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Articles Tagged "orthobiologics"

Researchers Pioneer 3D-Printed Bone Structures with Living Cells

by BONEZONE | Feb 2021

The technique could prove to be a solution for autologous grafts and bone reconstruction.   ... Read more »

FDA 510(k) Recap: 2020 Highlights Across the Market Segments

by BONEZONE | Dec 2020

Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap relevant. Here are 10 clearances that I found to be of interest throughout 2020.   ... Read more »

Cerapedics’ Deliberate, Thorough Approach was Crucial for i-FACTOR’s Success

by Patrick McGuire | Nov 2020

Cerapedics is one of only two companies with FDA Class III bone graft technology approved for the spine market. The company's leadership team shares the long road to commercialization. ... Read more »

FDA 510(k) Recap: First Clearances in 2020

by Julie A. Vetalice | Sep 2020

We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside of the U.S. and these clearances mark their entry into the market. ... Read more »

6 Orthopedic Trends You Can’t Ignore

by Carolyn LaWell | Mar 2020

3D printing, robotics, regenerative medicine and minimally invasive surgery are among the trends that orthopedic veterans say you must consider to remain relevant in the next decade.   ... Read more »

Evonik Developing Animal-Free/Fermentation-Based Collagen

by BONEZONE | Mar 2020

The fermentation-based collagen platform may effectively substitute the use of animal-derived collagen in medical and other markets.   ... Read more »

RTI Surgical to Become Pure-Play Spine Company with Sale of OEM Business

by BONEZONE | Jan 2020

Subsequent to closing of the $490 million transaction, the company will be a global spine company targeting double-digit growth.   ... Read more »

RoosterBio Expands Facility for Second Time in 2019

by BONEZONE | Dec 2019

Project will support the increasing global need for off-the-shelf cell banks and hMSC bioprocess media products.   ... Read more »

6 Orthobiologic Companies Move Clinical Trials Forward

by BONEZONE | Dec 2019

Multiple orthobiologic companies have engaged in clinical trials in 2019, seeking to demonstrate the efficacy of their cell-based products. We've recapped announcements from six of those companies.   ... Read more »

10 Takeaways from Orthopedics in 2019

by Mike Evers | Dec 2019

Acquisitions, biologics, enabling technology and loss of market share by the big players all made our list. Read the specifics and access our projections for 2019 revenue by company and segment.... Read more »

Executive Interview: Carmell Therapeutics on its Controlled Degradable Biologic

by Heather Tunstall | Dec 2019

Carmell Therapeutics' proprietary process binds and cross-links regenerative factors in lyophilized platelet-enriched plasma into solid and semi-solid plasma-based materials to accelerate healing in bone, tendon and wound care. The company is waiting on IND clearance before starting its pivotal tria... Read more »

Lack of Clinical Evidence Leaves Questions about Orthobiologic Development and Promotion

In the race to capitalize on patient-driven interest in stem cells, biologic and regenerative solutions, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence. Companies now have until November 2020 to comply with new FDA regulations. Enforcement, t... Read more »

Knee and Spine Osteoarthritis Ripe Areas for New Orthobiologic Products

by Heather Tunstall | Dec 2019

Dr. Steven Sampson, Founder of the well-known TOBI Symposium, shares his take on the state of regenerative medicine and the important areas of focus in the coming years.... Read more »

NASS Review: Spinal Robotics, Enabling Technologies, 3D Printing and Biologics

by Mike Evers | Oct 2019

Enabling technologies were the story of the North American Spine Society 2019 Annual Meeting, with the top spine players prominently featuring an array of robotic-assisted surgery ecosystems.   ... Read more »

MCRA Selected by Ortho RTI for Phase I/II Rotator Cuff Repair Human Trial

by BONEZONE | Sep 2019

The Canada-based company is evaluating its biopolymer matrix in the U.S. and expects to start the clinical program in 1Q20.   ... Read more »

HSS Launches First Study Testing Cell Therapy for Rotator Cuff Surgery

by BONEZONE | Sep 2019

The Hospital for Special Surgery has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery.   ... Read more »

RoosterBio Launches Umbilical Cord hMSC System for Cell Therapy Product Development

by BONEZONE | Sep 2019

RoosterVial™-hUC-XF is the regenerative medicine industry’s first xeno-free human umbilical cord mesenchymal stem/stromal cell bioprocess system designed to meet the needs of translationally focused product developers.   ... Read more »

RoosterBio Raises $15 Million in Initial Series B Round

by BONEZONE | Aug 2019

New funding, expected to close at $22MM, will support growth of its regenerative medicine MSC manufacturing platform worldwide.   ... Read more »

FDA 510(k) Recap: Large Players Notch Sports Medicine and Orthobiologics Clearances

by Julie A. Vetalice | Jul 2019

Arthrex, CONMED, DePuy Synthes and Zimmer Biomet are among the companies that received FDA 510(k) clearances in June.... Read more »

Celling Spine Acquires Assets of Link Spine

by BONEZONE | Jul 2019

Link had sought a company to further develop its system for facet fixation and minimally invasive surgery. Celling believes that this technology complements its current portfolio and supports the development of a biologically enhanced spinal fusion system.   ... Read more »

RoosterBio and Tissue Regeneration Therapeutics Collaborate on Human MSC Bioprocess Systems

by BONEZONE | May 2019

RoosterBio and Tissue Regeneration Therapeutics (TRT) will collaborate to develop TRT’s human umbilical cord-derived mesenchymal stem/stromal cell (hUC-MSCs) technology for commercialization to the entire regenerative medicine marketplace. This set of biological tools will be integrated with Roost... Read more »

M&A Recap: Three 2Q Announcements in Spine

by BONEZONE | May 2019

Of the 20 OEM-related M&A announcements we’ve covered in 2019 thus far, seven have related to the spine market. Of those, three were announced in rapid succession within this quarter. Let’s see who bought whom, and what they got: Medtronic/Titan Spine, Boston Scientific/Vertiflex and WishBon... Read more »

9 Orthopedic Companies that Recently Received Funding

by Carolyn LaWell | May 2019

Funding 2019 has driven research & development and regulatory activity for companies working to get their first product on the market and those seeking to expand globally. Familiar names like Intrinsic Therapeutics and Graftys, as well as new companies like HAPPE Spine and Magnesium Develop... Read more »

Burst of Orthopedic M&A at the Close of 1Q19

by BONEZONE | Mar 2019

Companies are taking strides to connect their devices with technologies that support improved patient outcomes. That connection can come in the form of M&A activity—which certainly applies to transactions announced over the month of March in joint replacement. In other segments, companies... Read more »

Smith & Nephew to Acquire Osiris

by BONEZONE | Mar 2019

The transaction includes BIO4 viable bone matrix, an alternative to autograft, and Cartiform cryopreserved viable osteochondral allograft for articular cartilage repair.     ... Read more »

Aesculap Biologics Announces NOVOCART 3D Trial Enrollment Milestone

by BONEZONE | Mar 2019

Approximately 117 study participants have been treated, bringing enrollment to 50% completion.   ... Read more »

Biologics, MIS, Robotics: Why Surgeons Say to Prioritize These Technologies

by BONEZONE | Feb 2019

These expert surgeon voices—upon which we often rely to identify both trends and opportunities of interest to you—speak to critical topics, including orthopedic industry evolution, minimally invasive spine surgery, robotics and sensors, and value-based implants.... Read more »

AAOS Preview: First-Time Exhibitors, New Offerings on the Exhibit Floor

by Julie A. Vetalice | Feb 2019

Each year, of the hundreds of exhibitors slated to be at the annual American Academy of Orthopaedic Surgeons meeting, I select a few you may not know. After you've gone to look at the robots, here are some other companies to meet.... Read more »

Histogenics to Explore Strategic Alternatives for NeoCart based on FDA Findings

by BONEZONE | Jan 2019

Histogenics expects to suspend development of NeoCart, a tissue engineered implant, after FDA indicated that an additional clinical trial would be required to accept a Biologics License Application submission.... Read more »

Year in Review: Orthopaedic Companies New on Our Radar in 2018

by BONEZONE | Dec 2018

The companies highlighted here (either brand new or new to us) represent all five major market segments and comprise a broad geographical mix: Denmark, Finland, Israel, Italy, The Netherlands and the United States.... Read more »

puracon Completes Specialized Employee Training Program

by BONEZONE | Dec 2018

The 2.5-day program was to provide increased cooperation among the company's departments.... Read more »

Foot and Ankle Implant Opportunities Lie in Design, Technique Improvements

by BONEZONE | Dec 2018

David Kay, M.D., a foot/ankle surgeon, shares what he see in his crystal ball regarding plates, biologics and total ankle replacement: "We have a lot of unfinished work. Observe and listen to surgeons, sterile processing, material handlers and supervisors. Suspend your view of the world to see the p... Read more »

Orthobiologics for Fracture Repair, Knee Cartilage Defects: 3Q18 Study Highlights

by BONEZONE | Oct 2018

Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we tracked that announced completed studies in the last three months.... Read more »

Big Data, Biologics and Failure Rates Among Significant Interests for Surgeon

by BONEZONE | Oct 2018

"There has never been a greater need for the lowest rates of failure possible," says Dr. Adolph J. Yates. "Proven devices with low revision rates might be ... the safest bet compared to new designs that have yet to be vetted in an after-market environment."... Read more »

First Two United States Patients Receive CartiHeal’s Agili-C Implants

by BONEZONE | Aug 2018

The Israeli startup develops implants to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints; to date, 80 patients in Europe and Israel have been treated in the pivotal Agili-C IDE study.... Read more »

Cerapedics Enrolls Patients in P-15L Peptide-Enhanced Bone Graft IDE Trial

by BONEZONE | Aug 2018

P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation. Cerapedics has enrolled the first of 364 patients in this IDE clinical trial.... Read more »

Year-to-Date Funding Recap: Robotics, Imaging, ACL Implant, Cervical Disc and More

by BONEZONE | Jul 2018

These funding announcements feature technologies related to each of the market segments: spine, trauma, arthroscopy/soft tissue, joint reconstruction and orthobiologics.... Read more »

Success Story: Bruce Stroever on 30 Years of Leadership at MTF

by BONEZONE | Jul 2018

Do what you say you’re going to do – pay attention – embrace change – have vision…recently retired MTF Biologics CEO Bruce Stroever shares practical advice for newcomers and veterans alike, as well as predictions for the orthobiologics market.... Read more »

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

by BONEZONE | Jul 2018

A review of patent activity in 1H18 shows technological innovations from companies like Episurf, iOrthopedics, Orthocell and Spineology across arthroscopy/soft tissue repair, joint reconstruction, orthobiologics, spine and trauma.... Read more »

Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies

by Julie Vetalice | Jun 2018

The 1H18 product launches by the top orthopaedic companies were largely focused on the market segments of spine and joint reconstruction. We offer a list of new products and their descriptions. ... Read more »

Orthopaedic Industry Reaches $49.3 Billion, Grows 3.7%

by BONEZONE | May 2018

Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »

Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI

by BONEZONE | Apr 2018

Patrick Sweeney, M.D. is Founder of the Center for Minimally Invasive Surgery, an ambulatory surgery center in Illinois that addresses a range of orthopaedic and spinal conditions. He is also an inventor/entrepreneur, holing 30+ U.S. and European patents.... Read more »

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by BONEZONE | Feb 2018

The rule amends that inspections will be risk-based, not biennial.... Read more »

Musculoskeletal Transplant Foundation Rebrands as MTF Biologics

by BONEZONE | Oct 2017

Today, the surgeon-founded entity offers R&D in pursuit of new biologics to support tissue regeneration. ... Read more »

Bone Biologics Targets Spine Fusion with UCLA License Agreement

by BONEZONE | Sep 2017

Bone Biologics entered into an exclusive license agreement with UCLA for global application of NELL-1/DBX® protein in the treatment of osteoporosis and trauma through a technology transfer.... Read more »

R&D Recap: Leading Orthopaedic Device Company Product Initiatives

by BONEZONE | Jun 2017

Acquisitions, divestitures, market entries and exits have contributed to the shaping of product portfolios of the orthopaedic industry’s larger players, in recent years. We review their product development initiatives over the last 18 months to offer a good look at your competitors’ strateg... Read more »

Silver Ions Found Effective in Fighting Infections while Forming Bone

by BONEZONE | Mar 2017

An international team of researchers developed a scaffold that could prevent or kill MRSA and support bone tissue formation.... Read more »

Exactech Divests Spine Assets

by BONEZONE | Mar 2017

ChoiceSpine expands breadth of product and global distribution with acquisition.... Read more »

Revisiting Predictions: Orthobiologics, Payors and ASCs

by BONEZONE | Dec 2016

Robert S. Bray, Jr., M.D., revisits predictions from his OMTEC 2014 keynote—talking sustainable medicine, orthobiologics, care delivery and what can be gained from a relationship between OEMs and insurers.... Read more »

Scientists Engineer Stem Cells to Regrow Cartilage

by BONEZONE | Dec 2016

Scientists have programmed stem cells to grow cartilage on a 3D woven scaffold shaped like a femoral head. The technology’s first focus is hip arthritis.... Read more »

2016: The Year in Products and Services

by BONEZONE | Dec 2016

What are you working on for 2017? How do your daily tasks align with overall growth objectives? We look forward to sharing your successes in these pages next year. Until then, let’s reflect on what fueled momentum this year.... Read more »

Surgeons Seek Muscle-Sparing Techniques in Arthroscopy/Soft Tissue Repair Market

by BONEZONE | Apr 2016

Growth in the arthroscopy and soft tissue repair market is propelled by surgeon requests for devices that employ muscle- and tissue-sparing techniques to return patients to activity faster and with less pain. This is largely being driven by patients in this segment, particularly athletes and “week... Read more »