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.

14 Jun 2024
Admin
News Article

Xeltis Receives IDE Approval from FDA for initiation of US Pivotal Trial for aXess™

Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess™, its restorative vascular access conduit

Xeltis

Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.

aXess

aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for hemodialysis vascular access, combining the safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG).
The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.

Xeltis' Implants Platform

Xeltis' groundbreaking implants platform is an important development in vascular replacement technology as, over time, its implants are gradually replaced by the patients' own living healthy tissue.
Xeltis' novel technology has already treated over 100 patients across different clinical trials.

Words from CEO: Xeltis

Eliane Schutte, Chief Executive Officer, Xeltis commented: ""We have already shown outstanding 12-month data from our first-in-human study in Europe and are looking forward to starting this pivotal trial in the US. We are very proud of the potential for aXess to transform the field of vascular access by stopping the cycle of interventions and infections and bringing our unique restorative solution to hemodialysis patients worldwide."

Words from CMO: Xeltis

Paulo Neves, Chief Medical Officer, Xeltis said: ""Our focus is on improving the outcomes for patients on dialysis. aXess offers this potential through its avoidance of the reinterventions and complications associated with other vascular access solutions. This pivotal study is important in assessing and demonstrating this and marks a significant milestone in our clinical strategy in the US.""

The US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to hemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine EU countries.

About Xeltis

Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels.
Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year.
The Company's proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient's own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place.
Xeltis' most advanced product currently under clinical development is aXess™, an implantable blood vessel for hemodialysis vascular access.
Xeltis' groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases.

Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.

About aXess

aXess is a restorative conduit which enables the creation of a new, permanent, living vessel for hemodialysis vascular access.
It combines the safety and patency of a fistula with the speed to treatment of an AV graft.
The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by renal disease patients.

Trial for aXess

A first-in-human trial of aXess demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions.
A pivotal trial of aXess is currently enrolling up to 110 patients in nine EU countries.

Let’s apply Data-Driven Pricing to Your APIs

Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.

Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.

Start using market intelligence today and allow yourself to be in control in the API market.

Check it out today and make more informed sourcing decisions! Learn More!