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Opening of FX Shoulder USA: the French Shoulder Arthroplasty Specialist

Posted On February 20, 2018 By OrthoSpineNews In Recon, Top Stories /  

DALLAS, February 20, 2018 /PRNewswire/ —

FX Solutions, French number two in shoulder arthroplasty, has established an US subsidiary named FX Shoulder USA, Inc. to further expand directly into the US markets and to provide its current and future United State clients with an unique, large and innovative offer of shoulder implants.

FX Shoulder USA, based in Dallas, TX, was formed to proudly be the exclusive distributor for FX Solutions products effective January 1, 2018.

Created in 2011, FX Solutions has generated an annual growth of its turnover of more than 60% since its creation and plans to keep the same growth in 2018, particularly in the United States.

Its products have been approved in the USA since 2016 with the Humelock II, its only lockable shoulder trauma prosthesis available in the US. In January 2017, FX Solutions further expanded its portfolio with the introduction of the Humelock Reversed, a 145° reverse angle (available since 2011 in Europe). Additionally, in June 2017 it’s short stem Humeris was released as its primary platform.

FX Shoulder USA has quickly built a strong network of surgeons and distributors in Florida, Pennsylvania, Rhode Island, Maryland, Georgia and Texas and looks to further expand its distribution across the Midwest and West Coast. The group has strong growth ambitions and aims to develop rapidly in North America, the world’s largest market for shoulder prostheses.

FX Shoulder USA is the only company worldwide, and especially in the United States, to focus exclusively on shoulder arthroplasty. With a very technical and customer service-oriented approach, the company offers the best choice in shoulders replacement, adapted to any procedure the surgeon would require.

FX Shoulder USA will exhibit at the American Academy of Orthopedic Surgeons (AAOS) March 6-10, 2018 in New Orleans at booth n°3158 and at the American Shoulder and Elbow Surgeons (ASES) in Chicago in October 2018.

http://www.fxshoulder.com

1-800-280-0775
info@fxshoulder.com

SOURCE FX Shoulder USA, Inc

 

(Logo: https://mma.prnewswire.com/media/642925/FX_Shoulder_USA_Logo.jpg )

(Photo: https://mma.prnewswire.com/media/643325/FX_Shoulder_USA_Humeris.jpg )

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Nexxt Spine Marks 250th Implantation of the NEXXT MATRIXX® System Interbody

Posted On February 19, 2018 By OrthoSpineNews In Spine, Top Stories /  

February 19, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced the milestone of the 250th implantation of the NEXXT MATRIXX® System.

Launched in 2017 the NEXXT MATRIXX® System is a collection of 3D printed porous titanium interbodies that leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

“It is exciting to review the images surgeons are submitting showing the level of bone formation 12 weeks post-operative,” stated Nexxt Spine President, Andy Elsbury. Mr. Elsbury continued, “Multiple surgeons are taking so much pride in the results they are achieving.”

One of the first implantations of the NEXXT MATRIXX System® was conducted by Dr. George Picetti, Orthopedic Surgeon with Sutter Medical Group in Sacramento, California. “I am particularly pleased with the bone formation and cage integration I have seen in my twelve-week follow-up appointments with the NEXXT MATRIXX® Interbody System,” remarked Dr. Picetti.

Mr. Elsbury also stated, “Another pleasantly surprising trend since launch is how quickly surgeons progressed from initial cervical usage to the lumbar interbodies. Surgeons have moved to the NEXXT MATRIXX® System being their standard of care now that they have seen the post-operative results.”

Dr. Michael McNamara, Orthopedic Surgeon with the Bone and Joint Institute of Tennessee, was also one of the first surgeons to implant the device. “The surgeries have gone extremely well. The instrumentation is intuitive and allows me to accurately place the implants,” said Dr. McNamara.

The first products to feature the NEXXT MATRIXX® technology are available for both cervical and lumbar indications in an assortment of height, length, width and lordotic angulation combinations to accommodate the unique anatomic and clinical circumstances of each patient. The NEXXT MATRIXX® System will launch additional product lines in 2018.

About Nexxt Spine

Nexxt Spine, LLC is a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions. The company is dedicated to increasing efficiency and patient outcomes through the development of new and innovative products. Nexxt Spine manufactures on the most technologically advanced platforms in order to treat painful and debilitating spinal injuries. Nexxt Spine is located in Noblesville, Indiana where all spinal implants and 95% of surgical instruments are manufactured in a state of the art facility.

Contacts

Nexxt Spine
Sarah Koch
Info@NexxtSpine.com

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TranS1® Announces Three New Patents

Posted On February 15, 2018 By OrthoSpineNews In Spine, Top Stories /  

Denver, Feb. 13, 2018 (GLOBE NEWSWIRE) — TranS1®, a spinal device company focused on breakthrough solutions that minimize tissue trauma, today announced it has added three new patents to its portfolio. The patents relate to two new developments associated with presacral interbody fusion, including two new expandable cages designed to create lordosis at L5-S1, along with a new technique to perform sacroiliac (SI) fusion.

“TranS1’s patent portfolio remains one of the strongest in the industry,” said Jeffrey Schell, chief executive officer of TranS1, who is also a patent attorney. “Our strategy remains to advance the most innovative technologies to lessen tissue trauma during spine surgery and to vigorously guard those technological innovations through domestic and international patent protection.”

TranS1 offers a full complement of minimally invasive surgery (MIS) solutions for spinal pathologies, including the award-winning Pylon™ posterolateral decortication and bone graft placement system, the KeyLIF™ MIS Oblique Lateral Interbody Fusion system and the AxiaLIF® presacral interbody fusion system.The AxiaLIF procedure allows for minimally invasive spinal fusion at L5-S1 for patients with certain spinal pathologies. Presacral interbody fusion at L5-S1 was awarded a Category 1 CPT® Code (22586) in 2013 by the American Medical Association’s CPT Editorial Committee.  According to the CPT Editorial Panel, procedures recognized as Category 1 are widely performed throughout the United States, consistent with accepted medical practice and supported by relevant published research demonstrating the clinical efficacy of the procedure.

In addition to its full suite of MIS procedures and devices, TranS1 has also created and continues to develop a patent portfolio focused on spinal health technologies. The company remains committed to becoming the most innovative in the industry by developing new technologies, applying lessons learned from its development of related approaches, and by attracting the most experienced engineers and surgeons to its team. In all, TranS1 has more than 100 issued patents and has filed more than 50 new patent applications in the last three years.

About TranS1
Headquartered in Denver, TranS1 develops medical breakthroughs to solve spinal pathologies that minimize trauma to the tissues surrounding the spine. The company’s flagship product, AxiaLIF+, is a minimally invasive option for surgeons to accomplish spinal fusion at the L5-S1 joint. The company was named Denver’s Most Innovative Workplace by the 80/95 Awards, presented by the Denver Post. In 2017, the company won the “New Spine Technology” award from Orthopedics This Week for its Pylon™ MIS Posterolateral Decortication and Bone Graft Placement System. For more information, visit www.TranS1.com.

# # #

Doyle Albee
dalbee@mapr.agency
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Simplify Medical Completes Enrollment in IDE Trial Studying Simplify Disc in One Level of Spine for Cervical Disc Replacement

Posted On February 14, 2018 By OrthoSpineNews In Spine, Top Stories /  

February 14, 2018

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced completion of enrollment in its U.S. IDE trial studying the Simplify Disc used for one-level cervical implantation of the device between C3 to C7 compared with a historical control group. The trial enrolled 166 patients at 16 U.S. sites.

“We want to thank the surgeon investigators, their staffs and the patients participating in the Simplify trial for their time and tremendous support,” said David Hovda, chief executive officer of Simplify Medical. “Recognizing that most of the devices used in disc replacement today require patients to be exposed to substantial ionizing radiation from CT scans post-operatively, it’s important for patients and physicians to have an alternative that minimizes that risk.”

The trial’s national co-primary investigator Domagoj Coric, MD, with Carolina Neurosurgery and Spine Associates, said, “The Simplify Disc is straightforward to implant, with materials designed to optimize biocompatibility and lower disc heights to better match cervical anatomy. We are pleased with the positive early clinical outcomes and look forward to seeing the longer-term study results, anticipating that they will validate the promise seen to date.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “The Simplify Disc is made of materials designed to optimize MRI imaging of the disc space and adjacent spinal canal without artifact. This can minimize or eliminate the use of post-operative CT scans and their risk of radiation to patients, and we look forward to having this capability as an option for treating our patients with cervical disc disease.”

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT scans post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

The Simplify Disc used in two levels of the spine is being studied in a second IDE trial in the U.S., which is approximately 40 percent enrolled and enrollment is expected to be completed by the end of 2018. The prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. For information about eligibility or enrollment in the two-level clinical trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

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Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant

Posted On February 14, 2018 By OrthoSpineNews In Spine, Top Stories /  

February 14, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that enrollment is now complete in the Company’s SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

Spineology’s deployable graft containment mesh implant is a uniquely porous device that deploys within the disc space as it is filled, permitting the contained bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

Spineology’s OptiMesh® deployable graft containment implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data to support a regulatory submission for expanded indications, allowing the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Dr. Stéphane Lavoie of DeLand, Florida enrolled the first SCOUT subject. As one of the top enrolling sites, Dr. Lavoie also enrolled the final study subject. “The Spineology interbody fusion system allows me to efficiently prepare the disc space for fusion through a very small access, reducing surgical time and trauma to the surrounding tissues. It has been exciting to participate in the clinical trial for this unique fusion system and I have been pleased with my patient outcomes.”

“The unique deployable mesh allows me to create a confirming bone graft pack to support new bone growth,” added Dr. Martin Krag, Professor of Orthopaedics at the University of Vermont Larner College of Medicine. “Importantly, patient satisfaction is very good. At our institution we have observed rapid and substantial improvements in pain and function scores for study subjects post-surgery.”

Early results in the SCOUT trial have been encouraging. Dr. John Chi will be formally presenting interim SCOUT results at the upcoming meeting of the International Society for the Advancement of Spine Surgery (ISASS) to be held this April in Toronto, Canada. Dr. Chi is an Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital, the top enrolling site in the SCOUT IDE trial.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients will be followed for 24 months minimum and the company is gathering data on hospital parameters, pain and function, patient satisfaction, safety and radiographic fusion. The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Subsequent to appropriate follow-up, the clinical outcomes data collected will allow Spineology to submit a De Novo application to the FDA to seek marketing clearance for interbody mesh fusion indications in the U.S.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com

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Camber Spine Technologies Announces First Implantations Of SPIRA™-C Open Matrix Cervical Interbody

Posted On February 12, 2018 By OrthoSpineNews In Spine, Top Stories /  

WAYNE, Pa., Feb. 12, 2018 /PRNewswire/ — Camber Spine, a leading innovator in spine and medical technologies, today announced the first surgeries using the company’s proprietary SPIRA™-C Open Matrix Cervical Interbody device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology. The first cases were performed successfully this past week with several surgeons across the country performing multilevel ACDF procedures.

Dr. Michael Dorsi, M.D. of Ventura Neurosurgery was one of the first surgeon design team members to perform a multilevel procedure using SPIRA™-C this past week. According to Dr. Dorsi: “I really appreciate the design of this implant. Upon insertion, I feel as though the cage has immediate stability because of the roughened surface which provides significant friction. The arched design has large openings which allows for significant graft packing and creates a snowshoe-like effect of distributed load sharing which should decrease the risk of subsidence. The open matrix architecture eliminates the need for the central lumen in traditional cervical cages, potentially speeding up the mechanical fusion process, optimizing clinical and fusion outcomes.”

Dr. Michael Dorsi, M.D., is a board-certified, fellowship trained neurosurgeon who has been providing state-of-the-art care to the greater Ventura County area since 2012. Dr. Dorsi attended The Johns Hopkins University, graduated Phi Beta Kappa with Highest Honors and a degree in Neuroscience and subsequently completed his residency training in neurosurgery. He was awarded the Cloward Award from the American Association of Neurological Surgeons for Fellowship Training in Minimally and Invasive Spine Surgery at UCLA.

SPIRA™-C was designed to address surgeon frustrations associated with traditional cervical interbody devices such as the need for immediate stability. SPIRA™-C was developed for Camber Spine under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company. With an extensive faculty of dedicated physicians, IMSE leverages the collaborative balance between engineering and surgeon ingenuity to create next-level medical devices. The SPIRA™-C design team included several John Hopkins trained Neurosurgeons, all with extensive backgrounds treating complicated cervical pathologies.

“Surgeon design team members are a key component to our success. The insight they provide helps us create smarter solutions, maximizing technological advances and ultimately driving innovation in minimally invasive spine surgery. We are fortunate to have an esteemed surgeon such as Dr. Dorsi on our team helping us turn surgeon frustrations into innovations. There is a lot of excitement around the SPIRA™ technology platform and we expect products like SPIRA™-C and SPIRA™ALIF to fuel our continued sales growth.”

– Seth Anderson, Founding Partner and Vice President, Surgeon Relations

SPIRA™-C is the second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology specifically designed to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

About Camber Spine

Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber Spine, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.

All of Camber Spine’s products are proudly MADE IN THE USA.

SOURCE Camber Spine Technologies

Related Links

http://cambermedtech.com

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SAGICO Participating in the International Spinal Osteotomy Meeting in Europe with a Focus on Clinical Validation for Aria™ and Arion™ Interbody Devices

Posted On February 8, 2018 By OrthoSpineNews In Spine, Top Stories /  

Tampa, FL, USA, February 5, 2018: As part of the US commercial launch of Aria Surefit™ Lumbar Expandable Interbody and the first-to-market Arion™ Cervical Expandable interbody, representatives from SAGICO USA and SAGICO EU will be attending the 2018 International Spinal Osteotomy Meeting at Koç University Hospital on February 10, 2018. SAGICO will be meeting with several Key Opinion Leaders and discussing the preliminary data review of clinical research being conducted.

SAGICO anticipates releasing portions of the company’s new and ongoing clinical data efforts focusing on Aria™ and Arion™ which were recently cleared by the FDA.  James Gibson, CEO of SAGICO USA, explained, “with the recent release of our innovative interbody portfolio we are now focusing on the continuous cycle of clinical validation.  With over 4,000 surgical interbody cases completed, we have strong data that will differentiate our products in the North American market.”  He added, “the key to the introduction of our unique portfolio will be continued surgeon and clinical collaboration in both the US and abroad.”

The prestigious International Spinal Osteotomy Meeting is an annual event with scientific lectures and data being presented ranging from principles of thoracolumbar and sagittal balance and osteotomies in cervical and upper thoracic spine.

Koç University hospital is part of the Koç Healthcare group among with two other hospitals, American Hospital and MedAmerican Ambulatory Care Surgery Center. The Koç University Health Science Campus houses the university’s notable school of medicine.

Faculty members include surgeons from leading teaching facilities in the USA and Europe. The meeting’s faculty includes KOLs from Columbia University in New York, UCSF Spine Center in San Francisco, Switzerland, France, Belgium, Italy and the host nation of Turkey.  The multinational meeting is full of excellent lectures from prominent experts, clinical review of new procedures, case discussions, debate sessions, video demonstrations, and workshops from industry experts all designed to raise physician competence. 

MORE ABOUT SAGICO: Spinal Analytics & Geometrical Implant Co, (SAGICO) and its principals have many years of spinal industry success spanning multiple continents in more than 60 countries. SAGICO and its affiliates are privately held companies with global partners and shareholders and an aggressive pipeline that includes: novel artificial disk implants (TDR), Porous Titanium interbody technology, Expandable VBR options and unique Pedicle Screw Systems optimized for Complex & Pediatric surgery are just a few of the product lines SAGICO offers. SAGICO’s US corporate based operations are located in Tampa, Florida.

DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more.

Learn more @: www.SAGICO.co

To schedule an interview please contact SAGICO in the USA: Telephone: 813-830-3636

 

Limited USA and International Distributor Opportunities Remain

 

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Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA XP Expandable Spacer System

Posted On February 6, 2018 By OrthoSpineNews In Regulatory, Top Stories /  

February 06, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ: OFIX), a global medical device company focused on musculoskeletal healing products, today announced the 510(k) clearance and U.S. limited market launch of the FORZA® XP Expandable Spacer System.

Designed to restore normal disc height in patients suffering from degenerative disc disease, the FORZA XP Expandable Spacer System can be expanded after insertion into the disc space in order to fit the patient’s anatomy. Made primarily of titanium alloy, these expandable interbodies are used for PLIF (Posterior Lumbar Interbody Fusion) and TLIF (Transforaminal Lumbar Interbody Fusion) procedures. Unlike the incremental expansion offered by some expandable interbody devices, the Orthofix System allows for a continuous controlled expansion and a custom fit to the disc space. Once the desired expansion is achieved the device features automatic locking which further adds to its ease of use.

“The FORZA XP Expandable Spacer System is a strong addition to our robust portfolio and makes Orthofix competitive in one of the fastest growing segments in spine,” said Ray Fujikawa, President of Orthofix Spine Fixation. “This new system offers an industry-leading 6.5mm starting height and also enables surgeons to place bone graft material inside the device after implantation. The ability to pack our new expandable device with bone graft post expansion is extremely important to ensure proper contact of the material with the vertebral endplates.”

The FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine. The FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation such as the Orthofix Trinity ELITE® allograft tissue and the Firebird® Spinal Fixation System.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix, International N.V.
Investor Relations:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

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Positive Pre-Clinical Results Using CelGro® in Anterior Cruciate Ligament (ACL) Reconstruction

Posted On February 5, 2018 By OrthoSpineNews In Biologics, Top Stories /  

February 04, 2018

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC) (“Orthocell” or the “Company”) is pleased to announce positive pre-clinical results using CelGro® collagen rope for Anterior Cruciate Ligament (ACL) reconstruction.

Orthocell Managing Director Paul Anderson said:“We are extremely excited by the potential of this technology.An off the shelf biological device that augments ACL reconstruction is highly desired by the orthopaedic industry and Orthocell is ideally placed to deliver a superior product in this rapidly growing and lucrative market.Not only does this data support the potential for an off the shelf augment to ACL reconstruction, but it also acts to validate CelGro® as a collagen medical device platform technology, for use across multiple indications including bone, tendons and peripheral nerves.”

The pre-clinical study was led by Chief Scientific Officer, Professor Ming-Hao Zheng, in conjunction with the University of Western Australia. The study was designed to show CelGro® collagen rope was equal to, or better than the use of an autologous tendon graft (such as hamstring) for ACL reconstruction, which can result in donor site discomfort and other associated complications.

The top line data indicated CelGro® rope, made from braided collagen fibers has superior biomechanical properties and is capable of replacing autologous grafts for ACL reconstruction. Further, the host ligament stem cells from the ACL stump are capable of ingrowth into the collagen rope for tissue regeneration and integrating with native bone with a tensile strength similar to that of the natural ligament. Professor Zheng presented the positive results at the Raine Medical Research Foundation ACL symposium (“ACL Symposium”), highlighting that collagen rope may eliminate the need for autograft harvest, thus circumventing the donor site morbidity.

Professor Freddie Fu, keynote speaker at the ACL Symposium, Chairman of the Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, specialist in ACL reconstruction, commented: “The use of this new collagen rope for ACL reconstruction is very promising. It could reduce the donor site morbidity and shorten surgical timeframes.” Professor Freddie Fu is a world-renowned orthopaedic surgeon and has treated high profile athletes, including Zlatan Ibrahimovic, striker for Manchester United.

72 cases were involved in the study with 36 cases receiving an autograft and the other 36 cases receiving CelGro® collagen rope for ACL reconstruction. Cases were evaluated at multiple time points undergoing either a regeneration assessment or mechanical test to assess the performance of the CelGro® collagen rope when compared to autologous tendon graft for ACL reconstruction. More pre-clinical studies will be required before human trials can begin.

Treatment of ruptured anterior cruciate ligaments

The ACL is one of the major stabilising ligaments of the knee. It connects the thigh bone (femur) to the shin bone (tibia), and once it ruptures, it is incapable of healing. The ACL can be injured in several ways including changing direction rapidly, landing from a jump or direct contact or impact. A ruptured ACL is a common injury suffered by active patients, usually requiring surgical intervention, with a long period for rehabilitation before returning to preinjury activities. There are between 100,000 and 200,000 ACL ruptures per year in the United States alone.

Successful ACL reconstruction surgery tightens your knee and restores its stability. It also helps patients avoid further injury and a return to work and playing sports. Surgical repair mostly involves reconstructing the ACL using grafts from the patient’s hamstring tendon, a procedure that removes part of the patients own tendon to take the place of the ruptured ACL. However, harvesting the patient’s tendon to replace the ruptured ACL is time consuming and can be problematic with ongoing donor site discomfort and in some cases subsequent rupturing of the harvested tendon.

To address the ACL reconstruction issues, Orthocell is developing a biological augment for ACL reconstruction, which could make treatment much more efficient and effective by simplifying techniques, reducing surgery time and mitigating the risks associated with harvesting the patient’s own tendon.

Contacts

General enquiries:

Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor enquiries:
Vesparum Capital
Joel Seah, +61 3 8582 4800
orthocell@vesparum.com
or
Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

 

Photo of ACL reconstruction using CelGro(R) collagen rope (Graphic: Business Wire)

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Controlling the chaos as a device rep – Why my “system” stunk and yours might, too

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

Life as a device rep is primarily reactive and can be chaotic. You’re often the last person called or thought of in the process. I always loved when I’d proactively check if any cases had been added for me at my account and hear, “Oh yeah, we added this one and it’s scheduled for….30 minutes from now.. are you going to be here?” Life comes at you fast after hearing that. And you have to be prepared, or you lose.

After you change your pants, you probably start calling and texting frantically to the rest of your team. Now your at the mercy of everyone else helping you locate what you need (if they’re even able to take your call). If they’re not answering, you start checking all the different tools you might use to organize your business.

As a ortho rep, here are the tools I was using to manage my territory:

Phone Notes Kept track of random thoughts for various hospitals & surgeon preferences.
Excel Products & Pricing – created my own spreadsheet of all the products, numbers, and the relative discounts across all the hospital.
iBooks This is where I kept all the PDF’s (including my beautiful pricing sheet) of op-techs and relevant journal articles
Contacts I tried to get each hospital organized as much as possible in these with all the various numbers between SPD, Accounts Payable (for POs), OR Front desk, and then the various ORs that we commonly operated in.

Side note: The notes section of these contacts were a mess of different people and contacts at the hospital. Often, I just went back to the notes to manage these
Scannable App I used this to take pictures of my usage pages after the procedure. This was much more efficient than having stacks of old usage in my bag until the end the month. I didn’t use this to track anything other than to essentially have a centralized storage location of all my documents

This was helpful in locating and identifying discrepancies in usage. Also allowed for quickly re-sending usage to Accounts Payable when looking for POs at the end of the month.

–       Something to consider: transmitting usage forms with patient information included in the email is a breach of HIPAA.
Google Calendar Being in trauma, this was critical. Being in two different branches, everyone had their own process for managing these. Groups of calendars and procedures for scheduling them and/or inviting others when needing assistance.
Word Some of the accounts where we had inventory consigned, I created booklets to leave at the account for any associates to be able to use when resetting trays or locating items. These included pictures, packing slips/par level information, surgeon notes, etc
Binders I created these beauties for different hospitals where we had instruments consigned. These had laminated pictures of trays, inventory lists, and billing sheets.

That’s 8 off the top of my head, and I’m sure there were more. Here’s just a few problems with my “system”:

  1. There was no consistency – each hospital, surgeon, procedure had a different place/location housing the information I needed. When it came to crunch time, it would be frustrating and time-consuming sifting through these different platforms to find the info I needed.
  2. This “system” was specific to me. When a colleague came to help me out with coverage, I had to spend a considerable amount of time just helping them get to the OR (we all know how complicate that can be anymore!)
  3. It’s not scalable. So much of what went on at each hospital was dependent on my knowledge. Even if I was away on vacation, I still spent a considerable amount of time on the phone explaining how to do various tasks. Upon return, I always had a few days of clean-up to get things back in order.

If your territory is completely dependent on you to run properly, you’re probably working yourself into an early grave, while also limiting your growth potential.

You need to control the chaos. When you’re using a platform like Surg.io, you could filter your calendar to see where all of those tubs are at in real-time and make a quick and informed decision.

Centralizing your tools allows you to take control on your side of the OR. Organizing your business more effectively before and after procedures. This centralized system that allows you to filter and plan your schedule, review outstanding PO’s, analyze your product mix and sales trends, and more. Everything you need to work smarter. Even further, working on the same platform with the rest of your team takes everyone to the next level.

 

Here’s a case file to organize everything for your procedure before and after.

If you are interested in learning how you can easily get started doing this, I would be happy to show you how simple it is. Choose 5 of your surgeons, a couple hospitals, and however many manufacturers you want. I’ll personally walk you through setting up your basics to get you off and running. What do you have to lose, except a lot of wasted time and frustration? You stand to gain a more sustainable system that can actually help you be more successful.

Let’s talk:

jwertz@surg.io

480-426-1389

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