A Medical Device Daily

Serica Technologies (Medford, Massachusetts), a growth-stage device company developing silk-based biomaterial platforms for tissue regeneration, reported that it has closed on $6 million of additional funding, supported by existing investors, Morningside Technology Ventures, Prism VentureWorks and Ivy Capital Partners. The company said it has now raised a total of $23.5 million since its inception in 1998.

"With the confidence demonstrated by our investors, particularly in this challenging economic environment, this additional funding provides Serica with a very strong financial position to execute on our commercialization plan for the SeriACL in Europe, and to continue our clinical program to gain approval in the U.S. market," said President/CEO Gregory Altman, PhD.

The company said it is moving forward with expanding its clinical, engineering and scientific teams, as part of a strategic growth plan. "We have added significant depth in both R&D and quality affairs, and have expanded our staff in other key areas, in our planned approach to prepare for commercialization," Altman said.

The company also reported that it has received ISO 13485:2003 certification, meeting stringent international quality standards required for medical device manufacturers. ISO certification is the standard recognized and accepted by most regulatory bodies worldwide as proof of an effective quality system.

The company's lead product, the SeriACL, is currently in clinical development as a biocompatible and biodegradable ligament graft, for repair of the anterior cruciate ligament.

Serica is developing products for a wide variety of applications where current materials fail to meet the needs of clinicians and patients, including connective tissue repair of the knee, shoulder, abdomen, breast, neck and face.

The Life Sciences Greenhouse of Central Pennsylvania (LSGPA; Harrisburg, Pennsylvania) reported an investment of $500,000 in Apeliotus Vision Science (Atlanta), an early-stage company developing a simple, cost-effective tool for early diagnosis of age-related macular degeneration (AMD).

AMD is a progressive disease that affects the vision of more than 30 million people worldwide, yet there is currently no good means for early detection of the condition. Available methods are impractical for routine clinical testing because of the long turn-around time and high cost.

Apeliotus said it aims to change that with the AdaptDx, a technology developed by Dr. Greg Jackson of the Penn State College of Medicine (Hershey, Pennsylvania) and Dr. Cynthia Owsley at the University of Alabama at Birmingham.

"In the U.S. alone, there are an estimated 13 million people with some vision loss from AMD," said CEO John Edwards. "That translates into roughly one out of every six U.S. citizens over age 65, and the prevalence only rises as we age."

The AdaptDx measures the eye's ability to adapt to the dark. In an initial study the device detected the onset of AMD well before it became clinically evident, the company said. Researchers and investors hope that early detection, combined with therapy using currently available drugs, will prevent or slow vision loss. Similar in size, operation and cost to the instruments routinely used for glaucoma screening, the company said the AdaptDx test is completely non-invasive and takes less than 15 minutes.

The Life Sciences Greenhouse of Central Pennsylvania accelerates economic growth and life sciences technology commercialization through seed and pre-seed stage investments of up to $1 million in emerging life sciences companies.

In other financing news, Varian Medical Systems (Palo Alto, California) said that its board has authorized it to repurchase an additional 8 million shares of its common stock in 2009. The program permits stock repurchases at the discretion of the management on the open market, in privately negotiated transactions, or in Rule 10b5-1 share repurchase plans.

As of Sept. 26, Varian had 5.9 million shares under a 12 million share repurchase authorization that expires at the end of this year. Since initiating share repurchase authorizations at the end of fiscal year 2001, the company has spent $1.4 billion to repurchase 36 million shares of common stock at an average price of $40.13 a share.

Varian makes devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices.