1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

Amplifi Vascular Hits Three Milestones: FDA IDE Approval, Successful FIH Study, and $6.9M Series A

11 Oct 2025
Admin
News Article

Amplifi Vascular Hits Three Milestones: FDA IDE Approval, Successful FIH Study, and $6.9M Series A

Amplifi Vascular, developer of the first-of-its-kind Vein Dilation System for hemodialysis access, announced three major developments:

Positive First-in-Human (FIH) Study Results
$6.9 Million Series A Financing Close
FDA Investigational Device Exemption (IDE) Approval

First-in-Human Study Highlights

The FIH study enrolled 19 patients to pre-dilate veins before arteriovenous fistula (AVF) surgery. Key outcomes:

Rapid post-procedure vein enlargement
Successful fistula creation
Physiological maturation: ≥5mm diameter and ≥500ml/min flow
Early functional use of AVFs
Safety: No significant device-related adverse events

“Our study not only met its primary objectives but also demonstrated rapid vein enlargement that facilitated successful fistula creation and early use.”

Sean Morris, President & CEO, Amplifi Vascular.

FDA IDE Approval & Next Steps

With FDA IDE approval, Amplifi can initiate AMPLIFI-1, a U.S. clinical investigation evaluating:

Safety and performance
Time to functional maturation compared with standard care

“Early outcomes suggest that proactive vein dilation prior to AVF surgery can significantly improve the likelihood of achieving a usable fistula sooner—an outcome that matters greatly to our dialysis patients.”

Dr. Surendra Shenoy, Washington University, St. Louis School of Medicine.

About Amplifi Vascular

Amplifi Vascular is focused on improving hemodialysis access by enabling reliable, early-maturing forearm AVFs. Its Vein Dilation System delivers controlled, temporary therapy to enlarge target veins prior to surgery, aiming to:

Increase AVF success rates
Reduce catheter dependence and re-interventions
Lower overall costs of care

These milestones position Amplifi Vascular as a promising innovator in the hemodialysis access space, combining clinical validation, regulatory progress, and financial backing to advance patient care.