Medical Device Daily and MDDs

A year after filing for an initial public offering, Bioheart (Sunrise, Florida) closed the deal by pricing 1.1 million shares at $5.25 each.

Gross proceeds of $5.8 million are a far cry from the $35 million the company had initially hoped for. And last fall, Bioheart raised its target to $53.6 million when it set terms at 3.575 million shares priced between $14 and $16 per share.

As of Sept. 30, the company reported $9.5 million in cash and equivalents after posting a loss of $9.2 million during the first nine months of 2007. After expenses, net proceeds from the IPO would be just $1.5 million, but expense prepayments will allow Bioheart to take home $4.6 million in cash proceeds. That take-home total could increase to $5.4 million if underwriter Dawson James Securities exercises its option to purchase an additional 165,000 shares to cover any overallotments.

Most of the money from the offering will support a Phase II/III trial of MyoCell, Bioheart's autologous cell-based treatment for heart failure. The product is intended to repair and regenerate heart muscle by taking myoblasts from a patient's thigh muscle, growing them in a cell-culturing process, and injecting them into scar tissue within the heart wall using the company's MyoCath catheter.

Data from the double-blind, randomized, placebo-controlled, 330-patient trial are expected in 3Q09. Primary endpoints include improvement in six-minute walk distance and quality of life, as well as safety. If the findings are positive, Bioheart said it intends to ask the FDA to consider the trial pivotal and a basis for approval.

The company plans to pursue limited approval in Europe as early as 2Q08 based on Phase II data. Due to a limited number of patients treated, the Phase II trial did not initially show statistical significance for any of the efficacy endpoints.

Additional proceeds from the IPO will be used for license payments, repayment of principal and accrued interest on debt, working capital and other general corporate purposes. Behind MyoCell, Bioheart has earlier-stage autologous cell therapy programs for acute heart attack and abnormal heart rhythm as well as an adipose tissue processing system, endoventricular catheters and an allogenic myoblast program.

In other financings:

  • Accumetrics (San Diego), a privately maker of the VerifyNow family of tests that measure patient response to antiplatelet drugs, reported raising $28.8 million in a Series D round.
    The syndicate was led by Arnerich Massena & Associates, and BBT Fund. Also participating in the round were previous investors: Essex Woodland Health Ventures, RiverVest, PTV Sciences, KB Partners and Kaiser Permanente Ventures.
    "Completion of this ... financing enables us to initiate the GRAVITAS study and positions the company for commercial success," said Steven Frankel, CEO of Accumetrics. "We believe the results of the GRAVITAS trial will establish the VerifyNow system as a routine diagnostic tool."