Dr. Helmus has over 28 years managing the R&D and Business Development of medical and controlled drug delivery devices. He focuses on developing commercialization strategies of potentially disruptive technology as well as managing intellectual property development (30 issued US patents) and supporting patent litigation. Mike’s patents and patent applications include drug eluting coatings, bioactive biomaterials and coatings, lubricious coatings, treatment of restenosis, nanoenabled therapies, biosensors, calcification mitigation of bioprosthetic heart valves, and improved medical devices such as stents, catheters, annuloplasty rings, heart valves, and interventional devices. He supports testing and regulatory submissions; due diligence evaluations of medical devices, combination devices, tissue engineered constructs and nanoenabled therapies; materials selection for medical and combination devices based on synthetic, biologic, and biodegradable compositions; formulation of controlled drug delivery coatings; design and interpretation of biocompatibility and thrombogenicity studies; failure and explant analysis; expert opinions on the biocompatibility of nanoformulated therapies; and expert opinions on IP.

Dr. Helmus is an expert in biomaterials, biocompatibility and biomaterial databases (Committee Chair, ASM International, Materials for Medical Devices Database http://products.asminternational.org/meddev/index.aspx). His medical device experience includes: Drug eluting stents and coatings, large and small diameter vascular grafts, mechanical and biologic heart valves, central venous catheters, wound dressings, sealants such as fibrin sealant, and percutaneous connectors.

Dr. Helmus partners with client companies in the areas of:

• Commercialization
  • Developing commercialization strategies
  • Identification of commercializable therapeutic applications
  • Due diligence evaluations of medical devices
  
  
• Intellectual Property
  • Managing intellectual property development
  • Supporting patent litigation
  • Expert opinions on intellectual property
  
  
• Medical Devices
  • Testing and regulatory submissions
  • Materials selection
  • Formulation of controlled drug delivery coatings
  • Design and interpretation of biocompatibility and thrombogenicity studies
  • Failure and explant analysis
  
  
• Expert opinions on the biocompatibility of nanoformulated therapies
  
  
• Biomaterials Development
  • Bioactive
  • Smart
  • Lubricious
  • Nanoenabled