MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, commented today on various recent media reports concerning certain of the Company's tissue products and the amniotic tissue industry.
While MiMedx's allografts have been in the market for over six years and over 170,000 units have been shipped, the Company's recent rapid growth in the advanced wound care market has placed it in a leadership role and that has attracted attention from numerous sources.
Parker H. Petit, Chairman and CEO commented, "When a company takes a leadership role with a new and promising healthcare technology, it deserves scrutiny from regulatory authorities, patients, physicians, and shareholders. Naturally some media reports will follow. Ideally, the scrutiny and the media reports would be fair and objective and accomplished with integrity. In our case, we believe that some of this scrutiny and the resultant media coverage may be prompted by competitors from which we have taken significant market share and who may seek to discredit our products or from short sellers who stand to profit from creating confusion in the stock market. That being the case, there is likely to be more misinformation being disseminated than usual. This type of misinformation does not serve our patients, their prescribing physicians, MiMedx or even the FDA very well. " Petit continued, "Our goals are to help all of our constituents thoroughly understand this promising new medical technology and the various regulatory pathways, and clear up all the misinformation and misunderstandings created by various media reports. We also want to reiterate our goal of maintaining strict compliance with the regulations." On September 4, 2013, MiMedx issued a press release regarding the recent "Untitled Letter" it received from the FDA, which raised an issue regarding the proper regulatory pathway for the Company's micronized product line. As stated in that press release, the micronized product line represents approximately 15% of the Company's projected 2014 revenues and the Company believed that it would be able to achieve its published revenue goals for the balance of 2013, as well as 2014, even without the micronized product. Further, as the Company announced on September 12, 2013, the Company has scheduled a meeting with the FDA on October 16, 2013, to discuss the Untitled Letter and seek resolution of the issue raised.
First and foremost, it is important to understand that the majority of the Company's products are not impacted by the FDA's Untitled Letter.
MiMedx processes two general types of amniotic membrane allografts: one type is in the form of sheet allografts and the other is a micronized version of these same sheet allografts. The sheet allografts make up approximately 85 percent of the Company's projected 2014 revenues, and the regulatory status of this product category has not been questioned.
In order to fully appreciate the regulatory status of MiMedx's products, it is essential to understand the regulatory status of human tissue in the United States. "There are multiple acceptable regulatory avenues that may be pursued for various human tissue products that are regulated by the FDA," explained Bill Taylor, the Company's President and COO. "One route is to qualify for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 in the Code of Federal Regulations, which is the regulatory standard for many human tissue products on the market today. If tissue qualifies for regulation solely under Section 361, it is not required to be 'licensed' by the FDA and in fact, no license is available. This is true not just of placental tissue, but also corneas, dermis, tendon and bone products, many of which also qualify as Section 361 tissue that do not require biologics licenses. The FDA has determined that additional tests for safety and efficacy are not required for products that qualify for regulation solely under Section 361." Other regulatory pathways, for tissue products that do not meet the standard for regulation solely under Section 361, include approval as a biological via the FDA's Biologics License Applications (BLA) process or as a medical device under the FDA's Pre-Market Approval (PMA) process.
All of the above regulatory avenues are acceptable and legal, so long as a product properly qualifies under the applicable regulations.
Taylor commented, "A recent article states that there are currently no FDA 'licensed' products that contain placental tissue. The article fails to mention that the reason is that if a product derived from placental tissue qualifies for regulation solely under Section 361, a license is not required. The article also fails to point out that, while such tissue may not be 'licensed,' it is nevertheless still regulated by the FDA." Accordingly, all of MiMedx's human tissue allografts are regulated by the FDA. The Section 361 status of the vast majority of MiMedx's product offering - the sheet allografts - is not in question. "The only question the FDA has raised is whether the product line that is a micronized version of the sheet allografts is properly marketed as Section 361 tissue. We believe that our micronized products do qualify for regulation solely under Section 361 based on the opinion provided by our outside regulatory counsel, as well as the Establishment Inspection Report, dated December 4, 2012, confirming that no action was indicated following a directed inspection conducted by the FDA in July 2012, for the express purpose of determining the status of the Company's micronized product. We are committed to working with the FDA to find a resolution to this outstanding issue," stated Petit.
Second, some articles have failed to mention the extensive donor screening and tissue testing procedures applicable to tissue products under FDA regulations, as well as the standards of the American Association of Tissue Banks. Moreover, while there are some tissue types for which sterility is not required, such as organ transplants and other tissues with living cells, there are many other tissues for which sterility standards are established. According to Taylor, "MiMedx follows the sterilization standards of the Association for the Advancement of Medical Instrumentation, and we terminally sterilize our tissue with e-beam irradiation, in conformance with a very detailed and specific process which has been audited by the FDA." Third, the Company noted that a recent article incorrectly asserted that the Company's website stated its "placenta-based injections can be used for spinal surgeries." According to Mr. Taylor, "The Company website has never stated that the injectable product could be used for spinal surgeries. Rather, the Company website lists spinal surgical barrier applications as a use for the Company's AmnioFix@ membrane product. The article appears to confuse our product lines and does not accurately explain the differences amongst our products, nor does it accurately represent the statements made by the Company related to the respective products." Fourth, a reader might infer from some of the news reports that the Untitled Letter from the FDA stated that the Company has not conducted clinical trials of its injectable products. "In conformance with the legal opinion from regulatory counsel that our micronized products qualify for regulation solely under Section 361, we have not conducted any clinical trials as part of a 'licensing' process for the FDA. We have however, conducted clinical trials that demonstrated statistically significant results that have been published in peer-reviewed journals. These results demonstrate that our products can be efficacious when other more long-standing traditional treatment methods have failed and that our products require fewer treatments than competing products. We do not necessarily list all of our clinical trials on our website, but a complete listing can be found at www.clinicaltrials.gov," commented Taylor. "Moreover, we have distributed more than 170,000 tissue based allografts, with no reportable adverse reactions." "It would be a shame to allow the misinformation that has been introduced to negatively impact patient care and to detract from the remarkable scientific progress that has been made in the area of amniotic membrane allografts. That is particularly true in light of the cost-effectiveness of our grafts. Our competitors' wound care grafts are approximately fifteen times larger than the average diabetic foot ulcer and twelve times larger than the average venous leg ulcer, and consequently, because they are single use, the rest of the material is discarded. By utilizing CMS/Medicare data, we have estimated that over $100 million a year of these products is discarded and becomes biohazard waste. CMS is considering making certain changes in their reimbursement schedule to reduce this wastage factor. If those reimbursement changes take place, we believe the changes will benefit the use of the EpiFix@ allografts because they are available in numerous small sizes," concluded Petit.
Finally, Mr. Petit added, "We will not address the outstanding shareholder lawsuits, except to say that we believe the claims to be without merit and that the complaints on file are subject to dismissal. We plan to ask the court to dismiss them at an appropriate time. Everyone should particularly disregard comments by plaintiff's lawyers as being obviously self-serving." MiMedx is clearly aligned with the Food and Drug Administration relative to being certain that the use of amniotic membrane tissue develops in an orderly and precise manner while ensuring patient safety, clinical efficacy and regulatory compliance. MiMedx executives have decades of experience in healthcare, and they are extremely focused on all of these matters. The Company has and will continue to be very focused on being certain that this new and beneficial technology finds its way into clinical usage through the correct regulatory channels.