The only amniotic membrane grafts cleared by the FDA
The BioTissue ocular product line includes Prokera®, AmnioGraft®, and AmnioGuard®.
BioTissue’s proprietary CryoTek® cryopreservation process maintains full biologic components and structural integrity equivalent to fresh tissue, which helps rapidly restore the cornea’s own healing capabilities.10,11
BioTissue’s CryoTek cryopreserved amniotic membrane products are the only amniotic membrane grafts cleared by the FDA for their therapeutic properties in repairing and healing ocular surface inflammation.15
How does Prokera lead to better patient outcomes?
Prokera corneal bandages are designed for treating damaged corneas by creating an environment for regenerative healing. Prokera helps expedite and empower the eye’s healing abilities for better patient outcomes.
Prokera excels at restoring a normal and healthy epithelium, while minimizing the risk of scar tissue formation. Heat-dehydrated amniotic membrane grafts are processed in a way that destroys crucial biologic components, increasing the risks for repeated epithelial defects or erosions, chronic inflammation, scarring, vision loss, or pain.16,17
Prokera can be easily incorporated into any eye care practice to optimize outcomes.
1. Effective, easy treatment
- Can be easily placed during a regular office visit or used with surgical interventions
- May reduce the need for additional patient visits with slow or poor healing
2. Highly reimbursed
- Medical device classification ensures high reimbursement
- Average Medicare reimbursement: $1,458
- Minimizes a patient’s cost-burden of treatment
3. Minimal storage needs
- Easy-to-use packaging
- Conveniently stored in any on-site refrigerator or freezer
The Prokera product family includes:
- Prokera Classic: Maintains orbital space with a symblepharon ring for cases where prevention of closure or adhesion is a concern.
- Prokera Slim: Uses ComfortRing™ technology for a lower profile device that contours to the ocular surface to maintain comfort during treatment.
- Prokera Plus: Maximizes the therapeutic benefit with a double layer of cryopreserved amniotic membrane tissue, for patients who need intensive treatment.
- Prokera Clear: Provides patient with visual acuity during treatment with a 6mm ClearView™ aperture, which is crucial for monocular needs.
How does AmnioGraft accelerate post-op recovery?
AmnioGraft, a cryopreserved amniotic membrane graft, supports accelerated post-op recovery and ensures superior patient outcomes when used in ocular surface reconstructive procedures.18-21
- Promote regenerative healing. AmnioGraft helps create a healing environment that is conducive to more effective healing of the ocular surface and improved clinical outcomes.
- Expedite recovery. Post-op recovery time is accelerated, as AmnioGraft reduces inflammation and promotes rapid healing, typically in 2-3 weeks.4,19-24
Less recurrence. A recent study of over 280 patients showed a recurrence rate of less than 1% after surgical excision of primary, single-headed pterygium with cryopreserved AM.22
How can AmnioGuard suppress inflammation?
AmnioGuard is an ultra-thick, cryopreserved amniotic membrane graft that suppresses inflammation, promotes healing, and provides durable tensile strength to avoid surgical challenges associated with reconstructive procedures.25-28
- Harnessing regenerative healing potential. AmnioGuard helps achieve complete epithelialization, without wound dehiscence, and excellent prosthesis fit at final follow-up with no clinically significant complications.27
- Excellent alternative to other homologous grafts. AmnioGuard serves as an excellent alternative to other homologous tissue grafts for ocular surface reconstruction and management of Anophthalmic socket contracture.27
- Super stability and advanced healing outcomes. AmnioGuard has been shown to help promote superior stability in post-glaucoma treatment and optimal healing in post-oculoplasty surgery.25
Why should ECPs trust BioTissue?
Roger Kennedy said one of the reasons he loves working at the company is the story behind it.
“It started with Dr. Scheffer Tseng and his wife, Amy Tseng,” Kennedy said. “Amy Tseng was working at a top-four CPA firm and had a very successful career. Dr. Tseng was a researcher, an ophthalmologist, and eventually chair at Bascom Palmer. As his research on limbal stem cells, amniotic tissue, birth tissue, and the benefits of it progressed, they both decided to quit their jobs and start a research company.”
He said their belief in the powerful potential of what they’d witnessed in certain biological aspects of the product over more than 20 years eventually led them to begin commercialization and the rigorous process involved with that.
“Today, we have over 200 employees. We have 600 applications and over 300 peer-reviewed studies,” Kennedy said. “It's really a success story, and everyone’s goal at BioTissue is to help realize the full potential of regenerative therapy.”
To do that, he said BioTissue leverages all of the benefits of the amniotic membrane and umbilical cord to create treatment options both in and outside of the eye. In addition to BioTissue Ocular, BioTissue Surgical serves specialty areas such as orthopedics, diabetics, urology, and trauma.
“We’re learning there’s a whole host of indications for which this technology can be used to create successful treatment options,” Kennedy explained.
BioTissue products impact moderate to severe dry eye disease
Kennedy said one area in which they’ve experienced “extreme” success is in the treatment of moderate-to-severe dry eye disease, which he said is probably the “most popular” indication on the ocular side.
“But it’s not limited to that,” Kennedy said. “With the in-office Prokera, we treat many conditions, including moderate-to-severe dry eye, non-healing defects, corneal ulcers, herpetic keratitis, and graft versus host disease. We have a whole range of in-office applications.”
On the surgical side, he said Dr. Desai recently published “the largest pterygium study conducted showing an extremely low recurrence rate using our product.”
Kennedy said they’ve also had success treating conjunctivochalasis (CCH) with their graft and that oculoplastics has “really come on board” using AmnioGuard, which is their umbilical cord product.
“Basically, for any type of substitute in which you need an allograft, you can have a biologic allograft with umbilical cord in our AmnioGuard product,” he explained. “So there's a whole host of indications for our products.”
How Prokera products treat neurotrophic keratitis
In his practice, Dr. Dierker said the most common reason they use the Prokera products—both Prokera Slim and Prokera Clear—is to treat the corneal sequelae of dry eye. He said in those situations, the treatment is usually geared toward patients with Superficial Punctate Keratitis (SPK) who aren’t improving with lubricants, topical steroids, and immunomodulatory drugs—and also filamentary keratitis.
“But I also think we increasingly understand that patients with more end-stage disease, or progressive dry eye disease, actually end up with neurotrophic keratitis,” Dierker said. “So that's probably the biggest area of growth in the last year or two in my clinic is treating patients with neurotrophic keratitis, even at the earliest stage—stage one, where it's just SPK that won't go away. And I use the Prokera line of products for those patients.”
Kennedy said that’s a common trend in other parts of the country as well. In fact, the American Academy of Ophthalmology’s (AAO) EyeWiki references the Mackie scale for assessing neurotrophic keratitis and lists Prokera as a treatment consideration for stage one disease.
“I know it's been referred to frequently over the years, but with the definition of dry eye disease changing to include neurosensory abnormalities and the knowledge we’re gaining about the integral role of nerves in dry eye disease, I think the more you look for it, the more you’ll find it, especially among SPK patients,” he said. “That’s why we’re encouraging more corneal sensitivity testing—especially for dry eye patients and especially at the SPK stage. In our experience, patients often have some level of reduced sensitivity in the cornea. Once that’s identified, appropriate treatments can be recommended.”
Referencing Prokera as one of the treatment options, he said that although there are other products available, Prokera provides “the benefits of cleaning up the ocular surface, controlling inflammation, and preventing any type of scarring.”
“So there's a whole host of reasons why Prokera makes a lot of sense for neurotrophic keratitis,” Kennedy said.
The only amniotic membrane for anti-inflammation and anti-scarring
When asked what differentiates BioTissue’s product line from competitors in the space for ocular surface disease treatment, Kennedy said their focus on the uniquely healing properties of birth tissue based on Dr. Tseng’s research sets them apart.
“He left his chair position at Bascom Palmer due to his research about how incredible fresh amniotic membrane is for healing,” Kennedy said. “Fetal healing is more efficient because it’s part of the development process. So things like inflammation and scarring are better controlled.”
“That’s what amniotic transplantation is,” he added. “It's bringing fetal healing to the adult environment.”
Kennedy said one of the reasons the amniotic membrane is so rich in therapeutic properties is due to the key complex they’ve isolated.
“About ten years ago Dr. Tseng and his team isolated HC-HA/PTX3 and our product is cryopreserved to retain it,” he explained. “Additionally, we have the only amniotic membrane product with an FDA designation of anti-inflammation and anti-scarring that is FDA cleared. It’s the only amniotic membrane product with a 510(k) clearance.”
Alleviate the financial burden for patients
Kennedy said a nice value proposition is that providers will get a product that's fast acting.
“We have a whole host of studies that show effectiveness in reducing signs and symptoms in as little as three to five days,” he said. “We see that reduction in signs and symptoms last as long as three to nine months.”
He added that treatment with BioTissue products is reimbursed by most commercial payers.
“So it’s a really good option as far as practice growth, doing the right thing, and being clinically effective for your patients,” Kennedy said. “Since treating ocular surface disease can be expensive, it can also alleviate some of the financial burden for patients.”
Look for new gel formulations to come
As far as BioTissue’s pipeline, he said as a birth tissue company, everything they do in the future will be based on leveraging that platform technology—and that they already have an accepted Investigational New Drug (IND) application for a new gel formulation for their amniotic membrane.
“We're going to be starting clinical trials during the back half of this year,” Kennedy said. “I think immediately, getting some type of gel formulation is going to be our focus on the ocular side.”
Noting that they’re in a strong position regarding offering treatments for the moderate-to-severe state of ocular surface disease, he said they’d like to become more involved in treating the spectrum of mild disease, too.
“Whether it's product development for something like a gel or partnering via business development with other companies, we'd like to take ownership of the continuum of care so we can help patients from a mild state to a severe state with that same technology, with appropriate platforms for each of them,” Kennedy said.
He said they’re also very excited about what they’re doing outside of eyecare to treat conditions such as diabetic foot ulcers and osteoarthritis of the knee.
“Those treatments use the same technology as Prokera, AmnioGraft, and AmnioGuard,” Kennedy explained.
When asked if a gel formulation would retain the same biologic properties as their current offerings, he said it would.
“Since our primary focus is on retaining fetal healing simulation, whatever we do, we want to isolate and retain that HC-HA/PTX3, and hopefully in different formulations,” Kennedy said.
When it comes to ocular surface disease and the solutions BioTissue brings to the table, Kennedy said that in observing the trends, he thinks they’re in a great position.
“We’re learning that ocular surface disease is so pervasive, so prevalent, and so complex, and there are many different ways to treat it,” he said. “When you look at how the definition of dry eye disease has changed over the years, there have been so many changes. So, who knows what it's going to be five years from now, or 10 years from now? It’s really an exciting space and I’m happy to be working with a company that’s part of it.”
To learn more about BioTissue’s products, Kennedy recommended peer-to-peer interactions and taking advantage of their Professional Education platform, opportunities, and events they offer, which can be found on the BioTissue website.
*BioTissue Inc. has published conceptual research elucidating the underlying science of birth tissue, amniotic membrane. This breakthrough research suggests that the HC-HA/PTX3 Complex plays an important role in facilitating an ideal environment suitable to manage healing across a range of surgical and wound management applications. This is disclosed in BioTissue’s regulatory applications to the FDA. Each surgeon must evaluate the appropriateness of the techniques based on his or her own medical training and expertise. Many variables including patient pathology, anatomy, and surgical techniques may influence procedural outcomes. While these clinical experiences are valid, the results are not necessarily typical, indicative or representative of all procedures in which BioTissue’s products are utilized.
