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Science & FDA

New research, clinical studies and FDA 510(k) decisions in the lanes CXU competes in. Read from PubMed, ClinicalTrials.gov and openFDA.

Key takeaway

Flowable collagen in wound care is the busiest research lane, with 164 papers in 12 months. FDA made 3 comparable 510(k) decisions in the last 6 months, ahead of Conexeu Sciences’ own 510(k) premarket notification, planned Q1 2027.

Supporting data
  • 377 papers in 12 months across 4 research queries
  • 33 recent: dated within 60 days of the read
  • 252 registered studies across 3 queries
  • 11 comparable 510(k) decisions in 3 years, 3 in 6 months
What we’re doing

Turn the newest paper into an unbranded clinician explainer, and keep the 510(k) comparables list current for the submission.

Conexeu Sciences regulatory status

CXU: Thermosensitive flowable collagen scaffold (Ten-Minute Tissue)

CXU is an investigational medical device candidate in preclinical development. It has not been submitted to or reviewed by the U.S. Food and Drug Administration. Safety and effectiveness have not been established.

Status line (rule R6): it travels with every mention of CXU. Copy it as written.

Next milestone 510(k) premarket notification, lead wound-care candidate Planned Q1 2027 Source: Conexeu Knowledge System, Aug 22

Research

PubMed E-utilities, read Nov 12, 2026. Newest papers per query, linked to PubMed. 6 papers carry a date after the read: PubMed lists the journal issue date, which can be ahead of online publication.

ECM in regenerative aesthetics

139 12 months241 3 years (extracellular matrix[tiab] OR collagen scaffold[tiab]) AND (aesthetic*[tiab] OR facial[tiab] OR soft tissue augmentation[tiab])

Flowable collagen in wound care

164 12 months337 3 years (flowable[tiab] OR injectable[tiab] OR thermosensitive[tiab]) AND collagen[tiab] AND wound*[tiab]

GLP-1 and facial soft tissue

74 12 months98 3 years (semaglutide[tiab] OR tirzepatide[tiab] OR GLP-1[tiab]) AND (facial[tiab] OR skin laxity[tiab] OR soft tissue[tiab])

Clinical studies

ClinicalTrials.gov API v2, read Nov 12, 2026. Registered studies matching each query, most recently updated first. A match on the query is not a judgement that the study is comparable.

Flowable and injectable wound matrices

160 studies registered flowable wound matrix OR injectable collagen wound

ECM and collagen fillers in aesthetics

78 studies registered collagen filler OR biostimulator OR extracellular matrix aesthetic

Regenerative breast reconstruction

14 studies registered breast reconstruction regenerative OR bioprinted breast

FDA 510(k) decisions for comparable devices

openFDA device API, read Nov 12, 2026. Collagen wound dressings and flowable matrices: 11 decisions in 3 years. CXU itself has no FDA decision: see the status above.

Collagen Wound Powder K260596 · 510(k) · last 6 months Ventris Medical Jul 2, 2026 Substantially Equivalent KGN
Roosin Collagen Dressing K253974 · 510(k) · last 6 months Roosin Medical Co., Ltd. Jun 3, 2026 Substantially Equivalent KGN
Promogran Prisma™ Collagen Matrix with ORC and Silver K251999 · 510(k) Solventum Germany GmbH Mar 13, 2026 Substantially Equivalent FRO
SurgiAid Collagen Wound Dressing (HA) K242100 · 510(k) Maxigen Biotech, Inc. Oct 16, 2025 Substantially Equivalent KGN
Collagen Wound Dressing K252001 · 510(k) Winner Medical Co., Ltd. Oct 10, 2025 Substantially Equivalent KGN
Bovine Dermis Collagen Dermal Matrix K243071 · 510(k) Collagen Matrix, Inc. Dec 19, 2024 Substantially Equivalent KGN
LUOFUCON® Silver Collagen Dressing K240809 · 510(k) Huizhou Foryou Medical Devices Co., Ltd. Dec 16, 2024 Substantially Equivalent FRO
LUOFUCON® Collagen Particles (Collagen Wound Dressing) K232796 · 510(k) Huizhou Foryou Medical Devices Co., Ltd. Apr 25, 2024 Substantially Equivalent KGN
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix K240424 · 510(k) Collagen Matrix, Inc. Mar 12, 2024 Substantially Equivalent MQV
HealiAid Dental Collagen Wound Dressing K230529 · 510(k) Maxigen Biotech, Inc. Nov 22, 2023 Substantially Equivalent OLR