In So Many Words is a timely chat with an ophthalmic industry thought leader.

Bio-Tissue creates regenerative therapy products using its proprietary CryoTek technology. This preserves the extracellular matrix structure and components, including HC-HA/PTX3, which has been shown to coordinate regenerative healing. Tom Daniells, chief commercial officer for Bio-Tissue, discusses how the development of this technology has affected the company and what the future holds for the regenerative market.

Ophthalmology Management: Bio-Tissue has the only FDA approved cryopreserved membrane for wound healing – what does that position mean for your company?

Tom Daniells: We spent more than 10 years identifying a key complex in placental tissue ­— HC-HA/PTX3 — that triggers the wound healing response. More than 30 years of NIH grant funding helped sponsor our work. Some companies in this field have tried to “genericize” the use of amniotic tissues, saying it’s all the same, but that’s not the case; ours is fundamentally different.

We’re also still learning more about our tissue — at AAO 2017, Thomas John, MD, of the Thomas John Vision Institute, presented the first study to demonstrate a single application of our tissue could stimulate corneal nerve regeneration. Among the results from that study, subjects treated with our cryopreserved amniotic membrane had pain scores decrease from 7.1 ± 1.5 at baseline to 2.2 ± 1.1 at one month and 1.0 ± 0.0 at three months. We’re also seeing great results in anti-pain uses from Tufts Medical Center, in Boston. Recent work there demonstrated that amniotic membrane can reduce ocular surface pain, which could prove an alternative to the use of addictive opioid medication.

OM: What can you tell us about the NEI-sponsored Shunt Tube Exposure Prevention study (STEPS), examining the use of AmnioGuard on patients undergoing glaucoma drainage device implantation?

TD: AmnioGuard is our cryopreserved umbilical product, which is 10 times thicker than our amniotic tissue. Our goal is to see if that thicker tissue, which is more resistant to erosion, would make it a better choice for tube shunt covers. The phase 2 trials were completed in December 2017, and we found AmnioGuard outperformed pericardium, which is considered the gold standard for shunt covers; there were two erosions in the pericardium group and zero for AmnioGuard.

OM: Will you discuss Bio-Tissue’s pipeline?

TD: Over the next 12 to 20 months we will be doing line extensions for many of our products; a good example of this is our recent introduction of a new model of the Prokera corneal bandage, Prokera Slim, for more mild ocular symptoms. Even more exciting for us, though, is the development of our platform into other forms, such as gels or drops. This will allow us to work towards treatments for advanced dry eye and examine uses for the posterior segment. We also have an NIH grant exploring an injectable form of HC-HA/PTX3 to prevent proliferative vitreoretinopathy from occurring after retinal detachment.

OM: How do you think bio-regeneratives will change the ophthalmic market?

TD: The traditional approach to medicine is using a single modality solution, but at Bio-Tissue we believe we can shift to multimodality therapies via a single application and, ultimately, regeneration. The human body is full of stem cells, but many are not activated. Our product creates an environment conducive to healing, allowing those cells to act in the way nature intends.

A challenge for us, though, is helping eye-care professionals understand that our tissues are not just for severe indications or a last resort. The studies mentioned above show that using our tissue sooner is better, so if a physician reaches for Prokera at an earlier disease stage they could prevent further progression. The reason they don’t use it sooner, I think, is most doctors were trained with Prokera as something to use sparingly, and that’s because Prokera wasn’t eligible for reimbursement until 2011, five years after its release.

We keep track of utilization at the clinics we serve, and so far we’ve done a great job of getting our products into practices, but they’re being used for worst-case scenarios. A goal for us over the next five years is moving them up earlier into the treatment paradigm.

OM: You helped your prior employer grow from a less than $10 million company to $140 million plus. How have you fared since joining Bio-Tissue in 2012?

TD: Since Bio-Tissue is a privately held company, we can’t publicly disclose all of that information. What I can say is we’ve had double-digit growth over the course of the last five to seven years, and it continues to increase. Our vision is to be a $100 million company by 2020, and we’re hitting our milestones for that goal. We’ve also grown our sales team from 12 members to more than 50 in the time I’ve been here.

Another consideration for Bio-Tissue’s growth is the FDA’s new guidance documents for regulating the regenerative therapy market (readable at https://tinyurl.com/y9n8q6vx ). In the next three to five years, companies like Bio-Tissue will need to become more like bio-tech companies, instead of tissue processors, and most of the products from this field will be considered biologics. Whereas now the barriers to entry in bio-regeneratives are low, these changes will treat these products more like a drug, requiring clinical trials and specifications for certain indications. It’s important for eye-care professionals to know about these new requirements, so they can ask if their clinic’s regenerative supplier is meeting them. OM