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Bioheart, Inc. Announces Financial Results for First Quarter 2008

SUNRISE, Fla., May 15 /PRNewswire-FirstCall/ -- Bioheart, Inc. (Nasdaq: BHRT) a biotechnology company that is focused on the development of autologous (patient-derived) cell therapies and devices for the treatment of chronic and acute heart damage, today announced financial results for the quarter ended March 31, 2008.

Financial Highlights

-- On February 19, 2008, the Company completed its initial public offering

(IPO) of common stock for gross proceeds of approximately $5.8 million.

The net cash proceeds from the IPO are expected to be utilized to

commence full-scale enrollment in a Phase II/III MARVEL Clinical Trial

of MyoCell(R) in the U.S. and Europe.

Clinical Highlights

-- On January 18, 2008, the final 12-month results of the MYOHEART Trial,

a Phase I dose-escalation study of MyoCell in the United States, the

Company's lead product candidate, were presented at the Fourth Annual

International Conference on Cell Therapy for Cardiovascular Diseases

(NY). The results, presented by Warren Sherman, MD, Principal

Investigator and Director, Cell-based Endovascular Therapies, Columbia

University Medical Center, NY, suggested trends in improved quality of

life measurements sustained out to 12 months following treatment,

without unexpected rates of serious adverse events related to the

therapy given its patient population.

-- On April 1, 2008, the final six-month results of the Phase II SEISMIC

Trial of MyoCell in Europe, was presented during the clinical trial

sessions at the American College of Cardiology. These results suggested

that MyoCell is a safe and potentially effective alternative treatment

to standard medical therapy alone for improving heart function among

patients with previously implanted cardiac devices who are experiencing

congestive heart failure.

-- Bioheart initiated its patient registry clinical trial protocol for

MyoCell with MyoCath(R) Injection Catheter delivery in Korea, Singapore

and Switzerland, adding to the number of patients enrolled and

commitment to purchase Bioheart catheters for research purposes.

Other Business Highlights

-- On March 17, 2008, the Company was awarded a U.S. Patent for a method

to repair damaged myocardium (heart tissue) by a combination of cell

transplantation and electrostimulation. The award of this patent brings

to more than 100 the number of related patents and patents pending to

which the Company holds rights. The patent covers methods for repairing

damaged heart tissue by providing electrostimulation to patient-derived

myogenic cells either in the laboratory, while the cells are expanding,

or after the cells are implanted into the damaged areas of the

patient's heart.

-- The May 2008 issue of Cath Lab Digest featured an article on MyoCell

Therapy and the SEISMIC Trial and an interview with Warren Sherman, MD,

Director, Cardiac Cell-based Endovascular Therapies, Columbia

University Medical Center, New York, New York and Principal

Investigator of the MYOHEART Trial and the Phase II/III MARVEL Trial.

Revenues for the quarter ended March 31, 2008 increased to $25,995 compared to $13,805 in first quarter of 2007. During the quarter, we also recognized $61,500 of development revenue for services performed under a clinical registry agreement. The Company reported a net loss for the first quarter of 2008 of $3.3 million, or $(0.24) per share, compared to a net loss of $2.3 million, or $(0.18) per share, for the same quarter last year. The increase in the Company's net loss in the first quarter of 2008 as compared to the first quarter of 2007 is primarily attributable to increased interest expense related to $10 million of debt incurred by the Company in June 2007. Amortization of the value of warrants issued in connection with the Company's $5 million loan from Bank of America comprised a substantial portion of this interest expense. The value of these warrants was fully amortized during the quarter and, accordingly, the Company expects its interest expense to decrease in the second quarter of 2008.

Research and development expenses for the first quarter of 2008 were $1.4 million, comparable to $1.4 million in the first quarter last year. The primary focus of the Company's research and development activities during the quarter related to the MARVEL and SEISMIC Trials. The Company ended the quarter with cash and cash equivalents totaling $4.8 million.

"This past quarter was significant for Bioheart as we made a lot of progress in a short period of time, both in our business, with the completion of the IPO, and clinically, with the presentation of final results from our MYOHEART and SEISMIC Trials," said William M. Pinon, president and chief executive officer of Bioheart. "We are planning to build on that momentum as we focus on MARVEL Trial site activation and patient enrollment, in order to expand our clinical body of evidence in treating congestive heart failure patients. This Phase II/III, 330-patient, double-blind, randomized, placebo-controlled trial is designed to study the safety and efficacy of our MyoCell therapy on myocardial function in congestive heart failure patients who have had prior heart attacks."

The MARVEL Trial is the largest clinical trial of its kind to date, investigating the use of autologous myoblasts to treat patients suffering from congestive heart failure. These myoblasts, adult stem cells that are precursors to muscle, are derived from the patient's own body. When injected into scar tissue within the heart wall, myoblasts have shown they are capable of engrafting in the damaged tissue and differentiating into mature muscle cells capable of augmenting cardiac function.

About Bioheart, Inc.:

Bioheart, Inc. is a biotechnology company 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, is an innovative muscle 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 proteins.

MyoCell, MyoCell SDF-1 and MyoCath are trademarks of Bioheart, Inc.

Forward-Looking Statements:

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; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; and (ix) 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.

- Financial Tables on Following Pages -

Bioheart, Inc. and Subsidiaries

Consolidated Balance Sheets

March 31, December 31,

2008 2007

(Unaudited) (Derived from

audited financial



Current assets

Cash and cash equivalents $4,783,789 $5,492,157

Receivables 24,605 52,642

Inventory 390,074 372,054

Prepaid expenses and other current assets 2,782,159 261,030

Total current assets 7,980,627 6,177,883

Property and equipment, net 416,438 444,506

Deferred offering costs - 3,484,070

Deferred loan costs, net 593,944 1,146,716

Other assets 68,854 71,148

Total assets $9,059,863 $11,324,323


Current liabilities

Accounts payable $2,178,068 $2,134,256

Accrued expenses 4,296,348 4,511,775

Deferred revenue 485,786 547,286

Notes payable - current 6,725,374 6,671,112

Total current liabilities 13,685,576 13,864,429

Deferred rent 18,856 21,426

Note payable - long term 2,491,199 2,943,432

Total liabilities 16,195,631 16,829,287

Commitments and contingencies

Shareholders' deficit

Preferred stock ($0.001 par value)

5,000,000 shares authorized; none

issued and outstanding - -

Common stock ($0.001 par value) 50,000,000

shares authorized; 14,447,138 and

13,347,138 shares issued and

outstanding as of March 31, 2008

and December 31, 2007, respectively 14,447 13,347

Additional paid-in capital 78,720,440 77,061,296

Deficit accumulated during the

development stage (85,870,655) (82,579,607)

Total shareholders' deficit (7,135,768) (5,504,964)

Total liabilities and shareholders'

deficit $9,059,863 $11,324,323

Bioheart, Inc. and Subsidiaries

Consolidated Statements of Operations

For the Three-Month Period

Ended March 31,

2008 2007


Revenues $25,995 $13,805

Cost of sales 3,125 7,359

Gross profit 22,870 6,446

Development revenues 61,500 -


Research and development 1,358,057 1,400,590

Marketing, general and administrative 1,072,269 877,376

Depreciation and amortization 45,628 46,447

Total expenses 2,475,954 2,324,413

Loss from operations (2,391,584) (2,317,967)

Interest income 33,946 40,624

Interest expense (933,410) (561)

Net interest (expense) income (899,464) 40,063

Loss before income taxes (3,291,048) (2,277,904)

Income taxes - -

Net loss $(3,291,048) $(2,277,904)

Loss per share - basic and diluted $(0.24) $(0.18)

Weighted average shares outstanding - basic

and diluted 13,854,830 12,919,835

Contact: William Kline Lytham Partners, LLC

Chief Financial Officer Joe Diaz

Nicholas Burke Joe Dorame

VP - Financial Operations Robert Blum

(954) 835-1500 (602) 889-9700

SOURCE Bioheart, Inc.
Copyright©2008 PR Newswire.
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