Michael Helmus, Ph.D.

Dr. Helmus has over 31 years experience with managing the R&D of medical and controlled drug delivery devices. He has a focus on developing commercialization strategies of potentially disruptive technology as well as managing intellectual property development (36 issued US patents). Dr. Helmus has experience with patent litigation. Dr. Helmus’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 opinions on IP.

Dr. Helmus has expertise in biomaterials, biocompatibility and biomaterial databases 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.

Books and Reports

Helmus M, Medlin D (eds). Medical Device Materials II: Proceedings from The Materials & Processes for Medical Devices Conference 2004, ASM International, St. Paul, MN, August 25–27, 2004.

Helmus MN (ed). Biomaterials in the design and reliability of medical devices. Kluwer Academic/Plenum Publishers and Landes Bioscience, NY, NY, and Georgetown, TX, 2003.

Helmus MN . Opportunities for biomaterials. Decision Resource Report, pp.1–113, February 1995.

Helmus MN. Outlook for biomedical materials. Decision Resources Report, Decision Resources, pp. 1–201, December 1990.

Book and Encyclopedia Chapters

Helmus MN, Cunanan CM. Mechanical and bioprosthetic heart valves. In: Biomaterials for Artificial Organs. Webster T, Lysaght M (eds), Woodhead Publishing, pp 113–162, 2011.

Snyder RW, Helmus MN. Cardiovascular biomaterials. Chapter 16. In: Biomedical Engineering and Design. 2nd Edition. Kutz M (ed), McGraw Hill, 2009.

Helmus M, Gammel P, Allen F, Gittins M. Commercializing bionanotechnology: From the academic lab to products. In: Bionanotechnology: Global Prospects. Reisner D (ed), CRC Press, pp 71–78, 2009.

Snyder RW, Helmus MN. Cardiovascular biomaterials. In: Standard Handbook of Biomedical Engineering & Design. Kutz M (ed), McGraw Hill, pp.14.1–14.11, 2003.

Helmus MN (ed). Overview and introduction: Unique aspects of biomaterials in the safety and efficacy of medical implant devices. Chapter 1: Biomaterials in the design and reliability of medical devices. Kluwer Academic/Plenum Publishers and Landes Bioscience, New York, NY, and Georgetown, TX, 2003.

Helmus MN (ed). Failure analysis: Learning for the future from the past. Biomaterials in the design and reliability of medical devices. Kluwer Academic/Plenum Publishers and Landes Bioscience, New York, NY, and Georgetown, TX, 2003.

Helmus MN, Verheyden A. Medical device infections. In: Disinfection, Sterilization, and Preservation. 5th ed., Seymour Block, ed., 2001, pp. 957-966.

Helmus MN, Tweden K. Materials selection for medical devices. Chapter 2. Encyclopedic Handbook of Biomaterials, Wise D, et al (eds), Marcel Dekker, Inc., NY, 1995.

Helmus MN. The outlook for environmentally degradable plastics. In: Degradable materials: Perspectives, issues and opportunities. Barenberg SA, Brash JL, Narayan R, Redpath AE (eds). C.R.C. Press, Boca Raton, pp. 619–640, 1990.

Helmus MN, Botan EA, Malone JM, Botzko KM, Reinert RL, Bevans-Lynch R, Brendel K, Duhamel RC, Snyder RW. Sterility and pyrogenicity issues of synthetic vascular grafts. ASTM Symposium on Vascular Graft Update : Safety and Performance, pp. 236–249, November 27–28, 1984.

Snyder RW, Helmus MN. Vascular prosthesis. In: Encyclopedia for Medical Devices and Instrumentation. Webster J (ed), John Wiley, NY, pp. 2839–2847, 1988.

Helmus MN, Malhotra OP, Gibbons DF. Plasma interaction on block copolymers as determined by platelet adhesion. In: Adv. Chem. Series, No. 199. Cooper SL, Peppas NA (eds), ACS, Washington, pp. 81-93, 1982.

Technical Publications, Peer Reviewed Publications, and Presentations

Picha G, Helmus MN, Barenberg S, Gibbons DF, Martin R, Nose Y. The characterization of intima development in left ventricular assist device and total artificial heart. Transactions of the American Society for Artificial Internal Organs 1976; 22:554.

Harasaki H, Picha G, Barenberg S, Helmus MN, Kiraly R, Nose Y. Endothelialization of cardiac prostheses after long term implantation. Abstract, Transactions of the American Society for Artificial Internal Organs 1977.

Harasaki H, Picha G, Helmus MN, Fields A, Kiraly R, Nose Y. Ultrastructural study on in vivo blood compatibility of biolized materials. Poster Session, Thrombosis and Haemostasis, Philadelphia, PA, 1977.

Helmus MN, Gibbons DF, Jones RD. The effect of surface charge on arterial thrombosis. World Biomaterials Congress, Vienna, Austria, April 1980.

Helmus MN, Malhotra OP, Gibbons DF. Plasma interaction on block copolymers as determined by platelet adhesion. Biomaterials: Interfacial Phenomena and Applications, Materials Engineering and Sciences Division and Committee on Fundamentals of Life Sciences of the American Institute of Chemical Engineers, Chicago, IL, November 1980.

Helmus MN, Gibbons DF, Jones RD. Surface analysis of copolymers of L-Glutamic Acid and L-Leucine. Journal of Colloid and Interface Science 1982; 89:567.
Botzko KM, Tenney BW, Gelfand J, Helmus MN, Malone J, Guidoin R, Snyder RW. The effects of a cross-linked albumin coating on Dacron vascular prostheses. 4th Annual Canadian Biomaterials Society 1983, pp 7.1-7.3.

Helmus MN, Gibbons DF, Jones RD. The effect of surface charge on arterial thrombosis. Journal of Biomedical Materials Research 1984; 18:165.

Kambic H, Murabayashi S, Yozu R, Morimoto T, Furuse M, Harasaki H, George C, Helmus M, Snyder R. Small vessel replacement with elastomeric protein composite materials: Preliminary Studies. Transactions of the American Society for Artificial Internal Organs 1984; 30:406.

Helmus M, Schwope A. Glutamic acid copolymers for controlled release of proteins. Presented at Cetus/Triton Biosciences Symposium, Drug Delivery of Proteins and Peptides, Emeryville, CA, October 31, 1985.

Helmus MN, Botan EA, Malone JM, Botzko KM, Reinert RL, Bevans-Lynch R, Brendel K, Duhamel RC, Snyder RW. Sterility and pyrogenicity issues of synthetic vascular grafts. ASTM Symposium on Vascular Graft Update : Safety and Performance, November 27–28, 1984.

Kesler KA, Herring MB, Arnold MP, Glover JL, Park HM, Helmus MN, Bendick PJ. Enhanced strength of endothelial attachment on polyester elastomer and polytetraflouroethylene graft surfaces with fibronectin substrate. Journal of Vascular Surgery 1986; 3:58.

Botan EA, Helmus MN, Malone JM, Reinert RL, Bevans-Lynch R. The recovery of endotoxin from seeded vascular grafts. In: Detection of Bacterial Endotoxins with the Limulus Amebocyte Lysate Test, A.R. Liss, Inc., pp. 263–272, 1987.

Barenberg SA, Andrade JD, Bonsen P, Crowninshield R, Gantz W, Haubold A, Helmus MN, Galetti PM, Hench LL, Kronenthal R, Lemons J, Mueller E, Ostler MI, Refojo M, Shalaby S, Shaw J, Williams J. Report of the Committee to Survey the Needs and Opportunities for the Biomaterials Industry. Biomaterials Industry Subpanel, National Research Council, March 1987.

Snyder RW, Helmus MN. Vascular prostheses for the 1980's. 14th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery, Bad Nauheim, February 14–16, 1985.

Barenberg SA, Andrade JD, Bonsen P, Crowninshield R, Gantz W, Haubold A, Helmus MN, Galetti PM, Hench LL, Kronenthal R, Lemons J, Mueller E, Ostler MI, Refojo M, Shalaby S, Shaw J, Williams J. Abridged report of the committee to survey the needs and opportunities for the biomaterials industry. Journal of Biomedical Materials Research 1988; 22:1267.

Helmus MN. Overview of biomedical materials. Materials Research Society Bullletin, pp. 33–38, September 1991.

Helmus MN, Raleigh C, McGrath J, Tolkoff J. Medical device design—A Systems Approach: Central Venous Catheters. Advanced Materials: Looking Ahead to the 21st Century. Transactions, 22nd International Proceeding of Society for the Advancement of Material and Process Engineering, Boston, MA, November 1990.

Helmus MN, Mirsch W. An overview of current biological and synthetic graft materials. Limitiations of current technology, Vascular Experts Symposium, St. Jude Medical, Inc., Amelia Island, FL, March 14–17, 1991.

Helmus MN. Materials selection for medical devices—A systems approach: Heart valves. Poster Session for Polymers for Biosystems, Winter Gordon Conference, February 24–28, 1992.

Helmus MN. Materials selection, controlled drug delivery for medical devices. Department Pharmaceutics, University of Minnesota, April 3, 1992.

Helmus MN. Material Selection for blood contacting devices. Biomedical Engineering Seminar, University of Minnesota, November 17, 1992.

Helmus MN. Materials for controlled drug delivery coatings for medical devices. Workshop on Tissue-Material Interactions, Biomedical Interfacial Engineering, University of Minnesota, May 11, 1993.

Helmus MN. Biomaterials selection for critical medical devices. Poster Session for Biocompatibility and Biomaterials, Gordon Conference, July 12–16, 1993.

Helmus MN, Hubbell JA. Materials selection. In: Cardiovascular Biomaterials and Biocompatibility. Harker LA, Ratner BD, Didisheim P (eds), Supplement, Cardiovscular Pathology, Vol. 2, No. 3 Suppl.: 53S-71S, 1993.

Helmus MN. Design requirements for cardiovascular devices. Short Course, Evaluation and Testing of Cardiovascular Devices, November 15–16, 1993.

Helmus MN Chair, Levy R (Co-Chair). Society for Biomaterials, Course Notebook, pp. 2–11, Bloomington, MN, 1993.

Helmus MN. Cardiovascular biomaterials. University of Minnestota, Biomedical Engineering Seminar, November 30, 1993.

Tweden KS, Blevitt J, Harasaki H, Helmus M, Glass J, Dickerson K, Craig WS, Pierschbacher M. RGD modification of cardiovascular prosthetic materials. Cardiovascular Science and Technology Conference, Washington, DC, December 10–12, 1993.

Tweden KS, Haraskai H, Jones M, Blevitt JM, Craig WS, Pierschbacher M, Helmus M. Accelerated healing of cardiovascular textiles promoted by an RGD peptide. Journal of Heart Valve Disease 1995; 4 (Suppl. I):S90–97.

Helmus MN. Design requirements for cardiovascular devices. Short Course, Evaluation and Testing of Cardiovascular Devices, June 12–13, 1995. Helmus MN Chair, Coury AJ, Co-Chair, Society for Biomaterials, Course Notebook, Cerritos, CA, 1995.

Helmus MN. 1) The evolution of heart valve prostheses. 2) Selecting elastomers for heart valves. 3) Present and future applications for fibrin sealant in cardiovascular surgery. 6thScience and Technology Seminar, Baxter’s Business and Technology Strategies, Hyatt Regency O’Hare, August 28–29, 1995.

Zhou J, Quintero L, Helmus MN, Lee C, Kafesjian R. Porcine aoritc wall flexibility fresh vs denacol vs. glutaraldehyde fixed. ASAIO Journal 1997; 43(5):M470-M475.

Helmus M. Introduction/general perspective. Frontiers of Industrial Research, International Society for Applied Cardiovascular Biology, Abstract, March 1998: Cardiovascular Pathology 1998; 7(5):281.

Helmus MN. New Materials and Surface Modifications for Intracoronary Stents. Workshop, Cardiovascular Stents: Materials, Thrombosis, and Restenosis, April 22, 1998, Society for Biomaterials.

Helmus MN. From bioprosthetic to tissue engineered constructs for heart valve replacement. First International Symposium, Tisue Engineering for Heart Valve Bioprostheses, Satellite Symposium of the World Symposium on Heart Valve Disease, Abstract, pp 35–36, Westminster, London, June 11, 1999.

Cunanan CM, Helmus MN, Shen S, Lohre JH, Fishbein MC. Assessment of the calcification potential of five commercially available bioprosthetic heart valves in the rat subcutaneous model. VIII International Symposium Cardiac Bioprostheses Scientific Program and Schedule, Cancun, November 2000.

Helmus MN. Biomaterials in the design of tissue heart valve replacement. Department Bioengineering, University of Pittsburgh, September 8, 2000.

Helmus MN. Medical textiles: Meeting the unique functional needs of medical implants. 1st Organizational Meeting, Center for Research on Advanced Fibrous Structures, College of Textiles, North Carolina State University, January 31, 2001.

Helmus MN. Future of implantable medical textiles. Industrial Fabrics Association International, Expo 2001, October 18, 2001.

Helmus M. Biomaterials in the design of cardiovascular devices. Conference MD&M East 2002. Drug Delivery, Tissue Engineering and Cardiovascular Devices: Pre-clinical and Clinical Development, June 5, 2002.

Helmus MN, Miller K. Biocompatibility, meeting a key functional requirement of next generation medical devices. Keynote talk, The UWEB 7th Summer Symposium, “The good, bad, and the ugly of the interaction of living systems with synthetic materials” University of Washington, Seattle, WA, August 27–29, 2003.

Helmus MN. Metallic biomaterials. Keynote talk, ASM Materials & Processes for Medical Devices Conference, September 8–9, 2003; Boston Chapter ASM International, November 18, 2004.

Ranade SV, Richard RE, Schwarz MC, Helmus MN. AFM characterization of paclitaxel delivery from drug eluting stents. Abstract, Controlled Release Society, 2004.

Hemus MN. Nano and microscale systems for medical devices: What do they enable? Cleveland Clinic, NanoMedicine Summit, October 25, 2004.

Helmus MN. Nano and microscale systems for medical devices: What do they enable? Emerging Technology and Best Practices Seminar Series: Thinking Small: Nanoscience and Engineering, Department of Manufacturing Engineering, Boston University, October 29, 2004.

Ranade SV, Miller KM, Richard RE, Chan AK, Allen MJ, Helmus MN. Physical characterization of controlled release of paclitaxel from the TAXUS Express2TM drug eluting stent. Journal of Biomedical Materials Research 2004; 71A:625–634.

Ranade SV, Richard RE, Helmus MN. Styreneic block copolymers for biomaterial and drug delivery applications. Acta Biomaterialia 2005; 1:137–144.

Helmus MN. Biocompatibility: Key functional requirements of next generation medical devices, PMSE Symposium on Polymers & Medical Devices. American Chemical Society, San Diego, CA, March 2005.

Helmus MN. Medical Devices: What does nanotechnology enable? NSTI Nanotech 2005, Anaheim, CA. May 2005. http://www.nsti.org/Nanotech2005/slides/1248.pdf

Helmus MN. Nanotechnology for medical devices: What does it enable? Nanomedicine: Commercializing Drug Discovery, Delivery, and Diagnostics Monday, October 3, 2005.

Helmus MN. Patent strategy for emerging companies. Mass Medic Friday, October 14, 2005.

Helmus MN. Nanotechnology for medical devices: Issues for commercialization. ASM International, Materials & Processes for Medical Devices Conference, Boston, MA, November 14–16, 2005.

Helmus MN, Gammel P, Allen F, Migliorato P. Nanotech enables new applications of chemical and biosensors. American Laboratory, pp. 34–38, March 2006.
Helmus MN. Commercializing nanotechnology. Biopharma Application, CoSponsored by the Biology and Chemistry Departments, UMASS Boston, MA, April 24, 2006.

Helmus MN. Commercializing nanotechnology for biopharma applications. Atlantic Nanoforum, Washington, DC, September 28, 2006.

Helmus MN. Commercializing nanotechnology for biopharma applications. Plenary talk, Materials, Medicine, and Nanotechnology Summit to Open Nano-Week 2006, Cleveland, OH, October 2–6, 2006.

Helmus MN. Commercializing nanoenabled sensors. 19th Meeting of the BEMA Roundtable, NRC, November 3, 2006.

Helmus MN. Commercializing nanotechnology for biopharma applications. Nanomedicine Seminar, IGERT Nanomedicine Science and Technology Program, April 13, 2007.

Helmus MN. University industry relationships: Ethical Challenges. The Fourth International Conference on Ethical Issues in Biomedical Engineering, April 20–22, 2007.

Helmus MN. Medical applications and human health issues. Nanotechnology and Public Policy Basic Science, Applications, and Regulatory Implications, Northeastern University, May 1, 2007.

Helmus MN. Invited Speaker: Biocompatibility: Meeting a key functional requirement of next-generation medical devices. Session B: Medical Devices: Current Materials, Methods And Development, Society Toxicologic Pathology, 26th Annual Symposium, June 12, 2007; Helmus MN, Gibbons DF, Cebon D. Toxicol Pathol 2008; 36(1):70–80.

Helmus MN. Invited Speaker. Failure analysis: Reevaluating functional requirements of medical devices. Cleveland Clinic and ASM International, Opportunities for Next Generation Medical Devices, August 5–7, 2008,

Helmus MN. Impact of consultants and contract R&D. Roundtable on Biomedical Engineering Materials and Applications (BEMA) National Materials Advisory Board of the National Academies, Navigating Speed bumps in Medical Product Development from Bench to Bedside, December 17, 2009.

Helmus MN. Materials selection for medical devices. 1-day course, Medical Design & Manufacturing MDM, Minneapolis, MN, October 14, 2010.

Helmus MN. Translating medical technology from bench to bedside. 1) Biomedical Engineering, Columbia University Fall 2010 Graduate Seminar Series, October 22, 2010; 2) Biomedical Engineering, SUNY Downstate Medical Center, December 3, 2010.

Helmus MN. Panelist and presenter, Plenary Session, Engineering Personalized Health, AIMBE 2011, D.C., February 22, 2010. http://www.aimbe.org/annual-event/program/

• Consultant, Medical Devices, Biomaterials, Drug Delivery, and Nanotechnology, 2007–2011
• Senior Vice-President, Biopharma, Advance Nanotech, 2005–2007
• Vice President, Advanced Biomaterials (2003–2005), Vice President, Materials Science & Technology, (2000–2003), Boston Scientific, 2000–2005
• Director R&D, Materials and Tissue Technology, Edwards Lifesciences, Heart Valve Therapy, 1995–2000
• Director R&D, Materials and Tissue Technology, Baxter CVS, Heart Valve Therapy Division, R&D
• Principal Research Scientist, Schneider USA, Pfizer Inc., 1992–1995
• Manager, Research Programs, St. Jude Medical, Inc., 1990–1992
• Director of Research, Harbor Medical Devices, Inc., 1988–1990
• Senior Consultant, Product Technology Section, Arthur D. Little, Inc., 1985–1988
• Engineering Research Manager, Bard Cardiosurgery Division, 1984–1985
• Senior Project Engineer, Bard Implants Division, 1981–1984
• Research Chemist, Department of Physical and Life Sciences, Franklin Research Center,
  1980–1981
• Engineering Student Trainee, GS-3, Naval Facilities Engineering Command, Electrical Engineering Division; Engineering Student Trainee, GS-4, Naval Research Laboratory,
  1972–1973

• Fellow of the American Institute of Medical and Biological Engineering (since 1998)
• ASM International
  – Committee Chair, ASM International, Materials for Medical Devices Database
  – Vice Chairman, ASM Medical Materials Strategic Advisory Committee