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TISSUE REGENERATION TECHNOLOGIES, LLC EXECUTIVE SUMMARY JANUARY 1, 2014 130 Arnold Mill Park Woodstock, Georgia 30188 (877) 966-1315 [email protected]

 · Web viewTissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is an Ohio limited liability company with its principal place of business in Woodstock, Georgia

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Page 1:  · Web viewTissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is an Ohio limited liability company with its principal place of business in Woodstock, Georgia

TISSUE REGENERATION TECHNOLOGIES, LLC

EXECUTIVE SUMMARYJANUARY 1, 2014

130 Arnold Mill ParkWoodstock, Georgia 30188

(877) [email protected]

Page 2:  · Web viewTissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is an Ohio limited liability company with its principal place of business in Woodstock, Georgia

TABLE OF CONTENTS

Description of Business

Overview 1

TRT Technology 1

Product Lines 2

Intellectual Property 2

Business Stage and Objectives 3

Regulatory Trials and Strategy 3

Scientific Studies and Research 3

Business Structure 4

Management 4

History of the Shockwave Industry 6

Exhibits

Exhibit A – TRT Publications List A-1

Exhibit B – TRT Patent List B-1

Exhibit C – TRT Product Lines and Descriptions C-1

Exhibit D – TRT Financial Information D-1

Disclaimer: This Executive Summary of Tissue Regeneration Technologies, LLC is for information purposes only, and does not represent an offer or proposal of any transaction, investment or otherwise. None of the information contained herein is to be relied upon for any purpose whatsoever, and Tissue Regeneration Technologies, LLC explicitly disclaims any warranties or representations as to the accuracy or completeness of the information contained herein. Nothing herein is to be construed as binding or obligating Tissue Regeneration Technologies, LLC to perform any action whatsoever.

Page 3:  · Web viewTissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is an Ohio limited liability company with its principal place of business in Woodstock, Georgia

DESCRIPTION OF BUSINESS

Overview

Tissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is an Ohio limited liability company with its principal place of business in Woodstock, Georgia. It was founded in 2004 as Shockwave Technical Service, LLC, and amended its name to its current form in 2006. TRT is a medical technology company that develops, manufactures, and sells shockwave devices used to treat a variety of medical conditions. Originally conceived and operated as a research and development company, TRT began marketing and sales operations of certain of its products in 2008. TRT is currently engaged in business throughout the United States, and has a strong international presence through its German affiliate, MTS Europe GmbH (hereinafter referred to as “MTS”).

TRT Technology

TRT develops and manufactures its “MultiWave” devices through its German affiliate, MTS. The technology utilized in the devices can be categorized into two groups: (1) patented, unfocused “SoftWaves” for soft tissue indications (e.g., wounds), and (2) focused shockwaves for lithotripsy and bony indications (e.g., non-healing fractures).

The patented MultiWave technology uses various lens configurations to produce pressure waves. These waves have a characteristic pressure profile of short rise-times reaching high amplitudes (comparable to a sonic boom). The pressure waves can be shaped through a reflector, which enables the transmission of either highly-focused shockwaves for use on urinary stones or non-union fractures, or soft-focused pressure waves (i.e., SoftWaves) for most soft tissue indications.

TRT’s patented SoftWave technology is distinguished from competitors’ shockwave technology in that TRT uses a patented parabolic (as opposed to an ellipsoid) reflector in the therapy head, which allows delivery of unfocused waves of acoustic energy over a broad target area. TRT’s SoftWave technology generates less pain, has a higher efficacy rate, and has a lower re-treatment rate than competitors’ high-energy, focused shockwave systems. TRT is the first company to discover that “soft waves” have the same or better clinical benefit as high-energy focused shockwaves for most medical conditions. Following this discovery, TRT further developed the idea into a useful format, and secured patents protecting its inventions.

The advantages of SoftWave technology include the following benefits: (1) treatments do not require anesthesia; (2) larger surfaces, such as wounds, can be treated faster and easier than with competing shockwave devices; and (3) SoftWave devices can be manufactured to be smaller and less expensive than competing shockwave devices, alleviating the need for a costly field service organization.

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Product Lines

TRT currently has product lines developed for the treatment of five distinct areas of care:

LithoGold – Lithotripsy and urology indications OrthoGold – Orthopedic indications DermaGold – Wound care indications CardioGold – Cardiac and vascular indications VetGold – Veterinary indications UroGold – Urologic indications

Each of these devices has successfully undergone CE approval. TRT has the rights to distribute the products throughout North America, and MTS has the rights to distribute in all other locations.

TRT currently has approval to distribute two devices in the United States: the LithoGold and VetGold systems. In Canada, TRT is approved to distribute the LithoGold, DermaGold, and VetGold systems, along with specific products in its OrthoGold line.

A more detailed description of TRT’s product lines and their current respective statuses can be found in the attached Exhibit C.

Intellectual Property

TRT was the first company to recognize (and patent the inventions used to generate) the biologic response generated by unfocused SoftWave technology, including: (1) promotion of growth factors (e.g., VEGF, BPM, and OP); (2) promotion of nitric oxide; (3) improved vascularity; and (4) migration and differentiation of stem cells.

TRT owns (or has rights to), and has aggressively prosecuted and defended, approximately 35 patents or patent applications related to its products and their methods of operation and effectiveness. To date, TRT has been awarded 21 patents by the United States Patent and Trademark Office (“USPTO”).

TRT’s intellectual property rights are derived from the following sources: (1) a royalty-free, exclusive license in perpetuity from a patent holding company primarily owned by members of TRT’s Board of Managers; (2) patents and patent applications acquired directly by TRT; (3) patents and patent applications held by MTS; and (4) a patent policy and assignment agreement entered into by certain of TRT’s affiliates, globally assigning to TRT these affiliates’ know-how, show how, trade secrets, and other non-patented technology and study data.

TRT’s patents and patent applications have been assigned to General Patent, LLC (hereinafter referred to as “General Patent”), a company primarily owned by members of TRT’s Board of Managers. The purpose of this assignment to General Patent is twofold: (1) the patent

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applications include certain process and apparatus claims which are not necessary for the TRT’s business, and (2) TRT wants to maintain commonality of ownership of the patents and patent applications for ease of assignment, license, or transferability. General Patent has granted to TRT a sole exclusive, royalty-free, perpetual, and irrevocable license to use and develop all of its patents and patent applications necessary for TRT’s business. TRT believes this license provides the intellectual property necessary to preserve its technology and business in the marketplace.

A more complete description and list of the intellectual property held by, or held for the benefit of, TRT can be found in the attached Exhibit B.

Business Stage and Objectives

TRT has spent the majority of its start-up capital on research and development. Its R&D efforts at that stage focused on developing the DermaGold, LithoGold, and CardioGold devices. Following the commencement of sales operations in 2008, TRT significantly curtailed its R&D expenditures. In addition to its reduced research and development efforts, TRT currently focuses its efforts on three primary initiatives: (1) selling approved devices throughout North America, (2) securing legal protection for its products and intellectual property, and (3) obtaining regulatory approval or clearance in the United States for its DermaGold and OrthoGold lines. TRT believes this last goal represents the greatest value for its business, and is crucial to the company’s success. TRT is currently considering reorganizing its business model to create and leverage partnerships or joint ventures with field-specific experts.

Regulatory Trials and Strategy

TRT has engaged regulatory consultants and other industry experts to develop and execute a regulatory pathway for product approval. This is a comprehensive and integrated effort, taking into account clinical studies, regulatory approval, reimbursement approaches, and product development and marketing. Currently, TRT is concentrating its regulatory efforts on securing approval of its MultiWave technology for the following indications: (1) acute and chronic wounds (including burns) and ulcers, (2) tendinopathies, and (3) non-healing bone fractures. In connection with the first indication, TRT is anticipating the imminent submission of a PMA to the FDA for the approval of its OrthoGold280 device, using data accumulated from an Austrian study. With respect to the latter two, TRT is currently sponsoring an FDA trial using its DermaGold device for use on combat and civilian extremity wounds. In addition to its ongoing FDA Class III approval efforts, TRT has engaged outside regulatory counsel to identify methods for obtaining Class I or II clearance of, where appropriate, the DermaGold for wound care, increase of blood supply, pain therapy, or therapeutic massage therapy.

More specific information about the products’ respective regulatory approval processes can be found in Exhibit C.

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Scientific Studies and Research

TRT has sponsored over 50 scientific studies at hospitals and universities, including world-renowned institutions such as Sloan-Kettering, Harvard University, UPMC, UCSF, Walter Reed Army Medical Center, Georgetown University, the University of Vienna, the University of Innsbruck, and the Ludwig Boltzmann Institute. The purpose of these studies is to better understand the working mechanism of MultiWaves technology and prove the viability of the technology for numerous indications. As TRT expected, the studies have demonstrated the clinical effectiveness of SoftWaves in treating acute and chronic wounds. The studies have also shown the regenerative effect of SoftWaves on most tissue including bone, blood vessel, muscle, and nerve. A list of publications resulting from these studies can be found in the attached Exhibit A.

Business Structure

TRT is an Ohio limited liability company with its primary office in Woodstock, Georgia. Its day-to-day operation are managed by John Warlick, its Chief Executive Officer, and it is governed by a seven-member Board of Managers, further described below. In addition to the primary corporate entity, TRT is affiliated with three other entities that are important for TRT’s business.

General Patent, LLC – General Patent currently holds certain patent applications licensed to TRT on a royalty-free, exclusive basis. General Patent is primarily owned by members of TRT’s Board of Managers.

Cardiac Regeneration Technologies, LLC – CRT was formed as a majority-owned subsidiary of TRT in 2006 to raise capital specifically to study the effects of shockwave therapy on ischemic heart disease and to develop a disposable cardiac shockwave applicator. After a subsequent private offering, TRT’s interest in CRT, while still significant, was no longer controlling. TRT licenses to CRT, on an exclusive, royalty-free basis, its rights to cardiac-related intellectual property. CRT has temporarily placed its study on hold until sufficient funding is obtained to complete a Phase II trial.

MTS Europe GmbH – In 2004, TRT acquired 51% of MTS, a manufacturing company located in Konstanz, Germany, through which TRT performs certain manufacturing and technology development initiatives. MTS is currently undergoing reorganization and TRT is considering several options for the reconfiguration of its interests in MTS.

Management

Set forth below are brief biographies of TRT’s Managers and Officers:

Jouko J. Rissanen, Chairman of the Board of Managers – Mr. Rissanen is a Manager of

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TRT and the President CRT. A healthcare executive with more than 30 years’ experience, Mr. Rissanen founded seven medical companies, all of which became or were acquired by public companies. The medical companies Mr. Rissanen founded are Cardiac Systems (sold to Intermedics, Inc.), Occumedics (sold to Storz Medical), Med Fusion (sold to Medex, Inc.), Sensor Technology (sold to Eli Lilly), Quality Diagnostic Cardiac Services (sold to Matria, Inc.), and WebMD (IPO).

John Warlick, Co-Founder, Chief Executive Officer, and Manager – Mr. Warlick co-founded TRT is an Initial Member, Manager and Chief Executive Officer of TRT. Mr. Warlick has been employed in the shockwave industry since 1985 and was the founder of the first publicly-traded company in the field. In 1996, he founded OssaTronics, the predecessor to HealthTronics, a publicly-traded healthcare company (Nasdaq:HTRN). From 1996 until mid-2000, Mr. Warlick held various positions as the Vice President of HealthTronics and the President of both HealthTronics and OssaTronics. From 1991 until 1996, he was the Vice President of Sales and later the President and a Director of Servicetrends, Inc., the nation’s first third-party lithotripter service company. From 1989 to 1991, he was the Vice President of Sales for Energy Four, a medical consumables company. From 1985 to 1988 he was the sales operations manager of Dornier Medical Systems. Prior to this Mr. Warlick was employed by Lockheed. Mr. Warlick earned a B.S. in Financial Management from Clemson University.

Mark Gronowski, Co-Founder and Manager – Mr. Gronowski co-founded TRT and is an Initial Member and Manager of our company. He is also a co-founder and partial owner of Lincoln Land Lithotripsy, Inc., Ohio Mobile Lithotripsy, LLC, Mobile One Lithotripsy, LLC, and Premier Mobile Lithotripsy, LLC, which operate in the lithotripsy industry, and American Shockwave Therapies, LLC, a company operating in the orthopedic industry. In 1997, Mr. Gronowski was a distributor for HealthTronics Surgical Services, Inc., selling and servicing medical shockwave devices. From 1991 to 1996, he was Senior Account Manager for Dornier Medical Systems. Prior to 1991, he was a sales representative for several companies, selling various products including cardiac monitors. Mr. Gronowski earned a B.S. from Eastern Illinois University.

Michael Rozmajzl, Manager – Mr. Rozmajzl is a Manager of TRT. He was the company’s General Counsel and CFO from 2004 until 2012. He currently serves as General Counsel for both Amendia, Inc., a spinal implant company, and Vivex Biomedical, Inc., a biologics company. Mr. Rozmajzl formerly practiced as an attorney at Kohrman, Jackson, & Krantz, PLL, concentrating on business, securities, and tax law. From 1993 through 1998, he was employed by PricewaterhouseCoopers where he worked in the audit and international financial service practice groups. Mr. Rozmajzl obtained his bachelors degree in accounting from Miami University and his law degree from Case Western Reserve University.

Joachim (John) Voss, Manager – Mr. Voss is a Manager of TRT. Educated as an electronics engineer, Mr. Voss has more than 20 years’ experience in the aerospace and medical industries, in positions ranging from R&D to sales to general management. In 1989, he was co-founder of HMT, the first company to introduce shockwave

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technology into the orthopedic market. In order to bring this technology to the U.S. market, Mr. Voss co-founded OssaTronics (predecessor to HealthTronics) with John Warlick in 1996 and held a position on the board for many years. After a successful IPO of HealthTronics, Mr. Voss semi-retired, withdrawing from day-to-day business activities although he stays abreast of developments in the field of shockwave technology.

History of the Shockwave Industry

The roots of the modern shockwave industry go back many years, to the days when forward-looking clinicians, investors, and researchers first suspected that alternative uses for shockwaves existed outside of urology. The first such new indication concerned delayed and non-union fractures, a malady that affects two to three percent of all fracture patients, at great expense to the healthcare system. The TRT team’s first interest in non-urologic shockwaves first developed in the late 1990s at an orthopedic meeting in New Orleans. The team learned there that a publicly-held company obtained FDA approval to market a new and improved electromagnetic stimulator for non-union fractures. It was that company’s only device and they competed with much larger entities for this relatively small market; yet at that time, the market capitalization for that single-product start-up company exceeded $300 million. TRT’s innovators knew their new shockwave technology offered numerous clinical and financial advantages over those stimulators, which had to be worn over a period of months, for hours at a time, with arguable clinical results.

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TRT Executive SummaryExhibit A – TRT Publications List

EXHIBIT ATRT PUBLICATIONS LIST

[1] W. Bauermeister, “Diagnose und Therapie des myofaszialen Triggerpunkt Syndroms durch Lokalisierung und Stimulation sensibilisierter Nozizeptoren mit fokussierten elektrohydraulischen Stosswellen,” MOT, no. 5, pp. 65–74, 2005.

[2] W. Schaden, R. Thiele, C. Kölpl, and A. Pusch, “Extrakorporale Stosswellentherapie (ESWT bei Hautläsionen,” Medizinisch-Orthopädische Technik MOT, no. 5, pp. 1–3, 2005.

[3] L. TRT, “DermaGold Case Studies,” Case Report, TRT LLC, 2007.

[4] O. van der Jagt, W. Schaden, H. T. van Schie, T. Piscaer, J. Waarsing, J. Verhaar, H. Weinans, and J. van der Linden, “Unfocused extracorporeal shockwave therapy diminishes bone loss in rats,” 2007.

[5] S. Edelmann, B. F. Fink, R. E. Fergueson, S. Kirakodu, K. Novak, J. Novak, W. Balke, and H. C. Vasconez, “A study of the biological factors and wound healing of a skin flap model treated with unfocused extracorporeal shockwave therapy,” 2007.

[6] W. Schaden, R. Thiele, C. Kolpl, M. Pusch, A. Nissan, C. E. Attinger, M. E. Maniscalco-Theberge, G. E. Peoples, E. A. Elster, and A. Stojadinovic, “Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study,” J Surg Res, vol. 143, no. 1, pp. 1–12, 2007.

[7] C. Wang, Y. Kuo, R. Wu, R. Liu, C. Hsu, F. Wang, and K. Yang, “Extracorporeal shockwave treatment for chronic diabetic foot ulcers,” J Surg Res, vol. 152, pp. 96–103, 3 2008.

[8] R. Saggini, A. Figus, A. Troccola, V. Cocco, A. Saggini, and N. Scuderi, “Extracorporeal shock wave therapy for management of chronic ulcers in the lower extremities,” Ultrasound Med Biol, vol. 34, pp. 1261–1271, August 2008.

[9] A. Stojadinovic, E. A. Elster, K. Anam, D. Tadaki, M. Amare, S. Zins, and T. A. Davis, “Angiogenic response to extracorporeal shock wave treatment in murine skin isografts,” Angiogenesis, vol. 11, no. 4, pp. 369–380, 2008.

[10] S. Sathishkumar, A. Meka, D. Dawson, N. House, W. Schaden, M. J. Novak, J. L. Ebersole, and L. Kesavalu, “Extracorporeal shock wave therapy induces alveolar bone regeneration,” J Dent Res, vol. 87, no. 7, pp. 687–691, 2008.

[11] A. Stojadinovic, J. Carlson, G. Schultz, T. Davis, and E. Elster, “Topical advances in wound care.,” Gynecol Oncol, 2008 Sep 13.

[12] J. Dumfarth, D. Zimpfer, M. Vogele-Kadletz, J. Holfeld, F. Sihorsch, W. Schaden, M. Czerny, S. Aharinejad, E. Wolner, and M. Grimm, “Prophylactic low-energy shock wave therapy improves wound healing after vein harvesting for coronary artery bypass graft surgery: A prospective, randomized trial,” Ann Thorac Surg, vol. 86, pp. 1909–1913, December 2008.

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TRT Executive SummaryExhibit A – TRT Publications List

[13] T. A. Davis, A. Stojadinovic, K. Anam, M. Amare, S. Naik, G. E. Peoples, D. Tadaki, and E. A. Elster, “Extracorporeal shock wave therapy suppresses the early proinflammatory immune response to a severe cutaneous burn injury,” International Wound Journal, vol. 6, pp. 11–21, 1 2009.

[14] S. Helm, “Die Wundheilung – eine neue Indikation für die Stosswelle?” Diplomarbeit, Ludwig Boltzmann Institut für experimentelle und klinische Traumatologie Austrian Cluster for Tissue Regeneration, 2 2009.

[15] D. O. Mayer, C. Dorfmüller and M. Lachat, “Eine neue Methode zur Stimulation der Heilung komplexer Wunden: die Stosswellentherapie,” Zeitschrift für Wundheilung, pp. 232–237, 3 2009.

[16] E. Elster, A. Stojadinovic, J. Forsberg, S. Shawen, C. Andersen, and W. Schaden, “Extracorporeal shock wave therapy for nonunion of the tibia,” 4 2009.

[17] D. Zimpfer, S. Aharinejad, J. Holfeld, A. Thomas, J. Dumfarth, R. Rosenhek, M. Czerny, W. Schaden, M. Gmeiner, E. Wolner, and M. Grimm, “Direct epicardial shock wave therapy improves ventricular function and induces angiogenesis in ischemic heart failure,” J Thorac Cardiovasc Surg, vol. 137, pp. 963–970, Apr 2009.

[18] Y.-R. Kuo, C.-T. Wang, F.-S. Wang, Y.-C. Chiang, and C.-J. Wang, “Extracorporeal shock-wave ther- apy enhanced wound healing via increasing topical blood perfusion and tissue regeneration in a rat model of stz-induced diabetes,” Wound Repair Regen, vol. 17, pp. 522–30, 7 2009.

[19] O. van der Jagt, J. van der Linden, W. Schaden, H. van Schie, T. Piscaer, J. Verhaar, H. Weinans, and J. Waarsing, “Unfocused extracorporeal shock wave therapy as potential treatment for osteoporosis,” J Orthop Res, pp. 1528–1533, November 2009.

[20] R. Mittermayr, J. Hartinger, C. Dorfmü̈ller, H. Redl, W. Schaden, and H. Kaufman, “La thérapie par ondes de choc extracorporelle (eswt) dans la cicatrisation des plaies: technologie, mécanismes, et efficacité clinique,” JOURNAL DES PLAIES ET CICATRISATIONS, pp. 6–16, 12 2009.

[21] E. A. Elster, A. Stojadinovic, J. Forsberg, S. Shawen, R. C. Andersen, and W. Schaden, “Extracorporeal shock wave therapy for nonunion of the tibia,” J Orthop Trauma, vol. 24, pp. 133–41, Mar 2010.

[22] A. M. Larking, S. Duport, M. Clinton, M. Hardy, and K. Andrews, “Randomized control of extra- corporeal shock wave therapy versus placebo for chronic decubitus ulceration,” Clin Rehabil, vol. 24, pp. 222–9, Mar 2010.

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TRT Executive SummaryExhibit A – TRT Publications List

[23] J. P. Furia, P. J. Juliano, A. M. Wade, W. Schaden, and R. Mittermayr, “Shock wave therapy compared with intramedullary screw fixation for nonunion of proximal fifth metatarsal metaphyseal-diaphyseal fractures,” J Bone Joint Surg Am, vol. 92, pp. 846–54, Apr 2010.

[24] I. Zwetzich, O. Dorfmann, S. Langer, H. Steinau, C. Dorfmü̈ller, C. Ottomann, and A. Ring, “Vorstel- lung eines neuartigen in vivo Wundmodells zur Analyse der Wirkung extrakorporaler Stosswellen auf Mikrozirkulation und Angiogenese.” Poster, 41. Jahrestagung der der Deutschen Gesellschaft der Plas- tischen, Rekonstruktiven und Ästhetischen Chirurgie e.V., Dresden, 9 2010.

[25] C. Ottoman, B. Hartmann, W. Schaden, A. Stojadinovic, and P. Lavin, “Prospective randomized trial of accelerated re-epithelialization of skin graft donor sites using extracorporeal shock wave therapy,” J Am Coll Surg, vol. 211, pp. 568–9, Oct 2010.

[26] A. Stojadinovic, B. Kyle Potter, J. Eberhardt, S. B. Shawen, R. C. Andersen, J. A. Forsberg, C. Shwery, E. A. Ester, and W. Schaden, “Development of a prognostic naive bayesian classifier for successful treatment of nonunions,” J Bone Joint Surg Am, vol. 93, pp. 187–94, Jan 2011.

[27] C. Ottomann, A. Stojadinovic, P. Lavin, F. Gennon, M. Heggeness, R. Thiele, W. Schaden, and B. Hart- mann, “Prospective randomized phase ii trial of accelerated re-epithelialization of superficial 2nd degree (iia◦) burn wounds using extracorporeal shock wave therapy,” 1 2011.

[28] O. P. van der Jagt, T. M. Piscaer, W. Schaden, J. Li, N. Kops, H. Jahr, J. C. van der Linden, J. H. Waarsing, J. A. N. Verhaar, M. de Jong, and H. Weinans, “Unfocused extracorporeal shock waves induce anabolic effects in rat bone,” J Bone Joint Surg Am, vol. 93, pp. 38–48, Jan 2011.

[29] R. Mittermayr, J. Hartinger, V. Antonic, A. Meinl, S. Pfeifer, A. Stojadinovic, W. Schaden, and H. Redl, “Extracorporeal shock wave therapy (eswt) minimizes ischemic tissue necrosis irrespective of application time and promotes tissue revascularization by stimulating angiogenesis,” Ann Surg, Mar 2011.

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TRT Executive SummaryExhibit B – TRT Patent List

EXHIBIT BTRT PATENT LIST

U.S. Patents – 217470240DN0079

Pressure pulse/shock wave therapy methods and an apparatus for conducting the therapeutic methods

7841995DN0079DIV1

Pressure pulse/shock wave therapy methods and an apparatus for conducting the therapeutic methods

7905845DN0079DIV2

Pressure pulse/shock wave therapy methods and an apparatus for conducting the therapeutic methods

7883482DN0079DIV3

Pressure pulse/shock wave therapy methods and an apparatus for conducting the therapeutic methods

7507213DN0090 Pressure pulse/shock wave therapy methods for organs

7537572DN0091 Treatment or pre-treatment for radiation/chemical exposure

7601127DN0092

Therapeutic stimulation of genital tissue or reproductive organ of an infertility or impotence diagnosed patient

7497834DN0093 Germicidal method for eradicating or preventing the formation of biofilms

7497835DN0094 Method of treatment for and prevention of periodontal disease

7544171DN0095 Methods for promoting nerve regeneration and neuronal growth and elongation

7600343DN0096 Method of stimulating plant growth

7578796DN0097 Method of shockwave treating fish and shellfish

7497836DN0099 Germicidal method for treating or preventing sinusitis

8162859DN0100 Shock Wave Treatment Device and Method of Use

7594930DN0105 Method of attaching soft tissue to bone

7988648DN0112 Pancreas Regeneration Treatment For Diabetics Using Extracorporeal Acoustic Shock Waves

8257282DN012

Pressure Pulse/Shock Wave Apparatus for Generating Waves Having Plane, Nearly Plane, Convergent Off Target or Divergent Characteristics

7390308SWS001 Apparatus and process for optimized electro-hydraulic pressure pulse generation

6217531MTS Adjustable electrode and related method

7695443D31458US Device for generating shock waves

7775995D31464US The Use of a Thyristor for Electric Switching During the Generation of Shock Waves

U.S. Publications – 82007/0239082DN0108 Shock Wave Treatment Device

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TRT Executive SummaryExhibit B – TRT Patent List

2008/0191596DN0113 An Improved Device For Producing Electrical Discharges in an Aqueous Medium

2008/0269651DN0116 Wound Care Bandaging In Combination With Acoustic Shock Wave Applications

2009/0041864DN0120 Apparatus and Method for Cellular Extract Enhancement

2009/0088670DN0122 Shock Wave Coupling Adapter and Method of Use

2009/0093739DN0133 Apparatus for Generating Electrical Discharge

2011/0177576DN0139 Shock Wave Cell Treatment Device And Method To Enhance Cell Replication

2008/018311115928-19 Device And Method For Generating Shock Waves

EPO – 2EP1981463DN0100 Shock Wave Treatment Device And Method Of Use

EP1981412DN0108 Improved Shock Wave Treatment Device

PCT – 2WO 2007/098300DN0100 Shock Wave Treatment Device And Method Of Use

WO 2007/087470DN0108 Improved Shock Wave Treatment Device

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TRT Executive SummaryExhibit C – TRT Product Lines and Descriptions

Orthopedics

Overview: The OrthoGold device can be used to treat plantar fasciitis, tendonitis, hip bursitis, avascular necrosis, osteoarthritis, delayed- or non-union extremity fractures, osteomyelitis, and osteoporosis. It is approved in the European Union, China, most of South America, and Canada for treating orthopedic conditions.

Ownership: Patents for underlying technology are owned by General Patent, LLC with an exclusive, royalty-free, perpetual license granted to Tissue Regeneration Technologies, LLC. 1, 2

Market Potential: $ 4 billion3

Funds Needed & Use of Proceeds:

Amount: Use:

$50,000 Regulatory approval process(OrthoGold 280)

Roadmap to Profitability: The OrthoGold 280 has completed clinical trials, and the Premarket Approval (PMA) Application has been drafted and is ready to submit to the FDA. The current standard of care for OrthoGold-targeted indications is the EXOGEN Ultrasound Bone Healing System, which provides significantly poorer results. Once the PMA Application has been submitted, there is typically a 12-month waiting period for Class III device approval. The OrthoGold 100 would require $1.5-2mm to begin the clinical trial process and allow TRT to prosecute the FDA application through approval.

Sources:1. General Patent, LLC Index of Patents2. August 2005 GP-TRT Patent License Agreement3. July 7, 2013 SANUWAVE Health, Inc. Form 8-K, Exhibit 99.1, p. 8

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TRT Executive SummaryExhibit C – TRT Product Lines and Descriptions

Urology

Overview: The LithoGold can be used to treat kidney and urethral stones, prostatitis, benign prostatic hyperplasia, incontinence, and erectile dysfunction. It is currently approved for use in the United States for treating kidney and urethral stones, and it is approved in the European Union, China, most of South America, and Canada for treating other urological conditions.

Ownership: Patents for underlying technology are owned by General Patent, LLC. 1

Market Potential: $10 billion2

Funds Needed & Use of Proceeds:

Amount: Use:

$50,000 Complete testing and approval process

Roadmap to Profitability: Basic research has been started in San Francisco, Chicago, and New York. TRT is currently in negotiations with the FDA to determine whether the LithoGold will be classified as a Class II or Class III device, which will have a significant impact on its clinical trial and approval process. If the device is approved as Class II, the complete testing and approval process may cost as little $50,000. The Class III testing and approval process will only be entered into if TRT secures a strategic partner to contribute the majority of the funds needed for the process. TRT is currently in negotiations with three of the largest providers of urological devices to license and sell TRT products to or through these companies, and many potential strategic alliances exist.

Sources:1. General Patent, LLC Index of Patents2. Internal estimate.

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TRT Executive SummaryExhibit C – TRT Product Lines and Descriptions

Wound Care

Overview: The DermaGold can be used to treat skin lesions, including diabetic and decubitus ulcers, post-operative wound healing defects, post-traumatic wounds, deep partial thickness burns, and arterial ulcers. It is approved in the European Union, Canada, and most of South America for treating dermatological conditions.

Ownership: Patents for underlying technology are owned by General Patent, LLC with an exclusive, royalty-free, perpetual license granted to Tissue Regeneration Technologies, LLC. 1, 2

Market Potential: $5 billion 3

Funds Needed & Use of Proceeds: There are currently no capital requirements to further develop this product line.

Roadmap to Profitability: The DermaGold has recently been resubmitted as a class 2 medical device. A new 510k will be submitted to the FDA in the next couple of months. Many potential strategic partners, particularly SANUWAVE Health, Inc., exist.

Sources:1. General Patent, LLC Index of Patents2. August 2005 GP-TRT Patent License Agreement3. July 7, 2013 SANUWAVE Health, Inc. Form 8-K, Exhibit 99.1, p. 8

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TRT Executive SummaryExhibit C – TRT Product Lines and Descriptions

Cardiology

Overview: The CardioGold can be used to treat ischemic heart disease, calcified valves and promote nerve and blood vessel regeneration.

Ownership: Patents for underlying technology are owned by General Patent, LLC with an exclusive, royalty-free, perpetual license granted to Tissue Regeneration Technologies, LLC. Tissue Regeneration Technologies, LLC has sublicensed its interest to Cardiac Regeneration Technologies, LLC for the duration of the patent’s life in return for a one-time payment. 1, 2, 3

Market Potential: $4 billion 4

Funds Needed & Use of Proceeds:

Amount: Use:

$500,000 Provision of device and supplies

Roadmap to Profitability: Basic research has been completed in Austria and safety data have been very positive. A randomized controlled trial has been approved at the University of Innsbruck, and funding has been approved for the study with the exception of $250,000 needed to provided equipment for the study.

Sources:1. General Patent, LLC Index of Patents2. August 2005 GP-TRT Patent License Agreement3. July 2006 TRT-CRT Patent License Agreement

July 7, 2013 SANUWAVE Health, Inc. Form 8-K, Exhibit 99.1, p. 8 predicts a $1 billion market for treating ischemic heart disease. Internal estimates predict an additional $3 billion dollar market for treating other cardiological conditions

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TRT Executive SummaryExhibit D – TRT Financial Information

EXHIBIT DTRT FINANCIAL INFORMATION

(See attached.)

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