Orthobiologic Soft Tissue Repair

October 5, 2021

Biorez Awarded Four New Patents for BioBrace

Biorez Awarded Four New Patents for BioBrace
The BioBrace Implant is a biocomposite soft tissue scaffold intended to reinforce soft tissue repair and promote healing.
September 10, 2021

Fuse Medical Launches FuseChoice Dermal Matrix

Fuse Medical Launches FuseChoice Dermal Matrix
Dermal matrices are used in sports medicine applications such as protection, reinforcement and covering of a tendon or soft tissue.
August 5, 2021

Embody Announces $20.5 Million Funding Round

Embody Announces $20.5 Million Funding Round
The funds will support postmarket clinical studies of the Tapestry Biointegrative impland and launch of the RCR for rotator cuff repair.
June 30, 2021

Histogen Initiates Knee Cartilage Regeneration Trial

Histogen Initiates Knee Cartilage Regeneration Trial
Histogen's human extracellular matri is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects.
June 4, 2021

Histogen Development and Pipeline Update

Histogen Development and Pipeline Update
The company plans to focus its regenerative medicine platform on orthopedic product candidates to repair the knee and spinal disc.
March 30, 2021

Amplicore Closes Seed Funding Round

Amplicore Closes Seed Funding Round
The $4 million investment will support the company as it develops injectable products to treat osteoarthritis and meniscal tears.
January 5, 2021

Ortho RTI Partners to Support Soft Tissue Repair

Ortho RTI Partners to Support Soft Tissue Repair
The agreement provides the Buoy Suspension Fractional System for use in a clinical trial for rotator cuff tear repair with Ortho-R Chitosan-PRP hybrid drug/biologic.
October 12, 2020

CartiHeal Agili-C Granted Breakthrough Device Designation

CartiHeal Agili-C Granted Breakthrough Device Designation
FDA granted Breakthrough Device Designation for CartiHeal's Agili-C implant™, a cell-free implant for treatment of cartilage and osteochondral defects.
August 3, 2020

Anika Inorganic Growth Offsets COVID Declines

Anika Inorganic Growth Offsets COVID Declines
Sports medicine revenue from the acquisition of Parcus Medical and Arthrosurface helped Anika navigate the low point of the COVID orthopedic market in 2Q20.

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July 16, 2020

Bioventus Invests $15 Million in CartiHeal

Bioventus Invests $15 Million in CartiHeal
Bioventus has an agreed option structure to acquire CartiHeal upon milestone achievements, such as FDA approval of the Agili-C implant.
May 8, 2020

Smith+Nephew Weekly Sales Decline -47% in April

Smith+Nephew Weekly Sales Decline -47% in April
Orthopedic sales for the company declined 9.5% in 1Q20 before dropping by nearly half through April. However, the company sees initial recovery signs as countries gradually restart elective procedures.

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May 7, 2020

Vericel Confident in Near-Term MACI Recovery

Vericel Confident in Near-Term MACI Recovery
Vericel's MACI revenue grew 22% in 1Q20 despite mid-March disruptions from COVID-19. The company believes it has passed the market low point and remains confident it will recoup most lost procedures.

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May 5, 2020

Embody Raises Funds for Soft Tissue Repair Technology

Embody Raises Funds for Soft Tissue Repair Technology
Funds will support commercial launch and postmarket clinical studies of Tapestry to treat Achilles tendon and ligament injuries.
April 7, 2020

InGeneron Cell Therapy in Rotator Cuff Repair – Study Results

InGeneron Cell Therapy in Rotator Cuff Repair – Study Results
InGeneron announces favorable study results using regenerative autologous adipose-derived cells that are prepared with the Transpose® RT System for treatment of partial-thickness rotator cuff tears.
March 18, 2020

Renovos to Develop Next-Gen Technology to “Tame” BMP-2 Diffusion

Renovos to Develop Next-Gen Technology to “Tame” BMP-2 Diffusion
Regenerative medicine is an emerging market with solutions to not only heal but also grow tissue and bone. Renovos is addressing the issue of biological molecule diffusion through a synthetic nanoclay gel technology platform called Renovite.
March 12, 2020

Ortho Regenerative Technologies Results from Rotator Cuff Tear Repair Study

Ortho Regenerative Technologies Results from Rotator Cuff Tear Repair Study
Ortho Regenerative Technologies confirmed the safety profile of ORTHO-R biopolymer as well as statistical significance over standard-of-care following completion of a pivotal preclinical study in rotator cuff tear repair.
January 21, 2020

Anika Therapeutics Takes Major Step in Strategic Transformation with Acquisition of Parcus Medical and Arthrosurface

Anika Therapeutics Takes Major Step in Strategic Transformation with Acquisition of Parcus Medical and Arthrosurface
With the acquisitions of Parcus Medical and Arthrosurface, Anika looks ready to complete a major step in its five-year strategic plan to become a leader in joint preservation and restoration.

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January 14, 2020

Embody Gains Additional Funding for ACL Repair

Embody Gains Additional Funding for ACL Repair
Embody is receiving a $2.5 million Phase II research award. Funds will support development and clinical assessment of collagen-based MICROBRACE™ ACL technology for anterior cruciate ligament repair.
December 9, 2019

CartiHeal Announces Positive Interim Results of Agili-C IDE Study

CartiHeal Announces Positive Interim Results of Agili-C IDE Study
CartiHeal announced that per the results of an interim analysis of the IDE study of Agili-C™ in the treatment of cartilage lesions, trial enrollment will stop at 250 subjects.
November 25, 2019

Arthrosurface Introduces SpiralUp TCL Allograft

Arthrosurface Introduces SpiralUp TCL Allograft
Arthrosurface launched SpiralUp™, a talocalcaneal allograft system to treat peritalar subluxation and other injuries resulting in instability in the subtalar joint.
November 19, 2019

Smith+Nephew REGENTEN Bioinductive Implant Study Results

Smith+Nephew REGENTEN Bioinductive Implant Study Results
A prospective, non-comparative arm study of Smith+Nephew's REGENETEN™ in 23 U.S. patients with large and massive rotator cuff tears demonstrated a 96% tendon healing rate at two years. 
July 10, 2019

Arthrosurface Launches SpeedSpiral CMC System

Arthrosurface launched SpeedSpiral, a carpometacarpal system to treat osteoarthritis in the thumb.
June 12, 2019

CartiHeal Enrolls 200th Patient in Agili-C Study

CartiHeal, developer of the Agili-C implant to treat cartilage and osteochondral defects, enrolled the 200th patient in the Agili-C IDE pivotal clinical study.
June 11, 2019

InGeneron Increases Series D Financing

InGeneron has extended its Series D financing to USD $43MM to bring regenerative cell therapy for rotator cuff tears into clinical use.
May 30, 2019

CartiHeal’s Agili-C Implant In-vitro Study Results

CartiHeal announced a study demonstrating that the Agili-C implant may enhance osteogenic differentiation of human bone marrow-derived mesenchymal stem cells.
April 17, 2019

Smith & Nephew Completes Osiris Acquisition

Smith & Nephew completed its acquisition of Osiris Therapeutics, which was announced in 1Q19.
April 16, 2019

RepliCel Secures New Patents for Tendon Repair Technology

Replicel was granted patents in China, Europe and Russia addressing the use of fibroblast cell technology to treat chronically damaged tendons. 
March 12, 2019

MTF Biologics Debuts CartiMax Viable Cartilage Allograft

MTF Biologics and ConMed launched CartiMax® Viable Cartilage Allograft, an off-the-shelf putty-like cartilage for use in the knee, foot and ankle.
March 12, 2019

AlloSource Announces 2-Year Shelf Life for ProChondrix CR Allograft

AlloSource revealed that ProChondrix® CR fresh cryopreserved osteochondral allograft now has a two-year shelf life, based on the results of real-time testing.
March 7, 2019

CartiHeal Study Enrolls 150th Patient

CartiHeal announced treatment of the 150th patient in the IDE clinical study of Agili-C for knee cartilage repair.
March 5, 2019

Embody Receives Additional Funding for Soft Tissue Repair

Embody received US $3.6MM to support pre-launch and pre-commercial activities for the Tapestry collagen-based microfiber implant, used in Achilles tendon and rotator cuff repairs.
March 4, 2019

Aesculap Biologics Announces NOVOCART 3D Trial Enrollment Milestone

Aesculap Biologics achieved 50% enrollment in its Phase III clinical trial of NOVOCART® 3D, an autologous chondrocyte transplantation system to treat articular cartilage defects in the knee.
January 3, 2019

Histogenics to Explore Strategic Alternatives for NeoCart Cartilage Treatment

Histogenics plans to evaluate the range of potential strategic alternatives for its NeoCart® cell therapy following FDA's indication that an additional clinical trial would be required before acceptance of a Biologics License Application submission. 
November 13, 2018

CartiHeal Enrolls First Agili-C Patient on East Coast

CartiHeal announced successful enrollment of the first patient in the Agili-C IDE pivotal study on the East Coast.
November 7, 2018

CartiHeal: Positive Study Results for Agili-C Implant

CartiHeal announced a study demonstrating that its Agili-C implant promotes the regenerative capacity of articular cartilage defects in a human cadaveric ex-vivo model.
October 26, 2018

CartiHeal Reaches 100th Surgery in Agili-C IDE Study

CartiHeal has successfully enrolled and treated the 100th patient in the pivotal IDE study of the Agili-C implant. 
October 23, 2018

Regentis Biomaterials Expands SAGE Trial of GelrinC

Regentis Biomaterials expanded the SAGE clinical trial of GelrinC to 11 U.S. sites. The investigational device is in evaluation to regrow knee cartilage.
September 6, 2018

Histogenics’ Top-Line Results From Phase 3 Trial of NeoCart

Histogenics' Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year.
August 27, 2018

Wright Medical Acquiring Cartiva

Wright Medical is acquiring Cartiva, a manufacturer of the Synthetic Cartilage Implant to treat arthritis in the great toe, for US $435MM. The transaction is expected to close in 4Q18.
August 17, 2018

First U.S. Patients Receive Agili-C Implants

CartiHeal announced successful enrollment of the first two U.S. patients in the Agili-C IDE pivotal study.
August 8, 2018

Vericel Posts 2Q18 MACI Revenue Growth

For 2Q18, Vericel posted MACI orthobiologic revenue of US $14.1MM, +9.3% vs. 2Q17, with 1H18 revenue of $26.2MM, +46.3% vs. 1H17.

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June 6, 2018

Vericel Closes $74.8MM Public Offering

Vericel closed its underwritten public offering of 5,750,000 shares of is common stock for $13/share, for gross proceeds of ~US $74.8MM. 
June 1, 2018

Vericel Prices $65MM Public Offering of Stock

Vericel, developer of MACI® autologous cultured chondrocytes for cartilage repair, priced its underwritten public offering of 5MM shares of common stock at $13/share.
May 23, 2018

Ortho RTi Allowed Second European Patent for Ortho-R Technology

Ortho Regenerative Technologies received a Notice of Allowance from the EU Patent Office, which will protect the formulation of Ortho-R biopolymer for the biologic repair of tissue.   
April 20, 2018

Orthobiologics: Conversations with CEOs

At AAOS, we sat down with the CEOs of Bioventus and Histogenics to ask about opportunities that their companies are embracing, as well as the health of the orthobiologics market. Both mentioned advancements in therapies demonstrated through clinical trials and outcomes, and both discussed the importance of keeping younger, active patients healthy and mobile. Here we recap a portion of those conversations.
April 5, 2018

AlloSource and Stryker Launch ProChondrix CR Allograft

AlloSource and distribution partner Stryker launched ProChondrix® CR cryopreserved osteochondral allograft for articular cartilage repair.
April 4, 2018

RTI Surgical Reaches Milestone for Sterilization Processes

RTI Surgical reached a global milestone of >8 million biologic implants processed through proprietary sterilization, with no confirmed incidence of implant-associated infection.
March 23, 2018

Vericel’s MACI Shows Sustained Benefit at Five Years

Study results demonstrated that improvements in pain and function from use of Vericel's MACI vs. microfracture in the treatment of knee cartilage defects were sustained for five years following surgery.
March 19, 2018

Cartiva Treats First US Patient in Thumb OA Study

Cartiva treated the first U.S. patient in a study evaluating the Synthetic Cartilage Implant to treat first carpometacarpal joint OA at the base of the thumb.
February 27, 2018

Leader Biomedical Acquires International Orthopaedics

Leader Biomedical is acquiring International Orthopaedics, manufacturer of ICON total hip and hip resurfacing implants and instruments. 
January 31, 2018

Bioventus Invests in CartiHeal Study

CartiHeal gained an investment of $2.5MM from Bioventus to support the IDE trial of the Agili-C cartilage regeneration implant.
January 17, 2018

MiMedx Enrolls Patients in AmnioFix Phase III Trial

MiMedx commenced enrollment in a Phase III Investigational New Drug clinical trial of AmnioFix® Injectable in the treatment of Achilles Tendonitis.
December 15, 2017

Orthocell Granted European Tendon Regeneration Patent

Orthocell was granted a European Patent covering the manufacture of tendon regeneration cells used to form the Ortho-ATI® Autologous Tenocyte Implantation product.
December 6, 2017

Smith & Nephew Completes Rotation Medical Acquisition

Smith & Nephew completed its acquisition of Rotation Medical, developer of novel tissue regeneration technology for shoulder rotator cuff repair.
November 30, 2017

Rotation Medical Bioinductive Implant Study Update

Study results indicate that Rotation Medical's Bioinductive Implant may consistently heal rotator cuff tears, increase tendon thickness and prevent tear progression.
November 14, 2017

Vericel Reports 3Q17 MACI Revenue +19%

Vericel posted 3Q17 orthobiologic revenue of US $9.9MM, +19.3% vs. 3Q16, and YTD revenue of $27.8MM, +6.5% vs. the prior year.

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November 8, 2017

Smith & Nephew 3Q17 Orthopaedic Revenue +3% YoY

ORTHOWORLD estimates Smith & Nephew 3Q17 orthopaedic revenue of US $793.2MM, +3.3% from 3Q16, and YTD revenue of $2,454.1MM, +2.4% vs. the prior year.

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October 23, 2017

Smith & Nephew to Acquire Rotation Medical

Smith & Nephew entered into a definitive agreement to acquire Rotation Medical for US $125MM in initial cash. The transaction is expected to close by year-end.
September 21, 2017

SpinalCyte Receives Australian Patent for Cartilage Repair

SpinalCyte was issued Australian Patent No. 2015202319, “Methods and Compositions for Repair of Cartilage Using an In Vivo Bioreactor.”
September 7, 2017

MiMedx Can Launch Phase 3 IND Trial for Achilles Tendonitis

MiMedx received permission to proceed with an Investigational New Drug Phase III clinical trial of AmnioFix® Injectable in the treatment of Achilles Tendonitis.
August 28, 2017

Regentis Biomaterials Receives CE Mark Approval for GelrinC Implant

Regentis Biomaterials received CE Mark approval for a GelrinC biodegradable implant based on denatured human fibrinogen for the treatment of articular knee cartilage defects.
August 11, 2017

Vericel Reports 2Q17 Orthobiologic Revenue

Vericel posted 2Q17 orthobiologic revenue of US $12.9MM, +43.4% vs. 2Q16, and 1H17 revenue of $17.9MM, +27.9% vs. 1H16.

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August 7, 2017

MiMedx Files for Achilles Tendonitis IND Phase III Clinical Trial

MiMedx filed to initiate an Investigational New Drug Phase III clinical study comparing AmnioFix® Injectable to saline placebo in the treatment of Achilles Tendonitis.
August 2, 2017

MiMedx Plantar Fasciitis Clinical Trial Underway

MiMedx commenced a Phase III study to evaluate AmnioFix Injectable allograft vs. placebo in the treatment of Plantar Fasciitis. 
May 22, 2017

Vericel Signs Distribution Agreement with Orsini Pharmaceutical

Vericel entered into a 2-year renewable agreement with Orsini Pharmaceutical for distribution of Carticel® and MACI® in the U.S. and Puerto Rico. 
May 18, 2017

Rotation Medical BioInductive Implant REBUILD Study Results

Interim study results indicate that patients receiving Rotation Medical's Bioinductive Implant to treat rotator cuff disease reported statistically significant improvement at six months.
May 10, 2017

Vericel Licenses Products for Distribution in Southeast Asia

Vericel entered into a license agreement whereby Innovative Cellular Therapeutics will obtain exclusive rights to develop and distribute Carticel® and MACI® in Southeast Asia.
May 8, 2017

CartiHeal Raises $18.3 Million

CartiHeal closed a US $18.3MM financing round, supporting the recently-approved IDE clinical trial of the Agili-C™ implant.
April 27, 2017

SpinalCyte Receives New Australian Patent

SpinalCyte was issued Australian Patent No. 2013299505, “Generation of Cartilage Ex Vivo from Fibroblasts.”
April 25, 2017

Patient Enrollment Complete in Thumb OA Study of Cartiva SCI

Cartiva completed enrollment and treatment of all 50 patients in a multi-center study evaluating the Synthetic Cartilage Implant for thumb base OA.
March 28, 2017

Study Results: RepliCel’s RCT-01 Tendon Repair Clinical Trial

Six-month results from Phase I/II study indicate that RepliCel's RCT-01 fibroblasts demonstrated product safety and clinical potential for tendon regeneration and healing.
March 16, 2017

Active Implants Secures First Tranche of $40 Million Equity Financing

Active Implants completed the first US $10MM tranche of a $40MM Class D Units financing. Funds will support two ongoing clinical trials of the NUsurface® Meniscus Implant.
March 13, 2017

5-Year Clinical Data on Cartiva Synthetic Cartilage Implant

Five-year results from a clinical trial of the Cartiva Synthetic Cartilage Implant in the treatment of great toe arthritis demonstrated pain relief and functional outcomes equivalent to first MTP arthrodesis at two years post-op.
February 23, 2017

dCELL Technology for Orthopaedics Coming to U.S. in 2018

Tissue Regenix plans a 2018 launch for dCELL® decellularization technology in the U.S. for orthopaedic applications, initially addressing ACL repair. 
February 1, 2017

First US Implant of Vericel’s MACI

Vericel announced the first U.S. implant of MACI® autologous cultured chondrocytes for the treatment of symptomatic knee cartilage defects.
January 12, 2017

Histogenics’ NeoCart Phase I/Phase II Clinical Trial Data

Results from Phase I and Phase II study indicate that Histogenics' NeoCart® tissue-engineered implant is a safe, effective treatment for articular cartilage lesions through 5-year follow-up.
January 10, 2017

Cartiva Secures $8.5MM Funding

Cartiva secured US $8.5MM in a Series E financing. Proceeds will support commercialization of the Synthetic Cartilage Implant for treatment of great toe arthritis.
December 20, 2016

FDA Approves Investigational Device Exemption for Agili-C Implant

CartiHeal received FDA approval of its Investigational Device Exemption application submitted for the Agili-C™ implant, in support of a Premarket Approval application.
October 19, 2016

CollPlant VergenixSTR Receives CE Mark for Tendinopathy

CollPlant received CE Mark approval for Vergenix™STR soft tissue repair matrix for the treatment of tendinopathy. EU launch is anticipated in coming months.
September 30, 2016

Histogenics Closes $30.0 Million Private Placement

Histogenics closed its previously-announced US $30.0MM private placement. Funds will support development of NeoCart® novel cartilage repair therapy, including completion of the ongoing Phase III clinical trial.
September 26, 2016

Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial

Regentis Biomaterials received FDA Investigational Device Exemption approval to initiate a pivotal Phase III clinical study of its GelrinC procedure to treat focal knee cartilage defects.
September 16, 2016

Histogenics Announces $30.0MM Private Placement

Histogenics seeks to raise ~US $30.0MM in a private placement. Net proceeds will support development of NeoCart® cartilage repair therapy, including completion of an ongoing Phase III clinical trial.
August 16, 2016

Rotation Medical Completes $12MM Series B Financing

Rotation Medical completed a US $12MM Series B extension financing. Proceeds will support U.S. commercialization of its rotator cuff repair system, comprising a proprietary bioinductive implant and disposable instruments. 
May 10, 2016

Histogenics Acquires Rights to NeoCart for the Japanese Market

Histogenics acquired development and commercialization rights to NeoCart® for the Japanese market from its partner, Purpose Co. NeoCart autologous cell therapy is designed to treat knee cartilage defects. 
March 7, 2016

FDA Accepts Vericel’s BLA for MACI for in Knee Cartilage Defects

FDA has accepted for filing Vericel's BLA for MACI™, matrix-applied characterized autologous cultured chondrocytes intended to treat adult symptomatic knee cartilage defects.
March 1, 2016

LifeNet Health, Arthrex Extend Collaboration

LifeNet Health and Arthrex signed a new long-term agreement to provide allograft implants and instrumentation to surgeons and explore new applications, such as opportunities in cartilage repair.
February 10, 2016

Regentis Biomaterials Raises $15MM for U.S. Pivotal Clinical Trial

Regentis Biomaterials closed a US $15MM Series D investment round. Funds will primarily support a pivotal U.S. clinical trial of GelrinC®, a cell-free implant for the treatment of articular knee cartilage injuries.
February 9, 2016

Tentative Date for FDA Advisory Panel Review of Cartiva SCI

FDA tentatively scheduled a 2Q16 meeting of the Orthopaedic and Rehabilitation Devices Panel to review Cartiva's Premarket Approval Application for the Synthetic Cartilage Implant in the treatment of great toe osteoarthritis.
February 3, 2016

Histogenics Completes 50% Enrollment in NeoCart Phase III Trial

Histogenics has completed >50% of the required enrollment in its ongoing NeoCart® Phase III clinical trial in the treatment of knee cartilage defects.
January 19, 2016

AlloSource Receives Patent for ProChondrix Cartilage Repair Product

AlloSource was awarded U.S. Patent No. 9,186,253, Cartilage mosaic compositions and methods, for its ProChondrix® Cartilage Restoration Matrix allograft product.
January 12, 2016

Smith & Nephew Acquires BST-CarGel from Piramal

Smith & Nephew acquired BST-CarGel® cartilage repair product and IP assets from Piramal. Transaction terms were not disclosed. 
January 11, 2016

CartiHeal Raises $15 Million

CartiHeal completed a US $15MM financing round. Funds will support ongoing manufacturing scale-up, EU product commercialization in 2017 and clinical studies in new therapeutic areas for Agili-C™ cartilage regeneration technology. 
January 4, 2016

Vericel Submits BLA to FDA for MACI for Treatment of Knee Cartilage Defects

Vericel submitted a Biologics License Application to FDA for MACI™ matrix applied characterized autologous cultured chondrocytes, an investigational product intended to treat adult symptomatic cartilage defects of the knee.