Mike Helmus

About

MEDTECH EXECUTIVE
• Extensive experience in all phases of managing & commercializing medtech
• Inventions and 44 US Patents for Medtech and Drug Delivery
• Over 80 publications and presentations http://scholar.google.com/citations?user=fX7mQJMAAAAJ
• 41 Technology and Market Assessments and Commentaries
• Patent Expert: Litigation, Opinions, Reexams
• Strategic Management
• Team Leader: Functional, Project Team, Matrixed
• Innovation, Technical Strategy, Disease based strategy Teams
• Project Management & Stage Gate Processes

EXPERIENCE
• Commercialization strategies of potentially disruptive technology
• Assessing products, incubating emergent technologies
• Orthopedic, cardiovascular, less invasive, wound care, opthalmic, combination and biosensor
devices
• Nanoenabled, magnetic nano-particle drug delivery, bioactive, biocompatible and
thromboresistant coatings, electrospun polymers, injectable polymers, therapeutic NO and
statin releasing polymers, biodegradable polymers
• Drug Delivery utilizing synthetic, biologic, biogradable and nanoenabled materials
• White Space Innovation evaluations
• Planning Committee BEMA June 2015 Rountable on BioSensors
• Co-Chaired the review National Nanotechnology Initiative
http://www.nap.edu/catalog.php?record_id=18271
• Reviewer
- Center for Future Technologies in Cancer Care, Year 4 Proposals
- TechConnect Abstract

ADVISORY BOARDS:
Senseonics http://senseonics.com/company/scientific-advisory-board

ASM Int'l: Chair Medical Materials Database http://products.asminternational.org/meddev/index.aspx

U. Mass. Boston SAB

Michael Helmus has over 3 decades of experience leading and 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 (44 issued US patents). Dr. Helmus has experience with patent litigation. Michael has strong skills in assessing emergent technologies and products, incubating emergent technologies and identifying “White Space” opportunities and how they may impact future medical therapeutics, particularly in these times of change. His consulting casework over the past few years has been with technologies, established and emerging companies ranging from orthopedic, cardiovascular, less invasive devices, wound care, and opthalmic devices with a range of unique technologies ranging from nanoenabled, magnetic nano-particle drug delivery, bioactive, biocompatible and thromboresistant coatings, electrospun polymers, injectable polymers, therapeutic NO and statin releasing polymers, Point of Care Diagnostics and both drug and cellular combination devices. He has reviewed the emergence of nanoenabled sensors and the impact in the evolving field of personalized medicine.

Dr. Helmus has a strong core competence in Drug Delivery utilizing synthetic, biologic and biogradable materials to control the release of small and large molecules. He also is an expert in the use of coatings for drug delivery and nano-enabled drug delivery. The majority of his patents relate to drug delivery and he has been a expert in drug eluting stent patent litigation.

Dr. Helmus supports the product development process (including stage-gate processes) including 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 and thrombogencity, including effects of wear, of devices and nanoformulated therapies; and opinions on IP. He has managed groups up to 30 people.

Dr. Helmus has expertise in biomaterials, biocompatibility and biomaterial databases http://products.asminternational.org/meddev/index.aspx).

Dr. Helmus was on the Planning Committee BEMA June 2015 Rountable on BioSensors; Panelist, Plenary Session, Engineering Personalized Health, AIMBE 2011, D.C., Feb. 22.

He is a reviewer for year 4 proposal, Center for Future Technologies in Cancer Care. He recently served as Co-Chair National Nanotechnology Initiative Triennial Review: Phase II . Final report: http://www.nap.edu/catalog.php?record_id=18271

Work history

2007-Present M.N. Helmus, Ph.D, Consultant - Medical Devices, Drug Delivery, Tissue Engineering, Nanotechnology

MN Helmus, Ph.D., Consultant, Worcester, MA 2007-
Exponent, Consultant, Natick, MA 2011-2012
Amulet Pharmaceuticals, VP Biomaterials, Rockville, MD 2007-2008 (Nitric Oxide therapeutic polymers)

Commercialization of Medical Devices, Drug Delivery, Combination Devices: Orthopedic Implants, Heart Valves, Annuloplasty, Vascular Grafts, Stents, DES, CHF therapies, Wound dressings, Sealants, Ocular implants, Intravascular catheters, POC Diagnostics, Biosensors. Michael N Helmus, PhD has a unique collaboration with Baverstam Asscociates, http://www.baverstam.com/partners.asp. to collaborate using Baverstam's proprietary technology identification methodology to find technical solutions for the medical device and pharmaceutical product R&D and development process.


Expertise & Expert Opinions: Biocompatibility http://lnkd.in/Hxr-Cd, Thromboresistance, PreClinical testing, Stage Gate Process, Tissue Engineering, Nanotechnology, Injectable polymers, Electrospun polymers, Therapeutic polymers, Coatings.

Intellectual Property and Patents – Expert Witness, Expert Opinions, Reexams


2005-2007 SENIOR VICE-PRESIDENT, BIOPHARMA, Advance Nanotech, NY, NY
Management and incubation of Advance Nanotech’s academic investments from proof-of-concept into a product development path. Manage as a virtual company these external academic research teams by implementing project management tools and developing contracts and partnerships required to commercialize these nanoenabled products. The participation of Advance Nanotech’s biosensor development effort, BiMAT, in FLUTEST, Part of the European Commission's Support to Combat the Spread of Avian Influenza, is an example of this partnership development.

2000-2005 VICE PRESIDENT, ADVANCED BIOMATERIALS (2003-2005), VICE PRESIDENT, MATERIALS SCIENCE & TECHNOLOGY (2000-2003), Boston Scientific Corporation, Natick, MA. Head of center that leverages, evaluates and exploits biomaterials and drug delivery knowledge, expertise, and technology to cardiovascular stents, vascular prostheses, and cardiac implants. Provide thought leadership, external connections, and internal project support for emerging material technologies including bioactive polymeric materials, biodegradables, controlled drug delivery, smart materials and nanotechnology. 20 milestone patent award.

1995-2000 DIRECTOR R&D, MATERIALS AND TISSUE TECHNOLOGY, Edwards Lifesciences, Heart Valve Therapy, Irvine, CA.
DIRECTOR R&D, MATERIALS AND TISSUE TECHNOLOGY, Baxter CVS, Heart Valve Therapy Division, R&D, Irvine, CA.
Manage four R&D groups to provide materials and bioscience expertise on product development teams for mechanical and bioprosthetic heart valves, annuloplasty rings, repair devices and tissue-engineered cardiac implants. Project Team leader for cardiothoracic implants leading to release of the Duraflo coated annuloplasty rings and new sewing ring for the Mira pyrolytic carbon bileaflet mechanical valve. Managed and upgraded materials and tissue research capabilities (including biochemical and biomechanical) to become the state of the art R&D within the heart valve industry. Managed international joint development program for medical implants and extramural research programs for a) biomechanical and biochemical characterization of bioprosthetic heart valves and b) state of art finite element model of heart. Provide expertise for technology assessment and implementation of new projects. Function also includes failure analysis on a range of cardiovascular devices. Patents issued and pending on cardiovascular implants. Implemented review of product opportunities based on a disease based strategy. Implementation of PERT team review of projects. Baxter Technical Awards: 1999: 1) Study of Calcification and Durability of Pericardial Bioprosthetic Heart Valves, and 1998: 2) Application of Duraflo Heparin Treatment for Implantable Annuloplasty Rings, 3) The StarRing, The Edwards Mira Sewing Ring. Member Baxter CVG Technical Strategy Team (1996), Innovation team (1999-present), Disease-based strategy team (1999-2000); Member Baxter Technical Council, Core Competency Champion (1998-2000), peer review team for Baxter Technical Awards (1997-2000) and Baxter Technical Leader (1998-2000).

1992-1995 PRINCIPAL RESEARCH SCIENTIST, Schneider USA, Pfizer Inc., Plymouth, MN. Managed team composed of a senior principal engineer, polymer chemist, two chemists and a technician, as well as extramural research programs centered on improvement of angioplasty catheters and metallic endovascular stents by use of new materials and technologies. Major efforts entailed the development of devices and methodologies to reduce restenosis. Technology assessment of medical devices and biomedical materials and acquisition of external technology. Internal consultant on biomedical materials. Oversight of QC laboratory. Patents and Patents Pending in controlled drug delivery from endovascular stents, super-elastic nitinol angioplasty/guidewire, drug delivery catheters, and polyamide elastomer angioplasty balloon.

1990-1992 MANAGER, RESEARCH PROGRAMS, St. Jude Medical, Inc., St. Paul, MN. Implemented and managed research programs related to heart valve thrombo-embolism, enhanced recellularization on heart valve sewing cuffs, and bioprosthetic calcification in order to develop the next generation heart valves and programs related to anastomotic intmal hyperplasia, and small diameter vascular grafts. Use of cell adhesion peptides and proteins to reduce vascular tissue proliferation. Technology assessment of medical devices and biomedical materials and acquisition of external technology.

1988-1990 DIRECTOR OF RESEARCH, Harbor Medical Devices, Inc., Boston, MA.
Directed and implemented programs utilizing controlled delivery technology to improve implantable vascular access ports, catheters and percutaneous connectors. Conceived, prototyped, scaled-up, including commercial release, within one year, a controlled release heparin coating for use on central venous catheters (patents issued). Developed sintered titanium constructs with a gradient of pore sizes. Managed outside research program including development of animal protocols and budget administration as principal investigator on a NIH SBIR grant for percutaneous connectors.

1985-1988 SENIOR CONSULTANT in Product Technology Section, Arthur D. Little, Inc.
Designed and tested implantable drug delivery devices; Technology and market assessment of medical devices (including cardiovascular, orthopedic and wound managment), biomedical materials and controlled delivery devices. Proposal writing, management of contracts and project teams for implantable drug delivery systems based on biodegradable and non-degradable formulations, evaluation of cardiovascular implants, failure analysis of polyurethanes, evaluation of controlled release technology for protein based drugs, optimization of the fatigue life of a commercial bone cement, and evaluation of orthopedic implant devices.

1984-1985 ENGINEERING RESEARCH MANAGER, Bard Cardiosurgery Div., Billerica, MA.
1981-1984 SENIOR PROJECT ENGINEER, Bard Implants Div., Billerica, MA.
Corporate proposal writing, staff hiring, implementation and management of in-house and external small diameter graft pro¬gram. Managed internal program for biologic im-plant devices including collagen processing and characterization. Managed team consisting of Ph.D. biochemist, M.S. Biomedical Engineer, a plastics engineer, technicians, and representa¬tives of manufacturing, QA/QC and regulatory affairs. Responsibilities included PERT commit¬tees, screening committee for new products, and reporting progress to corporate R &D commit¬tee.

1980-1981 RESEARCH CHEMIST, Dept. Physical and Life Sci., Franklin Research Center, Philadelphia, PA. Proposal writing. Developed and tested hydrogel coated, sub-micron magnetic microspheres for cell separations. Applications included purified cell cultures for monoclonal antibodies and islet cell purification for insulin producing cells. Participated in FDA sponsored review of safety and efficacy of cardiovascular catheters.

1972-1973 ENGINEERING STUDENT TRAINEE, GS-3, Naval Facilities Engineering Command, Norfolk, VA, Electrical Engineering Div.; ENGINEERING STUDENT TRAINEE, GS-4, Naval Research Laboratory, Washington, DC.

Education and qualifications

Ph.D. 1980 BIOMEDICAL ENGINEERING, CASE WESTERN RESERVE U., CLEVELAND, OH Timken Honors Fellow, "The effect of surface charge on arterial thrombosis."
M.S. 1978 BIOMEDICAL ENGINEERING, CASE WESTERN RESERVE U., CLEVELAND, OH Timken Honors Fellow, "Plasma Interaction on Block Copolymers as Determined by Platelet Adhesion."
B.S. 1975 METALLURGY & MATERIALS SCIENCE, LEHIGH UNIVERSITY, BETHLEHEM, PA Highest Honors; Departmental Honors; Phi Beta Kappa; Tau Beta Pi; Omicron Delta Kappa; Phi Eta Sigma.
B.A. 1971 Honorary Degree, Central High School, Philadelphia, PA, Barnwell Honors.

Publications

see https://scholar.google.com/citations?user=fX7mQJMAAAAJ for patents and publications

PATENTS and PUBLISHED PATENT APPLICATIONS

1) M. N. Helmus, J. Tolkoff, C. L. Raleigh, “Medical Device Polymer," US Patent 5,447,724, Sept. 5, 1995; Coatings for medical devices that release pharmacologic agent to improve device function.
2) M. N. Helmus, J. Tolkoff, C. L. Raleigh, “Medical Device Polymer," US Patent 5,569,463, Oct. 29, 1996; Coatings for medical devices that release pharmacologic agent to improve device function.
3) Michael R. Forman, Michael N. Helmus, Joseph E. Laptewicz, Jr., US Patent 5,505,699, Apr. 9, 1996. Angioplasty Device formed from a hollow metallic tube, a balloon afixed adjacent to the distant end, with a flexible distal end and a removal hub to use the device as a guidewire.
4) Michael N. Helmus, Michael R. Forman, US Patent 5,569,197, Oct. 29, 1996. Drug Delivery Guide Wire.
5) Fritz Hostettler, David Rhum, Michael R. Forman, Michael N. Helmus, Ni Ding, Process for Producing Slippery, Tenaciously Adhering Hydrogel Coatings Containing a Polyurethane-Urea Polymer Hydrogel Commingles with at least One other, Dissimilar Polymer Hydrogel, US Patent 5,576,072, Nov. 19, 1996.
6) Niederhauser Werner (Au); Stowell Lori L (Us); Burgmeier Robert E (Us); Forman Michael R (Us); Helmus Michael N (Us), Dilatation Balloons Containing Polyesteretheramide Copolymer, W096/37240, Nov. 28, 1996.
7) Fritz Hostettler, David Rhum, Michael R. Forman, Michael N. Helmus, Ni Ding, Process for Producing Slippery, Tenaciously Adhering Hydrogel Coatings Containing a Polyurethane-Urea Polymer Hydrogel Commingled with at least One other, Dissimilar Polymer Hydrogel, US Patent 5,662,960, Sept. 2, 1997.
8) Ding, Ni,; Michael N. Helmus, Drug release stent coating process, US Patent 5,837,313, Nov. 17, 1998; Ding, N., Helmus, M. N., Drug release coated stent, International Patent Application, PCT/IB96/00272, April 1, 1996.
9) Fritz Hostettler, Michael N. Helmus, Ni Ding, Process for hydrophilicization of hydrophobic polymers, US Patent 5,849,368, Dec. 15, 1998.
10) Forman, Michael R., Helmus, Michael N., Stinson, Jonathan S., Balloon Catheter with impeller for perusing blood. European Patent Application, EP0884064A2 Dec. 12, 1998.
11) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N.; Ding; Ni, Slippery, tenaciously adhering hydrogel coatings containing a polyurethane-urea polymer hydrogel commingled with a poly(N-vinylpyrrolidone) polymer hydrogel, coated polymer and metal substrate materials, and coated medical devices, US Patent 5,919,570, July 6, 1999.
12) Helmus, Michael N., Scott, Michael J., Enhanced Biocompatibility Coatings for Medical Implants, WO99/38547, Aug. 5, 1999.
13) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N; Ding; Ni, Slippery, tenaciously adhering hydrophilic polyurethane hydrogel coatings, coated polymer substrate materials, and coated medical devices, US Patent 6,017,577, January 25, 2000.
14) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N; Ding; Ni; Process for the preparation of slippery, tenaciously adhering, hydrophilic polyurethane hydrogel coatings, coated metal substrate materials, and coated medical devices, US Patent 6,030,656, February 29, 2000.
15) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N; Ding; Ni; Slippery, tenaciously adhering hydrophilic polyurethane hydrogel coatings, coated metal substrate materials, and coated medical devices, US Patent 6,040,058, March 21, 2000.
16) Cunanan Crystal M; Loshbaugh Christine; Sarner Chris H; Helmus Michael N; Quintero Lillian, Crosslinking Of Bioprosthetic Material To Mitigate Post-Implantation Calcification, WO0016820 March 30, 2000.
17) Starr; Albert; Stobie; Robert; Helmus; Michael N.; Sewing ring having increased annular coaptation, US patent 6,045,576, April 4, 2000.
18) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N; Ding; Ni; Process for preparation of slippery, tenaciously adhering, hydrophilic polyurethane hydrogel coating, coated polymer and metal substrate materials, and coated medical devices, US Patent 6,080,488, June 27, 2000.
19) Ding, N; Helmus, M.N., Drug coating with topcoat, US Patent 6,099,562, Aug. 8, 2000.
20) Ding, N; Helmus, M.N., Medical devices with long term non-thrombogenic coatings, US Patent 6,120,536, Sept. 19, 2000.
21) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N; Ding; Ni; Medical device coated with interpenetrating network of hydrogel polymers, 6,120,904, Sept. 19, 2000.
22) Forman; Michael R.; Stinson; Jonathan S.; Helmus; Michael N.; Perfusion balloon catheter having a magnetically driven impeller, 6,129,704, October 10, 2000.
23) Crystal M. Cunanan; Helmus; Michael N.; Lohre, Jeffrey, M IN VIVO SCREENING METHODS FOR PREDICTING CALCIFICATION OF IMPLANTABLE PROSTHETIC MATERIAL WO/2001/015628 March 8 2001.
24) Cunanan; Crystal M.; Quintero;; Helmus; Michael N.; Loshbaugh; Christine; Sarner; H. Chris; Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby, 6,214,054, April 10, 2001.
25) Cunanan, Crystal M; Quintero, Lillian; Helmus, Michael N; Loshbaugh, Christine; Sarner, H. Chris; Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby; US Patent Appl. 20010032024; October 18, 2001.
26) Hostettler; Fritz; Rhum; David; Forman; Michael R.; Helmus; Michael N; Ding; Ni Process for the preparation of slippery, tenaciously adhering, hydrophilic polyurethane hydrogel coatings, coated polymer and metal substrate materials, and coated medical devices, 6,265,016, July 24, 2001.
27) Ding, Ni,; Michael N. Helmus, Drug coating with topcoat, US Patent 6,284,305, September 4, 2001.
28) Ding, Ni,; Michael N. Helmus, Drug coating with topcoat, US Patent Appl. 20020004101, January 10, 2002.
29) Helmus, Michael N; Cunanan, Crystal M; Tremble, Patrice; Delivery systems for periadventitial delivery for treatment of restenosis and anastomotic intimal hyperplasia, US Patent Appl. 20020026236, February 28, 2002.
30) Ding, Ni,; Michael N. Helmus, Drug release stent coating, US Patent 6,358,556, March 19, 2002.
31) Helmus, Michael N., Ding, Ni; Drug release coated stent, US Patent Appl. 20020032477, March 14, 2002.
32) Ding, Ni, Helmus, Michael N.; Drug Release Stent Coating, US Patent Appl. 20020071902,
June 13, 2002.
33) Ding, Ni, Helmus, Michael N.; Drug Release Coated Stent, US Patent Appl. 20020091433, July, 11, 2002.
34) Cunanan, Crystal M; Dinh, Tan Thanh; Loshbaugh, Christine; Sarner, H. Chris; Helmus, Michael N; Cabiling, Christine M; Methods for preparation of bioprosthetic tissue and implantable devices comprising such bioprosthetic tissue, US Patent Appl. 20020137024, September 26, 2002; WO0243778 A; 2002-06-06.
35) Bessler Anita B; Helmus Michael N, Enhanced Visualization of Medical Implants, WO0147438 2001-07-05.
36) Helmus Michael N; Cunanan Crystal; Tremble Patrice; Delivery Systems for treatment of restenosis and anastomotic intimal hyperplasia; WO0154748, 2001-08-02.
37) Helmus Michael N; Cunanan Crystal; Tremble Patrice; Kafesjian Ralph; Bioactive coatings to prevent tissue overgrowth on artifical heart valves; WO0154745 A; 2001-08-02.
38) Forman; Michael R.; Stinson; Jonathan S.; Helmus; Michael N.; Perfusion balloon catheter, 6,503,224, January 7, 2003.
39) Cunanan, Crystal M.; Dinh, Tan Thanh; Loshbaugh, Christine; Sarner, H. Chris; Helmus, Michael N.; Treatment of tissue, instruments and work surfaces to remove infectious agents, US Patent Appl. 20030050276, March 13, 2003.
40) Carpentier; Alain F. Carpentier; Sophie; Cunanan; Crystal M.; Quintero; Lillian; Helmus; Michael N; Loshbaugh; Christine; Sarner; H. Chris Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby; 6,547,827 April 15, 2003.
41) Helmus, M N Biodegradable implantable or insertable medical devices with controlled change of physical properties leading to biomechanical compatibility, 20030153972, August 14, 2003.
42) Ding, Ni, Helmus, Michael N.; Drug coating with topcoat, US Patent 6,620,194,
September 16, 2003.
43) Helmus, MN, Patch stabilization of rods for treatment of cardiac muscle, 20030195527, October 16, 2002.
44) Carpentier; Alain F. Carpentier; Sophie; Cunanan; Crystal M.; Quintero; Lillian; Helmus; Michael N; Loshbaugh; Christine; Sarner; H. Chris Method for treatment of biological tissues to mitigate post-implantation calcification and thrombosis; US Patent Appl. 20030226208 December 11, 2003.
45) Ding, Ni, Helmus, Michael N.; Drug coating with topcoat, US Patent Appl. 20040049265, March 11, 2004.
46) Helmus, Michael N; Cunanan, Crystal M; Tremble, Patrice; Delivery systems for periadventitial delivery for treatment of restenosis and anastomotic intimal hyperplasia, US Patent 6,730,313, May 14, 2004.
47) Zhong, Sheng-Ping, Helmus, MN, Ungs, Mark T. Lafontaine, Daniel M Puncture hole sealing device 20040122350 June 24, 2004.
48) Helmus, Michael N; Cunanan, Crystal M; Tremble, Patrice; Delivery systems for periadventitial delivery for treatment of restenosis and anastomotic intimal hyperplasia, US Patent Appl. 20040202711, October 14, 2004
49) Cunanan, Crystal M.; Dinh, Tan Thanh; Loshbaugh, Christine; Sarner, H. Chris; Helmus, Michael N.; Treatment of tissue, instruments and work surfaces to remove infectious agents 20050080040, April 14, 2005.
50) Ding, Ni; Helmus, Michael N.; Medical device with drug 20050106210 May 19, 2005.
51) Helmus, Michael N.; (Worcester, MA); Richard, Robert; (Wrentham, MA); Dixon, Melissa; (Milford, MA) Biomaterials for enhanced healing 20050187146 August 25, 2005.
52) Ding, Ni;; Helmus, Michael N.; Drug coating with topcoat 20050187611 August 25, 2005.
53) Helmus, Michael N.;Tenney, Barron; Dry spun styrene-isobutylene copolymers 20050208107 September 22, 2005.
54) Ding, Ni; Helmus, Michael N.; Drug coating with topcoat 20050208200 September 22, 2005.
55) Helmus, Michael N.; Ranade, Shrirang V. Implantable or insertable medical articles having covalently modified, biocompatible surfaces 20050238684 October 27, 2005.
56) Zhong, Sheng-Ping; Helmus, Michael N.; Smith, Scott R.; Hammer, Bruce E.; Magnetic resonance imaging of a medical device and proximate body tissue 20050240098 October 27, 2005.
57) Helmus, Michael N.; Cunanan; Crystal M. Tremble; Patrice Delivery systems for periadventitial delivery for treatment of restenosis and anastomotic intimal hyperplasia 6,730,313 May 4, 2004.
58) Helmus, Michael N.; Cunanan; Crystal M. Tremble; Patrice Delivery systems for periadventitial delivery for treatment of restenosis and anastomotic intimal hyperplasia 6,991,804 January 21. 2006.
59) Weber; Jan; Kocur; Gordon; Helmus; Michael; Palasis; Maria; Method of making a coated medical device United States Patent Application 20060030936 February 9, 2006.
60) Helmus, Michael N.: Medical implant with average surface charge density United States Patent Application 20060089709 April 27, 2006.
61) Xu, Yixin; Helmus, Michael N. Method and apparatus for coating a medical device by electroplating, United States Patent Application 20060124466 June 15, 2006.
62) Helmus, Michael N. Use of supercritical fluids to incorporate biologically active agents into nanoporous medical articles, United States Patent Application 20060127442, June 15, 2006.
63) Helmus, Michael N. Medical devices having vapor deposited nanoporous coatings for controlled therapeutic agent delivery, United States Patent Application 20060127443, June 15, 2006.
64) Helmus, Michael N.; Xu, Yixin; Ranade, Shrirang V.; Medical devices having nanostructured regions for controlled tissue biocompatibility and drug delivery, United States Patent Application 20060129215, June 15, 2006.
65) Helmus; Michael N.; Valint; Paul; Ranade; Shrirang V. Implantable or insertable medical devices having optimal surface energy, United States Patent Application 20060171980, August 3, 2006.
66) Richard; Robert E.; Strickler; Frederick H.; Schwarz; Marlene C.; Faust; Rudolf; Ranade; Shrirang V.; Helmus; Michael N.; Medical devices having porous polymeric regions for controlled drug delivery and regulated biocompatibility, United States Patent Application 20060171985, August 3, 2006.
67) Ranade; Shrirang V.;. Helmus; Michael N.; Richard; Robert E; Drug release regions for medical devices, which include polycyclic-structure-containing polymers, United States Patent Application 20060204545, September 14, 2006.
68) Helmus; Michael. N.; Patch stabilization of rods for treatment of cardiac muscle, 7,108,685, September 19, 2006.
69) Helmus, MN, Patch stabilization of rods for treatment of cardiac muscle, United States Patent Application 20070010799, January 11, 2007.
70) Helmus, Michael N. Self-assembled endovascular structures, United States Patent Application 20070048383, March 1, 2007.
71) Helmus; Michael. N.; Patch stabilization of rods for treatment of cardiac muscle, 7,195,776, March 27, 2007.
72) Carpentier; Alain F. Carpentier; Sophie; Cunanan; Crystal M.; Quintero; Lillian; Helmus; Michael N; Loshbaugh; Christine; Sarner; H. Chris; Method for treatment of biological tissues to mitigate post-implantation calcification and thrombosis, 7,214,344, May 8, 2007.
73) Tenney, B, Helmus, M. N., Medical articles having enhanced therapeutic agent binding United States Patent Application 20070110786 May 17, 2007.
74) Tenney; Barron; Xu; Yixin;Helmus; Michael N. Medical devices having nanoporous coatings for controlled therapeutic agent delivery United States Patent Application 20070224235 September 27, 2007.
75) Carpentier; Alain F. Carpentier; Sophie; Cunanan; Crystal M.; Quintero; Lillian; Helmus; Michael N; Loshbaugh; Christine; Sarner; H. Chris; TREATING BIOLOGICAL TISSUES TO MITIGATE POST-IMPLANTATION CALCIFICATION; United States Patent Application 20070255423, November 1, 2007.
76) Richard; Robert E.; Helmus; Michael N., Medical devices having bioactive surfaces, United States Patent Application 20070269480, November 22, 2007.
77) Helmus; Michael N.; Valint; Paul; Ranade; Shrirang V.; Bioactive polymers for imparting bioactive character to hydrophobic medical article surfaces United States Patent Application 20070280987, December 6, 2007.
78) Tenney; Barron; Helmus; Michael N; Xu; Yixin Medical devices having porous regions for controlled therapeutic agent exposure or delivery United States Patent Application 20080086113 April 10, 2008.
79) Helmus; Michael N.; Xu; Yixin; Benco; John METHOD AND APPARATUS FOR COATING A MEDICAL DEVICE BY ELECTROLESS PLATING United States Patent Application 20080102194
May 1, 2008.
80) Helmus; Michael N.; Tenney; Barron; Xu; Yixin; Alves; Kevin M.; Strickler; Frederick H.; Miller; Kathleen M.;; Boden; Mark; Medical articles for long term implantation United States Patent Application 20080208325, August 28, 2008.
81) Zhong; Sheng-Ping, Helmus; Michael N, Smith; Scott R., Hammer; Bruce E. 7,483,732 Magnetic resonance imaging of a medical device and proximate body tissue January 27, 2009.
82) Helmus; Michael N.; Xu; Yixin; Tenney; Barron W.; Valint; Paul L.; Ranade; Shrirang V.; Helmus; Michael N. ; MEDICAL DEVICES WITH TRIGGERABLE BIOADHESIVE MATERIAL United States Patent Application 20090098176, A pril 16, 2009
83) Weber; Jan; Kocur; Gordon; Helmus; Michael; Palasis; Maria; 7,601,382 Method of making a coated medical device United States Patent October 13, 2009
84) Helmus; Michael N., Valint; Paul, Ranade; Shrirang V. United States Patent 7,625,552
Bioactive polymers for imparting bioactive character to hydrophobic medical article surfaces
December 1, 2009.
85) Tenney; Barron, Helmus; Michael N. , Xu; Yixin United States Patent 7,666,179 Medical devices having porous regions for controlled therapeutic agent exposure or delivery February 23, 2010
86) Helmus; Michael N., Richard; Robert, Dixon; Melissa United States Patent 7,709,439 Biomaterials for enhanced healing May 4, 2010.
87) Ranade; Shrirang V., Helmus; Michael N., 7,767,220 Implantable or insertable medical articles having covalently modified, biocompatible surfaces August 3, 2010.
88) Tenney; Barron; Xu; Yixin; Helmus; Michael N. Medical Devices Having Nanoporous Coatings for Controlled Therapeutic Agent Delivery 20100233238 September 16, 2010
89) Helmus; Michael N., Medical Devices Having Vapor Deposited Nanoporous Coatings For Controlled Therapeutic Agent Delivery 20100280612 November 4, 2010
90) Ranade; Shrirang V. Helmus; Michael N., Richard; Robert E. Drug release regions for medical devices, which include polycyclic-structure-containing polymers 8,067,026 November 29, 2011
91) Helmus; Michael N., Xu; Yixin, Tenney; Barron W., Valint; Paul L., Ranade; Shrirang V. Medical devices with triggerable bioadhesive material 8,221,783 July 17, 2012
92) Carpentier; A, Carpentier; S Cunanan; C Quintero; L Helmus; Loshbaugh; C Sarner; HC Treating biological tissues to mitigate post-implantation calcification 8,236,241 Aug. 7, 2012
93) Richard; RE, , Strickler; FH, Schwarz; M C, Faust; R, Ranade; SV, Helmus; MN. Medical devices having porous polymeric regions for controlled drug delivery and regulated biocompatibility 8,535,702 September 17, 2013
94) Kantrowitz; Allen B.; Helmus; Michael N.; Bone Anchor, United States Patent Application 20130261676
October 3, 2013
95) Tenney; B, Xu; Y Helmus; MN Medical devices having nanoporous coatings for controlled therapeutic agent delivery 8,574,615 November 5, 2013
96) Zhong; Sheng-Ping, Helmus; Michael N., Ungs; Mark T., Lafontaine; Daniel M. Puncture hole sealing device 8,709,038, Apr. 29, 2014.
97) Kantrowitz; Allen B., Helmus; Michael N. Bone anchor 8,877,499 November 4, 2014

Books and Reports:

Final Report for the Triennial Review of the National Nanotechnology Initiative, Phase II. Washington, DC: The National Academies Press, 2013, C. Handwerker and M. Helmus co-chairs: http://www.nap.edu/catalog.php?record_id=18271

Interim Report for the Triennial Review of the National Nanotechnology Initiative, Phase II. Washington, DC: The National Academies Press, 2012, C. Handwerker and M. Helmus co-chairs

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

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

M.N. Helmus, "Opportunities for Biomaterials," Decision Resource Report, Feb. 1995, pp.1-113.

M. N. Helmus, "Outlook for Biomedical Materials," Decision Resources Report, Decision Resources, Dec. 1990, pp. 1-201.


Book and Encyclopedia Chapters:

M. N. Helmus and Crystal M. Cunanan, “Mechanical and Bioprosthetic Heart Valves”, in Biomaterials for Artificial Organs, T. Webster and M. Lysaght eds, Woodhead Publishing, pp. 113-157, 2011

R. W. Snyder and M. N. Helmus, “Cardiovascular Biomaterials”, in Biomedical Engineering and Design, 2nd ed, ed. Myer Kutz, McGraw Hill, 2009, Chapter 16.

Michael Helmus, Peter Gammel, Fred Allen and Magnus Gittins, “Commercializing Bionanotechnology: From the Academic Lab to Products," in Bionanotechnology: Global Prospects, ed. D. Reisner, CRC Press, 2009, pp 71-78.

R. W. Snyder and M. N. Helmus, “Cardiovascular Biomaterials," in Standard Handbook of Biomedical Engineering & Design, e. Myer Kutz, McGraw Hill, 2003, pp.14.1-14.11.

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," M. N. Helmus, ed. Kluwer Academic/Plenum Publishers and Landes Bioscience, NY, NY and Georgetown, TX, 2003.

M.N. Helmus, Failure Analysis: Learning for the Future from the Past, "Biomaterials in the design and reliability of medical devices," M. N. Helmus, ed. Kluwer Academic/Plenum Publishers and Landes Bioscience, NY, NY and Georgetown, TX, 2003.

M. N. Helmus, A. Verheyden, “Medical Device Infections," in Disinfection, Sterilization, and Preservation, 5th ed., Seymour Block, ed., 2001, pp. 957-966.

M. N. Helmus, K. Tweden, "Materials Selection for Medical Devices," Encyclopedic Handbook of Biomaterials, Donald Wise, et al, eds., Marcel Dekker, Inc., NY, Chapter 2, 1995.

M. N. Helmus, "The Outlook for Environmentally Degradable Plastics," in Degradable Materials: Perspectives, Issues and Opportunities," eds. S. A. Barenberg, J. L. Brash, R. Narayan, and A. E. Redpath, C. R. C. Press, Boca Raton, 1990, pp. 619-640.

M. N. Helmus, E. A. Botan, J. M. Malone, K. M. Botzko, R. L. Reinert, R. Bevans-Lynch, K. Brendel, R. C. Duhamel, R. W. Snyder,"Sterility and Pyrogenicity Issues of Synthetic Vascular Grafts," ASTM Symposium on Vascular Graft Update : Safety and Performance, Nov. 27-28, 1984, pp. 236-249.

R. W. Snyder, M. N. Helmus, "Vascular Prosthesis" in Encyclopedia for Medical Devices and Instrumentation, ed. J. Webster, John Wiley, N.Y., 1988. pp. 2839-2847.

M. N. Helmus, O. P. Malhotra, D. F. Gibbons, "Plasma Interaction on Block Copolymers as Determined by Platelet Adhesion," in Adv. Chem. Series, No. 199, eds. S. L. Cooper, N. A. Peppas, ACS, Washington, 1982, pp. 81-93.