Austin, TX – October 22, 2012-Spinal Restoration, Inc. announced today the closing of a $5 million financing round that will fund the company’s Biologic License Application (BLA) submission and early commercialization efforts for the Biostat System. The $5 million in financing includes $3 million in equity from current investors Austin Ventures, Sante Ventures, and MB Venture Partners, and a $2 million debt facility from Comerica Bank. Kevin Lalande, Managing Director of Sante’ Ventures commented, “The Biostat System is one of those rare technologies that truly has the potential to dramatically change the lives of millions of patients. Over the last five years, the management team at Spinal Restoration has done a masterful job establishing agreements with key industry partners and completing significant milestones, including preclinical studies, a pilot clinical trial, and now a Phase III clinical trial, while remaining very capital efficient.” Mr. Lalande concluded by saying “the current investors believe strongly in this technology and management team, and look forward to the Company’s BLA submission with FDA next year.”
Gary Sabins, President and CEO responded by saying, “The continued financial support and confidence of our existing investors reflects the potential of the Biostat System to help the millions of patients that suffer from debilitating discogenic low back pain each year. With the additional backing of Comerica Bank, Spinal Restoration is well funded to complete our BLA submission and initiate our commercialization efforts for the Biostat System.”
The Biostat System is the first intradiscal biologic therapy for discogenic pain to complete enrollment of a Phase III Investigational New Drug (IND) study. Spinal Restoration will complete the analysis of the 6-month primary endpoint data in the first quarter of next year. The company expects the outcomes from this study, along with data from its previous preclinical and pilot clinical studies, to provide the basis for a BLA submission to the FDA in mid 2013. If successful, the Phase III study of the Biostat System could have an extensive, far-reaching impact on the diagnosis and treatment of millions of patients who suffer from the debilitating effects of chronic discogenic low back pain.
About the Biostat System
The Biostat System is an investigational new drug and is limited by federal law to investigational use only. The Biostat System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, resorbable biologic tissue sealant, and the Biostat® Delivery Device, a proprietary application system designed to safely and effectively deliver the biologic to the intervertebral disc. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation, and enhancing tissue repair.
About Spinal Restoration
Spinal Restoration restores patients’ lives by delivering new therapies that address unmet needs in spine health management. These therapies are minimally invasive, early interventions with clinically proven results. The company is working with a diverse, highly regarded group of clinical and scientific advisors to develop and gain regulatory approval of the Biostat System, a proprietary resorbable biologic and delivery system for the treatment of chronic disc pain, based on solid scientific and clinical evidence. Visitwww.spinalrestoration.com for more information.
About Austin Ventures
Austin Ventures (“AV”) has worked with talented entrepreneurs to build valuable companies for over 25 years. With $3.9 billion under management, AV is the most active venture capital and growth equity firm in Texas and one of the most established in the nation. With an investment focus on business services and supply chain, financial services, new media, Internet, and information services, AV invests at all stages of company development, from $100,000 in “planned experiments” in early-stage ideas to $100+ million investments in expansion rounds and recapitalizations. AV’s strategy is to partner with talented executives and entrepreneurs through its CEO-in-Residence and Entrepreneur-in-Residence programs. Visit austinventures.com for more information.
About Sante´ Ventures
Santé Ventures is a life sciences venture capital firm that invests exclusively in early-stage companies developing innovative new medical technologies or healthcare delivery models. The firm was founded in 2006 and has $260 million in capital under management in two funds. For more information, visit www.santeventures.com.
About MB Venture Partners
MB Venture Partners is a Memphis, Tennessee venture capital firm that provides venture capital and strategic direction to life sciences companies. The firm invests in medical device and biotech companies at various stages of development and is especially interested in product solutions for musculoskeletal disease. The firm manages four separate funds totaling more than $110 million in committed capital and has invested in 25 start-ups. Additional information about the firm can be found at www.mbventures.com.
About Comerica Bank
Comerica Incorporated (NYSE: CMA) is a financial services company headquartered in Dallas, Texas, and strategically aligned by three business segments: The Business Bank, The Retail Bank, and Wealth Management. Comerica focuses on relationships, and helping people and businesses be successful. In addition to Texas, Comerica Bank locations can be found in Arizona, California, Florida and Michigan, with select businesses operating in several other states, as well as in Canada and Mexico.
President and CEO
Spinal Restoration, Inc.
Director of Product Development and Marketing
Spinal Restoration, Inc.