Zimmer Biomet Holdings Announces Audio Webcast and Conference Call of First Quarter 2018 Results

WARSAW, Ind.March 22, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced its first quarter sales and earnings conference call will be broadcast over the Internet on Thursday, April 26, 2018, at 8:30 a.m. Eastern Time.  A news release detailing the quarterly results will be made available at 6 a.m. Eastern Time the morning of the conference call.

The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985.  For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from April 27, 2018 to May 26, 2018.  To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

About the Company
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.


SOURCE Zimmer Biomet Holdings, Inc.

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Vericel Reports Publication of Results from the Phase 3 SUMMIT Extension Study Demonstrating Sustained Clinical Benefit of MACI Out to Five Years

CAMBRIDGE, Mass., March 23, 2018 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the publication of results from the MACI® (autologous cultured chondrocytes on porcine collagen membrane) Phase 3 SUMMIT  Extension Study in the American Journal of Sports Medicine.  The results demonstrated that the significantly greater improvements in Knee injury and Osteoarthritis Outcome Score (KOOS)1 pain and function scores for MACI versus microfracture shown in the two-year Phase 3 SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) study were maintained over the additional three-year follow-up in the SUMMIT Extension Study.

MACI is an autologous cellular scaffold product indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  MACI is the first FDA‑approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue.

The FDA approval of MACI was based on the results of the SUMMIT study, a Phase 3, prospective, multicenter, randomized, controlled study that enrolled a total of 144 patients.  The co-primary efficacy endpoint was the change from baseline to two years in the KOOS2 pain and function scores.  The SUMMIT study is the only Phase 3 clinical trial of a cartilage repair product to date to demonstrate statistically significant improvement over microfracture at both one and two years.2

The SUMMIT Extension Study was a three-year follow-up of the SUMMIT clinical trial, entailing up to five years of observation after surgery.  Of the 144 patients randomized in the SUMMIT study, 128 (89%) continued observation out to five years in the SUMMIT Extension Study.  Evaluation of these patients post treatment showed that there was sustained improvement in both KOOS pain and function for the study period.  A post‑hoc evaluation showed that the significantly greater improvement of MACI versus microfracture observed at the two-year endpoint was maintained at the five-year follow-up.  The frequency of adverse events and subsequent surgical procedures were similar in both the MACI and microfracture treatment groups.  The Extension Study is the first study in the field of cartilage repair to provide long-term, five-year follow-up results from a successful multicenter, superiority study in comparison to microfracture.

“MACI is the only FDA-approved cartilage repair product that has demonstrated significantly greater improvement versus microfracture in a Phase 3 controlled clinical trial,” said Nick Colangelo, Vericel’s president and chief executive officer. “It is important to both clinicians and patients that MACI, in addition to demonstrating significant improvements compared to microfracture as early as one year, maintains improvements over microfracture out to at least five years.”

The publication is entitled “Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfacture: Five-Year Follow-up of a Prospective Randomized Trial” and the full abstract is available on pubmed: http://journals.sagepub.com/doi/full/10.1177/0363546518756976

About MACI
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellular scaffold product that is indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane.  Autologous cultured chondrocytes are human-derived cells which are obtained from the patient’s own cartilage for the manufacture of MACI.

Limitations of Use

  • Effectiveness of MACI in joints other than the knee has not been established.
  • Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

Important Safety Information

  • MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.  MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders.  MACI is also not indicated for use in patients who have undergone prior knee surgery in the past six months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.
  • MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.  The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown.  Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.
  • Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases.  A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue.  Universal precautions should be employed when handling the biopsy samples and the MACI product.

About Articular Cartilage Defects of the Knee
Articular cartilage is a highly organized avascular tissue composed of chondrocytes embedded within an extracellular matrix of collagens, proteoglycans and noncollagenous proteins.  Its primary function is to enable the smooth articulation of joint surfaces, and to cushion compressive, tensile and shearing forces.  Articular cartilage damage is caused by both acute and repetitive trauma resulting in knee pain, effusion or mechanical symptoms such as catching and locking, and swelling.  Since articular cartilage is avascular it has little capacity to repair itself or regenerate.  Articular cartilage lesions that are left untreated may progress to debilitating joint pain, dysfunction, and osteoarthritis.3  The prevalence rate for cartilage lesions in the knee has been reported to be 63% in patients undergoing investigational arthroscopies.4

About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI®(autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel®(cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  For more information, please visit the company’s website at www.vcel.com.

MACI® and Epicel® are registered trademarks of Vericel Corporation. © 2018 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, regulatory progress, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities including maintenance of clinical benefit, regulatory approval requirements, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2018, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.


1Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.

2Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, et al. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: two-year follow-up of a prospective randomized trial. Am J Sports Med. 2014 Jun;42(6):1384-94.

3Bedi A, Feeley BT, Williams RJ. Management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(4):994‑1009.

4Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997;13(4):456-60.


Global Media Contacts:
David Schull
Russo Partners LLC
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)

Karen Chase
Russo Partners LLC
+1 646-942-5627 (office)
+1 917-547-0434 (mobile)

Investor Contacts:
Chad Rubin
The Trout Group
+1 (646) 378-2947

Lee Stern
The Trout Group
+1 (646) 378-2922

Stryker F1™ Small Bone Power System brings fresh innovation to the power tool market

KALAMAZOO, Michigan, USA, March 23, 2018 /PRNewswire/ — Stryker’s Instruments division announced today the launch of the Stryker F1™ Small Bone Power System, providing surgeons with a cordless, balanced, lightweight solution for procedures of the extremities.

Until now, extremities surgeons have, for the most part, used cord-and-console setups. While a console delivers the requisite power for working with small bones, it also comes with unavoidable compromises. It reduces maneuverability, may break the sterile operating field and with multiple components, can make both operation and troubleshooting less efficient. The Stryker F1 System allows for the elimination of cords, hand switches, and consoles and provides a much more efficient way to perform distal extremity procedures.

The Stryker F1 System is powered by SmartGRIP™ Technology. Surgeons have the choice of two unique gripping styles – the pencil or pistol-style SmartGRIP. Each SmartGRIP is a lightweight, well- balanced battery control module that contains lithium ion cells and enables the surgeon to operate three micro saws, a micro drill, and a universal motor for inserting k-wires and drilling. The five motors and three attachments are interchangeable between SmartGRIP Control Module, allowing surgeons to choose their specific approach. Each SmartGRIP Control Module:

  • Can remain on the shelf, unused, for 30 days without losing power and performance1
  • Provides consistent power and uptime
  • Contains insulation to increase resistance to thermal damage during exposure to high temperatures throughout sterilization
  • Includes a battery indicator light to display SmartGRIP Control Module status information

In addition to delivering procedural efficiency, the Stryker F1 System will connect to Smart Equipment Management (SEM), a new online data module designed to help optimize the management of Stryker’s smart devices through device-derived, actionable data. The Stryker F1 System pairs exclusively with the Resurfacing Tool, an innovative cutting accessory that provides a reduced level of chatter, increased cut accuracy, and increased cut speed when compared to a 4.0mm fluted egg bur2.

The Stryker F1 system has a small footprint, making it a great addition to both hospitals and surgery centers, and provides an all-inclusive, non-anodized container with two tray inserts to hold every component in the system. This allows SmartGRIP Control Modules to be sterilized in multiple ways3 allowing facilities to choose the sterile processing option that best meets their needs.

The Stryker F1 system provides the necessary power to complete the indicated procedures using the gripping style that is most comfortable for the surgeon and allows them to operate at their best.

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

Media contact
Jennifer Lentner
Sr. Director, Marketing Communications

1 Stryker engineering data on file. Kalamazoo, MI
2 The 2.5mm egg resurfacing tool (1900-015-025) had an equivalent cut speed when compared to the 4.0 mm fluted egg bur (1608-002-035). Under test lab conditions when compared to the 1608-002-035 using a bone substitute.
3 For complete cleaning and sterilization instructions, please refer to Stryker F1 Care Instructions.

SOURCE Stryker

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Aziyo Biologics Expands Bone Repair Franchise with Launch of OsteGro

March 22, 2018

SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo Biologics, Inc., a fully integrated regenerative medicine company, announced today the launch of OsteGro, an allograft bone matrix that supports new bone growth in orthopedic surgical procedures. The launch of OsteGro further expands the company’s bone repair franchise.

“We are excited to add OsteGro to our innovative orthopedic surgery product line. OsteGro represents the third product in our portfolio which already includes ViBone, a viable bone matrix, and OsteSpine, a complete line of precision machined cervical spacers,” says Darryl Roberts, Ph.D., General Manager, Strategic Tissue Partnerships at Aziyo. “Our goal is to build an industry leading franchise in biologic materials for orthopedic surgery. This launch is yet another step towards that goal.”

OsteGro is an allograft bone matrix developed with Aziyo’s proprietary processing methods that results in a bone graft that serves as a scaffold for new bone growth. Because OsteGro can be stored at room temperature, it is ready for immediate use in a wide range of surgical procedures. Bone repair allografts like OsteGro are used in procedures such as spinal fusion, hip reconstruction and bone fractures. OsteGro is part of the growing biologics segment of U.S. orthopedic market. This segment alone is estimated to total approximately $2 billion in annual sales.

About OsteGro™

OsteGro is composed of cancellous bone and partially demineralized cortical bone. It is easily molded to produce the desired shape in a clinical setting. Proprietary processing methods are utilized to preserve natural characteristics and components of the matrix. OsteGro is sterile and may be stored at room temperature. The matrix is regulated as a human tissue allograft.

About Aziyo Biologics, Inc.

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular, and other medical specialties. For more information, visit: www.aziyo.com.


Aziyo Biologics, Inc.
Erica Elchin, (510) 730-7896

Wright Medical Group N.V. Highlights New Product Launches at the American College of Foot and Ankle Surgeons (ACFAS) 2018 Scientific Conference

AMSTERDAM, The Netherlands, March 22, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it will highlight new innovations at the American College of Foot and Ankle Surgeons (ACFAS) 2018 Scientific Conference taking place at the Gaylord Opryland Hotel in Nashville, Tennessee, from March 22-25, 2018.

Wright will feature its full range of lower extremities and biologic solutions at exhibit booth #244, including the INVISION™ Total Ankle Revision System with PROPHECY Preoperative Navigation, the first preoperative planning system with patient-specific instrumentation for ankle revision arthroplasty.  The introduction of INVISION with PROPHECY is an important addition to Wright’s total ankle portfolio, extending the use of preoperative planning to the entire continuum of care from primary through revision procedures.

“The INVISION Total Ankle Revision System with PROPHECY Preoperative Navigation builds on Wright Medical’s commitment to providing physicians with innovative tools that lead to the best possible patient outcomes,” said Robert Palmisano, President and Chief Executive Officer of Wright.  “Total ankle arthroplasties provide a unique set of challenges for our physicians and we are excited to be bringing this technology to market to see its success in action.  The launch of INVISION with PROPHECY expands our leadership in total ankle technology and marks our ability to best address the total ankle replacement continuum of care.”

The PROPHECY System was first approved for total ankle replacement in 2012 and has been clinically proven to help surgeons accurately align ankle replacements1 and increase surgical efficiency by reducing OR time and potentially cost2.  Developed from the patient’s own CT scan, implant sizing and alignment are determined using the patient’s unobstructed anatomic landmarks and the surgeon’s preferences. PROPHECY alignment guides are subsequently created, providing patient-specific instruments to help the surgeon precisely position implants while reducing surgical steps, which in turn allows for less procedural complexity and surgery time.

“Revision of a failed total ankle arthroplasty remains a challenge,” said Dr. William McGarvey, Chief of Foot and Ankle Surgery at the McGovern Medical School at the University of Texas Health Science Center – Houston, who has performed several revision procedures with PROPHECY to date.  “The ability to preoperatively plan out these cases and determine appropriate alignment based on the individual patient’s CT data will provide surgeons with an extra level of confidence that the implants will be positioned in the optimal alignment.”

Key benefits of PROPHECY now include:

  • Full array of implant choices (INFINITY™, INBONE™ or INVISION™) to fit the patient’s specific needs
  • Ability to create a detailed revision surgical plan with or without failed implants currently in place
  • 3D visualization of how to manage bone loss and reconstruct joint height under unique revision conditions

Recent new products to be featured at ACFAS include:

INVISION™ Total Ankle Revision System – The first and only system developed specifically for total ankle revision arthroplasty, the INVISION Total Ankle Revision System provides a unique solution for even the most difficult revision procedures. Whether leveraged as a standalone construct or in conjunction with INFINITY and INBONE components, the INVISION Total Ankle Revision System is an important addition to the continuum of care from total ankle replacement through any necessary revisions. The INVISION Total Ankle Revision System helps surgeons re-build bone lost through previous surgeries and provides modularity to help restore natural joint height.

ORTHOLOC™ 3Di Ankle Fracture Low Profile System – The ORTHOLOC 3Di Ankle Fracture Low Profile System features a complete range of ankle fracture plates designed specifically for the foot and ankle surgeon. The system features low-profile, anatomic plate designs and ORTHOLOC 3Di polyaxial locking screw technology, providing an innovative fracture solution that addresses a primary need for one of the foot and ankle’s largest market segments.

For more information about Wright Medical’s portfolio of total ankle products, visit: www.totalankleinstitute.com

1 Hsu AR, Davis WH, Cohen BE, Jones CP, Ellington JK, Anderson RB. Radiographic outcomes of preoperative CT scan-device patient-specific total ankle arthroplasty. Foot Ankle Int 2015;36:1163-1169.
2 Hamid KS, Matson AP, Nwachukwu BU, Scott DJ, Mather RC, DeOrio JK. Determining the cost-savings threshold and alignment accuracy of patient-specific instrumentation in total ankle replacements. Foot Ankle Int 2016;38:49-57.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products.  The company is committed to delivering innovative, value-added solutions improving quality of life for patients worldwide and is a recognized leader of surgical solutions for the upper extremity (shoulder, elbow, wrist and hand), lower extremity (foot and ankle) and biologics markets, three of the fastest growing segments in orthopedics.  For more information about Wright, visit www.wright.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Tracy
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817

OrthoPediatrics Corp. Introduces PediFlex™ Advanced Surgical System

WARSAW, Ind., March 22, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the introduction of PediFlex™ Advanced, the Company’s next generation elastic nailing platform. The upgrade to the legacy system provides a modified flexible nail implant in multiple diameters and lengths, available in both stainless steel and titanium. The platform includes an innovative new inserter design, allowing for easy assembly and interchangeable collets for multiple nail sizes. Further, PediFlex™ Advanced features enhanced instruments for nail extraction and completes the next step in the evolution of OrthoPediatrics’ intramedullary nailing franchise.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma & Deformity Correction, stated, “We are committed to providing pediatric orthopedic surgeons with the most innovative systems to treat their patients, and flexible nailing is one of the most frequent pediatric implant procedures. The enhancements beyond the first generation PediFlex Nail System provide a significant advancement in pediatric fracture care. Additionally, this expansion represents OrthoPediatrics’ commitment to continuous improvement of its products.”

About PediFlex™ Advanced
PediFlex™ Advanced is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 37 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

OrthoSpineNews Interview with Matt Moreau, V.P. and General Manager of Stryker’s Sports Medicine Business

This month, at the American Academy of Orthopaedic Surgeons meeting, I had the privilege of interviewing Matt Moreau, the Vice President and General Manager of Stryker’s Sports Medicine business. Our topic of conversation was the new technologies that Stryker unveiled at AAOS. Two things were made clear during my discussion with Matt: Stryker’s passion for innovation and an unwavering dedication to patient care. Below are some questions I asked along with his responses.

Q1: What separates the Pivot Guardian Distraction System from what is on the market today? 

The most differentiated advancement designed into the Pivot Guardian Distraction System was eliminating the need for a post to achieve distraction, which helps mitigate complications such as skin tears, nerve damage or total groin numbness that can sometimes last for several weeks or longer for patients.  Since the inception of hip arthroscopy, surgeons have not been given an option from industry to mitigate these significant risks in an elective procedure. Beyond the post-free innovation, the system was really focused on enabling surgeons to see and do more versus current systems on the market.  The innovative boot was designed to better disperse pressure, as well as reduce the risk of heel slip during the procedure, which can save considerable operative and anesthesia time. The boot advancements also give surgeons the option to place the boot on the patient pre-operatively, which allows for patient feedback while they’re awake and potentially reduces OR set-up time.  Lastly, we believe the table design gives surgeons better intraoperative range of motion and more flexibility for c-arm positioning, which is critical to the procedure. 

Q2: What are the advantages of Cobra compared to other suture passers for arthroscopic rotator cuff repair that are currently on the market?

Three things come to mind right away.

  • Cobra’s innovative needle design and stronger material improves clinical performance by addressing misfires and tip breakages associated with the current standard of care.
  • Because the Cobra needle is reusable, it presents an opportunity for us to provide a better business solution to our customers.

3) Utilizing the Cobra technology also cuts down on waste and utilization of customer shelf space. Removing waste is always a goal during development, as well as minimizing or eliminating the need to occupy our customer’s valuable shelf space. 

Q3: When it comes to innovation, is Stryker exclusively focused on acquisitions?

We typically take a hybrid approach of internal development, while also looking at external technologies that would complement our pipeline.  Cobra was an example of purchasing an early stage and innovative technology that we refined over time until we felt it was really positioned to change the standard of care in rotator cuff surgery.

Thank you for taking the time to discuss the new technologies Stryker unveiled at AAOS. We are excited to see what the future holds for you and your team!


Related Link Here

Orthofix Receives FDA 510(k) Clearance of G-Beam Fusion Beaming System

March 22, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value added services, announced the U.S. Food and Drug Administration (FDA) 510(k)clearance for its new internal fixation system, the G-Beam™ Fusion Beaming System.

Designed primarily for the treatment of Charcot foot, a debilitating condition where the bones in the foot weaken and collapse, the G-Beam devices can be implanted in the medial and lateral columns of the foot to provide alignment, stabilization and fixation.

“In my practice I often see patients whose uncontrolled diabetes has led to the development of Charcot foot, an extremely disabling condition that if left untreated, can lead to amputation,” said Dr. William Grant, a podiatric surgeon from Virginia Beach, VA who designed the G-Beam system. “Using the G-Beam system allows us to anatomically realign the foot; enabling the bones to heal so these patients can return to a more normal independent lifestyle.”

When the use of internal fixation is recommended, the G-Beam system is designed to fuse the medial and/or lateral columns, as well as bones in the hindfoot, in order to restore a stable foot that may ultimately reduce the probability of an amputation. The system comes with single-use, sterile-packed implants and an efficient, compact instrumentation tray.

“The G-Beam Fusion Beaming System is the next step in working towards our objective of becoming a recognized premium solution provider in the Charcot and Diabetic foot market segments,” said Davide Bianchi, President of the Extremity Fixation business unit. “This system will allow us to establish ourselves in the internal fixation segment of Charcot treatment options, while leveraging our existing product lines, like TrueLok and the TL-HEX.”

About Charcot Foot

Charcot foot is a chronic and progressive joint disease causing weakening of the bones in the foot. It is a serious condition that can lead to deformity, disability and even amputation. Charcot foot can occur in people who have severe neuropathy (the loss of protective sensation in the limb) or nerve damage, a common diabetic foot complication. The World Health Organization estimates that more than 422 million people suffer from diabetes and that the number will more than double in the next 20 years. The prevalence of diagnosed Charcot foot in patients with diabetes is reported to be 0.08–7.5%. However, some studies suggest higher prevalence with as many as 13% of all diabetic patients and 29% of the neuropathic patients affected. To learn more about Charcot foot visit limbhealing.com.

The G-Beam Fusion Beaming System will be on display during the American College of Foot and Ankle Surgeons (ACFAS) annual meeting in Nashville TN, March 22-25. Orthofix invites those attending ACFAS to visit Booth #653 to learn more about this new internal fixation system.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.


Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
Media Relations
Denise Landry, 214-937-2529

Mark Foster Named President of Trice Medical

Trice Medical today announced the appointment of Vice President of Worldwide Sales and Chief Commercialization Officer, Mark Foster as President and CCO. Mr. Foster will retain his role as Chief Commercialization Officer and assume the duties and responsibilities of President from Jeffrey F. O’Donnell, Sr., who will remain the Company’s CEO.

“Mark has demonstrated tremendous leadership and management skills,” stated Jeffrey F. O’Donnell, Sr., Trice’s CEO. “Our Board of Directors admires his ability to execute and motivate teams to success. Mark will assume the role of President of the organization worldwide. I am looking forward to working with Mark to continue building the value of Trice Medical.”

Foster joined Trice in 2016, serving as VP of WW Sales and CCO. In that role, Foster led the Company’s product commercialization and sales worldwide, working closely with the product development, operations, sales, and marketing teams to solidify Trice Medical’s position as a leader in the orthopedic industry.

“I am honored and energized for the opportunity to further shape the direction of the organization. Trice has developed a dynamic imaging system that can deliver instant answers to patients, payors, and providers. It’s rare to find a platform that can bring value to all three of those stakeholders. The mi-eye two allows patients to get a dynamic evaluation of their knee or shoulder in an office setting, and to have their injections delivered under direct visualization, ensuring accurate placement. I’m looking forward to working with our team to find even more ways to deliver products that excite our customers,” said Foster.

Prior to Trice, Foster spent eight years with Smith & Nephew, a global medical technology company. His last position with Smith & Nephew was Vice President, U.S. Sports Medicine in the Advanced Surgical Device Division. Earlier in his career, Foster spent eight years with Boston Scientific in several different leadership roles. He started his healthcare career with Smith Kline Beecham. He holds a B.A. from the University of Richmond.

About Trice Medical

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient and the physician by providing instant answers. Trice has pioneered fully integrated camera-enabled technology, the mi-eye 2, which provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

For Inquires contact:

Cathy Whetstone

email: info@TriceMedical.com

Phone: +1 (610) 989 – 8080

Collagen Matrix, Inc. Names Gregory Pomrink as Vice President, Research and Development

OAKLAND, N.J.March 21, 2018 /PRNewswire/ — Collagen Matrix, Inc., a leader in regenerative medicine and a global manufacturer of collagen and mineral based medical devices, announced today the appointment of Gregory Pomrinkas Vice President, Research and Development to further leverage its six proprietary technologies across the company’s five key business units in Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery.

Greg joins the Collagen Matrix executive team as an accomplished medical device executive with over 30 years of extensive experience designing, developing and commercializing medical devices for the regeneration of bone and soft tissues.  “We are pleased to add Greg to our team as we continue to drive product development across our portfolio. Greg’s experience and knowledge will strengthen our executive team and I look forward to expanding our product pipeline across the various technology platforms that underlie Collagen Matrix,” said Bart J. Doedens, CEO of Collagen Matrix Inc.

Prior to joining Collagen Matrix, Greg held various Research and Development roles with LifeNet Health, NovaBone Products, Integra LifeSciences, Dentsply and Orthovita specializing in products for dentistry, sports medicine, orthopaedics/spine, and neurosurgery along with plastic and reconstructive surgery applications.  Greg has a Bachelor of Arts degree in Chemistry from Temple University along with a Master of Science degree in Chemistry from Lehigh University and a Master of Business Administration degree from Eastern University.

About Collagen Matrix
Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate.  The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery.  The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth. Opportunities continue to exist for collaboration through Product Distribution, Product Development and Contract Manufacturing.  More information about Collagen Matrix can be found at www.CollagenMatrix.com.

Contact: Margo Lane


SOURCE Collagen Matrix, Inc.

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