STR Adds Cash and Dane Miller

Soft Tissue Regeneration, Inc., (STR) has added money and expertise to its efforts to offer ACL (anterior cruciate ligament) patients an alternative to autograft or allograft therapies.

On January 6, 2013, the company announced the completion of a $5 million financing effort and the addition of Biomet, Inc. founder, Dane Miller, Ph.D. to the company’s board of directors. Charles Hart, Ph.D., and Richard Emmitt also joined the board. The first tranches of STR’s $5 million financing closed on November 19, 2013.

The company stated the financing commitment will allow for the completion of a European 15-patient Phase I clinical study of the company’s L-C Ligament. The first patient was enrolled in June 2013, in The Netherlands. The financing will also support STR’s continued regulatory and clinical activities with the FDA in preparation for a global pivotal clinical trial.

Resorbable Polymer Technology

STR focuses on the application of resorbable polymer scaffold technology.

The company’s devices are based on proprietary fiber, braid and mesh designs comprised of poly (L) lactic acid (PLLA), a resorbable polymer with a long and proven history of use in implantable medical devices. The company says its device designs are “ideally suited for tendon, ligament, and other soft tissue injuries when an implantable scaffold is required for the reinforcement and/or regeneration of functional tissue.”

The first STR device to reach the clinical stage, the L-C ligament, has, according to the company, the potential to advance the surgical repair of torn ACLs by obviating the need to utilize either the patient’s own tissue (autograft) with the pain and morbidity of a second surgical site, or the use of cadaver tissue (allograft) with the risks of infection and sub-optimal healing. Following three years of animal testing that demonstrated the ability of the L-C Ligament to remodel and regenerate functioning ligament, STR initiated the clinical study in Europe. As of this date, 10 patients that have received L-C Ligament implants are “all doing well.”

Company Co-Founder, President and CEO Joseph Reilly said the company has quickly progressed from a concept to a real product that is “already demonstrating clinically its potential to provide surgeons and their ACL patients with an alternative to the inherent morbidity and risks of autograft or allograft tendon.”

New Board Members

Miller is the founder, current member of the board, and former president and CEO of Biomet, Inc. With over 40 years of experience, he is considered one of the most distinguished entrepreneurs and executives in the medical device industry.

Hart is the former chief scientific officer and vice president of two of the pioneer companies in the field of regenerative medical technology, Advanced BioHealing, Inc. and BioMimetics Therapeutics, Inc. He has more than 30 years of experience.

Emmitt is a general partner with The Vertical Group with a 40-year career as an investor and board member of several medical device companies.

Current investors, Connecticut Innovations and Launch Capital led the $5 million financing. Miller and The Vertical Group also participated. “The new members of the board offer years of experience and the guidance and insight that will allow us to continue making clinical and regulatory advances, ” added Reilly.