ORTHOREBIRTH and Theradaptive Enter into License Agreement for THX-14, a Regenerative Treatment Candidate for Trauma with option to extend into Spine Fusion

ORTHOREBIRTH Obtains the Exclusive Rights to Develop and Commercialize THX-14 in Asia; Theradaptive Retains Rights in the US and Europe

Theradaptive Will Receive Milestone Payments and Royalties from ORTHOREBIRTH

BOSTON, 11 December 2019—Theradaptive, Inc and ORTHOREBIRTH Co., Ltd. today announced that they have entered into an exclusive license agreement to develop and commercialize THX-14, a combination product composed of Theradaptive’s proprietary material-binding biologic and ORTHOREBIRTH’s 510K-approved void filling material for the treatment of bone trauma, congenital skeletal defects with an option to extend into spinal fusion indications. At present, there are no approved regenerative therapeutics for congenital skeletal defects.

Under the terms of the agreement, ORTHOREBIRTH will be responsible for the development and commercialization of THX-14 in Asia and Theradaptive will be responsible for the US development and commercialization. The companies will be jointly responsible for conducting global clinical studies and coordinating commercial launch activities. Theradaptive will receive payments based on development milestones, as well as royalties on any future product sales in the licensed territory.

Theradaptive recently completed a pivotal preclinical study at the Cleveland Clinic in which THX-14 was observed to strongly induce bone regeneration across a five-centimeter gap in the most challenging trauma model available. THX-14 demonstrated superiority over autologous bone marrow without any observed serious adverse events. Theradaptive plans to initiate a Phase I/II human study in the fourth quarter of 2020.

THX-14 is a combination product composed of Theradaptive’s proprietary material-binding variant of a recombinant protein called Bone Morphogenetic Protein 2 (“tBMP-2”) and ORTHOREBIRTH’s proprietary 510K-approved bone void filling product, ReBOSSIS. tBMP-2 binds to materials present in ReBOSSIS with extremely high affinity, thus enabling targeted delivery of tBMP2 for precise regeneration of bone defects.

tBMP2 is Theradaptive’s lead therapeutic emerging from its computational platform that converts recombinant biologics into material-binding variants that can be delivered with high precision and tunable local persistence.

The World Health Organization estimates that 16,000 people die every day from traumatic injuries, and that for every person who dies, several thousand more are injured, many with permanent musculoskeletal injuries. Injury accounts for 16% of the global burden of disease. The inability to adequately treat bone fractures remains a pressing problem in both the developed and developing world.

“The THX-14 program brings together the latest in resorbable implants with tBMP-2, the most advanced bone regeneration therapeutic available today. ORTHOREBIRTH is committed to leveraging the latest developments in this space to develop life-changing treatments for patients around the world,” said Yasutoshi Nishikawa, Chief Executive Officer of ORTHOREBIRTH.

“Collaborating with ORTHOREBIRTH provides Theradaptive with an opportunity to work with a partner that is at the forefront of innovation in the orthopedic space,” said Luis Alvarez, Theradaptive’s Founder. “Their existing global network can accelerate the development of new regenerative therapies using our targeted delivery platform into the clinic.”

About ORTHOREBIRTH ORTHOREBIRTH aims to reduce the physical and mental burdens of both patients and doctors through the development of innovative medical apparatus. ORTHOREBIRTH’s goal is to improve the quality of life of those in the field of medicine on a global scale. ORTHOREBIRTH’s flagship product, ReBOSSIS, is a cottony-type, synthetic bone-void-filling material based on microfiber-producing technology and materials that can be applied in a wide variety of medical fields.

About Theradaptive Theradaptive develops regenerative therapeutics based on its targeted delivery platform that converts recombinant proteins into material-binding variants that bind to implants, devices, and injectable carriers in a paint-like manner to enable long-term local delivery with very low off-target effects. Theradaptive’s programs include targeted therapeutics for trauma, degenerative disc disease, cartilage injury, soft tissue repair, and localized oncotherapy.

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