BioRestorative Therapies CEO Mike Weinreb wrote a letter to its stockholders updating them on company changes, including a study for the brtxDISC Program.
The company sent its last update to shareholders in August 2013. Here are five key takeaways from the letter:
1. The company is closer to filing an investigational new drug/investigational device exemption study for the brtxDISC — a disc implanted stem cell program — to begin the study. Treatment includes culturing the patient's stem cells and delivering them via the company's proprietary medical device as an outpatient procedure.
2. In March the company partnered with Japanese-based global pharmaceutical company Rohto Pharmaceutical to provide stem cell research and development services to the company, which has $1.3 billion in annual sales.
3. The company received approval from the Western Institutional Review board to complete a retrospective safety study on some subjects previously treated with brtxDISC bulging and protruding disc procedure at a clinic in Colorado. The study is nearing completion and the company expects results by the end of the year.
4. Gregory Lutz, MD, was named chief medical advisor for spine medicine for the brtxDISC program. Dr. Lutz is leading efforts to design clinical protocol and identify trial sites and selecting contract research organizations to conduct the study. He will interact with the FDA on behalf of the company as well.
5. The company also appointed Wayne Olan, MD, to the scientific advisory board to help develop the disc program. Dr. Olan is a board-certified interventional neuroradiologist and also serves as a consulting physician to the National Institutes of Health.
6. Over the past 12 months, the company has presented at the LD Micro Conference in Los Angeles and the Marcum MicroCap Conference in New York to raise the company's profile among the investment community. Mr. Weinreb and other company executives have been working to shore up the company's financial position and have raised approximately $3 million through equity and debt issuances since last August, but will continue to seek additional funding.
7. The company will move corporate headquarters and operations in the future to Long Island, N.Y. The company is currently based in Jupiter, Fla., and hopes the location change will promote growth over the coming years.
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