Neuer Start, neuer Risk!!! (Seite 9)

[Shanghai2006]

Cytori Therapeutics, Inc. (CYTX) will provide a live webcast of its second quarter financial results and business update on Thursday, August 4, 2016 at 5:30 PM Eastern Time.

The dial-in information is as follows:

Dial-In Number: +1.877.402.3914
Conference ID: 54687177

Prior to the webcast at approximately 4:15 PM Eastern Time on August 4, Cytori will issue its second quarter earnings release which will review Cytori’s second quarter performance. The webcast will be available both live and by replay two hours after the call in the “Webcasts” section of the company’s investor relations website.

http://finance.yahoo.com/news/cytori-cell-therapy-phase-tria…

[Shanghai2006]

http://finance.yahoo.com/news/cytori-cell-therapy-phase-tria…

Cytori Therapeutics, Inc. (CYTX) announced today the publication of the results from an investigator-initiated Phase I trial using Cytori Cell Therapy in patients with insufficient maxillary bone prior to dental implantation. The publication reported approximately 42% greater bone formation in maxillary sinus floor elevation (MSFE) procedures treated with cells in combination with scaffolds versus those that received scaffold alone.

The study, conducted by investigators from Departments of Orthopedic Surgery, Oral and Maxillofacial Surgery, and Oral Cell Biology of the VU University in Amsterdam, The Netherlands, enrolled 10 patients requiring dental implants but who had insufficient bone into which the implant could be inserted. The maxillary bone deficiency was treated with two different commonly-used, off-the-shelf bone calcium phosphate scaffolds that were used either alone or pre-loaded with Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori’s Celution™ System. In six patients, the patient served as their own control as one side of the mouth was treated with scaffold alone and the other side was treated with ADRC-supplemented grafts. Six months after treatment all patients underwent dental implant placement at which time a biopsy of the regenerated bone at the graft site was performed.

The trial results reported approximately 42% greater bone formation in grafts that were supplemented with ADRCs. Specifically, in patients who received both a control scaffold and a contralateral ADRC- supplemented scaffold, the ratio of bone volume to total graft volume as measured by micro computerized tomography (microCT) was 19.5% ± 3.8% in grafts supplemented with ADRCs versus 13.7% ± 4.4% for the control grafts (p = 0.03). A similar trend was seen by histologic assessment of biopsies. They also noted that all 10 patients were treated uneventfully, with no adverse effects reported or detected in a large set of safety parameters through ≥3 years of follow-up.

Regarding the findings, the authors stated: “A striking observation from the histomorphometric and micro-CT analyses was the active bone formation observed at the cranial side of the biopsies in 7 out of 10 of the selected bone biopsies taken from the study [ADRC-treated] side, but only in 1 case from the control side. To our knowledge, this phenomenon has never been described before and may be unique to the current set-up.”

The American Academy of Implant Dentistry reports that approximately 500,000 patients receive dental implant surgeries in the USA every year. A recent report estimated that the global market for dental implants is projected to reach $5.8 billion by 2022. Use of calcium phosphate scaffolds for bone repair and reconstruction is also common in orthopaedic surgery.

The paper is titled: “Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics” published in the journal Stem Cells Translational Medicine. A link to the abstract can be found here. A full copy can be obtained without charge by registering with the publisher.

[Shanghai2006]

Thirty-one patients (17 Cytori Cell Therapy, 14 placebo) were randomized prior to termination of enrollment, with 28 patients having 6 month or longer follow-up data. Trial enrollment was terminated prior to the planned target (45 patients per trial) due to the prolonged period of enrollment and safety reviews. ATHENA and ATHENA II trial data were combined for analyses. The key results were as follows: Improvements in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score (a validated questionnaire for disease specific health related quality of life) were observed in the Cytori Cell Therapy group relative to the placebo group. The mean (95% CI) between group differences (Cytori Cell Therapy minus placebo) for the change from baseline were as follows: 3 months = -4.7 (-20.3, 10.9) (p=0.54) 6 months = -9.4 (-22.5, 3.8) (p=0.154) 12 months = -16.3 (-31.7, -1.0) (p=0.038). The SF-36 (a validated questionnaire for generic health related quality of life) results showed trends toward improvement in the Cytori Cell Therapy group relative to the placebo group, with several domains associated with nominal p-values less than 0.05. At 12 months, New York Heart Association class improved in 57% of ADRC-treated patients compared to 15% of placebo patients. The corresponding values for the Canadian Cardiovascular Society class were 67% and 27%. Echocardiogram and treadmill testing was performed at baseline and 6 months post-treatment. The mean change from baseline to 6 months in maximum oxygen consumption was 45.4±222 mL/min (ADRC, n=15) vs. -9.5±137 mL/min (placebo, n =10) [mean (95% CI) between group difference = 54.9 (-109, 219), p=0.495]. Left ventricular ejection fraction, left ventricular end-systolic volume and left ventricular end-systolic volume showed no relevant differences between groups. Heart failure hospitalizations were reported in 3/17 (17.6%) and 5/14 (35.7%) of cell treated and placebo treated groups respectively. Central adjudication of these events showed the respective numbers to be 2/17 (11.7%) and 3/14 (21.4%). Regarding safety, 18 of 31 patients (58.1%) were reported to have at least one serious adverse event during the trial (Cytori Cell Therapy 9/17 (52.9%), placebo 9/14 (64.3%)). Major Adverse Cardiovascular Events (MACE) occurred in 6/17 (35.3%) of ADRC patients and 3/14 (21.4%) of placebo patients. Two fatal events were reported during the trial with both occurring in the Cytori Cell Therapy group (myocardial ischemia – day 2 post-procedure, decompensation of heart failure – day 291 post-procedure).

Cytori ATHENA Trial for Chronic Ischemic Cardiovascular Disease | wallstreet-online.de - Vollständiger Artikel unter:
http://www.wallstreet-online.de/nachricht/8716972-cytori-ath…

http://onlinelibrary.wiley.com/doi/10.1002/ccd.26601/epdf?r3…

[nicotoll9]

SAN DIEGO & TOKIO - (BUSINESS WIRE) - Cytori Therapeutics, Inc. (NASDAQ: CYTX) gab heute bekannt, dass die Verwendung von Cytori Cell Therapy ™ wurde für die klinische Anwendung am 24. Juni genehmigt, 2016 Knie-Arthrose auf der Tokyo Osteoarthritis zu behandeln Klinik unter dem "Gesetz über die Sicherheit der Regenerative Medizin 'Japanisch, die am 25. November 2014 in Kraft gesetzt wurde.

Tokyo Osteoarthritis Klinik wird sofort beginnen Knie-Arthrose-Patienten mit Cytori Zelltherapie zu behandeln. Diese Genehmigung unterliegt den Einrichtungen im Rahmen der Klinik Schirm beschränkt, sondern schränkt die Zahl der Patienten, die behandelt werden können. Solche Zulassungen werden von dem sozialen Gesundheitssystems nicht erstattet und die Patienten werden die Kosten für die Behandlung verantwortlich.

"Osteoarthritis ist sehr verbreitet in Japan und die neue Gesetzgebung gibt uns einen zugelassenen Weg neuartige regenerative Therapien für die Patienten heute zu machen", sagte Dr. Masayuki Yamakawa, CEO der Tokyo Osteoarthritis Clinic.

In Japan wurde eine Klasse-I-Meldung Celution-System von Cytori gewährt ursprünglich im Jahr 2012. Die jüngste Gesetzgebung im Jahr 2013 von der japanischen Diät ursprünglich weitergegeben und später erlassen und durchgesetzt werden, stellt einen Mechanismus führenden Gesundheitseinrichtungen in Japan ermöglichen, bestimmte Technologien der regenerativen Medizin zu verwenden, gilt als innovativ und sicher von der japanischen Regierung für bestimmte Indikationen, wenn sie von einem zertifizierten und akkreditierten regenerativen Medizin Ausschuss genehmigt.

"Die innovative regenerative Medizin Gesetz vor kurzem in Japan zugelassen Möglichkeiten für therapeutische Innovation für Cytori erweitert schafft", sagte John Harris, Cytoris Vice President & General Manager, Zelltherapie. "Diese Registrierung und die in der Zukunft zu erwarten sollten wichtige Elemente sein, uns zu helfen Zugang für unsere Cytori Zelltherapie zu einer großen Population von Patienten in Japan mit Arthrose leiden erweitern. Für die Tokyo Osteoarthritis Clinic, ist dies ein wichtiger Meilenstein, und ich glaube, dass sie für die Führung in Arthritis-Therapie in Japan gut aufgestellt sind. "

Über Cytori

Cytori Therapeutics ist ein spätes Stadium der Zelltherapie Unternehmen in der Entwicklung autologer Zelltherapien aus dem Fettgewebe eine Vielzahl von Erkrankungen zu behandeln. Daten aus präklinischen Studien und klinischen Studien deuten darauf hin, dass Cytori Cell Therapy ™ wirkt in erster Linie durch den Blutfluss zu verbessern, das Immunsystem modulieren und Wundheilung zu erleichtern. Als Ergebnis Cytori Cell Therapy ™ kann Vorteile über mehrere Krankheitszustände liefern und kann am Point-of-Care durch Cytori eigenen Technologien und Produkte für den Arzt und Patienten zur Verfügung gestellt werden. Für weitere Informationen besuchen www.cytori.com.

Über Tokyo OA Clinic

Tokyo OA Clinic ist eine engagierte Knie-Arthrose Klinik unter "Die Klinik-Gruppe." Die angeschlossenen Ärzte verwenden Durchbruch Technologie Osteoarthritis zu behandeln. Ihr Team arbeitet eng mit der Wissenschaft, Klinik und Industrie hohe Behandlungen für Patienten in Japan zu bringen. Für weitere Informationen, besuchen Sie bitte https://www.knee-joint.net/. Für Medienanfragen wenden Sie sich bitte an Frau Yanagino, 03-6455-5307; Patienten können 0120-013-706 nennen.

[zocker1564]

Cytori Cell Therapy™ Leads to Improved Function and Reduced Scar Tissue in a Urinary Injury Model
Business Wire Cytori Therapeutics, Inc.
3 minutes ago

SAN DIEGO--(BUSINESS WIRE)--

Cytori Therapeutics, Inc. (CYTX) announced today the publication in The Journal of Urology of a preclinical study applying Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori Cell Therapy in a large animal model of urethral injury.

The results show that delivery of the cell therapy product immediately after injury resulted in a >50% decrease in fibrotic scar tissue from 17% of total urethral surface area in the control to 7% in the treated group (p=0.05) 30 days following treatment. The study further reported that delaying delivery of the cell therapy product until 30 days after injury—a time at which urethral fibrosis was well-established—led to >10-fold decrease in injured surface area (from 13% of the urethra in the control group to 1% in the treated group; p<0.05) at 60 days after injury (30 days after treatment). ADRC-treatment was also associated with a statistically significant increase in the maximum pressure generated by the urethra, an important component of urinary sphincter function.

This study was led by Drs. Giles Karsenty and Romain Boissier of Aix-Marseille University in Marseille, France supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille.

“These now published findings support the use of either immediate or delayed application of Cytori Cell Therapy to help reduce injury and scarring,” said Dr. Marc Hedrick, President and CEO of Cytori. “This important safety and proof of concept preclinical study will be useful in forthcoming regulatory submissions in the US, Europe and Japan.”

Data from this preclinical study supported the company’s recently enrolled the STAR clinical trial, an FDA-approved, 88 patient, multi-center, randomized controlled Phase III trial of Cytori Cell Therapy for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma as well as the investigator-initiated, ADRESU urinary incontinence trial currently enrolling in Japan. A reduction in cutaneous fibrosis as measured by the modified Rodnan Skin Score (mRSS) of the hand was also noted in the previous published SCLERADEC I clinical trial.

[nicotoll9]

Dr. Cugat könnte sehr gut Daten an den Tisch bringen, die einen wesentlichen Einfluss auf die Marktwahrnehmung der Wirksamkeit von ADRC haben. Gemäß der Mitteilung:

"Daten vorgelegt werden gehören Sicherheit, Machbarkeit, Patienten berichteten Ergebnisse in Bezug auf Aktivität und Schmerzen sowie serielle Magnetresonanztomographie (MRT) des Knies durch ein Jahr."

MRI-Daten über den Verlauf eines Jahres Behandlungsstandard verglichen ist sehr bedeutsam. Wenn es eine visuelle Korrelation / Reaktion zeigt, die mit einer positiven Reaktion in den anderen Ergebnissen vis a vis SOC angemessen ist, würde man sich fragen, ob es nicht eine ähnliche Reaktion in der OA-Studie sein kann von Cytori durchgeführt werden?

Dov, die "bemerkenswert" Erectile Dysfunction Indikation ist sehr interessant und hat völlig unbemerkt geblieben. Was auch von großem Interesse ist, ist die Aussage von Dr. Haahr: "Wir planen bereits eine doppelblinde, randomisierte Follow-up-Studie."

ADRC werden in einer großen Anzahl von Indikationen von denen viele getestet Leben für Patienten und uns als Investoren zu ändern sein könnte. Ich hoffe, dass nach der Ausgabe Rechte der Forscher Studien führte eine größere Sichtbarkeit von der Firma erhalten wird ..

Wenn die ersten Daten aus dem Französisch Ermittler Studie für eine kleine Anzahl von Sklerodermie-Patienten führte veröffentlicht wurde ich sah sofort, dass es niedrig hängenden Früchte, war und sagte, so viel auf diesem Message Board vociferously. Die andere Angabe, die mich verhext ist die cryptoglandula Fistel und Fistel im allgemeinen Indikationen. Ein großer medizinischer Bedarf an dem wir eine Behandlung haben. Warum die Verzögerung ?????

In aller Ehrlichkeit sollten wir nicht in dieser Situation sein. Diese Plattform kann die Behandlung einer Vielzahl von Indikationen revolutionieren.

Viele schlagen vor, dass wir aufgrund der dem 48-Wochen-Analyse der Sklerodermie (STAR) Versuchsdaten und die anschließende Einreichung an die FDA mit der angemessenen Wartezeit auf die Märkte für Kapital gehen müssen wird zurück. Ich möchte darauf hinweisen, dass die primäre Indikation die 24 Wochen Cochin ist Punktzahl mit den wichtigsten sekundären Indikationen hätten 1. Raynaud-Condition Score und 2. Sklerodermie Health Assessment Questionnaire (SHAQ), beide sind 24 Wochen Datensätze. Diese Daten werden viel früher als 48 Wochen. Wenn es wie die früheren Studien die Erfolgswahrscheinlichkeit Spuren steigt geometrisch ......... und tun so die Freier.

[nicotoll9]

Natürlich gehören die alle in den Knast......bin aber leider noch drinnen, meine verluste sind gewaltig...

6 juni
8 juni
23 juni
29 juni
ist Cytori auf Konferenzen :-) Nur supertolle news, wenn jetzt Panterschaften gelingen Phase Skl. 3
unsw. dan kann es doch noch passieren.....
ich glaube wir stehen nahe an einem gewaltigen Kurssprung.........

[Zimtzicke]

http://www.wallstreet-online.de/nachricht/8668313-presentati…

[nicotoll9]

6 juni
8 juni
23 juni
29 juni
ist Cytori auf Konferenzen :-)
ich glaube wir stehen nahe an einem gewaltigen Kurssprung.........

[zocker1564]

Cytori Announces Commencement of Subscription Period for Previously Announced Rights Offering
Nachrichtenquelle: Business Wire (engl.) | 31.05.2016, 13:00

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today it has commenced the subscription period for its previously announced rights offering of up to 6,896,551 units consisting of shares of common stock and warrants to purchase shares of common stock to existing stockholders. The rights offering will remain open until 5:00 PM Eastern Time on Thursday, June 9, 2016, unless extended. Rights holders will need to exercise their subscription rights prior to that date and time.

If exercising subscription rights through a broker, dealer, bank or other nominee, rights holders should promptly contact their nominee and submit subscription documents and payment for the units subscribed for in accordance with the instructions and within the time period provided by such nominee. The broker, dealer, bank or other nominee may establish a deadline before June 9 by which instructions to exercise subscription rights, along with the required subscription payment, must be received.

All record holders of rights certificates that wish to participate in the rights offering must deliver a properly completed and signed rights certificate, together with payment of the subscription price for both basic subscription rights and any oversubscription privilege election, to the Subscription Agent, to be received before 5:00 PM Eastern Time on June 9, 2016. The Subscription Agent is:

By mail: By hand or overnight courier:
Broadridge Corporate Issuer Solutions, Inc.
Attn: BCIS Re-Organization Dept.
P.O. Box 1317
Brentwood, New York 11717-0693
[phone] (toll free)

Broadridge Corporate Issuer Solutions, Inc.
Attn: BCIS IWS
51 Mercedes Way
Edgewood, New York 11717
[phone]

Under the rights offering, Cytori has distributed one non-transferable subscription right for each share of common stock held on the previously announced record date of May 20, 2016. Each right entitles the holder to purchase one unit at the subscription price of $2.90 per unit, composed of one share of common stock and 0.5 of a warrant, with each whole warrant exercisable to purchase one share of common stock at an exercise price of $3.48 per share for 30 months from the date of issuance. Cytori has applied to list the warrants on NASDAQ, although there is no assurance that a sufficient number of subscription rights will be exercised so that the warrants will meet the minimum listing criteria to be accepted for listing on NASDAQ under the symbol “CTYXW.” The warrants may be redeemed by Cytori prior to their expiration if Cytori’s common stock closes above $8.70 per share for 10 consecutive trading days. The subscription rights are non-transferrable and may only be exercised during the anticipated subscription period commencing today through 5:00 PM ET on Thursday, June 9, 2016, unless extended. A registration statement relating to these securities has been declared effective by the Securities and Exchange Commission.

Holders who fully exercise their basic subscription rights will be entitled, if available, to subscribe for an additional amount of units that are not purchased by other stockholders, on a pro rata basis and subject to ownership limitations.

Cytori has engaged Maxim Group LLC as dealer-manager for the rights offering.

Each stockholder of record as of May 20, 2016 will receive by mail an information packet that explains the rights offering. Stockholders with specific questions are urged to contact Broadridge Corporate Issuer Solutions, Cytori's information agent for the rights offering, by calling [phone] (toll-free); or Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, email: [e-mail] or telephone [phone].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The Company's registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on May 26, 2016. The prospectus as well as prospectus supplement no. 1 thereto dated May 31, 2016 and all of the Company's SEC filings may be found in the Investor Relations section of Cytori's website at www.ir.cytori.com.