Court Enters Order Under Which Vascular Solutions Will Cease Manufacture, Sales and Distribution of R-Band

SOMERSET, N.J., May 21, 2013 /PRNewswire/ -- Terumo Medical Corporation (Terumo), today announced that it was pleased with the U.S. District Court for the District of New Jersey's Order approving an agreement of the parties under which Vascular Solutions Inc. will cease further manufacture, sales, and distribution of its R-Band™ Radial Hemostasis Device, pending litigation of Terumo's claims.

In February, Terumo filed a patent infringement lawsuit alleging that the R Band™ Radial Hemostasis Device infringes on U.S. patent and trademark rights held by Terumo Medical Corporation for its proprietary TR Band™ Radial Compression Device. The R-Band is distributed in the U.S. by Vascular Solutions and manufactured by Lepu Medical Technology. Terumo sought an injunction against further sales of the infringing product.

"Terumo is extremely gratified with the Court's Order. We are thankful for the opportunity to successfully defend our TR Band™ device, which is a critical part of our transradial solutions portfolio," said James Rushworth, President, Terumo Interventional Systems and Onset Medical Corporation. "As a market leader, Terumo is committed to doing what is right for our business and, when appropriate, we will vigorously protect our investments, assets and intellectual property."

Terumo's market-leading TR Band™ Radial Compression Device is used to achieve patent hemostasis immediately following a transradial access diagnostic and intervention in the treatment of cardiac and vascular disease. The clear band is placed around the patient's wrist to effectively stop access-point bleeding. The TR Band™ features dual compression balloons that maintain precise pressure on the radial artery to ensure blood return without compromising local nerve structure. Transradial access interventions have been shown to significantly reduce bleeding complications by up to 75 percent when compared to femoral (through the groin) interventions.

Vascular Solutions Reports Q4

Net sales of hemostat products (mainly consisting of D-Stat(R) Dry, D-Stat Flowable, and D-Stat Radial) were $5.5 million, down 6% from the year-ago fourth quarter and a 4% decline from the September quarter level. "The hemostatic patch market remains intensely competitive and price sensitive," Mr. Root said. "In mid-2011, we launched the new Silver versions of our D-Stat Dry and Thrombix(R) products, which add an antimicrobial agent. We believe these new products will help us maintain our market-leading position in the hemostat patch market in 2012."
Vascular Solutions will host a live webcast starting at 3:30 p.m., Central Time today to discuss the information contained in this press release. The live webcast may be accessed on the investor relations portion of the company's web site at www.vasc.com . An audio replay of the call will be available until Wednesday, February 8, 2012, by dialing             1-888-203-1112       and entering conference ID# 3945548. A recording of the call will also be archived on the Company's web site, www.vasc.com until Wednesday, February 8, 2012. During the conference call the Company may answer one or more questions concerning business and financial developments and trends, the Company's view on earnings forecasts and new product development and financial matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.

Vascular Solutions Q3 2011

Net sales of hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable and D-Stat Radial products) were $5.7 million in the third quarter, a decrease of 6% from the third quarter of 2010 and a decrease of 4% from the second quarter of 2011. "The hemostatic patch market has become even more price competitive. At the very end of the second quarter we launched our new Silver versions of the D-Stat Dry and Thrombix(R) products, which add an antimicrobial ingredient to the patches while leaving our pricing unchanged. We continue to expect these Silver versions to allow us to at least maintain our market-leading position in the hemostat patch market into 2012," Mr. Root said.

As previously disclosed, King Pharmaceuticals, Inc. notified Vascular Solutions on July 6, 2011, that it was electing to not proceed further with efforts to obtain a surgical use indication from the FDA for the company's Thrombi-Gel products and to not complete development of the company's Thrombi-Paste products. As a result, Vascular Solutions recognized an additional $2.6 million of license revenue during the third quarter of 2011 as the remaining deferred license revenue originally allocated to the Thrombi-Paste products and the surgical use indication of the Thrombi-Gel products as part of the agreements entered into with King in 2007. Starting in the fourth quarter of 2011, amortization of deferred revenue is expected to be $87,000 per quarter.


Hemostat Products: It appears that revenues will continue to be flat or declining in Vascular Solution’s hemostat product lines. Management cited competitive pricing pressure for Vascular Solution’s D-Stat Dry product. However, the company could see upside if Marine Polymer’s injunction against competitor HemCon is enforced. Marine Polymer was awarded an injunction in September but Hemcon was subsequently given a stay. The injunction would prevent HemCon from selling such products as the HemCon Bandage and the Chitoflex and Dental Dressings. Vascular Solutions management did say that launches of Silver versions of the D-Stat Dry and Thrombix products, which include a new antimicrobial ingredient, would enable the company to maintain hemostat market share.

Vascular Solutions Acquires Zerusa For US$4.3 Mln

(RTTNews) - Medical devices company Vascular Solutions, Inc. (VASC: News ) said Thursday it has acquired the assets of Zerusa Limited for 3.15 million euros or US$4.3 million. The deal allows the company to have sole control for the sale of Guardian hemostasis valves in the U.S. and abroad.
As per the terms, Vascular will pay 2.85 million euros or US$3.9 million at closing and 0.3 million euros or US$0.4 million six months after closing.
Vascular said the acquisition will be accounted for as a business combination in the first quarter of 2011. The company expects the deal to be accretive to earnings by about $0.01 per share in 2011, with insubstantial transition and integration costs incurred in the first quarter of 2011.
Zerusa is an Ireland based medical device company, which makes Guardian hemostasis valves that are are designed to maintain hemostasis during interventional catheterization procedures.
Vascular Solutions has been selling the Guardian hemostasis valves in the U.S. under an exclusive distribution relationship with Zerusa since 2007.
In 2010, worldwide sales of the Guardian hemostasis valves were $1.7 million, consisting of $1.3 million in sales

Vascular Solutions Announces Record Third Quarter Results. Edited

Vascular Solutions, Inc. (Nasdaq: VASC) today reported financial results for the third quarter ended September 30, 2010. Highlights of the third quarter include:
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....

Vascular Solutions Wins Appeal In Disparagement Litigation With Marine Polymer; To Accept $3.2 Mln In Damages

Monday, medical device company Vascular Solutions, Inc. (VASC:News ) said that the First Circuit of the U.S. Court of Appeals has affirmed the earlier judgment in its favor in its product disparagement litigation with Marine Polymer Technologies and $2.7 million in damages to be paid to Vascular.
In the two-week trial in April 2008, the jury has issued a permanent injunction prohibiting Marine Polymer from making disparaging statements concerning the safety of Vascular Solutions' D-Stat hemostat products. The jury had also awarded $4.5 million in damages to Vascular Solutions and found five statements made by Marine Polymer regarding Vascular Solutions' D-Stat products false.
The Appeals Court,however, has determined that due to differences in opinion among the judges Vascular may either accept a $2.7 million award of damages, plus interest, or insist upon a new trial limited to the issue of determining the reasonable amount of damages.
Adding interest at the statutory rate, Vascular said that it calculates the $2.7 million award to currently total approximately $3.2 million. Today's appellate decision is subject to Marine Polymer Technologies' ability to petition for rehearing by the First Circuit and appeal to the U.S. Supreme Court. The permanent injunction issued against Marine Polymer at the conclusion of the earlier trial will remain in effect.
Independently, the Appeals Court found that the evidence "provides ample proof of malice. And the most inflammatory of the five statements, and the most glaringly unsupported, are the two that associated D-Stat Dry with specific and serious outcomes in percentages that would be remarkable for a relatively straightforward medical task -- to stop bleeding at a modest-size doctor-created incision."
Howard Root, CEO, Vascular Solutions, said, "In order to conclude this litigation, we intend to accept the $2.7 million award of damages, plus interest, and to forgo the cost and distraction of an additional trial on damages. We expect the final steps in this litigation to be concluded during the first half of 2010, and the approximately $3.2 million in damages and interest to be collected by Vascular Solutions without substantial additional expense."
VASC is currently trading at $8.40, down $0.05 or 0.59, on the Nasdaq.

Vascular Solutions - Q3 Edited

Our highest sales product category in the third quarter was our hemostat products with $6.4 million in net revenue, a 10% increase from the third quarter of 2008. With the second quarter exit of one of our competitors in the hemostatic patch market, in the third quarter we were able to drive continued growth of our D-Stat Dry and Thrombix patches.
We also increased sales of our new Wrap version of the Dry, which is configured to be placed around, in-dwelling lines of catheters. In the third quarter, we recorded $153,000 in sales of ThrombiGel and Thrombi-Pad to King Pharmaceuticals under our distribution agreement, a quarterly level that we expect roughly to continue until we receive approval for the surgical indication for the ThrombiGel product.
In July, we completed the enrollment of the final patient in our ThrombiGel surgical clinical study and we have now completed the necessary 60 day follow up and expect to analyze the data and submit our PMA to the FDA by the end of December. We believe that this surgical indication will greatly expand King’s ability to sell our ThrombiGel into their targeted surgical markets, which based on current FDA review times. We are projecting to receive by the end of 2010.
In the fourth quarter, we also expect to launch the new Rad-Band, a low cost compression device for use following radial artery catheterizations, which has already received FDA clearance and also an improved version of our original D-Stat Radial. We are completing the build of launch quantities of our new Hunter biopsy marker device.
However, due to an FDA comment letter on our 510(k) submission in the third quarter, we will now need to submit additional information, which will push the launch of this device, the Hunter product, into 2010. Related to our hemostat products, we continue to await the appellate decision on our $4.5 million jury verdict for defamation against Marine Polymer Technologies, which has now been increased with interest to $5.2 million.
The oral argument was heard by the first circuit of the US Court of Appeals in Boston on February 4. Once the appeals court issues its decision, the only remaining steps would be a possible petition for rehearing by the entire panel of the first circuit and a potential writ of appeal to the U.S. Supreme Court. Only after all the appeals are exhausted will we record any resulting gain in our projections of net income or cash flow.
We continue to be highly confident in a favorable decision on the entire award, including interest, but given the delay by the appeals court, we do not expect to receive the judgment, if affirmed, until 2010.
In the third quarter, we also increased sales of Zerusa’s Guardian hemostatic valve by 15% sequentially over the second quarter. In October, the FDA cleared Zerusa’s 510(k) application for the new Guardian II version that we expect to launch next week. We believe that this new Guardian II version, particularly when combined with the Flamingo inflation device that we distribute for Pursue Medical, will substantially increase sales of access products in 2010.

Chris Cooley - FTN Equity Capital Markets
Just two quick follow-ups, James, maybe could you remind us what you kind of view the maintenance CapEx run rate going forward, as we think about 2010 and beyond? Then, secondly, when you just look at your hemostatic products, we’ve seen some of the larger coronary players report softness in that market in terms of PCI volumes, and also seen some pricing. Kind of can you walk us through, maybe either Howard or James, what’s baked into your assumptions for the market and pricing, as we think about the hemostatic space between now and calendar year end?

James Hennen
I’ll start with the CapEx question. We’ve been running the last three years at about $1 million a year in CapEx, but going into 2010, we may in which making some margin improvements and bringing some things in-house as far as more manufacturing capabilities. So we haven’t given guidance on 2010, but it may be more than that general $1 million, maybe $1.5 million type range, so nothing a substantially increase over $1 million run rate. So that’s where we expect it to be.

Howard Root
In terms of the market, in PCI volumes I mean I’ve been aware of the big companies in our space, with Saint Jude and Boston Scientific yesterday and their comments. The nice thing about our business strategy is we’re not dependent on market growth in order for us to be successful.
So, playing in the clinical niches, which sometimes we got abused for saying that we’re a small product company, now it’s really a plus, because we can go out there and develop new things, which aren’t material increases and most of the times actually decreases in the budget and even if the number of procedures don’t go up, they just shift to the next technology and being a clinically differentiated company plays well there.
In terms of pricing, we always focus on that being flat, but we don’t have price increases. In the patch market, I think we have bought a couple of new product launches a year or two ago or new product free samples a year ago and I think we’ve won that game. We’ve got the clinical data on our side.
We can show the benefit of our product and we’ve got approved indications, which a lot of these patches just don’t have. So I think you’ve seen in the last two quarters resumption on that area and I think keeping a steady price, not falling victim to the low cost patches that don’t have the data, has done us well.
In terms of long-term market, I am still optimistic about our strategy and I’m optimistic about the healthcare system. I need to get a little bit of certainty in terms of the healthcare reform and what’s going to go on as a general matter, a global matter, but as far as it affects Vascular Solutions that really like this space we are in because in a turbulent world, certainly start ups are going to have a hard time with it, anyone trying to replicate what we’re doing is going to have a hard time doing it and the big companies are having a hard time to find growth.
So we are in the perfect middle ground where we can still grow double digits with products that don’t demand an increase in the market and we have a wide-ranging international market open to us that we can expand into 2010 and beyond as well. I pay attention to what’s going on in the market, but it doesn’t affect us day-to-day, and I’m glad we are in that space because it’s not all roses out there for the overall healthcare system in the U.S.

source: seekingalpha

Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve

MINNEAPOLIS and GALWAY, Ireland, Oct. 12, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) and Zerusa Limited today announced that they have received 510(k) clearance with the FDA for the sale of the Guardian(r) II Next Generation hemostasis valve in the United States. Under the terms of an agreement between the two companies from July 2007, Vascular Solutions is the exclusive distributor of the Guardian device in the United States. Zerusa recently began the rollout of its CE marked Guardian II launch through its distribution network in Europe, the Middle East and other markets. Howard Root, Chief Executive Officer of Vascular Solutions, commented: "We're delighted to be able to offer this next generation of the Guardian hemostasis valve to our customers through our 85+ employee direct U.S. sales force. The device enhancements contained in this new device are well suited to our U.S. customers, and we're looking forward to making an expanded impact with this product in the marketplace." Liam Mulloy, Chief Executive Officer of Zerusa Limited, commented: "We appreciate all the market feedback both from Vascular Solutions and our other partners to date. This has directly led to device enhancements on our Guardian II hemostasis valve - while maintaining the key benefits appreciated by our customers worldwide such as blood loss minimization, management of multiple devices and ease of use. We look forward to building on our relationship with Vascular Solutions to further develop the U.S. market opportunity."

Guardian II - Unique Seal Technology (Click image to enlarge).

Provides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.
Allows separation of guidewires and other devices during complex procedures.
Click-open and Click-close Design
Allows single handed operation
Unique proximal cap is easily depressed for both opening and closing the lumen.
Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases.

Ergonomic Design

Practical design allows the Guardian to fit comfortably in a physician’s hand.
Subtle finger tabs have been added for improved handling characteristics.
Actual device length 92mm.
8 French Lumen
Allows multiple or large therapeutic devices to be inserted during procedures.
Secure Device Lock
Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.

Vascular Solutions - UBS Global Life Sciences Conference

Vascular Solutions and Orthovita to present at UBS Global Life Sciences Conference

MINNEAPOLIS, Sept. 15, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 2009 UBS Global Life Sciences Conference in New York City on Tuesday, September 22, 2009 at 8:00am (EDT). Howard Root, Chief Executive Officer of Vascular Solutions, will deliver the Company's presentation. To hear the live audio webcast and view the slides of the Vascular Solutions' presentation, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

MALVERN, Pa.--(Business Wire)-- Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, September 21st, at 1:00 p.m. Eastern Time, at the Grand Hyatt New York, 109 East 42nd Street at Grand Central Terminal, New York, New York. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=67_MRUUVNQ.

Hemostat IFU and Brochure Downloads

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Vascular Solutions - Q2

Net revenue from hemostat products (primarily consisting of the D-Stat(r) Dry, D-Stat Flowable and D-Stat Radial products) was $6.4 million during the second quarter, an increase of 6% over the second quarter of 2008. "The two principal reasons for our sales growth in hemostat products were the exit of a competitor's patch product from the market and the growing sales of our new 'Wrap' version of the D-Stat Dry," commented CEO Mr. Root.

Vascular Solutions to Participate in Jefferies 3rd Annual Healthcare Conference

Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to participate in the Jefferies 3rd Annual Healthcare Conference being held this week in New York City. Howard Root, Chief Executive Officer of Vascular Solutions, will present on Wednesday, June 17th at 4:15pm (EDT). To hear the live audio webcast of the panel discussion, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

Vascular Solutions Announces First Quarter Results; Net Revenue Increases 12% to $15.8 Million; Net Income Increases 300% to $0.06 Per Share

MINNEAPOLIS, April 16, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today reported financial results for the first quarter ended March 31, 2009........  While our net revenue increased by 12% over the first quarter of 2008, it was approximately $700,000 below our expectations. The primary reason for the revenue shortfall was the decision by our partner King Pharmaceuticals to suspend the clinical development of our Thrombi-Paste(tm) product, solely due to economic reasons...............

Net revenue from hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable, Thrombi-Gel(r), Thrombi-Pad(r) and D-Stat Radial products) was $5.8 million during the first quarter, essentially even compared to the first quarter of 2008. "The hemostatic patch market continues to be very competitive, but with the imminent exit of a major competitor and the launch of our new D-Stat Dry Wrap version in the first quarter, we believe that we will continue to hold and increase our market-leading position in this market," commented Mr. Root. Vascular Solutions will host a live webcast starting at 3:30 p.m., Central Time today to discuss the information contained in this press release. The live web cast may be accessed on the investor relations portion of the company's web site at www.vascularsolutions.com. An audio replay of the call will be available until Thursday, April 23, 2009 by dialing 1-888-203-1112 and entering conference ID# 8256754. A recording of the call will also be archived on the Company's web site, www.vascularsolutions.com until Thursday, April 23, 2009. During the conference call the Company may answer one or more questions concerning business and financial developments and trends, the Company's view on earnings forecasts and new product development and financial matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.

Vascular Solutions - Edited 10k

Thrombin qualification project expenses were $-0- for the year ended December 31, 2008 compared to $147,000 for the year ended December 31, 2007. On October 18, 2004, we entered into a supply agreement with Sigma-Aldrich Fine Chemicals, an operating division of Sigma-Aldrich, Inc. (Sigma) for the supply of thrombin to us. Pursuant to the terms of the agreement, we have paid for certain development costs of Sigma to allow Sigma to produce thrombin for our use. The initial contract term ends after 10 years and is automatically extended for up to five additional successive one year terms unless one party delivers notice of termination at least one year prior to the scheduled termination of the agreement. During the term of the agreement, Sigma has agreed not to sell thrombin of the type developed for us under the agreement in or as a component of a hemostatic product for medical use. We do not have any minimum purchase requirements under the agreement; however, if we purchase less than three lots of thrombin in any year then (1) Sigma will be released from its agreement not to sell thrombin in or as a component of a hemostatic product for medical use, and (2) Sigma will have the right to terminate the agreement upon 30 days notice.
The Sigma contract was part of our plan to fully qualify a second source of thrombin (in addition to the Thrombin-JMI(R) Supply Agreement discussed in "Agreements with King Pharmaceuticals, Inc." above) and to bring the new thrombin through the regulatory process to be used in our hemostatic products. We have purchased $2.7 million of thrombin from Sigma, of which we have expensed approximately $0.4 million in our development work and used approximately $0.3 million in product manufacturing. We received regulatory approval in the first quarter of 2008 allowing us to use the Sigma thrombin in our international hemostat products. A $0.7 million expense was incurred in the fourth quarter of 2008 relating to a reserve recorded against our existing supply of Sigma thrombin due to the uncertainty of whether this amount of thrombin will be utilized prior to expiration of its shelf life. The remaining Sigma thrombin balance of $1.3 million at December 31, 2008 is expected to be used in our hemostat products sold in international markets before expiration of its shelf life.
As described in "Agreements with King Pharmaceuticals, Inc." above, in January 2007 we entered into the Thrombin-JMI(R) Supply Agreement in the United States with King with a price fixed throughout the 10 year term, adjusted for a producer price index tied to pharmaceuticals. The thrombin price under the agreement is confidential information; however, the price reflects a 25% discount to the price we paid in the last year of our previous thrombin supply agreement with King. The Thrombin-JMI(R) Supply Agreement does not terminate or affect our ability to complete the qualification of our own second thrombin source; however, with the near-term economic need to qualify a second source eliminated, we will be able to evaluate and plan our continuing expenses and steps on this project. We do not expect to incur any significant thrombin qualification expenses in 2009.

Vascular Solutions Ranked as One of the 500 Fastest Growing Technology Companies in North America

Vascular Solutions, Inc. today announced that it has once again been included on the 2008 Deloitte Technology Fast 500, a ranking of the 500 fastest growing technology companies in North America. Rankings are based on percentage revenue growth over five years, from 2003-2007.
Vascular Solutions' CEO, Howard Root, commented: "This is the fifth year that we have been ranked as one of the 500 fastest growing technology companies in North America, which is a testament to the continued dedication and hard work of our employees. It is especially pleasing to be able to achieve our 346% revenue growth over the past five years through advancing our mission of delivering excellence in vascular devices. We are honored to be one of just three Minnesota companies on the Deloitte's Technology Fast 500 list for 2008."

Excerpt Vascular Solutions Inc. Q3 2008

.........Our highest sales product category in the third quarter was our hemostat products, with $5.8 million in net revenue in the third quarter, a decrease of 4% from the third quarter of 2007. The three causes for the decline were the continued reduction in sales of our Duett sealing device, which is our legacy product that we have chosen to not actively promote, the as-planned conversion from hospital pricing to distributor pricing in Germany as a result of the switch to a distributor sales model, and the decline in sales to King Pharmaceuticals.
In the third quarter of 2008, King purchased $90,000 of Thrombi-Gel and Thrombi-Pad, with an additional order planned but delayed by us until the fourth quarter due to our recently completed facility expansion. We recently -- we expect King purchases to continue at the current level until we receive FDA approval for the surgical indication for the Thrombi-Gel product, which we currently target for the end of 2009.
D-Stat Dry sales were essentially constant on a sequential quarter basis, as we have maintained our leading market share in the face of intense price competition from the non-thrombin patches.

Vascular Solutions Announce Hemostasis Products Highest Earner Q2

Reporting on Q2 results Vascular Solutions, CEO Howard Root today announced "Our highest sales product category in the second quarter was our hemostat products, with $6 million in net revenue in the second quarter, a decrease of 11% from the second quarter of 2007, but an increase of 2% over the first quarter of 2008.
In the second quarter of 2007, our partner King Pharmaceuticals placed a $725,000 stocking order for their initial launch of the ThrombiGel and ThrombiPad products, which is the primary reason for the reduction in revenue year-over-year.
In the second quarter of 2008, King purchased $246,000 of ThrombiGel and ThrombiPad, as they continue to ramp their sales into the surgical and trauma markets, consistent with our long-term plans.
To assist in growing D-Stat Dry sales, in the second quarter we initiated new programs with our direct sales force to maintain our focus on the D-Stat Dry, and to expand into new accounts to address the competitive challenges, with good results to date."

Discussing lower International results Howard repeatedly pointed to "lower percentage sales growth in international markets, as a result of the transition from hospital pricing to distributor pricing in Germany in the second quarter. " and the finalising of a series of litigations including "a $4.5 million jury verdict in our trial against Marine Polymer Technologies. Following the verdict, the court has now dismissed all of Marine Polymer's post-trial objections, and has entered judgment, including interest, at $5.1 million. The court also issued a permanent injunction against Marine Polymer's representatives for making slanderous statements about our D-Stat Dry. "

James Hennen CFO discussing Thrombin VSI said "We currently have remaining approximately $400,000 inventory of Thrombin-VSI in vials, and approximately $810,000 in bulk Thrombin. We expect to consume the supply of Thrombin-VSI over the next several years in hemostatic products sold in European markets."

During the Q&A Howard pointed to "aggressive sampling" by competitors in Q4 & Q1 and explained labs tend to use the free product first until they "see that it doesn't work, and then come back to something else."

He further claimed "we are the clear number one patch in the US market, which is the vast majority of that market. When you are number one, it's hard to grow more."

Source: seekingalpha

Vascular Closure - Hemostasis of the femoral artery

Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis. Simple compression – the use of hand pressure, clamps, and/or sandbags – is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patient’s clotting capability to return to a normal state.Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort. Once hemostasis has been achieved, the patient’s leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding.

Vascular Closure Products

Morris Innovative - FISH

St.Jude - Angioseal

Medtronic Inc. - EVS vascular stapling system, Clo-Sur PAD

Covidien - VascuSeal

Abbott - Closure S, Perclose A-T, Perclose ProGlide, Prostar, StarClose, Chitoseal

AccessClosure - Mynx

Cardiva - Boomerang

Medafor - MPatch

Sutura - SuperStitch

Vascular Solutions - Duett, Duett Pro, D-Stat

Radi Medical - FemoStop, RadiStop

Vascular Solutions to Present At FBR 12th Annual Spring Investor Conference

MINNEAPOLIS, May 14, 2008 (PRIME NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at FBR Capital Markets' 12th Annual Spring Investor Conference on Wednesday, May 28, 2008 at 1:35pm (EDT).
Howard Root, Chief Executive Officer of Vascular Solutions, will deliver the Company's presentation. To hear the live audio webcast and view the slides of the Vascular Solutions' presentation, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.