SEATTLE, WA—Calypso Medical Technologies, Inc., a developer of targeting technology used for accurate, precise real-time tracking of tumor targets, today announced the online publication of a clinical study in Urology (The GOLD JOURNAL). The prospective, multi-site study, entitled, “Assessing the Impact of Margin Reduction (AIM),” is the first outcomes-based study to evaluate the quality of life of high-dose intensity-modulated radiotherapy (IMRT) to the prostate with tightly contoured treatment technically described as “reduced treatment margins.” The study findings demonstrate that the use of the Calypso System during high dose external beam radiation for prostate cancer resulted in a significant reduction in rectal and urinary treatment-related side effects.

“This is the first comparative study to show that margin reduction in prostate cancer radiation therapy has clinically significant and measurable benefits in decreasing acute toxicity and short-term side effects. By reducing acute toxicity, we hope these patients may also experience a significant reduction of long-term side effects,” said Dr. Constantine Mantz, radiation oncologist at 21st Century Oncology in Cape Coral, Fla. and lead investigator of the study. “When prostate cancer patients evaluate treatment options, their objective is to select the therapeutic approach that will cure the cancer while allowing them to remain as fully functional as possible. The Calypso System, which enables physicians to deliver increased doses of radiation directly to the tumor while sparing the surrounding healthy organs from exposure, is fundamental to our overall approach of treating prostate cancer.”

Organ motion is prevalent, variable and unpredictable during radiation therapy and can be caused by normal physiologic events such as  digestion, breathing or coughing. Tracking and responding to this motion is critical for radiation treatments because internal movement of the organ and tumor increases the likelihood that the radiation beam will miss the intended target and deliver radiation to the surrounding healthy tissue, causing side effects. To ensure that the treatment target stays within the path of the radiation beam, physicians typically increase the planning treatment volume (PTV) margin, which is defined as the area of healthy tissue surrounding the prostate tumor that is exposed to the radiation beam.  With real-time tracking of the target using the Calypso technology, physicians are able to decrease the PTV margins, thereby subjecting less healthy tissue to radiation.

Researchers compared the AIM study group of 64 patients to 153 patients in a comparator study1 published in the New England Journal of Medicine in 2008. Beacon® electromagnetic transponders, which are the size of a grain of rice and emit signals that track the location of the prostate with sub-millimeter accuracy, were implanted into the prostates of the AIM study group. This level of precision allowed researchers to reduce the PTV margin while at the same time increase the radiation dose to 81 Gray (Gy) to more effectively treat the cancer. Comparator patients were treated using standard institutional processes and larger PTV margins.

In both groups, patient-reported quality of life was assessed before and after the completion of radiation therapy using a clinically validated questionnaire, the Expanded Prostate Cancer Index Composite (EPIC) that measures several different domains of the patient’s health. Changes in scores were compared between the AIM study and comparator groups while accounting for important patient and cancer characteristics.  The AIM study group experienced significantly fewer side effects associated with bowel urgency and frequency, fecal incontinence and urinary irritation than the comparator group. AIM patients not receiving hormonal therapy also experienced smaller, yet statistically significant advantages over the comparator group in terms of sexual function.

“Without any tracking at all, I used to use a ten millimeter treatment margin. With Calypso, I use a three millimeter treatment margin and the AIM study results demonstrate an improvement in patient-reported quality of life,” said Howard M. Sandler, M.D., chair of radiation oncology at Cedars-Sinai Medical Center’s Samuel Oschin Comprehensive Cancer Institute in Los Angeles, lead author on the AIM study and investigator in the New England Journal of Medicine comparator study. “Of all the technologies that are available, the Calypso System is the only one that can do real-time tracking as well as localization and provides an important advantage in terms of keeping the radiation beam on the prostate.”

The Calypso System, with its GPS for the Body® technology, is the only product platform that provides real-time tumor tracking during radiation treatment. Calypso Medical’s proprietary technology utilizes miniature Beacon transponders implanted in the diseased organ to provide accurate, precise, continuous information about the tumor target’s position during external beam radiation therapy. Currently the Calypso System is cleared by the U.S. Food & Drug Administration (FDA) for use in radiation therapy for the prostate and prostatic bed; however, the technology is designed for body-wide applications.

“This study validates our long-held belief that the ability to track tumor motion in real-time is a critical component in adapting radiation therapy, as it assures the clinician and the patient that radiation is delivered to the cancerous tissue while sparing healthy tissue and decreasing unwanted side effects,” said Kenneth Russell, M.D., medical director at Calypso Medical. “We are excited about these results as we move forward in expanding the reach of our technology into applications where the tumors experience higher velocity movement.”

About Calypso Medical
Calypso Medical Technologies, Inc. is a Seattle-based, privately held medical device company. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon® electromagnetic transponders) to continuously, accurately and objectively track the location of tumors for improved accuracy and management of radiation therapy delivery. The technology is designed for bodywide cancers commonly treated with radiation therapy. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed. The Company has strategic relationships with Varian Medical Systems, Siemens Healthcare, Elekta Corporation and Philips Medical. Additional information can be found at http://www.calypsomedical.com.

References
1Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostatecancer survivors. N Engl J Med (2008; 358:1250–1261).
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Contacts
Jon Siegal/Krystin Hayward
Schwartz Communications
(781)684-0770

David Betz
Calypso Medical
(206) 330-2621

“The prevention and treatment of unsatisfactory skin scarring remains an important unmet medical need” said Lincoln Krochmal, MD, CEO & President of Excaliard Pharmaceuticals.  “Unsatisfactory skin scarring can be associated with various dermatologic conditions such as hypertrophic scars and keloids, elective and reconstructive surgery, traumatic wounds, Caesarian sections and burns. We are delighted with our Phase 1 study results indicating EXC 001 delivered locally has a very impressive safety profile. We look forward to further evaluating the safety and efficacy of our novel therapeutic in Phase 2 trials for conditions in which the amelioration of scarring post-operatively would be highly desirable by the patient.”

“EXC 001 is a second generation antisense medicine that inhibits fibrosis. In a variety of animal models of scar formation, EXC 001 has demonstrated significant and reproducible reductions in skin scar formation,” said Nicholas Dean, PhD., Founder and Chief Scientific Officer. “EXC 001 is an exciting and novel approach to reducing skin scarring, and represents the first time an antisense medicine has been used for this significant, unmet medical need.”

About Excaliard Pharmaceuticals
Excaliard Pharmaceuticals, Inc., is a venture capital-funded biotechnology company founded in 2007 focused on the development and commercialization of novel and innovative drugs for the amelioration of skin scarring and other fibrotic disorders. EXC 001 was co-discovered by Isis Pharmaceuticals Inc (NASDAQ: ISIS) and Excaliard, and licensed to Excaliard Pharmaceuticals.

Contact:
Lincoln Krochmal, M.D.
President and Chief Executive Officer
760-431-1850
www.Excaliard.com

LENEXA, KS – CyDex Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent to CyDex entitled “Sulfoalkyl Ether Cyclodextrin Compositions.” This patent, along with other previously issued technology patents, will provide broad protection for CyDex’s Captisol® technology until 2029. The most recent of these previously issued patents – for a new Captisol that flows better, dissolves faster, and packs more densely than previous morphologies – was announced on December 9, 2009.

The patent announced today (U.S. Patent No. 7,635,773) covers a manufacturing process for producing ultra high-purity modified cyclodextrins, and specifically the beta cyclodextrin sulfobutyl ether sodium salt product known as Captisol. Captisol is CyDex’s proven enabling drug delivery technology that aids in the solubilization, stabilization and taste masking of active pharmaceutical ingredients.

“Receiving this new patent is an important achievement as we continue to license Captisol technology and develop our own products that target unmet needs in hospital intravenous therapy,” said Dr. Theron Odlaug, President and Chief Executive Officer of CyDex Pharmaceuticals. “High-purity Captisol removes many impurities and degradants so that the composition can be used to increase the stability of highly sensitive active pharmaceutical ingredients. Together with the morphology patent we received earlier this month, this patent ultimately provides broader protection for our clients using Captisol and provides them with critical life-cycle management for their products.”

Captisol is manufactured using a validated, patent-protected process and conforms to USP <1078> on Good Manufacturing Practices for Bulk Pharmaceutical Excipients.

About CyDex Pharmaceuticals, Inc.

CyDex Pharmaceuticals, Inc. is a specialty pharmaceutical company developing products and licensing its Captisol® technology. Captisol is currently incorporated in five FDA approved medications and marketed by three of the company’s licensees: Pfizer, Bristol-Myers Squibb and Prism Pharmaceuticals. In addition, the company is supporting drug development efforts with more than 40 other companies worldwide. The company maintains patents in the U.S. and worldwide for its Captisol technology and Captisol enabled products, and comprehensive FDA Manufacturing and Safety Drug Master Files. For additional information on business development opportunities, please contact Richard White  at 913.685.8850. CyDex is a privately held company located in suburban Kansas City. To learn more about the company, please visit www.cydexpharma.com.

Contact:

Allen K. Roberson
Chief Financial Officer
CyDex Pharmaceuticals, Inc.
913.685.8850

SAN DIEGO, CA  – Accumetrics, Inc., developer and marketer of the VerifyNow® System, the first rapid and easy-to-use diagnostic system for measuring an individual’s response to multiple antiplatelet agents, announced that 2009 included a doubling in the number of international and U.S. distribution agreements, as well as positive medical community support, and significant capital financing that will take the company into 2011.

In 2009, the company continued its commitment to creating a powerful, worldwide distribution network aimed at gaining adoption of its products at enduser levels. Spanning Europe, Latin America and Asia, Accumetrics currently has partnerships with 20 leading international distributors who provide the company with local representation in over 30 countries. Latest additions to the international
distribution network include Keller Medical in Germany, ZAO “Schag” in Russia and VSA Alta Complejidad S.A. in Argentina.

Accumetrics continued to strengthen its U.S. presence by partnering with 10 cardiovascular specialty distributors to enhance support to the company’s growing base of clinicians in the domestic hospital market. Accumetrics has also partnered with National Distribution & Contracting, Inc. (NDC), the largest organization of independent medical supply distributors in North America, to
expand its distribution network in the physician office lab marketplace.

Increasing evidence of the clinical value of platelet reactivity testing was demonstrated in several presentations of new clinical studies including the POPular study, presented at the American Heart Association Scientific Sessions in November, and a meta-analysis presented at a symposium during the 2009 Transcatheter Cardiovascular Therapeutics (TCT ) Conference . These data also
build upon the anticipation of the results of the GRAVITAS trial, which has now completed 80% enrollment.

“2009 has proven to be an outstanding year of growth for Accumetrics,” said Timothy I. Still, CEO and President of Accumetrics. “We look at 2010 as a breakthrough year for the company, and are pleased to be in a position to capitalize on the growing clinical acceptance of platelet reactivity testing.”

Accumetrics concluded 2009 with $17.1 million in new capital financing, which will fully support the company into 2011. Proceeds will fund a number of key 2010 milestones including expanded claims for existing products, new product development and continued expansion of commercialization efforts.

About Accumetrics
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.

Accumetrics’ VerifyNow System is the first rapid and easy to use platform for measuring an individual’s response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient™) and clopidogrel (Plavix®), and the GP IIb/IIIa inhibitors (e.g. ReoPro® and Integrilin®), the VerifyNow System provides a valuable tool to help physicians make more informed treatment decisions.

The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of Sanofi-Aventis. Effient is a trademark of Eli Lilly and Company.

CONTACT:
Megan Rusnack
Lippert/Heilshorn & Associates
212-838-3777

Timothy I. Still
President and CEO
Accumetrics
858-404-8260

The study will enroll 30 patients who will undergo a routine follow-up angiogram at six to eight months. Initial results from the first patients included in the registry will be presented at the annual EuroPCR conference taking place May 25 to 28, 2010 in Paris.

The first patients were enrolled by Pieter R. Stella, M.D., Ph.D., director of the Heart Catheterization Laboratories and Clinical Cardiovascular Research at the University Medical Centre in Utrecht, the Netherlands, who serves as principal investigator for the study.

“Left main disease presents unique challenges. Today, most left main blockages are left unstented or are addressed with bypass surgery. Tryton’s innovative system may offer the ability to definitively treat these lesions, setting the stage for stenting to become the new standard of care for the treatment of left main coronary artery disease, rather than bypass surgery,” said Dr. Stella.

“The Tryton Side Branch Stent has now been implanted in more than 500 European patients. This rapid adoption, in a limited number of centers, demonstrates significant repeat usage and is especially gratifying,” said J. Greg Davis, president and CEO of Tryton Medical. “We believe the Tryton-LM registry will help us understand how the Tryton Side Branch Stent may provide a solution for these difficult-to-treat bifurcation lesions.”

 About the Tryton Side Branch Stent System

The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. Approximately twenty-two percent of patients treated for coronary artery disease have diseased bifurcated lesions.

Tryton’s highly deliverable cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.

The Tryton Side Branch Stent System demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side branch artery. The stent system has received CE Mark approval in Europe and is not approved in the United States.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company`s Side Branch Stent System, approved for sale in Europe, is designed to offer a dedicated strategy for treating these challenging cases. The privately held company is backed by Spray Ventures, PTV Sciences, and RiverVest Ventures. For more information please visit www.trytonmedical.com.

Media Contact:
Nicole Osmer
(650) 454-0504