Wednesday, September 04, 2013 5:32:46 PM
MiMedx Addresses FDA Untitled Letter And Reiterates 2013 And 2014 Guidance
MARIETTA, Ga., Sept. 4, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, confirmed today that it is in receipt of an "Untitled Letter" from the Food and Drug Administration ("FDA"). The Company further announced that it expressly disagrees with the position in the letter and has been in conversation with the FDA to resolve the matter as quickly as possible. The letter questions the Company's Amnion / Chorion Injectable products' eligibility for marketing solely under Section 361 of the Public Health Service Act.
As explained on the FDA's website, an "Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter."
Bill Taylor, the Company's President and COO, commented, "The Company was surprised by this letter considering the FDA conducted a directed inspection of our facility in July 2012, one of the express purposes of which was to 'determine the status of the [Company's] AmnioFix® injectable product.' The inspection report indicated that 'information regarding the [Company's] AmnioFix® Injectable product, which was rolled out August 2011, was collected and forwarded to CBER for review. The information collected included advertising, packaging, process procedures and studies conducted related to the product.' Following that inspection, the inspector advised us that CBER had completed its review and had no findings or further questions and, therefore, the inspection was classified as NAI, or No Action Indicated. The formal establishment inspection report confirming the NAI conclusion was issued on December 4, 2012." The establishment report is posted on the Company's website at www.mimedx.com.
MiMedx is very focused on regulatory compliance and proceeded with marketing the injectable product only after receiving advice from outside legal counsel that the product met the criteria for regulation as an HCT/P under Section 361 of the Public Health Service Act. The Company believes the FDA's conclusion is based on a misunderstanding of the micronization process and is responding to the Untitled Letter and will reiterate its request for a meeting with the FDA.
The Company reiterated its expected revenue range for 2013 of $54 million to $60 million and its 2014 goal of $90 million to $110 million. The revenues from the Company's injectable are projected to be approximately 15% of the Company's 2014 revenues.
Parker H. "Pete" Petit, the Company's Chairman & CEO, stated, "Based on other precedents, the Company believes it should be able to continue to sell its injectable products, but even if that not the case, management believes it can refocus its resources to achieve its stated revenue goals."
About the Company
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include the device technologies HydroFix® and CollaFix™, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies are processed from human amniotic membrane that is derived from the donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary Purion® Process, to produce a safe, effective and minimally manipulated implant for homologous use. MiMedx® is the leading supplier of amniotic tissue, having supplied over 170,000 allografts to date to distributors and OEMs for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Jeff Beck - Somewhere Over The Rainbow (Live) (HD) May 2010
STANLEY JORDAN - Stairway To Heaven (live 1994)
Recent MDXG News
- MIMEDX Announces First Quarter 2024 Operating and Financial Results • GlobeNewswire Inc. • 04/30/2024 08:01:00 PM
- MIMEDX to Host First Quarter 2024 Operating and Financial Results Conference Call on April 30 • GlobeNewswire Inc. • 04/16/2024 12:00:00 PM
- MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA • GlobeNewswire Inc. • 03/27/2024 12:00:00 PM
- MIMEDX Expands Portfolio with Fibrillar Collagen Wound Dressing • GlobeNewswire Inc. • 03/20/2024 11:00:00 AM
- MIMEDX Introduces E-Commerce and Account Management Platform • GlobeNewswire Inc. • 03/13/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 11:28:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 11:27:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 11:27:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 01:11:28 PM
- MIMEDX Announces Appointment of Two New Independent Directors • GlobeNewswire Inc. • 03/04/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 09:22:13 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/28/2024 09:02:35 PM
- MIMEDX Announces Fourth Quarter and Full Year 2023 Operating and Financial Results • GlobeNewswire Inc. • 02/28/2024 09:01:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/21/2024 09:40:32 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/20/2024 08:55:24 PM
- MIMEDX to Present at TD Cowen 44th Annual Health Care Conference • GlobeNewswire Inc. • 02/20/2024 01:00:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/16/2024 09:37:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:22:04 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/15/2024 08:11:01 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/14/2024 09:13:13 PM
- MIMEDX to Host Fourth Quarter and Full Year 2023 Operating and Financial Results Conference Call on February 28 • GlobeNewswire Inc. • 02/12/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 01:09:53 PM
- MIMEDX Announces Improved Capital Structure with New Senior Secured Credit Facilities and Debt Refinancing • GlobeNewswire Inc. • 01/22/2024 01:00:00 PM
- MIMEDX Provides AXIOFILL® Update & Reiterates 2023 Full Year Net Sales and Fourth Quarter Adjusted EBITDA Margin Outlook • GlobeNewswire Inc. • 12/29/2023 10:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 09:30:30 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM