Power T Handle Wins Spine Innovation Award

Power T Handle, LLC, a surgeon-driven, innovative company, announced today that it has received a Spine Technology Award from Orthopedics This Week during the 2018 National Association of Spine Surgeons (NASS) meeting in Los Angeles, CA last week. The Power T Handle is a surgical instrument that delivers operating room efficiencies through increased speed and reduced surgeon fatigue while preserving tactile feedback and precision in spinal and other surgical procedures. The Spine Technology Awards bring recognition to new, innovative spine surgery products and the teams that created them.

Justin Iorio, MD, orthopedic surgeon at Syracuse Orthopedic Specialists, Syracuse, NY, noted, “The Power T Handle addresses an unmet need in complex spine surgical procedures, and the success of this product can be directly attributed to the benefits it offers surgeons, hospitals and patients. I rely on the Power T Handle in my complex spinal fusion procedures as it saves time in the OR, reduces the strain on the surgeon while providing the feel and precision needed to perform surgical procedures with excellent outcomes.”

This first-of-its-kind, wireless power solution allows for seamless integration of a low speed, high torque power driver that preserves the tactile feel and manual capabilities of a traditional T handle. The low-profile design does not interfere with an intra-operative fluoroscopy, and is compatible with existing surgical instruments. The Power T Handle delivers hassle-free power by eliminating many of the cumbersome features of current power equipment. The Power T Handle is also economical as there is no investment in capital equipment, no reprocessing, no maintenance costs and no batteries to recharge.

Kevin Cahill, MD, PhD, President and Co-founder of Power T Handle, LLC stated, “We are honored to have received The Spine Technology Award. Our team at Power T Handle, LLC is committed to developing disruptive technologies and better power solutions for surgeons.”

About Power T Handle, LLC 

The Power T Handle was developed by a team of experienced medical device engineers led by Kevin Cahill, MD, PhD. The Power T Handle was designed to overcome the many limitations of existing power instruments currently available to surgeons. The Power T Handle provides surgeons with the power, precision and feedback necessary to perform surgery without the fatigue, hassle and cost of traditional instrumentation.

OrthoSensor Announces Milestone Of 50,000 VERASENSE Sensors Distributed Globally

Implanet UK announces its first surgery in the United Kingdom

October 04, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee surgery implants, announces the completion of its first surgery in the United Kingdom via Implanet UK, at the Royal Orthopaedic Hospital of Birmingham, following the opening of its branch in early June1.

The recent listing of Implanet UK and its Jazz® platform on the NHS (National Health Service), the United Kingdom’s public health system providing the bulk of care, particularly in hospitals, allows Implanet UK to offer Jazz® to all public hospitals in the country.

As a reminder, the United Kingdom is the second largest market in Europe for spinal fusion back surgery. The potential in adult degenerative spine disease is estimated at over $100 million2.

Next press release: 3rd quarter 2018 revenue on October 9, 2018 before the market opens.

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 IMPLANET announces opening of a United Kingdom sales branch
2 Mordor Intelligence 2017 study

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1-917-385-21 60
implanet@alphabronze.net

SeaSpine – Growing Strong

October 03, 2018 / By RTT News

(RTTNews.com) – Shares of SeaSpine Holdings Corp. ( SPNE ) have returned more than 60% year-to-date, clearly outpacing the 12% gain of the iShares Nasdaq Biotechnology index.

SeaSpine is a medical technology company focused on developing and commercializing surgical solutions namely, orthobiologics and spinal implants, for the treatment of patients suffering from spinal disorders.

Between 2012 and 2017, Company launched a total of 30 products, thanks to increased annual research and development spending. This year, more than 6 products are expected to be launched, of which 4 products have already been launched.

SeaSpine reports revenue in two product categories namely orthobiologics and spinal implants.

The orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. The spinal implant portfolio consists of an extensive line of products to facilitate spinal fusion in MIS, complex spine, deformity and degenerative procedures.

The Company generates 90% of its revenue from the U.S. spine market. Apart from the U.S., the Company’s products are sold in over 30 countries worldwide.

 

READ THE REST HERE

 

Paragon 28® releases another wave of state of the art plating options, adding to the expansive Baby Gorilla® Mini Plating System- launches Medial and Lateral Talar Neck Fracture Plates, Zig Zag Plates, and Zig-Zag Spanning Plates

ENGLEWOOD, Colo.Oct. 3, 2018 /PRNewswire/ — Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The Baby Gorilla® Medial and Lateral Talar Neck plates are highly contoured in order to fit the unique curvature and anatomy of the talar neck. The plate geometry and screw hole locations are designed in order to provide fixation and stability around commonly observed fracture patterns. Additionally, the medial talar neck plate contains extended bridge lengths to accommodate ancillary fixation should cross screw fixation be appropriate.

The Lateral Talar Neck Plates come in two sizes, both small and medium for left and right feet while the medial talar neck plate is offered in a left and right option.

The Zig Zag and Zig Zag Spanning plates can be used universally in application but excel when addressing highly comminuted areas, revisions, hardware removal and metatarsal fractures. The Zig Zag plates come in multiple lengths and screw hole options, from a 5-hole plate up to as large as a 19-hole option. Additionally, the Zig Zag Spanning plate comes in three length options to address the needs of each patient.

The modularity of the Baby Gorilla® Mini Plating system allows both small plate caddies to utilize the same screws and instrumentation used by all other 80+ Baby Gorilla® plating options, all in a single set. All plates are designed to accept both 2.0mm and 2.5mm locking and non-locking plate screws. Additionally, the Baby Gorilla® system includes state of the art foot and ankle specific instrumentation including curettes, reduction clamps, osteotomes, as well as small pin compression and distraction devices.

For more information, contact: Jim Edson, VP of Product Marketing and Management, jedson@paragon28.com

SOURCE Paragon 28, Inc.

Amedica Announces Closing of the Sale of its Spine Business to CTL Medical

SALT LAKE CITY, Oct. 03, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA) today announced that it has completed the previously-announced sale of its spine business to CTL Medical, a Dallas, TX-based privately held medical device manufacturer, on October 1, 2018, all as more fully described below.

As previously announced, Amedica and CTL Medical entered in an asset purchase agreement, dated September 5, 2018, whereby CTL Medical agreed to acquire all of Amedica’s commercial spine business for total consideration of up to $10 million. As a result of the closing, CTL Medical is now the exclusive owner of Amedica’s portfolio of metal and silicon nitride spine products, which are presently sold under the brand names of Taurus, Preference, and Valeo, with access to future silicon nitride spine technologies. Manufacturing, R&D, and all intellectual property related to the core biomaterial technology of silicon nitride remains with Amedica in Salt Lake City. Amedica will serve as CTL’s exclusive OEM provider of silicon nitride products.

“We are pleased to have closed this transaction so quickly after the September announcement. Amedica is now free of the considerable costs and complexity attendant to retail spine sales, allowing the company to focus on the core biomaterials and OEM business instead. We will fully support CTL spine sales in terms of clinical and basic science, surgeon education, and any other necessary sales support. Most importantly, as a debt-free company, Amedica can now focus on revenue opportunities outside of spine where our R&D program is particularly strong, such as in the dental and arthroplasty markets,” said Dr. Sonny Bal, Chairman of the Board at Amedica Corporation. “In our opinion, this is the leanest, most efficient, and overall best position that Amedica has ever been in as a company, from a cash position or otherwise, with multiple strategic options going forward,” added Dr. Bal.

Daniel Chon, President and CEO of CTL Medical noted, “The depth of science behind silicon nitride research continues to impress us. We, at CTL Medical, the only company to possess such highly differentiated biomaterial in spine, are extremely bullish on the outlook and opportunities in our industry. The closing of the acquisition now gives us the green light to unleash the talents of our engineers to drive innovation by applying the attributes of silicon nitride across our entire product portfolio. The sheer amount of energy, interest, and excitement that this acquisition has created is already noticed worldwide and was clearly visible during the North American Spine Society (NASS), hosted in Los Angeles last week. The responses from our global partners, surgeons and distributors were extremely positive and equally encouraging. We believe that as our two organizations come together, each with distinct strengths, as one pulls from the front and the other pushes from the back, a new era, movement, and momentum in our industry will be seen and felt.”

The description of the asset purchase agreement and the transaction set forth above is qualified in its entirety by reference to the full text of the agreement, which was included as part of the Company’s Form 8-K filed with the Securities and Exchange Commission on September 6, 2018.

About Amedica
Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

About CTL Medical
CTL Medical is a forward thinking medical device design, development and manufacturing company that produces a full line of cervical, thoracic, and lumbar products (hence “CTL”) at its manufacturing headquarters in Dallas, Texas.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Such forward-looking statements include but are not limited to statements about the benefits of the transaction, including future accretive value to CTL and Amedica’s future financial results, operating plans, objectives, expectations and intentions, and other statements that are not historical facts. These forward-looking statements are subject to risks and uncertainties that may cause actual results or events to differ materially from those projected, including but not limited to the risks that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which Amedica and CTL operate; the ability of CTL to promptly and effectively integrate Amedica’s commercial spine business; the reaction to the transaction of the companies’ customers, employees, and counterparties; and the diversion of management time on transaction-related issues. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts: Amedica IR 801-839-3502 IR@amedica.com

SI-BONE, Inc. Announces that NICE, the UK Nat’l Institute for Health and Care Excellence, Published Medical Technology Guidance Supports iFuse for Treatment of Sacroiliac Joint Pain

Positive Commercial Payor Policy By Priority Health of Michigan Covering coflex® For The Surgical Treatment Of Lumbar Spinal Stenosis

NEW YORKOct. 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, today announced the issuance of a Priority Health of Michigan Medical Policy. The policy, effective August 20 2018, now includes coverage of the coflex®  Interlaminar Stabilization® device for lumbar spinal stenosis with no prior authorization required. This issuance adds to the continual growth of positive commercial payor policies for coflex®.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 years) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine.  The coflex® device is a non-fusion, motion-preserving stabilization implant, that is FDA PMA-approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

Marc Viscogliosi, Chairman & CEO of Paradigm Spine, said, “This coverage policy by Priority Health of Michigan reflects the continued adoption and understanding of the benefits coflex® offers patients with lumbar spinal stenosis. We look forward to expanding patient access to the coflex® technology to the more than 786,000 lives covered by Priority Health of Michigan – Michigan’s second largest health plan that is nationally recognized for improving the health and lives of the people it serves by providing quality care that’s accessible and affordable.”

To learn more about coflex® Interlaminar Stabilization®, please visit www.coflexsolution.com.

About Paradigm Spine, LLC
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment.  For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

OMNIlife science™, Inc. Achieves Milestone with OMNIBotics® Active Spacer

RAYNHAM, Mass.Oct. 3, 2018 /PRNewswire/ — OMNIlife science, Inc. (“OMNI”), a privately-held, medical technology company targeting the $15 billion global hip and knee replacement device market, reported today that the positive clinical benefits of the OMNIBotics® Robotic Active Spacer continue to be reinforced by more than 1,000 successful procedures performed to date. Orthopaedic surgeons have been evaluating this revolutionary system that utilizes a miniature robot to ensure the ligaments will be “balanced” after the knee replacement.

A basic tenet of knee replacement is to balance the tension of the ligaments to ensure smoother knee function and better alignment. However, balancing frequently involves making small incisions in tighter ligaments to create equal ligament tension. The Active Spacer helps the surgeon position implants in anatomic alignment while maintaining ligament balance without having to incise ligaments. Early data on the use of the Active Spacer is showing a much higher rate of patient satisfaction at both three and six months’ post-surgery than what has been typically reported in the literature.

“We are pleased the benefits of OMNIBotics Active Spacer technology continue to be validated by multiple surgeons,” said Rick Epstein, CEO of OMNI. “Our OMNIBotics robotic-assisted technology guides the surgeon to the optimal implant position to achieve both mechanical alignment and balance, and each of the cuts are made with robotic precision. We believe a properly aligned and carefully balanced knee will result in optimized patient outcomes and it is exciting to be working with surgeons to advance the field of knee replacement with robotics.”

OMNIBotics with Active Spacer is the first and only robotic system to integrate ligament tension with bone alignment.

“I’ve been doing knee surgery for 25 years,” stated Jeffrey H. DeClaire, M.D. (DeClaire LaMacchia Orthopedic Institute, Rochester Hills, MI), “and I’ve always been very focused on balancing the knee, but there’s never been any way to measure and validate ligament balance and ligament tension in knee arthroplasty until the OMNIBotics Active Spacer.  This is a real breakthrough because now I know that each total knee arthroplasty I perform is precisely balanced with consistency and reproducibility that significantly improves the accuracy of the procedure, in addition to facilitating improved patient outcomes and patient satisfaction.”

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

ApiFix Surpasses 250 Scoliosis Patients Treated and Six-Year Follow-up of Earliest Cases

October 02, 2018

BOSTON–(BUSINESS WIRE)–ApiFix Ltd., a leading motion-preservation scoliosis correction company, announced today that its patented Minimally Invasive Deformity Correction (MID-C) technology has now been used to treat more than 250 young patients diagnosed with progressive scoliosis. The company also announced that the earliest treated patients have reached their six-year follow-up milestone.

ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility using a least invasive surgical approach. Patient recovery is relatively pain-free and is measured in days, not months. The MID-C system acts as an “internal brace” that incorporates a patented unidirectional, self-adjusting rod mechanism with motion-preserving polyaxial joints allowing additional non-invasive post-operative correction over time and is removable.

The MID-C device has been used for treatment in multiple countries, with more than 100 patients now having greater than two-year follow-up. A typical ApiFix surgical procedure takes about 90 minutes with minimal blood loss (~50cc) and short hospitalization and recovery times (1-2 days and 1-2 weeks, respectively). In contrast to fusion correction procedures, the MID-C system allows for additional deformity correction with standard post-operative exercises. Patients’ normal daily activities are unencumbered since spine flexibility and mobility are retained.

Available treatment options for progressive scoliosis in the U.S. have been limited despite continued advances in both surgical and non-surgical systems – a perspective shared by Randy Betz, MD, past president of the Scoliosis Research Society.

“Despite great recent advancements, our options to address progressive curvature in young patients today remain limited,” said Dr. Betz. “Bracing systems are required to be worn many hours per day and do not correct the deformity. Standard spinal fusions correct the deformity but have a much longer recovery time and result in a permanent loss of mobility. The introduction of a procedure that can effectively correct spinal deformity with less invasive, motion-preserving techniques will have a dramatic effect on the quality of life for these patients and their families.”

“The new ApiFix surgery is much less invasive than standard fusion procedures, allowing for a significantly shorter recovery,” said Ron El-Hawary, MD, Chief of Orthopedics, IWK Health Centre in Halifax, Canada, who has been impressed with his use of the MID-C device in patients. “We see that patients have more flexibility and they will likely have better participation in sports, dance and other activities performing at the same level or higher than previously. Based on my own experience and the overall early experience of many patients beyond two-years follow-up, I believe this device has great promise in offering a completely different option for adolescent idiopathic scoliosis patients with progressive curves.”

Paul Mraz, ApiFix CEO, is committed to establishing a new standard of care for spinal deformity treatment, generating peer-reviewed evidence, and working with the FDA to help make this new technology available for patients in the United States. The device is currently investigational in the United States and is under review by FDA in a Humanitarian Device Exemption application.

“Our review of the extensive clinical experience with the MID-C system and our ongoing collection of new data continue to underscore ApiFix’s positive results realized in patients with progressive spinal deformity,” said Mraz. “ApiFix represents a game-changing opportunity for patients and families and a viable alternative to irreversible fusion procedures. We look forward to making this technology more widely available worldwide.”

About ApiFix Ltd.

Founded in 2011, ApiFix Ltd. is a privately held medical device company based in Misgav, ISRAEL and Boston, Massachusetts, USA and a portfolio company of The Trendlines Group Ltd. (SGX: 42T; OTCQX: TRNLY). ApiFix is a leading motion-preservation scoliosis correction company developing a unique platform technology that represents a disruptive approach to spine deformity treatment. ApiFix’s Minimally Invasive Deformity Correction (MID-C) system has CE Mark approval and is available in Europe, Israel, Singapore and Canada. More information is available at www.apifix.com.

Contacts

for ApiFix Ltd.
Paul Williams, 310/569-0023
paul@medialinecommunications.com