SoCalBio Roundup
The Latest from SoCalBio Device and Biotech Companies
By Ahmed Enany, Editor-in-Chief

RESEARCH GRANTS

Recent SBIR/STTR Grants from the NIH

CLINICAL STUDIES

Edwards Gets Nod to Test Minimally-Invasive Heart Valve

On March 20, Edwards Lifesciences received approval from the FDA to begin testing its Sapien transcatheter aortic heart valve technology against conventional open-heart surgery and medical management. The trials will commence at two study sites, and eventually expanded to 15. The studies aim to prove that the Sapien is not inferior to conventional treatment.

Second Sight Tests Next-Generation Retinal Implant

On January 9, Second Sight Medical Products of Sylmar received an IDE from the FDA to conduct a clinical study on the Argus II Retinal Prosthesis System. The second generation electronic retinal implant is designed to treat blindness resulting from Retinitis Pigmentosa. An IDE trial of the first generation implant (Argus 16), which has 16 electrodes, is still ongoing at the USC Doheny Eye Institute. The Argus 16 was implanted in six subjects between 2002 and 2004. The implant has enabled them to detect light and motion as well as locate basic objects. Five of the subjects are now using their Argus 16 retinal prostheses at home. The newer Argus II has more electrodes to provide patients with higher resolution images.

COLLABORATIONS

PRIVATE FINANCING

Group Purchasing

SoCalBio Group Purchasing Program Maximizes
 Membership Benefits

Representatives of SoCalBio Group Purchasing Program partners during an orientation meeting on February 14, 2007 at the Wilshire Grand Hotel in downtown Los Angeles. From left to right: David Aller, Monitor Liability Managers; Mark Essa, Business Wire; Charles McWilliams, VWR; Steve Harsh, VWR; Tom Heebink, BIO; Colony Lyle, Chubb; Bill Lewis, Bolton & Company; Stefan Hurwicz, Airgas; John Vidmar, Airgas; Dennis Rainey, ABD Insurance; Craig Welch, Airgas; and Jack Ward, Airgas.

The Southern California Biomedical Council (SoCalBio) has teamed up with the Biotechnology Industry Organization (BIO) to offer group purchasing discounts to device and biotech companies in Los Angeles and Orange Counties, the Inland Empire and the Gold Coast. Tailored to meet the needs of particularly small and mid-size firms, this program offers unrivaled cost savings on the procurement of products and services in the following areas:

• Lab supplies from VWR,

• Office and technology supplies from Office Depot,

• Employee benefits from ABD Insurance,

• Employee screening services from ChoicePoint,

• D&O liability insurance from Monitor Liability Managers in collaboration with Bolton Company,

• Product, property, and professional liability insurance from Chubb in collaboration with Bolton Company.

• News distribution from Business Wire,

• Industrial gases from Air Gas,

• Moving and storage from Humboldt, and

• Pre-owned lab equipment from BioSurplus.

According to Ken Charhut (photo right), president & CEO of Orqis Medical and SoCalBio board member, "The SoCalBio Group Purchasing Program represents significant savings to privately backed companies like ours where every dollar must be put to work creating value for the company and its shareholders."

To learn more about the SoCalBio Group Purchasing Program, contact the Southern California Biomedical Council at scbc@socalbio.org. 

On April 17, Masimo Corp., an Irvine-based provider of non-invasive patient monitoring devices, filed for a $150 million IPO. Underwriters include Piper Jaffray and Deutsche Bank Securities.

In early May, Devax Inc., also based in Irvine, filed to go public. The company plans to raise $85 million. Bear Stearns and Thomas Weisel Partners will serve as co-lead underwriters. Devax is the only company working on a drug-eluting stent that can be placed in regions where arteries bifurcate.

On March 29, the Aliso Viejo maker of breast biopsy systems began trading on NASDAQ under ticker symbol SENO. The company sold 5.5 million shares at $8 _ a price below the $9 to $10 range set by underwriters Bank of America and Citigroup, which had previously reduced the range from $11 to $13. SenoRx's flagship product is the EnCor system, a cleared device that enables physicians to obtain multiple biopsy samples with a single probe insertion. SenoRx is also working on products for treating breast cancer, including a radiation balloon for localized therapy, and devices for extracting tissue and cosmetic reconstruction. 

In March, CamSight Company obtained FDA clearance to market its Opti intraoral camera system (see right). This device provides a magnified view of the mouth projected on a computer or TV screen. It is designed to assist dentists in describing dental procedures and showing patients before-and-after views. Opti is just one of the FDA-cleared systems designed and manufactured by CamSight to ease and facilitate dental procedures.

Nestled in the industrial row along San Fernando Road about four miles north of the USC Health Sciences campus, CamSight is regarded as a leader among digital dental equipment manufacturers and software developers. The company was founded in 1996 by Ben Yoo, who helped pioneer dental microsurgery by launching the first digital surgical microscope to allow dentists to work via a monitor with hands-free operation.