Pubblicità
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di Giancarlo Nicoli
Aug
12
Stereotaxis Reports Record Results for Second Quarter 2010
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From the press release
Revenue Increases 19% to Record $15.0 Million
Recurring Revenue Sets Record at $5.6 Million, an Increase of 24%
Record Gross Margin Dollars of $10.1 Million
Operating Loss Decreases 14% to $5.7 Million
Net Loss Declines 48% to $3.9 Million
Company Reiterates 2010 Outlook
ST. LOUIS, Aug 02, 2010 /PRNewswire via COMTEX/ –
Stereotaxis, Inc. (Nasdaq: STXS) today reported record results for the second quarter ended June 30, 2010. Results included record recurring revenue, record gross margin dollars, a decline in the operating loss and a significant reduction in the net loss. In addition, new capital orders more than doubled from the level in the second quarter of 2009 to $10.2 million.
Revenue for the recent second quarter totaled $15.0 million, 19% above $12.6 million in revenue in the second quarter of 2009. The growth was driven by a 16% increase in revenue from capital equipment and higher recurring revenue. The Company recognized revenue on seven Niobe(R) Magnetic Navigation Systems and $2.5 million in Odyssey(TM) systems. Disposables, services and accessories revenue set another record at $5.6 million, 24% above recurring revenue in the second quarter last year, reflecting continued growth in clinical procedures.
For the first six months of 2010, revenue increased 8% to $25.6 million compared with $23.8 million in the first half of 2009. Gross margin grew 14% to $17.8 million, or 69.4% of revenue, compared with $15.7 million, or 65.8% of revenue in the first half of the prior year. Operating expenses were $29.7 million for the first six months of 2010 compared with $29.4 million in the same period of 2009. The operating loss decreased to $11.9 million for the first six months of 2010 compared with $13.8 million for the comparable period of 2009.
Michael P. Kaminski, President and Chief Executive Officer, said, “This was a strong quarter for the Company and our results demonstrate that we are on track to hit our plan for 2010. The success of our focus on driving adoption in the installed base, especially in the U.S., was reflected in our financial results, characterized by higher utilization, growing recurring revenue, and increased capital orders. Of the $10.2 million in new orders, $5.1 million were generated in North America. New orders were comprised of seven Niobe systems, including three in the U.S., two in Europe and two for the rest of the world, as well as $2.6 million in orders related to Odyssey.
“We remain focused on this key initiative, working closely with hospitals and clinicians to reinforce the safety and efficacy of our systems for complex EP procedures and to demonstrate the value that our technologies bring to patient care. We have begun to see progress in driving adoption; we are at the beginning of this effort and there is much opportunity ahead in both the U.S. and internationally.
“The $10.1 million gross margin set another record and was a milestone for the company. It is an example of the leveragability of our model as we continue to drive revenue growth. We are committed to containing operating expenses and driving our bottom-line performance. We are excited about the momentum and reiterate our outlook for revenue and key financial metrics for 2010,” concluded Mr. Kaminski.
Second Quarter 2010 Financial Performance
Gross margin for the quarter increased 26% to $10.1 million from $8.0 million in the second quarter of 2009. This represented 67.2% of total revenue compared with 63.1% a year ago. Second quarter operating expenses totaled $15.8 million, an increase of 8% compared with $14.6 million in the second quarter of 2009. Included in the recent operating expenses were increased severance costs and foreign exchange totaling $0.7 million.
The operating loss in the second quarter was $5.7 million compared with $6.7 million in the same quarter of the prior year. The Company reported a net loss for the 2010 second quarter of $3.9 million, or $0.08 per share. The net loss includes a positive adjustment in value for warrants issued in 2008 of $0.05 per share as a result of the decline in the Company’s stock price at June 30, 2010 versus March 31, 2010. This compares with a net loss for the second quarter of 2009 of $7.4 million, or $0.18 per share. Excluding the effect of the repricing of the warrants in the recent second quarter, the net loss was $6.4 million, or $0.13 per share. The weighted average shares for the second quarter of 2010 totaled 49.9 million compared with 41.7 million in the second quarter of last year. The increase was due in large part to the issuance of 7.5 million shares as part of the stock offering completed in October 2009.
Cash burn for the first six months of 2010, including payments against the Biosense Webster advance, was $14.2 million compared with $17.3 million in the first six months of 2009. Cash and equivalents at June 30, 2010 totaled $22.0 million, compared with $30.5 million at December 31, 2009. Total debt was $26.7 million, including $15.5 million drawn against the Company’s $30 million line of credit.
2010 Financial Outlook
The Company reaffirmed its outlook for 2010 as follows:
- New capital order growth in excess of 40%
- Total revenue growth in the mid-20% range
- Gross margins above 65%
- Operating expenses between $60 and $65 million
Conference Call Information
The Company has scheduled a conference call for 4:30 p.m. Eastern Time today to discuss its financial results for the second quarter. To access the conference call, please dial (877) 941-9205. International participants can call (480) 629-9835. An audio replay of the call will be available for seven days following the call at (800) 406-7325 for U.S. callers or (303) 590-3030 for those calling outside the U.S. The password required to access the replay is 4329312#. The call will also be available on the Internet live and for 90 days thereafter at the following URL:
http://www.videonewswire.com/event.asp?id=70601
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. Stereotaxis’ Odyssey solutions integrate and manage information from disparate information sources, eliminating the challenge of interacting simultaneously with many separate diagnostic systems, driving optimized workflow and improved productivity. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
STEREOTAXIS, INC.
BALANCE SHEETS
December
June 30, 31,
2010 2009
--- ---
(Unaudited)
Assets
Current Assets:
Cash and cash equivalents $22,014,249 $30,546,550
Accounts receivable, net of allowance
of $294,368 and $322,463 in 2010 and
2009, respectively 14,147,775 11,152,648
Current portion of long-term
receivables 63,800 66,800
Inventories 4,272,702 4,403,675
Prepaid expenses and other current
assets 3,024,675 3,872,535
--------- ---------
Total current assets 43,523,201 50,042,208
Property and equipment, net 4,445,477 4,790,310
Intangible assets 2,742,778 1,144,445
Long-term Receivables 146,425 138,441
Other assets 5,112 5,112
----- -----
Total assets $50,862,993 $56,120,516
=========== ===========
Liabilities and stockholders' equity
Current liabilities:
Current maturities of long-term debt $19,499,999 $3,333,333
Accounts payable 5,766,991 3,881,205
Accrued liabilities 7,698,627 8,615,287
Deferred contract revenue 7,606,228 7,191,492
Warrants 3,172,562 4,142,614
--------- ---------
Total current liabilities 43,744,407 27,163,931
Long term debt, less current
maturities 7,154,045 20,346,655
Long term deferred contract revenue 789,381 948,574
Other liabilities 14,134 20,013
Stockholders' equity:
Preferred stock, par value $0.001;
10,000,000 shares authorized at 2010
and 2009; none outstanding at 2010
and 2009 - -
Common stock, par value $0.001;
100,000,000 shares authorized at 2010
and 2009; 50,356,233 and 50,208,171
issued at 2010 and 2009, respectively 50,356 50,208
Additional paid-in capital 335,058,197 331,249,918
Treasury stock, 40,151 shares at 2010
and 2009 (205,999) (205,999)
Accumulated deficit (335,741,528) (323,452,784)
------------ ------------
Total stockholders' equity (838,974) 7,641,343
-------- ---------
Total liabilities and stockholders'
equity $50,862,993 $56,120,516
=========== ===========
STEREOTAXIS, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
June 30,
--------
2010 2009
---- ----
Revenue
System $9,439,857 $8,162,504
Disposables, service and
accessories 5,578,221 4,481,833
--------- ---------
Total revenue 15,018,078 12,644,337
Cost of revenue
System 4,313,774 3,212,031
Disposables, service and
accessories 612,379 1,453,854
------- ---------
Total cost of revenue 4,926,153 4,665,885
Gross margin 10,091,925 7,978,452
Operating expenses:
Research and development 3,358,008 3,636,007
Sales and marketing 8,446,612 7,680,549
General and administration 3,976,057 3,314,678
Total operating expenses 15,780,677 14,631,234
---------- ----------
Operating loss (5,688,752) (6,652,782)
Other income/(expense) 2,507,221 304,709
Interest income 2,148 4,376
Interest expense (682,804) (1,096,080)
-------- ----------
Net loss $(3,862,187) $(7,439,777)
=========== ===========
Net loss per common share:
Basic and diluted $(0.08) $(0.18)
Weighted average shares
used in computing net
loss per common share:
Basic and diluted 49,885,589 41,670,130
========== ==========
Six Months Ended
June 30,
--------
2010 2009
---- ----
Revenue
System $14,673,611 $15,023,312
Disposables, service and
accessories 10,961,076 8,754,162
---------- ---------
Total revenue 25,634,687 23,777,474
Cost of revenue
System 6,390,490 5,775,513
Disposables, service and
accessories 1,456,332 2,351,052
--------- ---------
Total cost of revenue 7,846,822 8,126,565
Gross margin 17,787,865 15,650,909
Operating expenses:
Research and development 6,727,546 6,945,870
Sales and marketing 15,141,730 15,133,984
General and administration 7,866,394 7,352,843
Total operating expenses 29,735,670 29,432,697
---------- ----------
Operating loss (11,947,805) (13,781,788)
Other income/(expense) 970,052 555,646
Interest income 4,930 31,349
Interest expense (1,315,921) (1,775,071)
---------- ----------
Net loss $(12,288,744) $(14,969,864)
============ ============
Net loss per common share:
Basic and diluted $(0.25) $(0.36)
Weighted average shares
used in computing net
loss per common share:
Basic and diluted 49,753,046 41,476,704
========== ==========
SOURCE: Stereotaxis, Inc.
 |
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Investimenti, Stereotaxis, Stereotaxisdi Giancarlo Nicoli
Jul
18
Stereotaxis Announces Strong Increase in New Capital Orders in Second Quarter 2010
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From the press release
Stereotaxis Announces Strong Increase in New Capital Orders in Second Quarter 2010
Capital Orders Double from Second Quarter 2009; 42% Sequential Growth
North America Rebounds to Represent 50% of Total Orders
ST. LOUIS, July 13, 2010 /PRNewswire via COMTEX/ –
Stereotaxis, Inc. (Nasdaq: STXS) announced today that its new capital order momentum continued to build in the second quarter of 2010. The Company generated new capital orders of $10.2 million, more than doubling new capital orders from the 2009 second quarter and representing a 42% sequential increase over orders in the first quarter of 2010. New orders from North America totaled $5.1 million of the total orders in the quarter.
“Our new capital order momentum in the quarter validates our view that driving clinical adoption builds both procedure revenue and market interest,” said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis. “The largest increase was in North America where we have focused on clinical adoption. As a result, procedures in the U.S. are steadily increasing, resulting in higher utilization and stronger reference sites. In addition, we continue to generate a strong and balanced performance from Europe and the rest of the world.”
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. Stereotaxis’ Odyssey(TM) solutions integrate and manage information from disparate information sources, eliminating the challenge of interacting simultaneously with many separate diagnostic systems, driving optimized workflow and improved productivity. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
SOURCE Stereotaxis, Inc.
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Investimenti, Stereotaxis, Stereotaxisdi Giancarlo Nicoli
May
13
New Data Demonstrate Safety, Efficacy of Stereotaxis for Patients with AFIB, VT and Congenital Defects
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From the press release
INNOVATIVE ODYSSEY NETWORK CONNECTS INDUSTRY LEADERS THROUGHOUT HRS EXHIBITS
Data Underscores Stereotaxis’ Clinical Leadership in EP, Evident at Heart Rhythm 2010
ST. LOUIS, May 13, 2010 /PRNewswire via COMTEX/ –Stereotaxis’ (Nasdaq: STXS) safety and efficacy in the treatment of patients with complex arrhythmias such as atrial fibrillation, ventricular tachycardia, and congenital heart defects will be featured prominently in the scientific program of the 31st Annual Heart Rhythm Scientific Sessions in Denver, Colorado. Eight podium presentations and eight posters will underscore the broad clinical leadership that Stereotaxis has achieved in the treatment of patients with complex cardiac arrhythmias. Stereotaxis will display its advanced tools for the electrophysiology lab in booth # 1103.
In addition, Dr. J. Peter Weiss and his colleagues from Intermountain Medical Center in Salt Lake City, Utah will present a live case using a non-localized magnetic catheter in a patient with left-sided atrial flutter remotely from the control room of their fully integrated Odyssey lab in Salt Lake City. The case will be presented on Thursday, May 13th at 10:30 am in the Four Seasons Ballroom 3-4.
ATRIAL FIBRILLATION
Catheter ablation for atrial fibrillation is in high demand, with some studies indicating that the procedure is significantly growing each year. Dr. Arash Arya and colleagues from the Heart Center, University of Leipzig in Leipzig, Germany, will present the poster, “Catheter Ablation of Atrial Fibrillation Using Remote Magnetic Catheter Navigation: A Case-Control Study” during Poster Session 6 on Saturday, May 15th at 9 a.m. in the main exhibit hall.
Additional data will be presented by Dr. David Burkhardt and colleagues at St. David’s Medical Center in Austin, Texas during Poster Session 4 on Friday, May 14th at 9 a.m. and by Dr. Shinsuke Miyazaki and physicians from Hopital Cardiologique du Haut-Leveque in Bordeaux, France during Poster Session 5 on Friday, May 14th at 2:00 p.m., both in the main exhibit hall.
CONGENITAL DEFECTS
The congenital heart defect patient group is one of the most challenging populations facing the electrophysiologist and particularly attractive for treatment with the advanced tools offered by Stereotaxis. Dr. Thomas Baurnfeind from the Thoraxcenter at Erasmus Medical Center in Rotterdam, The Netherlands will present the paper, “The Usefulness of Ablation Guided by Remote Navigation in Patients with Complex Congenital Heart Disease.” This paper will be presented on Thursday, 5/13 at 2:15 pm in Room 102.
VENTRICULAR TACHYCARDIA
Due to complex anatomy, the sensitive nature of ventricular tissue, and potentially lethal outcomes, treating ventricular tachycardia is a major challenge for electrophysiologists, and requires the delivery of robust lesions for clinical success.
As previously announced, Hiroshi Nakagawa, MD, PhD, Co-Director of the Heart Rhythm Institute at the University of Oklahoma Health Sciences Center will deliver a podium presentation titled “Substrate Ablation of Scar Ventricular Tachycardia Using Magnetic Catheter Maneuvering System,” on Friday, May 14, at 2:45 pm, Korbel Ballroom 4F. Additionally, Petr Neuzil, MD, PhD, from Na Holmoce Hospital in Prague, will present a poster with early results from the “Stereotaxis Study to Obliterate Persistent Ventricular Tachycardia” or “STOP-VT” study during Poster Session 2 on Thursday, May 13th at 9:00 a.m. in the main exhibit hall.
“We are very excited to see the results from two important VT studies,” said Michael P. Kaminski, President and CEO of Stereotaxis. “VT is among the most challenging arrhythmias to treat. There are a growing number of patients with VT and a limited number of clinicians who perform the complex procedure, creating few options for patients. Based on what we’re seeing at several centers performing VT ablations routinely, we believe that catheter ablation with magnetic navigation can effectively terminate a high majority of documented ventricular tachycardias, particularly among patients who had previously suffered a heart attack.”
ODYSSEY BROADLY FEATURED AT HRS
An innovative Odyssey Network will be featured throughout the HRS exhibit floor including demonstrations in the Siemens Medical Solutions, Philips Medical Systems, and Biosense Webster booths. Odyssey will also support a live interactive demonstration of the Stereotaxis magnetic navigation system through a remote VPN connection between Denver and St. Louis. Customers will have an opportunity to receive a hands-on demonstration of the comprehensive Odyssey Enterprise Solution with its fully integrated, real-time information management platform to integrate, record, and network interventional lab data throughout hospitals and around the world.
“The broad showcase of Odyssey at this year’s HRS validates the level of interest building among customers and partners,” said Michael P. Kaminski. “We believe that the combination of our partner solutions coupled with the unique benefits of Odyssey provides customers with an innovative platform that addresses unmet customer needs from advanced treatment to referral outreach.”
About Heart Rhythm 2010
Heart Rhythm 2010, the Heart Rhythm Society’s 31st Annual Scientific Sessions, will be held at the Colorado Convention Center, May 12 — 15, 2010. For more information, visit www.hrsonline.org/sessions.
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. Stereotaxis’ Odyssey workstation integrates and standardizes data through a consolidated display of multiple systems, eliminating the challenge of interacting simultaneously with many separate diagnostic systems. The magnetic irrigated catheter is not approved for the treatment of atrial fibrillation in the US. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada. For more information visit www.stereotaxis.com.
About Odyssey
The Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information around the world. Odyssey Vision standardizes data integration for magnetic and standard interventional labs by enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Through its proprietary data compression technology, Cinema enables sharing of live and recorded procedure data via a laptop anywhere over a secure high speed Internet connection. Hospitals can also share procedures with other institutions using Odyssey Network Connect providing a global forum for defining clinical best practices across a broad spectrum of medical procedures. For more information visit www.odysseyexperience.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
SOURCE: Stereotaxis, Inc.
Tags:
Investimenti, Stereotaxis, Stereotaxisdi Giancarlo Nicoli
May
13
Stereotaxis and Siemens Promote Integrated Odyssey(TM) Solutions
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From the press release
Companies Collaborate to Showcase the Odyssey Network at Heart Rhythm 2010
ST. LOUIS, May 12, 2010 /PRNewswire via COMTEX/ –At the Heart Rhythm Society’s 31st Annual Scientific Sessions, Stereotaxis, Inc. (Nasdaq: STXS) will promote its Odyssey Enterprise Solution with a live network connection between the Stereotaxis and Siemens Healthcare exhibits. The demonstration will be remotely powered through the Stereotaxis Odyssey Enterprise Cinema platform connected to a customer viewing station in the Siemens booth to demonstrate the capability of remote viewing, recording and collaboration in Siemens large display for Artis zee(R) labs. Attendees will experience the innovative features of Odyssey Enterprise Cinema and Network Connect in combination with the Siemens consolidated display. The exhibits will be open from May 13 to 15 at the Colorado Convention Center in Denver, Colorado, with each company offering its components for sale at HRS.
“Siemens remains focused on delivering innovative solutions to our cardiology customers, such as the ability to acquire three-dimensional images of the heart’s structures utilizing syngo(R) DynaCT Cardiac and to distribute and display the information to the clinical team to support decision-making,” said Claus Grill, vice president, Cardiac, Interventional/Neuro, and X-ray Systems, Siemens Healthcare. “Odyssey Enterprise Cinema and Network Connect is clearly aligned with this initiative by delivering synchronized data from Siemens labs throughout hospital networks and around the world.”
“The integration of state-of-the-art Siemens labs with Odyssey Enterprise Solutions provides a great opportunity for Stereotaxis,” said Michael P. Kaminski, Stereotaxis President and CEO. “The combination of the large display solution from Siemens with Odyssey offers a powerful combination of products that will deliver real value to our joint customers.”
About Odyssey www.OdysseyExperience.com
The Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording, and networking interventional lab information around the world. Odyssey Vision standardizes data integration for magnetic and standard interventional labs by enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Through its proprietary data compression technology, Cinema enables sharing of live and recorded procedure data via a laptop anywhere over a secure high speed Internet connection. Hospitals can also share procedures with other institutions using Odyssey Network Connect providing a global forum for defining clinical best practices across a broad spectrum of medical procedures.
About Stereotaxis www.Stereotaxis.com
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. Stereotaxis’ Odyssey solutions integrate and manage information from disparate information sources, eliminating the challenge of interacting simultaneously with many separate diagnostic systems, driving optimized workflow and improved productivity. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
SOURCE: Stereotaxis, Inc.
Tags:
Investimenti, Stereotaxis, Stereotaxisdi Giancarlo Nicoli
May
13
Stereotaxis Announces Vdrive(TM), a New Technology for Remote Navigation of Diagnostic Devices
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From the press release
ST. LOUIS, May 11, 2010 /PRNewswire via COMTEX/ –Stereotaxis, Inc. (Nasdaq: STXS) today announces the introduction of its new Vdrive(TM), an expansion of its Magnetic Navigation platform that facilitates remote manipulation of diagnostic devices used during electrophysiology (EP) procedures. The company is planning to preview the Vdrive at the HRS meeting this week, and will be commercially available when regulatory processes are complete.
During complex ablation procedures, electrophysiologists commonly use multiple advanced diagnostic catheters and positioning sheaths. Navigation of these devices is a significant component of an electrophysiologist’s workflow. Vdrive is designed to significantly improve the efficiency of remote procedures.
Vdrive works with Stereotaxis’ Magnetic Platform and enables the electrophysiologist to fully and remotely control diagnostic catheters and accessories. The Vdrive module will be installed near the patient table and disposable components will be needed for each procedure. The disposable for circular mapping catheter control will be made available initially, to be followed shortly thereafter by disposables for sheath and intra-cardiac echocardiography (ICE) control.
Vdrive will join QuickCAS(TM), Stereotaxis’ catheter advancement system, as the fundamental elements of Stereotaxis’ disposable product portfolio. Vdrive uses mechanical and electronic controls for its remote operations and is expandable to work with major types of EP diagnostic catheters.
“Stereotaxis is committed to developing long-term solutions for our EP customers,” said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis, Inc. “By providing physicians with a helping hand to control diagnostic catheters and accessories, Vdrive has the potential to enable a much simplified and enhanced EP workflow and much improved efficiency. This significant product milestone is a direct outcome of our global collaboration with EP industry thought leaders, and an exciting result of our ongoing investment in strategic product innovations.”
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of arrhythmias and coronary artery disease. The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The unparalleled clinical capability of Stereotaxis has driven more than 130 hospitals to adopt magnetic navigation for a growing number of complex ablation cases in all four chambers of the heart. Stereotaxis technology is now installed and used by 9 out of the Top 10 Best U.S. Heart Hospitals as ranked by U.S. News and World Report, and more than one third of the EP academic training centers in the United States have included Stereotaxis into their arrhythmia treatment laboratories. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe, Canada and elsewhere.
About Odyssey
The Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information around the world. Odyssey Vision standardizes data integration for magnetic and standard interventional labs by enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Through its proprietary data compression technology, Cinema enables sharing of live and recorded procedure data via a laptop anywhere over a secure high speed Internet connection. Hospitals can also share procedures with other institutions using Odyssey Network Connect providing a global forum for defining clinical best practices across a broad spectrum of medical procedures.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
SOURCE: Stereotaxis, Inc.
Tags:
Investimenti, Stereotaxis, Stereotaxisdi Giancarlo Nicoli
May
9
Stereotaxis Reports First Quarter 2010 Financial Results
Filed Under Investimenti, Stereotaxis | Leave a Comment
from the press release
–Recurring Revenue Increases 26% to a Record $5.4 Million
–Record Gross Margin of 72.5%
–Operating Loss Decreases 12% to $6.3 Million
–Cash Burn Decreases 44% to $6.4 Million
–2010 Guidance Reiterated
ST. LOUIS, May 6, 2010 /PRNewswire via COMTEX/ –Stereotaxis, Inc. (Nasdaq: STXS) today reported financial results for the first quarter ended March 31, 2010 highlighted by recurring revenue and gross margin achieving record levels while operating losses continued to decline. In addition, the Company reported that its efforts to drive clinical adoption within the U.S. market are favorably impacting utilization rates.
Revenue for the recent first quarter was $10.6 million compared with $11.1 million in the same quarter a year ago. Deferred revenue of $8.1 million at March 31, 2010 increased by $0.9 million from December 31, 2009. The increase was principally due to the deferral of one Niobe system where title was transferred, however other revenue recognition criteria were not met by March 31, 2010. The Company recognized revenue on four Niobe(R) Magnetic Navigation Systems. Disposables, services and accessories revenue set another record at $5.4 million, 26% above recurring revenue in the first quarter of 2009, largely due to growth in clinical procedures. Recurring revenue comprised 51% of the total revenue in the quarter.
Michael P. Kaminski, President and Chief Executive Officer, said, “Our strategy to drive deeper penetration into the U.S. market is progressing as planned on all fronts. The organizational, clinical adoption and training elements of this strategy are all designed to drive utilization of Niobe for the treatment of complex cardiac arrhythmias. Growth in U.S. utilization is on plan, which is a direct result of our refocused approach. We are working closely with institutions and clinicians to provide continual learning, and realize full value of the magnetic navigation platform. The significant growth in clinical utilization demonstrates the success of this approach and we believe it will be the catalyst for driving market adoption of our technology.”
Mr. Kaminski continued. “During the quarter, we generated new orders totaling $7.3 million. $5.8 million of the new orders are related to five Niobe systems, one in the U.S., three in Europe and one in Asia Pacific, as well as $1.5 million in orders for Odyssey. As U.S. customers realize the full value of the system and reference sites strengthen, we are confident that sales of the Niobe platform will increase. At the same time, Odyssey continues to represent an important avenue for growth in 2010, in both Niobe and traditional non-magnetic labs. Outside of the U.S., in both Europe and Asia, our Niobe sales remain strong. In addition, revenue per patient continues to trend favorably as our first quarter 2010 results exceeded 2009 levels.
“For the remainder of the year, our top priorities continue to be driving clinical utilization and adoption for complex EP procedures, increasing U.S. Niobe order rates, and building Odyssey orders through internal sales efforts as well as with potential channel partners. At the same time, we are generating very strong gross margins, achieving another record in the first quarter, as recurring revenue comprised over 50% of total revenue. With our continued focus on operating expenses, we believe we can leverage revenue growth to substantially enhance our bottom-line performance during the year,” concluded Mr. Kaminski.
First Quarter 2010 Financial Performance
Gross margin for the quarter was $7.7 million, or 72.5% of revenue, flat with gross margin dollars but an increase from the 68.9% of revenue in the first quarter of 2009. First quarter operating expenses decreased 6% to $14 million from $14.8 million in the first quarter of the prior year. Cash burn improved 44% to $6.4 million for the first quarter of 2010 compared with $11.5 million in the first quarter of 2009.
The operating loss in the first quarter was $6.3 million compared with $7.1 million in the prior year. The Company reported a net loss for the first quarter of 2010 of $8.4 million, or $0.17 per share. The net loss includes an adjustment in value for warrants issued in 2008 of $0.03 per share that results from the appreciation in the Company’s stock price at March 31, 2010 versus December 31, 2009. This compares with a net loss for the first quarter of 2009 of $7.5 million, or $0.18 per share. The weighted average shares for the recent first quarter totaled 49.6 million compared with 41.3 million in the first quarter of last year. The increase was due in large part to the issuance of 7,475,000 shares as part of the stock offering completed in October 2009.
Cash and equivalents at March 31, 2010 totaled $24.5 million, compared with $30.5 million at December 31, 2009. Total debt was $22.7 million, including $10 million drawn against the Company’s $30 million line of credit.
2010 Financial Guidance
The Company reaffirmed its outlook for 2010 as follows:
- New capital order growth in excess of 40%
- Total revenue growth in the mid-20% range
- Gross margins above 65%
- Operating expenses between $60 and $65 million
Conference Call Information
The Company has scheduled a conference call for 8:30 a.m. Eastern Time today to discuss its financial results for the first quarter. To access the conference call, please dial (877) 941-2930. International participants can call (480) 629-9690. An audio replay of the call will be available for seven days following the call at (800) 406-7325 for U.S. callers or (303) 590-3030 for those calling outside the U.S. The password required to access the replay is 4284791#. The call will also be available on the Internet live and for 90 days thereafter at the following URL:
http://www.videonewswire.com/event.asp?id=68445
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. Stereotaxis’ Odyssey solutions integrate and manage information from disparate information sources, eliminating the challenge of interacting simultaneously with many separate diagnostic systems, driving optimized workflow and improved productivity. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
STEREOTAXIS, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
------------------
March 31,
---------
2010 2009
---- ----
Revenue
System $5,233,755 $6,860,807
Disposables, service and accessories 5,382,854 4,272,327
--------- ---------
Total revenue 10,616,609 11,133,134
Cost of revenue
System 2,076,717 2,563,483
Disposables, service and accessories 843,953 897,199
------- -------
Total cost of revenue 2,920,670 3,460,682
Gross margin 7,695,939 7,672,452
Operating expenses:
Research and development 3,369,538 3,309,862
Sales and marketing 6,695,117 7,453,439
General and administration 3,890,336 4,038,156
Total operating expenses 13,954,991 14,801,457
---------- ----------
Operating loss (6,259,052) (7,129,005)
Other income/(expense) (1,537,169) 250,937
Interest income 2,782 26,972
Interest expense (633,118) (678,991)
-------- --------
Net loss $(8,426,557) $(7,530,087)
=========== ===========
Net loss per common share:
Basic and diluted $(0.17) $(0.18)
Weighted average shares used in
computing net loss per common share:
Basic and diluted 49,621,318 41,281,130
STEREOTAXIS, INC.
BALANCE SHEETS
December
March 31, 31,
--------- ---------
2010 2009
--- ---
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $24,512,979 $30,546,550
Accounts receivable, net of allowance
of $177,362 and $322,463 in 2010 and
2009, respectively 10,580,935 11,152,648
Current portion of long-term
receivables 66,800 66,800
Inventories 4,940,183 4,403,675
Prepaid expenses and other current
assets 4,048,203 3,872,535
--------- ---------
Total current assets 44,149,100 50,042,208
Property and equipment, net 4,584,611 4,790,310
Intangible assets 1,111,111 1,144,445
Long-term receivables 127,762 138,441
Other assets 5,113 5,112
----- -----
Total assets $49,977,697 $56,120,516
=========== ===========
Liabilities and stockholders' equity
Current liabilities:
Current maturities of long-term debt $14,166,666 $3,333,333
Accounts payable 5,037,547 3,881,205
Accrued liabilities 6,995,774 8,615,287
Deferred revenue 8,120,584 7,191,492
Warrants 5,679,783 4,142,614
--------- ---------
Total current liabilities 40,000,354 27,163,931
Long term debt, less current
maturities 8,489,530 20,346,655
Long term deferred revenue 822,928 948,574
Other liabilities 16,733 20,013
Stockholders' equity:
Preferred stock, par value $0.001;
10,000,000 shares authorized at 2010
and 2009; none outstanding at 2010
and 2009 - -
Common stock, par value $0.001;
100,000,000 shares authorized at 2010
and 2009; 50,424,664 and 50,208,171
issued at 2010 and 2009, respectively 50,425 50,208
Additional paid-in capital 332,683,067 331,249,918
Treasury stock, 40,151 shares at 2010
and 2009 (205,999) (205,999)
Accumulated deficit (331,879,341) (323,452,784)
------------ ------------
Total stockholders' equity 648,152 7,641,343
------- ---------
Total liabilities and stockholders'
equity $49,977,697 $56,120,516
=========== ===========
SOURCE: Stereotaxis, Inc.
Tags:
Investimenti, Stereotaxis, Stereotaxisdi Giancarlo Nicoli
May
5
Stereotaxis Updates Progress on Major Clinical Initiative Related to Electrophysiology (EP) Treatment of Ventricular Tachycardia
Filed Under Investimenti, Stereotaxis | Leave a Comment
from the press release
Stereotaxis Updates Progress on Major Clinical Initiative Related to Electrophysiology (EP) Treatment of Ventricular Tachycardia
ST. LOUIS, May 4, 2010 /PRNewswire via COMTEX/ –Stereotaxis, Inc. (Nasdaq: STXS) today updates progress on a global multi-center clinical study on ventricular tachycardia treatment outcomes by using the company’s proprietary Niobe(R) Magnetic Navigation System.
Ventricular tachycardia (VT) is a life-threatening arrhythmia because it may lead to ventricular fibrillation, asystole, and sudden death. VT is one of the most challenging arrhythmias facing electrophysiologists due to complex anatomy, the sensitive nature of ventricular tissue, and potentially lethal outcomes. Catheter ablation of VT, one of the fastest growing EP procedures globally, requires the delivery of robust lesions for clinical success.
The prospective multi-center clinical effort, named “Study to Obliterate Persistent Ventricular Tachycardia” (STOP-VT), will be conducted at The Hospital of University of Pennsylvania, Methodist Hospital (Indianapolis), Na Holmoce Hospital (Prague), Loyola University Medical Center (Chicago), and Herzentrum Leipzig GmbH (Germany). During the upcoming 31st Annual Heart Rhythm Society Scientific Sessions in Denver, CO, Petr Neuzil, MD, PhD, from Na Holmoce Hospital in Prague, will present a poster detailing the early results of the “STOP-VT” study.
“Based upon our excellent clinical results, we believe that treatment with magnetically-enabled radiofrequency catheters can effectively terminate a vast majority of documented ventricular tachycardias in patients who had suffered a previous heart attack,” commented Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis, Inc. “This global initiative further exemplifies our commitment to developing long-term solutions for our EP customers.”
“Ablation of ventricular tachycardia is an excellent application for Stereotaxis magnetic navigation,” said John Miller, MD, Professor of Medicine, Krannert Institute of Cardiology, Indiana University School of Medicine. “Our experience has been that the precise intricate mapping and enhanced safety of magnetic navigation allows us to perform successful ablation of complex arrhythmias without the pitfalls associated with manual techniques.”
During the upcoming 31st Annual Heart Rhythm Society Scientific Sessions in Denver, CO, additional VT outcome data will be presented by established Stereotaxis users. Hiroshi Nakagawa, MD, PhD, Co-Director of the Heart Rhythm Institute at the University of Oklahoma Health Sciences Center and one of the world’s foremost experts on contact force and lesion formation, will present a paper entitled, “Substrate Ablation of Scar Ventricular Tachycardia Using Magnetic Catheter Maneuvering System.” In addition to the VT data, several Stereotaxis users from around the world will present clinical results related to atrial fibrillation (AF), pediatric and congenital arrhythmia, supraventricular tachycardia (SVT), atrial flutter, and use with implantable devices through a series of presentations and posters.
The unparalleled clinical capability of Stereotaxis has driven more than 130 hospitals to adopt magnetic navigation for a growing number of complex ablation cases in all four chambers of the heart. Stereotaxis technology is now installed and used by 9 out of the Top 10 Best U.S. Heart Hospitals as ranked by U.S. News and World Report. More than one third of the EP academic training centers in the United States have included Stereotaxis into their arrhythmia treatment laboratories.
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of arrhythmias and coronary artery disease. The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe, Canada and elsewhere.
About Odyssey
The Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information around the world. Odyssey Vision standardizes data integration for magnetic and standard interventional labs by enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Through its proprietary data compression technology, Cinema enables sharing of live and recorded procedure data via a laptop anywhere over a secure high speed Internet connection. Hospitals can also share procedures with other institutions using Odyssey Network Connect providing a global forum for defining clinical best practices across a broad spectrum of medical procedures.
SOURCE: Stereotaxis, Inc.
Tags:
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