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Additional Strategic Funding for CartiHeal’s Ongoing AGILI-C™ IDE Clinical Study $2.5M boost by Bioventus brings latest investment round to $21M

Posted On February 1, 2018 By OrthoSpineNews In Financial, Top Stories /  

KFAR SABA, ISRAEL and DURHAM, NC– January 31, 2018 CartiHeal, developer of the proprietary Agili-C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints, has secured a $2.5M investment from Bioventus, a global leader in orthobiologics – reflecting the growing interest in CartiHeal’s technology.

Bioventus’s $2.5M boost complements CartiHeal’s latest financing round, led by aMoon, together with Johnson & Johnson Innovation (JJDC Inc.), Peregrine Ventures, and Elron, bringing the total round to $21M.

The funding will focus on CartiHeal’s ongoing Agili-C IDE clinical study. Further to the trial’s initiation 3 months ago, over thirty patients were already enrolled, according to enrollment rate forecasts.

CartiHeal CEO, Nir Altschuler: “This investment is a vote of confidence by an important orthobiologic strategic player. Bioventus joins our team of strategic investors who perceived the potential of the Agili-C implant. We are confident that Bioventus will bring substantial added value to CartiHeal.”

“Agili-C shows great promise to relieve osteoarthritis pain for a large patient population and we look forward following the pivotal trial to a successful culmination,” said Tony Bihl, CEO, Bioventus.

About CartiHeal

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

About the Agili-C™ implant IDE multinational pivotal study

The Agili-C™ IDE study is set to include a minimum of 250 patients in US and OUS centers, aiming for a PMA submission. The trial’s objective is to demonstrate the superiority of the Agili-C™ implant over the surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both osteoarthritic knees and knees without degenerative changes.

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. Orthobiologic products from Bioventus include offerings for bone healing, bone graft and knee osteoarthritis. 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 and the Bioventus logo are registered trademarks of Bioventus, LLC.

For Bioventus Contact: Thomas Hill, 919-474-6715, thomashill@bioventusglobal.com

For CartiHeal Contact: info@cartiheal.com

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Study Shows Patients with MicroPort’s Medial-Pivot Knee Are More Likely to Forget They’ve Had a Joint Replacement

Posted On January 30, 2018 By OrthoSpineNews In Recon, Top Stories /  

January 30, 2018

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting edge joint replacement implants designed to help patients achieve full function faster, announced that The Journal of Arthroplasty has published a retrospective, comparative study that evaluated patient satisfaction after total knee arthroplasty (TKA) using the MicroPort Orthopedics’ MicroPort Orthopedics’ Evolution® Medial-Pivot (MP) Knee System. The study showed that patients who underwent the MP-TKA scored significantly better on the Forgotten Joint Score (FJS) than those who underwent the PS-TKA, particularly with regard to deep knee flexion and stability of the prosthesis.

“The goal of TKA surgery is to provide a joint replacement that functions as closely as possible to a normal knee and I believe that this study further validates the superiority of the medial-pivot design over traditional designs with regard to patient outcomes,” says David Backstein, MD, MEd, FRCSC, Head of Orthopaedic Surgery at Mount Sinai Hospital in Toronto, Ontario. “MicroPort’s medial-pivot features an insert designed to promote medial stability and lateral mobility and a femoral component with constant radii of curvature, resulting in greater stability and kinematics that closely replicate the natural motion of the knee.”

The article titled, “A Retrospective Comparison of a Medial Pivot and Posterior-Stabilized Total Knee Arthroplasty with Respect to Patient-Reported and Radiographic Outcomes,” was authored by Drs. David Samy and David Backstein from the Granovsky Gluskin Division of Orthopaedics at University of Toronto. A total of 164 patients, 76 in the MP-TKA group and 88 in the PS-TKA group, were evaluated at one-year follow-up using the FJS, a recently developed, validated measure of patient satisfaction after TKA. The FJS score is based on a 12-item questionnaire related to patients’ ability to forget their artificial joint in everyday life. To date, this study is the first to compare an MP-TKA and a PS-TKA using the FJS as a primary outcome measure.

Studies show that around 20 percent of patients are not satisfied with the outcome of their total knee replacement as a result of residual pain and functional issues that can often attributed to implant design1. Based on the results of this study as well as previous studies showing 95% patient satisfaction and 98.8% survivorship at 17 years, it is clear that the unique design of the MP-TKA can deliver reproducible outcomes that drive patient satisfaction2. Furthermore, it is the only medial-pivot system on the market with a clinically-proven 20-year history.

About MicroPort Orthopedics
Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort Scientific
MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 20 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements
Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

Sources:

1. Thambiah, Matthew Dhanaraj et al. “Patient Satisfaction after Total Knee Arthroplasty: An Asian Perspective.” Singapore Medical Journal 56.5 (2015): 259–263.
2. Macheras, George A. et al. “A long term clinical outcome of the Medial Pivot Knee Arthroplasty System.” The Knee 24 (2017): 447-453.

Contacts

LaVoie HealthScience
Sharon Correia, 617-412-8779
scorreia@lavoiehealthscience.com

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Paradigm Spine Announces Landmark Publication Of coflex® Vs. Decompression Alone In The Journal Of Neurosurgery Spine

Posted On January 29, 2018 By OrthoSpineNews In Spine, Top Stories /  

NEW YORK, Jan. 29, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced publication of the ESCADA 2-year trial results (European Study of coflex And Decompression Alone) in the January 2018 issue of the Journal of Neurosurgery Spine (JNS), official journal of the American Association of Neurological Surgeons (AANS). ESCADA reports a prospective, randomized, controlled, multi-center trial comparing decompression alone to decompression with coflex® Interlaminar Stabilization® for treatment of moderate to severe lumbar spinal stenosis.  coflex is the first and only motion preserving minimally invasive treatment for moderate to severe spinal stenosis post decompression.  A total of 225 patients were enrolled in the study with 91% follow up at 2 years.

The study authors concluded that decompression with coflex Interlaminar Stabilization extends the durability and sustainability of a decompression procedure.

“These data strongly validate for the surgical spine community that coflex is a safe and effective protector of a decompression procedure,” said Marc Viscogliosi, President and CEO of Paradigm Spine.  “This means that surgeons treating patients with lumbar spinal stenosis can be more confident than ever in their treatment options, knowing that a randomized controlled trial has demonstrated with statistical significance that nearly twice as many patients with decompression alone have a risk of secondary intervention as compared to coflex patients. coflex is the first and only lumbar spinal device that has produced the highest level of evidence in two separate prospective, randomized, controlled studies against two different control groups – which exhibits the thoroughness and reproducibility of these findings. There is now potentially a more effective surgical option between the two typical treatments for lumbar spinal stenosis, and we are proud to lead the way in changing the standard of care for surgeons and their patients with this diagnosis.”

Highlights of ESCADA results:

  • The rate of patients achieving Composite Clinical Success was statistically superior in the coflex group vs. the Decompression Alone group (p=0.017)
  • Patients who received Decompression Alone experienced significantly more loss of foraminal and posterior disc height maintenance compared to the coflex group (p<0.001)
  • The Decompression Alone group experienced 228% more subsequent epidural steroid injections compared to the coflex group (p=0.0065)
  • coflex patients experienced 2.4 times more improvement in walking distance measurements compared to Decompression Alone patients (p=0.062)
  • At 24 months, the Decompression Alone group was 1.4 times more likely to be taking opioids compared to the coflex group

The ESCADA trial included seven sites in Europe / Germany with a total of 225 patients who were randomized to either decompression alone (DA, control group) or decompression with coflex Interlaminar Stabilization (coflex, study group). Overall trial success was based on a combined outcome measure called Composite Clinical Success (CCS),  in which all four components must be met: 1) ODI success with improvement > 15 points; 2) survivorship with no secondary surgical interventions or lumbar injections; 3) neurologic maintenance or improvement without worsening; 4) no device-related severe adverse events. This is the same success criteria that was used in the U.S. IDE study of coflex that has published 5-year follow-up, allowing some direct comparisons to be drawn between the cohorts representing 547 patients collectively.  Secondary measures were also collected such as walking distance, foraminal and disc height maintenance, leg and back pain scores, and opioid use.

“With the important work of the ESCADA trial, we can see that coflex extends the success and durability of a decompression procedure for lumbar spinal stenosis, while still allowing natural motion to occur,” says ESCADA author and Principal Investigator Professor Michael Rauschmann. “The U.S. IDE study first investigated and defined the long-term problems with lumbar fusion procedures that can be alleviated with coflex.  And now, through this controlled trial, we can begin to answer the questions of the sustainability of decompression alone, and the need to provide additional stabilization for those patients with coflex at first surgical intervention to avoid future complications.”

Journal of Neurosurgery Spine. January 2018. Volume 28, Issue 1 (http://thejns.org/doi/full/10.3171/2017.11.SPINE17643).

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion.  Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 50 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

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AANA, VirtaMed Collaboration to Set New Standards for Arthroscopy Training

Posted On January 26, 2018 By OrthoSpineNews In Recon, Top Stories /  

SCHLIEREN, Switzerland and ROSEMONT, Illinois, Jan. 25, 2018 /PRNewswire/ — The Arthroscopy Association of North America (AANA) and VirtaMed have signed a two-year collaboration agreement making VirtaMed the preferred and exclusive partner for virtual reality simulation training. AANA and VirtaMed will work together to advance and improve the training of arthroscopic surgery skills and standards for proficiency-based training curricula by leveraging the latest virtual reality simulation technology and AANA’s expertise in Arthroscopic Surgery education.

The most immediate result of the contract, signed in January 2018, is that the Orthopedic Learning Center (OLC) in Rosemont, IL, will be equipped with VirtaMed ArthroS™ simulators for knee, shoulder and hip arthroscopy training, as well as FAST basic skills training. “We are excited about the opportunity to add high-fidelity simulation into our selection of educational tools. VirtaMed’s top-notch virtual reality simulators are a perfect match to the new OLC with upgraded facilities and state-of-the-art technologies,” says AANA President Robert E. Hunter, M.D.

“We have assessed all virtual reality arthroscopy simulators on the market, and VirtaMed was clearly the best fit to partner with AANA,” says AANA CEO Laura Downes, CAE. “The combination of lifelike anatomic models, high-fidelity graphics and original tools adapted for simulation make the VirtaMed ArthroS™ the closest thing to real surgery.”

AANA and VirtaMed will create new content for the simulator in all its disciplines, as well as a learning curriculum that fully leverages competency-based simulation training and assessment. The two organizations will begin with creating curriculums and proficiency exams shortly after they have collected data from course participants as well as faculty and the more experienced members of AANA early this year.

VirtaMed simulators enable proficiency-based learning as well as skills assessment. VirtaMed and AANA want to use these tools to create standards and best practices for arthroscopic training and assessment across the United States. “Our goal is to improve patient care by advancing education in arthroscopy, and we want to ensure all arthroscopic surgeons have access to high-quality skills training and continuous education. Working with VirtaMed’s first-rate simulators, experienced developers and dedicated education specialists will help us reach that goal,” explains AANA Learning Center Committee Chair, Joseph C. Tauro, M.D.

“We are honored to have been selected as the preferred and exclusive partner by such an influential organization,” says Rick Hoedt, General Manager at VirtaMed Inc. “With the various medtech customers and other societies we have as partners, it is further proof that our product and services lead the market in realism and that VirtaMed really is the go-to partner for surgical simulation. We share the same goals as AANA regarding education and training and are excited to join forces officially to enhance arthroscopy education. We’re also looking forward to working together with residency programs and simulation centers around the country and world to implement the new standard and to share best practices and standardization for improving patient safety.”

About AANA

The Arthroscopy Association of North America (AANA) is an international professional society of more than 4,000 orthopaedic surgeons and other medical professionals who are committed to advancing the art and science of arthroscopy and minimally invasive surgery through education, skills assessment and advocacy.  Our vision is be a global leader in arthroscopy and advancing minimally invasive surgical education, advocacy and skills assessment to improve patient care.

About VirtaMed

VirtaMed is the world leader in high-fidelity virtual reality simulators for instructional training of minimally invasive diagnostic and therapeutic interventions in orthopedics, urology and women’s health. VirtaMed also creates customized simulators for medical associations and medical device companies using original instruments and anatomic models for realistic feedback.

Contact:

AANA
Arthroscopy Association of North America
9400 West Higgins Road, Suite 200
Rosemont, IL 60018, United States
www.aana.org

Christine Nogal
Director of Marketing and Member Services
christinen@aana.org
Tel. +1(847)993-2063

VIRTAMED
VirtaMed AG
Rütistrasse 12
8952 Schlieren, Zurich, Switzerland

VirtaMed Inc.
16144 Churchview Drive
Lithia, FL 33547, USA
www.virtamed.com

Angina Herrmann
Head of Marketing
angina.herrmann@virtamed.com
Tel. +41-44-542-91-20

SOURCE VirtaMed

Related Links

http://www.virtamed.com

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Published Data Show Successful 24-Month Sacroiliac Joint Fusion and Pain Reduction with the SImmetry® System

Posted On January 25, 2018 By OrthoSpineNews In Spine, Top Stories /  

January 24, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the peer-reviewed publication of two-year data of the SImmetry Sacroiliac Joint Fusion System in The Open Orthopaedics Journal. The data show SImmetry provides radiographically evident sacroiliac (SI) joint fusion as early as 12 months with higher fusion rates observed at 24 months, while effectively reducing pain in patients with SI joint disorders. The SImmetry Sacroiliac Joint Fusion System is designed to treat SI joint dysfunction, an underserved condition and, according to the Centers for Disease Control and Prevention (CDC), one of the nation’s leading causes of lower back pain.

“This study demonstrated the SImmetry System effectively promoted SI joint fusion through decortication and also demonstrated a reduction in pain,” said Camille Farhat, President and CEO, RTI Surgical.

This multi-site study evaluated long-term fusion and pain reduction in 18 patients. The study examined computed tomography (CT) evidence of fusion at 12 and 24 months following SI joint fusion performed with decortication and bone grafting. CT scans were independently assessed by three trained musculoskeletal radiologists blinded to one another’s assessments. Fusion was predefined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). At 24 months post-surgery, 17 of 18 patients (94 percent) had evidence of bridging bone, with 15 of 18 patients (83 percent) categorized as Solid fusion across the SI joint. Of the patients with bridging bone, 15 of 17 (88 percent) were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.

In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. No procedure- or device-related serious adverse events were reported. These data were presented at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting.

RTI Surgical recently acquired the SImmetry Sacroiliac Joint Fusion System, a burgeoning therapy that accentuates RTI’s robust spine portfolio and accelerates the company’s growth.

“This is the first of many publications of clinical data demonstrating the value of SImmetry for patients with SI joint pathology,” Farhat said. “RTI is committed to furthering the body of clinical evidence supporting this technology.”

RTI continues to gather clinical data to support SImmetry, including the EVoluSIon Clinical Study, to include up to 40 sites and 250 patients evaluating SI joint fusion and pain reduction. More than 150 patients have been enrolled to date. An early analysis of the first 50 patients reported in December 2017 showed 72 percent of patients achieved the minimal clinically important difference of ≥ 20-point improvement in SI joint pain through six months. Further, the study showed a 54 percent reduction in mean SI joint pain at six months and, notably, the reduction in opioid use (55 percent) was much greater than previously reported with other SI joint fusion products.

The CDC lists back problems as the second most common cause of disability in U.S. adults1. Approximately 20 percent of all chronic low back pain derives from the sacroiliac joint2.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. Additionally, the statement relating to the expected size of the SIJF market in the United States in 2024 is a forward-looking statement. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

1 Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.

2 Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

Contacts

RTI Surgical, Inc.
MEDIA CONTACT:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
INVESTOR CONTACT:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

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MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

Posted On January 23, 2018 By OrthoSpineNews In Regulatory, Top Stories /  

WASHINGTON, Jan. 23, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of the first orthopedic de novo by the U.S. Food and Drug Administration (FDA) on December 19, 2017, enabling IlluminOss Medical, Inc. to initiate commercialization in the U.S. of the Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.

IlluminOss Medical retained MCRA in August of 2016 to lead interactions and correspondence with the FDA for the Bone Stabilization System. The IlluminOss System is a PET balloon infused with a photodynamic monomer, which when exposed to light, polymerizes the monomer, resulting in a solid intramedullary (IM) rod. This is an important treatment option for the fixation and stabilization of actual and impending pathological fractures of the humerus through a minimally invasive procedure. IlluminOss Medical’s Founder & Chief Technical Officer, Robert Rabiner said “Being granted the first orthopedic de novo by the FDA is a significant achievement for both IlluminOss Medical and our partner, MCRA. We knew messaging and presentation of data was critical to the success of our submission, and we knew MCRA had an incredible track record of positive FDA interactions, regulatory strategies, and success. After our successful U.S. clinical trial, MCRA was able to effectively present our clinical and performance data to the FDA in a clear concise manner. Their interactions minimized the potential miscommunications with the agency, and delivered the first Ortho de novo.”

Dave McGurl, Director of Regulatory Affairs, at MCRA, said “We are pleased that FDA has implemented the de novo pathway which allows innovative technologies, such as those being developed by IlluminOss Medical, find a pathway to U.S. market and ultimately to patients. MCRA is at the forefront of helping companies navigate this relatively new regulatory pathway, and achieve success in bringing novel devices to the U.S. market that was not possible even a few years ago.”

About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

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Additional US Patents Issued to Catalyst OrthoScience, Inc. for Its Stemless Shoulder Arthroplasty Technology

Posted On January 19, 2018 By OrthoSpineNews In Recon, Regulatory, Top Stories /  

NAPLES, Fla., Jan. 19, 2018 /PRNewswire/ — Catalyst OrthoScience, Inc. has been granted four new patents by the United States Patent and Trademark Office for technologies incorporated in the CSR™ Total Shoulder Replacement System.  The Catalyst CSR™ Total Shoulder System is a new canal-sparing, anatomic shoulder arthroplasty system that provides consistently reproducible shoulder joint restoration with an humeral implant that is smaller, more anatomically-shaped, and less invasive than traditional shoulder replacement surgery.

U.S. Patent Number

Title

Patent Issue Date

9,814,588

Glenoid Arthroplasty with Multi-directional Fixation

November 14, 2017

9,814,587

Humeral Arthroplasty

November 14, 2017

9,814,471

Glenoid Arthroplasty with Offset Reamers

November 14, 2017

9,775,716

Glenoid Arthroplasty

October 3, 2107

These patents expand the portfolio of Catalyst intellectual property related to the Company’s proprietary glenoid and humeral implant designs and instrumentation. “The granting of these patents endorses the extent of our technology and provides Catalyst with further protection for its product offerings in the shoulder replacement market,” said Bob Kaufman, CEO of Catalyst OrthoScience. “We have built a solid intellectual property portfolio and will continue to work to extend the depth and breadth of that protection.”

With core technology driven by surgeon and patient need, Catalyst has been able to draw a loyal following of orthopedic surgeons since receiving FDA clearance for the CSR™ total shoulder replacement solution last year. “Catalyst’s core technology is truly innovative, as evidenced by not only the growing patent portfolio, but also by the growing number of high caliber shoulder specialists who have embraced Catalyst as an important part of their clinical offering,” said Rod Allen, Catalyst’s Senior Vice President of Sales and Marketing.

Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D. who realized, based on his own experience as a fellowship-trained shoulder specialist, that improvements were needed to make shoulder replacement surgery less invasive and to give patients a more normal feeling shoulder after surgery.  “It feels great to be granted these patents,” said Dr. Goldberg. “I’m still amazed at how much our team has accomplished in such a short timeframe, and now patients are seeing the benefit.”

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 is the Catalyst CSR Shoulder System. 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 glenoid instrumentation for a less invasive approach that preserves the natural anatomy and removes less of the patient’s bone.

Catalyst OrthoScience’s products are marketed under a portfolio 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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Smith & Nephew’s Episode of Care Assurance Program (eCAP) reduces hospital readmission by 97% following total joint replacement surgery

Posted On January 18, 2018 By OrthoSpineNews In Recon, Top Stories /  

LONDON, Jan. 18, 2018 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces results showing a 97.3% decrease in readmission rates for joint arthroplasties (TJA) conducted under its Episode of Care Assurance Program (eCAP).

Working with Provider PPI, eCAP combines Smith & Nephew’s leading hip and knee implants with its PICO™ Negative Pressure Wound Therapy and ACTICOAT™ Flex 7 Antimicrobial Barrier Dressings. These products are applied post-surgery; PICO may help protect the incision by reducing seroma and hematoma fluid collections, reducing edema and lateral tension and improving perfusion.1-5 ACTICOAT Flex 7, which contains Nanocrystalline Silver, provides an effective barrier to microbial contamination to help deter surgical site infections.6

Over the past 14 months 1,380 TJAs have been conducted under the eCAP program with only two readmissions, a readmission rate of only 0.145% as compared to published rates of 5.3% or more.7

“As healthcare systems move from fee for service to pay for value, healthcare providers are increasingly responsible for the episode of care for the patient,” said Glenn Warner, President Smith & Nephew US. “eCAP can help enable providers to reduce costly readmissions after TJA by adding class-leading wound care products to help manage surgical incisions. We are proud to support our customers with innovative programs that deliver improved care in a large-scale, real-world setting.”

Smith & Nephew worked with Provider PPI, a group purchasing organization, to implement this program at Provider PPI’s client facilities in late 2016 with positive results, and is now serving 16 facilities across the US.

“Adding PICO and ACTICOAT products from Smith & Nephew to our TJA cases has been a great win for our health system clients and their patients,” said Paul Gallagher, Vice President, Provider PPI. “I am extremely pleased to see our readmission rate drop to nearly zero. In Smith & Nephew we’ve worked with a comprehensive product solutions partner that’s willing to stand behind its product portfolio.”

References

  1. Lumb H. Bacterial barrier testing (wet-wet) of PICO™ dressing with a 7 day test duration against S. marcescens.
  2. Wilkes RP, et al. Closed incision management with negative pressure wound therapy (CIM): Biomechanics. Surg Innov 2011.
  3. Karlakki S, et al. Negative Pressure Wound Therapy for management of the surgical incision in Orthopedic surgery. A review of evidence and mechanisms for an emerging indication. Bone Joint Res 2013; 2: 276-284.
  4. Canonico S, et al. Therapeutic possibilities with portable NPWT. Initial multidisciplinary observations with the negative pressure device. Acta Vulnol 2012; 10: 57-66.
  5. Selvaggi F, et al. New advances in Negative Pressure Wound Therapy (NPWT) for surgical wounds of patients affected with Crohn’s Disease. Surg Tech Int 2014; XXIV: 83- 89.
  6. Burrell et al. Efficacy of Silver-Coated Dressing as Bacterial Barriers in a Rodent Burn Sepsis Model, WOUNDS 1999; 11(4):64-71.
  7. Unplanned Readmission After Total Joint Arthroplasty: Rates, Reasons, And Risk Factors – The Journal Of Bone & Joint Surgery – jbjs.org – Volume 95-A – Number 20 October 16, 2013.

    For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult each product’s Instructions for Use (IFU) prior to use.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE: SNN)

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the  statements.   For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other     problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew

Related Links

https://www.smith-nephew.com

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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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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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