On February 19, 2026 the clinical trial record for MEC REGENERATE shows a prospective evaluation of an injectable recombinant collagen based device that targets facial laxity, skin quality, volume deficiency in the mid face and wrinkles. The trial is listed as not yet recruiting. Sponsors are 303 Pharma s.r.l. and Nextrasearch S.r.l.s. The record provides a trial link to ClinicalTrials.gov and notes the not yet recruiting status.
In this article we explain what this listing means for clinicians, researchers and regulatory professionals who follow medical device development. The device MEC REGENERATE is described as an injectable collagen based product intended to address mid face laxity, volume deficiency and wrinkles. This is an early stage clinical evaluation and does not imply current patient use. The trial design focuses on safety and performance data collection to inform potential future regulatory submissions.
What is MEC REGENERATE and what is the trial seeking to assess?
The listing describes MEC REGENERATE as an injectable recombinant collagen based product designed to address laxity, skin quality and volume deficiency in the mid face and to reduce wrinkles. The trial is a prospective clinical evaluation intended to assess safety and performance of the device in a controlled setting. This framework aligns with regulatory expectations for device evaluation under issued guidance. The not yet recruiting status indicates that no enrollment has begun at this time. Sponsors are 303 Pharma s.r.l. and Nextrasearch S.r.l.s, and the trial is registered on ClinicalTrials.gov with the identifier NCT07413445.
How is MEC REGENERATE described in this listing?
Device type is an injectable collagen based product. The description signals a treatment intended to improve facial contour in the mid region by addressing volume deficiency and wrinkles. As an early stage clinical evaluation the trial will collect safety data and performance signals related to the device in human subjects when recruitment begins.
External source: ClinicalTrials.gov record for NCT07413445 is available at ClinicalTrials.gov.
Who sponsors the study and what is its current status?
Sponsored by 303 Pharma s.r.l. and Nextrasearch S.r.l.s, the trial is listed as not yet recruiting. This status means there is no active enrollment and the study has not started patient recruitment at this time. Sponsors oversee study design, management and regulatory compliance as described in the listing.
Who are the sponsors and what is their role?
The companies named are involved in the development and oversight of the investigation. Their exact duties in site selection, data collection and reporting are defined by the trial protocol and applicable regulations.
What safety and regulatory considerations apply to this evaluation?
Safety and performance data collection is the core objective of the prospective evaluation. The device is described as a recombinant collagen based injectable product used for mid face indications including laxity and volume deficiency. Under MDR guidance manufacturers must demonstrate safety and performance of new devices before market use. The current listing signals early stage review and does not confer marketing approval or clearance. Clinicians and regulators should monitor trial updates for changes in status and any reported safety signals.
What regulatory notes should clinicians watch?
In line with regulation practice the trial aims to document real world safety signals and performance outcomes to support future filings. Data tends to be used to inform risk management, labeling and potential next steps in regulatory submissions.
What happens next for clinicians and researchers?
If recruitment proceeds the investigators will pursue patient safety and performance measures while ensuring compliance with applicable device regulations. The trial record and sponsor communications will guide clinicians who may consider the product for future studies or expansion into practice settings once regulatory clearance is achieved. Stakeholders should watch for updates on trial status and results.
What should be monitored in the near term?
Key items include enrollment status changes, adverse event reporting patterns and any regulatory submissions linked to the device.
Frequently asked questions
- What is MEC REGENERATE and what is being tested in this trial? The trial aims to assess safety and performance of an injectable recombinant collagen based device for mid face indications. This listing does not claim marketing approval.
- What does not yet recruiting mean for patients and clinicians? It means recruitment has not started yet and the trial status may change. Regulatory oversight remains in place.
- Who are the sponsors and how do they influence the study? Sponsors provide oversight of protocol design and regulatory compliance as described in the listing.
Key takeaways
- The MEC REGENERATE listing describes an injectable recombinant collagen based product intended to address mid face laxity and volume deficiency.
- The trial is not recruiting at this time.
- Sponsors are 303 Pharma s.r.l. and Nextrasearch S.r.l.s.
Professional disclaimer
This information is intended for regulatory and clinical professionals. It is not legal advice and does not replace regulatory filings or guidance from authorities.
Announcement information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07413445?term=medical+device