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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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New Data and Surgical Experiences with OMNIBotics® Active Spacer™ Ligament Balancing System Presented at Prestigious Orthopaedics Conference

Posted On February 5, 2018 By OrthoSpineNews In Recon /  

RAYNHAM, Mass., Feb. 5, 2018 /PRNewswire/ — OMNIlife science™, Inc. (“OMNI™”), an established medical technology company targeting the $15 billion global hip and knee replacement device market, announced that several presentations about their breakthrough OMNIBotics Active Spacer technology were featured at the International Congress for Joint Reconstruction (ICJR) 10th Annual Hip & Knee Conference held in Vail, CO from January 18-21.

The ICJR focuses on providing a comprehensive orthopaedic learning experience for their members, delivering timely and relevant education. The more than 150 attendees learned about OMNIBotics Active Spacer technology in both a pre-recorded surgery presentation and a podium presentation. The surgery, “TKA Utilizing OMNIBotics Active Spacer Robotically Assisted Ligament Balancing System” was performed and narrated by Jeffrey H. DeClaire, MD, DeClaire LaMacchia Orthopaedic Institute, Rochester Hills, MI. The podium presentation “Ligament Balancing Technology in TKA” was given by John Keggi, M.D., Connecticut Joint Replacement Institute, Hartford, CT.

Dr. DeClaire commented, “With this new technology and the ability to capture accurate data, the Active Spacer can help to more accurately and consistently restore the normal soft tissue balance of the knee with the potential to improve patient outcomes and patient satisfaction.”

The OMNIBotics Active Spacer, with more than 150 procedures performed to date, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. Since sub-optimal soft tissue balancing is a potential contributing factor to patient dissatisfaction with their knee replacement, OMNI developed this device to address that need. When the OMNIBotics Active Spacer is combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective.

“The Active Spacer provides the most accurate and useful information to date for achieving good balance in knee replacement patients,” stated Dr. Keggi. “Surgeons can now see the full motion and precise balance of the knee in real time, which provides important feedback to optimize the function of the knee.”

The OMNIBotics Active Spacer received FDA clearance in early September, 2017 and is currently in clinical evaluation at six sites in the United States and one in Australia.

About OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

Forward-Looking Statements

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward‐looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward‐looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

Contact

Cindy Holloway, Director of Marketing Communications
Phone: (508) 824‐2444
cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com

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InVivo Therapeutics Announces Appointment of Richard Toselli, M.D., as President and Chief Executive Officer

Posted On February 5, 2018 By OrthoSpineNews In Biologics /  

February 05, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Richard Toselli, M.D., has been appointed President and Chief Executive Officer of InVivo, having been appointed the company’s Acting CEO in December 2017. Dr. Toselli also has been appointed to the company’s Board of Directors and will continue to serve in his capacity as InVivo’s Chief Medical Officer, which role he assumed upon joining the company in July 2017. Dr. Toselli, a Board-certified neurosurgeon, has led an accomplished career in surgical medical affairs, with senior leadership experience at Sanofi, DePuy, and Johnson & Johnson.

“I am delighted to announce Rich’s full-time role as CEO,” stated Ann Merrifield, InVivo’s Chair of the Board of Directors. “Rich has demonstrated clear vision, a strategic mind, and committed leadership in his time at InVivo. His background in surgical device innovation and neurological surgery is uniquely suited to the company’s focus in development.”

Dr. Toselli said, “I am excited about the opportunity to work closely with our seasoned leadership team and accomplished Board members and advisors as we chart the company’s path forward. Our priority is to focus on our core competencies, advance our breakthrough Neuro-Spinal Scaffold™ clinical program, and achieve this progress in an expedited, cost-efficient manner. We continue to evaluate our strategic and financing options, regarding which we believe we have gained additional flexibility by entering into the recently announced stock purchase agreement with Lincoln Park.”

Dr. Toselli continued, “As we have previously announced, we are in ongoing discussions with the FDA, including the potential of a proposed randomized controlled clinical trial to supplement the existing clinical evidence we have attained in our INSPIRE study for our Neuro-Spinal Scaffold™ investigational device. We expect to provide additional clarity on this clinical path in the second quarter of this year.”

Biographical Background

Prior to joining InVivo, Dr. Toselli served as Chief Medical Officer for Cochlear Limited. In that role, he was responsible for global clinical, regulatory, and medical affairs teams reporting to the Chief Executive Officer. Previously, Dr. Toselli served five years at Sanofi in various levels of increasing responsibility, including Vice President of Global Medical Affairs – Immunology and Inflammation, Biologics Division; Vice President of Global Medical Affairs and Head of the Biosurgery Discovery Performance Unit; and Vice President of Global Medical Affairs, Biosurgery. Prior to this, he served as Chief Medical/Technology Officer for Covidien Surgical, and earlier held various roles at DePuy Spine including Director of Medical Affairs, Worldwide Vice President of Research and Development, and Worldwide Vice President of Clinical Evidence and External Relations. He held the position of Vice President of Evidence-Based Medicine at Johnson & Johnson for the device sector. Dr. Toselli holds a bachelor of arts from Providence College, his medical degree from Brown University, and a master of business administration from the UNC’s Kenan-Flagler Business School. Dr. Toselli is a board-certified neurological surgeon.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™ received the 2015 Becker’s Healthcare Spine Device Award. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the status of the company’s clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s discussions and engagement with the FDA; the company’s ability to initiate, conduct and complete clinical trials; the expected benefits and potential efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical trials and future product commercialization; and other risks associated with the company’s business, research, product development, attainment of regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended September 30, 2017, and its other filings with the SEC, including the company’s most recent Form 10-K, its Form 10-Qs and its current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

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SANUWAVE Announces First Time Exhibition at EWMA in Poland in May 2018

Posted On February 2, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, Feb. 02, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at EWMA (European Wound Management Association) in Krakow, Poland on May 9 – 11, 2018. This will be a great opportunity to re-invigorate our flagship wound care device, the dermaPACE® System, after receiving US FDA clearance for the treatment of Diabetic Foot Ulcers (DFUs) in December 2017.  The dermaPACE system is currently CE Marked within Europe for the treatment of various acute and chronic conditions of the skin.

“We are excited to be presenting at EWMA in Krakow, Poland, our first time as an exhibitor.  Since FDA clearance, the support coming from the wound care community has been overwhelmingly positive, both domestically and internationally,” stated Kevin A. Richardson, CEO and Chairman of the Board.  Mr. Richardson continued, “This will be the start of our reemergence in the wound care space.”  The Company is using this occasion to showcase their lead wound care product, the dermaPACE System.  This Extracorporeal Shockwave Technology (ESWT) device based upon electrohydraulic principles has been proven, in two US-based randomized-controlled clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers.  Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects.  The dermaPACE System exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment.  The use of the dermaPACE System allows the clinician to more easily, and more cost-effectively, manage wounds.   More importantly, the patient’s quality of life improves significantly.  While new to the U.S. market, the dermaPACE System already enjoys a strong support base in Italy, Spain, and the BeNeLex countries.  Additional distribution bases include: Germany, Austria, Switzerland, Romania and Great Britain.

If you are interested in scheduling a meeting with the team, please contact Peter Stegagno via e-mail at peter.stegagno@sanuwave.com; otherwise, please stop by our booth at the conference in May.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

Contact:

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Peter Stegagno

Vice President Operation, Regulatory, and Clinical

678-578-0111 (Office)

678-670-9478 (Mobile)

peter.stegagno@sanuwave.com
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Hard-to-Heal Bones Could Use a Protein Boost

Posted On February 2, 2018 By OrthoSpineNews In Extremities /  
February 1, 2018/GEN

The occasional bone fracture from a sports injury, motor vehicle accident, or just plain bad luck may seem commonplace in today’s world of advanced medical treatments. Yet, there is always the possibility that the break won’t heal properly or quickly—even with the aid of pins, plates, or a cast. Scientists and physicians have unsuccessfully tried to overcome this potential problem through the administration of bone morphogenetic proteins (BMPs). These regenerative factors were initially designed to promote spinal fusion and bone repair, but studies found that the molecules can over perform, causing excessive or misdirected bone growth.

Now a collaborative team of investigators, led by scientists at the University of Michigan Medical School, have discovered a new molecule they believe will provide the assisted growth to bones that was originally intended using BMPs. Findings from the new study were published today in npj Regenerative Medicine, in an article entitled “Intraoperative Delivery of the Notch Ligand Jagged-1 Regenerates Appendicular and Craniofacial Bone Defects.”

“Each year, 33% of US citizens suffer from a musculoskeletal condition that requires medical intervention, with direct medical costs approaching $1 trillion USD per year,” the researchers write. “Despite the ubiquity of skeletal dysfunction, there are currently limited safe and efficacious bone growth factors in clinical use.”

“Novel therapies have gone underdeveloped because of this assumption that bones heal without problem,” added senior study investigator Kurt Hankenson, D.V.M., Ph.D., a professor of orthopedic surgery at Michigan Medicine. “The reality is there’s a huge number of fractures that occur each year that don’t heal very well.”

Due to the limited number of options for aiding patients with bone healing, the research team began to look for novel approaches. What they attempted was the delivery of additional Jagged-1—a potent osteoinductive protein known to activate the Notch signaling pathway that regulates bone healing—at the spot of a bone injury.

 

READ THE REST HERE

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First Triojection cases in Germany were recently completed by Prof. Dr. Thomas Vogl MD.

Posted On February 2, 2018 By OrthoSpineNews In Spine /  

January 31, 2018

Minimus Spine Inc., manufacturer of the patented Triojection System, intended to produce ozone gas for spinal disc herniations, announced today that the first cases of Triojection in Germany were recently performed. The cases were done at the University of Frankfurt and performed by Prof. Dr. Thomas Vogl MD, Director of the Institute for Diagnostic and Interventional Radiology at the J.W. Goethe University Hospital Frankfurt am Main.

“I successfully completed 10 Triojection cases in December”, said Dr.Vogl. “It is an elegant design and simple to use. I particularly appreciate how Triojection is designed for safety and consistency. Triojection is unique in that it creates the ozone inside a sterile syringe and simultaneously measures the concentration of ozone within the syringe. This product advances the state of the art and gives me a new level of confidence in what is actually administered to the patient’s disc. Early results have been favorable and I intend to continue with Triojection in my practice.”

David Hooper Ph.D., Minimus Spine’s CEO, added “We are excited to have Dr. Vogl as one of our earliest adopters. He is a leader in his field and his support validates our belief that Triojection sets a new standard for spinal ozone injections.”

Dr. Vogl is a listed author on more than 500 peer reviewed articles related to interventional radiology and currently sits on the editorial boards for the journals European Radiology and Academic Radiology. The University of Frankfurt has been performing spinal ozone injections for more than 10 years. In 2012, Dr. Vogl and his colleagues published a key paper describing the reduction of disk volume following intradiscal ozone injection in 283 subjects with disc herniation.

About Minimus Spine Inc.: Established in 2006, Minimus Spine is a privately held medical device company dedicated to developing the Triojection technology the non-surgical treatment of herniated discs. Minimus Spine’s CEO and team largely stem from Spinal Concepts, another spinal startup that was sold to Abbott for $170M. The company is positioning itself for sale to one of several medical device strategics after achieving successful European adoption of its product. Minimus Spine maintains its headquarters in Austin, TX. For more information on Minimus Spine, please visit www.minimusspine.com or email info@minimusspine.com.

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Centric Medical Announces First Quarter Participation at Industry Meetings to Showcase Its Foot & Ankle Portfolio

Posted On February 2, 2018 By OrthoSpineNews In Extremities /  

January 31, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today that it will be participating in the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting which will be held March 6-10 in New Orleans, Louisiana, as well as the 76th Annual 2018 American College of Foot and Ankle Surgeons (ACFAS) Meeting to be held March 22-25 in Nashville, Tennessee. The meetings are expected to attract over 12,000 and 1,800 surgeons, respectfully, with other healthcare professionals from across the globe.

Centric Medical will be promoting the TARSA-LINK® Stand-Alone Wedge Fixation System, the TARSA-LINK® BUNION Stand-Alone Wedge Fixation System, the ROGUE™ Hammertoe Correction System, as well as the newly FDA cleared Foot Plating System and the Cannulated Screw System. In addition, Centric Medical will highlight their Biologics systems, including OSTEO-LINK® 100% Demineralized Bone Matrix and MARROW CELLUTION™ Bone Marrow Harvesting System. Centric Medical’s booth number at AAOS is 714, and booth number at ACFAS is 339.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

For Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Anika Therapeutics Announces Strategic Collaboration with the Institute of Integrative Biology at the University of Liverpool to Develop an Innovative Therapy for Osteoarthritis

Posted On February 1, 2018 By OrthoSpineNews In Biologics /  

February 01, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced an agreement with the Institute of Integrative Biology at the University of Liverpool to collaborate on research to develop an injectable mesenchymal stem cell (MSC) therapy for the treatment of osteoarthritis (OA).

The purpose of this three-year research collaboration is to develop a novel MSC therapy for the treatment of OA, and if successful, is expected to yield a lead candidate that will move toward clinical development within a year of the collaboration’s completion.

Osteoarthritis is the most common chronic condition of the joints, affecting over 230 million people globally. OA can affect any joint, but it occurs most often in knees, hips, lower back, neck, small joints of the fingers, and the bases of the thumb and big toe. In normal joints, cartilage covers the end of each bone and acts as a cushion between the bones. However, osteoarthritis causes this cartilage to break down, causing pain, swelling and problems moving the joint.

“We are very excited to partner with the University of Liverpool and Professor Hollander to continue his research into an innovative treatment for osteoarthritis patients,” said Dr. Charles H. Sherwood, Chief Executive Officer, Anika Therapeutics. “This research will consist of a novel product design and pre-clinical testing, that has the potential to produce an advanced therapy to treat the joint damage and pain caused by this debilitating condition.”

Anthony Hollander, the Head of the Institute of Integrative Biology, said, “Cellular therapy is already being used in some countries for osteoarthritis with some evidence that it transiently reduces pain. Our new approach to cellular therapy may provide a durable treatment for osteoarthritis.” He added, “This collaboration with Anika will allow us to accelerate any discoveries through to clinical and commercial development.”

About the Institute for Integrative Biology at the University of Liverpool

The Institute of Integrative Biology (IIB; https://www.liverpool.ac.uk/integrative-biology/) provide one of the most vibrant and integrated biosciences environments in the UK. The Institute comprises 220 staff (including 75 Principal Investigators) and 150 postgraduate students. With a research income of ~£9.5m annually. Scientists deliver ground-breaking research within four key research themes, including the Centre for Genomic Research, the Centre for Proteome Research,, the Centre for Cell Imaging, and the NMR Centre for Structural Biology. The IIB has a large impact throughout the world, through major partnerships with large companies such as Unilever and AstraZeneca, and strong global links into major research enterprises in Japan, Brazil, USA and China.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the first, second, fourth, and fifth paragraphs of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the potential product that could be yielded by the Company’s collaboration with the University of Liverpool and the timeline for the delivery and clinical trial work associated with such product. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or timely file and receive FDA or other regulatory approvals or clearances of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (ii) the Company’s research and product development efforts, including those with the University of Liverpool, and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations and production planning; (iv) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (v) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (vi) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (vii) the Company’s ability to provide an adequate and timely supply of its products to its customers; (viii) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (ix) the Company’s ability to achieve its growth targets.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, Chief Financial Officer
Tel: (781) 457-9000
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418, sonal@w2ogroup.com
or
University of Liverpool
Nicola Frost
Press Officer, External Relations, Marketing and Communications
University of Liverpool
nicola.frost@liverpool.ac.uk,
Tel: +44 (0)151 795 9620

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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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US Spinal Implants and VCF Market Report Suite 2017-2023 – Motion Preservation Segment Will Be the Fastest Growing in the Market – ResearchAndMarkets.com

Posted On February 1, 2018 By OrthoSpineNews In Spine /  

February 01, 2018

DUBLIN–(BUSINESS WIRE)–The “Spinal Implants and Vertebral Compression Fracture (VCF) Market Report Suite for US 2017-2023 – MedSuite (Includes 10 Reports)” report has been added to ResearchAndMarkets.com’s offering.

Despite many challenges, growth is expected in many market segments, as the patient demographics in the U.S. maintain a steady demand for such procedures. Growth has slowed in the last few years as newer, minimally invasive innovations gradually cannibalized the traditional spine market. The motion preservation segment will be the fastest growing in the market, and will be continually driven by novel and emerging technologies.

The biggest limiting factor for the spinal fusion markets is the development of motion preservation technology. Lumbar artificial discs (LADs) have not been as successful at cannibalizing thoracolumbar fixation devices as previously anticipated due to a lack of reimbursement and unfavorable clinical results. Favorable reimbursement policies are expected for these devices as favorable clinical results involving newer devices emerge.

One of the key drivers for the interbody fusion market is the increase in the target population, which is composed of aging baby boomers. The majority of spinal fusion procedures are performed on those individuals over the age of 60. This age group is the fastest growing demographic in the United States.

Minimally invasive interbody options will continue to cannibalize areas of the standard interbody market, particularly traditional ALIF and PLIF approaches. However, other areas of the standard market will continue to experience growth.

General Report Contents

  • Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
  • Market Drivers & Limiters for each chapter segment
  • Competitive Analysis for each chapter segment
  • Section on recent mergers & acquisitions

Companies Mentioned

  • Medtronic
  • DePuy Synthes
  • Stryker
  • Zimmer Biomet
  • Globus Medical
  • NuVasive
  • Orthofix
  • K2M
  • Alphatec Spine
  • DJO
  • Aesculap
  • Atlas Spine
  • Benvenue Medical
  • Centinel Spine
  • Custom Spine
  • DFine
  • Exactech
  • Inion
  • Life Spine
  • Orthofix
  • Osseon
  • Paradigm BioDevices
  • Pioneer Surgical

Key Topics Covered:

  1. Executive Summary
  2. Research Methodology
  3. U.S. Spinal Implants and VCF Market Overview
  4. Procedure Numbers
  5. Cervical Fixation Market
  6. Thoracolumbar Fixation Market
  7. Interbody Device Market
  8. Motion Preservation Device Market
  9. Vertebral Compression Fracture Market
  10. Spinal Electrical Stimulation Device Market

For more information about this report visit https://www.researchandmarkets.com/research/tmsqnk/us_spinal?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Orthopedic Devices

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