Key Developments: Cytori Therapeutics, Inc. (CYTX.O)
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9 Feb 2010
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Latest Key Developments
Cytori Therapeutics, Inc.'s StemSource Cell Bank to Be Installed at Cosmetic Surgery Seishin in Japan
Cytori Therapeutics, Inc. announced that it has received an order for a StemSource Cell Bank from Cosmetic Surgery Seishin in Japan. The Cell Bank includes a StemSource processing system along with all other equipment, software, database, and protocols required to cryopreserve patients` own adipose-derived regenerative cells when the cells are younger and more viable.
Cytori Therapeutics, Inc. Receives U.S. Patent For Cell-Enriched Fat Grafting
Cytori Therapeutics, Inc. announced that it has received U.S. Patent No. 7,651,684 (the 684 patent) which covers the Company's methods for delivering adipose-derived stem and regenerative cell-enriched fat grafts into patients. The 684 patent specifically covers cell-enriched fat grafts to treat soft-tissue defects and urinary incontinence. In addition, the 684 patent covers methods for delivering cell-enriched fat grafts to a patient`s breast, wrinkles, lips, under the eyes, cheeks, chin, and other parts of the body.
FDA Grants 510(k) Marketing Clearance For Cytori Therapeutics Inc.'s PureGraft System
Cytori Therapeutics Inc. announced that The FDA has granted Cytori Therapeutics 510(k) marketing clearance for its PureGraft System. Cytori will now launch the first and only device in the United States cleared for aesthetic body contouring using autologous fat. PureGraft allows a patient's own fat tissue to rapidly be prepared in approximately 15 minutes for re-injection back into the same patient for aesthetic contouring. PureGraft is able to prepare both small and large volumes of fat grafting tissue ranging from 50 mL to 250 mL. Puregraft maintains sterility while optimizing the yield of tissue to be grafted, which provides significant utility to physicians. In contrast to traditional methods of graft preparation, PureGraft washes the graft and drains the tumescent fluid, free lipid and debris in a closed sterile system, allowing for a cleaner graft in less time than it would take to prepare a comparable volume of graft tissue traditionally. PureGraft will be sold in the United States directly by Cytori as well as through select distribution partners on a non-exclusive basis. The product will be available in the first quarter of 2010 and will be formally launched at the American Society of Aesthetic Plastic Surgeons in May 2010.
Cytori Therapeutics Inc. Announces Promising Results in Cell-Enriched Breast Reconstruction Trial
Cytori Therapeutics Inc. announced that interim results from a European clinical trial, RESTORE 2, demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results are based on six-month follow up from the first 32 women enrolled and treated. The highlights from the interim data of RESTORE 2 clinical trial include: a high rate of patient satisfaction (73%) and physician satisfaction (82%) with the overall outcome after a single treatment was reported in difficult to treat breast cancer patients; mean patient and physician satisfaction scores dramatically improved for breast symmetry, scarring and deformity from baseline to six month follow-up; qualitative analyses of imaging data confirmed clinical improvement in both breast defect and overall breast shape. The shape of the breast improved (58%), significantly improved (13%), or remained stable (29%) in all of the 31 cases assessed (100%). None of the patients had negative changes in the overall shape of their breasts. The shape of the defect improved (47%), significantly improved (11%), or remained stable (31%) in 17 of the 19 cases (89%).
Cytori Therapeutics, Inc. Reports Preclinical Results that Suggest Adipose-Derived Regenerative Cells may Reverse Periodontal Disease
Cytori Therapeutics, Inc. reported results from their preclinical study on the use of uncultured adipose-derived regenerative cells (ADRCs) in the treatment of critical periodontal defects in a rat model. The results suggest that the use of ADRCs may reverse the effects of periodontal disease, evidenced by significantly improved alveolar bone healing and decreased gingival (gum) invasion of the defect. As part of the study design, 20 immuno-deficient rats were treated for four critical defects in each. One of the defects was treated with uncultured human ADRCs and a second with cultured human adipose-derived stem cells (ADSC`s), both in Platelet Rich Plasma (PRP). A third was treated with PRP alone and a fourth with no treatment. The study`s results showed that at six weeks post-treatment the defects treated with the uncultured ADRCs and with the cultured ADSCs showed a statistically significant (p<0.001) improvement in healing of the alveolar bone compared to the two controls. Furthermore, uncultured ADRC and cultured ADSC treatment significantly decreased the gingival invasion of the defect when compared to no treatment (p<0.001) and PRP alone (p<0.05).
Cytori Therapeutics, Inc. Reaffirms FY 2009 Product Revenue Guidance
Cytori Therapeutics, Inc. maintained its guidance of $10 million in product revenue for fiscal 2009.
Cytori Therapeutics, Inc. Comments on Patent Appeal
Cytori Therapeutics, Inc. announced that it has been informed that the United States Federal Court in the Central District of California upheld a June 2008 decision relating to U.S. patent number 6,777,231 (the 231 patent). The Court's decision has no impact on Cytori's products or clinical applications under development. Cytori's products do not practice the '231 patent. Cytori's Celution System yields an output comprising a diverse mixture of cells found in adipose tissue whereas the '231 patent covers a narrowly defined population of adipose derived adult stem cells in an environment substantially free of other cellular materials found in adipose tissue. The narrowly defined population of cells that are covered by the '231 patent require different isolation or processing techniques, which the Celution System, by design, does not perform.
Cytori Therapeutics Inc. Expands Patent Protection For Celution System and Uses For Adipose Derived Stem And Regenerative Cells
Cytori Therapeutics Inc. announced that it has recently received a Notice of Allowance from the U.S. Patent and Trademark Office related to uses of the Celution System for the treatment of bone related disorders. Specifically, the allowed claims cover prosthetic devices that can be seeded with adipose derived stem and regenerative cells for use in bone healing and regeneration. In addition, the Company received a second Notice of Allowance related to methods of obtaining clinically safe outputs from the Celution System. The allowed claims cover methods of testing the Celution output for contaminants such as red blood cells, lipids, enzymes, aggregates, and endotoxins, among other things.
Cytori Therapeutics Inc. Receives Equity Commitment; Investment Fund To Purchase Up To 7.15 Million Shares Over Next 12 Months
Cytori Therapeutics Inc. announced that it has entered into an equity agreement with Seaside 88, LP (Seaside). Under the terms of the agreement, Seaside has committed to purchase up to 7.15 million Cytori common shares, in a series of closings every two weeks in the amount of 275,000 shares each for a total of up to 26 purchases. Cytori and Seaside expect to close the first sale of 275,000 shares for gross proceeds of $852,000 on June 22, 2009. Cytori has the right to discontinue the agreement between the 13th and 14th closings, based on Cytori's assessment of its financing needs at that time. The purchase price for all closings executed under the agreement is determined by applying a 13% discount to a volume-weighted-average price (VWAP) of Cytori`s common stock. The price of the shares to be sold at today`s initial closing will be based on Cytori`s share price on June 19. The pricing of all subsequent closings will be based on Cytori`s share price for the ten trading days preceding each closing date. The scheduled closings will not take place if the Cytori`s VWAP for the 10 preceding trading days is less than $2.50.
Cytori Therapeutics Inc. Reports Publication of Cardiovascular Preclinical Study; Adipose Stem & Regenerative Cells Improve Function in Heart Attack Model
Cytori Therapeutics Inc. announced publication of the first preclinical study to demonstrate adipose-derived stem and regenerative cells (ADRCs) significantly improved cardiac function after a heart attack. This preclinical cardiac cell therapy study was reported online ahead of print in the International Journal of Cardiology. The study was funded by Cytori Therapeutics and conducted at Tulane University. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data are expected to be reported in early 2010. The APOLLO study is sponsored by Cytori and has incorporated the Company`s Celution System to automate the processing of the patients` cells at the point of care. In Cytori's preclinical study, 17 large animals (pigs) were treated with their own uncultured adipose-derived stem and regenerative cells immediately following induction of a severe myocardial infarction. Uncultured cells include a multitude of heterogeneous cell types that Cytori believes facilitate several therapeutic mechanisms. Several functional measurements within the study indicated statistically significant improvement in both heart function and structure.
Q+A-Skin cells transformed directly to nerve in study
WASHINGTON, Jan 27 (Reuters) - Using just three genes, California researchers have transformed mouse skin cells directly into nerve cells called neurons.
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