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October 27, 2017 OrthoSpineNews

FARMINGDALE, N.Y., Oct. 25, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (NASDAQ:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today cited data that demonstrated the use of BoneScalpel can produce up to a 40% cost reduction in biologic grafting material spend in spinal fusion procedures.

The data was presented today by Dr. Wade Jensen of the Center for Neurosciences, Orthopaedics & Spine (“CNOS”), at the 32nd Annual Meeting of the North American Spine Society (“NASS”) in Orlando, Florida.  The data showed an average cost savings of $1,066 in bone graft material when the Misonix BoneScalpel was employed compared to the use of standard power drill instruments. The Misonix BoneScalpel ultrasonically cuts bone using a 1mm thick blunt blade. The result is a clean cut that preserves healthy bone which can be used for grafting, and spares the surrounding soft tissue. The study is based on a retrospective analysis including 144 cases, 44 of which were done using the Misonix BoneScalpel. The remaining 100 cases were done with a 3mm rotating matchstick drill bit (“burr”) currently in broad use in surgical suites throughout the U.S. An estimated $1.9 billion is spent annually on bone graft substitutes.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “The data presented today are a strong validation of the efficacy of the BoneScalpel in producing significant cost savings in the surgical suite. This data demonstrates the value of using ultrasonic bone removal over standard electric power instruments both in the precision of the bone removal and the reduction in overall bone destruction. The ability to ultrasonically remove bone in a manner that enhances the ability for successful bone grafting while minimizing the need for biological grafting material represents an important step forward for patients, surgeons and medical institutions. We believe that the BoneScalpel can become the standard of care for precision bone cutting while sparing soft tissue and delivering significant cost savings to the healthcare process.”

Misonix will be exhibiting at NASS 2017 at booth #765 from Wednesday, October 25, 2017 through Saturday, October 28, 2017.

About NASS
The North American Spine Society (“NASS”) is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, ​value- and evidence-based spine care for patients.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications.  Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact
Misonix Contact:
Joe Dwyer
631-694-9555
invest@misonix.com

Investor Contact
Joe Diaz
Lytham Partners
602-889-9700
info@misonix.com

 


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October 27, 2017 OrthoSpineNews

October 26, 2017

CHICAGO–(BUSINESS WIRE)–Medacta International, developer of innovative surgical techniques and products for the hip, knee, spine, and sports medicine disciplines, recently expanded its expertise to the world of shoulder surgery. The family-owned orthopedics leader today announced it has received FDA clearance for the Anatomic Shoulder and Reverse Shoulder components of its modular Medacta Shoulder System. The company also announced the successful completion of the first surgery in the United States utilizing the system, which was performed by Matthew D. Saltzman, M.D., Associate Professor of Orthopaedic Surgery at the Northwestern Memorial Hospital in Chicago, Illinois.

“The procedure went very well,” said Dr. Saltzman, who specializes in shoulder and elbow surgeries and has been practicing orthopedics for 14 years. “The Medacta Shoulder System’s instrumentation and implants allow for impressive anatomic restoration, resulting in an efficient surgery and, hopefully, improved patient outcomes.”

The Medacta Shoulder System, unveiled in February 2017 following its first ever surgery in Europe, is a modular solution that features a broad range of options, including wide-ranging sizes, adjustable offset, and innovative configurations. Developed by an international team of expert surgeons, the platform offers the modularity and compatibility demanded by today’s marketplace, while still respecting anatomic conversion from primary to reverse.

The Shoulder System is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute’s Clinical Excellence Program and is part of a multi-center, post-marketing, prospective, open clinical study that will collect clinical and radiological outcomes for the next ten years. The M.O.R.E. Institute provides continuous educational and developmental support to Medacta surgeons as they work towards discovering new technologies and supporting patients.

“The new Medacta Shoulder System is a continuation of our effort to improve orthopedic implant design and configurability for the benefit of both surgeons and their patients,” said Francesco Siccardi, Executive Vice President of Medacta International. “This latest surgery in the United States marks a milestone for Medacta in line with our company’s patient-centric vision and the same ambition that has helped us become a leader in knee, hip, and spine technology.”

Medacta will launch the Shoulder System for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting, which will be held in New Orleans in March 2018. For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta International

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com


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October 26, 2017 OrthoSpineNews

October 25, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the completion of enrollment in its second pivotal Phase III trial evaluating CINGAL®, its novel HA-corticosteroid combination viscosupplement1 for the treatment of symptoms associated with osteoarthritis (“OA”) of the knee.

CINGAL is poised to be the first and only viscosupplement in the U.S. market to combine triamcinolone hexacetonide, a well-established, FDA-approved steroid utilized to treat inflammation, with Anika’s proprietary cross-linked, non-animal-derived hyaluronic acid, which is the active ingredient in the company’s global market-leading viscosupplements, ORTHOVISC® and MONOVISC®. The second pivotal Phase III trial, which will evaluate 576 patients with mild to moderate knee osteoarthritis, is designed to evaluate the safety of CINGAL as well as its effectiveness in improving pain, function, and quality of life measures over a 26-week period, in comparison to MONOVISC and triamcinolone hexacetonide.

“We’re proud to have rapidly achieved this major milestone on the path to seeking U.S. regulatory approval for CINGAL, which is key to driving future growth for the company and adding to our market leadership position in orthobiologics,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With its novel and proprietary combination of two proven treatments, and its demonstrated ability to provide immediate and long-lasting pain relief, CINGAL will bridge a significant gap in the non-invasive, non-opioid osteoarthritis treatment landscape, which has not seen a major innovation for over a decade.”

Anika recently published results from its initial Phase III trial, which formed the basis for CINGAL’s Health Canada and CE Mark approvals in November 2015 and March 2016, respectively. The trial, which compared the safety and efficacy of CINGAL to MONOVISC and placebo (saline), showed that CINGAL provided superior short term pain relief after injection as compared to HA alone, and superior relief from OA-related pain, stiffness, and function through 26 weeks as compared to placebo (saline).

Anika expects to complete the CINGAL second pivotal Phase III trial in the first half of 2018 and anticipates FDA approval the following year.

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 ORTHOVISCMONOVISC, 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 sentences of the second, third, 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 driving the Company’s future growth and the Company’s expectations regarding completion of the second pivotal Phase III study for CINGAL and FDA approval of CINGAL. 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, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) 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; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

1 Viscosupplements are injected by a licensed medical professional into synovial joints to replenish the natural cushioning within joints that depletes with age and degenerative orthopedic diseases, causing pain.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com


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October 26, 2017 OrthoSpineNews
Warren, NJ, October 26, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today FDA 510(k) clearance and full commercial launch of FIBERGRAFT BG Matrix – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Matrix is the third generation product in the company’s FIBERGRAFT line of bioactive glass fiber based products. FIBERGRAFT BG Matrix leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary type I collagen based bioactive carrier.

FIBERGRAFT BG Matrix – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseaous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Here are some comments from the early users of FIBERGRAFT BG Matrix:
Dr. Paul Slosar MD of the San Francisco Spine Institute commented, “I have an interest in the growing scientific research focused on bone graft extenders and am impressed by the FiberGraft’s basic science data. I recently had the opportunity to use the Fibergraft Matrix in several cases where I needed to augment my posterior fusion, when we didn’t have enough autograft. The Fibergraft had excellent handling characteristics and interdigitated very nicely with the host bone. The Fibergraft provided me with an excellent option to reinforce my bone graft and, based on their scientific data, I anticipate excellent clinical fusion results.”

Dr. Adam Bruggeman MD of the Texas Spine Care Center commented, “Fibergraft Matrix from Prosidyan is an innovative update to their leading fiber based bioglass portfolio. Matrix is easy to manipulate, allowing for multiple applications. It is now my preferred graft for all biologic applications in the spine.”

Dr. Todd Allen, MD, PhD Associate Professor Orthopaedic Surgery UCSD commented, “The structural and handling features are dynamic and second to none with an innate ability to wrap around bony structures and wick needed blood and cells to the region. The structural and biologic capabilities of this unique synthetic are powerful, and make this a great product for the future of spine surgery, both in open and MIS applications.”

Prosidyan’s Founder & CEO Charanpreet Bagga informed that FIBERGRAFT BG Matrix was presented at the 2017 North American Spine Society Innovative Technology Presentations on October 25th by Dr. William Walsh PhD, of UNSW. There were only seven technologies selected for presentation at this forum and FIBERGRAFT is the only synthetic bone graft substitute selected for this prestigious forum.

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 9,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.

Contact Information
Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com

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October 26, 2017 OrthoSpineNews

UNION CITY, Calif.Oct. 25, 2017 /PRNewswire/ — Mizuho OSI®, a leading manufacturer of specialty surgical tables, pressure management solutions, and table specific patient care kits, is introducing its newest technology, the Levó Head Positioning System at NASS 2017. Using an innovative electro-mechanical technology to enable the device’s motion, the Levó System introduces a new level of actuated control and precision to head positioning for all spine procedures from cervical to sacrum. The Company is unveiling the technology in booth #717 for physicians to experience the elevated positioning capabilities afforded by Levó.

Positioning patients for spine surgery is essential for optimal operating conditions and operative site exposure. The Levó System is designed to provide the surgical team with an interface that is safe, fast, and easy to engage. The technology’s unique interface places the surgeon in control, supporting initial head positioning and cervical spine corrections throughout the procedure. Various interchangeable modules that support the use of a skull clamp or face pillow comprise a versatile platform that delivers optimal utilization within each practice.

Designed to provide fluid, yet controlled motion, Levó’s functionality supports an improved workflow and enhanced surgical access. This is achieved through key modules, including the QuickConnect System, which supports the efficient attachment of a skull clamp, and the Control Handles, which allow for intraoperative adjustments.

“In designing the Levó System, we wanted to offer surgeons a seamless and flexible solution that affords them better control over patient positioning during these delicate procedures,” said Greg Neukirch, vice president of Marketing and Sales at Mizuho OSI. “We’re proud to unveil a solution we believe works to enhance clinicians’ surgical experience, providing for safe and precise care when positioning a patient’s head for all prone spine procedures.”

Mizuho OSI is offering hands-on demonstrations of the Levó Head Positioning System at NASS 2017 in Orlando, Fla. from October 25-27 in Booth #717.

About Mizuho OSI

Mizuho OSI® is a U.S. based company and the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improves patient outcomes in spine and orthopedic surgeries, a range of general surgical tables, and consumable surgical patient care products. Mizuho OSI products are sold direct in the U.S. and Germany, and by the Mizuho Corporation in Japan. Both companies sell their products and solutions worldwide through authorized international distributors. Mizuho OSI is a wholly owned subsidiary of Mizuho Corporation located in Tokyo, Japan, a leading surgical table manufacturer in Asia. The Mizuho Group also includes Trilux Medical®, a subsidiary of Mizuho OSI. Trilux Medical is a provider and manufacturer of surgical lights, surgical pendants, operating room patient integration, video management systems, and turn-key operating room solutions. Trilux Medical products and solutions are sold direct in Germany and worldwide through authorized international distributors. More information is available at www.mizuhosi.com

 

SOURCE Mizuho OSI

Related Links

http://www.mizuhosi.com


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October 26, 2017 OrthoSpineNews

October 26, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results from the third quarter 2017 on Thursday, November 2, 2017 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss third quarter results at 8:30 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical Inc.
Jonathon Singer
Chief Financial and Administrative Officer
jsinger@rtix.com
or
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com


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October 26, 2017 OrthoSpineNews

WESTMINSTER, Colo.Oct. 26, 2017 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that more than 150 leading U.S. hospitals have now adopted use of i-FACTOR™ Peptide Enhanced Bone Graft. Cerapedics received Premarket Approval (PMA) for i-FACTOR bone graft from the U.S. Food and Drug Administration (FDA) in late 2015 for use in ACDF procedures in patients with degenerative cervical disc disease. The company had initiated U.S. commercial activities in June 2016 following FDA approval of final IFU labeling and additional product sizes.

“The available options including bone morphogenetic protein therapies present both safety risks and significant costs,” said Dan Peterson, MD, FAANS & FACS, neurosurgeon at Austin Brain and Spine. “Increasingly surgeons and hospitals are recognizing the advantages of the i-FACTOR Bone Graft’s synthetic small peptide (P-15) technology in helping to improve safety and outcomes.”

i‐FACTOR Bone Graft is based on proprietary P-15 technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. It is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine backed by Level 1 human clinical data.

“We are continually hearing about development of new options to support bone regrowth and repair, including use of stem cell technologies,” said Neill Wright, MD, FAANS, Herbert Lourie Professor of Neurological Surgery at Washington University School of Medicine. “In many cases, available data do not confirm that both performance and costs are in line to deliver optimal outcomes for patients and hospitals. With i-FACTOR Bone Graft we have that data and can feel confident about both performance and cost advantages.”

In September 2017, Cerapedics announced publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR Bone Graft. The results published in the peer reviewed journal Neurosurgeryshow i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft.

“Our national commercialization and sales strategy is well positioned to meet the rapidly expanding interest in i-FACTOR Bone Graft,” said Glen Kashuba, CEO of Cerapedics. “We fully expect the rate of adoption to continue to grow rapidly in 2018 with over 100 additional hospital approvals pending as more surgeons and hospitals recognize the clear advantages of our technology over currently available options.”

About Cerapedics
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

 


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October 26, 2017 OrthoSpineNews

OR AKIVA, IsraelOct. 26, 2017 /PRNewswire/ –Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced first surgeries with its enhanced 3D expandable cage, the FLXfit™15.  The FLXfit™15 offers enhanced performance and versatility by providing additional device sizes with the ability to further expand the device up to 4mm to achieve controlled expansion and lordosis correction of up to 15⁰.

Dr. Marc Weinstein, at the Spine Center at the Florida Orthopaedic Institute in Tampa, FL commented, “EOI’s attention to surgeons’ feedback and ability to innovate quickly is imperative in this environment”. He said, “This new higher range expansion will enable us to better treat our patients and restore segmental lordosis up to 15 degrees. This will have a tremendous impact on our ability to improve the patient’s sagittal balance and long-term surgical outcomes.” Dr. Weinstein concluded ,”This is an ideal implant for my L5/S1 fusion patients given the reduced size on entry and the need for enhanced lordosis at this level.”

Dr. Hamad Farhat, of Chicago, Illinois said, “The new 32mm length option adds great flexibility in treating patients with smaller anatomies as well as higher vertebral levels. The smaller size will allow 15 degrees of lordosis correction with additional space to pack more bone graft material”. He explained, “Expandable cages play a key role in successful MIS fusion procedures. The ability to deliver an ALIF type footprint cage with upto 15 degrees of lordosis correction through a minimal, unilateral approach is definitively a paradigm change in the MIS fusion market.”

Ofer Bokobza, CEO of Expanding Orthopedics, commented, “We are excited with the first surgeries with the FLXfit™15. This represents our continued commitment for innovation and collaboration with our surgeons to deliver state of the art spine fusion technology designed to improve long term patients’ outcome.”  He said ,”We believe that the performance and versatility of the new FLXfit™ family will catapult EOI to gain greater share in fusion surgery both in MIS and open approaches.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:

David Elkaim
VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347) 3219683

 

SOURCE Expanding Orthopedics Inc.


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October 26, 2017 OrthoSpineNews

ORLANDO, Fla.Oct. 26, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced the results of a new study demonstrating reduced subsidence for its Lateral Spine Truss System (LSTS) as compared to annular interbody implant designs today at the annual meeting of the North American Spine Society.  The study was led by Vijay Goel, PhD at the University of Toledo, one of the country’s foremost orthopedic biomechanics institutes.

“Our biomechanical testing showed the 4WEB 18mm wide, 40mm long LSTS implant performed better in resisting subsidence than the competitive 21mm wide, 60mm long annular design lateral device.  This finding was consistent across all density foam blocks tested.   These results are indicative of the optimized load distribution that is inherent to the 4WEB truss implant technology,” said Vijay Goel, PhD at the University of Toledo.

4WEB’s proprietary open architecture truss design increases endplate to implant contact maximizing resistance to subsidence.  The additive manufacturing process for truss technology provides a hierarchal surface roughness spanning from the nano to macro scale which may contribute to stimulating an osteogenic response.

Tony Tannoury, MD, Director of Spine at Boston Medical Center, Boston University said, “Subsidence is a clinically documented occurrence in lateral fusion procedures with higher incidences being found among smaller footprint implants.  This research allows me to confidently conduct minimally invasive lateral access surgery and match the correct size implant to the patient anatomy with less concern of the cage subsiding.  The results of this study are particularly important for high risk patients with low bone density.”

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


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October 26, 2017 OrthoSpineNews

Jupiter, FL — (PR Newswire) — Atlas Spine, Inc., a high technology spine implant company focused on the development of innovative, disruptive implants and instrumentation for spine surgery, has hired Matthew Miller as Executive Vice President of Business Development.

Miller has over 25 years in orthopedics and spine experience and has co-founded or been instrumental in the development of several high-profile orthopedic and spine companies.

In 2005 he raised over $14 million in seed capital for SpineMedica, Inc., which licensed technology a hydrogel material from The Georgia Institute of Technology and Salumedica, Inc. as an artificial disc.  In 2007 Miller co-founded MiMedx Group, Inc. with licensed technology from the University of South Florida and the Shriners Hospital for Children. Miller and his team took the company public when Pete Petit stepped in to run the public company. Most recently he was a co-founder of The Genomics Cancer Institute, a company focused on the commercialization of genomic and esoteric cancer testing in partnership with NCI-accredited hospitals.

“I’m elated and grateful for the opportunity to be part of the team at Atlas Spine, Inc. Atlas is committed to developing innovative and disruptive spine implants and surgical technology. More importantly, the talent the company has assembled is inspiring. Every team member is committed to developing the best products that serve the needs of spine surgeons and benefit patient outcomes. I couldn’t be more pleased to jump back into the spine industry than I am with Atlas Spine, Inc.”

As Executive Vice President of Business Development, “I’ll be finalizing a mezzanine financing round and working with the executive team to deploy capital to support the launch of several products we have in front of the U.S. Food and Drug Administration. I can’t talk about the products prior to their approval, which for those who know me, is very difficult. We have some game-changing products coming to market. I can’t wait.”

Atlas Spine, Inc., is a privately held spine implant company based in Jupiter, Florida. Atlas is committed to the development of innovative spine implants that benefit surgeons and provide better patient outcomes. 

Media:  Please contact Matt Miller, at 813-368-6011 or mmiller@atlasspine.com for information about the company. Interviews and photos are available upon request.

 

Matt Miller

EVP Business Development

 

Atlas Spine, Inc.

1555 Jupiter Park Dr.

Jupiter, FL 33458

Office:  561-741-1108

Cell:  813-368-6011

www.atlasspine.com