A Medical Device Daily

Signostics (Palo Alto, California/Adelaide, Australia), a device company developing personal ultrasound devices, reported that it has raised $4 million in its latest round of financing, including new investments from Australian-based venture capital firms Brandon Capital Partners, Playford Capital, and Terra Rossa Capital, bringing the total amount raised to $13 million to date.

Signostics is developing a new generation of palm-sized, affordable personal ultrasound devices for point-of-care use by medical practitioners and veterinarians. The company recently obtained FDA and Australian TGA regulatory clearances and its Signos and SpeqView products also now bear the European CE mark.

"With rising healthcare costs and healthcare spending being re-evaluated, our breakthrough technology creates a much more affordable tool to deliver faster diagnosis at the point of care. Our products have many applications that are attractive in many different markets and the additional capital we raised will help us grow into our key target segments," said Dr. Neil Bartlett, CEO of Signostics.

The company has also expanded its board, adding four new directors, including David Fisher, Amanda Heyworth, Des Masters and David Shaw.

Signostics was established in Adelaide, Australia in 2005 and expanded into the U.S. in 2008. The company launched its first product into the veterinarian market in January and gained regulatory approvals to enter the human medical device market for the U.S., Europe, and Australia in May.

In other financing news, BioDelivery Sciences International (BDSI; Raleigh, North Carolina) reported receipt of $26.7 million in milestone payments from its commercial partner Meda (Solna, Sweden) in connection with the approval by the FDA of BDSI's cancer pain product Onsolis (fentanyl buccal soluble film) and satisfactory preparation of commercial launch supplies.

In addition to the $26.7 million received, BDSI will also receive a double-digit royalty on net sales of Onsolis, and the potential for additional milestone payments of up to another $30 million upon the achievement of certain sales thresholds. Onsolis will be commercialized in the U.S. by Meda Pharmaceuticals, the U.S. subsidiary of Meda and is expected to be available for sale in early 4Q09.

"The receipt of this milestone payment, together with approximately $5 million we have received from the exercise of outstanding warrants over the past several weeks, puts the company in the strongest financial position in its history, with approximately $30 million in cash and no long term debt. These funds allow us to immediately turn to accelerating the development of our exciting pipeline, particularly BEMA Buprenorphine and Bioral Amphotericin B, as well as to place a third BEMA product in the clinic next year," said Mark Sirgo, president/CEO of BDSI.

BDSI had previously recorded milestone payments from Meda as deferred revenue, and with the FDA approval, those amounts, together with the approval milestone, will be recognized as revenue to the company.