The license was focused on oral maxillofacial indications and finalized in 2020 (6 issued patents, 6 pending).The technology Amend licensed was developed to address the general medical need for strong adhesives that work over long periods of time in moist, mechanically demanding environments. Wyss used sophisticated chemistry – inspired by the tough and sticky mucus of the Dusky Arian Slug – to develop a biocompatible hydrogel and surgical glue that adheres to and protects wounds for weeks on wet, uneven surfaces, such as those found in the oral cavity.

The first product development effort Amend asked the MPWRM Resource Center (RC) to support was in 2021, with an initial focus on a non-resorbable tissue tape that can be used as an oral wound care “overlay” in multiple indications. Since successful wound closure and stable healing is key to predictable outcomes with most oral regenerative procedures, Amend Tissue Tape has the potential to directly impact the success of many of the soft and hard tissue regenerative treatments being performed today, and that the RC seeks to advance.

The technology Amend licensed from Wyss has the potential to be further differentiated as a resorbable “inlay” barrier used under tissue flaps to increase predictability and improve ease-of-use and outcomes in several DOC regenerative indications. Recently the company has also started to develop it as an oral nerve “wrap” to replace sutures and/or bridge gaps. In the future, this robust platform technology could also be loaded with drugs or biologics as a delivery vehicle to further enhance regenerative outcomes in especially challenging indications, or improve efficacy in many situations where local, more targeted delivery is desired.

This tremendous potential to significantly impact oral regenerative procedures and improve human health made Amend a strong candidate for RC support. This was especially true because they knew that they needed help and were clearly motived to tap into the expertise at the RC, beginning in the seed funding phase.

When Amend first approached the RC, they already had an existing small business with expertise in contract manufacturing for an orthopedic bone graft substitute they had been producing since 2015. They also had a strong business leader (Robby Lane) who knew how to raise capital and operate out of clean rooms under cGMP, FDA and state regulated processes. In addition, they had recently hired a dedicated engineer and technical leader, Jamie Shaikoski, to focus on advancing this very promising DOC technology.

The first thing Amend needed from the RC was a market assessment to confirm their assumptions about where this technology would have clinical value in the DOC space. They understood that their entire development program would be impacted by selecting the “right” indications. Through a series of in-depth interviews organized by the RC with key opinion leaders in this space, Amend got positive feedback but was quick to pivot to the indications where the clinical need and value was greatest.

In addition to tapping into the RC’s market knowledge, Amend benefited from multiple introductions to key potential partners and investors in the oral regenerative industry. They also valued the RC’s ability to provide technical and regulatory support, with a critical role in determining the best sterilization method for this new technology, which will be key to a successful FDA submission. Since the product value “in use” is related to how it handles, they also took advantage of the RC’s ability to organize surgical handling sessions with experienced clinicians who provided feedback on everything from technique to packaging, pricing, preferred configurations and even some brand elements the RC helped them develop. In general, Amend has worked closely with the RC to demonstrate efficacy to the FDA and engage clinicians who will drive clinical adoption.

The hope was that by working with the RC, Amend could significantly de-risk and fast track this promising new technology. This hope has been realized every step of the way with pre-clinicals and a successful FDA pre-submission meeting initiated in 2022. Based on the feedback they received, FDA clearance for the first indication as a non-resorbable oral wound dressing over periods of <24 hours is expected by Q1 2024. Preparations for the second 510(k) to allow for longer adhesion periods are already underway. In addition, the resorbable product (Amend Tissure) for barrier “inlay” indications will be ready for pre-clinical development by 2024.

In addition to the funding in 2021-2022 for development of Tissue Tape, Amend was recently awarded additional support by the RC to develop Tissure as a nerve “wrap” to avoid sutures and/or bridge gaps, with an initial focus on the trigeminal nerve in the oral and craniofacial space. This study and FDA submission will allow for general use of this technology in nerve indications, so even more patients can benefit. By initially helping the company develop an FDA strategy and clinical value proposition for Amend Tissue Tape, the RC is now able to support expansion of this technology platform into other indications – such as resorbable “inlay” barriers and nerve “wraps” – in the DOC space… and beyond.

Amend Surgical has made significant progress with support from the generous NIDCR grant that the RC has been charged with administering, shepherding them through (and over) the “Valley of Death” to clinical adoption and improved human health. Investors and potential industry partners are showing serious interest in working with Amend in the DOC space. Patients will be the ultimate beneficiaries.

This is one of many success stories we are proud to share!