A Medical Device Daily

Cianna Medical (Aliso Viejo, California) reported that it has successfully completed a funding round totaling more than $10 million. The funding will be used to further accelerate commercialization of the company's SAVI technology for breast cancer brachytherapy.

Participating in the funding round, the company's second, were Emergent Medical Partners, Saints Capital, Mitsubishi International, and Fog City Fund, plus several private individuals.

The innovative SAVI applicator provides a shortened course of high-dose radiation therapy for early-stage breast cancer patients following lumpectomy surgery. Carefully contoured radiation is delivered from within the breast and targets the area where the cancer is most likely to recur. SAVI allows physicians to precisely target radiation to the area that needs it most, minimizing exposure to healthy tissue. This approach reduces treatment time from six or seven weeks – which is generally required with conventional whole-breast irradiation – to just five days.

The technology's effectiveness has been documented in a number of scientific studies, most recently in a peer-reviewed paper published by University of California, San Diego researchers in Radiation and Oncology.

Cianna was created as a spinout from BioLucent (Aliso Viejo, California) concurrent with the sale of BioLucent's MammoPad breast cushion business to Hologic (Bedford, Massachusetts) in 2007 – the same year the company received 510(k) clearance for SAVI from the FDA. Cianna's first funding round of $9 million was completed in February 2008 (Medical Device Daily, Feb. 27, 2008).

In other financing news:

• BioMimetic Therapeutics (Franklin, Tennessee) reported that it has entered into a definitive purchase agreement with InterWest Partners X, LP, an affiliate of InterWest Partners, one of the company's existing stockholders, for the private placement of 941,177 shares of its common stock at a price of $8.50 per share. The purchase price represents a significant premium to the market price ($7.45 per share) of the common stock on the date of execution of the purchase agreement. The transaction is expected to raise about $8 million in gross proceeds.

The company said it intends to use the proceeds of the financing for general corporate purposes, including working capital.

The closing of the financing is expected to occur as soon as practicable, subject to the satisfaction of customary closing conditions.

In addition, the company's board has approved a rights offering of up to $17 million to be made, on a pro rata basis, to the company's existing stockholders of record as of April 21, 2009, also at a price of $8.50 per share. The company said it intends to proceed with the rights offering once a registration statement relating to the rights offering has been filed with, and declared effective by, the SEC.

In connection with the rights offering, the company entered into a standby purchase agreement with Novo A/S, an existing stockholder of the company to purchase up to $15 million of common stock in the offering, if this stock is not purchased by other current shareholders.

"While we remain confident in the outcome of our clinical pivotal trial with Augment, there are several reasons for proceeding with the private placement and the rights offering at this time, including the challenging conditions in the financial markets and the uncertainty of both the timing for achieving full liquidity for our auction rate securities and the timing for receipt of the $10 million milestone payment from Luitpold Pharmaceuticals for EU approval of GEM 21S. The potential initiation of a North American pivotal clinical trial for Augment Injectable Bone Graft (AIBG), the second product candidate in our pipeline, and additional expenses associated with commercializing Augment Bone Graft if approved in Canada later this year were also factors in our decision," said Dr. Samuel Lynch, president/CEO of BioMimetic.

BioMimetic is developing regenerative protein-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, spine and sports injury applications.

• Startup company MedShape Solutions (Atlanta) said it has raised $8 million and received regulatory approval for its first product – a medical implant used to treat shoulder injuries.

Medshape has developed a shape-changing polymer material that helps fuse bone to bone and soft tissue to bone. Surgeons drill a hole into the bone and insert the polymer to which soft tissue, like tendons, can be anchored.

In addition to the $8 million raised from angel investors, the company said it hopes to close on an additional $2 million round in the second quarter.

The company also won about $2 million in research grants from the state and federal governments this year.

The company said the $8 million will be used for product development and marketing of MedShape's family of four medical implants.

The company said it plans to enter the shoulder and knee repair market this year and generate about $3 million in revenue by the end of 2010.

The company is shooting to become cash-flow positive by 2012.

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