cytori8k_080812.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 8-K

Current Report 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 8, 2012

CYTORI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 

Delaware
001-34375
33-0827593
(State or Other Jurisdiction of Incorporation)
(Commission File
Number)
(I.R.S. Employer Identification Number)

3020 Callan Road, San Diego, California 92121
(Address of principal executive offices, with zip code)

(858) 458-0900
(Registrant's telephone number, including area code)

n/a
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see  General Instruction A.2. below):
 
 
 □
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
 □
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
 □
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
 □
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
 

 

Item 2.02                      Results of Operations and Financial Condition

On August 8, 2012 Cytori Therapeutics, Inc. (Company) issued a press release announcing its financial results for the second quarter ended June 30, 2012. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. In addition, on the same date, the Company has posted further insight into those results of operations in an open letter to its stockholders and other interested parties in the blog on the Investor Relations section of its website. A copy of the letter is attached hereto as exhibit 99.2.

The information disclosed under this Item 2.02 in this report, including Exhibits 99.1 and 99.2 hereto, are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.


Item 9.01                      Financial Statements and Exhibits

(d)           Exhibits

Exhibit No.     
Description
99.1
Cytori Therapeutics, Inc. Press Release, dated August 8, 2012 *
99.2
Cytori Therapeutics, Inc. Shareholder Letter, dated August 8, 2012 *

*
Exhibits 99.1 and 99.2 hereto are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.


 
 

 

SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.




 
CYTORI THERAPEUTICS, INC.
   
Date:  August 8, 2012
By: /s/ Mark E. Saad
 
Mark E. Saad
 
Chief Financial Officer
 








exhibit991_pressrelease.htm
CYTORI LOGO
 
 
August 8, 2012
 
Cytori Provides Business Update and Reports Second Quarter and First Half 2012 Results
 
SAN DIEGO--During the second quarter and first half of 2012, Cytori Therapeutics (NASDAQ: CYTX) made key advancements in its cardiac cell therapy pipeline, achieved important commercial and regulatory milestones, carefully managed its financial resources and remained on plan to achieve $9 million in revenue for the year. The Company has achieved or made measurable progress in the following milestones, year-to-date:
 
Clinical Pipeline
 
·  
Received approval from the FDA to begin the U.S. ATHENA IDE trial for chronic myocardial ischemia in refractory heart failure patients. Patient screening is active and the first patient is expected to be treated shortly;
 
·  
Published positive six month outcomes from the APOLLO heart attack trial in the Journal of the American College of Cardiology;
 

Commercial Business
 
·  
Expanded Celution® CE Mark certification to include broader wound healing and ischemia related indications-for-use;
 
·  
Received regulatory approval for Celution® in Russia and Croatia and obtained multiple additional Puregraft® approvals worldwide;
 
·  
Applied for formal approval of the Celution® System for breast reconstruction from the Medical Technology Assessment Committee in the U.K;
 
·  
Published positive 12 month outcomes from the RESTORE 2 trial in the European Journal of Surgical Oncology;
 
·  
Advanced negotiations to expand our Celution® CE Mark into cardiovascular and ischemic indications;
 
 
Operations & Financial Performance
 
·  
Reduced net cash used in operating activities in the first half of 2012 compared to the first half of 2011, with related reductions in sales, general and administrative expenses;
 
·  
Received a U.S. composition patent for soft tissue defects and a U.S. device patent for accelerating the healing of wounds;
 
·  
Made tangible progress in several of our active partnership opportunities;
 
“Our cardiovascular disease pipeline progressed in the first half of 2012,” said Christopher J. Calhoun, chief executive officer for Cytori Therapeutics. “In the U.S., our refractory heart failure trial (ATHENA) is actively screening patients, our EU acute heart attack trial (ADVANCE) protocol has been revised and is back in front of key regulators, and progress has been made in leveraging our cardiovascular clinical data to expand our European market access. We are also broadening our global footprint of approvals and indications-for-use, which directly expands our access to new markets and presents commercial opportunities which can be addressed with existing resources. Lastly, we continued to improve operations by lowering our quarterly cash utilization rate, while maintaining our investment in clinical development and remaining on plan to achieve 2012 revenue guidance.”
 
Financial Results
 
Total revenues were $4.4 million and $5.9 million for the second quarter and first half of 2012, respectively, which includes $2.4 million in development revenue recognized in the second quarter of 2012. This compares to $2.4 million and $5.0 million for the same periods of 2011, respectively, which includes $1.2 million in development revenue recognized in the first quarter of 2011.
 
Product revenues were $1.9 million and $3.4 million for the second quarter and first half of 2012, compared with $2.4 million and $3.8 million for the same periods in 2011.  Gross profit was $0.9 million and $1.5 million for the second quarter and first half of 2012, compared to $1.3 million and $1.8 million for the second quarter and first half of 2011, respectively. As previously reported, product sales will be weighted toward the second half of 2012, due in part to realizing the impact of new country approvals and expanded indications-for-use mentioned above.
 
Research and development expenses remained relatively stable at $3.2 million and $6.0 million for the second quarter and first half of 2012, compared to the same periods in 2011. In contrast, sales, general and administrative expenses were reduced to $6.4 million and $12.7 million in the second quarter and first half of 2012, a decrease of 19% and 13%, respectively, compared to the same periods in 2011.  This improvement was achieved in part by targeted reductions in headcount and external consulting costs.
 
Net loss was $7.9 million, or ($0.13) per share, and $17.2 million, or ($0.30) per share, for the second quarter and first half of 2012, respectively. This compares to $5.1 million, or ($0.10) per share, and $17.2 million, or ($0.33) per share for the second quarter and first half of 2011, respectively. Net loss for the second quarter and first half of 2011 includes non-cash credit of $5.2 million and $2.1 million respectively related to the change in the fair value of warrant and option liabilities compared to non-cash expense of $0.7 million and $0.6 million for the same periods in 2012. At the end of the second quarter of 2012, Cytori had $25.8 million in cash and cash equivalents and $2.0 million in accounts receivable, net of reserves.
 
Management Conference Call Webcast and Shareholder Letter Information
 
Cytori will host a management conference call at 5:00 p.m. Eastern Time today to further discuss the company’s progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section (http://ir.cytori.com) of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1.866.791.6247, Passcode: 4549443. More details on our business are contained in the ‘August 2012 Shareholder Letter' posted on the homepage of our Investor Relations website.
 
 
 
 

 
 
About Cytori
 
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects.  Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® system product family. www.cytori.com
 
Cautionary Statement Regarding Forward-Looking Statements
 
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, such as the successful initiation of the ATHENA clinical trial of the Company’s Celution® system for chronic myocardial ischemia, our efforts to expand our CE Mark, achieve our revenue projection for 2012, and execute a commercialization partnership agreement. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, such as those associated with the ATHENA clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, and other risks and uncertainties described under "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
 
###
 
Contact:
Investors                                                      Media
Tom Baker                                           Megan McCormick
tbaker@cytori.com                                                      mmccormick@cytori.com
+1.858.875.5258                                                      +1.858.875.5279

 
 

 



 

 
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
 
   
As of June 30, 2012
   
As of December 31, 2011
 
Assets
           
Current assets:
           
Cash and cash equivalents
  $ 25,771,000     $ 36,922,000  
Accounts receivable, net of reserves of $220,000 and of $474,000 in 2012 and 2011, respectively
    1,983,000       2,260,000  
Inventories, net
    3,108,000       3,318,000  
Other current assets
    1,115,000       837,000  
                 
Total current assets
    31,977,000       43,337,000  
                 
Property and equipment, net
    2,255,000       1,711,000  
Restricted cash and cash equivalents
    350,000       350,000  
Investment in joint venture
    164,000       250,000  
Other assets
    1,755,000       1,772,000  
Intangibles, net
    81,000       192,000  
Goodwill
    3,922,000       3,922,000  
                 
Total assets
  $ 40,504,000     $ 51,534,000  
                 
Liabilities and Stockholders’ Equity (Deficit)
               
Current liabilities:
               
Accounts payable and accrued expenses
  $ 5,066,000     $ 5,334,000  
Current portion of long-term obligations
    7,338,000       2,487,000  
                 
Total current liabilities
    12,404,000       7,821,000  
                 
Deferred revenues, related party
    1,107,000       3,520,000  
Deferred revenues
    5,296,000       5,244,000  
Warrant liability
    1,008,000       627,000  
Option liability
    2,100,000       1,910,000  
Long-term deferred rent
    600,000       504,000  
Long-term obligations, net of discount, less current portion
    17,441,000       21,962,000  
                 
Total liabilities
    39,956,000       41,588,000  
                 
Commitments and contingencies
               
Stockholders’ equity:
               
Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2012 and 2011
           
Common stock, $0.001 par value; 95,000,000 shares authorized; 58,706,856 and 56,594,683 shares issued and outstanding in 2012 and 2011, respectively
    59,000       57,000  
Additional paid-in capital
    260,146,000       252,338,000  
Accumulated deficit
    (259,657,000 )     (242,449,000 )
                 
Total stockholders’ equity
    548,000       9,946,000  
                 
Total liabilities and stockholders’ equity
  $ 40,504,000     $ 51,534,000  
 


 
 

 

CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
 

 
   
For the Three Months
Ended June 30,
   
For the Six Months
Ended June 30,
 
   
2012
   
2011
   
2012
   
2011
 
                         
 Product revenues
  $ 1,947,000     $ 2,411,000     $ 3,427,000     $ 3,773,000  
                                 
Cost of product revenues
    1,032,000       1,109,000       1,885,000       1,950,000  
                                 
Gross profit
    915,000       1,302,000       1,542,000       1,823,000  
                                 
Development revenues:
                               
Development, related party
    2,413,000             2,413,000       1,231,000  
Research grant and other
    16,000       11,000       19,000       15,000  
      2,429,000       11,000       2,432,000       1,246,000  
Operating expenses:
                               
Research and development
    3,224,000       3,071,000       6,060,000       6,118,000  
Sales and marketing
    2,581,000       3,716,000       4,956,000       6,942,000  
General and administrative
    3,788,000       4,147,000       7,712,000       7,692,000  
Change in fair value of warrant liability
    251,000       (5,649,000 )     381,000       (2,178,000 )
Change in fair value of option liability
    460,000       400,000       190,000       110,000  
                                 
Total operating expenses
    10,304,000       5,685,000       19,299,000       18,684,000  
                                 
Operating loss
    (6,960,000 )     (4,372,000 )     (15,325,000 )     (15,615,000 )
                                 
Other income (expense):
                               
Interest income
    1,000       1,000       2,000       4,000  
Interest expense
    (860,000 )     (696,000 )     (1,726,000 )     (1,434,000 )
Other income (expense), net
    (27,000 )     (15,000 )     (73,000 )     (62,000 )
Equity loss from investment in joint venture
    (37,000 )     (56,000 )     (86,000 )     (102,000 )
                                 
Total other income (expense)
    (923,000 )     (766,000 )     (1,883,000 )     (1,594,000 )
                                 
Net loss
  $ (7,883,000 )   $ (5,138,000 )   $ (17,208,000 )   $ (17,209,000 )
                                 
Basic and diluted net loss per common share
  $ (0.13 )   $ (0.10 )   $ (0.30 )   $ (0.33 )
                                 
Basic and diluted weighted average common shares
    58,676,092       52,411,642       58,080,541       52,204,348  

 

 
 
 

 

CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)

   
For the Six Months Ended June 30,
 
   
2012
   
2011
 
Cash flows from operating activities:
           
Net loss
  $ (17,208,000 )   $ (17,209,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    453,000       400,000  
Amortization of deferred financing costs and debt discount
    470,000       471,000  
Provision for doubtful accounts
    19,000       235,000  
Change in fair value of warrants
    381,000       (2,178,000 )
Change in fair value of option liabilities
    190,000       110,000  
Share-based compensation expense
    1,977,000       1,721,000  
Equity loss from investment in joint venture
    86,000       102,000  
Increases (decreases) in cash caused by changes in operating assets and liabilities:
               
Accounts receivable
    258,000       (623,000 )
Inventories
    210,000       (513,000 )
Other current assets
    (278,000 )     (15,000 )
Other assets
    17,000       (905,000 )
Accounts payable and accrued expenses
    (268,000 )     92,000  
Deferred revenues, related party
    (2,413,000 )     (1,231,000 )
Deferred revenues
    52,000       35,000  
Long-term deferred rent
    96,000       (24,000 )
                 
Net cash used in operating activities
    (15,958,000 )     (19,532,000 )
                 
Cash flows from investing activities:
               
Purchases of property and equipment
    (886,000 )     (433,000 )
                 
Net cash used in investing activities
    (886,000 )     (433,000 )
                 
Cash flows from financing activities:
               
Principal payments on long-term obligations
    (140,000 )     (2,230,000 )
Proceeds from exercise of employee stock options
    951,000       2,756,000  
Proceeds from sale of common stock
    4,946,000        
Costs from sale of common stock
    (64,000 )      
                 
Net cash provided by financing activities
    5,693,000       526,000  
                 
Net decrease in cash and cash equivalents
    (11,151,000 )     (19,439,000 )
                 
Cash and cash equivalents at beginning of period
    36,922,000       52,668,000  
                 
Cash and cash equivalents at end of period
  $ 25,771,000     $ 33,229,000  


 

 
 

 

exhibit992_pressrelease.htm
CYTORI LOGO
 
August 8, 2012
 
Dear Shareholders,
 
In the first half of 2012, we continued to execute on our three principal business areas: advancing our clinical pipeline, managing the commercial business, and meeting our stated operational and financial objectives. The following will detail the progress in each of the three categories.
 
Clinical Pipeline
 
We made substantial progress in both our American and European clinical trials.  We are actively screening patients in our U.S. trial (ATHENA).  In our European pivotal trial (ADVANCE), a modified clinical protocol has been submitted to multiple country regulatory authorities and is under review.
 
ATHENA – U.S. No-Option Chronic Myocardial Ischemia Clinical Trial
 
Dr. Tim Henry (co-principal investigator) at The Minneapolis Heart Institute Foundation is actively screening patients for the ATHENA trial.  Dr. Emerson Perin (co-principal investigator) and Dr. James T. Willerson (local principal investigator) at Texas Heart Institute are scheduled to begin screening patients later this month. The FDA recently approved Cytori to expand the trial from five to six sites. The four additional sites which we expect will soon receive local institutional review board approval, be initiated, trained and activated are:
 
Dr. Farrell Mendlesohn, Cardiology PC, in Birmingham, Alabama
Dr. Les Miller, University of South Florida, in Tampa, Florida
Dr. Carl Pepine, University of Florida, in Gainesville, Florida
Dr. Richard Schatz, Scripps Green Hospital in San Diego, California

We anticipate that all sites should be actively enrolling patients by our next quarterly update.  Full enrollment of the trial remains on schedule to be complete by mid-2013.
 
ADVANCE – European Pivotal Heart Attack Trial
 
The ADVANCE clinical trial protocol has been amended and we have submitted for country and hospital approvals under the revised trial design in several target countries. While the primary endpoint and principle investigators remain the same, the amended design reconciles varying diverse cell therapy regulatory guidelines within a G5 country focus, incorporates additional clinical outcomes to support reimbursement, modifies inclusion and exclusion criteria to accelerate enrollment, and incorporates a single treatment dose.  Enrollment is expected to resume in the fourth quarter of this year and is anticipated to enroll up to 216 patients in up to 35 hospitals in the G5, Canada, The Netherlands, and Poland.
 
Commercial Business
 
We commercialize several product lines into the soft tissue market across Europe, Asia-Pacific and the U.S.  These include devices for soft tissue defect repair and aesthetics, cell and tissue cryopreservation, and systems for cell-based translational medicine.  Simultaneously, we are directing specific activities toward market access and reimbursement.

Some of the key trends we have seen so far this year include: increased Celution® consumable utilization among our existing customers, expanded device base into new hospitals and markets, and another record quarter for Puregraft® sales.
 
 
Year-to-Date Product Approvals
Russia Celution®
Croatia Celution®
United States Puregraft® 850
Europe Puregraft® 850
Singapore Puregraft® 250
Australia Puregraft® 250
Taiwan Puregraft® 250
Croatia Puregraft® 250
Taiwan PureGraft™ 250

 
We reaffirm our $9 million product revenue target for 2012 based on three current data points: year to date sales of $3.4 million, the quality of our sales funnel, and the market access progress we have accomplished so far this year.
 
Revenue growth in the near-term will be driven primarily by increasing demand in three market segments:
 
1)  
Private-pay aesthetic and reconstructive procedures among new and existing customers
 
2)  
Academic hospitals to conduct investigator-initiated studies and translational medicine
 
3)  
Cryopreservation of adipose tissue and adipose-derived regenerative cells
 
 
 
 

 
 
European CE Mark and Expanded Indications-for-Use
 
We continued in an active dialogue and document exchange with our governing regulatory authority during the second quarter regarding our application to add claims for no-option chronic myocardial ischemia patients to our existing Celution® System CE Mark indications. We are currently preparing additional information recently requested by the clinical reviewer. This documentation will be submitted in the third quarter.
 
In the interim and in consultation with our notified body, we are pleased to add new CE Mark indications-for-use based on a growing body of clinical evidence. These broad indications-for-use include:

General Surgery Procedures to facilitate healing in patients with:
 
·  
Cryptoglandular fistula
·  
Deficiency or injury of: skin, fat, muscle and fascia
·  
Soft tissue wounds, ulcers or fistula associated with trauma, diabetes, ischemia or radiation injury
·  
Tissue ischemia

These new indications complement our existing claims:

The Celution® 805/CRS consumable set, in conjunction with the Celution® 800/CRS device and Celase®, are intended to digest adipose tissue in order to further extract, wash and concentrate stromal stem cells and other associated progenitor cells intended for autologous re-implantation or reinfusion for use in:
 
Plastic & reconstruction procedures to replace, repair, reconstruct, or augment:
 
·  
Surgical soft tissue defects, such as those seen in the breast due to mastectomies and lumpectomies
·  
Liposuction defects, such as those seen in the abdomen, back, thighs and buttocks
·  
Congenital asymmetry of soft tissues, such as those seen in the breast or face
·  
Anatomically deficient soft tissues, such as those seen in the breast, buttocks and face
·  
Soft tissue wasting disorders, such as those affecting the hands and face

Based on our discussions with our notified body and these expanded claims, our commercial team is taking steps to expand the market for Celution® for use in these broadened indications and for intravascular reinfusion. In aggregate, these claims should support both second half revenues and further growth in 2013.

Translational Medicine
 
Adipose-derived regenerative cells (ADRCs) function through several overlapping ‘mechanisms of action’ including angiogenesis (creating blood supply), inflammatory modulation, and facilitation of wound healing. These mechanisms are common to the underlying pathophysiology of many diverse diseases and injuries. For this reason, physicians are actively looking to ADRCs to address specific clinical problems, many of which cannot be treated effectively with current therapy.
 
The Celution® System provides access for these physicians to clinical grade ADRCs, within the context of their own clinical or health care facility. In return, the corresponding investigator relationships that are built, clinical data that is compiled and extensive global visibility of these individual efforts are contributing to establishing Cytori as the leading brand in Cell Therapy. For example, in Japan, approximately one in ten investigator-led clinical studies approved by the Ministry of Health under the new cell therapy clinical research guidelines utilizes Cytori technology. By the end of the year, we expect that this will increase to nearly 20% of the approved studies in Japan.
 
The current investigator led studies approved by Ministry of Health under their cell therapy clinical research guidelines include:
 
Nagoya University Hospital:  Momokazu Gotoh, MD, PhD
Urology:  Stress Urinary Incontinence
Study Title:  Clinical study of peri-urethral injection of autologous adipose-derived stem and regenerative cells from liposuction for the treatment of stress urinary incontinence

Osaka University Graduate School of Medicine: Masaki Mori, MD, PhD
Gastroenterology:  Intractable Fistula
Study Title:  Clinical study of the treatment for Fistula after gastrointestinal surgery by adipose derived regenerative cell transplantation
 
 
 
 

 

 
Tottori University: Bin Nakayama, MD, PhD
Plastic Surgery:  Breast Reconstruction
Study title:  Clinical study of breast reconstruction for post-partial mastectomy using adipose derived regenerative cells

Operational and Financial Performance
 
The company generated $3.4 million in product sales in the first half of 2012 while reducing sales and marketing expenses by 29% ($2.0 million) versus the same period in 2011 and tightly controlled R&D and G&A costs. Net cash used in operating activities was reduced by 18% during the first six months of 2012 to $16.0 million compared to the same period in the prior year. We will continue to keep downward pressure on non-R&D expense areas and expect further reductions in cash operating loss in the second half of the year. We ended the quarter with $25.8 million in cash and cash equivalents and $2.0 million in accounts receivable, net of reserves.
 
At the time of our last call, we disclosed that we were in multiple advanced partnering processes with two at a stage we described as ‘very near term’ to closure. Subsequently, both of these deals experienced delays that required additional time and effort by our team. Importantly, as of today we believe we have overcome the additional hurdles and that we are close to completion of both transactions. We remain highly confident on this important matter.
 
Cytori has obtained an average of one patent per month for the past four years, since receiving our first foundational U.S. patent in June 2008. We now have more than 50 issued and allowed patents worldwide, along with more than 75 additional patent applications under review. Our intellectual property position was strengthened during the quarter with the receipt of three patents, including one in the U.S. 

Summary
 
Significant clinical, regulatory, commercial and corporate accomplishments set the stage for several value drivers in the second half of the year. The key value drivers that we have achieved or expect to achieve include the following:
 
2012 Milestones
Completed
Approval to initiate ATHENA
P
Publish APOLLO primary endpoints (6-months)
P
Publish RESTORE 2 12-month results
P
UK breast reconstruction medical technology assessment application
P
Puregraft® 850 FDA Clearance
P
Puregraft® 250 & 850 Clearances O-U.S.
P
Execute strategic partnership
 
Begin enrollment in ATHENA
 
Cardiovascular CE Mark expansion
 
Publish APOLLO long-term (18-mo) outcomes
 
Publish PRECISE primary endpoints (6-mo)
 
Publish PRECISE long-term (18-mo) outcomes
 
Achieve $9 million revenue target for 2012
 

 
Sincerely,
 
SIGNATURE
Christopher J. Calhoun
 
Cautionary Statement Regarding Forward-Looking Statement
 
This shareholder letter includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our ability to achieve our revenue growth targets, obtain European no-option chronic myocardial ischemia claims, resume enrollment in the ADVANCE trial, obtain additional publications for APOLLO and PRECISE trials, achieve enrollment goals for the ATHENA trial, generate growth in the number of Investigator initiated trials, and completion of strategic corporate partnerships, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, regulatory uncertainties regarding the collection and results of clinical data, our ability to obtain sufficient data to support regulatory approvals and reimbursement, uncertainties relating to the success of our sales and marketing programs, changing and unpredictable regulatory environments, dependence on third party performance and the risk of natural disasters and other occurrences that may disrupt the normal business cycles in areas of our global operations, as well as other risks and uncertainties described under "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Forms 10-K and 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.