September 29, 2014, 12:05 pm
Bok Y. Lee, MO, FACS
Department of Surgery
New York Medical College
Valhalla, New York
Keith Wendell, PhD
American Institute of Regeneration
Simi Valley, California
Mt. Tamborine QLD, Australia
Noon Al-Waili, MD, PhD
Department of Surgery
North Shore University Hospital
Manhasset, New York
Glenn Butler, CHT
Life Support Technology Group
Mount Vernon Hospital
Sound Shore Health System
Mount Vernon, New York
This study was undertaken to investigate the efficacy of ultra-low microcurrent delivered by an electrotherapy device for the management of chronic wounds. In this study, 23 patients with chronic skin ulcers and 2 with abdominal dehisdence that was present for an average of 16.5 mo, who were not responsive to standard conservative treatment in a hospital setting, were treated with the device. Wounds were treated with direct current (maximum of 3 mA) of 1 polarity for 115 m and then with a current of the opposite polarity for another 11.5 min Treatment was applied through ultra-low microcurrents (in the mA to nA range) conducted through special wraps applied above and below the wound. The results revealed that 34.8% of cases achieved complete wound healing after an average of 45.6 h of treatment, and 39.1% achieved 5O% healing after an average of 39.7 h of treatment. Several patients achieved significant results after 1 to 2 treatments. The electrotherapy device not only accelerated healing but also appeared to negate the effect of a person’s age on wound healing.
Keywords: ultra-low microcurrent; ulcer; wound; antioxidants
Problems in wound healing continue to cause significant morbidity and mortality. It has been shown that high-voltage and low-pulsed electrical currents augment wound healing. 1-5 Electrical stimulation, which has been shown to clearly enhance healing of pressure ulcers in a significant number of individuals with spinal cord injury, 6 has shown beneficial effects during the inflammatory, proliferation, and maturation phases of a wound. 5
Recently, microcurrent stimulation has received attention as another type of electrotherapy that has proven effective in wound healing. Microcurrent electrical neuromuscular stimulation, a subsensory modality that employs current intensities between 1 and 999 pA, has been successfully used to enhance soft-tissue healing and to treat fracture nonunion. 7-9 Electrical stimulation at 20 pA, which induces the flow of electrons into the skin and subcutaneous injury, can effect wound healing. 10
Electroacupuncture treatment, a technique that uses stimulation of acupuncture needles with a low- frequency microcurrent, suppresses myostatin expression, which leads to a satellite cell—related proliferative reaction and repair in skeletal muscle. 11Cranial electrotherapy stimulation, a noninvasive technique that delivers a microcurrent to the brain via ear clip electrodes, has effectively treated several neurologic and psychiatric disorders; it can effectively treat chronic pain in those with spinal cord injury and is considered to be an effective agent for the treatment of flbromyalgia.12-13
In a study by FI-Husseini et al,14 microcurrent skin patch therapy after total knee arthroplasty led to better pain control with a markedly decreased need for tramadol as compared with the control group. This was accompanied by better wound healing and lower drain votume.14 Further, microcurrent relieves myocontracture and can enhance conventional rehabilitation programs for children with cerebral palsy.15 Studies from the 1980s suggest that microcurrent therapy is effective at relieving the adverse effects of radiation therapy.16 A total of 26 patients with head and neck cancer who were experiencing the late effects of radiotherapy were treated with impedance controlled microcurrent therapy for 1 wk. At the end of the course of microcurrent therapy, 92% of 26 patients exhibited improved cervical rotation, 85% had improved cervical extension/flexion, and 81% had improved cervical lateral flexion.17 Treatment of 30 healthy men with induced muscle damage by means of Accustat electromembrane microcurrent therapy reduced symptom severity.18 Microcurrent stimulation relieves the pain in temporomandibular joints through internal derangement.19
Microcurrent treatment, at an output of 100 pA and at individual subsensory levels, effectively reduced postexercise creatine kinase levels after induction of muscle damage. 20 In addition, the resufts showed enhanced soft tissue healing and treatment of fracture nonunion after subsensory electrostimulationa Accustat reduces some of the clinical features of delayed-onset muscle soreness. The mechanisms of action are not known but may be related to a reduction in disturbance of intracellular Ca2+. This clinical trial was conducted to evaluate the safety and efficacy of the electrotherapy device for healing of stage I to IV ulcers that have shown no significant response to conventional therapy over a period of 33 mo.
PATIENTS AND METHODS
The electrotherapy device is an electrical device that sends a pulsating stream of electrons in a relatively low concentration throughout the body. The device is noninvasive and delivers electrical currents that are compatible with the natural electrical energy of the human body. t is a battery- operated device that delivers a direct current (maximum of 3 mA) of 1 polarity for 11.5 mm and then switches to the opposite polarity for another 11 mitt The device produces a current range of 3 mA down to 100 nA. The frequency used produces a cycle that lasts approximately 23 mm. The device was designed to switch the direction of current flow halfway through the cycle. It runs on a rechargeable battery that produces a square wave bipolar current with voltage ranging from 5 V up to a maximum of 40 V. Electrodes are applied in 2 layers, and tap water is used as the conducting medium. The wraps cover a large surface area, thus reducing resistance and allowing an optimum number of electrons to flow freely into tissues.
A total of 25 patients with chronic wounds that were present for a period ranging from 3 to 60 mo were treated. Patient age ranged from 20 to 85 y. Assessment of ulcers was based on the scale used by the National Pressure Ulcer Advisory Panel Consensus Development Conference. In all, 18 lesions were stage Ill or IV, and 3 were stage II. The 4 remaining wounds were not staged. Lesions were present for an average of 18.5 mo. Associated conditions of chronic wounds included acquired immune deficiency syndrome, arterial insufficiency, cerebrovascular accident, chronic obstructive pulmonary disease, chronic renal failure, congestive heart failure, spinal cord injury, traumatic brain injury, and venous stasis (Table). Patients were treated for approximately 3.5 h/d, 5 d/wk, until the lesions had healed. A12-wk maximum was allowed for healing to take place. All patients were inpatients and were on wound care treatment for at least 3 months prior to the start of this study; no improvement in their condition was observed. For 23 min/d, patients were wrapped, above and below the wound, with the spongy bandage soaked in water. Conductive silicone electrodes were then wrapped over these and attached to the device with stud clips. For the first cycle, the device was set at a current output of 3 pA. For the subsequent 8 cycles of treatment, the device was set at an output of 400 nA, and treatment was continued for 3 h. The rate of wound closure was measured by reduction in size in square centimeters per day. The rate of closure for the 3 groups was then averaged (younger than 50 between 50 and 70 y, and older than 70 y). Comparisons were also made between the ‘ength of time that the lesion was present and the ‘length of time that treatment was provided.
Of the 25 patients who were treated for chronic wounds, 9 were younger than 50 y, 8 were between 50 and 70, and 8 were older than 70 y Among these 25 lesions, 23 were caused by pressure. The average healing rate for the 3 age groups was measured in centimeters per day as follows: 20 to 49 y—O.74 cm2/d; 50 to 70 y—O.73 cm2Id; and older than 70 —O73 cm2ld. The length of treatment necessary for complete healing was directly proportional to the duration of the lesion (Fig 1). Although no surgical debridement was performed, all necrotic tissue appeared to reabsorb spontaneously and was replaced with healthy granulation tissue and/or skin. Of all the stage III/IV lesions, 7 healed completely over a period of treatment (18—91 h. with an average of 50.5 h of treatment).
(Click image for larger size)
(Click image for larger size)
An additional 7 lesions healed by 350% over an average of 46 h of treatment. The remaining 4 lesions (III/IV) showed clearing of infection and neurotic tissue and influx of healthy granulation tissue, with an average of 26% healing over an average of 155 h of treatment. The 3 stage II lesions achieved complete heating over an average of 15 h of treatment. Of the 4 nonstaged wounds, 2 dehisced abdominal wounds and 1 ulcer of the left foot showed partial healing. Complete healing of the wound on the right foot with osteomyelitis was achieved. The Table summarizes demographic data, wound characteristics, and patient response to ultra-low microcurrent therapy. All patients showed the same response to ultra-low microcurrent therapy regardless of their age, and all age groups showed similar healing rates when treated with ultralow microcurrent (Fig 2).
Cells have complex electricity that is sensitive to changes in electrical fields. Metabolic, immunologic, and physiologic changes have been found to develop in different cell cultures after electrical current is applied. Endogenous bioelectricity, which includes electrical current and electrical potential, is essential for life. Electrical fields have been shown to control the direction and rate of epithelial cells that migrate into the wound. The investigators found that direct electrical therapy was effective in healing gum abscesses and accelerating wound healing21Substances that increase the electrical field, such as prostaglandin E2, enhance the wound healing rate and increase cell division.22-24 Electrical fields stimulate secretion of growth factor.24 Low pA current stimulates adenosine triphosphate production.25 Another study found that microcurrent stimulates dermal fibroblasts and U937 cells to secrete transforming growth factor-b1, which is an important regulator of cell-mediated inflammation and tissue regeneration.26
In one study, Accustat electromembrane reduced the severity of symptoms in 30 healthy men with induced muscle damage; the beneficial effects of microcurrent therapy on muscle damage are likely related to maintenance of intracellular Ca2+ homeostasis after muscle-damaging exercise.18 Further, an increase in collagen concentration has been found in and around the wound. A similar suggestion was reported when microcurrent was used for soft tissue repair.27 The higher level of intracellular calcium encourages increased synthesis of adenosine triphosphate, and protein synthesis is encouraged by mechanisms that control DNA, thus promoting cellular repair and replication.25
Direct and indirect evidence suggests that free radicals play a key role in normal biologic function and in the pathogenesis of certain human diseases. Oxidative stress as a consequence of an imbalance in prooxidant-antioxidant homeostasis in chronic wounds is thought to drive a deleterious sequence of events, finally resulting in the nonhealing state. Because the inflammatory phase does not resolve in chronic wounds, the load of reactive oxygen species persists over a long time with subsequent continuous damage and perpetuation of the inflammation.28 Patients with chronic lesions due to debilitating disease are expected to have high levels of free radicals. Their wounds are generally necrotic and infected with poor healing potential, again indicating a high concentration of free radicals.
Macrophage-derived cytokines expected at the wound site include tumor necrosis factor and platelet-derived growth factor. Platelet-derived growth factor function is subject to redox control at multiple levels. Tumor necrosis factor-a biosynthesis has been shown to be reactive oxygen species—inducible as well.29,30Actually, the device used in this experiment was supposed to deliver electrons to tissues and then to saturated free radicals with required electrons. The fact that these electrons are focused on a small region of the body may explain why heating changes appeared so rapidly.
The actual tissue regeneration coupled with absence of the age factor in healing, along with concomitant improvement noted in the general condition of the patient, points to a highly potent antioxidant effect on local tissues, as well as on tissues in general. This reduces free radicals and might facilitate tissue repair. Additional studies are needed to substantiate this suggestion. Per the protocol, each patient was considered a control for himself because of the chronicity of the lesions and the patient’s lack of responsiveness to conventional therapy; however, the main limitation of the study is the lack of a control group Therefore, a randomized, controlled study would be the appropriate next component of the current research plan.
1. Alvarez M, Mertz M, SmerbeckV, Eaglstein H. The healing of superficial skin wounds is stimulated by external electrical current. J Invest Dermatol. 1983;81:144-148.
2. Brown M. McDonnel M. Menton D. Electrical stimulation effects on cutaneous wound healing in rabbits. Phys Ther 1988;68:955-960.
3. Weiss DS, Eagistein WH, Falanga V. Exogenous electric current reduces the formation of hypertrophic scars. J Dermatol Surg Oncol. 1989;15:1272-1275.
4. Bogie KM, Reger SI, Levine SF, Sahgal V. Electrical stimulation for pressure sore prevention and wound healing. Assist Technol. 2000;12:50-66.
5. Demir I-I, Balay H, Kirnap M. A comparative study of the effects of electrical stimulation and laser treatment on experimental wound healing in rats. J Rehabil Res 0ev. 2004;41 :147-1 54.
6. Baker LL, Rubayi St Villar F, Demuth 3K. Effect of electrical stimulation waveform on healing of ulcers in human beings with spinal cord injury. Wound Repair Regen. 1996;4:21-28.
7. Bach 5, Bilgrav K, Gotirup F, Jorgensen TE. The effect of electrical current on healing skin incision: an experimental study. EurJ Surg. 1991;157:171-174.
8. Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985;66:443-446.
9. Nessler JR Mass DP. Direct-current stimulation of tendon healing in vitro. din Orthop Relat Res.1987;217:303-312
10. Fleischi 0, Lauchi T Electrical stimulation in wound healing. J Foot Ankle Surg. 1977;36:457-461.
11. Takaoka Y, Ohta M, Ito A, eta!. Electroacupuncture suppresses myostatin gene expression: cell proliferative reaction in mouse skeietai muscle. Physiol Genomics. 2007;30:102-11O.
12. Tan 0, Rintala DH, Thornby JI, Yang J, Wade W, Vasilev C. Using cranial electrotherapy stimulation to treat pain associated with spinal cord injury. J Rehabi Res Dev. 2006;43:461-474.
‘13. Lichtbroun AS Raicer MM Smith RB. The treatment of fibromyalgia with cranial electrotherapy stimulation. J din Rheumatol. 2001;7:72-78.
14. El-Husseini T, El-Kawy S, Shalaby F El-Sebai M Microcurrent skin patches for postoperative pain control in total knee arthroplasty: a pilot study. ml Orthop. 2007;31:229-233.
15. Maeripaa H, Jaakkola R SandstrOm M Von Wendi L. Does microcurrent stimulation increase the range of movement of ank’e dorsiflexion in children with cerebral paisy? Disabil Rehabil. 2004;26:669-677
16. King GE, Scheelz J, Jacob RF, Martin JW. Electrotherapy and hyperbaric oxygen: promising treatments for postradiation compJications. J Prosthet Dent. 1989;62:331-334.
17. LennoxAJ, ShaferJP, HatcherM, Bell J, FunderSJ. Pilot study of impedance-controlled microcurrent therapy for managing radiation-induced fibrosis in head-and-neck cancer patients. Int J Radiat Oncol Biol Phys. 2002;54:23-34.
18 Lambert Ml, Marcus P, Burgess T, Noakes ID. Electro-membrane microcurrent therapy reduces signs and symptoms of muscle damage. Med Sci Sports Exere. 2002:34:602-607.
19 Bertolucci LE, Grey T. Clinical comparative study of microcurrent electrical stimulation to mid- laser and placebo treatment in degenerative joint disease of the temporomandibular joint. Cranio.1995;13:116-120.
20. A JD, Maftacola CC, Perrin DH. Effect of microcurrent stimulation on delayed-onset muscle soreness: a double-blind comparison. J Athi Train. 1999;34:334-337.
21. AL-Waili N. Electrotherapy for chronic gum and periapical abscesses. J Pak Med Assoc.1989;39:161-162.
22. Song B, Zhao M, ForresterV, McCaig D. Electrical cues regulate the orientation and frequency
of cell division and the rate of wound healing in vivo. Proc Nati Acad S U S A. 2002;99:13577-13582.
23. McCaig D, Rajnicek M, Song B, Zhao M. Has electrical growth cone guidance found its potential? Trends Neurosci. 2002;25:354-359.
24. Zhao M, Bai F- Wang E, Forrester V, McCaig D. Electrical stimulation directly induces preangiogenic response in vascular endothelial cells by signaling through VEGF receptors. J Cell
Sci. 2003;1 17:397-405.
25. Cheng N, Van Hoof F, Bockx E, et al. The effects of electric currents on ATP generation, protein synthesis, and membrane transport in rat skin. din Orthop Relat Res. 1982;171 :264-272.
26. Todd I, Clothier RH, Huggins ML, etal. Electrical stimulation of transforming growth factorbeta 1 secretion by human dermal fibroblasts and the U937 human monocytic cell line. AlternLab Anim.
27. Denegar CD, Pernin DH, Rogol A, Rutt R. Influence of transcutaneous electrical nerve stimulation on pain, range of motion, and serum cortisol concentration in females experiencing delayed onset muscle soreness. J Orthop Sports Phys Ther. 1989;1:100-103.
28. Wlaschek M, Scharffetter-Kochariek K. Oxidative stress in chronic venous leg ulcers. Wound Repair Regen. 2005;13:452-461.
29. Haddad JJ, Saade NE, Safieh-Garabedian B. Redox regulation of TNF-alpha biosynthesis:
augmentation by irreversible inhibition of gammaglutamylcysteine synthetase and the involvement of an lkappaB-alphaINF-kappaB-indepenclent pathway in alveolar epithelial cells. Cell Signal. 2002;14:211-218.
30. Haddad JJ. Redox regulation of pro-inflammatory cytokines and IkappaB-alpha/NF-kappaB nuclear translocation and activation. Biochem Biophys Res Commun. 2002;296:847-856.
September 17, 2014, 4:01 pm
Leonhardt Ventures Heart Failure Technology Showcase Las Vegas Sept. 16th, 2014First heart pacemaker able to recruit repairative stem cells to damaged heart tissue - THE MYOSTIM PACER First wireless energy microcurrent devices for directing stem cell therapy repair of damaged hearts to be presented SANTA MONICA, Calif., Sept. 14th, 2014 -- Leonhardt Ventures will showcase its cardiovascular and heart disease related technologies Tuesday, September 16th, 7pm to 8pm @ The Caesars Palace Hotel. Conveniently located in the same hotel as Heart Failure Society of America Annual Meeting that takes place September 14th to 17th in Las Vegas - http://www.hfsa.org/annual_meeting.asp. Please RSVP to Ms. Maddy Clemens at email@example.com
. The room for the meeting will depend on the number of participants signed up to attend. Ms. Clemens will email you back the exact room number shortly after you RSVP. Heart Failure treatment related technologies to be showcased include: MyoStim Pacers – http:/www.myostimpacers.com - world's first heart failure pacemaker designed to recruit reparative stem cells to damaged and weakened heart tissue via a homing signal + MyoStim Microcurrent devices for treating critical limb ischemia and diabetic leg and foot ulcers. Bioheart, Inc. – http://www.bioheartinc.com - Phase III leader in applying adult muscle stem cells to treat advanced heart failure since 1999. Only cell type known to grow new contractile muscle in the depths of scar tissue. BioPace – biological pacemaker made entirely of living cells. Preparing for first clinical case at Utrecht University The Netherlands. CoroStim – world's first vibrational energy emitting pacemaker add-on node designed to prevent plaque formation in high risk coronary arteries. AortaCell Stemergy - Wireless non-invasive energy device designed to recruit stem cells to weakened vessel wall tissue for repair. Wetling Microcurrent - http://www.wetlinghealth.com/ - wireless microcurrent device for multiple healing applications. BioLeonhardt – http://www.bioleonhardt.com - First implantable, programmable, refillable stem cell pump (20 ml chamber) and electrical stimulation combination device for multi-stage cell and gene therapy for treating advanced heart failure. Featuring combined utilization of MicroRNAs, nutrient time release SDF-1, hydrogel, cardiac stem cells, iPS cells and muscle progenitor stem cells. First method to utilize an implantable, programmable and re-fillable stem cell pump for multiple dosages of delivery over time. Stem Cell Micro Infusion Pump by Fluid Synchrony - www.fluidsynchrony.com - implantable, programmable and re-fillable stem cell micro infusion pump (2ml chamber) designed for controlled micro dose delivery of stem cells, selected growth factors and drugs over time to specific target organ locations. Cardiobridge – http://www.cardiobridge.com - Highest flow rate 10FR circulatory support catheter pump in clinical testing for acute decompensating heart failure and high-risk PCI. Data on 30 clinical patients will be presented. Procyrion Implantable Heart Pumps - www.procyrion.com - The Procyrion device consists of a small, continuous flow pump mounted within a self-expanding anchoring system. The device is advanced through a catheter in the femoral artery to the descending thoracic aorta. The self-expanding anchors deploy to fix the pump to the aortic wall. HeartScore - www.heartscore.co – Full lineup of cardiovascular diagnostic and @ home monitoring products. LVSens – Implantable heart sensor placed percutaneously by catheter. Valvublator - Catheter based devices for decalcifying, cell sodding and surface modifying heart valves to avoid need for implants + a removable percutaneously placed heart valve for select cases where the patients own valve cannot be regenerated immediately. The Leonhardt Ventures' Cal-X Stars Innovation Accelerator Scientific Advisory Board is made up of leading heart failure physicians, stem cell scientists, cardiologists and electrophysiologists - http://calxstars.com/scientific-advisory-board/. Portfolio companies are guided by a 70 person experienced board of mentors, advisors and management team members - http://calxstars.com/team-cal-x/ Leonhardt Vineyards (www.leonhardtvineyards.com) gold medal winning wines, sold exclusively through Trader Joes 415 stores nationwide, will be served. About Leonhardt Ventures: Since 1982 Leonhardt Ventures has a strong history of inventing, developing, backing and bringing to market leadership products for treating heart and cardiovascular disease. Over 200,000 patients have been treated to date with Leonhardt inventions. Leonhardt Venture's started the Cal-X Stars Business Accelerator in 2012 to guide forward cardiovascular and social good impact innovations over a 5 year period. Contact: Ms. Maddy Clemens, Meeting Scheduler @ email firstname.lastname@example.org
, Leonhardt Ventures, 1531 6th Street, Unit 401, Santa Monica, California, 90401 and Howard Leonhardt, President, at email@example.com
This PR distribution was issued via PRBuzz SOURCE Leonhardt Ventures RELATED LINKS http://www.leonhardtventures.com http://www.calxstars.com http://www.myostimpacers.com http://www.bioheartinc.com http://www.bioleonhardt.com http://www.wetlinghealth.com http://www.cardiobridge.com Read more news from Leonhardt Ventures. SOURCE Leonhardt Ventures #stemcells, #medtronc, #guidant, #bostonscientific, #st.judemedical, #biotronk, #sorinbiomedica, #crowdfunding, #santamonica, #sf, #LA, #HFSA, #heartfailure, #capricor, #mesoblast, #osiris, #cytoritherapeutics, #ISCO, #cardio3, #worldstemcellsummit, #WSCS
March 7, 2012, 6:47 pm
December 17, 2011, 10:00 am
SUNRISE, Fla., Nov. 6, 2008 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Nasdaq:BHRT) announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for nine new patent claims covering the use of electrical stimulation to enhance stem cell regeneration of damaged heart muscle.
The invention and its claims are deemed to be pioneering in that they harness the natural electro-chemical instructional program that teaches stem cells to become heart muscle and then apply this process to damaged heart muscle in patients suffering of heart failure. The stimulation not only attracts stem cells with a homing signal but also causes the release of beneficial proteins. The stimulation method may be applied with or without the injection of stem cells. The claims of the patent also cover pre-conditioning stem cells towards a cardiac phenotype by electrically stimulating them during culture before implantation into damaged heart muscle.
Bioheart built prototypes of devices that can run this electrical stimulation program and tested the proof of concept studies over the past several years leading up to this patent notice of allowance, working with Dr. Juan Chachques, Associate Professor Cardiac Surgery, Pompidou Hospital, Paris, France.
"This truly has the potential to be a landmark invention in the field of heart failure treatment," stated David Holmes, M.D., Chairman of Cardiology, Mayo Clinic, Rochester, Minnesota.
The inventors, Howard J. Leonhardt, Chairman, CEO and CTO of Bioheart, Inc. and Dr. Chachques, have previously partnered to receive other related patents for complementary devices and methods.
"We believe Bioheart's intellectual property estate is unmatched in the field of heart muscle repair," stated Howard Leonhardt.
"The best way to predict the future is to create it," stated Dr. Juan Chachques. "This invention could be regarded in the future as one of the most important developments ever in the fight to reduce the death rate from heart failure."
Bioheart, Inc. now holds the rights to more than 36 related patents with over 400 patent claims.
About Bioheart, Inc.:
Bioheart, Inc. (Nasdaq:BHRT) is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(r), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(r) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.
MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as "may", "will", "to", "plan", "expect", "believe", "anticipate", "intend", "could", "would", "estimate", or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to secure additional financing; (ii) the timely success and completion of our clinical trials; (iii) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (iv) regulatory approval of our product candidates; (v) our dependence on the success of our lead product candidate; (vi) our inability to predict the extent of our future losses or if or when we will become profitable; (vii) our ability to protect our intellectual property rights; and (viii) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2007, as amended by Amendment No. 1 on Form 10-K/A and its quarterly reports on Form 10-Q for the quarters ended March 31, 2008 and June 30, 2008.
CONTACT: Bioheart, Inc:
William Kline, Chief Financial Officer
RedChip Companies, Inc.
Bioheart Investor Relations:
(800) REDCHIP (733-2447), Ext. 118
Source: Bioheart, Inc.
Date: November 06, 2008 08:20 ET