Partners and Research Relationships
Bone Solutions has concluded several NDA/MTA agreements with major companies to review the work on OsteoCrete™ and several proprietary studies have been concluded. BSI plans to maintain these relationships but its corporate plan is to keep building this core group though its 5th FDA approval. At present, BSI owns and controls 100% of all marketing and distribution of its products, and does not have an exclusive relationship with any company. Some of its key working relationships include:
Bone Solutions has developed regulatory relationships with Boston Biomedical Associates of Northboro, Massachusetts (www.boston-biomedical.com), retained to be BSI's key outside regulatory/clinical advisor to achieve its multiple filings with the FDA and for CE Mark approval.
McDonnell Boehnen Hulbert & Berghoff LLP of Chicago, Illinois (www.mbhb.com) was retained in 2005 as the Company's Patent/Intellectual Property attorneys, led by Dan Boehnen who most recently has assisted in supplement filings for new patents, both domestic and foreign.
TESCA of Santa Barbara, California is assisting in the drafting of all documentation for FDA, CE Mark, and other Quality Control documents needed to launch our products.
For its CE Mark certification, KEMA (www.krqusa.com) is the Company’s notified body.
The Company will produce its products at BC Tech, Inc. in Santa Cruz, California (www.bc-tech.com).
NAMSA of Northwood, Ohio (www.namsa.com) is completing the bulk of research studies for initial FDA testing. Geneva Laboratories, Inc. of Elkhorn, Wisconsin (www.genevalabs.com) has completed much of the biocompatibility testing for BSI.
Scott A. Rodeo, MD, at Hospital for Special Surgery, (HSS), in their Department of Orthopaedic Surgery (Sports Medicine and Shoulder Service) and the Research Department (Laboratory for Soft Tissue Research. Hospital for Special Surgery, New York, NY, (www.hss.edu) has been named the top hospital in the nation in orthopedics by U.S.News & World Report in its 2007 "America's Best Hospitals" survey. Hospital for Special Surgery also ranked third in the nation for rheumatology. For the 17th consecutive year, HSS has ranked above all other hospitals in the Northeast in orthopedics and rheumatology.
Thomas G. Wilson, Jr., DDS, has been a private practitioner of periodontics in Dallas since 1974. His practice emphasizes state-of-the-art, minimally invasive nonsurgical and surgical treatment of gum diseases, utilizing advanced visualization and techniques that restore health to previously diseased tissue. Dr. Wilson has taught his innovative techniques to colleagues around the world. He is the author of numerous professional publications and books on periodontics and implant dentistry. He also is a Clinical Associate Professor at the University of Texas at San Antonio Dental School and Baylor University College of Dentistry and has served as editor in chief of an international dental journal.
Wilson Sonsini Goodrich and Rosati (www.wsgr) is one of the leading law firms in the US, ranked in the Top 25 in the US with a strong emphasis on the Life Sciences. This firm is working with BSI on its current Offering Documents.
Wilson Sonsini Goodrich and Rosati (www.wsgr) is one of the leading law firms in the US, ranked in the Top 25 in the US with a strong emphasis on the Life Sciences. This firm is working with BSI on its current Offering Documents.