New Haven, Conn. (PRWEB) January 06, 2014
Soft Tissue Regeneration, Inc. (“STR”), a developer of regenerative orthopedic devices for tendon and ligament repair, today announced the completion of a financing and the addition of three new members to the company’s board of directors. The $5 million financing commitment will permit STR to complete its European Phase I clinical study and continue the FDA regulatory process for the Company’s L-C Ligament®, a bioresorbable, implantable scaffold for the repair and regeneration of an injured or torn anterior cruciate ligament (“ACL”). In conjunction with this financing, Dane Miller, Ph.D., Charles Hart, Ph.D., and Richard Emmitt are joining the STR board of directors, offering deep industry expertise in medical devices and investments.
Current investors, Connecticut Innovations and Launch Capital, led the $5 million financing and Dane Miller and The Vertical Group also participated. The financing allows STR to complete its 15-patient Phase I clinical study of the L-C Ligament in Europe, which enrolled the first patient in June, 2013, in The Netherlands. The financing will also support STR’s continued regulatory and clinical activities with the United States Food and Drug Administration (FDA) in preparation for a global pivotal clinical trial. The first tranche of STR’s $5 million financing closed on Nov. 19, 2013.
“STR 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,” said Joseph Reilly, president, CEO, and co-founder of STR. “The new members of the board of directors offer years of experience and the guidance and insight that will allow us to continue making clinical and regulatory advances.”
The new members to the STR board of directors include:
Dane Miller, Ph.D. – Miller is the founder, current member of the board of directors, and former president and CEO of Biomet, a pioneer and leading company in the orthopedic industry. Miller offers insights and knowledge from his more than 40 years of experience and is considered one of the most distinguished entrepreneurs and executives in the medical device industry.
Charles Hart, Ph.D. – Hart is the former chief scientific officer and vice president of two of the pioneers in the field of regenerative medical technology, Advanced BioHealing and BioMimetics. He has more than 30 years of experience in commercializing advances in biomaterials and biotechnology.
Richard Emmitt – Emmitt is a general partner with The Vertical Group, a leading venture capital firm focused on the medical device industry. During his 40-year career, he has invested in and served as a member of the board of directors at several of the most successful medical device companies.
About STR and the L-C Ligament: Soft Tissue Regeneration, Inc. is a medical device company focused on the application of resorbable polymer scaffold technology to address unmet needs of surgeons and their patients. 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 STR 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 is the L-C Ligament. This device has the potential to advance the surgical repair of torn ACL’s 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 has demonstrated the ability of the L-C Ligament to remodel and regenerate functioning ligament, STR has initiated a 15 patient Phase I clinical study in Europe. The first patient was treated in June, 2013 in Zwolle, The Netherlands and, as of this date, the 10 patients that have received L-C Ligament implants are all doing well.