Coventry, RI 02816, USMedical Devices & Equipmentwww.bimedical.org
Apocrine™ Prosthetic-Skin Interface forms a protective barrier between an amputees's limb and the prosthesis. It reduces the skin irritation and odor that accompanies many prostheses thereby significantly improving an amputee's quality of life.BI Medical, LLC is a FDA registered medical device company targeting the 8M orthotic and prosthetic (O&P) users in the US. BI Medical was incorporated in the State of Delaware in 2016 and operates out of its headquarters at the 141,000 square foot, BioSci Labs in Coventry, RhodeIsland. Drawing upon many years of medical device experience, the management team, scientists and industry collaborators, introduced Apocrine Interface, in 2018 to address long felt needs among the amputee population. This Class I, FDA listed device is manufactured in an ISO 13485cleanroom facility and currently available for sale through Cascade, the largest US O&P distributor. This applicator-based product is being followed up with two spray versions targeting the larger brace and orthotic markets. BI Medical's patented line of applicator and spray coatings addressbacterial and fungal issues responsible for skin irritation, pain and odor associated with prosthetic liners, braces and pediatric helmets. The technology has been validated by extensive research and published scientific studies conducted by collaborators at Brown University, theProvidence VA Center for Restorative and Regenerative Medicine and Rhode Island Hospital demonstrating safety and efficacy. The company's mission is to be the Standard of Care for orthotic and prosthetic treatment. Using the Apocrine technology, BI Medical believes that it cansignificantly improve a patient's quality of life, mobility and health while providing a high level of profitability for its investors. The first key hire will be the VP of Marketing with demonstrated DTC marketing experience. A potential individual has been identified.
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Apocrine™ Prosthetic-Skin Interface is a unique formulation of silver and titanium to treat irritation, odor and bacterial colonization common to many prosthetic liners. Unlike creams, deodorants and impregnated materials, Apocrine successfully treats liners through 3 modes of action. First, the sponge tip applicator physically removes debris and bacterial by-products. Second, it deep cleans by penetrating into the pores and interstices. Third, it creates a flexible thin film that chemically bonds forming a long lasting protective physical barrier.Apocrine Silver will be launched in Q2, 2019, to address similar issues in orthotic devices such as braces. Formulated as a spray, Apocrine Silver kills odor and protects the device from bacteria and fungal by-products.Apocrine Cleaner will be launched in Q4, 2019, for orthotic devices where skin sensitivity is critical such as pediatric cranial helmets. It removes microbial by-products and debris and provides long lasting protection.
Mark Roby, Ph.D., MBAMr. Roby has over 35 years of experience in the medical device industry developing and commercializing products. He has held executive positions at Davol, Medtronic and U.S. Surgical including general management, Marketing, R&D, Operations, Clinical and Quality.
Ms. Stone is experienced in managing operations, business development, marketing, product commercializing and creating strategies to improve productivity and efficiency. She has helped numerous businesses grow and develop into thriving organizations through consulting, mentoring, and as a board advisor.
Mr. Sandler started out as a CPA then founded and owned his own marketing communications firm which served clients such as Boston Scientific, J&J and early-start-ups. Mr. Sandler was the founder and president of SRK Group and VMARK Associates that were leading marketing strategy and communications firms serving the life sciences industry and other clients. Earlier in his career, Mr. Sandler served as the CFO of Research Media, Inc. a company that developed product launch programs for pharmaceutical firms. Prior to that, he was the CFO of National Information Services, a publicly held minicomputer systems company.
Mr. Hutchinson, VP Quality/Regulatory, has over 35 years of experience in both industry and academic medical products development and commercialization. He has guided the development, manufacturing, market authorization, and launch of medical products in every major global market including those at Hygeia Sciences, Becton Dickinson, Pharmacia, Pfizer and CR Bard.
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