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WCTF.org Transplant News

Transplant news, links, and other general medical news -- updated regularly.


Monday, May 12, 2008

 

Transplant agency reviews liver surgeries after report (The Daily American)

PITTSBURGH — A national transplant agency has begun a review of liver transplants after a newspaper reported that hundreds performed annually were unnecessary and caused patients to die earlier than they would have without a transplant. [more]

 

Astellas: U.S. not ready to approve transplant drug (Reuters via Yahoo! Philippines News)

TOKYO, May 7 - Japan's Astellas Pharma said on Wednesday it would suffer further delays in approval for a new version of its key transplant drug after U.S. authorities said they were not ready to approve it for liver transplants. [more]

 

Care Gateway

Heart transplant Definition Heart transplantation is a surgical procedure to remove a damaged or diseased heart and replace it with a healthy donor heart. [more]

 

Growing a new organ (Fortune Small Business via Yahoo! Finance)

Some 15,000 Americans are on a waiting list for a liver transplant, and it is a grueling - and ghoulish - vigil. Most organs available for transplant come from someone who has died in an accident. [full story]

 

Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device

Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device

WALTHAM, Mass., May 12 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (BULLETIN BOARD: ABOS) announced today that the Company has received approval from the U.S. Food and Drug Administration ("FDA") of an Investigational Device Exemption ("IDE") to begin the pivotal clinical trial for SEPET(TM), Arbios' extracorporeal (outside the body) liver assist device for blood purification of acutely ill patients suffering from chronic liver disease.

"We are pleased to have received FDA approval to start the SEPET pivotal trial and to have fully satisfied the points addressed in the FDA's previously issued conditional approval," commented CEO and President Shawn Cain. "We were pleased with the compelling results from the SEPET feasibility trial, and we are excited to initiate the pivotal clinical phase of SEPET's development. The pivotal trial design includes adaptive measures to optimize our ability to achieve the trial's primary and secondary endpoints. We believe that the pivotal trial, if successful, should support our filing for approval of SEPET in the United States and marketing efforts in the United States and the European Union. Further, we believe that the design of this trial will enhance physician acceptance of SEPET as a much needed tool in sustaining patients through acute life threatening episodes of liver failure, a market which we believe exceeds a billion dollars annually."

Trial Design

There are three segments to the pivotal trial design. During the first segment of the trial, 5 non-randomized patients will be treated with SEPET to allow us to validate the patient selection criteria, clinical protocol, case report forms, and other trial related documents. During the second segment of the trial, we expect to enroll 116 patients in this randomized, controlled phase of the trial. This segment is targeted to achieve the co-primary endpoints, which are 1) the percentage of patients achieving improvement in hepatic encephalopathy ("HE") grade by a minimum of two grades by the end of Day 7 in the SEPET treatment group versus the standard medical care group, using a 1:1 randomization between the two groups; and 2) the 30-day transplant free survival rate in all patients (i.e. control and treatment groups) who do reach a two grade HE improvement versus all patients who do not reach a two grade HE improvement. Pending review and approval by the Data Safety Monitoring Board, the third segment would permit the size of the trial to be increased by an additional 52 patients, if the co-primary efficacy endpoints are reached or have not reached statistical significance but have shown a positive trend. If the co-primary endpoints of the trial are reached upon completion of segment two, extension of the trial into segment three may result in the achievement of statistical significance of one or more secondary endpoints of the trial relating to clinical, functional, and reimbursement advantages for SEPET treatment over standard medical care.

Patient Inclusion/Exclusion Criteria for the Trial

To be a candidate for the pivotal trial, a patient must have chronic liver disease and be experiencing an acute episode that results in hospitalization with an HE grade of between II and IV. In addition, the patient must not be responding satisfactorily to standard medical care (e.g. fluid replacement, antibiotics, lactulose) for 20 to 26 hours prior to randomization. Patients contraindicated for a liver transplant (e.g. advanced liver cancer patients and drinking alcoholics) are excluded from the trial.

"We hope to shortly receive permission from the German regulatory authority to begin segment one of the pivotal trial at one or two clinical sites in Germany," commented Mr. Cain. "Over the next several months we will also seek IRB approvals for up to 24 clinical sites in the United States and Europe. While we currently have very limited financial resources, we hope that the FDA's approval to initiate the pivotal trial may enable us to raise the capital needed to implement our clinical and regulatory plans for SEPET."

About Arbios' SEPET(TM) Liver Assist Device

The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge containing microporous hollow fibers with proprietary permeability characteristics. When a patient's blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (e.g., hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). These substances would otherwise progressively accumulate in the patient's bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver. SEPET(TM) is designed for use with standard blood dialysis systems available in hospital intensive care units.

According to the American Liver Foundation, liver disease is among the top seven causes of death in adults in the United States between the ages of 25 - 64. In fact, one out of every 10 Americans has some form of liver disease. There is currently no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable through provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions, such as respiration.

About Arbios Systems

Arbios Systems, Inc. is developing proprietary medical devices and cell-based therapies to enhance the survival of millions of patients each year who experience, or are at risk for, life-threatening episodes of liver failure. The Arbios product candidate portfolio includes the SEPET(TM) Liver Assist Device, a novel blood purification therapy that provides enhanced "liver dialysis," and the HepatAssist(TM) Cell-Based Liver Support System, a bio-artificial liver that combines blood detoxification with liver cell therapy to replace whole liver function in patients with the most severe forms of liver failure. For more information on the Company, please visit http://www.arbios.com/.

This press release contains forward-looking statements, including, but not limited to, statements regarding the Company's belief that, the pivotal trial, if successful, should support approval of SEPET in the United States and marketing efforts in the United States and the European Union, the Company's expectations with respect to the timing, design and implementation of the pivotal trial, including the Company's plans with respect to seeking approvals for sites to conduct the pivotal trial, and the Company's hope that the FDA's approval to initiate the pivotal trial, may enable us to raise the capital needed to implement our clinical and regulatory plans for SEPET. The forward- looking statements contained in this press release involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the Company's ability to timely and successfully raise capital, the goals and results of clinical trials, compliance with regulatory requirements, the likelihood of obtaining marketing approval, labeling of the Company's products, the need for subsequent substantial additional financing to complete clinical development of its products, future markets and demand for the Company's products, and Arbios' ability to successfully market its products and technologies. These statements represent the judgment of Arbios' management as of this date and are subject to risks and uncertainties that could adversely affect the Company. Arbios cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements. Please refer to our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007, and to our subsequent Quarterly Reports on Form 10-Q, for a description of risks that may affect our results or business conditions. The Company does not undertake any obligation to publicly release the result of any revisions to such forward- looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events except as required by law. SEPET(TM) and HepatAssist(TM) are trademarks of Arbios Systems, Inc.

First Call Analyst:
FCMN Contact:


Source: Arbios Systems, Inc.

CONTACT: Shawn Cain, President and CEO, +1-781-839-7292, Scott Hayashi,
CFO, +1-626-356-3105, both of Arbios; Investors, Lisa Wilson, +1-212-759-3929;
Media, Doug MacDougall, +1-781-235-3060

Web site:

http://www.arbios.com/


-------
Profile: Transplant News


 

Novadaq Reports Financial Results for the First Quarter of 2008

Novadaq Reports Financial Results for the First Quarter of 2008

TORONTO, May 12 /PRNewswire-FirstCall/ -- Novadaq(R) Technologies Inc. (TSX: NDQ), a developer of real-time imaging and image guidance systems for use in the operating room, today announced financial results for the first quarter ended March 31, 2008. In this press release, unless otherwise indicated, all dollar amounts are expressed in US dollars.

Q1 2008 Highlights

- SPY gaining traction with 14 new SPY systems installed, 22% increase
in SPY consumable sales and 20% increase in SPY capital revenue from
Q4 2007.

- Sentara Hospital System, Virginia's largest cardiac surgery program
completes multiple SPY System capital purchase and adopts SPY as
standard of care.

- SPY adopted in 9 leading plastic and reconstructive surgery centers
(including Cleveland Clinic, Duke University, and University of
Southern California) since Q4 2007 launch.

- SPY Scope testing in large animal model continues to demonstrate
efficacy of SPY imaging in minimally invasive surgery applications
and is on-track for human trials in Q4 2008.

Events Subsequent to Q1 2008

- Positive results from two European centers using OPTTX presented at
the Association for Research in Vision and Ophthalmology annual
meeting support OPTTX partnership opportunities.

"I am pleased with the developing fundamentals of the SPY business as we had our best quarter for SPY placements, and showed strong growth in consumable and capital sales." said Dr. Arun Menawat, President and Chief Executive Officer of Novadaq Technologies Inc. "Plastic surgery has been a catalyst in accelerating SPY adoption, and continued growth in SPY will be supported by the launch of quantification software in the second half of 2008 and by our continued support in getting surgeons paid for SPY procedures."

Financial Results

Quarter Ended March 31, 2008 "Q1-2008" Compared to Quarter Ended
March 31, 2007 "Q1-2007"

Revenue increased to approximately $2,773,000 in Q1-2008 from approximately $1,427,000 in Q1-2007. Recurring revenue, which includes SPY and TMR consumables, rentals and parts increased from approximately $693,000 in Q1-2007 to $1,496,000 in Q1-2008. The primary reason for the increase is that TMR consumable revenue was recognized for a full quarter in 2008. Capital sale revenue increased from approximately $734,000 in Q1-2007 to $919,000 in Q1-2008, as an increase in SPY capital of $540,000 was partly offset by a decrease in TMR capital of $363,000. Service revenue, which increased from nil in Q1-2007 to approximately $358,000 in Q1-2008 relates partly to the TMR business which was acquired in the last few days of Q1-2007, and to PINPOINT, which was acquired after Q1-2007.

Recurring revenue and service revenue increased from Q4-2007 to Q1-2008 whereas capital sale revenue decreased, as an increase in SPY capital sale revenue was more than offset by decreases in TMR and PINPOINT capital revenue.

Gross profit increased to approximately $1,305,000 in Q1-2008 from approximately $679,000 in Q1-2007 as a result of the increase in revenue described above. Gross profit as a percent of sales was substantially unchanged.

Sales and marketing expenses increased by approximately $567,000 to approximately $2,784,000 in Q1-2008 from approximately $2,217,000 in Q1-2007 due to expansion of a direct sales team through 2007 and into 2008. $242,000 of the increase occurred from Q4-2007 to Q1-2008.

Research and development expenses increased by approximately $317,000 to approximately $1,612,000 in Q1-2008 from approximately $1,295,000 in Q1-2007. The increase relates primarily to the establishment of a research and development center in Vancouver B.C. staffed by former employees of Xillix. Research and development expenses in Q1-2008 increased by $79,000 from Q4-2007. The increase related primarily to patent costs.

General and administration expenses increased by approximately $581,000 to approximately $1,459,000 in Q1-2008 from $878,000 in Q1-2007. Increases relate primarily to costs incurred to defend patents in Japan and general increases to support a direct sales team, and the acquired TMR business. General and administrative expenses in Q1-2008 decreased by $50,000 from Q4-2007 due to lower professional fees.

Depreciation expense increased to approximately $89,000 in Q1-2008 from approximately $52,000 in Q1-2007 primarily as a result of computer equipment purchased in 2007 for sales representatives hired during the period. Depreciation expense in Q1-2008 was generally consistent with Q4-2007.

Amortization increased by from $121,000 in Q1-2007 to $308,000 in Q1-2008 as a result of the acquisition of intangibles related to TMR and Xillix. Amortization in Q1-2008 was slightly higher than amortization in Q4-2007 because the final earn out amount associated with the TMR acquisition was calculated effective December 31, 2007.

The Company had interest expense in Q1-2007 of approximately $9,000 relating to a $3,000,000 note payable issued on March 20, 2007 in connection with the acquisition of TMR distribution rights. The note was repaid in 2007 and there was no interest expense in Q1-2008.

Interest income decreased by approximately $36,000 to $158,000 in Q1-2008 from $194,000 in Q1-2007. The primary reason was lower interest rates.

Net loss increased by approximately $1,138,000 to approximately $4,839,000 in Q1-2008 from approximately $3,701,000 in Q1-2007 primarily as a result of an increase in sales and marketing costs of approximately $567,000, an increase in R&D expenses of approximately $317,000, an increase in general and administrative expenses of approximately $581,000 which were partly offset by an increase in gross profit of $626,000.

As at March 31, 2008 the Company had cash, cash equivalents and short-term investments of approximately $14,775,000, a decrease of approximately $4,086,000 from December 31, 2007. Approximately $4,075,000 of the decrease relates to a net loss incurred during the period after deducting items not involving cash, a source of approximately $2,489,000 in net changes in non-cash working capital relating primarily to the collection of accounts receivable from Edwards, an investment in the TMR business of $2,089,000 relating to the payment to Edwards of earn-out purchase consideration, and an investment of approximately $436,000 in property, plant and equipment.

As at March 31, 2008 there were a total of 24,533,982 common shares (26,094,395 on a fully diluted basis) and no preferred shares outstanding. As at March 31, 2008 a total of 1,560,413 stock options were outstanding under the Company's employee stock option plan.

Conference call

Novadaq will host a conference call on Monday, May 12, 2008 at 10:00 a.m. EST to discuss the financial results for the first quarter ended March 31, 2008. To access the conference call by telephone, dial 416-644-3422 or 1-800-731-5319. Please connect approximately ten minutes prior to the beginning of the call to ensure participation. The conference call will be archived for replay until May 19, 2008 at midnight. To access the archived conference call, dial 416-640-1917 or 1-877-289-8525 and enter the reservation number 21270216 followed by the number sign.

A live audio webcast of the conference call will be available at www.novadaq.com. Please connect at least ten minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived at the above website for 365 days.

For complete financial results, please see our filings at www.sedar.com.

About Novadaq Technologies

Novadaq Technologies Inc. commercializes real-time imaging and image guidance systems for use in the operating room. With one set of proprietary core technologies, Novadaq's products have multiple applications. Novadaq's SPY System enables cardiac surgeons to diagnose intra-operatively by visually assessing coronary vasculature and bypass graft functionality during the course of heart bypass surgery. The SPY System is also indicated for use during other surgeries, such as cardiovascular, plastic, reconstructive, organ transplant and urological procedures. SPY can be used to visualize blood vessels, tumors, tumor margins and the lymphatic system. Novadaq introduced PINPOINT, its first minimally invasive imaging system for autofluorescence in October 2007. PINPOINT allows surgeons to differentiate between healthy and cancerous tissue in the lung and other hollow organs. Further expanding its portfolio of minimally invasive products, Novadaq is developing SPYscope which combines the typical features of a standard endoscope with the additional capabilities of SPY imaging. Novadaq is the exclusive United States distributor of PLC Medical's CO2 HEART LASER System, used in the same cardiac procedures as the SPY System. Novadaq also offers the OPTTX(R) System, which leverages the company(1)s core imaging technology and is designed for the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD). For more information, please visit the company's website at www.novadaq.com.

Forward looking Statements

Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Novadaq's current beliefs as well as assumptions made by and information currently available to Novadaq and relate to, among other things, results of future clinical tests of PINPOINT and the SPY System, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONSOLIDATED BALANCE SHEET
(expressed in U.S. $)
Unaudited

March 31, December 31,
2008 2007
$ $
--------------------------

ASSETS
Current
Cash and cash equivalents 7,514,062 7,417,929
Short-term investments 7,261,108 11,443,506
Accounts receivable 2,259,637 4,743,994
Current portion of prepaid expenses and
other receivables 1,119,484 1,185,707
Inventory 1,744,899 2,031,932
--------------------------
Total current assets 19,899,190 26,823,068
--------------------------
Long-term investments 426,000 426,000
Long-term receivable 52,312 -
Property, plant and equipment, net 2,942,731 2,785,342
Prepaid expenses 340,290 323,761
Deferred development costs 331,183 331,183
Intangible assets 10,722,513 11,030,760
--------------------------
34,714,219 41,720,114
--------------------------
--------------------------

LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 3,991,841 6,289,722
Current portion of deferred revenue 908,729 995,099
--------------------------
Total current liabilities 4,900,570 7,284,821
--------------------------
Deferred revenue 461,145 446,118
--------------------------
Total liabilities 5,361,715 7,730,939
--------------------------

Shareholders' equity
Share capital 80,134,644 80,109,644
Contributed surplus 4,462,448 4,285,187
Accumulated other comprehensive loss (69,000) (69,000)
Deficit (55,175,588) (50,336,656)
--------------------------
Total shareholders' equity 29,352,504 33,989,175
--------------------------
34,714,219 41,720,114
--------------------------
--------------------------

CONSOLIDATED STATEMENTS OF LOSS AND
COMPREHENSIVE LOSS AND DEFICIT
(expressed in U.S. $)
Unaudited

Three months Three months
ended ended
March 31, March 31,
2008 2007
$ $
--------------------------

Revenues
Product sales 2,414,585 1,427,424
Service revenue 358,077 -
--------------------------
Total revenues 2,772,662 1,427,424
Cost of sales 1,468,191 748,062
--------------------------
Gross profit 1,304,471 679,362
--------------------------

Operating expenses
Sales and marketing 2,784,126 2,216,885
Research and development 1,612,091 1,294,876
General and administration 1,459,018 878,466
Depreciation 88,815 51,955
Amortization 308,247 121,522
Loss on foreign exchange 49,526 1,418
--------------------------
6,301,823 4,565,122
--------------------------
Loss before the following (4,997,352) (3,885,760)
Interest expense - (9,396)
Interest income 158,420 194,023
--------------------------
Net loss and comprehensive loss for the period (4,838,932) (3,701,133)

Deficit, beginning of period (50,336,656) (34,675,721)
--------------------------
Deficit, end of period (55,175,588) (38,376,854)
--------------------------
--------------------------

Basic and fully diluted loss per share (0.20) (0.19)
--------------------------
--------------------------

CONSOLIDATED STATEMENTS OF CASH FLOWS
(expressed in U.S. $)
Unaudited

Three months Three months
ended ended
March 31, March 31,
2008 2007
$ $
--------------------------

OPERATING ACTIVITIES
Net loss for the period (4,838,932) (3,701,133)
Add items not involving cash
Depreciation and amortization 586,845 368,599
Stock option compensation 177,261 93,212
--------------------------
(4,074,826) (3,239,322)
Net change in non-cash working capital
balances related to operations 2,488,832 (217,612)
--------------------------
Cash provided by (used in) operating
activities (1,585,994) (3,456,934)
--------------------------

FINANCING ACTIVITIES
Issuance of common shares, net 25,000 -
--------------------------
Cash provided by financing activities 25,000 -
--------------------------

INVESTING ACTIVITIES
Research and development costs - (37,892)
Purchase of plant, property and equipment (435,987) (515,766)
Purchase of TMR business (2,089,284) (2,386,117)
Sale of short-term investments, net 4,182,398 4,691,291
--------------------------
Cash provided by investing activities 1,657,127 1,751,516
--------------------------

Net increase (decrease) in cash and cash
equivalents during the period 96,133 (1,705,418)
Cash and cash equivalents, beginning of period 7,417,929 2,311,973
--------------------------
Cash and cash equivalents, end of period 7,514,062 606,555
--------------------------
--------------------------

Source: Novadaq Technologies Inc.

CONTACT: visit our website at www.novadaq.com, or contact: Arun Menawat,
PhD, MBA, President & CEO, Novadaq Technologies Inc., (905) 629-3822 x 202,
amenawat@novadaq.com; Michael Moore, Investor Relations, The Equicom Group,
(416) 815-0700 x 241, mmoore@equicomgroup.com


-------
Profile: Transplant News


 

Lung Transplant Program - Home

Cedars-Sinai blends the multidisciplinary expertise of an experienced team of surgeons, pulmonologists, diagnostic imaging specialists and specially trained transplant nurses to [more]

 

SpineMark Appoints Wendy L. Wilts as EVP of Operations

SpineMark Appoints Wendy L. Wilts as EVP of Operations

Key Executive Hire Supports Company's Continued Growth

SAN DIEGO, May 12 /PRNewswire/ -- SpineMark Corporation, a spine care services organization that partners with hospitals and physicians to develop spine centers, has hired Wendy L. Wilts as executive vice president of operations. She will be responsible for managing the day-to-day operations of the company and its subsidiaries.

"Wendy is an important addition to the SpineMark executive team and comes at a key time for us," said Marcy T. Rogers, M.Ed., president and CEO of SpineMark. "We have hit many 'firsts' with our SpineMark CRO Management and the launching of our first two regional SRO's in Denver and Los Angeles. Wendy's deep experience in practice management, physician recruitment and program development allows her to effectively translate our vision and help us continue to grow our unique model of providing hospital and physician partners with infrastructure and resources that improve the quality of life of patients with spine disorders and injuries."

Wilts brings more than 25 years of experience in healthcare operations to her role at SpineMark. Most recently, she was vice president of operations for Sanford Health System's neurosciences and hospital-based services division, where she worked with SpineMark to develop a Spine Center of Excellence. She was also charged with building a transplant program and expanding the facility's hospitalist and intensivist programs.

"The concept of Centers of Excellence is revolutionary for the industry, and SpineMark's dedication to ensuring that patients can receive quality care for their health issues through this effort made the decision to join the company a very simple one," Wilts said. "My experience working with SpineMark to build a Spine Center of Excellence within Sanford Health System allowed me to see the ins and outs of such an undertaking and how well equipped this company is to continue this paradigm shift in the healthcare industry."

In her 14 years with Sanford Health System, Wilts served in a number of roles, including vice president of operations for the surgical and cardiovascular departments, director of cardiovascular services, director of practice development and regional director of operations for the primary care division.

Wilts began her career with the Central Plains Clinic where, as clinic manager, she was responsible for the day-to-day management of three primary care sites and after-hours services.

Wilts is affiliated with numerous groups, including the Medical Group Management Association (national and South Dakota chapter), the American College of Medical Practice Executives, Institute of Healthcare Improvement and the National HealthCare Advisory Board. Wilts studied biology at Augustana College before transferring to the University of South Dakota and earning a bachelor's degree in business administration. She also received Lean HealthCare Certification through the University of Michigan.

About SpineMark

SpineMark Corporation is an innovative service organization dedicated to transforming the delivery of spine care. The company partners with hospitals and physicians across the United States and abroad to develop and operate comprehensive, evidence-based spine centers of excellence. By building a global network of spine centers, spine research organizations and state-of-the-art medical conference facilities, SpineMark is improving the overall quality of life of patients afflicted with spine disorders and injuries.

Driven by the specialized experience and expertise of its leadership team and medical advisory board, SpineMark's goal is to create a global network, based on clinically validated best practices for spine care that streamline diagnosis and treatment, simplify referrals and accelerate the recovery process.

First Call Analyst:
FCMN Contact:


Source: SpineMark Corporation

CONTACT: Julie Johnson of WeissComm Partners, +1-451-946-3681,
jjohnson@wcpglobal.com, for SpineMark Corporation


-------
Profile: Transplant News


 

Novadaq appoints John T. Reidy Chief Financial Officer

Novadaq appoints John T. Reidy Chief Financial Officer

Former GE Healthcare Canada Country Financial Officer Joins Novadaq

TORONTO, May 12 /PRNewswire-FirstCall/ -- Novadaq(R) Technologies Inc. (TSX: NDQ), a developer of real-time imaging and image guidance systems for use in the operating room, today announced that John T. Reidy, has been appointed Chief Financial Officer of Novadaq Technologies Inc., assuming the role on June 1, 2008. Novadaq also announced today that Roger Deck, current Chief Financial Officer, will move to a senior business management role within the Company and will work closely with Dr. Rick Mangat, Novadaq VP and General Manager, to further strengthen operating activities of the business.

Mr. Reidy joins Novadaq with more than twenty years of financial management experience. Prior to his appointment at Novadaq and since 2004, Mr. Reidy led the finance department at GE Healthcare Canada where he served as Country Financial Officer and was responsible for a portfolio of business units. Between 1998 and 2004, Mr. Reidy held the position of Head of Risk Management and Operational Review for Amersham, PLC a United Kingdom (U.K.) multinational $2 Billion diagnostics and life sciences company listed in both the U.K. and United States. Throughout his career, Mr. Reidy has held various executive financial management positions with other companies including NCR. Mr. Reidy holds an M.B.A. from the Manchester Business School in Manchester and accounting designations in both the U.K. and Canada.

"John is a veteran of the healthcare and IT industries and is a perfect addition to Novadaq's executive team, as his wealth of experience will further strengthen our collective knowledge and capabilities," said Dr. Arun Menawat, President and CEO of Novadaq Technologies Inc. "I am also excited to have Roger in his new role, as he has made significant contributions during his tenure at Novadaq."

About Novadaq Technologies

Novadaq Technologies Inc. commercializes real-time imaging and image guidance systems for use in the operating room. With one set of proprietary core technologies, Novadaq's products have multiple applications. Novadaq's SPY(R) System enables cardiac surgeons to diagnose intra-operatively by visually assessing coronary vasculature and bypass graft functionality during the course of heart bypass surgery. The SPY System is also indicated for use during other surgeries, such as cardiovascular, plastic, reconstructive, organ transplant and urological procedures. SPY can be used to visualize blood vessels, tumors, tumor margins and the lymphatic system. Novadaq introduced PINPOINT(TM), its first minimally invasive imaging system for autofluorescence in October 2007. PINPOINT allows surgeons to differentiate between healthy and cancerous tissue in the lungs and other hollow organs. Further expanding its portfolio of minimally invasive products, Novadaq is developing SPYscope which combines the typical features of a standard endoscope with the additional capabilities of SPY imaging. Novadaq is the exclusive United States distributor of PLC Medical's CO(2) HEART LASER System, used in the same cardiac procedures as the SPY System. Novadaq also offers the OPTTX(R) System, which leverages the company's core imaging technology and is designed for the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD). For more information, please visit the company's website at www.novadaq.com.

Forward looking Statements

Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Novadaq's current beliefs as well as assumptions made by and information currently available to Novadaq and relate to, among other things, results of future clinical tests of PINPOINT and the SPY System, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Source: Novadaq Technologies Inc.

CONTACT: visit our website at www.novadaq.com, or contact: Arun Menawat,
PhD, MBA, President & CEO, Novadaq Technologies Inc., (905) 629-3822 x 202,
amenawat@novadaq.com; Michael Moore, Investor Relations, The Equicom Group,
(416) 815-0700 x 241, mmoore@equicomgroup.com


-------
Profile: Transplant News


 

Cytochroma Appoints R. Richard Wieland II As CFO

Cytochroma Appoints R. Richard Wieland II As CFO

MARKHAM, ON, May 12 /PRNewswire/ -- Cytochroma today announced that it has appointed R. Richard Wieland II as its Chief Financial Officer (CFO). Mr. Wieland, 63, brings to Cytochroma nearly 40 years of experience in finance and financial management, at both public and private companies, and will be based in Cytochroma's Illinois office.

"Rich has strong leadership skills, extensive experience managing finance departments and significant expertise in the capital markets," stated Charles W. Bishop, PhD, Cytochroma's President and CEO. "He joins Cytochroma at a critical inflection point in its growth. The Company now has multiple Vitamin D-based therapies in clinical development and it requires a seasoned CFO who can play a key role in expanding and evolving the corporate and financial infrastructure."

Previous to Cytochroma, Mr. Wieland was Executive Vice President & CFO of Advanced Life Sciences where he helped that company list on the NASDAQ stock market in 2005 and prepared it for Sarbanes-Oxley implementation. Mr. Wieland also led the successful initial public offering of MediChem Life Sciences, where he served as Executive Vice President & CFO. Earlier in his career, Mr. Wieland held senior level financial and management positions at BioGenex Laboratories, Cancer Treatment Centers, Fujisawa USA, LyphoMed and Procter & Gamble. He holds an MBA from Washington University and a Bachelor's degree in Accounting and Finance from Monmouth College.

"Cytochroma is at an exciting time in its development and has an outstanding management team in place," stated Mr. Wieland. "As CFO, I look forward to working with this team to build a strong and sustainable specialty pharmaceutical company."

Cytochroma has a diverse portfolio of Vitamin D-based therapeutics designed to treat disorders related to abnormal or insufficient Vitamin D metabolism in chronic kidney disease (CKD) patients. These new products will address target markets that are expected to grow significantly, reaching more than $1.2 billion annually by 2010 in North America alone. Cytochroma has three lead product candidates in development for CKD patients: CTA018 and CTAP201 are being developed for the treatment of secondary hyperparathyroidism (SHPT), while CTAP101 is being developed for the treatment of Vitamin D insufficiency.

About Chronic Kidney Disease

According to the National Kidney Foundation (NKF), more than nine million North American patients suffer from moderate CKD (Stages 3 and 4) to severe CKD (Stage 5). Stages 3 and 4 are characterized by progressively decreasing kidney function as measured by glomerular filtration rate. In Stage 5, kidney function is altogether absent and patients require regular dialysis or kidney transplant for survival. An estimated 70-90% of CKD patients have Vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases. Mounting evidence continues to link Vitamin D insufficiency with CKD progression and increased morbidity and mortality in CKD patients. CKD is most frequently caused by diabetes or hypertension, both of which are consequences of a growing obesity epidemic in countries worldwide.

About Cytochroma

Cytochroma is a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary products to treat and prevent the clinical consequences of Vitamin D insufficiency and SHPT associated with CKD. The Company's Vitamin D-based therapeutics are designed to safely and effectively treat patients with Stage 3, 4 or 5 CKD. In addition, Cytochroma is developing novel therapies to treat hyperphosphatemia in these same patients. For more information, please visit www.cytochroma.com.

Source: Cytochroma Inc.

CONTACT: Eric J. Messner, Vice President, Commercial Operations, Tel:
(847) 236-7707 (Bannockburn, IL), Tel: (905) 479-5306 ext. 338 (Markham, ON),
eric.messner@cytochroma.com; Media Inquiries: Robert Stanislaro, FD, Tel:
(212) 850-5657, robert.stanislaro@fd.com


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Profile: Transplant News


 

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