YOKNEAM, Israel–(BUSINESS WIRE)–Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel. Led by Co-Principal Investigators Dr. Ran Harel and Prof. Yigal Mirovsky, the open label, prospective, single arm, multi-center study will evaluate the safety, performance, accuracy and usability of XVS during spine fusion procedures involving pedicle screw placement. The number of subjects will range from eight to 22, depending on the number of screws placed in each subject, with a minimum of 85 total screws placed in the study. The first human case was completed August 5, with cases expected to continue for approximately three months. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists using the Gertzbein score (GS). Usability will be evaluated using a User Experience Questionnaire (UEQ), which wil be completed by the surgeons at the end of each procedure.

Augmedics’ xvision-spine system (XVS) is an augmented-reality surgical navigation system designed to give surgeons “X-ray vision” during complex procedures. With XVS, surgeons can see and navigate inside a patient’s body through skin and tissue, which may lead to easier, faster and safer surgeries. The XVS system comprises a transparent near-eye-display headset and has all elements of traditional navigation systems. It accurately determines the position of surgical tools, in real-time, and superimposes them on patient’s CT data. The navigation data is then projected onto the surgeon’s retina using the transparent near-eye-display headset, allowing surgeons to simultaneously look at their patient and see the navigation data without averting their eyes to a remote screen.

XVS has the potential for use in many procedures, with its first intended use in minimally invasive or open spine surgeries. XVS uses patented see-through optics to project a 3D image of a patient’s spine, as well as axial and sagittal planes, onto a surgeon’s retina, in real-time, with surgical precision and outstanding depth perception.

“This first-in-human study is a critical step towards providing surgeons a more intuitive way to navigate in surgery that allows them to always keep their eyes on the patient,” said Nissan Elimelech, CEO of Augmedics. “We believe that XVS has the potential to deliver precise results and easier, faster and safer surgeries.”

The first-in-human clinical trial follows Augmedics’ successful second cadaver study, which was completed in November 2017 by four surgeons in Baltimore, Maryland.

About Augmedics

Founded in 2014, Augmedics seeks to improve healthcare by developing cutting-edge technologies that will revolutionize surgical treatment. The company’s first product, the xvision-spine (XVS) system, is an augmented-reality surgical navigation system designed to allow surgeons to see and navigate inside a patient’s body during complex procedures. The XVS system, with XVS Software, has the intended use to precisely locate anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal implant procedures such as pedicle screw placement, Iliosacral screw placement or interbody device placement.

Augmedics is funded by various investors, led by AO-Invest, an investment arm of the AO-Foundation, and has received numerous honors, including Technion’s BizTEC 2014, MedTech Innovator 2016 and MEDinISRAEL 2017. It was a finalist at TechCrunch Disrupt San Francisco 2017 Startup Battlefield and recognized as a leading HealthTech Innovator in the 2017 Global Digital Health 100 by the Journal of mHealth.

RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc. (OTC: FZMD) (“Fuse” or the “Company”), announced the completion of the acquisition of Palm Springs Partners, LLC d/b/a Maxim Surgical (“Maxim”), a manufacturing company in the spinal fusion device market and full-service medical device and distribution company (the “Acquisition”). The effective date of Acquisition was August 1, 2018.

Formed in April 2011, Maxim designs and manufactures its own spinal interbody spacers and distributes a wide variety of spine, sports medicine, and biologics product lines. Inclusive in the Maxim portfolio of spinal implant products is the Maxim Surgical X-Treme Interbody Fusion System that previously received 510(k) clearance from the U.S. Food & Drug Administration (“FDA”). Maxim’s long-term strategy is to bring more innovative spinal implant products to market for retail and wholesale distribution.

Management Commentary on Acquisition

Christopher C. Reeg, Chief Executive Officer of Fuse said, “We are very excited that Maxim has become part of the Fuse family. Maxim’s portfolio of products bolsters our strategy of expanding Fuse into medical device design and manufacturing.”

“We believe that integrating Maxim with our operations will enhance Fuse’s earnings immediately and allow us to be even better positioned to meet our customers’ needs,” added Mr. Reeg.

About Fuse Medical, Inc.

Fuse provides a broad portfolio of orthopedic implants including internal and external fixation products; upper and lower extremity plating; total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications. Our biologics offerings include human allografts, substitute bone materials, and tendons, as well as, regenerative tissues and fluids to augment orthopedic surgeries. For more information about Fuse, please visit:www.fusemedical.com.

About Maxim Surgical

Maxim Surgical, based in Richardson, Texas, is a privately-held medical device manufacturing company which is focused on the development of innovative solutions for the spinal fusion device market. Founded in 2011, the company’s primary mission is to provide surgeons and their patients with high-quality medical implants with a value approach. Maxim has close partnerships with key industry leaders and a world-class development team to manufacture cutting-edge implant products at a cost savings for the surgical spinal fusion market. Learn more at www.maximsurgical.com.

Forward Looking Statements

Certain statements in this press release, including those related to an anticipated purchase of all of the outstanding membership units and plans for the consolidated company, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced the publication of a pre-clinical animal study comparing the performance of spinal implants made from a variety of materials, which illustrated the bone in-growth and biological fixation capabilities of its 3D-printed Tritanium cages. The study was published in the July issue of The Spine Journal.

The purpose of the study was to compare the bone in-growth and biomechanical differences of interbody cages with various material technologies in an ovine lumbar interbody fusion model. The cages involved in this study included traditional PEEK cages, plasma-sprayed titanium-coated PEEK cages, and Stryker’s 3D-printed porous Tritanium cages.¹

The results demonstrated that the Tritanium cages exhibited significantly greater total bone volume within the graft window at both 8 and 16 weeks compared to the PEEK cages (p<0.01).¹Tritanium cages also were the only cages that showed a decrease in range of motion and an increase in stiffness across all three loading directions (axial rotation, flexion-extension, and lateral bending) between the 8-week and 16-week time points (p-value ≤0.01). ¹

“The results of this study provide an evidence-based approach to decision-making regarding interbody materials for spinal fusion, as there is significant variability in the materials commonly used for interbody cages in spine surgery,” said Sigurd H. Berven, M.D., orthopaedic surgeon at the University of California, San Francisco. “The study showed the potential for bone in-growth into and around the Tritanium cages.”

According to Michael Carter, vice president and general manager of Stryker’s Spine division, 3D printing, also known as additive manufacturing, allows the creation of a material with “precisely randomized”² porous structures designed to mimic bone.² “Stryker’s proprietary Tritanium Technology, a novel, highly porous titanium alloy material designed for bone in-growth and biological fixation, is based on additive manufacturing techniques for orthopaedic surgery pioneered by Stryker over 15 years ago,” Carter said. “This important study reinforces the value of our growing line of Tritanium interbody cages and demonstrates Stryker’s commitment to bringing the latest in advanced technologies to our customers.”

The study titled “Bony Ingrowth Potential of 3D Printed Porous Titanium Alloy: A Direct Comparison of Interbody Cage Materials in an In Vivo Ovine Lumbar Fusion Model,” can be accessed here.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at stryker.com and builttofuse.com. Follow the Spine division on Twitter @stryker_spine.

References

1. McGilvray, Kirk C., et al. Bony ingrowth potential of 3D printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model, Spine J. 2018; Volume 18, Issue 7, 1250-1260.
2. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.

Content ID TRITA-PB-2_18140

Dr. Berven is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. 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 your Stryker representative if you have questions about the availability of Stryker products in your area.