Bioheart Reports Year End 2008 Results; Reviews 2008 and 1Q09 Progress and 2009 Business Objectives On Thursday May 7, 2009, 7:00 am EDT SUNRISE, Fla., May 7, 2009 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Other OTC:BHRT.PK - News) reports financial results for the year ended December 31, 2008, provides a review of its progress in 2008 and 1Q 2009 and outlines 2009 annual business objectives. Bioheart's Form 10-K was filed on April 15, 2009 and Bioheart's Form 10-K/A was filed on April 30, 2009. Highlights 1Q 2009 * Completed call center set up to support at-home heart failure monitoring. * Began shipments of Bioheart 3370 Heart Failure Monitoring Systems in U.S. market. * Initiated streamlining of MyoCell(r) MARVEL clinical protocol design to reduce costs and implement additional safety monitoring including 24-hour call center beat-to-beat ECG monitoring following myoblast implantation. * Presented MyoCell(r) clinical data at the 5th Annual Cell Therapy for Cardiovascular Diseases Meeting in New York and the American College of Cardiology Meeting in Orlando, Florida. * Sold $104,350 worth of Bioheart MyoCath(r) catheters to researchers and reached $109,000 in revenues for the quarter. * Renegotiated BlueCrest loan at favorable terms. Reduced monthly payments from $180,000 to $31,520 through June 2009. Highlights for 2008 include the following: * Increased from 5 clinical sites for MyoCell(r) in the USA to 35 in Phase II/III clinical trial for advanced heart failure. * Presented results from Phase II SEISMIC study of MyoCell demonstrating that 83% to 94% of treated patients improved in CHF class and/or 6-minute walk while only 6% to 17% worsened; whereas, in the control group treated only with drugs, 69% worsened. * Obtained CE Mark commercial approval for Bioheart TGI-1200 stem cell processing device and disposables. * Launched sales of Bioheart 3370 Heart Failure Monitoring Systems with U.S. FDA 510(k) authorization and CMS reimbursement. * Acquired rights to Bioheart-Monebo Cardiobelt(r) with FDA 510(k) authorization. * Acquired certain rights to Bioheart A&C Bio Science T-PLS(r) true pulsatile life support system with CE Mark commercial approval. * Expanded MyoCell(r) production capacity from 30 cases per month to over 1,000 with new commercial scale facility in Asia in partnership with Bioheart Manufacturing Asia, Inc. (BHM, Inc.) * Bioheart received two new pioneering patents for utilizing electrical stimulation to enhance muscle stem cell transplantation for treating heart failure including patent claims for converting stem cells to heart cells. * Achieved total revenues in 2008 of $154,051. Bioheart reduced its monthly operating expenses in the third and fourth quarters of 2008 from a September 2008 peak of $1.5 million down to $444,078 in January mostly due to a decrease in general and administrative and research and development expenses, offset in part by a planned increase in sales and marketing expenses. The Company anticipates continued significant reduction in operating expenses in 2009 as Bioheart further shifts its resources toward managing sales and marketing activities, assumed mostly by its distribution partners, and away from research and development. The Company expects to keep reduced cash operating losses to approximately $500,000 per month in the near term. Net loss for 2008 was $14.2 million or $0.97 per share on a basic and diluted basis, as compared to $18.07 million, or $1.37 per share on a basic and diluted basis for 2007. The reduction to net loss is attributable in part to decreased operating expenses but was offset by increased sales and marketing expenses, coinciding with market launches for the Bioheart 3370 Heart Failure Monitoring System and the Bioheart TGI-1200 Stem and Endothelial Progenitor Cell Processing System, as well as pre-clinical studies for MyoCell SDF-1, now moving into clinical trial, and acquisition of the Bioheart-Monebo Cardiobelt(r). Bioheart, Inc. ended the year reaching the milestone of $82,532,746 in additional paid-in capital. Over the course of its history Bioheart has utilized over $30 million in grant funding bringing the total invested in research programs and company development since founding to $122 million. Cash and cash equivalents were $50,091 on December 31, 2008 compared to $5.5 million as of December 31, 2007. The Company will require additional capital in the near term for its operations to bridge to the point where profits from revenues can totally support expenses. For further information on the company's year end 2008 financial results, please refer to Bioheart's Form 10-K filed with the SEC on April 15, 2009 (SEC file number 001-33718) and 10-K/A filed with the SEC on April 30, 2009 (SEC file number 001-33718). 2009 Business Objectives Bioheart's business objectives for 2009 and beyond include the following: * Reach Bioheart 3370 Heart Failure Monitoring Systems sales of an annual run rate of $22 million. FDA 510(k), European CE Mark and Reimbursement already in place. * Complete interim analysis of MARVEL Study patients. * Expand global distribution network in Europe and Asia-Pacific and related sales pact. * Move MyoCell(r) SDF-1 second-generation composition for advanced heart failure into Phase II/III pivotal clinical trial. * Launch U.S. 510(k) authorized Bioheart-Monebo Cardiobelt(r) in U.S. market. * Keep operating loss for year to under $5.4 million. * Publish in peer reviewed journals Phase II SEISMIC and MYOHEART U.S. Dose Escalation Study Results. * Gain reimbursement approval for MyoCell in Europe for treating sickest heart failure patients. * Launch sales of CE Mark approved Bioheart A&C Bio Science T-PLS(r) Twin-Pulsatile Life Support System system in Europe. * Finish development with corporate partner of implantable heart failure sensor that communicates wirelessly with the Bioheart 3370 Heart Failure Monitoring System. * Finish development of implantable heart pump on percutaneous catheter with corporate partner in Korea, A&C Bio Science, Inc. * Sell off rights to non-core intellectual property and product developments to increase cash available for core heart failure focused developments: AortaCell, MyoStim, MyoValve, BioPace, EndoCell, and MyoCath. * Seek joint venture partner to commercially develop the A&C Bio Science LVAD/SVAD, a significantly lower-cost left ventricle assist device co-developed by Bioheart. * Continue to add devices to product lineup that feed information into the Bioheart 3370 24-hour monitoring system. About Bioheart, Inc. Bioheart, Inc. 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 http://www.bioheartinc.com.
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