BioGlue revenues were a record $36.5 million for the first nine months of 2008, compared to $32.4 million in the first nine months of 2007, an increase of 13%. This increase was primarily due to the aggregate impact of a favorable product mix, and a 4% increase in the number of BioGlue milliliters shipped, which increased revenues by 10%, and an increase in average selling prices, which increased revenues by 3%..........Other medical device revenues in the third quarter and nine months of 2008 included $549,000 and $726,000 in sales of Hemostase MPH, which we began distributing in May of this year.........
During the quarter we were awarded another grant of $848,000, of which $212,000 has been received from the Department of Defense for our continued development of our BioFoam surgical matrix product. Our CE mark application for BioFoam is targeted to be submitted to our European notified body in December. We would expect that we would receive approval for the BioFoam CE mark in April of ’09.
Our plans are to launch this product throughout Europe beginning in the second quarter of 2009. After CE approval, we plan to conduct several post-approval studies to evaluate BioFoam in liver resections. These will be conducted at three European clinics, with approximately 15 patients per clinic.
For approval in the United States, we will need to submit an IDE application and conduct a clinical trial. We are currently targeting a December submission for the BioFoam IDE. The U.S. human study indication will be as an adjunct to control bleeding following liver resection surgery. We will initially be requesting a pilot clinical study at one or two centers, in 10 to 20 patients. We would expect our follow on pivotal U.S. study to include up to 200 patients. We estimate that it will take about two years to complete the pilot and pivotal studies in the United States.........
Our plans are to launch this product throughout Europe beginning in the second quarter of 2009. After CE approval, we plan to conduct several post-approval studies to evaluate BioFoam in liver resections. These will be conducted at three European clinics, with approximately 15 patients per clinic.
For approval in the United States, we will need to submit an IDE application and conduct a clinical trial. We are currently targeting a December submission for the BioFoam IDE. The U.S. human study indication will be as an adjunct to control bleeding following liver resection surgery. We will initially be requesting a pilot clinical study at one or two centers, in 10 to 20 patients. We would expect our follow on pivotal U.S. study to include up to 200 patients. We estimate that it will take about two years to complete the pilot and pivotal studies in the United States.........
Other medical device revenues, which consist primarily of sales of Hemostase MPH, are expected to be between $4.5 and $5.5 million in 2009. Product and tissue processing revenues could be affected by several factors, including but not limited to, the general economic environment, and its effect on demand for the company’s products and processed tissues, and changes in foreign currency exchange rates, and their effects on revenues generated in international markets. Again, this guidance assumes foreign currency exchange rates stay near current levels...............
And from the Q & A.
Greg Brash - Sidoti & Company
Okay, and is the -- just one last question, is the Hemostase MPH, is that tracking your expectations? Are you pleased with how the product is selling and the physician feedback?
Ashley Lee
Yes, we are, we’re getting a lot of attraction with that product, and we think it’s also very complimentary to BioGlue, and we think that it’s had some impact on the BioGlue sales increases.
Greg Brash - Sidoti & Company
Okay, I mean do you think doctors are pretty brand-loyal on this market? Obviously, you’re doing pretty well, and you’re still initial launch year, but are they pretty open to trying the product?
Ashley Lee
They are open to trying the product. When you see it work, it’s a very impressive visual reaction, because it works instantaneously so I think from that stand and it’s effective, so I think that it will continue to grow.
Greg Brash - Sidoti & Company
Okay, thanks guys.
Okay, and is the -- just one last question, is the Hemostase MPH, is that tracking your expectations? Are you pleased with how the product is selling and the physician feedback?
Ashley Lee
Yes, we are, we’re getting a lot of attraction with that product, and we think it’s also very complimentary to BioGlue, and we think that it’s had some impact on the BioGlue sales increases.
Greg Brash - Sidoti & Company
Okay, I mean do you think doctors are pretty brand-loyal on this market? Obviously, you’re doing pretty well, and you’re still initial launch year, but are they pretty open to trying the product?
Ashley Lee
They are open to trying the product. When you see it work, it’s a very impressive visual reaction, because it works instantaneously so I think from that stand and it’s effective, so I think that it will continue to grow.
Greg Brash - Sidoti & Company
Okay, thanks guys.
Source: seekingalpha
