A Medical Device Daily

Orqis Medical (Lake Forest, California), a clinical-stage company developing devices for the treatment of congestive heart failure (CHF), yesterday reported a $10 million venture debt commitment from Lighthouse Capital Partners (Menlo Park, California/Cambridge, Massachusetts).

Orqis said the new capital would enable it to accelerate the development of its Exeleras System, an implantable device for patients with mid- to late-stage CHF. The system in-corporates a pump, about the size of an implantable cardioverter defibrillator, placed in a minimally invasive manner.

It said it plans its first human implant with the Exeleras in the next 12 months. Ken Charhut, president/CEO of Orqis, said, “We now have the ability to fast-track the Exeleras program to address the enormous unmet needs of CHF patients.”

“Orqis Medical has emerged as a leader in the development of novel devices to treat congestive heart failure,” said Cristy Barnes of Lighthouse. “Exeleras now positions the company with a chronic therapy complementing [its] Cancion acute device, resulting in one of the most exciting opportunities in the cardiovascular area.”

Orqis's percutaneous Cancion System, for the treatment of acutely decompensated patients with chronic heart failure, is CE-marked and currently under an investigational device exemption investigation in the U.S. in the MOMENTUM pivotal trial.

Lighthouse invests capital in the form of secured loans to early- and expansion-stage technology and life science companies that have received equity financing from top-tier venture capital firms.

Dilon Technologies (Newport News, Virginia), a manufacturer of high-resolution molecular imaging systems said it completed an equity offering of $7.25 million placed by Taglich Brothers (New York), an investment banker focus- ed on microcap companies.

Dilon is developing a product dubbed Breast-Specific Gamma Imaging (BSGI), an imaging technique enabled by Dilon's camera technology and an imaging component for breast cancer detection that it says is not found in other types of breast imaging. With the system, a patient receives a small dose of a radiopharmaceutical tracing agent absorbed by the cells of the body. And because cancer cells have a higher rate of metabolic activity, they absorb up to nine times more of the agent to reveal focal points, or “hot spots” indicating cancer.

Michael Taglich, president of Taglich Brothers, said, “Based on the spectacular clinical results that the Dilon 6800 Gamma Camera has shown in detecting breast cancer, we are convinced that it should be regarded as an integral part of the standard of care for breast cancer detection and preoperative planning.”

“The capital infusion provides funding for the advancement of our national sales operations and international business ventures,” said Lon Slane, president of Dilon.

Dilon says that other possible applications of the compact system include treatment of the parathyroid and pediatrics, and other body parts “small enough to fit within the 6 inch by 8 inch field of view.”

In other financing activity, Uroplasty (Minnetonka, Minnesota) reported the closing of a $2.1 million financing, principally with institutional investors. Uroplasty issued about 1.4 million shares of common stock at $1.50 a share, and five-year warrants exercisable at $2.50 a share to purchase 695,000 additional shares.

The company said the funding would support expansion of U.S. sales and marketing and for working capital and general corporate needs.

Uroplasty, with subsidiaries in the Netherlands and the UK, manufactures products used to treat voiding dysfunctions, including urinary and fecal incontinence, overactive bladder and vesicoureteral reflux.

Its Urgent PC neuromodulation system is a minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. The Urgent PC system is sold in the U.S., Canada and countries recognizing the CE mark. Outside the U.S., Urgent PC also is indicated for treating fecal incontinence.

The I-STOP Mid-Urethral Sling is a biocompatible, tension-free sling used to treat female stress urinary incontinence.

Macroplastique Implants, Uroplasty's soft-tissue bulking agent, is used to treat both female and male urinary incontinence and to treat vesicoureteral reflux in children.