dermaPACE® orthoPACE® OssaTron®
SANUWAVE Health, Inc. is an emerging leader in the development and commercialization of noninvasive, biological response activating devices in the regenerative medicine area for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE's portfolio of products and product candidates activate biologic signaling and angiogenic responses, including revascularization and microcirculatory improvement, helping restore the body's normal healing processes and regeneration. SANUWAVE is applying its Pulsed Acoustic Cellular Expression (PACE®) technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions.
Headquartered in Alpharetta, GA, SANUWAVE designs, manufactures, markets, and services its industry leading products worldwide.
We have already demonstrated that this technology is safe and effective in the European community for the stimulation of bone and chronic tendonitis regeneration in the musculoskeletal environment.
Our lead development product for the global wound care market, dermaPACE, has received CE marking for use on acute and chronic defects of the skin and subcutaneous soft tissue. In the U.S. the dermaPACE has recently completed a pivotal Phase III, Investigational Device Exemption (IDE) study for the treatment of diabetic foot ulcers. The results were highly positive and clinically relevant.
Our musculoskeletal regenerative device, orthoPACE, launched in Europe for orthopedic, trauma and sports medicine indications in 2010.
We are now entirely focused on developing and commercializing this technology to stimulate tissue healing in all wound healing conditions to include DFU, decubitus ulcers (pressure sores), burns and other skin eruption conditions; orthopedic/spine applications such as fracture healing and fusion, creating improved bone density in osteoporosis and to eliminate chronic pain from trauma or arthritis; plastic/cosmetic applications such as cellulite smoothing, preconditioning for graft and transplant acceptance, skin tightening, scarring and other aesthetic uses; and potential developments in cardiac indications for removing plaque due to atherosclerosis and improving blood supply to the heart muscle.
Board of Directors
Christopher M. Cashman joined the Company as Chief Executive Officer and President in September of 2009 and as a director in October of 2009, and joined SANUWAVE, Inc. as President, Chief Executive Officer and a director in December of 2005. Mr. Cashman brings to our board of directors, among other skills and qualifications, a unique understanding of our strategies and operations through his years of experience with various public and private healthcare companies. Immediately prior to joining SANUWAVE, Inc., he served as President of Therapeutic Surfaces for Kinetic Concepts, Inc., a global leader in advanced wound care, from October of 2005 to December of 2005. In November of 2001, Mr. Cashman conducted a management buyout of Snowden Pencer, Inc., a minimally invasive surgical device manufacturer, and assumed the role of Chief Executive Officer and President until Snowden Pencer, Inc. was sold to Cardinal Health, Inc. in March 2004. Mr. Cashman also served as a business unit head with Genzyme Biosurgery and held several senior sales and marketing positions with Genzyme Surgical Products and Deknatel Snowden Pencer. Mr. Cashman graduated from the United States Naval Academy in 1989 with a B.S. in Economics and served on a fast attack submarine as Supply Officer. He received his M.B.A. in 2001 from the Kellogg Graduate School of Management at Northwestern University.
Thomas H. Robinson joined the Company as a member of the board of directors in October of 2009 and joined SANUWAVE, Inc. as a member of the board of directors in August of 2005. Mr. Robinson brings to our board of directors experience based on his diverse experience with medical device companies both in providing executive search services to them as well as working for them in leadership and Director positions. Since 2010, Mr. Robinson has been a partner with Russell Reynolds Associates, a global executive search firm, in their global Medical Technology Practice leading senior executive searches. From 1998 to 2010, Mr. Robinson served as managing partner of Spencer Stuart, Inc.'s North American medical technology practice. From 1993 to 1997, Mr. Robinson served as President of the emerging markets business at Boston Scientific Corporation, a global medical devices manufacturer. From 1991 to 1993, Mr. Robinson served as President and Chief Operating Officer of Brunswick Biomedical, a cardiology medical device company. Mr. Robinson is also a member of the board of directors and is chairman of the compensation committee of Cynosure, Inc., a publicly traded aesthetic medical laser company.
Kevin A. Richardson, II joined the Company as chairman of the board of directors in October of 2009 and joined SANUWAVE, Inc. as chairman of the board of directors in August of 2005. Mr. Richardson brings to our board of directors a broad array of financial knowledge for healthcare and other industries. Since 2004, Mr. Richardson has served as managing partner of Prides Capital LLC, an investment management firm. Mr. Richardson is also a member of the board of directors of eDiets.com, Inc., a publicly traded weight loss solutions company, and Pegasus Solutions, Inc., a travel technology company.
John F. Nemelka joined the Company as a member of the board of directors in October of 2009 and joined SANUWAVE, Inc. as a member of the board of directors in August of 2005. Mr. Nemelka brings to our board of directors a diverse financial and operational experience. Since 2001, Mr. Nemelka has served as a managing principal of NightWatch Capital Advisors, LLC, an investment management firm. Mr. Nemelka is also interim Chief Executive Officer and a member of the board of directors of SWK Holdings Corporation, a publicly traded holding company, formerly named KANA Software, Inc., a provider of customer service software solutions.
Ronald M. Sparks, Jr. joined the Company as a member of the board of directors in September of 2011. Mr. Sparks brings extensive experience in the medical device industry, specifically in wound care and orthopedics. Mr. Sparks is the Chief Executive Officer and Chairman at Navilyst Medical, Inc., a best-in-class image-guided medical solutions company. He is also an Industry Executive at Avista Capital Holdings, L.P., a leading private equity firm. Previously, Mr. Sparks served as President, Chief Executive Officer and Executive Director for Accellent Inc., the largest provider of integrated contract manufacturing and design services to the medical device industry. In November 2005, Mr. Sparks led the sale of Accellent to the private equity firm Kohlberg Kravis Roberts & Co. in a transaction valued at approximately $1.3 billion. Prior to Accellent, Mr. Sparks had a 20-year career at Smith & Nephew, plc, where he was a Member of the Group Executive Committee and served as President of the Endoscopy Division from 1998 to 2003. Mr. Sparks served as the President of the Wound Management Division from 1995 to 1998. While at Smith & Nephew, Ron was integrally involved in the successful launch of Dermagraft®, a cell based therapy used to treat diabetic foot ulcers. He has served as Trustee of the Arthroscopy Association of North America (AANA) Education Foundation since 2006, is an Honorary Fellow of the American Sports Medicine Institute (ASMI) and is an honorary member of the International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine (ISAKOS). Mr. Sparks graduated from the University of Massachusetts at Amherst with a BA in Finance and Accounting, and completed the INSEAD Advanced Management Program in Fontainebleau, France.
Barbara M. Henagan joined the Company as a member of the board of directors in September of 2011. Ms. Henagan has more than 30 years of direct private equity investing experience. She is a founding member of Linx Partners, a private equity investment firm that partners with family owners, entrepreneurs and management to acquire and grow middle-market industrial companies. Previously, she was Senior Managing Director of Bradford Ventures, Ltd. Ms. Henagan is Chairman of the Board of Metaltech Service Center, Inc. and is a member of the Board of Trustees of the Atlanta Speech School and the Atlanta Botanical Garden, where she previously served as Chairman. She is on the Board of Councilors of The Carter Center and is a member of the Goizueta Business School Advisory Board of Emory University. Ms. Henagan holds an MBA from Columbia University and a BA from Princeton University.
Christopher M. Cashman, CEO
Christopher M. Cashman joined SANUWAVE Health, an emerging leader in regenerative medicine, as Director, President and Chief Executive Officer in December, 2005. Immediately prior, he served as President of Therapeutic Surfaces for Kinetic Concepts, Inc, a global leader in advanced wound care. He conducted a management buyout in November 2001 of Snowden Pencer, a minimally invasive surgical device manufacturer, and assumed the role of CEO and President. In March 2004, Snowden Pencer was sold to Cardinal Health. Mr. Cashman has also served as a business unit head with Genzyme Biosurgery and held several senior sales and marketing positions with Genzyme Surgical Products and Deknatel Snowden Pencer. Mr. Cashman graduated from the United States Naval Academy in 1989 with a B.S. degree in Economics and served on a fast attack submarine as Supply Officer. He received his M.B.A. degree in 2001 from The Kellogg Graduate School of Management at Northwestern University.
Barry Jenkins, CFO
Barry Jenkins joined SANUWAVE as Chief Financial Officer in April 2006. His previous position was with Automatic Data Processing (ADP), where he served as Chief Financial Officer for the Benefits Services Division. Mr. Jenkins began his career with Price Waterhouse and progressed to a Senior Manager. He was the Vice President of Finance at AHL Services, a public company which grew to over $900 million during his tenure. As the Chief Financial Officer at Snowden Pencer, Mr. Jenkins helped grow the corporation prior to the company being sold to Cardinal Health in March, 2004. He is a Certified Public Accountant with 25 years of financial management experience and is a Cum Laude graduate of Virginia Tech.
Peter Stegagno, VP of Operations
Peter Stegagno joined SANUWAVE as Vice President, Operations in March 2006. Mr. Stegagno brings to SANUWAVE 16 years experience in the medical device market encompassing manufacturing, design & development, quality assurance and international & domestic regulatory affairs. He has been instrumental in the development and deployment of international operational processes for leading medical device companies. He most recently served as Vice President of Quality and Regulatory Affairs for Elekta, and other medical device companies including Genzyme Biosurgery. Before focusing on the medical field, he enjoyed a successful career encompassing production roles in the space industry, including avionics guidance systems for military applications and control computers for the space shuttle. Mr. Stegagno graduated from Tufts University with a B.S. degree in Chemical Engineering.
Iulian Cioanta, PhD, VP of Research & Development
Iulian Cioanta joined SANUWAVE in June 2007 as Vice President of Research and Development. Prior to joining SANUWAVE, Dr. Cioanta served as Business Unit Manager with Cordis Endovascular, a Johnson & Johnson company, Director of Development Engineering with Kensey Nash Corporation, Research Manager at ArgoMed Inc. and Project Manager and Scientist with the Institute for the Design of Research Apparatuses. During his career, Dr. Cioanta worked 12 years in the medical device industry and eight years in academia at Polytechnic University of Bucharest in Romania, Leicester University in U.K. and Duke University in the United States. He received a M.S. degree in Mechanical Engineering and Technology from the Polytechnic University of Bucharest, and he earned his PhD degree in Biomedical Engineering from Duke University in the field of extracorporeal shock wave lithotripsy. Dr. Cioanta is an acknowledged scientist who has published in the field of acoustic and bioengineering, and he is an author of 15 issued patents and 8 pending patents.
Bernie Laurel, VP of Sales & Marketing
Bernie Laurel joined SANUWAVE as Vice President of Sales and Marketing in November 2009 with more than fifteen years experience in sales and marketing, including expertise in the advanced wound care market. Prior to joining SANUWAVE, he was Vice President of Sales and Marketing for Medela, Inc.'s newly-formed Healthcare America's business unit, where he drove overall planning, marketing strategy, new product development, distribution, direct and indirect sales, and other business development initiatives. Bernie was also Vice President of Marketing for Imagyn Medical Technologies, a newly public urologic device manufacturer, and he held sales, marketing and consulting roles in several privately-funded device start-ups.
Anne Stefurak, VP of Medical Policy & Reimbursement
Anne Stefurak re-joined SANUWAVE in November 2009 as Vice President of Medical Policy and Reimbursement with more than twenty years in the medical field working with local, regional and national insurance companies, medical device companies, technology assessment organizations, advocacy groups, academic centers, various physician offices, and radiation oncology centers. Anne brings experience with payer reimbursement, invasive as well as non-invasive medical device technology, sales and marketing, coverage policy, appeals, contracting and FDA compliance. Before rejoining SANUWAVE, Anne worked as Director of National Policy and Reimbursement at Physician Oncology Services. Anne also brings expertise as a Regional Access Manager and Senior Regional Reimbursement Manager at Cyberonics, National Provider Relations Manager at National Healthcare Network, and Manager of Provider Relations at Aetna U.S. Healthcare.
Market Value....$31,361,304 a/o December 8, 2011
Shares Outstanding...20,907,536 a/o November 14, 2011
Shareholders of Record...75 a/o March 28, 2011
U.S. Reporting SEC Filer
SIC: 3841 - Surgical & Medical Instruments
Incorporated in Nevada, 2004
Formerly: Rub Music Enterprises, INC until 11/2009
Transfer Agent: Action Stock Transfer Corporation
2649 E. Fort Union Blvd. Suite 214
Salt Lake City, UT 840421
Auditor/Accountant: BDO USA, LLP
755 West Big Beaver Suite 1900
Troy, MI 48084
Presentations & Press Releases
Rodman & Renshaw Global Investment Conference 9/12-9/13/2011
Conference Call 7/12/2011
SANUWAVE dermaPACE Technology Shown Superior to Hyperbaric Oxygen Therapy in Increasing Angiogenic and Tissue Regenerative Molecular Changes in Diabetic Foot Ulcers
SANUWAVE Appoints Private Equity Veteran Barbara M. Henagan to Board of Directors
dermaPACE Pivotal Phase III Clinical Trial Data in Diabetic Foot Ulcer Healing to be Presented at Plastic Surgery 2011
SANUWAVE Appoints Medical Technology Veteran Ron Sparks to Board of Directors
SANUWAVE to Present at the Rodman & Renshaw 13th Annual Global Investment Conference
SANUWAVE Health Granted U.S. Patent on Use of Acoustic Shock Waves to Treat Orthopedic Conditions
SANUWAVE Health Reports Second Quarter Financial Results and Provides Business Update
Positive Data Demonstrating dermaPACE® Safely Heals Diabetic Foot Ulcers to be Highlighted in CME Presentation at The American Podiatric Medical Association Meeting
SANUWAVE Announces American Medical Association Approval of CPT Category III Codes for Extracorporeal Shock Wave Technology in Wound Healing
SANUWAVE Announces Positive 24-week Data From its Pivotal Trial Investigating the Use of dermaPACE for the Treatment of Diabetic Foot Ulcers
SANUWAVE Health Submits Final Module of PMA Application for FDA Approval of dermaPACE® To Treat Diabetic Foot Ulcers
PACE® Technology Research Conducted at Cleveland Clinic Presented at the 2011 World Congress of Microsurgery
SANUWAVE in the News: The Gray Sheet® Interviews Christopher M. Cashman, President and CEO of SANUWAVE
U.S. Patent and Trademark Office Upholds Patentability Following an Ex Parte Reexamination Request
SANUWAVE Extracorporeal Shock Wave Technology Shown to Prevent and Repair Osteoarthritis Damage in Preclinical Model
SANUWAVE Health Reports First Quarter Financial Results
dermaPACE® Pivotal Phase III Clinical Trial Results for Diabetic Foot Ulcer Treatment to be Presented at the Symposium on Advanced Wound Care (SAWC) Spring 2011
SANUWAVE Health Raises $9.1 Million in Private Placement
SANUWAVE Health Reports 2010 Financial Results
Study Shows dermaPACE is More Effective than Hyperbaric Oxygen Therapy in DFU
SANUWAVE Health to Present at Roth Capital Partners 23rd Annual OC Growth Stock Conference
SANUWAVE Health Raises $4.1 Million
SANUWAVE Health Granted U.S. Patent on Use of Piezoelectric Fibers to Produce Acoustic Energy in the Shock Wave Spectrum
SANUWAVE Health Submits to FDA Second Module of PMA Application for dermaPACE for the Treatment of Diabetic Foot Ulcers
Click For Link to All SEC Filings in Edgar Database for Sanuwave Health, INC
10-K for 12/31/2009
10-Q for 3/31/2010
10-Q for 6/30/2010
10-Q for 9/30/2010
10-K for 12/31/2010
10-Q for 3/31/2011
10-Q for 6/30/2011
SANUWAVE Corporate Headquarters
11680 Great Oaks Way, Suite 350
Alpharetta, GA 30022
Barry Jenkins, CFO
Bernie Laurel, VP Sales & Marketing
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