MiMedx: Healing Revolutionized with the Unique Placental Tissue Allograft

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New advancements in placental derived technology have allowed MiMedx to help thousands of patients heal in wound care, surgical, orthopedics, and sports medicine uses with its allograft flagship products.

Arguably, one of the leading healthcare advancements of the last decade has been the innovation associated with placental tissue allografts.

Healthy, consenting mothers undergoing scheduled caesarean live births choose to donate placental tissues, which are typically discarded after the baby is born. The recovery of these membranes does not affect the baby or the delivery process. Therefore, the donation process does not share the ethical concerns associated with embryonic tissue.

This is a big deal: from burn victims to those with acute or chronic wounds such as diabetic foot ulcers and soft tissue injuries, utilizing EpiFix and Amnio—­­­­­Fix two allograft products from MiMedx—has been shown to speed up the rate of recovery and healing.

MiMedx knows all about accelerated healing with allografts. The biopharmaceutical leader in regenerative and therapeutic biologics has, as of mid-2017, supplied over one million allografts with its platform of regenerative products for applications in the wound care, burn, surgical, orthopedic, spine, sports medicine, pain management, ophthalmic, and dental sectors of healthcare. This accomplishment has occurred with zero adverse reactions attributed to its products.

“MiMedx became involved in this specific area in 2011,” shared Christopher M. Cashman, Executive Vice President and Chief Commercialization Officer for the company since 2014. “The company finished that year with less than $8 million in revenue. This year we expect to deliver revenues of approximately $320 million.”

Fortune Magazine has ranked MiMedx as the fifth-fastest growing public company in the country for 2017.

In 2016, the company was able to improve its top rank in the advanced skin substitute market to a 31 percent share, up from 24.9 percent in 2015. Revenue also increased by a third between 2015 to 2016 to $245 million. With zero debt, 27 consecutive quarters of straight revenue growth, and 26 of 27 quarters meeting or exceeding revenue guidance, MiMedx is not just on track for great growth, but is also setting the industry standard for similar organizations.

In healthcare, however, it’s not always about the money. The company is bringing life-changing healing to those who desperately need it.

“The company is very focused on evidence-based medicine and clinical research. We have conducted over 40 studies that have been peer reviewed and published; another 30 are ongoing. We have four Investigational New Drug (IND) studies in support of Biologics License Applications (BLA) pathways in the pain area for tendonitis and osteoarthritis of the knee. We have a commitment to raising the bar for research and clinical evidence in the marketplace that precedes product releases in our field,” added Cashman.

One of a Kind Processes and Products

So what makes MiMedx’s products—including EpiFix and AmnioFix, as well as EpiBurn®, EpiCord®, AminoCord®, and AmnioFill®—unique?

MiMedx proprietary processes and sterilization methods from these placental derived tissues are unlike any other in the industry. As described above, birthing mothers—who have had extensive physicals and workups prior to birth to assess their health, and who opt for planned C-sections—can donate their placental tissue, including the amniotic membrane and fluid and the umbilical cord.

The company’s patent protected PURION® Process is the foundation of the MiMedx AmnioFix and EpiFix products that serve to regenerate damaged or diseased tissues by delivering human extracellular matrix components, essential growth factors, and specialized mediating cytokines.

MiMedx’s PURION® Process safely and gently separates the placental tissues, cleans and reassembles layers, then dehydrates the tissue to preserve the key elements associated with healing. Through the company’s unique processes for dehydrating human placental tissues, MiMedx has demonstrated improved clinical outcomes through multiple published studies, increased patient quality of life, and estimates it has reduced the financial burden to the healthcare system.

The company has the distinct advantage of having a technology platform that includes over 220 proteins that are growth factors, cytokines and chemokines.

“These proteins act as a milieu of components that enhance healing, modulate inflammation, reduce scar tissue formation, and support angiogenesis,” stated Cashman.

This maintains the bioactivity of the product and guarantees its use with a five-year shelf life stored at ambient temperatures.

MiMedx’s dHACM (dehydrated human amnion/chorion membrane) EpiFix and AmnioFix sheet products are the first allografts to be recognized in the United States Pharmacopoeia (USP) National Formulary (NF) Monograph. The specification requires a stimulated strength quality and purity of a product to conform to the requirements of the monograph.

Historically, a USP-NF Monograph sets the standard for a pharmaceutical, food ingredient, or dietary supplement product. The publication of the Monograph has established the company’s leadership position as another standard by which MiMedx dHACM allografts are unmatched in the industry.

The Truth in Testing

The company’s products, although remarkable, aren’t the only reason MiMedx stands out in its field. The company is focused on evidence-based product development, which, in many instances, sets the company apart from its competitors.

MiMedx is in a unique position in the biopharmaceutical area because of its ability to develop clinical and scientific data with human tissue—namely the amniotic membrane and placenta—and actually use some of those product configurations in medical practice under Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations of the Section 361 of the Provincial Health Services Authority (PHSA). This valuable experience gives MiMedx a great advantage when initiating FDA clinical trials for other products requiring IND/BLA pathways.

An Unparalleled Performance Through Processing

What’s important in each of MiMedx’s products are the healing characteristics of the tissue. Over the last 20 years, products have been expensive, logistically difficult to use—as many are required to be stored in freezers—and wasteful. MiMedx’s five-year shelf life stored at ambient temperature changed the game.

“And it translated into outstanding healing results,” said Cashman. “In the past, 40 to 55 percent of diabetic foot ulcers might have healed in three months with other allograft technology. Our early studies have shown 90 percent of diabetic foot ulcers heal in six weeks.

“That’s a huge paradigm shift. Everyone—doctors and patients alike—want wounds or soft tissue injuries to heal as quickly as possible. What we’re doing is a huge, monumental shift towards improved health.”

New Opportunities

“We’re targeting three specific markets,” Cashman shared. “Advanced wound care is about 70 to 75 percent of our revenue. MiMedx is also active in surgical applications—think muscular and skeletal, including various techniques in general and plastic surgery.

“We’re also moving into our third area of focus, pain management, where our lead product AmnioFix is injected by sports medicine and pain specialists into inflamed areas like tendonitis or arthritic joints. This pain market in the knee, foot, and ankle has approximately 12 million procedures annually. This translates to an annual market opportunity of $12 billion at an average price point of $1,000 per application.”

MiMedx researchers have also developed CollaFix®, a product not yet commercially available, which combines proven collagen advancements with MiMedx’s human derived placental based technology for orthopedic applications where tensile strength is required for augmenting tendons and ligaments.

Where bovine skin (animal derived) was once used to produce collagen, MiMedx’s researchers are now able to manufacture the product with human collagen from the placenta. The company’s team anticipates it to be even more biocompatible, more economical to manufacture, and easier to obtain FDA clearance to market because of this.

3 and 1 in 20

MiMedx has grown very quickly, and looks like it will continue a similar trajectory. To enable this growth going forward, the company will expand its 350-sales-executive base to approximately 400 by January of 2018.

“In one example alone, there are 1.4 million non-healing, chronic diabetic foot ulcers and venous leg ulcers in the U.S. today. Of these, less than 150,000 patients are treated with an advanced skin dermal substitutes like EpiFix. There are plenty of wounds to heal,” Cashman shared.

Plenty of wounds to heal means plenty of opportunities for MiMedx to heal wounds. There’s a lot working in the company’s favor. First, Cashman cited the company’s outstanding leaders. From Chairman of the Board and CEO Parker “Pete” Petit to President and COO William C. Taylor, Cashman shared that the leaders have “brought together a significant executive team that has added tremendous value and knowledge to the business.”

Through its continued penetration of market opportunities in wound care, as well as the company’s expansion into surgical applications and pain management, Cashman shared that MiMedx is on track to hit its goal of tripling its revenue based on 2015’s figures: $560 million by 2020.

The company is prepared to also not double, but triple, capacity going forward. Both of its manufacturing facilities are Good Manufacturing Practices (GMP) compliant: approved to produce biopharmaceutical products. Its 125,000 square feet of office, lab, manufacturing, and distribution space has the capacity to manufacture $900 million in annual revenue.

MiMedx’s continuous focus on utilizing lean concepts and state-of-the-art processing techniques allows the company to lay the foundation for this monumental growth on the horizon.

The laser-cutting technology the organization introduced to its clean rooms in 2016 are one of the many upgrades that are driving the continuous improvement in gross payout dollars. This technology includes a high-resolution vision system and software that enables employees to precision-cut tissue grafts to unique sizes and shapes at extremely high speeds, creating greater efficiencies and less waste.

“The company is firing on all cylinders,” Cashman said. “We’re heavily invested in research, we have an incredibly strong executive management team with a plethora of business acumen, and a great foundation of hardworking, passionate employees who want to facilitate making a difference in patients’ lives.”

There isn’t any one thing that is our driver for success—it’s a combination of everything that we have to do with excellence that allows us to perform at such a high level. The people, though, they make the difference.”

The leadership of MiMedx knows there are still a lot of hurdles to clear, but the industry—and the patients—need these solutions.

“There are so many chronic wounds today that never get an advanced dermal tissue product and we are just starting to see promising acceptance in the operating rooms. Before, we were going through the process of pushing our product into the market for these applications. Now, we’re seeing our brands pulled into new markets. We can’t wait to see where we’re pulled next,” stated Cashman.