IN3 Investors Conference Paris
Presented today at IN3 Investors Conference in Paris on behalf of Cardiatis. I’ve got to admit, Cardiatis platform technology really rocks. Noureddine Frid, the lead entrepreneur and inventor has devevlop the first universally applicable endovascular aneurysm repair stent and the concept is testing well in clinical trials.
The presentation was simple this time, I covered the 5,000 year history of aneurysm repair in a couple of slides, explained how Cardiatis platform technology differs from current existing endovascular devices for aneurysm repair and then gave the coupe de grace:
“It is sufficient to say that in the field of aneurysm treatment Cardiatis is making history. We have a new answer to endovascular aneurysm repair and it is simple, it is elegant and it works.“
Quite an interest we generated among attending VCs and the industry brass. The Hilton was ok and Paris lovely as always.
Balt Neuroendovascular Business
Balt, a French privately held company specialized in the manufacture and distribution of intracerebral micro catheters, realized over US$17 million in revenue for 2007 mainly in the neuro-endovascular field.
Balt range of products include the LEO nitinol self expandable stent launched in 2003 for intra cranial indications, the VASCO braided microcatheter, the BOA balloon expandable Platinum Stent launched in 2000 for peripheral and intra cranial angioplasties, the Channel balloon expandable Platinum Stent for cerebral stenosis, the CORAIL balloon tipped guiding catheter and the CATCH thrombus retrieval system.
Balt has recently launched the Silk, a nitinol braided self expandable stent for cerebral aneurysm repair resorption, in Europe and on international markets.
XTENT’s Drug Eluting Stents Business
XTENT, a Menlo Park California medical device company, is focused on developing and commercializing customizable drug eluting stent systems for the treatment of coronary artery disease, the XTENT Custom NX DES Systems.
According to the company, XTENT Custom NX DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device. Devices are still in development and have not been approved for sale by any regulatory authority.
For the year ended December 2007, XTENT reported a net loss of $39 million, compared to $25 million for the same period in 2006.
During 2007 XTENT reported additional positive clinical data from its CUSTOM I and CUSTOM II trials, and completed enrollment in our CUSTOM III clinical trial. Gregory Casciaro, XTENT’s President and CEO, expects the company to receive CE Mark approval and to commercially launch its device in Europe in the second half of 2008.
XTENT is currently responding to the questions that it received from the Food and Drug Administration regarding its IDE submission and expect to commence enrollment in a U.S. clinical trial later this year.
Highlights of XTENT achievements in 2007 include:
- Raising over $68 million and completion of an initial public offering (IPO).
- Presenting positive six-month follow-up data from the CUSTOM II clinical trial, which assessed the safety and efficacy of Custom NX drug-eluting stent (DES) system for the treatment of long and multiple lesions in patients with coronary artery disease, at a late-breaking session at the EuroPCR meeting in May 2007.
- Presenting positive two-year follow-up data from the CUSTOM I clinical trial and positive one-year follow-up data from the CUSTOM II clinical trial, both at TCT in October 2007.
- Completing enrollment of the CUSTOM III clinical trial.
- Introducing design enhancements to the Custom NX DES system to allow for greater ease-of-use by clinicians.
- Submitting an IDE application to the FDA to initiate its CUSTOM IV clinical trial
- Submitting the design dossier for CE Mark.
- Expanding its Menlo Park, California facilities to prepare for manufacturing ramp-up.
Research and development expenses in 2007 totaled $31 million, compared to $19 million in 2006. General and administrative expenses for the year ended December 31, 2007, totaled $11.3 million, compared to $7.3 million for the same period in 2006.
XTENT ended the year 2007 with cash and cash equivalents of $58 million and expects to have operating expenses in the range of $25 to $30 million during the first half of 2008.