Aziyo Biologics Inc. and Cook Biotech Inc. announced the expansion of the Aziyo Bio Envelope franchise by entering into additional exclusive global license agreements expanding the applications for the Bio Envelope product into the field of neuromodulation.
 
The Bio Envelope is a natural extracellular matrix (ECM) scaffold that is intended to securely hold implantable devices, creating a stable environment following implantation. Bio Envelopes are intended to reduce the risk of device migration and erosion and may also facilitate device removal when future exchange or revision of the device is required. Currently the Bio Envelope is commercially available in the United States and internationally under the brand name CanGaroo for use with cardiac implantable electronic devices (CIEDs).
 
“When Aziyo purchased the CanGaroo brand and license in 2017, we saw tremendous potential for the product outside the current CIED market in areas such as neuromodulation,” said Andrew Green, general manager of Aziyo’s Cardiovascular division. “This new agreement with Cook Biotech is another step towards our goal of expanding and growing our Bio Envelope franchise.”
 
The new agreement with Cook Biotech provides a worldwide exclusive license for the Bio Envelope to be used with neuromodulation devices for applications such as deep brain stimulation, spinal cord and sacral nerve stimulation to relieve chronic pain, and nerve stimulation to help control bladder, digestive, abdomen, and bowel movements. The global neuromodulation market is approaching $3 billion, with the U.S. market representing approximately $2 billion.
 
“We’re excited to see the continued expanded use of our proprietary ECM technology and its benefit to patients,” said Umesh Patel, Cook Biotech president. “We look forward to working with our partners at Aziyo.”
 
The Bio Envelope is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS). Once implanted, it secures the implant in place, and evidence shows that over time it remodels into a vascularized pocket that may facilitate implant removal or revision when required. The CanGaroo Bio Envelope is a 510(k) U.S. Food and Drug Administration-cleared and CE Marked medical device.
 
Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular, and other medical specialties.
 
Cook Biotech Inc. develops and manufactures advanced tissue-repair products. Cook Biotech’s products are derived from proprietary extracellular matrix (ECM) technology using proprietary manufacturing processes. ECM, a naturally occurring biomaterial, possesses tissue-remodeling properties. Cook Biotech products are used to treat multiple types of wounds (e.g., burns, non-healing chronic wounds, diabetic wounds) and for patient treatments including hernia repair, fistula repair, otologic repair, and soft-tissue reinforcement. Cook Biotech sells its ECM products under several brands, including Biodesign and OASIS. Cook Biotech is part of the Cook Group, which includes Cook Medical in Bloomington, Ind. Cook Biotech is located in the Purdue Research Park in West Lafayette, Ind. It was established in 1995 following a Purdue University biomedical engineering research team’s discovery of the tissue-remodeling properties of ECM.