Orthovita Q1 2010 - Edited

Our biosurgery sales increased 12% during the first quarter of 2010, compared to the first quarter of 2009. Biosurgery offers an important strategic entry to hospitals where our Hemostats product have many application and new sales representatives benefit particularly from this product line as they seek to gain access to new accounts......

Graham Tenneco

What is the direction or do you think drift going to be or trends based on the Obama's healthcare plan and what might meaningful procedures and where an ASP basically?

Tony Koblish

We can't know all of that what's going to happen. However, I think the concept of evidence-based medicine and clinical data and clinical value proposition to the patients; I believe is going to be more and more important as we go forward. I think that we are exceptionally well positioned across all of our product platforms for that day, not just with Cortoss, which happens to have superb therapeutic benefit, value proposition to the patient, subsequent fracture benefit to the patient also reduced healthcare expenditure and re-hospitalization as shown in our clinical data, but we have an excellent proposition around the Vitoss business relative to more expensive therapies in bone grafting and our Vitagel business is also plays to demonstrate some effected clinical data around knee replacements etcetera. So, I think we are very well positioned in terms of comparative effectiveness, clinical data value proposition that one trend that’s not going to go away and I think that’s going to just be the price to play going forward. We are not going to get there all at once, but it’s going to happen and so I think cost effective, clinical value proposition we are very well situated for that eventuality, which is I think going to be the major fallout long-term.

Source: Seekingalpha

Quick-Close® Vascular Suturing System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Quick-Close® Vascular Suturing System
PMA Applicant: Interventional Therapies, LLC
Address: 1 Gorham Island, Westport, CT 06880
Approval Date: April 8, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080029a.pdf

What is it? The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The Suture Applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester [Novafil] ™) fitted with stainless steel rings. The Cinch Applier has a syringe-type shape with an extended handle.

How does it work? The Suture Applier is used to gain access to the puncture site of the femoral artery. Using manual control, and relying on the sense of touch, the device is used to place one end of the suture through one edge of the arterial wound. The Suture Applier is then re-positioned and the other end of the suture is inserted through the opposite edge of the wound site. As the Suture Applier is withdrawn from the wound site, the 24 inch length of suture is forced out of its housing. The Suture Applier places a single stitch of a non-absorbable, single thread suture to the wound site. The Cinch Applier gathers the two ends of the suture and then it places a stainless steel ring that acts in place of a knot to secure the suture in a closed position to stop the bleeding.

When is it used? The Quick Close Vascular Suturing System is used to close a puncture in the femoral artery following surgery. It is designed for use in small vascular punctures in blood vessels with diameters of 4 mm or larger.

What will it accomplish? The Quick-Close Vascular Suturing System is an alternative to applying manual pressure (compression) to stop bleeding. It allows patients to become mobile sooner than is possible with standard compression methods.

When should it not be used? There are no known contraindications for this device.