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Molecular Matrix, Inc. Receives a 510K Clearance for its Revolutionary Bone Graft Substitute Technology, Osteo-P™

Posted On January 17, 2018 By OrthoSpineNews In Regulatory /  

SACRAMENTO, CALIF. (PRWEB) JANUARY 17, 2018

Molecular Matrix, Inc (MMI) today announced the FDA clearance (510k) of Osteo-P™, a value-driven, effective musculoskeletal solution for bone regeneration.

The Osteo-P™ bone graft substitute is a non-mineralized, synthetic bone void filler made of a hyper-crosslinked carbohydrate polymer (HCCP). It is highly porous, biocompatible, biodegradable, and has shown exceptional capabilities of bone repair.

The polymer technology offers several advantages over current bone graft substitutes, including exceptional bone formation and implant resorption, real-time fusion monitoring, and the ability to hold a suture.

Based on proprietary research, Osteo-P™ is intended for the filling of bone defects created surgically or through traumatic injury. When placed or gently packed into bone voids, Osteo-P™ supports and guides the ingrowth of new bone across the graft site, after which it is resorbed and replaced by newly formed bone during the healing process.

“Osteo-P™ provides an optimal microenvironment for infiltration of bone precursors such as osteoblasts that have been known to play a key role in bone regeneration,” says Molecular Matrix founder and CEO Charles Lee, PhD. “This microenvironment includes a significant surface area that allows the flow of fluids and metabolites, leading to the formation of healthy bone.”

The product is available in large pore granules, sheets, cubes, wedges and cylinders offering greater application, flexibility, and excellent handling characteristics. Additionally, customized products are routinely manufactured for collaborative research projects and may be useful for complex anatomic defects.

“The compressibility and tensile strength of Osteo-P™ allows the scaffold to be gently packed in to fill a void.” says Kee D. Kim, MD, Professor of Neurological Surgery and Co-Director of the University of California Davis Health, Spine Center. “The degradation profile, in conjunction with host bone regeneration, results in the formation of the patient’s own healthy bone.”

Osteo-P™ is intended for single patient use only, and is provided in a one-time use, with double sterile packaging. It is not indicated for use as a structural support in load bearing applications. The technology is delivered in a ready to use sterile package, and stores at room temperature. Additionally, Osteo-P™ is not subject to degradation through hydrolysis, making shipping logistics more convenient.

“The Osteo-P™ bone void filler provides cutting edge technology for our sales channels, offering significant advantages over other bone void fillers in the market today. In addition, this technology platform ensures Molecular Matrix will continue to develop this technology for multiple other tissue regeneration initiatives and other specific clinical applications” states Jim Keefer, COO of Molecular Matrix. “We are all very excited about our future, and expect significant market penetration over the coming months and years.”

Molecular Matrix’s HCCP technology provides a broad platform for tissue engineering in the orthopedic disciplines. Its HCCP has been shown to be effective for bone regeneration, evidenced by bone precursor cell activities. The technology will bring advancements in orthopedics, spine, trauma, and dental applications with superior bone regeneration products.

About Molecular Matrix

MMI has assembled a strong management team and Board of Directors (BOD) and believes that the quality and experience of the group is a critical factor to the success of the Company. MMI’s management team and BOD have over 75 years of experience in research and development, spine and biologics, and commercialization of new technologies.

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Catalyst OrthoScience Strengthens Its Board of Directors with The Addition of Greg Rainey

Posted On January 17, 2018 By OrthoSpineNews In Extremities, Top Stories /  

NAPLES, Fla., Jan. 16, 2018 /PRNewswire/ — Catalyst OrthoScience, Inc., a cutting-edge medical device company focused on the upper extremity orthopedics market, today announced the addition of Greg Rainey to its Board of Directors.

Mr. Rainey brings over forty years of experience to the Catalyst OrthoScience Board. Mr. Rainey’s career has been in sales management and business development, serving a cross section of the healthcare industry including orthopedics, medical supplies and equipment, and biologics. Mr. Rainey is the founder and principal of CCI Performance Group, an executive consulting firm designed to deliver sustainable business solutions for both leading Fortune 500 healthcare companies and early-stage medical device ventures. Most recently, he served on the Board of Directors for RTI Surgical (RTIX), and currently sits on the Board of CAS Medical (CASM). Mr. Rainey’s experience includes Stryker Corporation where he served as Vice President of Sales for the Orthopedic Division. Prior to Stryker, Mr. Rainey held sales leadership positions Joint Medical Corporation and U.S. Surgical Corporation.  Mr. Rainey received his undergraduate degree in Biology from Loyola University.

“We are privileged to have Greg join our board at such an important time in our company’s history.  Greg’s successful track record in orthopedics is critical to us as we expand the market presence of our disruptive, stemless shoulder replacement technology. We look forward to his contributions,” said Bob Kaufman, Chairman and Chief Executive Officer of Catalyst OrthoScience.

The Catalyst CSR™ Total Shoulder System provides consistently reproducible shoulder joint restoration with a canal-sparing humeral implant that is smaller, more anatomically-shaped, and less invasive than traditional shoulder replacement

Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D. saw the need to make shoulder replacement surgery less invasive and give patients a more normal feeling shoulder after surgery.

About Catalyst OrthoScience Inc.

Headquartered in Naples, FL, Catalyst OrthoScience develops and markets innovative medical device solutions that make orthopedic surgery less invasive and more efficient for both surgeons and patients.

The company’s first offering, the Catalyst CSR™ Total Shoulder System, represents the next evolution in stemless total shoulder arthroplasty. The Catalyst CSR™ is a single-tray total shoulder arthroplasty system containing a non-spherical humeral implant for consistent anatomic joint line restoration and specialized, patented glenoid instrumentation for a less invasive approach that preserves the natural anatomy and removes less of the patient’s bone.  The Catalyst CSR™ System is optimal for use in both the inpatient and outpatient settings and was cleared for use by the FDA in 2016.

Catalyst OrthoScience’s products are marketed under a variety of brands including Catalyst OrthoScience® and Catalyst CSR™. For additional information on the Company, please visit  http://www.catalystortho.com.

 

SOURCE Catalyst OrthoScience, Inc.

Related Links

http://www.catalystortho.com

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Safe Orthopaedics Reports Strong Growth of 37% in Its 2017 Adjusted Revenues

Posted On January 16, 2018 By OrthoSpineNews In Financial /  

January 15, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialized in the design and marketing of single-use implants and instruments facilitating the minimally invasive treatment of spinal fracture conditions, is today announcing its revenues for the fourth quarter of 2017 and for the financial year ended to December 31, 2017, together with its cash position at December 31, 2017.

“In 2017, we successfully continued our commercial realignment to focus on both the fastest-growing regions, such as France and Germany, and on the most promising technologies, such as the minimally invasive treatment of spinal fractures”, said Pierre Dumouchel, Chief Executive Officer and co-founder of Safe Orthopaedics. “Our adjusted1 revenues recorded strong growth of 37%, while the steady pace of additions to our sales and marketing teams, which now account for 45% of our headcount, continues to pay off handsomely. Following on recent recruitments, we expect to maintain this strong growth momentum during 2018, as well as launching new technologies to provide even safer treatment options for vertebral fractures.”

in thousands of euros

2017
(12 months)

2016
(12 months)

 Change
France 1,582 1,182 +34%
Rest of the world (excluding United States) 1,528 1,083 +41%

Total adjusted1 revenues

 3,110 2,265 +37%
United States (discontinued operations) 0 100 n/a
Total revenues 3,110 2,365 +32%
in thousands of euros

Q4 2017
(3 months)

Q4 2016
(3 months)

 Change
France 443 327 +36%
Rest of the world (excluding United States) 336 313 +7%
Total revenues 780 640 +22%

Adjusted revenues1 in the financial year to December 31, 2017 came to €3,110 K, representing a strong increase of 37% compared to the previous year.

The robust top-line growth continued in France, with sales totaling €1,582 K versus €1,182 K in 2016. That represents an increase of 34% over the full year and of 36% in the fourth quarter of 2017. In the second half of 2017, Safe Orthopaedics hired two new sales representatives, who will have a positive impact on business in 2018.

Sales in the Rest of the world (excluding United States) continued to grow, with the top line advancing 41% to €1,527 K in 2017. High growth was mainly generated by longstanding distributors and rapid expansion in Latin America. Following very strong revenue growth in the third quarter, orders were affected by a minor catch-up effect in the fourth quarter due to a business contraction in the Middle East. As a result, Safe Orthopaedics decided together with its distributor to respond by introducing fresh commercial initiatives to revitalize sales in the region in 2018. During the fourth quarter of 2017, Safe Orthopaedics also hired a 25year experience sales manager covering export markets.

Safe Orthopaedics expanded into Germany during 2017, and the company intends to extend its French in selling its products on this territory. A team of sales Director and two sales representatives was hired to develop business in Germany. Their knowledge of the local market and their long experience in the spinal surgery sector will be valuable assets for its development. Safe Orthopaedics also attended the DWG German Spine Congress, during which the company presented its innovative product ranges and comforted its position on the German market.

Safe Orthopaedics reinforced its marketing team and implemented a European action plan. Plan will be mostly focused on boosting sales support and provide surgeons with a number of training courses to treat vertebral fractures.

Cash position

At December 31, 2017, Safe Orthopaedics had €3,725 thousands in available cash, compared with €3,664 thousands at December 31, 2016. Its cash position was strengthened by the successful completion in June 2017 of a €5.8 million rights issue. The capital it raised gave Safe Orthopaedics the requisite additional resources to bolster its French and international sales teams and to convince surgeons of the benefits of single-use instruments in each market segment.

Next report:

  • Full-year 2017 results on Monday, April 30, 2018 (before the market opening)
  • First-quarter 2018 revenues: Monday, May 14, 2018 (after the market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 34 employees.
For more information, visit: www.SafeOrtho.com

1 Revenues adjusted for operations discontinued in the United States since March 1, 2016

Contacts

Contacts
Safe Orthopaedics
François-Henri Reynaud, Tél.: +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
or
Nicolas Merigeau, Tél.: +33 (0)1 44 71 94 94
Media Relations
SafeOrtho@newcap.eu

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SPINEWAY : 1st complex surgery performed in the USA with Spineway’s MIS implants

Posted On January 16, 2018 By OrthoSpineNews In Spine /  

Ecully, 15 January 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces that the Texas Back Institute (TBI), a group of US hospitals specializing in neck and back pain, performed the first operation addressing scoliosis via minimally invasive surgery using the Group’s MONT-BLANC MIS implants.

This complex operation was successfully performed by Dr. Theodore Belanger at the Texas Health Presbyterian Hospital and positions Spineway as an innovative player in the treatment of scoliosis. Indeed, very few laboratories in the world offer solutions adapted to deforming conditions such as scoliosis with a minimally invasive approach.

Prior to this implant, Texas Back Institute performed a series of fifteen surgeries with Spineway’s MONT-BLANC MIS implants de Spineway on patients with degenerative conditions.

With 40 years’ experience, TBI is currently one of the biggest top-level multidisciplinary university centers in the US. With 9 medical centers and over 20 surgeons throughout the state of Texas, TBI is well-known and has cutting-edge expertise in the treatment of back conditions.

Theodore Belanger, Orthopedic Spine and Scoliosis Surgeon at TBI, said the following about this partnership: “I feel there is great promise in the innovative thinking at the core of Spineway, and I look forward to a strong working relationship between the company and the Texas Back Institute over the coming years!”

Building on this major step forward, Spineway will continue its expansion in the United States and confirms a sharp increase in its revenue for the 2017 financial year.

This press release is available in both English and French. In case of discrepancy, the French version shall prevail.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME

Find out all about Spineway at www.spineway.com

Next communication: 
2017 annual revenue – 17 January 2018, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015). 
ISIN code: FR0011398874 – Euronext Growth

Contacts:              

Investor Relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
finance.dsg@spineway.com		 Financial Communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/8ad5a411-2b11-4b70-882a-c93aa16f26e9

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Regenexx Publishes New Research Findings That May Help Alleviate the Opioid Crisis

Posted On January 16, 2018 By OrthoSpineNews In Biologics /  

January 16, 2018

BROOMFIELD, Colo.–(BUSINESS WIRE)–A significant number of opioid deaths worldwide involve patients who become addicted to prescription narcotics due to severe low back pain. Regenexx, a physician-run medical network and pioneer in the invention of orthopedic stem cell injections, has today released new research that examines a more effective alternative for treating lower back pain to bypass the harmful effects of opioids and high dose steroids. The study, led by Regenexx founder and world-renowned leader for interventional orthopedics, Christopher J. Centeno, MD, was recently published in the 2017 Journal of Experimental Orthopedics, titled, “The Use of Lumbar Epidural Injection of Platelet Lysate for Treatment of Radicular Pain.”

Epidural steroid injections have been a mainstay of lower back treatment for decades, but the fact that they often fail to manage pain long-term has led many patients to seek relief through high dose and addictive narcotics. “Despite being the most common non-surgical procedure for sciatica and lower back pain performed in the U.S., there is limited evidence of the efficacy of epidural steroid injections (ESI),” said Christopher J. Centeno, MD, CMO of Regenexx. “Additionally, some evidence suggests that high dose use of corticosteroids may have significant side effects.”

The research’s methodology included a registry-based, case series evaluating the use of platelet lysate epidural injections for the treatment of lumbar radicular pain as an alternative to corticosteroids. Backed by MRI findings that were consistent with symptoms, 470 participants were treated with epidural injections presenting with symptoms of lumbar radicular pain (also known as sciatica). Collected outcomes included numeric pain score, functional rating index, and a modified single assessment numeric evaluation rating.

“The main advantage of platelet lysate is that it’s anabolic rather than catabolic,” said Dr. Centeno. “This means that it has growth factors that can help things heal rather than high-dose steroids that can destroy tissue by killing cells. Platelet lysate also has anti-inflammatory cytokines, like A2M, IRAP, and TIMPs.”

Following treatment with platelet lysate, patients reported significant improvements in pain and subjective improvement through their 2-year follow-up. Notably, the regenerative platelet lysate injections produced relief for longer periods than usually seen with epidural steroid injections. These findings are very encouraging to physicians who treat lower back pain, as they are now actively seeking ways to help patients without turning to narcotics.

The research team consisted of Christopher Centeno, Jason Markle, Ehren Dodson, Ian Stemper, Matter Hyzy, Christopher Williams and Michael Freeman. The full study can be found online at the Journal of Orthopedics.

About Regenexx and the Regenexx Physician Network
The Regenexx® Procedures are the nation’s most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit: http://www.regenexx.com

Contacts

Regenexx
Susannah Spruill, 720-577-5409
regenexx@matternow.com

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EIT Emerging Implant Technology announces first FDA multilevel approval for their 3D printed cervical cage

Posted On January 16, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

TUTTLINGEN, GERMANY (PRWEB) JANUARY 16, 2018

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative 3D printed titanium implants for spinal applications today announced the U.S. Food and Drug Administration (FDA) clearance of the expansion of the label of their EIT Cellular Titanium® Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1).

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth. The anatomical design of the EIT cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapted to maximized vertebral endplate contact and sagittal balance restoration.

The fusion potential of the implants is supported by EIT’s proprietary 3D process including post-printing etching procedures, allowing for unique porous structures that are impossible to manufacture with traditional manufacturing techniques. “This is another important regulatory milestone for EIT,” said Guntmar Eisen, Founder and CEO of EIT. “Only very few cervical cages are approved for multilevel use and we are poised to quickly enter the US market with the most advanced technology and state of the art FDA labeling and compliance.”

This marks the first multi-level 3D printed cervical cage to enter the US market. The EIT cervical cage is to be used with supplemental fixation and designed for use with autogenous and/or allogenic bone graft to facilitate fusion. Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), assisted EIT on the FDA strategy and submission. Justin Eggleton, Senior Director of Regulatory Affairs commented “this clearance represents continued synergy between FDA and the medical community. The expanded indications to multiple levels in the cervical spine facilitates improved surgeon collaboration and the ability to collect data that will strengthen the total product lifecycle, which ultimately benefits patients.”

The company’s plans to complete the current product portfolio with a lateral lumbar cage in Q2 and a fully printed lateral expanding cage in Q4. For more information about the EIT 3D platform, visit http://www.eit-spine.de

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT has started to launch its products in the US in Q4 of 2017.

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Life Spine Achieves Monumental Sales Growth of ProLift® Expandable Spacer System for 2017

Posted On January 16, 2018 By OrthoSpineNews In Spine, Top Stories /  

January 16, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that revenues for ProLift Expandable Spacer System grew by 493% for 2017 as compared to 2016. “With the introduction of ProLift to the market in 2016, we have consistently experienced monumental sales growth quarter over quarter,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. “We are excited about the adoption of ProLift, and will continue to focus on technological advancements that strive to improve surgical efficiencies and patient outcomes through our Micro-Invasive Expandable Solutions. Products such as ProLift, TiBOW™, and LONGBOW® are the core competencies which we will continue to drive for our procedurally based product portfolios”.

Life Spine’s continued focus on Micro-Invasive Technologies includes additional clinical and procedural solutions with the AVATAR® Percutaneous Screw System, AILERON® Interspinous System, SIMPACT™ and TRI-FIN SI Joint Fixation, and the CENTRIC® family of retractors.

Zeshan Hyder, D.O., of Bone and Joint Specialists of Northwest Indiana notes, “The continued evolution of MIS surgery to reduce tissue morbidity, and restore anatomical alignment, especially in severe degenerative and collapsed disc, is being achieved in my practice with the expandable technologies such as ProLift, and the lateral system LONGBOW. Both of these systems reduce the requirements for multiple instrument passes by important neural structures while maintaining my surgical goals and positive patient outcomes. Additionally, ProLift provides me the benefits of reduced graft subsidence, seen in other titanium implants. This has been a game changer for my practice.”

ProLift continues Life Spine’s commitment of offering innovative Micro-Invasive procedural solutions to better improve patients’ lives. In addition, Life Spine launched its new website highlighting their complete core and Micro-Invasive procedural solutions. The website is a staple to the new look of Life Spine, and helps surgeons access information about advancements in surgical innovations.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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MiMedx Announces First Patients Have Enrolled In The Phase 3 Clinical Trial Of AmnioFix® Injectable In Patients With Recalcitrant Plantar Fasciitis Pain

Posted On January 16, 2018 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., Jan. 16, 2018 /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, today announced the first patients have been randomized and enrolled in the pivotal Phase 3 Investigational New Drug (IND) clinical trial to assess the safety and efficacy of AmnioFix® Injectable in patients with recalcitrant plantar fasciitis pain.

Top-line results from this study are expected in the second half of 2019.  Following the conclusion of this trial, MiMedx intends to file a Biologic License Application (BLA) with the U.S. Food and Drug Administration for AmnioFix® Injectable to treat moderate to severe plantar fasciitis pain that has failed conservative treatment for at least 30 days. The Company projects the filing of the BLA related to plantar fasciitis will be in 2020.

Plantar fasciitis is the most common cause of chronic heel pain in adults, making up 11–15% of the foot symptoms requiring professional care among adults, according to studies published in the Journal of Research in Medical Sciences. It is estimated that 1 in 10 people will develop PF during their lifetime. Plantar Fasciitis is one of the most common orthopedic com­plaints relating to the foot, affecting approximately 9% of the U.S. population with approximately one million people per year seeking medical treatment. The Company believes 60% of these patients could be potential candidates to receive an AmnioFix injection, which MiMedx estimates represents approximately a $450 million annual market opportunity for the Company.

This Phase 3, prospective, double blinded, randomized controlled trial will enroll approximately 164 patients at 15 centers.  Patients will be randomized 1:1 into two treatment groups; a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix Injectable.  The primary efficacy endpoint is the change in Visual Analog Scale (VAS) score between baseline and day 90, expressed as the difference in means between the two groups. The primary safety endpoint is 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-controlled group.

Parker H. “Pete” Petit, Chairman and CEO, said, “I am pleased to announce that we have commenced enrolling the first Phase 3 patients in this significant study.  For a long time, physicians treating musculoskeletal degeneration pain have highlighted the need for a new safe and durable first-line therapy, especially an injectable product. We believe AmnioFix Injectable meets this need and will quickly become the physician’s product of choice for the vast majority of their patients.”

Bill Taylor, President and COO, added, “We expect this Phase 3 study will confirm the results seen in our Phase 2B study that showed AmnioFix Injectable has the potential to provide an effective, safe and durable relief from pain associated with chronic plantar fasciitis.”

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 million 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.

Safe Harbor Statement
This press release includes forward-looking statements, including statements regarding the Company’s intention and timing of the filing of its Biologic License Application with the FDA, the belief that AmnioFix Injectable meets a market need and will quickly become the product of choice for  physicians, and that the Phase 3 study results will confirm the results seen in the Phase 2B study.. 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 additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; 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  the market may not adopt the utilization of AmnioFix Injectable as anticipated and it may not become the product of choice for physicians. 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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OrthoXel Announce FDA 510k and CE Mark Approval for their Orthopaedic Trauma Product the Apex Tibial Nail System

Posted On January 16, 2018 By OrthoSpineNews In Regulatory /  

CORK, Ireland, Jan. 16, 2018 /PRNewswire/ — OrthoXel, an innovative new orthopaedic trauma company, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, is delighted to announce that FDA 510k clearance and European CE mark approval have been granted for their Apex Tibial Nailing System. These approvals allow commercialization of the system in the US and EU markets.

The Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure. The Apex system’s revolutionary micromotion locking mode allows controlled axial movement with exceptional torsional stability, providing the ideal conditions for callus formation. Research shows that controlled small axial movements along the length of the bone help to accelerate healing, while twisting movements slow down healing.

The Apex system has a unique design featuring the first-ever implementation of this controlled micromotion in an intramedullary nailing platform, all with no changes to the established evidence-based reamed insertion technique. The Apex system also provides additional locking modes so the surgeon can customize the fixation to suit the needs of the patient, including: standard cross-locking, true rigid fixation with multiple proximal screw clamping to generate a substantially rigid construct, and dynamization locking with unparalleled built-in torsional stability. The state of the art reusable implantation kit allows fast and reliable nail implantation in any locking mode.

No other intramedullary nail currently on the market in the US or the EU gives surgeons the freedom to choose this ideal combination of flexibility and stability for their patients.

Pat O’ Connor CEO OrthoXel – “We are excited that the approvals in the major markets of the US and EU opens the opportunity for OrthoXel to get our devices in the hands of orthopaedic surgeons.  We look forward to identifying the best route to market for the product portfolio and rolling out the technology in the coming months.”

Professor James Harty Chief Medical Officer – “We have worked closely with the clinical research Facility in University College Cork and other agencies within the Health Service Executive (HSE), such that we are now in a position to commence implanting this unique nailing technology in patients at Cork University Hospital (CUH).  I am very excited by this implant, and we have already completed the control arm of the data analysis and look forward to publishing data in 2018.”

About OrthoXel

Founded in 2014, OrthoXel DAC is the only orthopaedic trauma company focused exclusively on improving patient outcomes through enhanced fixation to stimulate callus formation, with the aim of reducing healing time when OrthoXel intramedullary nails are implanted.

The novel Apex Tibial Nailing system is patent protected and the first technology that OrthoXel will commercialize for treatment of tibial fractures followed by a second device for femoral fractures.

For more information visit: www.orthoxel.net

Press Contact:

Alanna Carty Global Marketing Manager
E: 188759@email4pr.com
Tel: +353 (0) 86 274 1539

SOURCE OrthoXel

Related Links

http://www.orthoxel.net

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Hospital for Special Surgery Invests in Sectra Orthopaedic 3D Planning Software for Improved Surgical Outcomes

Posted On January 16, 2018 By OrthoSpineNews In Extremities, Top Stories /  

SHELTON, Connecticut, January 16, 2018 /PRNewswire/ —

International medical imaging IT and cybersecurity company Sectra (STO: SECT-B) announces that Hospital for Special Surgery (HSS), one of the most renowned orthopaedic hospitals in the US, has ordered Sectra’s 3D pre-operative planning solution. The software will provide HSS orthopaedic surgeons with advanced tools to enhance visualization of complex cases with the goal of improving patient outcomes.

“Sectra’s innovative 3D solutions will enable us to make full use of the acquired images, resulting in cutting edge delivery of care to our orthopaedic patients,” says William M. Ricci, MD, Chief of Orthopaedic Trauma Service at HSS. “This 3D platform will improve the quality of pre-operative planning with potential for improved surgical outcomes.”

The 3D pre-operative planning solution includes tools that allow the surgeon to render standard CT images into a three-dimensional interactive image that can be segmented, manipulated, mirrored, templated and 3D printed. The software will integrate with the existing Sectra radiology PACS at HSS to enable surgeons immediate access from anywhere in the hospital.

“This agreement adds software tools for advanced 3D virtual fracture reduction and trauma planning as well as efficient tools for 3D spine planning into the hands of all surgeons at HSS,” says Gustaf Schwang, General Manager Business Unit Orthopaedics at Sectra. “It also includes collaborative development of software, intended to deepen both companies’ leadership position in our respective markets.”

Video: Sectra’s 3D Trauma Pelvic

Sectra at AAOS
Visit Sectra at booth #3967 where the orthopaedic solution will be showcased.

Read more and secure your meeting with Sectra at AAOS.

About Sectra Enterprise Imaging

With more than 25 years of innovation and 1,700 installations, Sectra is a leading global provider of imaging IT solutions that support healthcare in achieving patient-centric care.

The orthopaedic solution is part of Sectra’s complete enterprise imaging offering which is comprised of PACS for imaging-intense departments-radiology, orthopaedics, pathology and cardiology, VNA and Cross Enterprise Workflow solutions. Using the same technical platform, customers can easily extend a departmental solution to create a comprehensive VNA and enterprise image management solution without major investments or the replacement of existing components.

Read more about Sectra and why Sectra PACS is “Best in KLAS” at http://www.sectra.com/medical/.

Contact details:
Andrea Sowitch, Vice President of Marketing
Sectra, Inc.
E-mail: andrea.sowitch@sectra.com
Phone: +1-203-925-0899 ext. 268

Torbjörn Kronander, President and CEO
Sectra AB
E-mail: torbjorn.kronander@sectra.se
Phone: +46-705-23-5227

SOURCE Sectra, Inc

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