chmcnfunds
11 years ago
Volcano Corporation : Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at EuroPCR 2013
SAN DIEGO and PARIS, May 23, 2013 /PRNewswire/ --
Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial during the hot line late breaking clinical trial session at EuroPCR 2013. These prospective results confirm prior retrospective publications, and demonstrate the clinical usefulness of an iFR(®)/Fractional Flow Reserve (FFR) Hybrid approach to simplify lesion assessment and to save the use of hyperemic drugs in a significant number of patients. It was also announced that this Hybrid iFR(®)/FFR strategy, along with intravascular ultrasound (IVUS) guidance, will be used in the multi-center SYNTAX2 trial in Europe starting later this year.
"An important step in the validation of any new technology is to identify a hypothesis based on observations, and to then prospectively test the hypothesis in a large number of centers to see if the observations translate to real-world practice," commented Javier Escaned, MD, PhD, Interventional Cardiologist at Hospital Clínico San Carlos, Madrid, Spain. "The ADVISE II study is the first prospective test of the true iFR algorithm that is analyzed through an independent physiology core lab (Cardialysis, Rotterdam, Netherlands). These preliminary results show that the prior observations can be replicated prospectively, and that a Hybrid iFR/FFR approach can provide a greater than 90% agreement with FFR while saving the use of hyperemic agent in more than half of patients."
The ADVISE II findings replicated prior iFR(®) retrospective publications which demonstrated that use of a Hybrid iFR(®)/FFR workflow delivered an overall classification agreement with an FFR in more than 90% of patients participating in the trial, while saving more than 50% of such patients from hyperemic drug administration. In fact, the preliminary analysis showed 91.5% agreement with FFR and 71.5% hyperemic drug savings on a per lesion basis. Patients in ADVISE II were recruited from more than 40 centers in the United States and Europe, and all analysis was performed with operators blinded from the iFR(®) values which were calculated offline at an independent core lab in Rotterdam, Netherlands.
Also presented this week were results from the first 392 real-time cases performed live in the cath lab from more than 20 centers in Europe, Japan and South Africa that are now equipped with the iFR(®) software. These results confirmed the prior results and those of the preliminary ADVISE II findings being presented at EuroPCR.
"After using iFR in real world clinical practice, its simplicity is clearly its strength. In a busy cath lab, saving time is important and the results in my early experience have been consistent and clinically useful," commented Andrew Sharp, MD, Interventional Cardiologist at Royal Devon & Exeter Hospital, Exeter, United Kingdom. "Once real-world operators have the opportunity to use both of these complementary technologies, I think they will be impressed."
Also announced at EuroPCR 2013 was the investigator-led SYNTAX2 study, which will be co-sponsored by Volcano and Boston Scientific Corporation. SYNTAX2 is designed to test precision guided percutaneous coronary intervention (PCI), using a clinical SYNTAX score as derived at Cardialysis in Rotterdam along with live iFR(®)/FFR Hybrid measurements of the vessel to determine which patients and lesions are treated. Boston Scientific SYNERGY(TM) drug-eluting stents will then be placed with IVUS guidance, using both Volcano and Boston Scientific IVUS devices, to provide more accurate stent placement than has been demonstrated with angiography alone.
"Modern-day stent design and techniques have improved dramatically since the very first SYNTAX study was enrolled more than five years ago," commented Professor Patrick Serruys, Rotterdam, Netherlands. "It is widely believed in the community that PCI is an excellent alternative to coronary bypass surgery in the right patients. The SYNTAX2 study will use a new 'clinical SYNTAX score' to first identify prospective patients we believe will benefit from a less-invasive PCI procedure, and then use physiology and IVUS guidance along with the modern-day drug-eluting stent technology. The goal is to show that delivering the most precise and modern-day PCI possible will allow more patients to be treated with this excellent alternative to bypass surgery."
"The fact that iFR has now been validated in more than 3,000 patients as part of these studies makes us comfortable in our understanding of the performance of the tool," commented Michel Lussier, President of Scientific and Clinical Affairs at Volcano. "iFR is not a replacement for FFR given the wealth of outcome data generated over the years in DEFER, FAME and FAME II. Future studies like SYNTAX2 that include iFR will now focus on clinical, economic and quality of life outcomes rather than comparisons to FFR now that those questions have been answered. This is an exciting time and we look forward to offering this tool to clinicians and interested researchers around the world to further the evidence that physiology can provide that next leap in improving PCI."
About Volcano Corporation
Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered "forward-looking statements." including statements regarding the potential benefits of the products and technologies described above, further development and expansion, anticipated clinical trials and the impact of clinical and other technical data. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include the pace and extent of market adoption of the company's products and technologies; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; growth strategies; timing and achievement of product development milestones; outcome of ongoing litigation; the impact and benefits of market development; product introductions; unexpected new data, safety and technical issues; market conditions; and other risks inherent to medical device development and commercialization. These and additional risks and uncertainties are more fully described in Volcano's filings made with the Securities and Exchange Commission, including our recent quarterly report on Form 10-Q. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Volcano Corporation
________________________________________________________
http://www.4-traders.com/VOLCANO-CORPORATION-17313/news/Volcano-Corporation-Volcano-Announces-Preliminary-Results-from-the-ADVISE-II-Study-and-Inclusion-i-16903943/
VOLC
chmcnfunds
11 years ago
olcano Stock Rating Upgraded by First Analysis (VOLC)
May 22nd, 2013 - 0 comments - Filed Under - by Patrick Bannon
Volcano (NASDAQ: VOLC) was upgraded by equities research analysts at First Analysis to an “overweight” rating in a research note issued to investors on Wednesday, Stock Ratings Network reports.
VOLC has been the subject of a number of other recent research reports. Analysts at Zacks reiterated a “neutral” rating on shares of Volcano in a research note to investors on Friday, May 10th. They now have a $18.00 price target on the stock. Separately, analysts at Jefferies Group cut their price target on shares of Volcano from $28.00 to $23.00 in a research note to investors on Tuesday, May 7th. They now have a “buy” rating on the stock. Finally, analysts at Roth Capital cut their price target on shares of Volcano from $28.00 to $26.00 in a research note to investors on Monday, May 6th. They now have a “buy” rating on the stock.
Seven research analysts have rated the stock with a hold rating and five have given a buy rating to the stock. The stock currently has an average rating of “Hold” and a consensus price target of $23.50.
Shares of Volcano (NASDAQ: VOLC) opened at 16.74 on Wednesday. Volcano has a 52 week low of $20.15 and a 52 week high of $30.59. The stock’s 50-day moving average is currently $22.0. The company has a market cap of $913.0 million and a P/E ratio of 196.94.
Volcano (NASDAQ: VOLC) last issued its quarterly earnings data on Thursday, May 2nd. The company reported $0.02 EPS for the quarter. The company had revenue of $93.20 million for the quarter, compared to the consensus estimate of $96.11 million. The company’s quarterly revenue was up 3.1% on a year-over-year basis. Volcano has set its FY13 guidance at $0.03-0.05 EPS. On average, analysts predict that Volcano will post $0.05 earnings per share for the current fiscal year.
Volcano Corporation (NASDAQ: VOLC) designs, develops, manufactures and commercializes a range of precision guided therapy tools, including intravascular ultrasound (IVUS), and fractional flow reserve (FFR), products.
________________________________________________________
http://www.dailypolitical.com/finance/stock-market/volcano-stock-rating-upgraded-by-first-analysis-volc.htm
VOLC
chmcnfunds
11 years ago
Volcano Corporation Announces Presentations At Upcoming Investor Conferences
SAN DIEGO, Calif., May 22, 2013 /PRNewswire/ --
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today that it will be participating in two upcoming investor conferences.
On Wednesday, May 29, the company will participate in the Deutsche Bank 38(th) Annual Health Care Conference. The presentation by John Dahldorf, chief financial officer, will begin at 4:50 p.m., Eastern Daylight Time (1:50 p.m., Pacific Daylight Time). The presentation will be available through the conference website at http://www.media-server.com/m/p/m59g27t9, and via the company's website at www.volcanocorp.com.
On Tuesday, June 4, the company will participate in the Jefferies 2013 Healthcare Conference. The presentation by John Dahldorf, chief financial officer, will begin at 1:30 p.m., Eastern Daylight Time (10:30 a.m., Pacific Daylight Time). The presentation will be available through the conference website at http://wsw.com/webcast/jeff77/volc/ and via the company's website at www.volcanocorp.com.
Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information--using light and sound as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together. For more information, visit the company's website at www.volcanocorp.com.
SOURCE Volcano Corporation
/CONTACT: John Dahldorf of Volcano Corporation, +1--858-720-4020, or Neal B. Rosen, +1-650-458-3014
/Web site: http://www.volcanocorp.com
VOLC
madtony
17 years ago
Volcano Announces U.S. and European Launch of Rotational IVUS and Integrated FFR
Friday March 28, 8:30 am ET
Volcano s5i platform offers multiple diagnostic modalities on a single system and user interface, providing choice for the first time to physicians and administrators
SAN DIEGO, March 28 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC - News), a leading manufacturer and developer of intravascular ultrasound (IVUS), functional measurement (FM) and Optical Coherence Tomography (OCT) products designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today the U.S. and European launch of the s5-Revo and s5-FFR (fractional flow reserve) options for the s5i integrated Imaging platform. These two new product options now enable rotational IVUS and FFR to operate on the same integrated Volcano s5i Integrated Imaging System as Volcano's previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three powerful diagnostic tools -- all on the same integrated IVUS platform.
Scott Huennekens, president and chief executive officer of Volcano, commented, "By adding high resolution rotational IVUS and pressure-based FFR to our already highly successful phased array s5 imaging platform, we will be providing a level of technology, clinical utility and convenience that is un-matched in the intravascular imaging field. No other company provides a system that integrates this level of functionality and convenience in a single platform. Our message now is simple: Volcano offers physicians all three technologies on one system -- you can choose which technology is best for your patient and clinical team."
Earlier generation consoles included only one of the three technologies now available on the s5i. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. The Volcano s5i can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple phased array IVUS, and pressure-based FFR guidewires) on a single platform, making modern day imaging consoles more flexible than ever before.
Joe Burnett, associate vice president of marketing for Volcano, said, "We believe that IVUS is one of the fastest growing market segments in interventional cardiology today. Our internal market model suggests that worldwide IVUS revenue grew approximately 15% in 2007. More and more physicians are augmenting their daily interpretation of angiography with this more exacting, precise technology. IVUS and FFR can provide objective measurements of lesion severity and stent expansion, thus removing some of the inherent guess work surrounding 2D x-ray images. We believe that having these modalities available on a single integrated system can only further adoption of these important therapy guidance tools."
Training and Education
As part of the s5-Revo and s5-FFR market introduction, Volcano is also launching Volcano TLC, a comprehensive on-site education program available to current and future Volcano customers, targeted to increase IVUS and FFR awareness and build staff proficiency with these new integrated systems. Volcano TLC (Training and Learning Clinics) offers a combination of keynote speaker presentations, physician proctorships, hands-on system training, guided proficiency tools and workflow troubleshooting, all designed to leverage modern-day IVUS and FFR technology, and to allow physicians to acquire these precise diagnostic measurements in less time than ever before.
To kick-off the Volcano TLC program, John McB. Hodgson, M.D., FSCAI will begin an 18 city speaking tour in the US and Canada. Dr. Hodgson will deliver a 90-minute presentation and case review highlighting the essential role of IVUS and FFR in determining lesion severity and guiding proper stent placement and expansion entitled "IVUS and FFR: More Important than Ever. A Guide to Optimal PCI on the Eve of Second Generation DES".
Dr. Hodgson commented, "IVUS and FFR play an invaluable role in modern-day PCI. As practitioners, we are routinely misled by using angiography alone to assess lesion severity and confirm proper stent placement. Although IVUS and FFR have long been available to augment angiography, legacy systems were cumbersome, and access to these systems was too limited to drive broader acceptance."
Dr. Hodgson continued, "The combination of more complex target lesions, concerns about late stent thrombosis, the launch of new faster, integrated IVUS and FFR technologies, and the growing awareness that angiography does not tell the whole story, has driven IVUS use dramatically higher in recent years. It is no wonder that the use of IVUS has increased so rapidly."
The Volcano TLC speaker program with Dr. John Hodgson will visit the following cities over the next three months; New York City, Framingham, Buckhead, Miami, Baltimore, Nashville, Pittsburgh, Cleveland, Rosemont, Milwaukee, Houston, Dallas, Seattle, Las Vegas, San Francisco, Fresno, Montreal and Toronto. For specific dates, times and locations, please refer to the Volcano website at http://www.volcanocorp.com.
Availability
Volcano will highlight the new s5i integrated systems at the American College of Cardiology ACC Symposium in Chicago, March 29th to April 2nd. Volcano will have these new systems on display at Booth number #18093 for live demonstrations, as well as transmitting cases from ACC live broadcast sites. The Volcano s5-Revo and s5-FFR options complement the existing s5 functionality, including ChromaFlo® for stent apposition assessment, and VH(TM) IVUS plaque composition analysis.
Volcano IVUS will also be highlighted in GE Healthcare's booth. GE's "Innova® IVUS" is based on Volcano's s5i, and offers clinicians a deeper level of integration. With Innova IVUS, patient data transfers automatically between Innova and the s5i, and IVUS commands are integrated directly into Innova Central, GE's bedside control device. Additionally, when the case is complete, IVUS and angio can be archived in the same "patient jacket", making future data retrieval faster and easier.
The Volcano s5i Imaging System has been tested in cooperation with GE, Philips, Siemens and Toshiba for safety and compatibility when used with their current lines of x-ray systems and equipment. The Volcano s5i has also been tested for compatibility with eleven different DICOM providers. The Volcano s5i will also be on display at the Phillips, Siemens and Toshiba booths at the ACC.
madtony
17 years ago
Volcano Announces Closing of CardioSpectra Acquisition
Tuesday December 18, 7:00 pm ET
SAN DIEGO, Dec. 18 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC - News), a provider of intravascular ultrasound (IVUS) and functional measurement (FM) products designed to enhance the diagnosis and treatment of vascular and structural heart disease, announced today that it has completed its previously announced acquisition of CardioSpectra, Inc.
CardioSpectra is a privately-held company developing innovative Optical Coherence Tomography (OCT) technology. CardioSpectra's unique OCT imaging system is expected to complement Volcano's existing product offerings and further enhance Volcano's position as an imaging technology leader in the field of interventional medicine.
Under terms of the agreement, which was announced on December 10, 2007, Volcano paid $25 million in cash at closing to CardioSpectra's shareholders and warrant holders. In addition, Volcano may make additional payments upon the achievement of certain product development, regulatory and revenue milestones. Any future payment may be made in cash or stock, or a combination of both at Volcano's discretion.
About Volcano
Volcano Corporation (Nasdaq: VOLC - News) offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH(TM) IVUS tissue characterization and ChromaFlo®. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires. Currently, more than 2,900 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States.
madtony
18 years ago
thanks curtbs http://www.sacbee.com/103/story/128141.html
Sounding out heart problems
Rancho Cordova's Volcano Corp. creates buzz among startups
By Jim Downing - Bee Staff Writer
Published 12:00 am PST Sunday, February 25, 2007
Story appeared in BUSINESS section, Page D1
Pity the poor patient whose heart is on display at Volcano Corp. in Rancho Cordova. One of his coronary arteries isn't doing so well.
It's splashed in vivid multicolor on the computer screen, a glob of red and white highlighting what one Volcano engineer calls "a big nasty plaque." Left unchecked, the glob spills open, the artery clogs -- and the patient's gone.
"Volcano was formed to find these plaques before they erupt," said Chief Executive Scott Huennekens.
The graphic shots show off the cardiac diagnostic technology that has fueled Volcano's rise as one of the nation's hottest new public companies: Since its June debut, the company's stock is up 142 percent -- ranking eighth among the 192 IPOs in the past 12 months.
For a tech company, that's the kind of performance often associated with a game-changing innovation.
But while Volcano undoubtedly has been creative, the firm owes its newfound success not so much to technical wizardry as to the clever recasting of a neglected ultrasound technology acquired in mid-2003.
"The digital revolution ... just never caught up with ultrasound until Volcano decided to say, 'Wait a second, the reason it's not growing is not because there's not good demand or good need. The reason it's not growing is because it's so difficult for doctors to use,' " said Thomas Gunderson, a senior analyst with Piper Jaffray and Co., one of four investment banking firms to underwrite Volcano's June stock offering.
Volcano, in fact, is the third in a line of firms to occupy the same building in Rancho Cordova and try to sell ultrasound catheters to the world's cardiologists. EndoSonics Corp., which helped pioneer the devices, operated from 1985 to 2000. It was bought by Dutch-owned Jomed NV, which in turn sold the business in July 2003 to Volcano, then a 25-employee Southern California startup.
In the years that followed, Volcano revamped its catheter system to better integrate it into hospital diagnostic labs and struck a distribution deal with giant GE Healthcare. It hired a veteran marketing team and quadrupled its Rancho Cordova research and development staff. By collaborating with cardiologists at the University of California, Davis, and elsewhere, Volcano has made its equipment an important tool in leading-edge research on heart disease.
The result: Sales have grown from roughly $45 million in 2003 to $103 million in 2006. Volcano and much-larger Boston Scientific each hold about half of the U.S. market for cardiac diagnostic ultrasound catheters.
And there's plenty of room for growth. While most hospital diagnostic labs have ultrasound catheter equipment, most cardiologists haven't made it one of their standard tools.
That's changing quickly, though, particularly because of rising concern about the effectiveness and safety of coronary artery stents -- tiny metal-mesh tubes used to prop open the blood vessels that supply oxygen to the heart.
Cardiologists in the United States perform about 1 million stent procedures a year. Ultrasound catheters like Volcano's produce a three-dimensional view of an artery from the inside, helping the doctor determine where to place a stent and to monitor it thereafter. Cardiologists say this ultrasound picture from inside the vessel complements the two-dimensional image of the arteries produced using the standard X-ray procedure, known as angiography.
Volcano Chief Financial Officer John Dahldorf said U.S. cardiologists now use ultrasound catheters in only about 10 percent of all stent procedures. As ultrasound becomes a more commonly used tool, Volcano stands to gain: Each procedure requires a new $640 disposable catheter. Sales of these disposable catheters accounted for about 60 percent of Volcano's revenues last year.
In addition, Volcano also is developing next-generation applications for ultrasound technology.
The company's creative hub is its "Innovation Center," a 30,000-square-foot, gymnasium-style building that opened 16 months ago just down the street from Volcano's headquarters and factory. The 80 engineers and programmers who work here sit in teams of a dozen or so, their low cubicles circled around whiteboards and messy conference tables. Bicycles appear to be allowed to park anywhere.
madtony
18 years ago
http://www.sacbee.com/103/story/123085.html
Earnings roundup: Volcano revenue rises 20% in fourth quarter
By Jim Downing - Bee Staff Writer
Last Updated 12:03 am PST Wednesday, February 14, 2007
Story appeared in BUSINESS section, Page D3
Rancho Cordova-based Volcano Corp. closed out the 2006 business year even stronger than expected.
Tuesday, the company announced a 20 percent increase in fourth-quarter revenue and a profit of $1.4 million, or 4 cents per share.
The revenue of $29.5 million for the quarter ending Dec. 31 was slightly higher than the company's Jan. 9 projection of $29 million, and well above an earlier consensus estimate from analysts of $26.6 million.
"We had a terrific 2006," said Chief Executive Scott Huennekens in a conference call with investors and analysts. "As we begin 2007, we are achieving our strategic, technology and financial objectives."
Volcano makes ultrasonic catheter systems used by cardiologists to evaluate the condition of coronary arteries and guide treatments for heart disease.
Chief Financial Officer John Dahldorf said the majority of the quarter's revenue growth stemmed from a 25 percent increase in sales of the firm's disposable ultrasonic catheters, which sell for about $640 each.
Volcano went public in June. Since then, its share value is up 125 percent, making it one of the nation's best-performing new stocks and the most successful Sacramento-area initial public offerings since the dot-com boom. The company employs about 400 people in Rancho Cordova.
Thomas Gunderson, a senior research analyst at Piper Jaffray & Co., said Volcano has impressed Wall Street investors by consistently meeting or beating revenue and product roll-out targets.
"Volcano has high credibility," he said.
For the year ending Dec. 31, Volcano reported revenue of $103 million and a net loss of $8.6 million.
For 2007, Dahldorf projected revenue of $120 million. However, he anticipated a net loss for the year of 15 cents a share, because of expenses tied to increased sales, marketing and research efforts, as well as stock-based compensation of $6.8 million.
Volcano's stock closed Tuesday at $19.70, up 20 cents or 1 percent, on the Nasdaq. The earnings announcement came after financial markets had closed, but the stock continued rising in after-hours trading.
madtony
18 years ago
Volcano Corporation Announces Distribution Agreement for Peripheral and Endovascular IVUS Indications in Japan
Tuesday February 13, 4:05 pm ET
Agreement Expected to Continue Volcano's Leadership Position in Peripheral IVUS in Japan
RANCHO CORDOVA, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC - News) today announced the signing of a distribution agreement with Johnson & Johnson K.K., Medical Company. The agreement appoints Cordis Endovascular Systems Japan as a distributor of IVUS products for use in peripheral and endovascular procedures in Japan.
Scott Huennekens, President and CEO of Volcano Corporation commented, "The strong endovascular sales and marketing organization of Cordis Endovascular Systems Japan has worked as a sub-distributor for our IVUS products in the peripheral and endovascular markets for a number of years. Due in large part to their leadership and market development, Volcano is currently the leader in IVUS products for these fields in Japan. This agreement appoints Cordis Endovascular Systems Japan as our direct distributor -- a change that should enable us to further enhance our working relationship and strengthen our position in the peripheral market." Mr. Huennekens continued, "By adding Cordis Endovascular to our Japan distribution team which also includes both Goodman K.K. and Fukuda Denshi (both serving the coronary markets), Volcano continues to build its presence in Japan. We know the team at Cordis Endovascular extremely well and hold them in very high regard."
According to Nobuyuki Sakai, M.D., D.M.Sc, Director, Neurosurgery and Kobe City General Hospital Stroke Center Kobe City General Hospital, "IVUS guided Carotid Artery Stenting (CAS) has clinical efficacy with some explicit benefits in spite of its invasive approach and additional device cost. IVUS can provide important inputs for effective CAS such as plaque length, distal end of plaque and plaque morphology. These inputs help to determine appropriate or optimal devices, including stent and protection devices. In post stent assessment, IVUS is very useful to confirm stent expansion and plaque coverage, whereas this can be difficult when using only fluoroscopy or carotid echography. In addition, IVUS can help evaluate thrombus and protrusion of the plaque into the vessel lumen after stenting. Again, it is difficult to visualize these important features using only fluoroscopy or carotid echography."
About Volcano Corporation
Volcano Corporation, which completed its IPO in June 2006, offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart diseases and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab and single-use phased array and rotational IVUS imaging catheters. Volcano also has unique advanced functionality options like VH tissue characterization and IVUS and angiography co-registration. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires. Currently, more than 2,500 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States. For more information, visit the company's website at www.volcanocorp.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding Volcano's business that are not historical facts may be "forward-looking statements" that involve risks and uncertainties. Specifically statements regarding the successful execution of collaboration agreements and relationships, ease of product use, the performance of the company's IVUS systems, customer acceptance and use of the company's products and technologies, the role of IVUS technology in optimizing stent placement, the role of IVUS in clarifying atherosclerotic disease process and guiding interventional and system therapies and the availability or results of clinical trial and collaboration activities are forward-looking statements that involve risks and uncertainties. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause Volcano's results to differ materially from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from the results presented are detailed in the company's 10-Q, most recent Registration Statement on Form S-1 and other filings made with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Volcano undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
madtony
18 years ago
Volcano Corporation Reports Record Quarterly Revenues; Total Year Revenues Reach $103 Million
Tuesday February 13, 4:05 pm ET
RANCHO CORDOVA, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC - News), a leading provider of intravascular ultrasound (IVUS) and functional measurement (FM) products designed to enhance the diagnosis and treatment of vascular and structural heart diseases, today announced results for the fourth quarter and all of fiscal 2006.
For the quarter ended December 31, 2006, Volcano reported record quarterly revenues of $29.5 million, a 20 percent increase over revenues of $24.7 million in the fourth quarter a year ago, and a six percent increase over revenues of $27.8 million in the third quarter of 2006. IVUS disposable revenues in the fourth quarter of 2006 increased 25 percent over the fourth quarter of 2005.
Volcano reported its second consecutive quarter of profitability on a GAAP basis, with net income of $1.4 million, or $0.04 per diluted share, versus a net loss of $6.9 million, or $1.01 per share, in the same quarter a year ago. The company recorded stock-based compensation expense of $901,000 compared with $494,000 in the fourth quarter of 2005. Excluding stock-based compensation expense, Volcano reported net income of $2.3 million, or $0.06 per diluted share, versus a net loss of $6.4 million, or $0.94 per share, in the fourth quarter of 2005. Weighted average diluted shares outstanding were 38.2 million in the fourth quarter of 2006 versus 6.8 million in the same period a year ago. The increase reflects the conversion of preferred stock to common stock, the exercise of warrants, the company's initial public offering in June 2006 and the completion of a follow on offering in December 2006.
For all of fiscal 2006, Volcano reported revenues of $103.0 million, a 12 percent increase over revenues of $91.9 million in fiscal 2005. For the year, IVUS disposable revenues increased nearly 23 percent over 2005. Volcano reported a net loss on a GAAP basis of $8.6 million, or $0.41 per share, compared to a net loss of $15.3 million, or $2.28 per share, in 2005. Excluding a non-recurring, non-cash charge of $1.2 million related to the early extinguishment of debt and stock-based compensation expense of $3.2 million, the company reported a net loss of $4.2 million, or $0.20 per share, compared with a net loss of $13.3 million, or $1.99 per share, in 2005. A reconciliation of the company's GAAP to non-GAAP results can be found in today's earnings press release on the company's website at www.volcanocorp.com.
During the fourth quarter of 2006 Volcano completed an equity offering, selling approximately 4.3 million primary shares -- including the underwriters' overallotment -- that generated net proceeds to the company of approximately $67.8 million.
"Our results for the quarter demonstrate the ability of our s5 family of consoles to both gain market share and increase the utilization of IVUS in the diagnosis and treatment of vascular disease," said Scott Huennekens, president and chief executive officer of Volcano. "Our consoles facilitate the integration of IVUS in the cath lab, and provide ease of use and enhanced functionality for clinicians. With the launch of our Revolution rotational high frequency catheter, we are now the only company offering the market both phased array and rotational catheters. In addition, the enhancements we have made to our functional measurement (FM) offerings are broadening our presence in that market as well," he continued.
During the quarter, Volcano announced a collaboration with three leading core labs under which the company will provide IVUS catheters free of charge for use in pivotal trials for drug-eluting stents to facilitate the use of IVUS and demonstrate its value in stent optimization. In addition, the company is in the final trial design for the CHECK study, or Carotid Histology Evaluation and Correlation to patient worKup that will be a registry of stented carotid artery patients in the United States, Japan and Europe who undergo IVUS imaging of their carotid arteries prior to stenting. Volcano expects to enroll the initial patients in the 300-patient study during 2007.
In addition, the company announced today a distribution agreement with Johnson & Johnson K.K. Medical Company, appointing Cordis Endovascular Systems Japan as a distributor of IVUS products for use in peripheral and endovascular procedures in Japan. Cordis has served as a sub-distributor for Volcano's IVUS products in these markets for a number of years.
"Volcano has had an excellent year, marked by the introduction of industry-leading technology, the development of important partnerships, and meaningful progress in our clinical trials," Huennekens noted.
"In addition to increasing our presence in the IVUS and FM markets during 2007, we will continue to lay the groundwork for future growth through market opportunities such as stent optimization, IVUS and angiography co-registration, IVUS during diagnostic angiographies, Intra-Cardiac Echo, vulnerable plaque and applications in the carotid and peripheral arteries," he continued.
Guidance for 2007
Volcano expects revenues of approximately $120.0 million in 2007. Gross margin for the year is expected to be 60-61 percent and operating expenses to be 68-69 percent of revenues. The company expects to report a net loss on a GAAP basis of approximately $0.15 per share, assuming weighted average basic shares outstanding at year-end of approximately 37.7 million. Excluding stock- based compensation, Volcano expects to report net income of $0.03 per share assuming weighted average diluted shares outstanding at year-end of approximately 41.9 million.
more...http://biz.yahoo.com/prnews/070213/sftu128.html?.v=58
madtony
18 years ago
Volcano Corporation Expects to Exceed Previously-Announced Revenue Guidance for Fiscal 2006
RANCHO CORDOVA, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC), a provider of intravascular ultrasound (IVUS) and functional measurement (FM) products designed to enhance the diagnosis and treatment of vascular and structural heart diseases, said today that it expects fiscal 2006 revenues to be approximately $103 million and revenues for the fourth quarter of 2006 to be approximately $29 million. This compares with prior revenue guidance given on November 1, 2006 for fiscal 2006 revenues of $98 million. These results reflect year-over-year revenue growth of approximately 12 percent and 20 percent for the full year and fourth quarter of 2006, respectively.
The company said that it was providing the updated 2006 revenue projection in advance of company meetings with the investment community and a presentation at the JP Morgan Healthcare Conference on Thursday, January 11. Further details of the company's fourth quarter and full-year operating and financial performance will be released later this quarter, which will be followed by a conference call and web cast open to all interested parties. Details of the earnings release date, conference call and web cast will be provided in a subsequent release.
As previously announced, Scott Huennekens, president and chief executive officer, will be speaking about the company at the JP Morgan Healthcare Conference, beginning tomorrow at 8 a.m., Pacific Standard Time (11 a.m., Eastern Standard Time). The presentation will be available through https://events.jpmorgan.com and via the company's website at www.volcanocorp.com.
Volcano Corporation offers a broad suite of devices that facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart diseases and guide optimal therapies. The company's intravascular (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab and single-use phased array and rotational IVUS imaging catheters. Volcano also has unique advanced functionality options such as VH tissue characterization and IVUS and angiography co-registration. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires. Currently, more than 2,300 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States. For more information, visit the company's website at www.volcanocorp.com
madtony
18 years ago
Thursday October 19, 8:00 am ET
GE Healthcare and Volcano Corporation Announce World's First Installation of Innova IVUS and Plans to Enable All Future U.S. Innova Labs to Be IVUS Ready
Pre - Cabling of all Innova Labs Will Facilitate Integration of Volcano's Intravascular Ultrasound (IVUS) Technology
WAUKESHA, Wis. & RANCHO CORDOVA, Calif.--(BUSINESS WIRE)--GE Healthcare (NYSE: GE - News) and Volcano Corporation (NASDAQ: VOLC - News) today announced the completion of the first commercial installation of Innova IVUS at PinnacleHealth Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, PA.
Innova IVUS is GE Healthcare's custom integration of Volcano's s5i IVUS imaging system with the best-of-class Innova all-digital X-ray cath lab imaging system. Innova IVUS optimizes clinical workflow by offering IVUS controls on the Innova Central bedside touchscreen. Data exchange between the IVUS system and Innova allows for automatic patient data transfer from Innova for IVUS cases and advanced archiving that links IVUS cases to cath cases.
Volcano's s5i product uses a new PC-based platform that reduces the size, weight and noise of the older generation IVUS consoles. This allows the unit to be located in the control room or in other areas outside of the daily traffic pattern of the cath lab. Clinicians have the ability to control the IVUS system through a variety of control devices located at the patient bedside, at the point of care, or both. Clinicians also have the flexibility to view IVUS images on the existing monitor bank, a separate dedicated IVUS monitor, and/or on a monitor in the control room.
Rajesh Dave, MD, Chairman of Endovascular Medicine at PinnacleHealth Heart and Vascular Institute said, "Volcano's novel IVUS features such as automatic border detection and VH(TM) IVUS plaque composition analysis result in faster IVUS results with more actionable information than was previously available with IVUS. Combine this with GE Healthcare's touchscreen control and easier workflow derived from the unique Innova IVUS application, and I believe IVUS will become increasingly integral in assuring proper stent deployment."
Additionally, GE and Volcano today announced GE's plans to include the cabling required to operate Volcano's IVUS technology on all future U.S. installations of GE Healthcare's Innova imaging systems. The inclusion of IVUS cabling as part of the standard installation creates the infrastructure required to operate Innova IVUS.
"Our decision to include IVUS cabling in all future U.S. Innova installations was based both on positive early customer feedback on Innova IVUS, as well as our belief in the market opportunity for IVUS," said Laura King, Global Vice President, Interventional Cardiology at GE Healthcare. "We believe clinicians will continue to utilize advanced, real-time imaging tools such as IVUS. This integration will make Innova IVUS simple and efficient for our customers."
Scott Huennekens, President and CEO of Volcano Corporation, added, "We believe that clinicians will increasingly demand advanced tools such as IVUS to assist in proper stent deployment, expansion, apposition, and lesion coverage. GE Healthcare's decision to include IVUS cabling in its standard installation will make it easier for a greater number of physicians and their patients to benefit from Volcano's IVUS technology."
Innova IVUS is currently available for sale to new and existing GE Healthcare customers and will be co-marketed by the GE and Volcano sales and marketing organizations in the United States, Europe, certain markets in Asia and other world markets. GE will also collaborate with Volcano to provide unparalleled cath lab design, installation and field repair/service of this new system. Customers will be able to contract with one vendor, GE, for their purchasing, installation and field service needs.
madtony
18 years ago
Volcano Corporation Erupts
Monday October 16, 9:29 am ET
By Billy Fisher (Motley Fool)
Those in search of fast money who were able to get in on the IPO of medical-device maker Volcano Corporation (Nasdaq: VOLC - News) have definitely found success. The IPO has proven to be one of the hottest offerings of the past six months. The company's stock is trading at $14.60, up 83% from an offer price of $8 since going public in mid-June. Only a handful of offerings have performed better over the same time period.
The company develops, manufactures, and commercializes intravascular ultrasound (IVUS) and functional measurement (FM) products that aid in the diagnosis and treatment of vascular and structural heart disease. Volcano has a worldwide installed base of more than 1,400 IVUS consoles and more than 700 FM consoles. The company generated $91.9 million in revenues from the sale of its products in 2005.
So what has led to this IPO's remarkable success? The company's second-quarter numbers have contributed significantly to the price run-up. In August, Volcano reported revenues of $25.9 million for its quarter ended June 30. These revenues represented a 30% increase over its first-quarter revenues and a 9% increase over revenues for its prior-year second quarter. The company's gross profit for the quarter also increased to $14.4 million, versus a gross profit of $11.6 million for the year-ago quarter.
In late August, the FDA also helped this stock by allowing the company to use its new ultrasound capability in General Electric's (NYSE: GE - News) Innova line of medical imaging systems. The combination of Volcano's ultrasound technology with GE's Innova X-ray catheter-system lab-imaging process will allow radiologists and cardiologists to more definitively identify artery disease and shorten procedure times.
Volcano has an up-and-coming, cutting-edge technology, and it's well-positioned in the market, considering that the company was founded just six years ago. Its technology also stands to benefit from an aging baby-boomer population in the United States, as does the rest of the medical-device industry. "We experienced growth with our IVUS catheters across all of our key geographies, and our results reflect our ability to grow market share and what we believe is the growing adoption of IVUS technology," said Scott Huennekens, Volcano's president and chief executive officer.
I'd consider the company's persistent presence in the red as the biggest risk to its stock price's continued appreciation. Volcano reported a net loss of $4.2 million, or $0.41 per share, for the second quarter, and it projects a net loss of $0.75 per share for its fiscal 2006. The future growth rate for adoption of its IVUS technology also leaves me somewhat uncertain, though I find the FDA approval of its ultrasound technology for GE's Innova line very promising.
For Fools with a high degree of risk tolerance, Volcano presents an interesting investment opportunity. If I were an investor who already owned the stock, I would certainly be holding on to it. As a potential new purchaser of Volcano, I would like to see how the company's next quarter or two unfold. I am intrigued that the company is running a gross profit on its sales.
I also realize that the company's net loss is largely attributable to two factors. First, Volcano recorded a non-recurring, non-cash charge of $1.2 million resulting from the early extinguishment of debt in connection with its initial public offering; and two, it has incurred research & development costs which should benefit future business. While I'm not diving in just yet as a new entrant, I definitely consider Volcano a stock to watch.
http://biz.yahoo.com/fool/061016/116100537401.html?.v=1
Fool contributor Billy Fisher does not own shares of any of the companies mentioned. The Fool recommends you tread carefully around its disclosure policy.
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