Clinical Results Sample Clauses

Clinical Results. To test the safety and efficacy of the Powerheart, a multi-center clinical trial study was conducted. 155 patients enrolled in four institutions. Of these patients, 130 were attached to the Powerheart and 25 were utilized as controls. The control patients allowed comparison of the Powerheart to standard medical care. The Powerheart was utilized for over 1200 hours during this study. Patients in the clinical trial experienced a total of 92 shockable episodes. The study found that the Powerheart had a sensitivity of 100% (correctly identifying shockable episodes), a specificity of 99.4 percent, (not allowing a non-shockable rhythm to be shocked). The average response time for the Powerheart was approximately 21 seconds. In addition, normal rhythm was restored by the FIRST shock of the Powerheart in 96 percent of the actual shocks delivered with energy levels as low as 50 joules. These results demonstrate that the Powerheart responded to every shockable event within seconds, successfully restored a normal rhythm and delivered shocks only when appropriate, confirming its safe to use.
Sample 1
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Clinical Results. Subject to the remainder of this Section 10.5 (Clinical Results), GSK shall have the right to (i) publish the results or summaries of results and protocols of, and status updates regarding, all GSK-sponsored or -supported studies conducted with respect to a Terminated Product in any clinical trial register maintained by GSK or its Affiliates and xxx.XxxxxxxxXxxxxx.xxx, in each case within such timescales as required by Applicable Law or GSK’s or its Affiliates’ standard operating procedures, irrespective of the outcome of such studies; (ii) publish the status of each Terminated Product in its annual and quarterly reports and any similar updates regarding each Terminated Product as related to GSK’s general research and development pipeline; and (iii) publish any anticipated publications set forth in Schedule 10.5 hereto. Notwithstanding the foregoing, GSK will provide Adaptimmune with no less than [***] days (or, with respect to any abstract, no less than [***]) to review the contents of any such proposed publication and will reasonably consider any comments provided by Adaptimmune to GSK during such review period. Within such [***] period (or [***] period, as applicable), Adaptimmune may request that any Confidential Information of Adaptimmune be removed from the proposed publication, and GSK shall remove such Confidential Information prior to any publication.
Sample 1
Clinical Results. Preop Pain VAS 6.1 4.2 1 yr post-op Pain VAS 1.8 2.3 2 yr post-op Pain VAS 1.2 3.3 Preop ODI 31 19 1 yr post-op ODI 13 16 2 yr post-op ODI 13 13 Preop Deformity VAS 7.2 5.7 1 yr post-op Deformity VAS 1.2 1.5 2 yr post-op Deformity VAS 1 2.1 Additional surgery 0 0 18 Summary XLIF for AIS, same or better than traditional approach • N = 10 – 4 AIS – 6 adult IS with adolescent onset • Mean Curve improvement: 53° → 20°. – Comparable correction to historical convex ASF • Coronal decompensation: 2.6 cm → 0.5 cm • Lumbar lordosis maintained. • Mean Pain improvement, VAS: 6.1 → 1.2 – avoids post-thoracotomy pain syndrome. • Minimal # motion segments fused → preserves mobility. 19 Discussion-Motion Preserving AIS Surgery • Maximize lumbar mobility with minimal residual deformity. • Produces similar radiographic improvements and reliable spinal balance to the traditional convex ASF technique. • Early outcomes favorable. • This new technique also avoids the disadvantages of PSF OR Competitor
Sample 1

Related to Clinical Results

  • Technical Report 64 23.3 Return Location...............................................64 23.4

  • Medical Records Medical records relating to Trial Subjects that are not submitted to Sponsor may include some of the same information as is included in Trial Data; however, Sponsor makes no claim of ownership to those documents or the information they contain. c.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Technical Reports deliver to the Agent, and shall procure that the Manager shall deliver to the Agent, on request copies of the latest complete technical reports in respect of the Vessels.

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Statistical and Market Data Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included in the Registration Statement, the Pricing Disclosure Package and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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