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March 2, 2021 OrthoSpineNews

BEDFORD, Mass., April 12, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (Nasdaq:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced results from the first study of its iTotal® PS total knee replacement presented at the 2017 British Association for Surgery of the Knee (BASK) Annual Meeting.

Researchers at a leading academic institution compared the knee motion, or kinematics, of patients implanted with a ConforMIS iTotal PS customized total knee replacement to patients implanted with an off-the-shelf Zimmer-Biomet NexGen® PS total knee replacement.  Similar to previously reported studies with the iTotal CR, this study demonstrated that ConforMIS iTotal PS patients’ knee motion patterns more closely resemble those of a normal knee than patients’ knee motion patterns with the traditional, off-the-shelf implant.

When a healthy knee bends, the lateral condyle, or outer portion of the end of the thigh bone or femur, rolls back on the shin bone or tibia and rotates externally, towards the outside of the knee. In this single-center study, financially supported by ConforMIS, researchers assessed the kinematics of 31 patients (13 patients with a ConforMIS iTotal PS implant and 18 patients with an off-the-shelf implant) at least six months after surgery using advanced real-time mobile x-ray imaging and 2D-3D registration.  Patients who received a ConforMIS iTotal PS demonstrated greater average range of motion during a deep knee bend (112° vs. 94°*). Additionally, iTotal PS patients saw greater lateral femoral rollback (11.73mm vs. 4.69mm*), medial translation (2.8mm vs. 1.0mm*) and greater axial rotation (10.85° vs. 7.58°) during deep knee bend, which is consistent with normal knee motion. (Note: * indicates statistical significance with p≤0.05)

“All findings from this study suggest that the iTotal PS has the kinematic and functional benefits that have been demonstrated with iTotal CR compared with traditional, off-the-shelf implants,” said William Kurtz, MD, Chief of Orthopedics at St Thomas Hospital in Nashville, TN and clinical investigator in the study. “Patients want to return to everyday activities after their recovery and, in my experience, maintaining normal knee motion is critical to achieving those goals. I have found that when you alter patients’ normal kinematics, as happens with off-the-shelf implants, there’s a greater risk that the patient won’t be able to return to their regular activities.”

In addition, two studies, financially supported by ConforMIS, were presented at BASK highlighting the variability in femoral and tibial anatomy which cannot be replicated by off-the-shelf implants, which are offered in a limited number of shapes and sizes:

  • A retrospective review of 24,042 CT data sets used to design customized iTotal implants found that 61% of knees exhibited a distal femoral offset of >1mm. Additionally, 83% exhibited >2mm of posterior condylar offset. Off-the-shelf implants are designed with fixed condylar offsets, which are unable to retain the natural condylar shape of the knee.
  • A similar analysis was conducted on tibial implants and found that the tibial trays were within 2mm or less of symmetrical only 12% of the time, while 22% were found to have asymmetry >5mm. The authors concluded that tibial trays that are either symmetric or have a fixed asymmetry based on medio-lateral size, as off-the-shelf implants do, may face challenges between maintaining proper rotation and adequate coverage.

“In its first year of release iTotal PS has met our expectations in terms of surgeon adoption and patient outcomes,” said Mark Augusti, MBA, Chief Executive Officer and President of ConforMIS. “Clinical research has demonstrated our implants offer superior clinical outcomes compared with off-the-shelf implants.  We are committed to continuing investing in the clinical study of our implants to demonstrate their superior clinical and economic value for patients, surgeons, hospitals, and payers across the healthcare continuum.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS’ clinical strategy, the potential clinical, economic or other impacts and advantages of using customized implants and the commercial launch of iTotal PS, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

 

CONTACT:

Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881

Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

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March 2, 2021 OrthoSpineNews

BEDFORD, Mass., March 02, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, today announced the full commercial launch of iTotal® PS, the only customized posterior stabilized knee replacement system.  Over 1,000 patients have been treated by select orthopedic surgeons using the iTotal PS during the limited launch over the past twelve months.  The full commercial launch will take place at the American Academy of Orthopaedic Surgeons meeting in Orlando, FL from March 1–5, 2016.

Recent studies have demonstrated that approximately twenty percent or more of patients who receive an off-the-shelf total knee replacement are not satisfied with the results.  The ConforMIS iTotal PS was designed to address the shortcomings of traditional knee replacements, which come in a fixed set of sizes and shapes.  The customized iTotal PS implant builds on the advantages of the iTotal CR system, first introduced in May 2011. The iTotal PS implants are customized for each patient to avoid overhang, rotation, and sizing compromises, common causes of pain after surgery.  In addition, iTotal PS is designed to restore the natural shape of each patient’s knee and has a customized cam and spine to provide optimal stability throughout the full range of motion.

Primary total knee implants are designed to either retain the patient’s own posterior cruciate ligament (cruciate retaining, or CR), or substitute for it (posterior stabilized, or PS). PS implants use a cam and spine feature to serve the function of the posterior cruciate ligament.  The choice between CR and PS is largely based on surgeon preference. However, PS is heavily preferred in the US market, representing approximately 72% by revenue of all primary total knee replacements.  With the launch of iTotal PS, combined with its existing iTotal CR, iDuo and iUni products, ConforMIS can address a much greater population of patients.

“The goal of a total knee replacement is a predictable outcome and a happy patient, every time.  With off-the-shelf implants, most of the time we must make compromises,” said Jose A. Rodriguez, MD, Chief of Reconstruction Arthroplasty and the Director of the Arthroplasty Fellowship Program at Lenox Hill Hospital in New York City.  “With ConforMIS, many of these compromises are eliminated because the implant fits anatomically.  The reliability with which I can achieve a knee that fits better, and functions more naturally for my patients, is greater with iTotal PS than with standard, off-the-shelf implants.”

“The full launch of the iTotal PS nearly triples our addressable market.  We believe this launch is our single biggest commercial opportunity to date,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS.  “With iTotal PS, we have now greatly expanded the number of patients who will be candidates for our customized knee replacement implants. We are very excited to bring the benefits of customized knee replacements to surgeons who prefer a posterior-stabilized design.  Since we initiated our limited launch of iTotal PS last year, the feedback from surgeons has been extremely positive.”

The ConforMIS customized knee replacement products offer significant benefits to hospitals with a unique just-in-time delivery model. This model includes a single, pre-sterilized kit of patient-specific instruments, a single reusable instrument tray, and no implant inventory. The ConforMIS iTotal CR has already demonstrated clinical and economic benefits for surgeons, patients, and hospitals for an entire episode of care, from the initial hospitalization through recovery.  We believe that promoting such clinical and economic benefits is critical to bundled payment programs such as the new Medicare Comprehensive Care for Joint Replacement (CJR).

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS’s strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, gross margin, operating trends, the potential clinical, economic or other impacts and advantages of using customized implants and the commercial launch of iTotal PS, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, expenses, gross margins and other results of operations, the impact of the CJR program, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT:

Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881

Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

Primary Logo

ConforMIS, Inc

 


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March 2, 2021 OrthoSpineNews

BEDFORD, Mass., June 21, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that their newest product to market, the iTotal® PS posterior-stabilized total knee replacement system, was named the winner of the Gold Stevie® Award in the Health & Pharmaceuticals Product category. The Stevie Award, presented by The American Business Awards, recognizes businesses and products that represent important advances in technology and innovation.

http://www.globenewswire.com/NewsRoom/AttachmentNg/ad232976-5886-4977-8505-64b806962bbaPhotos accompanying this announcement are available at

http://www.globenewswire.com/NewsRoom/AttachmentNg/210a197f-190c-4959-96cf-6f138a982013

“ConforMIS utilizes proprietary technology to offer a distinctive and innovative product line that represents major advances in joint replacement for patients, surgeons, hospitals and payers,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “The full commercial launch of the new iTotal PS customized knee replacement is another example of our dedication to and success in bringing high-quality, award-winning products to market in an expeditious manner. This most recent addition to our product portfolio allows us to greatly expand the number of individual patients that may be treated with our customized knee implants.”

(C) Copyright 2016 GlobeNewswire, Inc. All rights reserved.

Read more: http://www.virtual-strategy.com/2016/06/21/conformis-itotal%C2%AE-ps-customized-knee-replacement-honored-2016-gold-stevie%C2%AE-award-winner#ixzz4CEXGxj99
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Read more at http://www.virtual-strategy.com/2016/06/21/conformis-itotal%C2%AE-ps-customized-knee-replacement-honored-2016-gold-stevie%C2%AE-award-winner#axzz4CE72Ao00#MTx3CO8Af9sSZgqc.99


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January 29, 2021 OrthoSpineNews

TORONTO, March 24, 2015 (GLOBE NEWSWIRE) — Synergy Disc Replacement, Inc. (“SDRI” or “the Company”), developers of the SYNERGY DISC and alternative spine technologies, announced today the signing of a seven-year agreement appointing GM Medical Pacific Limited (“GM Medical”) the exclusive master distributor of the Company’s SYNERGY DISC in the Asia-Pacific region.

The SYNERGY DISC is the world’s first cervical disc replacement that is designed specifically to actively correct pre-operative deformity, prevent post-operative misalignment, and provide optimal stability for multi-level procedures. The SYNERGY DISC incorporates a revolutionary geometric design, offering multiple alignment corrections to provide surgeons with reliable and precise control of lordosis and sagittal balance.

“The SYNERGY DISC is an extremely versatile cervical disc replacement that is well suited for global markets. We are thrilled to be partnering with GM Medical, who has a strong reputation for bringing the most innovative medical devices to Asia-Pacific,” commented SDRI’s Chief Executive Officer, Devesh Menawat. “Asia-Pacific includes the fastest emerging markets in the World. GM Medical’s existing relations with top medical centers and vast experience in orthopedics will help drive adoption of the SYNERGY DISC at an accelerated rate.”

READ MORE HERE


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January 3, 2019 OrthoSpineNews

PRINCETON, N.J.Jan. 3, 2019 /PRNewswire/ — New Jersey’s acute care hospitals deliver a $23.6 billion boost to the state economy, along with 150,000 jobs, according to the 2018 Economic Impact Report by the New Jersey Hospital Association.

“Healthcare is a critical part of New Jersey’s economic infrastructure,” said NJHA President and CEO Cathy Bennett. “The $23.6 billion that hospitals and health systems contribute to the state economy ripples throughout all communities via jobs, income taxes paid by employees and goods and services purchased from other businesses. And most importantly, our hospitals are open to their communities 24/7/365 to provide the care we need.”

Both the total economic impact of New Jersey hospitals and the number of jobs they provide continues to grow. In last year’s report, the total economic contributions reached $23.4 billion, and the number of jobs topped out at 144,000. In fact, healthcare is the only industry that has added jobs in the state every year from 1990 through 2017, according to data from the N.J. Department of Labor.

The report is based on information from 2017 cost reports from 71 acute care hospitals filed with the N.J. Department of Health, along with other publicly available data sources.

In other key findings, New Jersey hospitals deliver:

  • $3.5 billion in services purchased from other businesses
  • More than $9 billion in total employee salaries
  • More than $500 million in state income taxes paid by hospital employees
  • More than $565 million in charity care services to New Jersey’s working poor and other uninsured residents.

NJHA’s Economic Impact Report is available online at www.njha.com/economic-impact/2018/, where users can search for data by county and by individual hospital. In addition, totals are available by teaching hospital status and state and federal legislative districts.

SOURCE New Jersey Hospital Association (NJHA)

(PRNewsfoto/New Jersey Hospital Association)

Related Links

http://www.njha.com


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January 3, 2019 OrthoSpineNews

SALT LAKE CITY, Jan. 03, 2019 (GLOBE NEWSWIRE) — SINTX Technologies (NASDAQ: SINT) today reported the independent publication of 30-year clinical outcomes of lumbar fusion surgeries, performed with silicon nitride implants. The paper titled “Anterior Lumbar Interbody Fusion Using Reaction Bonded Silicon Nitride Implants” appeared in the December 2018 edition of the World Neurosurgery journal, and the findings were also featured at the 2018 Annual Scientific Meeting of the Neurosurgical Society of Australasia.

Dr. Ralph Mobbs from the University of New South Wales, Sydney, authored the study. Dr. Mobbs stated: “This work is of historical significance, being the first clinical study of silicon nitride as an implant material, the first commercial anterior lumbar interbody fusion with a synthetic material, the first design of a spinal interbody implant with endplate porosity to promote fusion, and the longest clinical follow-up of any implant material in spine surgery. This report clearly establishes the place of silicon nitride in the annals of spine surgery,” said Professor Mobbs.

“This work reflects the only known use of silicon nitride implants, outside the spine products manufactured by our company,” said Dr. Sonny Bal, Chairman of SINTX Technologies. “Despite a much earlier material composition and implant design, silicon nitride proved itself even three decades after spinal implantation. These findings are entirely consistent with the more modern data published by us, showing earlier fusion, excellent biocompatibility, ease of radiographic imaging, and other advantages of our silicon nitride spine implants. The SINTX formulation of silicon nitride is enhanced and improved even further with sintering agents that accelerate bioactivity and confer antibacterial advantages.”

“This paper is a compelling affirmation of our full confidence in silicon nitride as the ideal spine biomaterial platform, whether as an implant, surface coating, or composite formulation with other biomaterials. This report will support our sales objectives, as we prepare an official launch in the coming months in Australia – the first place to use silicon nitride in spinal fusion surgery,” said Daniel Chon, CEO of Dallas-based CTL-Amedica, the exclusive retail channel for silicon nitride spinal implants made by SINTX Technologies.

About SINTX Technologies

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

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. 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. A discussion of those risks and uncertainties can be found in Sintx’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Sintx’s other filings with the SEC. SINTX disclaims any obligation to update any forward-looking statements. Sintx 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:
SINTX Technologies
801-839-3502
IR@sintx.com


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January 3, 2019 OrthoSpineNews

SAN DIEGOJan. 3, 2019 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced a new organizational structure and associated executive team that chief executive officer (CEO) J. Christopher (Chris) Barry has selected to lead the Company’s next phase of growth and innovation. Barry joined NuVasive as CEO on November 5, 2018.

“After assessing the Company over the past two months as CEO, it is clear that NuVasive benefits from significant talent across the organization. Our new structure will enable us to better capitalize on this talent by fostering cross-functional collaboration, consolidating complementary functions and increasing accountability,” said Barry. “I am confident this leadership team and our new structure, along with disciplined execution, will better position NuVasive to fulfill our commitments to patients, surgeons, employees and shareholders, and drive NuVasive’s success and sustainable growth.”

As part of the new organizational structure, NuVasive announced the following leadership team, all of whom will report to Barry. The following changes are effective immediately:

  • Matt Link will continue to serve as president in an expanded capacity to include direct management of NuVasive Clinical Services and Global Logistics. The integration of these functions rounds out oversight of the entire product life cycle, from development to launch to service to fulfillment, which will positively impact how the sales force brings disruptive innovation to surgeons and patients.
  • Raj Asarpota will continue to serve as executive vice president and chief financial officer, and lead the Company’s Finance, Accounting, Internal Audit and Tax functions.
  • Nate Sisitsky, Esq. will continue to serve as general counsel and corporate secretary, and lead the Company’s Legal function as well as the NuVasive Spine Foundation. In addition, he will also oversee the Company’s Real Estate and Facilities function.
  • Jim Garrett, Esq., chief compliance officer and leader of the Company’s Global Risk and Integrity (GRI) function, will assume an expanded role overseeing the Business and Quality Systems functions, including GRI, Regulatory Affairs/Quality Affairs, Information Technology, and Environmental Health & Safety.
  • Lucas Vitale is named chief human resources officer, and most recently served as vice president, Human Resources and Sales Training at NuVasive. He has been with the Company for more than four years.
  • Suzanne Hatcher will continue to lead the Company’s Internal and External Affairs functions, including Investor Relations, Public Relations and Internal Communications.
  • Dale Wolf will continue to oversee the Company’s manufacturing efforts, including the facility in West Carrollton, Ohio. He will leverage his significant prior experience, with Barry’s direct oversight, to facilitate successful operational and financial execution of the Company’s self-manufacturing efforts.

NuVasive’s Global Commercial regional leaders include Paul McClintock (U.S.), Erin McEachren (Europe), Takaaki Tanaka (Japan/China) and Jim Abraham (Australia/New Zealand).

As an outcome of streamlining top layers within the Company’s new organizational structure, the positions of executive vice president, People and Culture, and executive vice president, Global Process Transformation, previously held by Pete Leddy, Ph.D. and Stephen Rozow, respectively, have been eliminated. The Company thanks Pete and Steve for their commitment and dedication to NuVasive.

To read more about NuVasive’s leadership team, please visit www.nuvasive.com and click on the About section.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit  www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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January 3, 2019 OrthoSpineNews

WESTBOROUGH, Massachusetts – Jan. 3, 2019 – Miach Orthopaedics, Inc. a privately held company dedicated to developing bio-engineered surgical implants for connective tissue repair, today announced that medical device industry veteran Martha Shadan has been appointed president and chief executive officer. Miach’s first product under development is the Bridge-Enhanced® ACL Repair (BEAR®) technology, currently being studied in U.S. clinical trials. Shadan brings more than 30 years of medical device executive, marketing and commercialization expertise and has been executive chairwoman of the Miach board since September 2018.

During most of 2018, Shadan served as global vice president of marketing at Smith & Nephew plc, a role she assumed after the company acquired Rotation Medical, where she was president and CEO. Shadan led the company through FDA approval and commercialization of the Rotation Medical Bioinductive Implant for rotator cuff tears (now known as REGENETEN), as well as the company’s acquisition by Smith & Nephew in December 2017.

“We are very glad to have Martha Shadan joining the Miach team,” said Martha Murray, MD, founder and chief medical officer of Miach Orthopaedics. “Her experience in the medical device space with successful commercialization of medical devices brings in a very valuable skill set, and we are very much looking forward to working with her as the CEO.”

Shadan has successfully served in a number of senior leadership positions at Zimmer, Covidien, Bristol Myers Squibb Co. and Merck Millipore. She is actively involved with the Advanced Medical Technology Association (AdvaMed), serving on the Board of Directors since 2017 and Accel Board of Directors since 2015; serving as chairwoman of the Accel Board of Directors; and being a founding member of the Leadership Circle for the Women’s Executive Network (WEN). Shadan holds a master of business administration from Northeastern University, master of science in biology from Michigan State University, and bachelor of science in biology from the University of New Hampshire.

About ACL Injuries and the BEAR Implant

Every year, approximately 200,000 anterior cruciate ligament (ACL) injuries occur in the U.S. Without treatment, the ACL does not heal, resulting in ACL reconstruction surgery being one of the most common orthopaedic procedures in the U.S. Miach Orthopaedics’ new Bridge-Enhanced® ACL Repair (BEAR®) technology is a proprietary bio-engineered sponge used as a bridging scaffold to stimulate healing of the torn ACL. It is hoped this new technology will restore more normal anatomy and function of the knee, and thus enable a higher percentage of patients to get back to activities they enjoy. The BEAR implant is an investigational device and is only available in FDA-approved clinical trials.

About Miach Orthopaedics, Inc.

Miach Orthopaedics, Inc. is a privately held company located in Westborough, Massachusetts, near Boston, dedicated to developing bio-engineered surgical implants for connective tissue repair.  The company’s initial focus is on the Bridge-Enhanced® ACL Repair (BEAR®) technology as a viable alternative to conventional ACL reconstruction for patients who have sustained an ACL injury. The BEAR technology was pioneered by Martha Murray, M.D., at the Boston Children’s Hospital Department of Orthopaedic Surgery with initial research funding provided by the NFL Players Association, Boston Children’s Hospital and the National Institutes of Health. Miach closed a $22.5 million Series A round in September 2018 led by Amzak Health Investors LLC and DSM Venturing with participation from the NFL Players Association and additional investors.  For more information on Miach Orthopaedics and its products, visit www.miachortho.com and follow the company on Twitter and LinkedIn.

Miach Orthopaedics, Inc.

+1 800-590-6995
info@miachortho.com
www.miachortho.com
Twitter     LinkedIn

Media Contact

Joni Ramirez
Merryman Communications
joni@merrymancommunications.com
+1 323-532-0746

 


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January 3, 2019 OrthoSpineNews

CARLSBAD, Calif.Jan. 3, 2019 /PRNewswire/ — Oska Wellness, a pioneer of technology-driven wellness solutions dedicated to addressing the chronic pain epidemic in the U.S., will debut its next-generation Oska Pulse device at Pepcom’s Digital Experience! from 7:00 to 10:30 pm on Monday, January 7, 2019 at the Mirage hotel in Las Vegas. Like its predecessor, the new Oska Pulse is a revolutionary drug-free pain relief device that is clinically proven to reduce inflammation, increase circulation, improve mobility and alleviate pain using Pulsed Electromagnetic Field (PEMF) technology. Key advancements of the device provide added customer convenience and include:

  • Three times longer sessions for 90-minute PEMF pain relief sessions
  • 50 percent longer battery life – 15-hour total run time

A new CDC report found that overdoses corresponding strongly with use of synthetic opioids increased nearly 10 percent year-over-year in 2017 and, as a result, the average American life expectancy has been reduced by nearly four months for the first time since WWII. Pepcom’s Digital Experience! attendees are invited to visit Oska’s table at the show to learn more and test out the innovative new Oska Pulse device. Greg Houlgate, co-founder of Oska Wellness, will be available to discuss and demonstrate Oska Pulse, PEMF technology and how his personal experience with pain led him to recognize the need for an easy to use, affordable, drug-free pain relief alternative in the U.S.

“Chronic pain disrupts the lives of over 100 million Americans daily and is the leading cause of long-term disability in the U.S., affecting more people than diabetes, heart disease and cancer combined,” said Houlgate. “It’s very clear that the United States is fighting a battle with pain. Oska Pulse addresses this issue at the source and brings affordable, drug-free pain relief to those who need it most.”

Oska Pulse provides clinically-proven pain relief in the convenience of a wearable, portable and shareable PEMF device that seamlessly fits into any lifestyle. While PEMF technology is commonly used in doctors’ offices worldwide and is demonstrated in thousands of clinical studies to work at the source of pain and provide relief, Oska Pulse is the first device to make it available at an accessible price for home use. Unlike many other pain intervention therapies, Oska Pulse has no known side effects, is non-invasive, lightweight, portable, shareable, and provides safe, effective and affordable access to pain relief – all without medication.

The new Oska Pulse device will be available for purchase in January 2019 for $399 online at www.oskawellness.comFSAstore.comHSAstore.com and Amazon. To learn more about Oska, visit www.oskawellness.com.

About Oska Wellness

Co-founded in 2015 by Greg Houlgate, Oska Wellness is a pioneer of technology-driven wellness solutions that help people live more active lives with less pain. The brand’s cornerstone product, Oska Pulse, is a revolutionary drug-free pain relief device that is clinically proven to reduce inflammation, increase circulation, improve mobility and relieve pain. Oska Pulse utilizes Pulsed Electromagnetic Field (PEMF) technology, which is commonly used in doctors’ offices and clinically proven to work at the source of pain by accelerating the body’s ability to repair injured cells and increasing blood flow. Unlike many other pain intervention therapies, Oska Pulse has no known side effects, is non-invasive, lightweight, portable, shareable, and provides safe, effective and affordable access to pain relief – all without medication. Oska Pulse can be purchased online at www.oskawellness.comFSAstore.comHSAstore.com and Amazon. To learn more about Oska, visit www.oskawellness.com.

Contact: Megan Busch 
Rachel Kay Public Relations 
858-922-5045 
207077@email4pr.com

SOURCE Oska Wellness

Related Links

https://www.oskawellness.com


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January 3, 2019 OrthoSpineNews

SAN DIEGOJan. 3, 2019 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced a new organizational structure and associated executive team that chief executive officer (CEO) J. Christopher (Chris) Barry has selected to lead the Company’s next phase of growth and innovation. Barry joined NuVasive as CEO on November 5, 2018.

“After assessing the Company over the past two months as CEO, it is clear that NuVasive benefits from significant talent across the organization. Our new structure will enable us to better capitalize on this talent by fostering cross-functional collaboration, consolidating complementary functions and increasing accountability,” said Barry. “I am confident this leadership team and our new structure, along with disciplined execution, will better position NuVasive to fulfill our commitments to patients, surgeons, employees and shareholders, and drive NuVasive’s success and sustainable growth.”

As part of the new organizational structure, NuVasive announced the following leadership team, all of whom will report to Barry. The following changes are effective immediately:

  • Matt Link will continue to serve as president in an expanded capacity to include direct management of NuVasive Clinical Services and Global Logistics. The integration of these functions rounds out oversight of the entire product life cycle, from development to launch to service to fulfillment, which will positively impact how the sales force brings disruptive innovation to surgeons and patients.
  • Raj Asarpota will continue to serve as executive vice president and chief financial officer, and lead the Company’s Finance, Accounting, Internal Audit and Tax functions.
  • Nate Sisitsky, Esq. will continue to serve as general counsel and corporate secretary, and lead the Company’s Legal function as well as the NuVasive Spine Foundation. In addition, he will also oversee the Company’s Real Estate and Facilities function.
  • Jim Garrett, Esq., chief compliance officer and leader of the Company’s Global Risk and Integrity (GRI) function, will assume an expanded role overseeing the Business and Quality Systems functions, including GRI, Regulatory Affairs/Quality Affairs, Information Technology, and Environmental Health & Safety.
  • Lucas Vitale is named chief human resources officer, and most recently served as vice president, Human Resources and Sales Training at NuVasive. He has been with the Company for more than four years.
  • Suzanne Hatcher will continue to lead the Company’s Internal and External Affairs functions, including Investor Relations, Public Relations and Internal Communications.
  • Dale Wolf will continue to oversee the Company’s manufacturing efforts, including the facility in West Carrollton, Ohio. He will leverage his significant prior experience, with Barry’s direct oversight, to facilitate successful operational and financial execution of the Company’s self-manufacturing efforts.

NuVasive’s Global Commercial regional leaders include Paul McClintock (U.S.), Erin McEachren (Europe), Takaaki Tanaka (Japan/China) and Jim Abraham (Australia/New Zealand).

As an outcome of streamlining top layers within the Company’s new organizational structure, the positions of executive vice president, People and Culture, and executive vice president, Global Process Transformation, previously held by Pete Leddy, Ph.D. and Stephen Rozow, respectively, have been eliminated. The Company thanks Pete and Steve for their commitment and dedication to NuVasive.

To read more about NuVasive’s leadership team, please visit www.nuvasive.com and click on the About section.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit  www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com