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Cytomedix Submits Application to FDA Seeking Marketing Clearance of Its AutoloGel System - Includes Specific Claims for Healing Chronic Wounds
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ROCKVILLE, Md., Jan. 30, 2006 (PRIMEZONE) -- Cytomedix, Inc. (AMEX:GTF), a biotechnology company specializing in the research, development, licensing, and systems for treating non-healing chronic wounds including diabetic ulcers, today announced that the Company has submitted a premarket 510(k) application to the U.S. Food and Drug Administration (FDA) seeking clearance of its AutoloGel(tm) System for specific wound healing indications, based on the results of its diabetic foot ulcer clinical trial and other available data.
"We are pleased that our submission to FDA has been made in a very timely manner," stated Cytomedix Chairman and Chief Executive Officer K****ij Mohan. "We believe that the data from our clinical trial indicates high levels of safety and effectiveness that more than meet the level of 'reasonable assurance of safety and effectiveness' and a highly favorable benefit-risk ratio, the two key considerations that underpin the regulatory review of medical devices under FDA's laws and regulations. While we do not presume to predict FDA's decision, we look forward to working with the Agency toward a timely and favorable decision to obtain a marketing clearance for our product for specific claims reflecting the high healing rates and safety of the AutoloGel(tm) System. This event puts us another step closer to receiving the FDA clearance and Medicare reimbursement for our product as well as achieving greater awareness and acceptance of AutoloGel(tm) by the clinical community."
In recently completed clinical trials of the AutoloGel(tm) System, analysis of the size of wounds showed that 35 out of the 40 patients, i.e. 88% of the patients, had wounds that were less than or equal to 7 sq. cm in area and 2 cubic cm in volume. For these most common wound sizes in the study, the healing rate for the AutoloGel(tm) group was 81.3% and that for the Control group, which was treated with a control treatment, was 42.1%. The difference of 39.2 % between these rates is strongly statistically significant, with a p-value of 0.036. The healing rates of AutoloGel(tm) at 81.3% for the most common wound sizes in the study and 68.4% for all wound sizes are, to our knowledge, better than any other wound care products cleared by the FDA. Cytomedix has completed all planned analysis of clinical lab data, such as blood chemistry and other safety parameters. No statistical or clinical significance difference with safety of the control treatment was reported.
The 510(k), submitted to the FDA's Center for Biologics Research and Evaluation (CBER), must undergo a 90-day statutory review period. The Agency may request additional information or a different regulatory pathway that may lengthen its review process. Cytomedix has provided the Agency information comparing the AutoloGel(tm) System to other marketed platelet-rich plasma separation systems and wound care products for the same intended use and similar indications and cleared through the 510(k) process. Cytomedix believes the comparisons to these marketed products, called predicate devices, provide a strong basis supporting a clearance of the AutoloGel (tm)System using the traditional 510(k) process.
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses in the treatment of wounds and other applications. The current offering is AutoloGel(tm), a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The Company has concluded the blinded, prospective, multi-center clinical trial on the use of its technology in healing diabetic foot ulcers. Additional information regarding Cytomedix is available at: http://www.cytomedix.com.
SAFE HARBOR STATEMENT
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix's actual results may differ materially due to a number of factors, many of which are beyond Cytomedix's ability to predict or control, including among others, the success of new sales initiatives, governmental regulation, acceptance by the medical community and competition. There is no guarantee that the FDA will complete its review within any estimated timeframe, or that the FDA will fully agree with the Company in the interpretation of the data or the regulatory pathway and provide marketing clearance. Further, there is no guarantee that the Company will receive Medicare reimbursement for AutoloGel(tm) even assuming the FDA grants the Company's request for marketing clearance. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
UPDATE 1-Cytomedix shares tank after FDA denies claim on gel
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Shares of Cytomedix Inc. <GTF.A> lost more than half of their value on Tuesday after it said U.S. regulators denied the company's claim on a gel for healing diabetic foot ulcers.
A unit of the Food and Drug Administration denied the claim that Cytomedix's AutoloGel is substantially equivalent to a legally marketed device, the company said in a statement.
The primary grounds for the rejection appeared to be the use of bovine thrombin, a clotting agent derived from cows, in the gel, the company said.
Bovine thrombin is used on humans in surgery and other instances to stop bleeding, but the FDA body cited studies that said it could also lead to a bleeding tendency, the company added.
Cytomedix said it will appeal the agency's decision and expects the process to be completed in 60 to 90 days.
The company's shares were down $1.46 at $1.29 in morning trade on the American Stock Exchange.
Reuters are reporting: Cytomedix appeals against FDA decision on gel
Dec 27
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Cytomedix Inc. said it has appealed against the U.S. Food & Drug Administration's decision to deny the company's claim on a gel for healing diabetic foot ulcers.
In October, the regulator had denied Cytomedix's claim that AutoloGel was substantially equivalent to a legally marketed device.
In a statement, the biotechnology company said it continues to feel "very strongly" that its product merits 510(k) clearance and will hence present additional expert analysis and other clarifications to assist the FDA in its review process.
Re: Press Release: FDA application for AutoloGel for diabetic foot ulcers
Press Release: Cytomedix Submits Cost Effectiveness Study For AutoloGel to CMS
Study Shows AutoloGel 'Dominates' Standard of Care and Other Advanced Therapies
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Cytomedix, Inc. (AMEX:GTF) today announced that it has submitted, to the Centers for Medicare and Medicaid Services (CMS), a cost effectiveness analysis of AutoloGel(tm) as compared to certain alternative therapies for patients with diabetic foot ulcers. Results of the study show that AutoloGel(tm) is both more effective and less costly than standard of care and other therapies analyzed in the study.
The study was conducted by B&D Consulting (B&D), an independent, national, advisory and advocacy firm located in Washington, DC. B&D developed the research methodology, model structure, assumptions, and inputs from the peer-reviewed literature, including the publication of Cytomedix's completed clinical trial. Cytomedix paid B&D a fee for its work. This fee was not dependent on the results of the economic study.
This model developed by B&D simulates the clinical, cost, and quality-adjusted life years (QALYs) outcomes associated with using the AutoloGel(tm) System versus certain other treatment modalities in treating non-healing diabetic foot ulcers over a five-year period. The research shows that AutoloGel(tm) represents a potentially attractive treatment alternative for insurers and providers to address the cost burden and debilitating health effects associated with non-healing diabetic foot ulcers.
B&D's model relies upon published data regarding health outcomes as well as costs associated with AutoloGel(tm), a saline gel control, standard wound care, and certain other treatment modalities. The model varies rates of healing, recurrence, infection, amputation, and death and associated costs reported in the literature for a hypothetical group of 200,000 diabetic foot ulcer patients.
The estimated 5-year average direct wound care costs (exclusive of lost work, disability, etc.) when AutoloGel(tm) was used to treat the most commonly sized diabetic foot ulcers was approximately $15,000. This was markedly less than similar costs ranging from approximately $24,000 to $47,000 when either standard of care or other enhanced therapies were simulated. Furthermore, the model suggests a measurable increase in QALYs (a function of increased survival rates and fewer wound complications) when AutoloGel(tm) is used. Alternative treatments studied in this model included such therapies as some tissue engineered grafts, ultrasound, and single growth factor therapies. Therapies that did not have published, peer-reviewed studies of their use, with full wound healing as the primary endpoint, were not considered in the study.
The Company submitted this study to CMS for consideration as CMS works through its open National Coverage Assessment (NCA) on platelet-rich plasma (PRP) gel. According to the NCA Tracking Sheet maintained by CMS, the proposed decision memorandum due date is December 25, 2007, and the expected NCA completion date is March 24, 2008. The Company also anticipates that it will use this report and other data in its marketing efforts.
While cost is not an official factor in determination of national or local coverage decisions, the Company believes that the information may be helpful to CMS in considering the various data submitted regarding AutoloGel(tm). The Company also believes that the information from this study may be helpful to the Healthcare Common Procedure Coding System (HCPCS) Workgroup as they review the unique and specialized nature of PRP gel versus other wound care products in an effort to determine whether or not to grant a new HCPCS code appropriate for AutoloGel(tm).
"We are very pleased with the results of this study," said Dr. K****ij Mohan, Cytomedix Chairman and CEO. "It is gratifying to note that, according to the findings in this study, AutoloGel(tm) can provide patients with improved rates of healing and, therefore, better quality of life, and it also represents a significant cost-savings opportunity. We expect that this study will be of particular interest to CMS, commercial insurance companies, and other third-party payers, as well as to care providers such as long-term acute care facilities, nursing homes, or Veterans Administration hospitals sensitive to the cost savings provided by AutoloGel."
Re: Press Release: FDA application for AutoloGel for diabetic foot ulcers
Press release:
Cytomedix Announces That CMS Preliminarily Affirms Non-Coverage of PRP Gel
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Cytomedix, Inc. today announced that the Centers for Medicare and Medicaid Services has proposed to reaffirm its 2003 national non-coverage decision for autologous blood derived products for chronic non-healing wounds in a draft response to a national coverage reconsideration requested by Cytomedix. CMS cited a lack of adequate evidence and a need for further study of the product in the surgical and chronic wound care setting, the setting for which Cytomedix sought the broadest national coverage.
Cytomedix will vigorously seek a change to this preliminary decision, to be incorporated into CMS's final decision, due March 24, 2008. The proposed decision memorandum is available at the CMS website via the following link: https://www.cms.hhs.gov/mcd/viewdraf...emo.asp?id=208
"We are undoubtedly disappointed by the agency's actions in this draft decision, but we understand that this is a process," stated Dr. K****ij Mohan, Ph.D., Chairman and Chief Executive Officer of Cytomedix. "We faced similar challenges when seeking FDA clearance, but prevailed through the merits of our arguments and our ability to convince the FDA through their fair and objective appeals process that our product deserved market clearance. With a similar mindset, we will do all in our power to work with CMS to make this technology available to so many patients who need it," Dr. Mohan said.
"In the meantime, consistent with our existing strategy, we intend to aggressively pursue our efforts related to the launch of the FDA cleared AutoloGel(tm) System, set for mid first quarter 2008, targeting a significant portion of the market that does not depend on Medicare reimbursement. This includes capitated environments such as Long Term Acute Care Facilities and government agencies such as the Veterans Administration. The sales department now totals six and is focused on most key regions in the United States, complemented by an independent representative to handle sales and distribution in select areas of the country. Further additions to the sales and marketing department are anticipated later in 2008," Dr. Mohan added.
Cytomedix strongly disagrees with this proposed decision on several grounds, including, but not limited to, the following:
The strength of its prospective, well-controlled,
double-blinded, randomized clinical trial that shows higher
healing rates in diabetic foot ulcers than any other
technology including several that are reimbursed by
Medicare without having been reviewed nationally in a formal
coverage decision.
* Food and Drug Administration (FDA) clearance recently
obtained by Cytomedix for the use of its AutoloGel(tm)
System in exuding wounds including chronic wounds and other
surgically or mechanically debrided wounds.
* FDA clearance for licensees of Cytomedix patented technology for use of platelet-rich plasma (PRP) products in surgical
wounds and other applications such as use with bone chips
for orthopedic surgeries.
* The unmet need for diabetic foot ulcer and other chronic
wound patients who suffer from a lack of advanced treatments
with consistent, reliable clinical benefit.
According to CMS's website, a 30 day public comment period commenced immediately following the preliminary decision, which will be followed by a quiet period, culminating in CMS's final decision, due March 24, 2008. Those wishing to make public comment may do so via the following link: https://www.cms.hhs.gov/mcd/public_c...208&basketitem
Cytomedix plans to submit a written response during the public comment period and follow-up with a face-to-face meeting with CMS within the next 30 days. The nature of Cytomedix's efforts during the period leading up to a final decision will be aimed at achieving coverage, in some form, for PRP gel for use in chronic wounds. Cytomedix believes there are a number of scenarios, individually or in combination, under which CMS could provide coverage which include, but are not limited to, the following:
* Limitation on Coverage - CMS could limit the coverage to
chronic wounds for those treatments that have obtained FDA
clearance. This would respond to CMS's desire to provide
coverage only in those cases that are supported by a
sufficiently high standard of clinical evidence.
* Coverage with Evidence Development (CED) - CMS could provide
coverage while Cytomedix continues to gather further data
for clinical outcomes using mechanisms such as a prospective
wound registry. This further data would allow CMS to adapt
its coverage in the future to best serve patient needs.Cytomedix believes that some form of coverage would greatly facilitate patient access to this technology. Based on its experience and results, it is Cytomedix's opinion that this technology provides greater clinical benefit and cost effectiveness than many other technologies including several that have received coverage or payment through Medicare.
Cytomedix believes it is critical that coverage be granted for use on chronic wounds. Chronic wounds are an ailment that causes tremendous physical pain, emotional suffering, and financial hardship to millions of patients. The care of these wounds places a great cost burden on the healthcare system and there exist only limited treatment alternatives with consistent, reliable clinical benefit. Cytomedix believes the data strongly indicates significant clinical benefit to the use of PRP gel in treating chronic non-healing wounds.
The Company believes that the performance of its technology and the quality and quantity of the supporting clinical and cost-effectiveness data compares favorably with those of several other products that are reimbursed by Medicare. Furthermore, of the 61 public comments received by CMS under this National Coverage Assessment, all but three were supportive. Of the three that were non-supportive, one restricted its comments only to acute surgical incisions and another based its objections primarily on the grounds that the AutoloGel(tm) System did not have FDA clearance, an assertion that is clearly no longer accurate.
"We believe that, given the evidence that has been presented with our own randomized trial and other clinical studies and data, all Medicare patients, and not just those that can afford to pay for PRP therapy, should have access to it," said Dr. Mohan. "Furthermore, certain advanced therapies are paid for by Medicare despite the fact that they do not have any data developed under randomized, controlled trials or their performance does not show improvement over commonly available alternatives. This is in contrast to Cytomedix, as we have conducted our own randomized, controlled trial, and also commissioned a pharmaco-economic study comparing clinical and cost effectiveness across other wound care therapies indicating that our technology is dominant over the other technologies to which it was compared," Dr. Mohan added.
Purpose
AutoloGel™ Post-Market Surveillance Program
Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.
Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic (including anaphylaxis) and other adverse events associated with the application of AutoloGel on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the management of mechanically or surgically-debrided wounds.
Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors
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Study Type: Interventional
Study Design: Other, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title: The AutoloGel™ Post-Market Surveillance (TAPS) Program
Further study details as provided by Cytomedix:
Primary Outcome Measures:
Assess the incidence of hematological immunologic other ae's assoc with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechchanically or surgically debrided wounds [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Absence of coagulopathies caused by inhibitors to coagulation Factor V as determ. by a significant prolongation of the (PT) time and confirmed by sever depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
Device: AutoloGel System
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management , such as:
Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects
Press Release: FDA application for AutoloGel for diabetic foot ulcers
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