VenoStent GTM brain
VenoStent is developing a bioabsorbable external vascular wrap intended to improve dialysis access surgery outcomes.
category
Dialysis vascular access devicesmarket profile
- text: AV fistula failure can require repeat procedures and interrupt a patient's dialysis access.
- text: SelfWrap is investigational and the company says it is not available for sale in any country.
- text: SAVE-FistulaS is a randomized, multicenter study evaluating safety and effectiveness of the wrap in new fistula creation.
personas
- title: Vascular access surgeonpains:
- New fistulas may fail to mature or remain usable, requiring repeat interventions.
- A new implant must fit the surgical workflow and show clinical safety and effectiveness.
- title: Dialysis program medical director or nephrologistpains:
- Access failure disrupts treatment and can increase reliance on catheters.
- Patients experience the burden of additional procedures and unreliable access.
- title: Hospital vascular clinical trial investigatorpains:
- Needs eligible patients and a clear protocol for evaluating an investigational device.
- Must monitor safety, fistula usability and follow-up outcomes.
icp
- text: Hospitals and vascular access centers performing fistula creation for chronic kidney disease patients requiring hemodialysis.
- text: US clinical research sites with vascular surgeons and eligible patients who can participate in an investigational AVF trial.
message pillars
- text: Focus first on better renal dialysis access surgery outcomes.
- text: Provide bioabsorbable external vascular support.
- text: Emphasize the patient impact of failed access.
objections
- objection: Can the hospital purchase SelfWrap now?response: No. The company describes it as investigational and not available for sale; discuss trial participation instead.
- objection: Has efficacy been established for our patients?response: The randomized trial is designed to assess safety and effectiveness; review eligibility and results as they become available.
- objection: How does it compare with existing fistula support?response: Evaluate the clinical evidence, material and regulatory status for each alternative; Laminate's VasQ is a permanent external support, unlike the bioabsorbable SelfWrap.
competitors
- name: Laminate Medical Technologieswebsite: https://www.laminatemedical.com/vasq/why: VasQ is an external support for surgically created AV fistulas, with a permanent rather than bioabsorbable design.
- name: Humacytewhy: Develops bioengineered vessels for hemodialysis access, an adjacent alternative approach to creating access rather than a direct wrap equivalent.
influencers
- name: Tim Boireurl: https://www.prnewswire.com/news-releases/venostent-completes-20-million-series-a-with-4-million-investment-from-norwest-venture-partners-302183962.htmlwhy: CEO and co-founder discussing clinical development and financing.
keywords
- dialysis access failure
- arteriovenous fistula maturation
- vascular access support device
- bioabsorbable vascular wrap
- hemodialysis access clinical trial
- fistula patency improvement
voice
- Clinical and evidence-oriented
- Patient-centered
- Measured about investigational status
signals
- text: A vascular center is researching fistula maturation or AV access patency.
- text: A dialysis program seeks to reduce repeat interventions after access failure.
pricing
model: unknown
motion
unknownchannels
- clinical trials
- clinical publications
confidence
mediumFounders
- name: Tim Boiretitle: Founderrole: Founderbio: President and CEO of VenoStent, Inc. I developed these novel smart polymeric biomaterials for vascular applications during my PhD at Vanderbilt University. Focus of the technology shifted to hemodialysis access applications after participating in the 2014 NSF I-Corps program. BS, Chemical & Biological Engineering and Biotechnology, Tufts University, 2008; PhD, Biomedical Engineering, Vanderbilt University, 2017. Worked in R&D at Genzyme Corporation, 2008 - 2011. Grew up in Nashua, NH.
- name: Geoffrey Luckstitle: Founderrole: Founderbio: Co-founder & COO of pivotal trial-stage therapeutic medical device company developing bioabsorbable wraps to improve vascular surgery. Vandy MBA, UPenn Masters of Bioethics, UW-Madison UG Interested in tech and culture. Reading: the classics, religion, economics, finance, politics, philosophy, history, social sciences, etc. Born mellow and everywhere harshed.