Free Answering Brief in Opposition - District Court of Delaware - Delaware


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Category: District Court of Delaware
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Case 1:08-cv-00031-GMS

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EXHIBIT A

FDA > CDRH > 510(k) Premarket Notification Database Search Case 1:08-cv-00031-GMS Document 18-2 Filed 04/16/2008

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Device Classification Name 510(K) Number Device Name Applicant Contact Regulation Number Classification Product Code Date Received Decision Date Decision Classification Advisory Committee Review Advisory Committee Statement/Summary/Purged Status Summary Type Reviewed By Third Party Expedited Review Catheter, Steerable K070357 FLEXCATH STEERABLE SHEATH & DILATOR CRYOCATH TECHNOLOGIES, INC. 10 B Tano Road Santa Fe, NM 87506 Fred Milder 870.1280 DRA 02/07/2007 12/28/2007 Substantially Equivalent (SE) Cardiovascular Cardiovascular Summary Only Summary Traditional No No Database Updated 04/08/2008

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Device Classification Name 510(K) Number Device Name Applicant Contact Regulation Number Classification Product Code Date Received Decision Date Decision Classification Advisory Committee Review Advisory Committee Statement/Summary/Purged Status Summary Type Reviewed By Third Party Expedited Review Unit, Cryosurgical, Accessories K030303 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE CRYOCATH TECHNOLOGIES, INC. 16771 Chemin Ste Marie Kirkland, CA H9H 5 H3 Jean-Pierre Desmara 878.4350 GEH 01/29/2003 04/29/2003 Substantially Equivalent (SE) General & Plastic Surgery General & Plastic Surgery Summary Only Summary Traditional No No Database Updated 04/08/2008

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EXHIBIT B

CryoCor: Clinical Trials: Atrial Fibrillation Case 1:08-cv-00031-GMS Document 18-3

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Overview Atrial Fibrillation Atrial Flutter

Home > Clinical Trials > Atrial Fibrillation

Atrial Fibrillation Atrial fibrillation is by far the most commonly occurring cardiac arrhythmia affecting over 5.6 million individuals in the U.S. annually. Atrial fibrillation causes the upper chambers of the heart (atria) to beat at an irregular rate and in an irregular rhythm. This chaotic activity interrupts normal blood flow, predisposes the heart to the formation of blood clots and results in a 6x increase in stroke and a 2x increase in mortality. Over 80,000 strokes annually are caused by atrial fibrillation. Each year atrial fibrillation strikes more individuals than Parkinson's disease, epilepsy, and Alzheimer's' Disease combined. Patients with atrial fibrillation report symptoms such as heart palpitations (a racing heart), fatigue, weakness, shortness of breath, chest pain, and light-headedness. The current standard of care in the treatment of atrial fibrillation is life-long drug therapy -- typically agents used in the attempt to restore the heart to its normal rate and rhythm, and blood thinners to prevent blood clot formation. Unfortunately these drugs do not cure atrial fibrillation and they have sometimes severe side effects which include arrhythmias, blindness, depression, impotence, lung toxicity (pulmonary fibrosis), skin discoloration, hemorrhage, liver damage, thyroid damage, and even death. Since episodes of atrial fibrillation are unpredictable, patients will often avoid travel, stop exercise, and shun visits with family and friends. This loss of quality of life affects not only atrial fibrillation patients, but their family and friends as well. As an alternative to these ineffective medications, some clinicians use heat-based radiofrequency (RF) ablation devices to treat atrial fibrillation even though these devices are not approved for this use in the United States. Patient complications reported in literature from the use of RF ablation devices to treat atrial fibrillation have at times resulted in severe loss of health and even death. These complications include the narrowing of blood vessels between the lungs and the left atrium (pulmonary vein stenosis), the creation of stroke producing clots (emboli), and the creation of life-threatening openings between the heart and the esophagus (atrial esophageal fistulas). These complications of RF ablation have limited its use to treat atrial fibrillation in some settings. CryoCor cryoablation has been used to treat over 1,800 individuals worldwide for atrial flutter, atrial fibrillation and other cardiac arrhythmias. Unlike RF ablation, no pulmonary vein stenosis has been noted to date in cryoablation clinical studies or commercial use, nor have there been reports of atrial esophageal fistulas. As a result, CryoCor believes its Cardiac Cryoablation System may provide clinicians with treatment success at least equivalent to that now achieved in treating atrial fibrillation with either drugs or RF ablation but with fewer patient complications. [ back to top ]

Home | Corporate Profile | Products | Clinical Trials | Our Team | Investors | Careers | Contact Privacy Policy | Site Map © 2005 CryoCor, Inc.

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EXHIBIT C

CryoCor: Corporate Profile: Intellectual Property Case 1:08-cv-00031-GMS Document 18-4

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Business Opportunity Problem ­ Solution Procedure Intellectual Property

Home > Corporate Profile > Intellectual Property

INTELLECTUAL PROPERTY CryoCor has built a portfolio of proprietary technologies in the design, function and performance of its System allowing for protected pursuit of its business strategy in successfully treating various cardiac arrhythmias, for which patents will be assigned to the Company. CryoCor's comprehensive intellectual property (IP) portfolio provides a formidable barrier of entry due to its proprietary position in the application of cryothermy to achieve and maintain sufficiently low temperatures to safely and effectively treat atrial fibrillation, atrial flutter and other cardiac arrhythmias. Currently, CryoCor owns or licenses 39 issued United States patents and a number of pending United States patent applications covering various aspects of our products and technology. The Company also owns or licenses 24 patents issued outside of the United States and has a number of pending patent applications outside the United States.

Home | Corporate Profile | Products | Clinical Trials | Our Team | Investors | Careers | Contact Privacy Policy | Site Map © 2005 CryoCor, Inc.

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EXHIBIT D

Boston Scientific and CryoCor Announce Signing of Definitive Merger Agreement: PRN... Page 1 of 3 Case 1:08-cv-00031-GMS Document 18-5 Filed 04/16/2008 Page 2 of 4

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Boston Scientific and CryoCor Announce Signing of Definitive Merger Agreement
April 16, 2008 8:30 AM ET

NATICK, Mass. and SAN DIEGO, Calif., April
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16 /PRNewswire-FirstCall/ -- Boston Scientific Corporation BSX and CryoCor, Inc. CRYO today announced the signing of a definitive merger agreement, under which Boston Scientific will pay a cash purchase price of $1.35 per share of CryoCor, or approximately $17.6 million. This acquisition follows a development agreement, in place since June 2007, to pursue therapeutic solutions for atrial fibrillation, or "Afib." Afib is the most common cardiac arrhythmia and affects millions of patients. The existing development agreement involves the development of a console to deliver cryo energy to Boston Scientific's proprietary cryo balloon catheter. Boston Scientific's cryo balloon is being developed to provide a safe, standardized and broadly applicable method to isolate the electrical activity originating from the pulmonary veins, which are believed to be a source for the initiation and propagation of Afib.
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"In the current development project, CryoCor's console demonstrated its ability to efficiently deliver nitrous oxide to our proprietary cryo balloon catheter," said Fred Colen, Executive Vice President, Operations and Technology, Boston Scientific Cardiac Rhythm Management. "This acquisition will allow us to further refine

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this base console technology, and gaining exclusive rights to CryoCor's family of intellectual property will provide us a key strategic advantage. This is a good example of our Cardiac Rhythm Management and Electrophysiology teams working together to advance our most promising technologies and to potentially make new Afib solutions a reality for electrophysiologists and their patients." "We are pleased to see our cryoablation system and our intellectual property assets partnered with one of the world's leading electrophysiology companies," said Ed Brennan, Chief Executive Officer of CryoCor. The acquisition, which has been approved by the Board of Directors of CryoCor, is structured as a cash tender offer. The parties have agreed to commence the tender offer within the next 10 business days, followed by a second-step merger in which any untendered CryoCor shares would be converted into the right to receive the same cash price per share as shareholders who tendered in the tender offer. Both the tender offer and the merger are subject to terms and conditions detailed in the merger agreement. The merger is expected to close this quarter. About Boston Scientific Corporation

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Boston Scientific and CryoCor Announce Signing of Definitive Merger Agreement: PRN... Page 2 of 3 Case 1:08-cv-00031-GMS Document 18-5 Filed 04/16/2008 Page 3 of 4

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com. Boston Scientific's Electrophysiology business is a leader in cardiac ablation products designed to treat common cardiac arrhythmias. Its line of Blazer(TM), Blazer XP(TM) and Chilli II(TM) products are used to treat arrhythmias such as Atrial Flutter and Ventricular Tachycardia. The Electrophysiology business also supplies a complete line of multi-electrode diagnostic catheters, ultrasound (ICE) catheters and accessories. The cryo balloon catheter is currently under development and not approved for sale. About CryoCor, Inc. CryoCor is a medical technology company that has developed and manufactures a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The Company's product, the CryoCor Cardiac Cryoablation System, or the Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The Cryoablation System has been approved in Europe for the treatment of atrial fibrillation, and atrial flutter, the two most common and difficult to treat arrhythmias, since 2002. In the United States, CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the Cryoablation System for the treatment of atrial fibrillation and the Cryoablation System has been approved for the treatment of right atrial flutter. For more information please visit the Company's website at http://www.cryocor.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward- looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product development and performance, acquisitions and integration of acquired companies, development plans and expenditures, and our growth strategy. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward- looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

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Boston Scientific and CryoCor Announce Signing of Definitive Merger Agreement: PRN... Page 3 of 3 Case 1:08-cv-00031-GMS Document 18-5 Filed 04/16/2008 Page 4 of 4

Additional Information The tender offer described in this press release has not yet commenced, and this press release is neither an offer to purchase nor a solicitation of an offer to sell CryoCor common stock. Investors and security holders are urged to read both the tender offer statement and the solicitation/recommendation statement regarding the tender offer described in this press release when they become available because they will contain important information, including the terms of and conditions to the tender offer. The tender offer statement will be filed by Padres Acquisition Corp., an indirect wholly-owned subsidiary of Boston Scientific, with the Securities and Exchange Commission ("SEC") and the solicitation/recommendation statement will be filed by CryoCor with the SEC. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed by Boston Scientific and CryoCor with the SEC at the website maintained by the SEC at www.sec.gov. The tender offer statement and related materials, solicitation/recommendation statement, and such other documents may be obtained for free by directing such requests to Investor Relations of CryoCor, Inc.
CONTACTS FOR BOSTON SCIENTIFIC: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation CONTACTS FOR CRYOCOR: Gregory J. Tibbitts Chief Financial Officer CryoCor, Inc. (858) 909-2200 [email protected] Stephanie Carrington / Zack Kubow The Ruth Group (646) 536-7017 / 7036 [email protected] [email protected]

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