A Medical Device Daily

Electro-Optical Sciences (EOS; Irvington, New York) reported yesterday that it has filed a statement with the Securities and Exchange Commission describing a proposed initial public offering (IPO) of its common stock to raise up to $33 million. The number of shares to be offered and the price range for the offering have not yet been determined.

EOS is a medical device company developing a non-invasive, point-of-care instrument, using computer vision technology, for assisting in the early diagnosis of melanoma.

The company’s previous fund-raising came last year with an extension of a Series C preferred financing that brought it $9 million (Medical Device Daily, Nov. 2, 2004). At the time, the company also reported that it secured a protocol agreement with the FDA for its premarket approval (PMA) application pivotal trial of its MelaFind technology, a diagnostic system for melanoma detection.

MelaFind is described by the company as “a non-invasive, hand-held device that is placed against a suspected mole or lesion to capture, automatically and non-invasively, a series of multi-spectral digital images. It analyzes and quantifies information about the organization of the lesion’s cells, and then compares these results against standards developed from a secure database of previously diagnosed and digitized images.”

The results are confirmed over the Internet, with a parallel diagnosis performed simultaneously on the company’s server. A specific action can then be recommended to the physician. The process takes less than two minutes, according to EOS.

Preliminary tests “suggest that MelaFind should enable physicians to reduce error in diagnosing melanoma very significantly,” the company said.

Ladenburg Thalmann & Co. will serve as lead manager, with Stanford Group Co. acting as co-lead manager for the proposed offering.

Pegasus Biologics (Irvine, California), a privately held company developing collagen-based bioimplants for the repair of soft-tissue defects in orthopedic, spine and neurosurgery, reported raising $10 million in a Series B venture funding.

The company, focused on what it calls “intelligent” implants, said that the new financing would enable it to launch its initial products and support operational growth.

France Dixon Helfer, founder and president of Pegasus, said, “Our innovative collagen-based technologies have enabled us to develop uniquely intelligent bioimplants that will advance the field of soft-tissue repair and replacement in orthopedic, spine and neurosurgery. The proceeds of the financing will be used to launch our premier product, the Pegasus Biologics OrthAdapt Bioimplant, which promises to raise the bar in orthopedic soft-tissue repair.” He said it would also support completing of the company’s human studies on the DurAdapt Bioimplant for repair of the dura mater during craniotomy and spine operations and for final development of a biologic solution for replacement of the anterior cruciate ligament.

In a statement, Pegasus said it has licensed patented technologies from Biomedical Design (Marietta, Georgia) and is using these for bioimplant development. It describes these technologies as able to chemically process collagen-based bioimplants of human or animal origin so that they are “strong, biocompatible, adaptable for each indication and remodeled along the natural structure of the OrthAdapt Bioimplant in a controlled manner.”

Pegasus said, “No other company has the ability to provide organized remodeling in a collagen material that hasn’t been reconstituted. Additionally, a unique terminal sterilization process, using no harsh chemicals or radiation, completely kills pathogens while sparing the integrity of the natural collagen bioimplant.”

The financing was led by Three Arch Partners and Frazier HealthCare Ventures, with participation by Life Science Angel Investors. William Harrington, MD, a partner for Three Arch Partners, said that Pegasus “is well-positioned to redefine soft-tissue repair with innovative and patented technologies and a differentiated product portfolio offering surgeons better soft-tissue repair and replacement options.”

Michael Kaplan from Three Arch Partners and Trevor Moody from Frazier Healthcare Ventures have joined the company’s board.

In other financing news:

Implant Sciences (Wakefield, Massachusetts), a developer of products for medicine, national security and industry reported the execution of a revolving credit facility for $1.5 million with Bridge Bank (Santa Clara, California). The revolving credit facility has a one-year term, provides for advances of up to 80% of accounts receivable and is secured by certain company assets.

Implant Sciences is focused on using its core ion technology to develop products for the medical device, homeland security and semiconductor industries. In addition, to its other cancer treatment products the company recently received an FDA 510(k) approval for its new radioactive source for the use in the treatment of breast cancer. The company has commercialized portable and bench-top trace element detection devices to identify explosives.

NeoGenomics (Fort Myers, Florida) reported entering into a standby equity distribution agreement (SEDA) with Cornell Capital Partners (Jersey City, New Jersey). Under the SEDA terms, the company may periodically sell to Cornell shares of common stock for a price of up to $5 million. For each share of common stock purchased under the SEDA, Cornell will pay the company 98% of the lowest volume weighted average price of the company’s common stock as quoted on the Over-the-Counter Bulletin Board or other principal market on which the stock is traded for the five days following the notice date.

Cornell also will retain 5% of each advance under the SEDA. Cornell’s obligation to purchase shares of the company’s stock under the SEDA is subject to certain conditions, including the company obtaining an effective registration statement for shares of common stock sold under the SEDA and limited to $750,000 per weekly advance.

Robert Gasparini, president of NeoGenomics, said that the purpose of the equity line was “to ensure that the company was in a position to move quickly in the event that acquisitions or other strategic opportunities were presented . . . With three of the top 10 genetics laboratories being acquired in the last 12 months, it is clear to our board that the industry will consolidate further, and . . . our shareholders will realize significant benefits if we are able to participate in this trend.”

NeoGenomics, a clinical testing laboratory, offers genetic and molecular diagnostic testing services to the oncology and perinatology markets.