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PureGraft Approved in Europe...
July 29, 2010
Cytori’s (NASDAQ: CYTX) PureGraft™ System is now approved in Europe for autologous fat grafting procedures, which is another way of saying it can be used to take fat from one part of a patient’s body and move it to another part of their own body. Cytori will immediately begin commercializing the product to physicians in Europe either a standalone product or as a complement to Cytori’s Celution® 800/CRS System. Orders will be filled immediately based on existing demand from several countries.
Used independently, PureGraft™ rapidly and reliably produces optimal graft tissue for autologous fat grafting procedures replacing current non-standardized methods of graft preparation. In combination with the Celution® 800/CRS, PureGraft™ lowers processing times and increases processing volumes, improving the utility and efficiency of Cytori’s core product for soft tissue applications, which allows for the preparing of a cell-enriched fat graft.
Having both PureGraft™ and Celution® now approved in Europe allows us to offer a broader portfolio of products to plastic and cosmetic surgeons and expands our market opportunity. In addition, the PureGraft System offers a lower cost entry point for customers to whom we could potentially up-sell a Celution® System.
Further details may be found today's release or by visiting www.puregraft.com.
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CYTX Expands Celution EU Indications; To Support Hospital Sales
July 27, 2010
Cytori (NASDAQ: CYTX) expanded its Celution® System CE Mark by receiving additional indications-for-use, which build upon the existing device approval. The current Celution System indications-for-use allow for the digestion of adipose tissue to extract, wash and concentrate a patient’s own stem cells and other associated cells for re-injection back into the same patient. These new indications add specific medical applications for the re-injection of cells, which include:
· Breast reconstruction;
· Repair of soft tissue defects, and
· The facilitation of healing certain types of wounds, such as those resulting from Crohn’s disease
The importance of this development is that it improves the ability of our sales force and distributors to offer the Celution® System to hospitals. Until now, our sales activities have been focused mostly on private-pay plastic and cosmetic surgery clinics. Additionally, this supports our effort to gain reimbursement for stem and regenerative cell-enriched breast reconstruction and other reconstructive surgery procedures.
Clinical data from our RESTORE 2 breast reconstruction trial in Europe and other wound repair clinical studies were used to support the expanded CE Mark. The CE Mark, in addition to the 27 countries of the EU, is followed by eight additional countries around the world and facilitates other registrations around the world. For more information, please see the attached release.
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Adipose Stem Cell Review
July 16, 2010
The journal Current Stem Cell Research & Therapy recently published an issue dedicated entirely to adipose-derived stem cells.
If you're looking for a review of some of the earlier clinical and preclinical work in the field, it's worthwhile reading. Here's the link to the table of contents: http://www.bentham.org/cscrt/CurrentIssue.htm#8.
One of the articles looks at various sources of stem cells, including adipose, as a potential treatment for liver failure. The authors of this particular review describe their experience with the Celution System.
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Vote CYTX shares today...
July 15, 2010
Cytori's proxy season is underway. Remember to vote your shares. Investors should by now have received voting instructions either in the mail or electronically from your broker . More information can be found at the following link: http://tinyurl.com/2ec384n. Feel free to call us at 858.875.5279. with any questions. We're happy to help in any way we can.
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1st U.S. StemSource® Cell Bank Customer, BioLife, Now Open in Dallas
June 21, 2010
BioLife opened the first U.S. StemSource® Cell Bank in Dallas. This is the customer whom we had announced a sale to on May 28. So as to provide you with more details on their bank and business, we've posted below their announcement from this morning:
BioLife Opens First StemSource® Cell Bank in U.S.; Gives patients access to own fat tissue for future cosmetic & reconstructive surgical procedures
BioLife Cell Bank, LLC (www.BioLifeCellBank.com) has opened the first U.S. StemSource® Cell Bank, which offers patients a way to safely and affordably store their own adipose (fat) tissue or their own naturally occurring adipose (fat) tissue-derived stem and regenerative cells. This gives patients and physicians easy, multi-use access to cells and tissue for future approved or allowed reconstructive fat grafting or augmentation procedures using the patients’ own cells and/or tissue. Tissue and/or cells are extracted using a simple and safe liposuction procedure, and can be stored indefinitely.
“Historically fat from liposuction, which we now know has significant value, has been thrown away as medical waste,” said Dr. David Genecov, board certified plastic surgeon and Medical Director of BioLife Cell Bank. “Now we can save this tissue for facial, breast, body and reconstructive surgical procedures, which rely more and more on the use of fat as natural filler.”
Using a patient’s own tissue and/or cells for reconstructive or cosmetic procedures is preferred by many surgeons because it does not require the introduction of foreign or synthetic materials into the body.
The bank will serve the entire United States and will be operated out of Dallas by BioLife Cell Bank, LLC, utilizing the StemSource® Cell Bank equipment from Cytori Therapeutics. This is the fourth StemSource® Cell Bank to be installed worldwide and the first in the United States.
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CYTX: New Fat Grafting ICD-9 Codes in U.S.
June 4, 2010
Dear Investors,
Cytori’s medical affairs team has successfully added new ICD-9 codes in the United States, including one for fat grating into the breast with or without the use of an enriched graft and another for extraction of fat for banking, including extraction of cells for future use.
This is noteworthy because it's a first step toward securing reimbursement (CPT) codes that would specifically cover products and procedures for fat grafting or cell-enriched fat grafting.
ICD-9 codes help companies, hospitals and providers track in-patient procedures and more importantly assist these organizations in classifying and assigning reimbursement for such procedures.
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Live APOLLO follow up from EURO PCR
June 1, 2010
A live 18-month diagnostic follow-up on a patient enrolled in the APOLLO study was performed and broadcast during the Euro PCR conference on Friday, May 28. The co-principal investigator of the study, Dr. Duckers, noted during the procedure that this (single patient) outcome demonstrated sustained and further improvements at 18- months, in particular, improvements in infarct size and heart function.
“This outcome is consistent with our observations at 6 months. On the example of this patient, we see impressive improvements in the infarct size and heart function at 6 months, with sustained - and even further - improvements at 18 months.”
Below is a summary of what was recorded from the live case as presented by Dr. Duckers:
- The patient is a 50 year old male who presented with ST-elevated myocardial infarction (heart attack) who underwent primary percutaneous coronary intervention 18 months ago
- Contrast MRI infarct mass decreased from 37 gm, to 20 gm, to 19 gm at baselines, six-months, and 18 months respectively
- Anterior, septal and apical defects as measured by SPECT all improved at six and 18 months, respectively
During the live procedure, Dr. Duckers reviewed the recently reported six-month results from the APOLLO trial and presented the following conclusions:
- Intracoronary infusion of ADRCs resulted in improved LVEF, reduced perfusion defect and reduced infarct size, based on the six-month results reported in May
- Infarct size is one of the most important predictors for important clinical endpoints including re-hospitalization, subsequent infarct and death
- The APOLLO study showed evidence of improved local contractility in the areas of the heart damaged by the heart attack
Friday's diagnostic follow-up was performed at Erasmus University Hospital, one of the leading academic cardiology centers in Europe, and broadcast live to physicians attending a session at Euro PCR, the major European interventional cardiology meeting, on potential new heart attack treatments. Because the study is blinded, it’s unknown if the patient received adipose-derived stem and regenerative cells or placebo.
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First Quarter 2010 Results and Commercial and Clinical Update
May 6, 2010
Dear Shareholders,
The first quarter of 2010 was very strong for Cytori. In particular, we substantially grew product revenues, shipped more consumables per quarter than ever, launched a new product platform in the U.S. and completed several important objectives related to our pipeline.
Today, Cytori sells differentiated and proprietary products to the private-pay cosmetic surgery markets within the U.S., Europe, and Asia as well as innovative equipment for cell banking and research. In parallel, we are laying the foundation for future growth through advancements in our pipeline of therapeutic applications for our core product, the Celution® System. Celution® has been used by our physician customers to treat many debilitating or fatal medical conditions such as cardiovascular disease, non-healing and recalcitrant wounds from radiation injury, urinary incontinence and others.
For full letter, please click here.
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Notes from the Aesthetic Meeting
April 26, 2010
Investors, The feedback from our sales and marketing team at the aesthetic plastic surgery meeting this past weekend, where PureGraft™ was launched, has been extremely positive. One of the most relevant trends and observations coming out of the meeting is the influence fat grafting is starting to have on the industry. Fortunately for Cytori, this has translated into significant interest amongst surgeons at the conference in the PureGraft™ product, our Celbrush™ micro-droplet adipose delivery tool, and in our Celution® System, which was on display as part of our U.S. development pipeline.
For Cytori, quality and innovation of products aside, we don’t underestimate being in the right place, or in this case the right market, at the right time. Perhaps it’s a bit serendipitous, yet fortuitous for Cytori nonetheless, that fat grafting is an emerging growth area in plastic surgery. We can address this market today with PureGraft™ and expect to further grow this market in the future with Celution®.
For those of you looking for more details on PureGraft™, such as its attributes, product pricing, or how it’s bundled, we encourage you to have a look at our new e-commerce site at www.puregraft.com.
For Cytori, quality and innovation of products aside, we don’t underestimate being in the right place, or in this case the right market, at the right time. Perhaps it’s a bit serendipitous, yet fortuitous for Cytori nonetheless, that fat grafting is an emerging growth area in plastic surgery. We can address this market today with PureGraft™ and expect to further grow this market in the future with Celution®.
For those of you looking for more details on PureGraft™, such as its attributes, product pricing, or how it’s bundled, we encourage you to have a look at our new e-commerce site at www.puregraft.com.
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Fat Grafting at ASAPS
April 23, 2010
Fat grafting is one of the rising trends in cosmetic surgery, as illustrated by its presence at the annual meeting of the American Society of Aesthetic Plastic Surgery, April 22-27.
The following ASAPS sessions will focus on the use of fat grafting in cosmetic procedures.
SUNDAY, APRIL 25
9:15-10:15 AM: Interactive Video – New Directions in Autologous Fat Transfer to the Breast (Scientific Session A)
Roger K. Khouri, MD, Dennis C. Hammond, MD – Maryland Ballroom A-D
2:00-6:30 PM: 405/505: Buttocks Augmentation by Fat Grafting or Implants
Constantino G. Mendieta, MD, Jose Abel De La Pena, MD, Vernon Leroy Young, MD
4:30-6:30 PM: 511: Auto-Fat Grafting and Pursing Suspension Sutures in Facelift
Jose Guerrerosantos, MD
MONDAY, APRIL 26
11:00-11:30 AM: Interactive Video: Innovations in Liposuction: Fat Separation, Equalization & Preservation (Scientific Session B)
Simeon H. Wall, Jr., MD, Melinda J. Haws, MD – Potomac C
For a full schedule of ASAPS sessions, please click here.
Cytori is launching the PureGraft™ 250/PURE System, a revolutionary fat grafting technology that standardizes the graft preparation process for use in aesthetic body contouring. The PureGraft System sets a new standard for fat graft processing due to its speed, simplicity, safety and precision. The ease of use and simplicity of this innovative system sets it apart from other fat grafting methods. Learn more about the PureGraft launch.
The following ASAPS sessions will focus on the use of fat grafting in cosmetic procedures.
SUNDAY, APRIL 25
9:15-10:15 AM: Interactive Video – New Directions in Autologous Fat Transfer to the Breast (Scientific Session A)
Roger K. Khouri, MD, Dennis C. Hammond, MD – Maryland Ballroom A-D
2:00-6:30 PM: 405/505: Buttocks Augmentation by Fat Grafting or Implants
Constantino G. Mendieta, MD, Jose Abel De La Pena, MD, Vernon Leroy Young, MD
4:30-6:30 PM: 511: Auto-Fat Grafting and Pursing Suspension Sutures in Facelift
Jose Guerrerosantos, MD
MONDAY, APRIL 26
11:00-11:30 AM: Interactive Video: Innovations in Liposuction: Fat Separation, Equalization & Preservation (Scientific Session B)
Simeon H. Wall, Jr., MD, Melinda J. Haws, MD – Potomac C
For a full schedule of ASAPS sessions, please click here.
Cytori is launching the PureGraft™ 250/PURE System, a revolutionary fat grafting technology that standardizes the graft preparation process for use in aesthetic body contouring. The PureGraft System sets a new standard for fat graft processing due to its speed, simplicity, safety and precision. The ease of use and simplicity of this innovative system sets it apart from other fat grafting methods. Learn more about the PureGraft launch.
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About This Blog
Visit our shareholder blog to get periodic updates on our company and products as well as occasional commentary on industry developments impacting our business. Members of management as well as other employees will also provide candid insight from time time. Enjoy, TomBlog entiries include forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties are described under the "Risk Factors" in Cytori's Securities and Exchange Filings, including its annual report on Form 10-K. Cytori assumes no responsibility to update or revise any forward-looking statements contained in these notes to reflect events, trends or circumstances after the date of these blog entries.
Links to external websites and news and information sources may at times be provided. Any information, views or opinions expressed in these links do not necessarily represent the views of Cytori, nor can Cytori ensure the accuracy of any information contained in external links, in particular is it might relate to Cytori.
Recent Posts
- PureGraft Approved in Europe...
Jul 29, 2010 - CYTX Expands Celution EU Indications; To Support Hospital Sales
Jul 27, 2010 - Adipose Stem Cell Review
Jul 16, 2010 - Vote CYTX shares today...
Jul 15, 2010 - 1st U.S. StemSource® Cell Bank Customer, BioLife, Now Open in Dallas
Jun 21, 2010
