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Breast Reconstruction

1
Pipeline Programs
9
Companies
11
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

9 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
2 programs
1
ARTIA Reconstructive Tissue MatrixPhase 31 trial
NatrelleN/A1 trial
Active Trials
NCT00691327Completed84,329Est. Dec 2012
NCT06575192Recruiting783Est. Dec 2029
Sofregen Medical
Sofregen MedicalMA - Framingham
3 programs
BiodegradableN/A1 trial
SERI® Surgical ScaffoldN/A1 trial
Silk surgical meshN/A1 trial
Active Trials
NCT02033590Withdrawn0Est. Aug 2014
NCT01256502Completed160Est. Apr 2014
NCT01914653Completed17Est. Mar 2016
Melodi Health
Melodi HealthMN - Minneapolis
1 program
Absorbable Antibacterial MatrixN/A1 trial
Active Trials
NCT06027996Recruiting702Est. Jun 2028
Medtronic
MedtronicNJ - Phillipsburg
1 program
Conventional diathermyN/A1 trial
Active Trials
NCT04350411Completed108Est. May 2018
Innovation Pharmaceuticals
1 program
DuraSorb®N/A1 trial
Active Trials
NCT04646057Unknown168Est. Dec 2024
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
LSCIN/A1 trial
Active Trials
NCT06779019Completed40Est. Jul 2024
Biocorp
BiocorpFrance - Issoire
1 program
OviTex PRSN/A1 trial
Active Trials
NCT07135596Not Yet Recruiting235Est. Jun 2034
TELA Bio
TELA BioPA - Malvern
1 program
OviTex PRSN/A
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
PERLE Sterile Smooth Opaque gel filled mammary implantsN/A1 trial
Active Trials
NCT06013514RecruitingEst. Sep 2038

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
AbbVieARTIA Reconstructive Tissue Matrix
BiocorpOviTex PRS
Melodi HealthAbsorbable Antibacterial Matrix
GC BiopharmaPERLE Sterile Smooth Opaque gel filled mammary implants
UNION therapeuticsLSCI
Innovation PharmaceuticalsDuraSorb®
MedtronicConventional diathermy
Sofregen MedicalBiodegradable
Sofregen MedicalSilk surgical mesh
Sofregen MedicalSERI® Surgical Scaffold
AbbVieNatrelle

Clinical Trials (11)

Total enrollment: 86,542 patients across 11 trials

NCT06575192AbbVieARTIA Reconstructive Tissue Matrix

Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants

Start: Nov 2024Est. completion: Dec 2029783 patients
Phase 3Recruiting

Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

Start: Mar 2026Est. completion: Jun 2034235 patients
N/ANot Yet Recruiting
NCT06027996Melodi HealthAbsorbable Antibacterial Matrix

Melodi Matrix™ in Breast Reconstruction

Start: Aug 2024Est. completion: Jun 2028702 patients
N/ARecruiting
NCT06013514GC BiopharmaPERLE Sterile Smooth Opaque gel filled mammary implants

Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

Start: Jun 2024Est. completion: Sep 2038
N/ARecruiting

a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction

Start: Sep 2022Est. completion: Jul 202440 patients
N/ACompleted

DuraSorb® in Prosthetic Breast Reconstruction

Start: Jan 2021Est. completion: Dec 2024168 patients
N/AUnknown
NCT04350411MedtronicConventional diathermy

Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction

Start: Oct 2016Est. completion: May 2018108 patients
N/ACompleted

Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

Start: Jul 2014Est. completion: Aug 20140
N/AWithdrawn
NCT01914653Sofregen MedicalSilk surgical mesh

SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction

Start: Jun 2013Est. completion: Mar 201617 patients
N/ACompleted
NCT01256502Sofregen MedicalSERI® Surgical Scaffold

The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

Start: Oct 2010Est. completion: Apr 2014160 patients
N/ACompleted

Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Start: Dec 1997Est. completion: Dec 201284,329 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 86,542 patients
9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.