Founded in 2009, the technical founders of Nanofiber Solutions, Dr. John Lannutti and Dr. Jed Johnson, had previously worked for several years with cancer researchers and surgeons to build polymer scaffolds that mimicked structures found in the human body.
Today Nanofiber Solutions, Inc. is a Regenerative Medicine company developing a new class of implants for the $20B soft tissue, organ repair, and regeneration market. The technology is used to build off-the-shelf scaffolds that are critical in the development of life-saving and life-changing, tissue engineered implants for humans and animals.
Nanofiber Solutions developed the critical technologies for a groundbreaking surgery on an injured horse that had two damaged tendons. Generally, this type of injury is life-threatening; however, two equine surgeons performed a breakthrough procedure that was able to save the horse’s life.
Nanofiber Solutions provided two 20cm long nanofiber replacement tendons that were seeded with the horse’s stem cells and successfully connected to the threads of the original tendons. Within a few months, the stem cells had started to regenerate the lost tissue along the scaffold, and within nine months, the nanofiber scaffolds had been broken down and were replaced by fully functional tendons.
“Nanofibers are an exciting a new class of material which can be used for a wide range of applications from medical to consumer products such as, filtration, wound dressing, adsorbent, energy storage, protein separation, immobilization, drug delivery and composites. The main features of nanofibers are a large surface area-to-volume ratio, good mechanical, strength, excellent flexibility, and high porosity, all properties which make them suitable for many applications,” said Johnson.
He continued, “Tissue engineering and regenerative medicine are exciting fields that hold much promise for effective medical solutions. Our on-site manufactured nanofiber scaffolds provide an innovative and ideal platform to create an array of new clinical solutions.”
The company, with nine employees, has 38 issued and pending patents covering polymer nanofibers and scaffolds to simulate the 3D structure of human tissue has sold custom scaffolds and cell culture plates across the world since 2010.
The nanofiber scaffolds are made of biomimetic synthetic polycaprolactone (PCL) which closely resembles biological tissue which provides for a better 3D environment in which the cells can grow. Nanofiber Solutions manufactures products at their own facility in Ohio.
“Nanofiber Solutions products differ from other products because they can be customized to fit a researchers’ needs and applications. Competitor products are available in limited formats and are made of stiff rigid polymers such as polystyrene that aren’t biocompatible whereas Nanofiber’s 3D Scaffolds are available in a variety of formats and are soft,” continued Johnson adding, “In March 2018 we received FDA clearance for our Phoenix Wound Matrix product, and we are expecting another FDA clearance in Q1 of 2019 for our bone-tendon product.”
3D nanofiber scaffolds can be fully degradable or permanent depending on the polymer. The scaffolds are made up of nanofibers that range in diameter from 100-5,000nm. Production of scaffolds for other types of hollow organs, such as intestines and blood vessels are already in the early stages of development.
“Unlike real human cells which are costly for R&D, nano-fibers are synthetic, clean, have no cost related to storage and do not require freezing for transportation,” remarked Johnson.
In addition to manufacturing the world’s first nanofiber implants, the company’s products can also be used as a means to increase stem cell expansion rates for cellular therapy companies working to bring the promise of personalized stem cell treatments closer to reality. “Lastly, we manufacture enhanced cell culture plates to support basic research and drug discovery in academic and pharmaceutical labs,” he said.
The company engineers products to meet complex clinical requirements with bioengineered, synthetic scaffold products as the foundation for soft tissue and organ replacement, eliminating the need for organ donation, immune suppression and the risk of transplant rejection. The products are sold worldwide through distributors.
“We first heard about ARMI through our interactions with NSF, DoD and ARM and we want to understand cell-based RM to collaborate and partner with other ARMI members since our scaffold technology is ‘cell agnostic’ and can be used to deliver cells or biologics to a specific area and then our scaffold is resorbed into the body naturally,” he said.
Nanofiber’s extensive experience working with researchers using their polymer scaffolds in cell culture plates has allowed them to develop novel insights into the behavior of adherent cells with these scaffolds which they would like to share with ARMI members.
“Nanofiber Solutions’ products are used in regenerative medicine as a means to increase stem cell expansion rates for cellular therapy companies working to bring the promise of personalized stem cell treatments closer to reality,” Johnson concluded that he sees blood vessels next in line for development within the next two to three years which will help reduce the costs of wound care from $10,000’s to $1,000’s per patient.