GAITHERSBURG, MD, Sep 17, 2013 (Menafn - Marketwired via COMTEX) --Cytomedix, Inc. (otcqx:CMXI), a regenerative therapies companycommercializing and developing innovative cell based technologies,today announced that, in line with its strategy to build a profitableand successful company commercially focused on the wound care market,it will reorganize its research and development activities. As partof this initiative, the Company's ongoing financial support of thecurrent RECOVER-Stroke trial and the underlying ALDH Bright Celltechnology will be substantially concluded as of year-end 2013. TheCompany is exploring a range of strategic options for continuing itsclinical programs beyond year-end 2013, which options may include,among others, technology transfer, spinout, licensing or othersimilar transactions involving the underlying technology.
Cytomedix has restructured its Durham, N.C. research and developmentfacility to bring available resources and spending in line withcurrent and expected enrollment in the ongoing clinical programs. TheRECOVER-Stroke trial with ALD-401 has now enrolled 39 patients. TheCompany's present intention is to proceed with enrollment in thetrial through 2013 year-end with an enrollment goal of 50 patients atthat time. Depending on the success of the Company's efforts topursue strategic options for continuing its clinical programs, theCompany may determine to conclude the study beyond December 31 andunblind the study data at the assessments of the primary efficacyendpoint, i.e., 90 days post treatment of the last enrolled patient.
Martin Rosendale, Chief Executive Officer of Cytomedix, commented,"In line with our goal of building a more commercially focused andstreamlined organization at Cytomedix, we have presently concluded tolimit further investment in areas that are not part of our commercialbusiness objectives. While we have made important progress with theRECOVER-Stroke trial and remain of the opinion that the ALDH BrightCell adult stem cell population is novel and highly differentiated,we acknowledge that enrollment has been slower than expected. We willcontinue to seek and pursue opportunities that would allow us to movethe program forward and minimize the ongoing investment by Cytomedixbeyond year-end."
Mr. Rosendale added "This decision, along with the licensing of theAngel System recently announced, is expected to substantially reduceour cash burn and allow us to focus our efforts exclusively onAutoloGel and the significant opportunity we believe exists in thechronic wound care market. We believe this is the most financiallyresponsible action we can undertake to preserve and grow shareholdervalue."
The Company will continue to support third party funded studies whileit enrolls the stroke study through the end of the year. For example,the ongoing Phase 2 PACE study, is funded by the National Heart, Lungand Blood Institute, and is looking at the safety and value of brightcells for the treatment of Intermittent Claudication, a form ofperipheral arterial disease.
About Cytomedix
Cytomedix, Inc. is an autologous regenerative therapies companycommercializing innovative cell based technologies for orthopedicsand wound care. The Company markets the AutoloGel(TM) System, adevice for the production of autologous platelet rich plasma ("PRP")gel for use on a variety of exuding wounds and the Angel(R)Concentrated Platelet Rich Plasma System, a blood processing deviceand disposable products used for the separation of whole blood or amixture of blood and bone marrow, into red cells, platelet poorplasma ("PPP") and PRP in surgical settings. For additionalinformation please visit www.cytomedix.com.
Safe Harbor Statement - Statements contained in this press releasenot relating to historical facts are forward-looking statements thatare intended to fall within the safe harbor rule for such statementsunder the Private Securities Litigation Reform Act of 1995. Theinformation contained in the forward-looking statements is inherentlyuncertain, and Cytomedix' actual results may differ materially due toa number of factors, many of which are beyond Cytomedix' ability topredict or control, including among many others, risks anduncertainties related to the Company's ability to identify andconclude any of the contemplated strategic options for the Aldagenbright cell technology, to the Company's ability to successfullyexecute its Angel(R) and AutoloGel sales strategies, to successfullylaunch its efforts in outpatient and other clinics and to achieveAutoloGel expected reimbursement rates in 2013 and thereafter, tosuccessfully negotiate with physician offices as anticipated and torealize the anticipated sales growth from such treatments; to meetits stroke trial enrollment rates, to successfully realize sales ofthe Angel(R) Technology under the Arthrex licensing arrangementresulting in the royalty stream to the Company, the Company's abilityto successfully integrate the Aldagen acquisition, the Company'sability to expand patient populations as contemplated, its ability toraise capital as needed, its ability to provide Medicare patientswith access as expected, the Company's expectations of favorablefuture dialogue with potential strategic partners, and its ability tosuccessfully manage contemplated clinical trials, to manage andaddress the capital needs, human resource, management, compliance andother challenges of a larger, more complex and integrated businessenterprise, viability and effectiveness of the Company's salesapproach and overall marketing strategies, commercial success oracceptance by the medical community, competitive responses, theCompany's ability to raise additional capital and to continue as agoing concern, and Cytomedix's ability to execute on its strategy tomarket the AutoloGel(TM) System as contemplated. To the extent thatany statements made here are not historical, these statements areessentially forward-looking. The Company uses words and phrases suchas "believes", "forecasted," "projects," "is expected," "remainconfident," "will" and/or similar expressions to identifyforward-looking statements in this press release. Undue relianceshould not be placed on forward-looking information. Theseforward-looking statements are subject to known and unknown risks anduncertainties that could cause actual events to differ from theforward-looking statements. More information about some of theserisks and uncertainties may be found in the reports filed with theSecurities and Exchange Commission by Cytomedix, Inc. Cytomedixoperates in a highly competitive and rapidly changing business andregulatory environment, thus new or unforeseen risks may arise.Accordingly, investors should not place any reliance onforward-looking statements as a prediction of actual results. Exceptas is expressly required by the federal securities laws, Cytomedixundertakes no obligation to update or revise any forward-lookingstatements, whether as a result of new information, changedcircumstances or future events or for any other reason. Additionalrisks that could affect our future operating results are more fullydescribed in our U.S. Securities and Exchange Commission filings,including our Annual Report for the year ended December 31, 2012, asamended to date, and other subsequent filings. These filings areavailable at www.sec.gov.
Contacts:
Cytomedix, Inc.
Martin Rosendale
Chief Executive Officer
Steven A. Shallcross
EVP/Chief Financial Officer
(240) 499-2680
Investors
Michael Rice
LifeSci Advisors, LLC
[email protected]
(646) 597-6979