Knee Replacement – South America Analysis and Market Forecasts

Summary

Read the full report: https://www.reportlinker.com/p05089140

Over the past two decades, there has been increasing interest in Partial knee replacement (PKR) as a means of treating unicompartmental knee osteoarthritis. Indications have expanded while previous contraindications such as age, body mass index, patellofemoral osteoarthritis, and anterior cruciate ligament (ACL) deficiency have been lifted. Technological advancements in implant design, fixation methods, and surgical techniques have led to improved survival rates, better patient-reported outcomes, and reduced complications. Interest is growing in robotic-assisted techniques, which are poised to optimize results and reproducibility. Cementless designs also look promising, although given the anatomy of the knee condyles, this might introduce more risks to the overall procedure.

South American Partial knee replacement (PKR) market was estimated at $5+M in 2016 across the three markets (Argentina, Brazil, and Chile) covered in this report. By the end of the forecast period in 2023, it is estimated that the market will grow approximately at a Compound Annual Growth Rate (CAGR) of 7+%.Brazil represented the largest portion of the market in 2016, representing more than 70% of the regional revenue, and is expected to maintain this dominance through the forecast period. Argentina is expected to be the fastest-growing market through 2023.

As countries’ economy grows, the volume of partial knee replacement procedures is expected to increase further, primarily due to the demographics of an aging population and a trend towards early surgical intervention in younger patients. In the forecast years, launching and marketing a comprehensive large joint portfolio with a clear value proposition will remain critical to companies’ success as they jockey for market position. A long-term foothold within the global knee market hinges on how well companies can align themselves with the primary market force buffeting healthcare today: the need to deliver top-notch, cost-effective care.

The incidences of osteoarthritis of the knee and other degenerative knee diseases are increasing simultaneously with the aging population. Partial knee replacement (PKR), or unicondylar knee arthroplasty (UKA), is an alternative to total knee arthroplasty (TKA) used to treat patients whose osteoarthritic condition is isolated to the medial or lateral tibio-femoral compartments. PKR is a less invasive procedure than TKA that replaces only the damaged part of the joint with a prosthesis, resulting in less blood loss and the preservation of healthy ligaments, cartilage, and bone in the knee. The decision to undergo a PKR instead of TKR is based on the disease stage, patient expectations, published results, and surgeon expertise.

Given the heightened competitive pressures and shrinking reimbursement, the average selling price for Partial knee replacement (PKR) implants is expected to decline. However, it is expected that the revenue from increased procedure volume will make up for this loss.

This report focuses on the market outlook for Partial knee replacement (PKR) devices in South America (Argentina, Brazil, and Chile). The analysis identifies the key unmet needs in the PKR market, discusses the major drivers and barriers of adoption, and provides an in-depth understanding of physicians’ perceptions and the future outlook for this market by segment and geography.

Key Questions Answered
– What is the current and future Partial knee replacement (PKR) market outlook in the developed and emerging markets? What trends are affecting the South American market?
– Which are the key, high growth markets that PKR manufacturers should expand into?
– What are the unmet needs with the current generation of Partial knee replacement (PKR) devices? How will emerging technologies fulfill these unmet needs?
– What are the challenges and complications that have hindered widespread adoption?
– With developing the next-generation of devices, what aspects of the technology are device manufacturers focused on optimizing? How will new entrants impact the Partial knee replacement (PKR) market?

Scope
– Overview of recent key industry events and analysis of their market impact.
– Annualized total market revenue, procedure trends, and market outlooks by segment and by region through 2023.
– Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement considerations, evaluating market access in each region covered in the report, and implications of the emerging technologies in the market.
– Analysis of the current and future market competition in the global PKR market. Insightful review of industry drivers, barriers, and challenges.

Reasons to buy
The report will enable you to –
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Read the full report: https://www.reportlinker.com/p05089140

About Reportlinker
ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place.

https://www.reportlinker.com

__________________________
Contact Clare: clare@reportlinker.com
US: (339)-368-6001
Intl: +1 339-368-6001

SOURCE Reportlinker

MiMedx Reports MultiCenter randomized Controlled VLU Clinical Study Accepted for Publication in The International Wound Journal

Posted On August 31, 2017 By OrthoSpineNews In Biologics, Top Stories /

MARIETTA, Ga., Aug. 31, 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 their latest peer-reviewed clinical study of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts was accepted for publication in the International Wound Journal.

The paper entitled “A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers,” was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O’Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH. The electronic publication of the article in the International Wound Journal is expected to be made in the next few weeks. At that time, MiMedx expects to issue a follow-up press release with the detailed study results and link to the article.

Parker H. Petit, Chairman and CEO, stated, “This is the first large scale successful Venous Leg Ulcer (VLU) study to be completed in nearly 20 years, and the first large randomized controlled trial (RCT) of this quality on a biological allograft. No other organization has completed such a VLU study and achieved such compelling results. Our EpiFix bilayer allograft is the first and only biologic with these confirmed clinical results. This study is evidence that MiMedx continues to distance itself from our competitors.”

Bill Taylor, President and COO, said, “The 16 week randomized, fifteen-center, clinical trial evaluated the efficacy of MiMedx EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. The 109 subjects were randomized to receive EpiFix in addition to moist dressings and compression or moist dressings and compression alone. The primary endpoint was time to complete healing. Secondary endpoints were the proportion of subjects with complete healing by 12 and 16 weeks.”

Taylor continued, “The study results for the patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing. These results are vastly superior to VLU healing rates reported in studies of other advanced wound care products. In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm²for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm².”

“While we have achieved Medicare reimbursement coverage for both VLU’s and Diabetic Foot Ulcers (DFUs), our breadth of reimbursement coverage with commercial payers is primarily for DFUs. Commercial health insurance plans are heavily influenced by the results of published clinical studies, and numerous clinical studies have been conducted and published that confirm the healing effects of EpiFix on DFUs. With the publication of this study and its compelling results in VLU healing rates, we expect a significant revenue opportunity will develop for MiMedx as commercial payers see this body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of VLUs. We have used very conservative parameters to calculate the impact of gaining additional VLU coverage with payers. We estimate with the impact of this study, MiMedx can obtain VLU coverage for approximately 133 million additional commercial lives,” noted Petit.

Taylor added, “Published data indicates that the prevalence rate of VLUs in the commercial population is 0.183 percent. Assuming three to four EpiFix applications for a VLU, which is a very moderate assumption, and assuming an extremely conservative market penetration rate of 10 to 15 percent, we believe our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance will be between approximately $75 million and $150 million.”

Chris Cashman, EVP and Chief Commercialization Officer, commented, “We are extremely confident in our ability to achieve and exceed our VLU market penetration estimates if additional commercial insurance coverage is gained. Currently, only about 30% of the commercial plans that cover EpiFix for DFUs also cover EpiFix for VLUs as well. This study should dramatically increase that ratio. We now have approximately 350 sales professionals focused on the commercial wound care market, and we anticipate that number to grow to approximately 375 sales professionals by year-end. Given the VLU market opportunity, without even considering the approximate one million acute pressure ulcers that could also benefit from EpiFix applications, we are very excited about the revenue opportunities that this landmark clinical study can facilitate for MiMedx.”

“We are looking forward to soon reporting the full details of this study when the article is electronically published,” concluded Petit.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative 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 timing, results, and publication of clinical studies; the potential safety and efficacy, and additional approved uses and markets for our products; our expectations of how insurers will respond to this data and the size and timing of additional revenue opportunities; the estimated number of sales professionals by year-end; and the advantage over competitors that will be conferred by this result. 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 concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; insurance coverage decisions may not occur as anticipated or coverage requirements may change; that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be unable to hire sufficient qualified sales persons in a timely manner. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, 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.

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joimax®, Inc. Opens Its First Education & Training Center in Irvine, California, Posts Record Sales in the US and Continues to Make Gains with Endoscopic Reimbursement

Posted On August 31, 2017 By OrthoSpineNews In Spine, Top Stories /

August 31, 2017

IRVINE, Calif.–(BUSINESS WIRE)–joimax^® announces the grand opening of its new state-of-the-art Training and Education Center in Irvine, California. The company will be holding its first workshop at the Center on September 8-9th.

As the market leader in endoscopic spine surgery, joimax^® is fully dedicated to outstanding physician education, training and services worldwide. Due to the newly released US CPT reimbursement code, valid since January 1^st, 2017, the demand for joimax^® endoscopic procedures are growing monthly in the USA among patients as well as the physician community. This fast growing demand creates major needs which joimax^®, Inc. is addressing with fast expansion of its US organization.

“This new wet lab facility provides a major base for supporting our fast growing education needs for both our new sales and clinical associates, but moreover it’s a place for physicians to be trained,” states Bob Wolownik, National Director of Sales for joimax^® Inc.

joimax^® also announced that they are taking the lead in supporting this years’ workshops and educational sessions at:

SMISS Sept 14-16, 2017 – Las Vegas, NV
Sole Supporter of the Endoscopic Lab Session

ISASS Sept 22-23, 2017 – Long Beach, CA
Endoscopic Lab Supporter

NASS Oct. 25-28, 2017 – Orlando, FL
Endoscopic Spine Surgery Session Sponsor
and Endoscopic Lab Supporter

joimax^® has also made significant strides in reimbursement support for endoscopic spine procedures via a new external coding support hotline that it manages along with a payor correspondence package. joimax’s Vice President of Operations & Reimbursement, Brian Schneider, recently stated, “We have seen a significant rise in interest from both payors and physicians asking to receive information and streamline communication regarding the new endoscopic spine code.”

“As we received a first CPT reimbursement code for endoscopic spine surgery earlier this year and now invest wisely for future growth, joimax^® will continue to write a major success story in the US, similar to what it has accomplished in Europe and Asia,” states Maximilian Ries, General Manager for joimax^®, Inc. He announced that the company is continuing to post record sales by nearly doubling its year to date US revenues, which is in line with the company’s budget plan.

Overall joimax^® is very pleased with the great strides achieved in the US market and sees continued sustainable growth globally. “All this is an important step towards the full acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the physician and their patients in the US now as well,” echoes Wolfgang Ries, Founder and CEO of joimax^®.

The company’s European and Asian sales also show record numbers. Earlier this year, joimax^® also received multiple new product registrations in Asia and recently in Brazil to fully access this new market.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^® (for facet and sacroiliac joint therapy) or with EndoLIF^® and Percusys^® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press contact USA:
joimax^® Inc.
Melissa Brumley, +1 949 859 3472
Melissa.brumley@joimaxusa.com
or
Press contact Int.:
joimax^® GmbH
Sabine Jarosch, +49 721 25514, ext.213
sabine.jarosch@joimax.com

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Bone Therapeutics appoints Jean-Luc Vandebroek as Chief Financial Officer

Posted On August 31, 2017 By OrthoSpineNews In Biologics /

Gosselies, Belgium, 31 August 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris:BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedic and bone diseases, today announces the appointment of Jean-Luc Vandebroek as Chief Financial Officer, effective 1 September 2017. Jean-Luc will replace Wim Goemaere, who is leaving the Company to take up a senior position within a not-for-profit organisation. Wim will continue to support the Company as a Non-Executive Director, and will lead a managed succession during the transition period.

Jean-Luc Vandebroek is a seasoned finance executive with extensive international finance experience at major public and privately-owned companies. Jean-Luc has built a successful career spanning 15 years at the Belgian-US retailer, Delhaize Group (now Ahold Delhaize). During this period, he held various senior financial positions with increasing responsibility, including roles as Corporate Director Finance Europe and US and Vice President Finance BeLux. He later became Group Chief Financial Officer at Fluxys, a listed, pan-European gas infrastructure group, where he was responsible for the financing of large infrastructure investments using diverse forms of funding on capital markets. Prior to joining Bone Therapeutics, Jean-Luc served as Director and Chief Financial Officer of Moteo Two Wheels and Bihr Europe, the motorcycle division of Alcopa Group, a Belgian family holding with an annual revenue of around EUR 1.7 billion.

Steve Swinson, Chairman of Bone Therapeutics, commented: “We are pleased to welcome Jean-Luc Vandebroek to Bone Therapeutics. With his strong financial acumen, experience leading commercial-stage companies and understanding of corporate finance, Jean-Luc is well equipped to oversee Bone Therapeutics’ financial planning needs in its increasingly mature phase of development. The Board wishes to express its gratitude to Wim Goemaere for his significant contribution to the development of Bone Therapeutics, including stewarding the Company through a successful initial public offering in 2015 which raised EUR 37 million. We are glad that he will continue to support the Board of Bone Therapeutics as a Non-Executive Director and wish him well in his new role.”

Commenting on his appointment, Jean-Luc Vandebroek said: “I am delighted to be joining Bone Therapeutics at this exciting time in its development. I look forward to working with the Board and management team to help deliver value to shareholders and bring Bone Therapeutics’ innovative cell therapy products closer to the market and to patients.”

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB^®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB^®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA

Thomas Lienard, Chief Executive Officer

Wim Goemaere, Chief Financial Officer

Tel: +32 (0)2 529 59 90

investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:

Consilium Strategic Communications

Amber Fennell, Jessica Hodgson and Hendrik Thys

Tel: +44 (0) 20 3709 5701

bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:

NewCap Investor Relations & Financial Communications

Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau

Tel: + 33 (0)1 44 71 94 94

bone@newcap.eu

For US Media and Investor Enquiries

Westwicke Partners

John Woolford

Tel: + 1 443 213 0506

john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Bone Therapeutics SA via Globenewswire

This article appears in: News Headlines

Referenced Stocks: BOTHE

Seven of Colorado’s Top Private Orthopedic Practices Come Together to Form Orthopedic Centers of Colorado, Now the State’s Largest Practice

Posted On August 31, 2017 By OrthoSpineNews In Extremities, Spine, Sports Medicine, Top Stories /

DENVER, Aug. 31, 2017 /PRNewswire/ — Fifty-six of Colorado’s top orthopedic physicians, across seven practices, have united under a common vision of improving outcomes, efficiency, cost, and quality to form Orthopedic Centers of Colorado, LLC (OCC). With 19 offices across the Denver metro area, the combined practice is the largest provider of orthopedic and musculoskeletal care in the state.

The seven practices coming together as Orthopedic Centers of Colorado, LLC are:

Advanced Orthopedic & Sports Medicine Specialists P.C.
Colorado Orthopedic Consultants, P.C.
Denver Spine Surgeons, LLC
Denver-Vail Orthopedics, P.C.
Hand Surgery Associates, P.C.
Orthopedic Associates, LLC
Peak Orthopedics & Spine, PLLC

In a market where just 33 percent of physicians work in independent practice, down from 48 percent in 2012, this formation represents a physician-driven commitment to the private-practice model of medicine.

“The private-practice model has proven to deliver a higher level of quality at a more competitive price,” said Davis Hurley, MD, president of Orthopedic Centers of Colorado. “Patients will continue to benefit from the more personalized approach that private practice delivers to accommodate each patient’s needs.”

As a physician-driven organization, OCC will remain nimble enough to adapt to the ever-changing healthcare landscape, and emerge as pioneers in improved patient outcomes and reduced costs, while maintaining strong personal relationships with the patients from the communities we serve.

The seven practices will begin operating as Orthopedic Centers of Colorado on September 1, 2017. Patients of the practices will see no interruption in their care and services and will begin to see the OCC name on patient communications.

About Orthopedic Centers of Colorado, LLC
The number one choice for orthopedic, hand and spine health in Colorado and the Rocky Mountains, Orthopedic Centers of Colorado is an independent group of 56 physicians focused on patient specific care, quality outcomes, value and continuous improvement. We’ve assembled the best doctors across nearly 30 areas of expertise including Colorado’s best sports medicine and orthopedic physicians. Patients can visit any of our 19 convenient locations for care from doctors who believe quality patient care starts with a great patient experience. Learn more at orthocentersco.com

SOURCE Orthopedic Centers of Colorado, LLC

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Global Cartilage Repair Market 2017-2021 with Acelity, DePuy Synthes, Stryker & Smith & Nephew Dominating

Posted On August 31, 2017 By OrthoSpineNews In Sports Medicine /

DUBLIN, August 31, 2017 /PRNewswire/ —

The “Global Cartilage Repair Market 2017-2021” report has been added to Research and Markets’ offering.

The global cartilage repair market to grow at a CAGR of 11.59 % during the period 2017-2021.

The treatment of articular cartilage has evolved tremendously in the past decade. Reparative and restorative methods have been developed to address the significant source of morbidity in the young and active patients. Articular cartilage injury can be focal, which is localized or systemic. Procedures are being developed not only to alleviate the symptoms associated with articular cartilage defects but also to limit the progression of cartilage damages into degenerative diseases.

According to the report, one of the major drivers for this market is Rising incidence of accidental injuries. Globally, the road traffic injuries are increasing, with post complicated symptoms such as weakening of tendons, cartilage tear, and orthopedic issues.

The latest trend gaining momentum in the market is Gene therapy and stem cell therapy. Gene therapy is one of the promising fields in the cartilage repair. Many clinical studies have been performed for cartilage repair. The researchers are trying to develop gene therapy for cartilage repair and currently been investigated for clinical application.

Further, the report states that one of the major factors hindering the growth of this market is Product side effects. Surgeons use cartilage repair products such as tissue scaffold to improve the recovery. These products once grafted in the body may cause serious complications, resulting in their increased scrutiny for safety and efficacy. In many autologous chondrocyte implantation, there were common complications such as graft rejection, symptomatic hypertrophy, disturbed fusion and delamination.

Key vendors

Acelity
DePuy Synthes
Stryker
Smith & Nephew

Other prominent vendors

AlloSource
Bio-Tissue
CellGenix
Collagen Solutions
Geistlich Pharma
Orteq
RTI Surgical
TORNIER
Vericel
XTANT MEDICAL

Key Topics Covered:

Executive Summary
Scope Of The Report
Research Methodology
Introduction
Market Landscape
Market Segmentation By Product
Market Segmentation By End-User
Geographical Segmentation
Drivers And Challenges
Market Trends
Vendor Landscape
Key Vendor Analysis
Appendix

For more information about this report visit https://www.researchandmarkets.com/research/sng3nx/global_cartilage

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

Tiny cameras to help AHN doctors evaluate damaged knees

Posted On August 30, 2017 By OrthoSpineNews In Sports Medicine /

Aug. 29, 2017 – BEN SCHMITT

Highmark Health and Allegheny Health Network are exploring handheld diagnostic technology that could one day reduce the need for MRI in diagnosing some knee injuries, such as meniscal tears.

The health care networks on Tuesday announced a collaboration with medical device company Trice Medical to evaluate a new imaging tool called mi-eye, which allows doctors to view knee joints from their offices.

The arthroscopic device provides the ability to look inside joints for signs of wear.

“I think in the select patient, this definitely has a role to play, and it will save not only time but money to the system,” said Dr. Sam Akhavan, an AHN orthopedic surgeon who is participating in the study. “Traditionally, with joint injuries, the diagnostic process can span several weeks, often including an in-office physical exam, followed by an MRI, and then a follow-up consultation and surgery if needed.”

The study will look at the effectiveness of using the device to diagnose meniscal tears on a patient’s initial visit, possibly saving time and money.

Akhavan has enrolled six patients and expects to work with 100 before issuing a final analysis.

READ THE REST HERE

Author: OrthoSpineNews

Contacts

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