Northwestern Scientists Create Synthetic Bone Using 3-D Printer

Kristen Thometz | September 28, 2016

New technology developed in Chicago could lead to major advances in healing broken bones and other sports medicine injuries.

Using a commercially available 3-D printer and custom ink formulation, Northwestern University researchers created a synthetic bone capable of stimulating new bone growth.

“Ideally, it would be great if we could have these printers in a hospital setting where we can provide them the hyper-elastic bone ink, and then they can make patient-specific implants that day,” said Ramille Shah, assistant professor in the department of materials science and engineering, and surgery transplant division at Northwestern University.

“I think that is a possibility with this material.”

When used in recent studies, these 3-D printed bones successfully repaired spinal injuries in rodents and a large skull defect in a monkey. Those findings are being published Wednesday in the peer-reviewed journal Science Translational Medicine.

Printing a better bone

Shah heads a research lab at Northwestern that has spent the last several years working on developing 3-D printable materials, including the development of 3-D inks for both biomedical and non-biomedical applications.

Through this work researchers developed a “unique 3-D ink formulation” that makes it possible to print 3-D objects primarily composed of the main mineral found in natural bone tissue, Shah said. The other component of the 3-D ink is both biocompatible and biodegradable.

The printed product, which researchers are calling hyper-elastic bone, is “highly elastic,” even though it’s primarily made up of material that tends to be “very brittle,” Shah said.

 

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Global Sports Medicine Devices Market 2016: Hand-Wrist, Shoulders, Ankle-Foot, Knee, Back-Spine

Deerfield Beach, FL — (SBWIRE) — 09/22/2016 — Sports medicine is a branch of medicine that deals with the prevention and treatment of injuries incurred during sports activities, exercises or physical fitness training.Sports medicine devices therefore, include a wide range of products utilized for the prevention, recovery and cure of injuries related to the above physical activities. These injuries consist of fractures, sprains, soft tissue damage, joint dislocation, strain and musculoskeletal injuries. The increased global adoption of western sports has given rise to injuries that drive the market for sports medicine devices. Additionally, the growing demand for outpatient, minimally invasive surgeries, the growing awareness regarding the maintenance of an active lifestyle and the changing reimbursement landscape for innovative surgical technologies are key factors contributing to the growth of the sports medicine devices market.

On the other hand, the lack of trained professionals for sports medicine and the exorbitant price of certain devices and products serve to hinder market growth. Nevertheless, a general apprehension of the benefits of sports medicine devices- made possible through training programs and market penetration, and expansion in emerging countries of the Asia-Pacific region present key opportunities for the growth of this market. Technological advancements and the discovery of novel technologies are principle strategies followed by major players in this market. The key companies profiled in this report are Arthrocare Corporation, Biomet, Inc., Arthrex, Inc., Cayenne Medical Inc, Breg Inc., Zimmer Inc., Wright Medical Group Inc., Smith & Nephew Inc., Mueller Sports Medicine, Inc., and FH Orthopedics Inc. amongst others.

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The global sports medicine market is segmented into product type, application area and geography. On the basis of product type the market is segmented into orthopedic and support and recovery products. Orthopedic products include arthroscopy devices, fracture repair devices, artificial joint implants, orthobiologics and prosthesis. Support and recovery products include surgical equipment, compression clothing, support devices, tapes, bandages and others. Arthroscopy devices dominate the market due to their joint-related issues. Fracture repair devices and artificial joint implants are also gaining ground due to the rising incidence of fractures and growing demand for joint replacements.

On the basis of application, the market is segmented into Hand-wrist, Shoulders, Ankle-foot, Arm-elbow, Knee, Back-spine and Hip-groin. Shoulder and Knee treatment generated the highest revenue as most sports injuries are knee-related. Furthermore, the increasing number of age-related complications caused by diseases such as rheumatoid arthritis is also fueling market growth.

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KEY BENEFITS

Extensive analyses of the factors that drive and limit the growth of the global sports medicine market are provided.

Deep dive analysis of segments such as product type and applications provide insights that would enable companies to gain competitive edge.

In-depth analysis of various regions would enable an understanding of the trends in various regions so that companies can make region specific plans.

The competitive landscape section lists the market shares of major leaders within the global sports medicine market along with the key strategies adopted by them to achieve high monetary value.

Key deliverables

The sports medicine market is segmented according to product type, application and geography as follows:

By Product type

Orthopedic Products
Arthroscopy Devices
Fracture Repair Devices
Artificial Joint Implants
Orthobiologics
Prosthesis
Support and Recovery Products
Body Recovery and Support
Thermal Therapy (Cold/Hot Therapy)
Support Devices and Braces
Compression Clothing
Analgesics (Topical Pain Relief)
Body Repair and Reconstruction
Surgical Equipment
Bone/Cartilage Repair and Reconstruction
Soft Tissue Repair (Tendon and Ligament Repair)
Body Evaluation and Monitoring
Respiratory
Hemodynamic
Cardiac
Musculoskeletal
Accessories
Tapes
Bandages
Disinfectants
Wraps

By Application Area

Hand-wrist
Shoulders
Ankle-foot
Arm-elbow
Knee
Back-spine
Hip-groin

By geography

North America
Europe
Asia Pacific
LAMEA

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medi USA and Topical Gear Partner on Injury Prevention in the Sports Medicine Industry

WHITSETT, N.C., Sept. 20, 2016 /PRNewswire/ — medi USA, a global leader in compression therapy, orthopedics, spinal bracing, prosthetics and foot care with over 60 years of experience producing and distributing medical devices, has made a strategic investment in a sports medicine company, Topical Gear.

Topical Gear was formed in 2010 by a team of orthopedic sports medicine professionals who created performance wearables with T:25 Technology, which activates neuromuscular communication and targeted compression to enhance performance and keep patients stronger and healthier.

This new partnership challenges the traditional approach of addressing sports injury with an emphasis on prevention. A unique combination of compression technology is positioned to train muscles, increase proprioception and enhance performance to decrease the incidence of injury.

The union is a strong strategic fit, which leverages both companies’ respective strengths, including their diverse focus in the orthopedic and sports medicine industries.  By maximizing the product development talents and resources at both companies, the investment is expected to spark innovation and additional research and development, which will benefit club, college and professional sports channels alike.

For more information about the new partnership, please visit www.mediusa.com and www.topicalgear.com.

CONTACT: Jennifer Huber, 336-449-4440 ext. 129, jennifer.huber@mediusa.com

SOURCE medi USA

Related Links

http://www.mediusa.com

Study links Spring Loaded Technology’s Levitation Knee Brace to significant reduction in muscle fatigue

September 21, 2016

Spring Loaded Technology today reports the findings of a recent third-party study which links its LevitationTM, the world’s first compact bionic knee brace, to a significant reduction in factors that can lead to muscle fatigue. Research scientists observed the oxygen intake, carbon dioxide production and muscle activity of three healthy individuals as they repeated a squat to stand task with and without the assistance of the knee brace.

The study found that the LevitationTM Knee Brace, which uses a liquid spring technology to store energy as the leg is bent and return it as the leg is straightened, requires significantly less exertion from the user during energy expensive movements like rising to a stand from a full squat or crouched position. Data from the study revealed that participants used 25 percent less oxygen during the task cycle when compared to their consumption without the brace’s assistance. The researchers also found a drastic 40 percent reduction in carbon dioxide production.

The study was performed through the NSERC Engage Program at the University of New Brunswick by research scientists, Dr. Chris McGibbon in the Faculty of Kinesiology and Abeer Mohamed Abdelhady, PhD Candidate in the Dept. Mechanical Engineering.

“With the knee brace’s assistance, participants consumed less energy and were able to do more physical activity as measured with our squat test,” said Dr. Chris McGibbon. “The participants in this study also demonstrated a reduced respiratory exchange ratio (RER) while wearing the LevitationTM, meaning that they were burning more fat stores than carbohydrates. These findings are consistent with Spring Loaded Technology’s claim that LevitationTM reduces factors known to be associated with muscle fatigue—an exciting and unique accomplishment for knee braces and the field of bionics.”

The findings also support the brace’s ability to reduce demand on the muscles in order to improve performance, with participants showing an 85 percent reduction of activity in the quadriceps muscles and a 50 percent reduction of activity in the hamstring muscles during the squat task. Study participants were also able to perform up to 20 percent more squats when wearing the brace compared to the number of squats achieved when their knees were unassisted.

This data was drawn at the Levitation™ Knee Brace’s maximum assistance level. The level of assistance is adjustable and can be tailored to the user’s needs. This allows the user to specify different settings for different activities, or if the individual is recovering from an injury, to gradually reduce the level of assistance provided to zero as they recover their full strength.

“LevitationTM was designed to go above and beyond joint stabilization to assist strength and reduce fatigue. The result is a product intended to enhance mobility and expedite rehabilitation,” said Chris Cowper-Smith, CEO at Spring Loaded Technology. “It was important to us to have a study that shows our customers what sets us apart in the marketplace as they make an informed decision about which brace is best for them.”

LevitationTM Knee Braces ($1,750 USD) are currently available for pre-order.

Birmingham surgeon pioneers new rotator cuff surgery

Sep 9, 2016 – By Tim Steere, Birmingham Business Journal

 

Birmingham physician Kenneth Bramlett recently became the first in Alabama to offer a new form of rotator cuff surgery that is making waves throughout the medical community.

Bramlett is now using rotation medical rotator cuff bioinductive implants, a technology that significantly cuts down on recovery time by facilitating faster tissue growth in the rotator cuff tendon group.

The implant is placed on the bursal side of the supraspinatus tendon and attached first to the tendon with proprietary tendon staples and then to the humeral head using proprietary bone staples.

“Rotator cuff disease is the most frequently observed orthopedic condition in my sports medicine practice here in Alabama and in Dubai for patients over 45 years of age,” Bramlett said. “The ability to reinforce a direct rotator cuff tear or an early abrasional tear is a strong step forward in the healing process. It’s been a bit of a surprise to observe how little pain is associated with the Rotation Medical hybrid repairs and the ease of the early rehabilitation cycles.”

Rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports. The risk of injury increases with age.

The implant, manufactured by Rotation Medical, is suitable for a large segment of rotator cuff disease, from small partial tears to large full-thickness tears.

Collagen Meniscus Implant

Am J Orthop. 2016 September –

Collagen Meniscus Implant

The number of patients undergoing arthroscopic partial meniscectomy has continued to increase. However, this is potentially not a benign procedure, as there are increased contact pressures on the articular cartilage even with the removal of only a segment of the meniscus.

The Collagen Meniscus Implant (CMI, Ivy Sports Medicine) is a resorbable and biocompatible Type I collagen matrix that was developed to restore the segmental loss of meniscal tissue in the knee. It consists of a porous cross-linked matrix scaffold that allows for the ingrowth of the body’s own cells. The CMI is the only meniscal implant composed of purely biological materials and is available in an off-the-shelf supply.

The CMI is available in the United States for use in the restoration of segmental loss of the medial meniscus. The CMI can be utilized in either an acute or chronic situation. In the acute case, it would be indicated when the medial meniscus is irreparable, and that segment must be removed. In the chronic case, the patient would have had a previous partial meniscectomy and/or failed meniscus repair and had developed either pain or signs of early articular cartilage wear in the compartment. The procedure can be done arthroscopically and as an outpatient. The CMI can be kept on the shelf to be available as needed; it has a 2-year shelf life. There are specialized instruments for measuring the length of implant needed and for delivery of the implant.

 

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Author’s Disclosure Statement: Dr. Gersoff reports that he is a consultant for Ivy Sports Medicine and Vericell.

Ivy Sports Medicine(http://www.ivysportsmed.com/en)

 

Got knee pain? X-rays: the first, and best screening tool in diagnosing knee pain among middle-aged patients

A study in the Journal of the American Academy of Orthopaedic Surgeons investigates
ROSEMONT, Ill. (September 9, 2016)—Knee pain is common among Americans age 40 and up. Nearly 1 in 17 people visit doctors’ offices each year for knee pain or injuries from osteoarthritis—a progressive “wear and tear” disease of the joints. Those odds increase as the U.S. population continues to age and becomes even more overweight. While a magnetic resonance imaging (MRI) is one tool that can help doctors diagnose torn knee ligaments and cartilage and other problems, plain X-rays are the best first line screening tools for knee pain.

According to a study in the September issue of the Journal of American Academy of Orthopaedic Surgeons (JAAOS), a simple X-ray is frequently the best diagnostic tool, reducing both time and cost.

Whether a patient will need surgery for knee problems depends on how much arthritis he or she has. “If an X-ray shows that a person has significant arthritis, the MRI findings—like a meniscus tear—are less important because the amount of arthritis often dictates the treatment. Therefore, patients should always get a standing X-ray before getting an MRI to screen for knee pain in patients older than 40,” says Muyibat Adelani, MD, an orthopaedic surgeon with Washington University’s Department of Orthopedics and lead author of this study.

The study looked at 100 MRIs of knees from patients age 40 and up and found that:

  • The most common diagnoses are osteoarthritis (39 percent), and meniscal tears (29 percent)—the tearing of the wedge-shaped pieces of cartilage in the knee joint;
  • Nearly 1 of 4 MRIs was taken prior to the patient’s first having obtained a weight-bearing X-ray; and,
  • Only half of those MRIs obtained prior to meeting with an orthopaedic surgeon actually contributed to a patient’s diagnosis and treatment for osteoarthritis.

“Patients should always get weight-bearing X-rays before getting an MRI because MRIs are not always needed to diagnose knee problems,” says Dr. Adelani. In cases where arthritis is suspected, weight-bearing X-rays often are more than enough for orthopaedists to complete the diagnosis and treatment plan. An appropriately timed consultation with an orthopaedic surgeon can be more cost effective than first obtaining MRI scans.

More information about the AAOS
Follow the AAOS on Facebook, Twitter, and #JAAOS

Disclosures: From the Department of Orthopedics, Washington University, St. Louis, Mo. (Dr. Adelani, Dr. Brophy, Dr. Halstead, Dr. Smith, and Dr. Wright) and St. Louis Center for Cartilage Restoration and Repair, St. Louis (Dr. Mall).

Dr. Mall or an immediate family member is a member of a speakers’ bureau or has made paid presentations on behalf of Arthrex. Dr. Brophy or an immediate family member has stock or stock options held in Ostesys, and serves as a board member, owner, officer, or committee member of The American Orthopaedic Association, the American Orthopaedic Society for Sports Medicine, and the Orthopaedic Research Society. Dr. Halstead or an immediate family member serves as a board member, owner, officer, or committee member of the American Medical Society for Sports Medicine. Dr. Smith or an immediate family member is a member of a speakers’ bureau or has made paid presentations on behalf of Arthrex. Dr. Wright or an immediate family member has received research or institutional support from the National Institutes of Health (NIAMS and NICHD) and serves as a board member, owner, officer, or committee member of the American Board of Orthopaedic Surgery, The American Orthopaedic Association, and the American Orthopaedic Society for Sports Medicine. Neither Dr. Adelani nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article.

Contact(s):
Sheryl Cash
phone: 847-384-4032
Kayee Ip
phone: 847-384-4035

 

 

New foot and ankle surgeon joins Coastal Orthopedics

September 7, 2016

BRADENTON, Fla. — Dr. Andrés E. O’Daly, an orthopedic surgeon specializing in foot and ankle treatments, has just joined the comprehensive and full-service practice Coastal Orthopedics Sports Medicine & Pain Management (CoastalOrthopedics.com).

For the past year, Dr. O’Daly has been completing a foot and ankle surgery fellowship through the Department of Orthopaedic Surgery at the University of Alabama at Birmingham. He earned his Doctor of Medicine degree and completed his first orthopedic residency at the Central University of Venezuela.

“Since I was in Venezuela, I was interested in the mechanics of the foot,” said Dr. O’Daly. “It’s a growing, constantly evolving specialty with lots of innovation.”

Dr. O’Daly practiced as an orthopedic surgeon in Centro Medico de Caracas, one of the most prestigious clinics in Venezuela, focusing on sports medicine and joint reconstruction.

While receiving his medical training, Dr. O’Daly volunteered for a two-year clinical program at the Venezuelan Red Cross and interned at the Dr. Raúl Perdomo Hurtado Naval Hospital in Venezuela.

Dr. O’Daly earned his second residency from Johns Hopkins University after completing a research fellowship on peripheral nerve regeneration.

At Coastal Orthopedics, Dr. O’Daly will treat patients suffering from a variety of foot and ankle issues, including athletic injuries, fractures, dislocations, sprains, heel pain, Achilles tendon problems, arthritis and more.

“At Coastal Orthopedics, the motive is always patient care first,” said Dr. O’Daly. “I love the people at Coastal Orthopedics and the office.”

In the coming months, Dr. O’Daly will continue to be involved in an ongoing research project in conjunction with Johns Hopkins and the University of Alabama at Birmingham focused on ankle joint fracture care.

When he was working toward his fellowship at Johns Hopkins, Dr. O’Daly was honored with the Frank L. Coulson Jr. award for Clinical Excellence for several accomplishments, including communication and interpersonal skills, professionalism and humanism, diagnostic acumen, skillful negotiation of the healthcare system, a scholarly approach to clinical practice and a passion for patient care.

Dr. O’Daly, who recently moved to Bradenton with his wife and two daughters, is a member of the American Association of Orthopaedic Surgery and the American Orthopaedic Foot and Ankle Society.

About Coastal Orthopedics Sports Medicine & Pain Management
Founded in 1973 and based in Bradenton, Fla., Coastal Orthopedics is home to 15 orthopedic surgeons and pain management physicians who maintain hospital affiliations with Blake Medical Center, Manatee Memorial Hospital and Lakewood Ranch Medical Center. In addition to three offices and two ambulatory surgery centers each serving Florida’s West Coast, Coastal Orthopedics’ board-certified and fellowship-trained physicians and surgeons provide patients with the very latest in pain and orthopedic treatment technology. The company strives to repair and heal injuries relating to the entire musculoskeletal system. For more than 40 years, our highly skilled staff of physicians and surgeons has treated patients in specialty care including sports medicine, joint replacement, pain management and rehabilitation. Patients can experience restoration of function both surgically and non-surgically through the use of physician-guided strengthening, therapy, medications, injections and stretching. For more information, please visit CoastalOrthopedics.com or call 941-792-1404.

 

Sports Medicine Oregon Performs First Meniscus Replacements in Oregon with NUsurface® Implant

September 07, 2016

PORTLAND, Ore.–(BUSINESS WIRE)–Sports Medicine Oregon, a comprehensive orthopaedic clinic treating a wide variety of injuries and illnesses, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in Oregon have been performed by orthopaedic surgeons Drs. Richard Edelson and Jonathan Greenleaf. Sports Medicine Oregon and its affiliate Oregon Outpatient Surgery Center is the only site in Oregon – and one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN (Safety Using NUsurface®) clinical trial, which is designed to assess the safety and effectiveness of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.

The first patient to receive the implant in Oregon was 59-year-old Philomath resident Don Bennett. Bennett grew up playing basketball and initially tore his meniscus in his left knee while playing basketball 30 years ago, only to suffer another tear eight years later. He underwent two meniscectomy surgeries to treat the meniscus tears, but the pain in his knee gradually returned and increased in severity. Over the past five years, the physical demands of his daily job function as a water system maintenance specialist and even daily walking activity aggravated his knee to the point of constant pain.

“There are limited options for patients like Don, who experience persistent knee pain following meniscus injury and surgery,” Dr. Edelson said. “He had exhausted his non-surgical options. Even though his pain had increased in severity over the last five years, he was not a candidate for total knee replacement.”

The meniscus is a tissue pad between the thigh and shin bones. Once it is damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies (to remove the torn portion of the meniscus) are performed in the U.S. every year, more than the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus partial excision surgery.

“Meniscus injuries can be a very painful and debilitating problem, even leading to potential joint replacement at a young age,” Dr. Greenleaf said. “It is our belief that the NUsurface implant may allow patients to delay or avoid knee replacement and return to an improved level of activity without pain.”

It has been nearly two months since Bennett received the implant on July 13 through a small incision in his knee and completed a six-week rehabilitation program, and he has returned to his daily leisure and sports activities. With only a month left until his retirement from a 35-year career working for the city of Corvallis, he is most looking forward to salmon fishing, spending more time going on walks with his wife, attending his daughter’s Pac 12 volleyball games and coaching his son ahead of his basketball games.

“Prior to receiving the implant, I was living with constant pain and the fear that a total knee replacement was my only option,” Bennett said. “The NUsurface Meniscus Implant is giving me back my mobility. I’m looking forward to supporting my kids’ athletic endeavors, taking hikes with my wife and walking painlessly.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Sports Medicine Oregon

The goal of Sports Medicine Oregon is the restoration of active lifestyles to injured athletes of all ages. The team of specialty-trained physicians takes pride in providing the community with the highest quality orthopedic care. Whether it is the professional athlete or the weekend warrior, it strives to provide timely and comprehensive care at the state-of-the-art facility which includes full service X-ray, outpatient physical therapy, and the adjoining surgery center. For more information, please visit http://sportsmedicineoregon.com/.

About Oregon Outpatient Surgery Center

Oregon Outpatient Surgery Center is a multispecialty surgical center, which includes joint replacements. Oregon Outpatient Surgery Center provides caring, friendly, highly-skilled and trained professional staff, delivering the personal attention every patient deserves in a comfortable, professional atmosphere, a cost effect alternative to traditional surgical care.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visitwww.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Note to Editors: Photos of Don Bennett and Drs. Richard Edelson and Jonathan Greenleaf are available upon request.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Rotation Medical Bioinductive Implant Induces New Tissue Formation in Patients with Partial-Thickness Rotator Cuff Tears

September 07, 2016

PLYMOUTH, Minn.–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that study results published in the current issue of Muscle, Ligaments and Tendons Journal showed that the company’s collagen-based bioinductive implant induced new tissue formation in all study patients with rotator cuff tears. The Rotation Medical rotator cuff system is a novel, implant-based solution for rotator cuff repair and a new alternative to traditional surgical repair.

The study assessed the ability of Rotation Medical’s bioinductive implant to induce new tissue formation and limit tear progression when placed on the bursal surface of partial thickness cuff tears. The implant induced significant new tissue formation in all 13 patients by three months (mean increase in tendon thickness 2.2 ± 0.26 mm), and the tissue matured over time and became radiologically indistinguishable from the underlying tendon. No tear progression was observed on MRI in any of the patients during the 24-month post-operative period. All patients’ Constant and American Shoulder and Elbow Society clinical scores improved significantly over time.1

“Partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears,” said Dr. Desmond John Bokor, lead study investigator and associate professor in the Department of Orthopaedic Surgery at Macquarie University in Australia. “The results of this study demonstrate the ability of the bioinductive implant to induce new tendon-like tissue, enabling partial-thickness rotator cuff tears to decrease in size and in most cases disappear. The ability to heal partial-thickness rotator cuff defects, and thus prevent tear propagation and progressive tendon degeneration, represents a novel interventional treatment paradigm for these lesions.”

Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear. Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical bioinductive implant is designed to address this limitation by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.

“This study is further evidence that the Rotation Medical rotator cuff system has the potential to transform the treatment of rotator cuff disease,” said Martha Shadan, president and CEO of Rotation Medical. “Our bioinductive implant addresses both the biomechanics and biology required to heal a rotator cuff tendon tear, preventing rotator cuff tears from becoming larger over time, reducing the incidence of re-tears and, in some cases, shortening patient recovery time.”

The study, “Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up,” adds to the growing body of literature supporting the use of the bioinductive implant as a novel treatment for rotator cuff partial thickness tears. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.

About the Study

The implant was inserted via arthroscopic surgery. A total of 13 patients with intermediate (3-6 mm) to high-grade (>6 mm) partial thickness cuff tears completed two years of follow-up. At three, six, 12, and 24 months postoperatively, tendon thickness, defect size and quality were evaluated using magnetic resonance imaging (MRI), and clinical outcomes were assessed using the Constant and American Shoulder and Elbow Society scores. The partial-thickness cuff tears showed consistent filling of the defects, with complete healing in seven patients at 12 months, and a progressive improvement in tendon quality in the remaining patients. No tear progression was observed by MRI in any of the patients at 24 months. All clinical scores improved significantly over time. At 24 months, 12 of 13 patients (92 percent) had satisfactory or better results.

About Rotation Medical

Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit www.rotationmedical.com.

________________________
1 Bokor DJ, Sonnabend D, Deady L, Cass B, Young A, Van Kampen C, Arnoczky S. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscle Ligaments Tendons J. 2016 May 19;6(1):16-25. doi: 10.11138/mltj/2016.6.1.016.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com