Apr 15th 2016
Nanotherapeutics Grants Worldwide Rights to Amend Surgical, Inc. for NanoFUSE® DBM
Unique Bone Void Filler Will be the Anchor Product in Amend’s Product Portfolio
ALACHUA, Fla. — (BUSINESS WIRE) — Nanotherapeutics, Inc., an integrated biopharmaceutical company with a focus on advanced development and manufacturing, today announced that the Company has granted an exclusive worldwide license to its proprietary bone void filler product, NanoFUSE® DBM (demineralized bone matrix), to Alachua, FL-based Amend Surgical, Inc. Financial terms of the transaction were not disclosed, however, under the license agreement, Nanotherapeutics will become a minority shareholder in Amend Surgical.
The U.S. Food and Drug Administration (FDA)-cleared NanoFUSE® DBM is a novel composite allograft (human tissue graft) expressly designed to optimize surgical handling performance, graft stability, and osteoproductivity and has expanded 510(k) marketing clearance from the FDA for use in spinal fusion surgery. Specifically, NanoFUSE® DBM has been cleared for use with autograft (transplanted bone from a patient’s own body) as a bone graft extender in the posterolateral spine. As such, it represents an important tool for the orthopedic surgeon and is the first off-the-shelf DBM product containing bioactive glass available for use in an orthopedic clinical setting. As an adjunct to DBM, the incorporation of bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation). In particular, the combined properties of DBM and bioactive glass come together to create a highly favorable environment for bone fusion, as it remodels into the recipient’s skeletal system.
The malleable, putty-like NanoFUSE® DBM is placed by the surgeon into bony voids or gaps within the skeletal system that are not intrinsic to the stability of the bony structure (e.g., the extremities, pelvis and, as a bone graft extender, posterolateral spine). These gaps may be surgically created osseous defects or a result of prior traumatic injury. NanoFUSE® DBM is formulated so that it reconstitutes into a paste upon addition of a sterile fluid, such as saline, water for injection and/or autologous blood.
“NanoFUSE® DBM offers a real technological advance to surgeons and their patients, addressing a significant clinical need and we are therefore delighted to have the opportunity to launch the product into the worldwide market. Our license agreement with Nanotherapeutics also marks an important step for Amend Surgical, allowing our company to establish a market presence and to further differentiate our orthobiologics product portfolio,” stated Robby Lane, Chief Executive Officer of Amend Surgical.”
About Nanotherapeutics, Inc.
Nanotherapeutics is an integrated biopharmaceutical company with a focus on development and manufacturing. The Company has expertise in preclinical and clinical development, formulation optimization, and cGMP manufacturing of biopharmaceutical products and medical devices. The Company's proprietary platform technologies can be used with all drug types, ranging from small molecules, to proteins and vaccines. For more information, visit the Company website at www.nanotherapeutics.com.
About Amend Surgical, Inc.
Amend Surgical is a specialty medical technology company focused on enhancing the bone healing/regenerative capacity of bone grafts, including allograft and xenograft tissues and synthetic materials. The company’s pipeline includes novel, clinically evaluated, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.