CYTX
12-5-2015
EPS of ($0.07), in-line with the analyst estimate of ($0.07). Revenue for the quarter came in at $900 thousand versus the consensus estimate of $2.44 million
Ascendiant Capital initiated coverage on Cytori Therapeutics with a Buy rating and a price target of $1.25.
5-5-2015
Venta pública: Dilución
The purchase price for each Unit to be sold in the Initial Closing will be $0.77. The strike price of each warrant will be $1.02. Cierre día 8
Subject to receipt of any required stockholder approval pursuant to the rules of the Nasdaq Stock Market and the restructure of our outstanding debt under our loan agreement, we expect to complete a second closing (the Second Closing) in which we intend to sell additional Units having gross proceeds of $5.6 million.
7-4-2015
Cytori’s ECCS-50 cellular therapeutic as an orphan medicinal product for the treatment of scleroderma
http://www.streetinsider.com/Corporate+News/Cytori+Therapeutics+%28CYTX%29+ECCS-50+Granted+Orphan+Status+by+European+Medicines+Agency/10437401.html?si_client=intbro
6-4-2015
Cytori Therapeutics (CYTX), Lorem Vascular Receive Regulatory Clearance in China, Opening Purchase Order
Lorem Vascular will begin product launch of Celution in key hospitals in China immediately
Lorem Vascular will now begin to consummate partnerships with key hospitals throughout China to address specific vascular and non-vascular applications using patients’ own adipose derived regenerative cells, which have demonstrated clinical promise in studies around the world.”
In November 2013, Cytori Therapeutics and Lorem Vascular entered into a 30-year exclusive licensing agreement to commercialize Cytori Celution System in China, Hong Kong, Malaysia, Singapore, and Australia. As part of that agreement, Lorem Vascular agreed to pay up to $500 million in fees to Cytori for a 30-year exclusive license for all indications, excluding alopecia, in the licensed territories following specific revenue milestones, as well as royalties of 30% on gross profits from Lorem’s operations in China, Malaysia and Hong Kong.
Furthermore, following today’s news, Lorem Vascular placed an opening order of 23 Celution Devices and 1,100 Celution Consumable Sets, which is anticipated to be fulfilled throughout 2015. Following this opening order, Lorem Vascular has agreed to purchase annually a minimum of fifty (50) Celution Devices and fifty (50) Celution Consumable Sets for each of the Celution Devices for the next three years from CFDA clearance.
25-3-2015
Cytori Launches Celase® GMP Product
Celase® is a proprietary enzyme blend that was designed specifically to optimize Cytori’s automated adipose tissue dissociation process. Celase® is produced using avian and mammalian tissue-free raw materials, aseptic processes and sterile filtration under cGMP guidelines.
“Celase® GMP’s unique, best-in-class formulation is the result of significant investment made by Cytori,” said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics. “By making Celase® GMP broadly available to researchers, we believe Cytori can simultaneously accelerate the cell therapy field, de-risk clinical implementation and enhance our cash flows. This represents a clear win-win scenario for all parties.”
Integrating Celase® GMP into cell isolation study protocols can facilitate a smooth transition from bench and animal research to downstream clinical applications. Celase® has been approved by the U.S. FDA for use in clinical trials evaluating Cytori Cell Therapy™ in patients with chronic heart failure, osteoarthritis of the knee and hand manifestations of scleroderma.
http://finance.yahoo.com/news/cytori-launches-celase-gmp-product-120000410.html
23-4-2015
Resultados de las quemaduras térmicas
http://finance.yahoo.com/news/cytori-reports-preclinical-mechanistic-data-120000935.html
13-3-2015
Resultados Escleradec-1
http://finance.yahoo.com/news/cytori-provides-twelve-month-data-120000451.html
Presentará datos sobre las quemaduras térmicas en el Annual Meeting of the American Burn Association (ABA) in Chicago on April 21-24, 2015
The first presentation will describe the use of Cytori Cell Therapy in combination with a widely used skin substitute in a full thickness burn injury model. Data to be presented show increased wound vascularity and maturation in wounds treated with Cytori Cell Therapy. The second presentation will describe a novel model of full thickness thermal burn injury with concomitant radiation exposure. Data to be presented demonstrate that delivery of Cytori Cell Therapy accelerates wound re-epithelialization in this context. These data will form the basis of an Investigational Device Exemption (IDE) package to be submitted to FDA for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury.
http://finance.yahoo.com/news/cytori-presents-thermal-burn-data-120000480.html
17-3-2015
Dilución ATM de mano de Cowen por valor de 40 millones.
Sobre las quemaduras thermal burn
http://ir.cytori.com/investor-relations/News/news-details/2014/BARDA-Executes-Contract-Option-with-Cytori-for-Continued-Development-of-Thermal-Burn-Injury-Counter-Measure/default.aspx
FDA) has granted conditional approval for an Investigational Device Exemption (IDE) for a pivotal clinical trial, named the ‘STAR’ trial, to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma, a rare autoimmune disease affecting approximately 50,000 patients in the United States.
http://www.streetinsider.com/Corporate+News/Cytori+Therapeutics+%28CYTX%29+Reports+FDA+Granted+Conditional+Approval+for+U.S.+Pivotal+Clinical+Trial+in+Scleroderma/10084748.html?si_client=intbro
http://seekingalpha.com/article/2711865-cytori-why-this-undervalued-cell-therapy-biotech-is-a-buy
Mi idea era que tenía que volver a recuperar el dólar una vez autorizados a reanudar el estudio, pero, si lo paran, ya no lo tengo nada claro. Aunque supuestamente están avanzados y van a sacar las conclusiones con los datos que ya tienen no me huele bien. La cuestión es si el ensayo ese "thermal burn" con BARDA debería dar una valoración superior a la que tenemos ahora. ¿Alguna idea?
Acabo de darme una vuelta por el foro de yahoo. Veo descepción con las expectativas y cabreo con el CEO, es decir, que podemos tocar los 0,40.
http://biz.yahoo.com/e/141107/cytx10-q.html
Paran por lo pronto el estudio cuya reanudación ha autorizado la FDA (ATHENA) para analizar los datos. También paran por ahora otro estudio de células adiposas regenerativas que estaban iniciando y otro ortopédico (RECOVER). Mmmm. No me huele muy bien
during the delay the Company has made substantial progress on it next generation Celution® system, the Company has determined the most prudent course of action is to stop enrollment at 31 patients and analyze unblinded six month data. The 31st patient will reach the planned 6 month time-point this month. An analysis of the complete and verified 6 month data should be available early in 2015 for review and planning next steps.
adipose-derived regenerative cells (ADRCs) in the therapy of patients with end-stage heart failure already on a left ventricular assist device or LVAD in a trial called CELVAD. Recently, the NHLBI informed Cytori that initiation of a cell therapy trial on patients with LVADs will be delayed citing concerns around the feasibility related to treatment of LVAD patients, evolving nature of LVADs, endpoint selection, and the cost and complexity of the study. We will provide updates on the outlook for this trial when we are notified.
Inician uno ortopédico
eceived approval by the FDA to begin a US IDE pilot (phase II a/b) clinical trial of Cytori Cell Therapy in patients with osteoarthritis affecting the knees to be called ACT-OA. A total of 90 patients will be enrolled in this randomized, double-blind, placebo controlled clinical trial and followed for one year. The study, which is anticipated to begin enrollment in 2015, will examine the safety of Cytori Cell Therapy and several efficacy endpoints including symptom relief, function and activity level. Data should be available in 2016.
Participan en otro de escleroderma
Cytori has agreed to support a follow up confirmatory trial in France.
BARDA executed a significant contract extension option for ongoing research and development activities required to enable a pilot clinical trial of Cytori Cell Therapy in thermal burn treatment;
Resumen: Cytori intends to: finalize ATHENA and analyze the data, start the ACT-OA trial, wind down the RECOVER trial, support the initiation of its scleroderma and urinary incontinence trials in Europe and Japan respectively, file for CFDA class I approval, complete the next phase of the Celution® development program, and work with BARDA and FDA to plan our forthcoming thermal burn trial, among other activities. Financially, we intend to continue to improve our financial position through combination of activities including: additional expense reductions, profitable revenue growth, additional capital raise, partnerships, debt restructure or further debt term modification.
http://finance.yahoo.com/news/cytori-reports-third-quarter-2014-210500145.html
«Después de nada, o después de todo/ supe que todo no era más que nada.»
