LOS ANGELES, Sept. 26, 2018 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today at the North American Spine Society (NASS) Annual Meeting that the company has entered into an exclusive partnership with both TeDan Surgical Innovations and Lattus Spine, LLC to market a turnkey, best in class, Total Lateral Solution.

“Today is a truly exciting day for 4WEB as we establish a premier market position with these game changing partnerships,” said Jessee Hunt, 4WEB Medical President and CEO.  “The combination of our Truss Implant Technology and the Extreme Lateral access solution offered by TeDan and Lattus, address two major components of a Total Lateral Solution that is poised to make a meaningful impact on lateral spine clinical outcomes.”

The Extreme Lateral (XL) Access platform was developed to be the most user-friendly retractor system on the market. This was accomplished by integrating proprietary design elements that mitigate performance characteristics that surgeons find problematic in competitive retractors.  While TeDan will continue to market other surgical systems and fulfill contractual obligations to its existing customers, the company will no longer manufacture & distribute its flagship XL3 retractor.  Going forward, the company’s primary focus will be the advancement of 4WEB’s Lateral Spine Truss System™ through the continued development of the Lattus XL15 retractor.

“The optimized ergonomics of the XL platform allows the surgeon to focus on implant technology rather than the access portion of the procedure,” said Danny Fishman, President of TeDan.  “After analyzing the lateral market, we believe 4WEB’s Truss Implant Technology provides the best in class implant offering necessary to be competitive with the market leaders in lateral surgery.  We are thrilled to be exclusive partners with 4WEB in our common goal to provide an industry leading Total Lateral Solution.”

4WEB’s proprietary Truss Implant Technology™ mitigates the chance of subsidence and leverages mechanobiology to stimulate an osteogenic response that facilitates the healing process in spine fusion procedures. The 4WEB Total Lateral Solution combines the most innovative implant design and access solution to successfully compete with well-established leaders in the lateral spine market.

The transaction is subject to customary closing conditions.

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology™, and the Spine Truss Systems™, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

SCHLIEREN (ZURICH), Switzerland, Sept. 27, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced that the first patient has been treated in an investigator-led multicenter randomized controlled study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The University Medical Center Utrecht (UMCU) in the Netherlands is the principal investigating site for the study, which is entitled “A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion”. UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “It is gratifying to see this important trial get underway in spinal fusion, as this area of great medical need is the focus of our commercial activities. The study is expected to generate important data that can help further differentiate MagnetOs and improve outcomes for patients.”

The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “It is a privilege to be leading this investigation of MagnetOs. MagnetOs is supported by some fantastic scientific evidence and is a treatment which has the potential to significantly improve patients’ lives. Patients own bone remains the gold standard against which all other grafts should be measured, yet very few studies have investigated synthetic alternatives side by side with autograft in a clinical setting. This study is poised to provide a level of definitive clinical evidence that surgeons have been crying out for.”

About the study
The study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will enrolled in this study. Primary endpoint is posterior spinal fusion rate after one year based on CT-scans.

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

About Kuros Biosciences AG 
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

New York, NY, September 26, 2018 –Centinel Spine, LLC announced today that Dr. Arvind Dubey, MD, FRACS, Neurosurgeon and Spine Surgeon at Hobart Brain and Spine Centre in Hobart, Tasmania, Australia, performed a milestone procedure implanting his 1,000^th level of the STALIF C-Ti™ Anterior Cervical Integrated Interbody^®device.  The procedure was a 2-level ACDF and took place at the Royal Hobart Hospital.  Centinel Spine is the largest privately-held spine company focused on anterior column reconstruction and remains a leading provider of Integrated Interbody solutions, with over 30 years of clinical history and over 50,000 devices implanted.

After implanting his momentous 1000^th STALIF^® level, Dr. Arvind Dubey commented, “The STALIF C^® system offers me a very simple yet clinically effective system for treating my patients with degenerative disc disease.  The STALIF^® design and lag screws provide constant compressive fixation between the endplates and graft material.  The compressive fixation coupled with the titanium surface give me the best opportunity to achieve fusion and has resulted in great outcomes for my patients.”

STALIF Interbody devices are currently offered in three material options: PEEK, titanium-surfaced PEEK, and the recently launched 3D-printed, all-titanium FLX™ technology.  FLX implants feature a combination of solid and porous radiolucent titanium sections developed with the goal of reducing mechanical stiffness and improving visibility, as compared to solid titanium implants.  The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.  Furthermore, all three materials options are utilized with a single, streamlined instrument set.

“We are proud to announce Dr. Dubey reaching 1,000 STALIF levels implanted and congratulate him on this significant achievement.  This milestone further exemplifies Centinel Spine’s mission in partnering with surgeons throughout the world to become the world-wide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms,” says Centinel Spine Chairman & CEO, John Viscogliosi.

Centinel Spine will highlight the Company’s latest anterior column reconstruction technologies at the North American Spine Society (NASS) Annual Meeting−­held September 26-29, 2018 in Los Angeles, California at the Los Angeles Convention Center.  At the annual meeting, the company will demonstrate its commitment to advancing technology platforms for both fusion and motion preservation.  In Booth #2123, the company will showcase its recently acquired prodisc^® Total Disc Replacement portfolio−the most extensive total disc replacement portfolio in the world−as well as its recently launched proprietary FLX 3D-printed, all-titanium devices for both cervical and lumbar fusion.  Additionally, Centinel Spine technologies will be highlighted in multiple podium presentations and hosted industry events.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc^®Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use.  For more information on Centinel Spine products and technologies, please visit the company’s website at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica, LLC and Surgicraft, LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies, and continues its corporate mission of becoming the leading anterior column reconstruction spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of the Regatta™ Lateral System, featuring NanoMetalene® technology.

Regatta is a comprehensive, minimally invasive lateral interbody fusion system designed to efficiently and reproducibly treat the spine through indirect decompression and the restoration of sagittal alignment. Regatta offers a wide variety of implants to accommodate the patient’s anatomy, including 10 and 15 degree lordotic options for sagittal alignment and 18 and 23mm wide implants for complete endplate coverage. The Regatta lateral retractor and the EMG nerve detection dilators allow for customizable access with minimal tissue disruption through the psoas, while also providing the visualization necessary to effectively perform the procedure. The addition of new streamlined disc preparation and angled instruments to access challenging disc spaces combine to deliver the complete procedural solution.

“We are excited to provide this comprehensive lateral system to surgeons who perform less-invasive interbody fusion procedures that minimize the tissue disruption that typically accompanies traditional spinal fusion surgery. By optimizing each procedural element, from access to fusion, the surgeon can efficiently and effectively treat each patient’s unique spinal condition,” said Keith Valentine, President and Chief Executive Officer.

The Regatta interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene is a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide implants a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.

“The Regatta system offers a variety of sizes and angles of interbody implants to address the majority of patient anatomy requirements and my surgical correction goals. Additionally, the implant’s novel NanoMetalene titanium surface technology may allow for more rapid and reliable fusion healing, and allows me to consider a wider variety of graft materials, potentially reducing the cost of care,” stated Dr. James Bruffey, Orthopedic Spine Surgeon, Scripps Health – San Diego, CA.

SeaSpine will be conducting initial cases through a limited launch over the coming months and expects a full commercial launch of the Regatta Lateral System in the first half of 2019.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s 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. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design of the Regatta Lateral System to efficiently and reproducibly treat the spine, to provide customizable access with minimal tissue disruption while providing necessary visualization, and to access challenging disc spaces; the ability of the Regatta Lateral System to deliver a complete procedural solution and efficiently and effectively treat each patient’s unique spinal condition; and the timing of initial cases and full commercial launch of the Regatta Lateral System. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; unexpected delay, including as a result of developing and supporting the launch of new products, including the fact that newly launched products may require substantial additional development activities, which could introduce further delay, or as a result of obtaining regulatory clearances; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com