Surgeons’ Perspectives on Premium Implants in Total Joint Arthroplasty

Posted June 30, 2017 – Amy S. Wasterlain, MD; Ricardo J. Bello, MD, MPH; Jonathan Vigdorchik, MD; Ran Schwarzkopf, MD, MSc; William J. Long, MD, FRCSC

Abstract

Declining total joint arthroplasty reimbursement and rising implant prices have led many hospitals to restrict access to newer, more expensive total joint arthroplasty implants. The authors sought to understand arthroplasty surgeons’ perspectives on implants regarding innovation, product launch, costs, and cost-containment strategies including surgeon gain-sharing and patient cost-sharing. Members of the International Congress for Joint Reconstruction were surveyed regarding attitudes about implant technology and costs. Descriptive and univariate analyses were performed. A total of 126 surgeons responded from all 5 regions of the United States. Although 76.9% believed new products advance technology in orthopedics, most (66.7%) supported informing patients that new implants lack long-term clinical data and restricting new implants to a small number of investigators prior to widespread market launch. The survey revealed that 66.7% would forgo gain-sharing incentives in exchange for more freedom to choose implants. Further, 76.9% believed that patients should be allowed to pay incremental costs for “premium” implants. Surgeons who believed that premium products advance orthopedic technology were more willing to forgo gain-sharing (P=.040). Surgeons with higher surgical volume (P=.007), those who believed implant companies should be allowed to charge more for new technology (P<.001), and those who supported discussing costs with patients (P=.004) were more supportive of patient cost-sharing. Most arthroplasty surgeons believe technological innovation advances the field but support discussing the “unproven” nature of new implants with patients. Many surgeons support alternative payment models permitting surgeons and patients to retain implant selection autonomy. Most respondents prioritized patient beneficence and surgeon autonomy above personal financial gain. [Orthopedics. 201x; xx(x):xx–xx.]

During the past 20 years, increasing costs for total hip arthroplasty and total knee arthroplasty have outpaced increases in reimbursement.1 Implant costs can comprise up to 50% of Medicare’s reimbursement for the entire procedure and hospitalization.2,3 This rise in costs without a commensurate rise in reimbursement threatens hospitals’ financial stability and may therefore reduce patient access to care. In response, numerous cost-containment strategies have been proposed and implemented to reign in these costs. Value-based alternative payment models such as the Medicare bundled payment provide a fixed fee for all costs associated with a total joint arthroplasty, incentivizing all players to collaborate to provide better quality care at lower cost.4 Many hospitals have subsequently developed guidelines for implant use, restricting access to more expensive or newer implants.

Gain-sharing attempts to realign hospital and physician incentives by compensating surgeons for making cost effective decisions that yield savings for the hospital.4 Compensation may be in the form of bonus payments, additional personnel resources such as physician assistants, research funds, or another item of value to the physician or the department.5 Although surgeons may reap small rewards from gain-sharing, they may have less autonomy to choose the implants they believe are best for their patients.

 

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Zimmer Biomet Announces Leadership Transition

WARSAW, Ind.July 11, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced that David C. Dvorak has stepped down as President and Chief Executive Officer and a member of the Board of Directors, effective today. To assist with the transition, Mr. Dvorak will serve in an advisory capacity to the Company for a period of time. The Board has appointed Daniel P. Florin, Senior Vice President and Chief Financial Officer, to serve in the additional role of Interim CEO and a member of the Board of Directors until a permanent successor has been named.

The Zimmer Biomet Board is retaining a leading executive search firm to identify and evaluate candidates for the permanent CEO role.

Mr. Dvorak said, “Serving alongside Zimmer Biomet’s dedicated employees over the past 16 years and leading the Company as CEO for ten of those years has been a privilege and a highlight of my professional career. Our collective efforts grew employment from approximately 3,000 in 2001 to 18,000 today and built a Fortune 500 company. I am particularly proud of what we have accomplished working together with surgeons and clinicians to help millions of patients globally improve their quality of life.”

Larry C. Glasscock, Chairman of the Board of Zimmer Biomet, commented, “During David’s ten-year tenure as CEO, Zimmer Biomet has transformed into a truly global leader in musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services. With this strong platform in place, there is tremendous opportunity for Zimmer Biomet. On behalf of the Board, I thank David for his many important contributions to our Company and industry over the years and wish him much success in the future.”

Mr. Glasscock continued, “We are fortunate to have a leader of Dan’s caliber and experience to step into the CEO role on an interim basis while the Board conducts its search process. Dan’s knowledge of Zimmer Biomet and his achievements here and at other medical device companies make him an excellent choice to support the Company through this interim period. We appreciate his willingness to take on this expanded role.”

Mr. Florin said, “Zimmer Biomet has a talented and dedicated team and an unmatched portfolio. I am honored to assume the Interim CEO role and I look forward to working closely with the Board, senior leadership team and our sales force as we strive to support our customers and enhance stockholder value.”

About Dan Florin

Dan Florin was appointed Senior Vice President and Chief Financial Officer of Zimmer Biomet in June 2015 and has over 16 years of executive experience in the medical device industry. He previously served as Senior Vice President and Chief Financial Officer of Biomet from June 2007 to June 2015. Prior to joining Biomet, Mr. Florin served as Vice President and Corporate Controller of Boston Scientific Corporation from 2001 until 2007. Before being appointed Corporate Controller in 2001, Mr. Florin served in financial leadership positions within Boston Scientific Corporation and its various business units. Mr. Florin previously worked for C.R. Bard from October 1990 through June 1995, and Deloitte from September 1986 to October 1990. Mr. Florin holds a Bachelor’s degree in Business Administration with a concentration in Accounting from the University of Notre Dame and an Executive MBA from Boston University.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  All statements that address expectations, plans or projections about the future, including statements about Zimmer Biomet’s management transition plans, growth prospects and business strategy, are forward-looking statements.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in its periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZBH-Corp

 

SOURCE Zimmer Biomet Holdings, Inc.

Spinal Elements Promotes Jason Blain to President & Chief Operating Officer

July 11, 2017

MARIETTA, Ga.–(BUSINESS WIRE)–Leading spinal solutions provider Spinal Elements today announced that Jason Blain has been appointed to the position of President and Chief Operating Officer (COO). In this new position, he will have responsibility for product development, quality, marketing, operations, and regulatory compliance. Mr. Blain will report to Spinal Elements CEO, Chris Fair and also will serve as a member of the board of directors.

Mr. Blain brings more than 20 years of experience in orthopedics, including hip replacements, knee replacements, trauma and spine products to his new role. He previously served as President of Spinal Elements and was a co-founder of that organization prior to Amendia’s acquisition of Spinal Elements in April of this year. The combined company was recently renamed Spinal Elements.

“Jason co-founded Spinal Elements in California and is chiefly responsible for their commitment to innovation of premium products and technologies for nearly 15 years. His track record of bringing best in class products to the marketplace will accelerate the combined company’s growth toward becoming the preferred spinal solutions provider to our clinicians and independent distributors,” said Chris Fair, CEO of Spinal Elements, “I look forward to working closely with Jason as we build a stronger connection with surgeons and the products we develop.”

Blain commented regarding his new role, “I look forward to taking on these expanded responsibilities as we continue to drive Spinal Elements toward being the preferred spine surgery solutions provider. We have a number of disruptive technologies that we will be bringing to the market in the coming months as we improve the operations of our recently-combined companies. This is an exciting time to be a part of the organization.”

Prior to founding Spinal Elements, Jason had roles of increasing responsibility in product development, manufacturing, regulatory affairs and quality assurance with Smith & Nephew, Alphatec, and Nuvasive. He has a bachelor’s degree in mechanical engineering from Christian Brothers University in Memphis, TN.

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.amendia.com or www.spinalelements.com.

Contacts

for Spinal Elements
Laura Charlton (formerly Johnson)
(760) 450-7749 cell
laurajohnsonpr@yahoo.com

The ASC CerviKit by Xenco Medical Expands Nationwide with Disposable Spinal Systems for Ambulatory Surgery Centers

July 11, 2017

SAN DIEGO–(BUSINESS WIRE)–Xenco Medical has announced the nationwide expansion of the ASC CerviKit, the compact delivery and storage platform for the company’s breakthrough, entirely disposable Anterior Cervical Discectomy and Fusion (ACDF) systems engineered from a highly durable composite polymer. The ASC CerviKit includes all of Xenco Medical’s single-use cervical implant families and is designed to be both lightweight and easily transportable. Designed to address the space constraints of ambulatory surgery centers, the systems in the ASC CerviKit offer a streamlined approach to the ACDF procedure as breakthrough single-use, composite polymer cervical implant systems. Comprising Xenco Medical’s pre-loaded Cervical interbodies and pre-loaded cervical plates as well as the supporting, single-use instruments, the ASC CerviKit is indicative of a larger movement in healthcare towards streamlined, efficient care.

With the single-use, composite polymer instrument and implants locked together in the sterile package, the Xenco Medical systems are designed to both increase efficiency in the OR as well as eliminate the internal logistics associated with the autoclave process. Existing at the intersection of materials science and biomechanical engineering, Xenco Medical’s single-use spinal systems are the first polymer-based devices of their kind. In addition to Xenco Medical’s cervical interbodies, The ASC CerviKit stores Xenco Medical’s newly launched Merge Cervical Plate system, a single-use platform using the company’s Snap-Align technology. The Merge Cervical Plate allows the surgeon to choose whether to attach the plate to the interbody prior to implantation or to connect in situ.

“Eliminating the costs, labor, and time associated with the autoclave process, the single-use systems in the ASC CerviKit have had extraordinary success in reducing logistical inefficiencies at outpatient surgery centers,” said Xenco Medical Founder and CEO Jason Haider.

Unlike the traditional metal instruments that are reused in hundreds of patients until a mechanical failure, Xenco Medical’s single-use systems are perfectly calibrated and sterile-packaged for patient-specific use. Made from a highly reinforced composite polymer, Xenco Medical’s patient-specific spinal systems have previously made news for outperforming aluminum metal in maintaining structural integrity.

About Xenco Medical

Xenco Medical is an American medical technology company committed to disruptive innovation for the purposes of creating a safer surgical environment. Through Xenco Medical’s line of disposable, sterile-packaged spinal systems, Xenco Medical seeks to ensure that the outcome of spine surgeries reflect the ability of the surgeons rather than the limitations of their instruments. For more information on Xenco Medical, visit www.xencomedical.com.

Contacts

Xenco Medical, LLC
Maicy Lunes
858-202-1505
mlunes@xencomedical.com

 

Medicrea Reports First Half 2017 Sales

July 11, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today sales for the first half of 2017.

2017 First Half Sales

€ millions H1 2016 H1 2017 Variation
Sales 14.8 14.7 -1%

Movements in exchange rates had no significant impact on the evolution of sales over the period

Group sales remained steady over the first half of 2017 compared to the previous year despite solid performance during the month of June, notably in the U.S. where sales increased 10% over the prior year period. The global breakdown of the Group’s revenue demonstrates an ongoing growth trend in France, the Company’s domestic direct sales market, where sales increased by 8% compared to the first half of 2016. In Brazil, the Company’s historic leading export distribution market, the Company continued to face challenges related to local economic and regulatory factors leading to a 63% decrease in sales in the period compared to H1 2016. In April 2017, the Brazilian regulatory body, ANVISA, performed a long-awaited mandatory inspection of the Company’s recently-opened combined headquarters and manufacturing facilities in France. Following the successful ANVISA inspection, activity with Brazil is expected to resume in early 2018.

Revenue generated by Medicrea’s UNiD™ ASI systems technology for personalized spine continued to accelerate throughout the first half of 2017, particularly in the U.S. where a growth of 41% was seen compared to the first half of 2016. Since the Company FDA-cleared the first-ever personalized approach to spine surgery with patient-specific implants in November of 2014, the number of cases performed in the U.S. has now surpassed the total internationally and reached more than $15 million in cumulative sales at the end of the first half of 2017 for UNiD™ TEK and associated Medicrea implants, particularly the patient-specific UNiD Rod used in conjunction with the Company’s portfolio of PASS® spinal systems for degenerative and complex spinal indications.

As of the end of the first half of 2017, more than 1,500 UNiD™ ASI surgeries have been performed worldwide with a record number of UNiD™ TEK, patient-specific implants, manufactured and used in surgery during the month of June. The Company also performed the world’s first personalized minimally-invasive spine surgery in the U.S. by developing and launching patient-specific UNiD™ MIS Rod for minimally-invasive spine surgery.

Denys Sournac, President and CEO of Medicrea, stated, “The significant FDA clearances obtained in the first half of 2017 evidence the Company’s focus of placing UNiD™ ASI technology for Adaptive Spine Intelligence into the hands of surgeons. We are creating easy-to-use compatible implant hardware and IT software systems that surgeons know and trust. The addition of PASS® TULIP will open new doors for Medicrea to gain market share for our patient-specific UNiD™ Rod, by lowering the barrier to entry for the large number of surgeons trained on top-loading instrumentation.”

Recently, the Company announced FDA clearance of the UNiD™ HUB, a data-driven digital portal with surgical strategy and predictive modeling functionality, as well as the FDA clearance for and first U.S. surgery with the PASS® TULIP top-loading fixation, presenting an elegant solution to surgeons trained on this system – the global standard for posterior fixation.

Next financial publication: Results for the 1st half of 2017: September 28, 2017, after market.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87

DePuy Synthes Launches Single Use Kits For Wrist Fracture Surgery

WEST CHESTER, Pa.July 11, 2017 /PRNewswire/ — DePuy Synthes* has introduced the Distal Radius Sterile Kit, a pre-sterilized, single-use kit of instruments and implants to treat wrist fractures. The streamlined kits provide customers with the company’s market-leading plate and screw implants with instrumentation designed to help optimize operating room efficiency and eliminate procedural sterilization costs.

An estimated 640,000 wrist fractures occur annually in men and women of all ages in the United States and are one of the most frequently seen fractures in the emergency room in people under 65.1 With such a high volume of procedures, surgeon and provider customers want a solution that enables high-quality treatment for patients while improving efficiency, reducing costs and minimizing delays associated with instrumentation and sterilization problems. One Canadian study demonstrated that surgical delays as brief as 10 minutes may cost a hospital more than $130,000 in staffing costs alone per year.2

The Distal Radius Sterile Kit consists of one Variable Angle LCP® Two-Column Volar Distal Radius Plate, a distribution of screws, and the required fixation instrumentation—commonly what is needed for up to 80 percent of distal radius fracture cases currently treated with plates and screws. The simplified composition of the kit is designed to drive repeatable, more consistent procedures.

“It’s important in trauma cases for the instrumentation to be arranged in a way that the surgeon can focus on the patient without distraction from the back table,” said Marc Richard**, M.D., Associate Professor, Hand, Upper Extremity and Microvascular Surgery, Department of Orthopaedic Surgery, Duke University Medical Center. “In my experience with these sterile kits, they have helped assure availability of the distal radius plates during unscheduled trauma cases.  Additionally, I have found that the simplified set and instrumentation can help the scrub team preserve operating room efficiency.”

The Distal Radius Sterile kit brings value to healthcare systems by eliminating costs and time for sterilization. A UK industry report cites that single-use kits may save approximately $285 per procedure for sterilization, transport, and handling.3  To learn more about the Distal Radius Sterile Kits, visit www.DePuySynthes.com/DRSK.

“The Distal Radius Sterile Kit is an example of how we are responding to customer needs by providing value beyond the implant,” said I.V. Hall, Global Franchise Leader, DePuy Synthes Trauma. “By combining our market-leading plate and screw solution with single-use instrumentation, we are supporting our customers ranging from academic medical centers to community hospitals in providing high-quality care in an efficient, cost-effective way.”

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes Products, Inc. and its subsidiaries.
**Consultant to DePuy Synthes Trauma
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved
DSUS/TRM/0617/1491

1 Nellans, Kate W., et al. The Epidemiology of Distal Radius Fractures. Hand Clin. 2012 May; 28(2): 113–125.
Wong J, Khu KJ, Kaderali Z, Bernstein M. Delays in the operating room: signs of an imperfect system. Canadian Journal of Surgery. 2010;53(3):189-195.
3 Goldrein T, Locsei T, Craigwood, A. DYQ06 – Costs of Orthopaedic Surgery. Innovia Technology Report. 2010. Note: costs were converted from GBP to USD using 2010 conversion rates.

SOURCE DePuy Synthes

 

Back Pain Centers of America Announces Stryker’s Spine Division as a Finalist in the Awards of Excellence, “Technology Innovation” Category

Back Pain Centers of America (BPC), which connects people searching for solutions to their neck and back pain with a reputable physician in their area, announces that Stryker’s Spine division is a finalist in the 2017 Awards of Excellence for the Technology Innovation Award. This award is one of three categories of awards being presented in our 2017 series. The Technology Innovation Award recognizes the top innovations advancing the field of orthopedic medicine, and Stryker’s Spine Division is being honored for its LITe BIO Delivery System.

The LITe BIO Delivery System is a uniquely designed hand-held device used to facilitate delivery of bone graft material to spinal surgery sites. The first-of-its-kind design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

“We are pleased to be recognized as a finalist in the Technology Innovation Award category,” said John Mayor, Vice President, Global Marketing for Stryker’s Spine division. “The new LITe BIO Delivery System combines three key features—a low-profile design, the versatility to accommodate any graft material, and direct visualization to aid in the precise placement of the graft. The LITe BIO Delivery System’s design offers a combination of features that no other bone graft delivery system on the market possesses.”

“We created this award category to recognize innovation and advances in medicine and technology,” said Brent Wheeler, president of Back Pain Centers of America. “We applaud Stryker’s Spine division for its innovation in addressing existing challenges in spinal fusion procedures.”

More information about the LITe BIO Delivery System can be found here.

About Stryker 
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at http://www.stryker.com.

About Back Pain Centers of America 
Back Pain Centers of America (BPC) has helped people find safe, reliable relief for chronic pain since 2009. The call centers match patients searching for relief for neck and back pain to reputable, board-certified healthcare practices in their geographic area. BPC has the largest network of minimally-invasive spine centers in America. This service is free to patients. For more information, please visit http://www.backpaincenters.com. Also follow BPC on LinkedIn, Facebook, or Twitter.

InVivo Therapeutics Appoints Richard Toselli, M.D. as Chief Medical Officer

July 10, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Richard Toselli, M.D., as Chief Medical Officer, effective July 5, 2017. Dr. Toselli, a fellowship-trained spinal neurosurgeon, will assume all responsibilities related to the company’s clinical and regulatory strategy.

Prior to joining InVivo, Dr. Toselli served as Chief Medical Officer for Cochlear Limited. In that role, he was responsible for global clinical, regulatory, and medical affairs teams reporting to the CEO. Prior to that, Dr. Toselli served five years at Sanofi in various levels of increasing responsibility, including Vice President of Global Medical Affairs – Immunology and Inflammation, Biologics Division; Vice President of Global Medical Affairs and Head of the Biosurgery Discovery Performance Unit; and Vice President of Global Medical Affairs, Biosurgery. Before his time at Sanofi, he served as Chief Medical/Technology Officer for Covidien Surgical, and earlier held various roles at DePuy Spine including Director of Medical Affairs, Worldwide Vice President of Research and Development, and Worldwide Vice President of Clinical Evidence and External Relations. He subsequently held the position of Vice President of Evidence-Based Medicine at Johnson & Johnson for the device sector.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We are pleased to welcome Rich to the InVivo team during this pivotal moment in the company’s history. His deep industry experience paired with his medical training as a spine trauma neurosurgeon make him an invaluable asset as we look to finish enrollment of our pivotal probable benefit study and file for marketing approval.”

Dr. Toselli’s previous academic positions include Assistant Professor at Brown University, Associate Professor, Director of Spine Center, and Associate Chief of Staff at the University of North Carolina (UNC), and Associate Professor at the University of Vermont. He holds a bachelor of arts from Providence College, his medical degree from Brown University, and a masters of business administration from the UNC’s Kenan-Flagler Business School. Dr. Toselli is a board-certified neurological surgeon.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the progress of the clinical program and the timing of the completion of enrollment in the INSPIRE Study and of the filing of an application for marketing approval. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Cartiva, Inc., Announces Multiple Presentations at American Orthopaedic Foot and Ankle Society Annual Meeting 2017

July 10, 2017

ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc. (Company), a developer of innovative products for treating cartilage damage and osteoarthritis, announced today that clinical data on its Cartiva Synthetic Implant (SCI) will be presented at the American Orthopaedic Foot and Ankle Society (AOFAS) Annual Meeting taking place July 12-15 at the Washington State Convention Center in Seattle, Washington. The AOFAS is a medical specialty society comprised of more than 2,200 orthopaedic surgeons from the US and abroad who specialize in the care of patients with injuries, diseases and other conditions of the foot and ankle. The presentations include:

  • Friday, July 14th 10:15 AM to 10:20 AM, podium presentation by Mark A. Glazebrook, MSc, MD, PhD, FRCSC, “Revision of Implant to Great Toe Fusion: Did We “Burn a Bridge” With a Synthetic Implant Hemiarthroplasty?”
  • Saturday, July 15th 8:20 AM to 8:25 AM, podium presentation by Judith F. Baumhauer, MD, MPH, “Correlation of Hallux Rigidus Coughlin Grade with First MTP Motion, Intra-operative Cartilage Loss and Treatment Success for 1st MTP Arthrodesis and Hemi-Arthroplasty.” This abstract was selected by the AOFAS Program Committee as one of three finalists for the prestigious Roger A. Mann Award. The Mann award is given in recognition of the best clinical paper accepted for presentation at the annual meeting. The winner of the award will be announced during the meeting on Friday, July 14th.
  • Saturday, July 15th 9:10 AM to 9:15 AM, podium presentation by Andrew J. Goldberg, OBE, MD, MBBS, FRCS, FRCS (Tr&Orth), “The Influence of Patient Factors on the Outcome of Synthetic Cartilage Implant Hemiarthroplasty versus First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.”

In addition, the Company will sponsor a symposium on Friday July 14th from 6:30 AM to 8:00 AM, Level 6, Rooms 611 & 612. Entitled “The Difference is DATA™ – Cartiva Synthetic Cartilage Implant for Hallux Rigidus”, the symposium’s faculty includes Judith F. Baumhauer, MD, MPH, Michael J. Coughlin, MD, Timothy R. Daniels, MD, FRCSC, Mark A. Glazebrook, MSc, MD, PhD, FRCSC, David B. Thordarson, MD and Keith L. Wapner, MD.

The Company invites all conference attendees to visit Cartiva exhibitor Booth #1211 for ongoing demonstrations of its Cartiva SCI technology.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with cartilage damage and osteoarthritis. Cartiva’s venture investors include New Enterprise Associates and Windham Venture Partners. Additional information is available on the company’s website at www.cartiva.net.

Contacts

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer

Ortho Development Corporation signs exclusive distribution agreement with China Pioneer Pharma Holdings Limited

DRAPER, Utah, July 5, 2017 – Ortho Development® Corporation (ODEV) is pleased to announce the signing of an agreement with China Pioneer Pharma Holdings Limited (CPP) as the exclusive distributor of ODEV’s Balanced Knee® System in the People’s Republic of China.

China has recently surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for total knee replacement procedures in China has been increasing rapidly. “Our strategic vision includes expanding distribution beyond the U.S. and Japanese markets into high-growth, emerging markets like China,” said Brent Bartholomew, President of ODEV. “We have been seeking the right distribution partner in China for quite some time, and are delighted to be working with an established, reputable partner like CPP.”

CPP is one of the largest comprehensive marketing, promotion and channel management service providers dedicated to importing pharmaceutical products and medical devices in China. Their portfolio includes ophthalmology, pain management, cardiovascular, respiratory, gastroenterology, immunology, orthopedics and other therapeutic areas, and a range of medical devices covering various medical specialties, including ophthalmology, odontology and wound care, etc. As of 31 December 2016, CPP sold products through its nationwide marketing, promotion and channel management service networks to approximately 30,000 hospitals and other medical institutions and over 108,000 pharmacies across all provinces, municipalities and autonomous regions in China.

Ortho Development’s Balanced Knee® System (BKS) includes implants and instrumentation for primary and revision total knee replacement procedures. The design is based on proven technology with over 17 years of successful clinical results and more than 70,000 implanted worldwide. BKS implants are offered in a wide range of sizes and options to allow optimal anatomical fit for a variety of patients. The system has a patented locking mechanism specifically designed to minimize the micro-motion between the plastic tibial insert and the titanium tibial base plate implants. Simple and intuitive instrumentation facilitates reproducibility in the hands of every surgeon and aides in proper intraoperative balancing of the knee joint.

The medical device registration in China for the BKS has already been completed, and CPP intends to begin marketing the product immediately. Following the tender and bidding process with specific hospitals, CPP expects the first knee replacement procedures in China with BKS will occur in early 2018.

About Ortho Development Corporation

Ortho Development Corporation was founded in 1994 and is a privately held company located in Draper, Utah, U.S.A. The company is passionate about designing and manufacturing the best, clinically proven, high-performance orthopedic devices in the world. The primary product focus is total knee and hip joint replacement; and also includes trauma fracture repair, and spine treatment. Ortho Development products are distributed through a growing network of independent sales reps and distributors and are used by hundreds of surgeons at world-renowned orthopaedic hospitals and teaching universities, as well as in a widespread number of regional and community hospitals. The company’s majority shareholder is Japan Medical Dynamic Marketing, Inc. (Japan MDM), a publicly-traded, Japanese medical device distribution company.