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"Hello. Cytomedix has posted their 10-Q and in this report are clear and defined discussions on their previous submissions and ongoing strategies regarding reimbursement. What may be disappointing is the lack of promoting their own sales of Autologel. Sales declined albeit very modestly.
"AutoloGelTM kit sales decreased primarily due to the Company's focus on re-tooling its sales strategy to best address targeted opportunities within the non-reimbursement sensitive market."
It would only seem logical that Cytomedix would focus on these areas as CMS has agreed to reconsider their NCD. The CMS decision could unlock huge value in the licensing revenue but not seeing increases in their own sales of Autologel now could be viewed as a negative. Further dissecting of the Q does reveal that they are trying to watch every dime so that may explain that little result may be a product of limited effort in an effort to moderate expenses. The increase in licensing revenue is a pleasant surprise as it demonstrates the proliferation and acceptance of PRP in other areas. Certainly a reversal of the CMS ruling could escalate those revenue streams.
There has been some manner of confusion here related to the FDA's decision and what the FDA has actually been asked to decide. This exerpt clearly addresses and explains the ruling. "On October 13, 2006, the FDA denied Cytomedix's claim that AutoloGelTM is substantially equivalent to predicate devices, as asserted in the 510(k), and delivered to Cytomedix a Non-Substantial Equivalence ("NSE") determination letter." This ruling does not and has never addressed the actual use of Autologel. It simply denies Cytomedix's ability to make marketing claims regarding it's use. The actual use of Autologel is addressed in the opening comment, "Cytomedix's proprietary AutoloGelTM Process to produce a platelet-rich plasma gel ("AutoloGelTM") that has been used by physicians in their practice of medicine for the treatment of wounds." There simply is no FDA jusidiction over the actual use of Autologel. Perhaps this Q filing clarifies this misconception.
Perhaps the most compelling comments from the Q were the discussions on the trial and it's outcomes. "FDA's Center for Biologics Evaluation and Research ("CBER") cites published articles that contend bovine thrombin creates antibodies that may decrease a patient's Factor V count (a clotting agent naturally found within blood) which could cause a bleeding tendency. The analysis and clinical interpretation of the data in Cytomedix's submission to the FDA had concluded that the data from the clinical trial does not demonstrate this complication. No statistically or clinically significant differences were noted between the AutoloGelTM and control from baseline to endpoint laboratory shifts in hematology, clotting factors, and Factor V tests. Additionally, no clinically important changes in clotting factors that would cause concern about the effect of the PRP gel or control on Factor V activity were found during an independent medical expert review of the medical records, including clinical lab test data and concomitant medications."
CBER does not rely on clinical patient trial data, simply published articles. There appears to be little or no consideration given to actual patient based clinical data. Furthermore, CBER complicates logic by approving a similar bovine product. "Of note, the FDA recently cleared bovine thrombin for the treatment of espistaxis (nose bleeds). This product has an implied treatment regimen that could involve the repeated use of bovine thrombin because there is a high rate of recurrences of nosebleeds in people who are afflicted by that condition. Such repeated use may be similar to that of AutoloGelTM and may represent a comparable safety profile. Cytomedix has alerted the review panel to this development as it believes this decision provides a reasonable precedent for clearance for AutoloGelTM."
If CBER were to conclude that the use of bovine thrombin presented a health risk, it could only do so citing it's possible repeated use to treat chronic wounds. Most often, wounds are treated with multiple applications of the gel. We know a single use of bovine thrombin presents no threat or safety risk in the eyes of the FDA as bovine thrombin is used everyday in multiple settings. The only question appears to be that of repeated use. The approval of a nasal inhalant for internal and repeated use using bovine thrombin seems to be contradictory to their initial stance. It seems that the "published articles" cited initially by CBER in their claims of denial regarding Autologel were not applicable or have no bearing to this application for some unknown reason.
Regardless of how the FDA responds to the appeal, ample evidence appears to exist to support use and reimbursement of Autologel.
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