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$2 Million Grant Award Assists Wound Care Product Development
The company wanted to develop new wound-care products and penetrate new markets, including the treatment of second- and third-degree burns. Resources were limited for product development.
Collaborated and co-wrote a research grant proposal that was submitted to the Department of Defense for the newly created Armed Forces Institute of Regenerative Medicine.
Grant was awarded and company received $2 million in funding for five years, which facilitated the development of pre-clinical animal models for burns and submission of a pilot clinical study.
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Recruitment Efforts Produce New Clinical Trial Sites
The number of clinical sites was insufficient to support the clinical trial of the company's leading bone repair product. One clinical trial site dropped out of the study and the remaining trial sites were slow to recruit patients.
Developed a project plan and initiated a recruitment strategy for surgeons. On-site visits were initiated in the U.S. and European medical centers that encouraged surgeons to participate in the clinical trials.
The company recruited and contracted with several new clinical trial sites. Phase I of the clinical trial was completed with full patient enrollment.
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Market Research Analysis Expands Growth Opportunities
Increased sales for an immunological assay reagent that analyzed cytokines and discovered growth factors were needed. The market had not been studied and a customer target assessment had not been conducted.
A strategic market research analysis was performed. Company focused on designated customer segment that included new suppliers and original equipment manufacturers.
Reagents sales increased 20% over 15 months.
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New Product Penetrates Cartilage Repair Market
The company wanted to enter the cartilage repair market using a proprietary cell-based repair technology. Senior management did not fully understand the target product profile and claims for a cell-based combination product.
Conducted strategic market research and developed a TPP for a percutaneous, injectable cartilage-repair product.
Target product claims shaped the research and development of a hydrogel scaffold with tissue repair cells.
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Software Update Imparts Invaluable Data & Support
The Microsoft Great Plains accounting software used by customers to place orders needed to be linked with product description brochures and technical support. Detailed descriptions and the technical properties of various cellular reagents, stored as separate PDF files, were necessary.
The existing PDF files were entered into a database and linked to MS Great Plains.
Products and technical product support information were directly linked into a cohesive database system.
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Database Targets Out-Licensing Opportunities
Company wanted to out-license several proprietary technologies that were no longer a focus on core business. No database or targeted list of companies existed that the company's IP covered.
Conducted a search of foreign and domestic companies and created a database that listed the companies' IP, assets, stage of development, and contact information.
Identified and contacted more than 60 companies. Three companies conveyed an interest in possible licensing deals.
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Research Findings are Published in Leading Spine Journal
The spine surgeons in the orthopedic department wanted to research new treatment modalities for spinal fusion. No current or planned orthopedic research projects that involved bone repair cells for spinal fusion were available.
An R&D team of orthopedic residents, technical staff, medical students, and undergraduate students was assembled. A research plan and budget were approved, and the work was completed over three years. A pre-clinical animal model was developed and results were acquired.
Data was generated, and the findings were published in a leading spine journal. The model was utilized at Aastrom Biosciences and eventually led to an FDA approval of a clinical trial.
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Patent Expansion Strategy Generates Four New Patents
Company's proprietary technologies with additional patent protection needed to be enhanced and expanded for bi-aesthetic repair technology. The R&D staff's resources were limited and inexperienced in filing disclosures and patents, hindering progress in protecting the IP.
Designated procedures and assisted staff to drive completion of the patent filing initiatives.
Four new patents were filed in the U.S. and globally.
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Study Validates Stem Cell Viability in Spinal Surgery
A multi-year, pre-clinical animal model for spinal fusion using stem cells and a biomaterial scaffold needed to be developed as a prerequisite for an FDA submission for a human clinical study. The research lab's scientists did not possess the large animal surgical skill set to perform the study.
Orthopedic surgical residents interested in specializing in spinal surgery were recruited and trained to perform the animal surgery.
The animal surgery was a success, and the project demonstrated that stem cells and a biomaterial scaffold could result in good spinal fusion efficacy.
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Portal Intranet Site Provides Companywide Access
The company needed to expand competitive business databases and competitive technology intelligence assessments. Updates at monthly meetings for middle and senior management were also needed. Key employees were unable to attend monthly CI meetings or had no access to the quarterly CTI reports.
A dedicated server and competitive technology and business intelligent intranet site licenses (Microsoft Office SharePoint Server) were purchased.
A portal intranet site was launched in 10 weeks that included RSS feeds, a discussion board, future meetings calendar, a competitive analysis matrix, links to a medical library system, and technology management committee and various committee sites.
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Surgeons Perform Spinal Fusion Clinical Studies
A new bone repair product for spinal fusion needed to be developed to penetrate the orthopedic bone repair market. KOLs for orthopedic spinal surgery had not been recruited to aid in product design and clinical trial design.
Conducted site visits with Director of Marketing and Product Development. Solicited input and recruited surgeons for spinal fusion clinical studies.
A clinical trial study was developed and was successfully submitted to the FDA.
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Startup Acquires Funding to Develop Patent Technologies
The Department of Orthopedic Research at Brown University wanted to expand translational research capabilities and develop clinical trials and commercial therapies. Patents had not been filed to protect the intellectual property developed in the laboratory.
The Research Administration filed domestic and foreign patent applications.
The patent filings facilitated a startup company, Traumatos Therapeutics LLC. Company secured financing from a Rhode Island government agency and various federal government sources.