Stryker’s Spine Division Receives FDA Clearance for 3D-Printed Tritanium® C Anterior Cervical Cage

Posted On September 20, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

September 20, 2017

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

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

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

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

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

Intended Use (US)

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

About Stryker

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

References

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

Content ID TRICC-PR-1_15507

Contacts

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

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

Band-LOK Announces Allowance for Two New U.S Patents for the Tether Clamp and Implantation System

Posted On September 20, 2017 By OrthoSpineNews In Regulatory, Top Stories /

CHARLOTTE, NC (PRWEB) SEPTEMBER 19, 2017

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

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

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

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

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

Additional patent applications are pending.

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

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

Augmedics Secures $8.3 Million in Series A Funding for Augmented-Reality Surgical Visualization System

Posted On September 20, 2017 By OrthoSpineNews In Financial, Spine /

September 19, 2017

YOKNEAM, Israel–(BUSINESS WIRE)–Augmedics, a developer of an augmented-reality (AR) surgical visualization system, has secured $8.3 million in Series A funding. Led by Davos, Switzerland-based AO Invest, which is fully funded by the non-profit AO Foundation, as well as Israeli Innovation Authority, Terra Venture Partners and other undisclosed investors. Augmedics will use the proceeds to complete research and development as well as pre-clinical and clinical trials of its ViZOR System, establish strategic distribution partnerships, and seek 510(k) clearance for The ViZOR from the US. Food and Drug Administration.

According to Technavio, the global market size for surgical navigation systems is estimated to grow to $900 million by 2020, with compounded annual growth rate (CAGR) of seven percent. Augmedics intends to disrupt this sizeable market with its ViZOR System, an AR surgical visualization system designed to give surgeons “X-ray vision” during complex procedures. With The ViZOR, surgeons can see inside a patient’s anatomy through skin and tissue, for easier, faster and safer surgeries. The ViZOR can be used in many procedures, with the first intended use in minimally invasive spine surgeries. The ViZOR uses proprietary patented see-through AR optics to project a 3D image of a patient’s spine onto a surgeon’s retina, in real-time, with surgical precision and outstanding depth perception. The technology was designed to save time during surgery, reduce radiation exposure and reduce the number of unnecessary repeat operations and hospitalizations.

“The ViZOR System brings disruptive augmented reality technology to spine surgeries to increase safety and enhance surgical performance,” said Nissan Elimelech, CEO of Augmedics. “Augmedics designed The ViZOR to give surgeons the first-time opportunity to actually see inside a patients’ anatomy, providing valuable real-time information in a comfortable and intuitive manner.”

In the future, the ViZOR System will leverage various sensors to collect big surgical data to process and analyze using deep learning algorithms. Ultimately, it will also make suggestions, provide alerts, and perform other surgical assistance during the procedure.

“With deep domain knowledge, crystal-clear thinking and continuous improvement, the Augmedics team was able to develop a product that brings tremendous value to surgeons,” said Michel Orsinger, chairman, AO Invest. “We are happy to work with them and believe in AR’s potential to shape the future of surgery and contribute to better clinical outcomes for patients. With Augmedics, we believe we are backing the leading company in the field. The accuracy, usability and feel of the product are very impressive and promising.”

Founded in 2014, Augmedics received seed financing from TerraLab incubator, an incubator of the Israeli Innovation Authority.

About AO Invest
AO Invest is an investment fund for start-ups run by a board of medical and business experts. The organization focuses on start-ups that are developing innovative technology for orthopedic and trauma surgeons and patients. AO Invest specializes in emerging areas such as visualization, simulation, robotics, data management and digital health, investing not only capital but also know-how and expertise. The group invests in the range of $500,000 to $3 million. AO Invest’s sole investor is the AO Foundation, a surgeon-led, not-for-profit organization.

About Augmedics
Founded in 2014, Augmedics develops cutting edge technologies for future surgery. The company’s ViZOR System is an augmented reality surgical visualization solution designed to allow surgeons to see inside a patient’s anatomy during complex procedures. First intended for use in minimally invasive spinal surgery, The ViZOR can help improve procedures by allowing surgeons to see the patient’s spine through skin and tissue, as if they had X-ray vision, eliminating some of the limitations of minimally invasive spine surgery. Augmedics has received numerous honors, including Technion’s BizTEC 2014, MedTech Innovator 2016, and MEDinISRAEL 2017.

Contacts

Nobles Global Communications
Diana Soltesz, 818-618-5634
diana@noblesgc.com

Ajo LP Invests $2.60 Million in RTI Surgical, Inc. (RTIX)

Posted On September 19, 2017 By OrthoSpineNews In Financial /

Posted by: Erica Schwartz / September 19, 2017

Ajo LP acquired a new position in shares of RTI Surgical, Inc. (NASDAQ:RTIX) during the second quarter, according to its most recent 13F filing with the Securities & Exchange Commission. The firm acquired 443,898 shares of the medical equipment provider’s stock, valued at approximately $2,597,000. Ajo LP owned 0.76% of RTI Surgical as of its most recent SEC filing.

Other large investors also recently modified their holdings of the company. Geode Capital Management LLC grew its position in RTI Surgical by 3.7% in the first quarter. Geode Capital Management LLC now owns 456,346 shares of the medical equipment provider’s stock valued at $1,825,000 after purchasing an additional 16,235 shares in the last quarter. Russell Investments Group Ltd. grew its position in RTI Surgical by 176.0% in the first quarter. Russell Investments Group Ltd. now owns 78,055 shares of the medical equipment provider’s stock valued at $313,000 after purchasing an additional 49,777 shares in the last quarter. Bank of New York Mellon Corp grew its position in RTI Surgical by 3.5% in the first quarter. Bank of New York Mellon Corp now owns 255,656 shares of the medical equipment provider’s stock valued at $1,022,000 after purchasing an additional 8,679 shares in the last quarter. Kennedy Capital Management Inc. grew its position in RTI Surgical by 20.0% in the first quarter. Kennedy Capital Management Inc. now owns 1,422,371 shares of the medical equipment provider’s stock valued at $5,689,000 after purchasing an additional 236,923 shares in the last quarter. Finally, Dimensional Fund Advisors LP grew its position in RTI Surgical by 2.0% in the first quarter. Dimensional Fund Advisors LP now owns 3,900,031 shares of the medical equipment provider’s stock valued at $15,600,000 after purchasing an additional 74,933 shares in the last quarter. Institutional investors and hedge funds own 69.99% of the company’s stock.

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Centinel Spine to Acquire DePuy Synthes Prodisc Assets

Posted On September 19, 2017 By OrthoSpineNews In Spine, Top Stories /

September 19, 2017/Orthoworld

Centinel Spine has entered into an agreement to purchase DePuy Synthes’ worldwide prodisc assets. The acquisition is expected to close in mid-4Q17. Terms were not disclosed.

Upon completion, Centinel Spine will add cervical and lumbar artificial disc systems prodisc-C, prodisc-L, prodisc-C Vivo, prodisc-C Nova, prodisc-O and Discover to its portfolio, which presently includes MIDLINE and STALIF interbody devices as well as ALTOS® posterior cervical stabilization, the ACTILIF™ Cervical Cage, etc.

The acquisition also serves as a catalyst for Centinel’s ex-U.S. expansion. The company has focused on the U.S. and Australian markets, and plans to use the prodisc portfolio to launch into more ex-U.S. markets, says John Viscogliosi, Chairman & Chief Executive Officer of Centinel Spine and a Principal at the private equity and venture capital firm Viscogliosi Bros., LLC.

Additionally, Viscogliosi told ORTHOWORLD, prodisc-C and prodisc-L are the only assets in the purchase with premarket approval in the U.S. Centinel intends to initiate U.S. clinical studies to secure approval for other products in the portfolio.

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Bone Solutions Inc. Launches OsteoCrete® Magnesium-Based Bone Void Filler

Posted On September 19, 2017 By OrthoSpineNews In Biologics, Top Stories /

(PRWEB) SEPTEMBER 19, 2017

Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, TX, announces the launch of its magnesium-based orthopedic medical device, OsteoCrete®. OsteoCrete® bone void filler is designed to assist with bone repair and generation, and it’s the first in the U.S. to incorporate magnesium, a critical property for bone health and development.

“We’re excited to bring this important orthopedic technological advancement to the market,” says BSI president and CEO, Drew Diaz. “OsteoCrete® provides surgeons a much-needed option currently not available, as it’s the only bone-repair product made with magnesium.”

“Many modern devices used for bone repair or replacement are calcium-based and do not exhibit a combination of compressive strength and expandability necessary for optimal binding quality,” Diaz stated. OsteoCrete® is also resorbable, or capable of being assimilated back into the body, as it is replaced with bone as the patient heals. OsteoCrete® is also injectable, moldable, and biocompatible.

Magnesium contains high specific strength and an elastic modulus that closely resembles human bone. Most of the magnesium in the body (60%) is stored in bone and helps to preserve and develop bone structure by working with Vitamin D and calcium. Its effectiveness was a key component of BSI’s approach to developing its OsteoCrete® technology.

The FDA has cleared this orthopedic platform technology for use in bone-related surgical procedures ranging from complex sport-related injuries to all musculoskeletal extremities trauma cases.

“We’ve been fortunate to have surgeons test OsteoCrete® in various studies, and they were impressed about its positive effects and performance. It’s an incredible development for both patients and surgeons,” Diaz stated.

OsteoCrete® is currently being distributed to clinics and surgical centers around the country for immediate use.

About Bone Solutions Inc.
Bone Solutions Inc. (‘BSI’) (http://www.bonesolutionsinc.com) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler.

Media Contact:
Bone Solutions Inc.:
Drew Diaz
President/CEO
817-809-8850
diaz(at)bonesolutions.net

Organogenesis Names New Chief Commercial Officer and Chief Operating Officer

Posted On September 19, 2017 By OrthoSpineNews In Biologics, Top Stories /

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.

MiMedx To Host Shareholder Call On September 21, 2017 To Update Progress On Various Strategic Initiatives And Respond To Topics Requested By Shareholders

Posted On September 19, 2017 By OrthoSpineNews In Biologics, Financial /

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.

Spine Devices Market Worth US$ 8,348.2 Million by 2022

Posted On September 19, 2017 By OrthoSpineNews In Financial, Spine /

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.

Request For Sample Report @ https://www.factmr.com/connectus/sample?flag=S&rep_id=259

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.

Click to View Complete Report @ https://www.factmr.com/report/259/spine-devices-market

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

MiMedx Files With The FDA To Initiate The Company’s Investigational New Drug Phase 2 Clinical Trial For Osteoarthritis Of The Knee

Posted On September 19, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

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.

Month: September 2017

Contacts

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