A Medical Device Daily

Confluent Surgical (Waltham, Massachusetts), a privately held company developing products based on its in situ polymerized hydrogels and associated delivery systems for the field of biosurgery, reported that it has completed a $23 million Series D round of venture funding, led by Three Arch Partners.

Ascension Health Ventures also invested in the round along with participating existing investors that include Essex Woodlands Health Ventures, SV Life Sciences, Cross Atlantic Partners and HLM Venture Partners.

"This strong financial commitment will help Confluent launch the DuraSeal Dural Sealant system worldwide and amplify the commercial success DuraSeal has been enjoying in select countries outside of the U.S. where it is currently marketed," said Amar Sawhney, PhD, president, CEO and co-founder of Confluent Surgical.

Confluent's lead product, DuraSeal Dural Sealant system, is currently marketed in select international territories and has completed a pivotal multi-center clinical evaluation in the U.S.

This past November, a recommendation for a premarket approval (PMA) application for DuraSeal was given by the Neurological Devices Panel convened by the FDA's Medical Devices Advisory Committee.

DuraSeal, which the panel recommended for approval, with conditions, is designed to be used during cranial surgery in conjunction with sutured dural repair to provide watertight closure. It is the first such product to receive panel backing for that indication.

The DuraSeal system consists of a gel sealant and a syringe delivery system in a single-use kit. The blue paste-like gel is formed through the combination of two solutions and is applied along the suture line to close the small pinholes that are formed when sutures are used, as well as other smaller gaps.

The two substances are mixed as they exit the tip of the delivery system. The substance is broken down over time during the healing process and cleared by the body, primarily through the kidneys.

According to the company, a watertight closure during dual procedures "remains elusive" and there currently is no FDA-approved method or standard of care for sealing the dura following a sutured closure. Other products currently are used off-label by neurosurgeons.

The DuraSeal system received the CE mark in 2003.

Confluent's other products include the SprayGel Adhesion Barrier System for prevention of adhesions in abdominal and pelvic surgery. The company also is developing surgical sealing and adhesion barrier products for spine and orthopedic surgery.

iScience Surgical (Redwood City, California), a developer of surgical devices for the treatment of ocular diseases, reported it has closed $15 million in Series C financing.

New investor Three Arch Partners led the round, with existing investors Prism Venture Partners, De Novo Ventures, Asset Management Partners and Pacific Horizon Ventures also contributing.

As part of the financing, Wilfred Jaeger, co-founder and partner of Three Arch Partners, will join the company's board of directors.

iScience Surgical is focused on developing high-resolution imaging systems and microsurgical instruments for the treatment of glaucoma, a sight-threatening circulatory disorder of the eye that affects nearly 4.2 million Americans and 69 million people worldwide.

DOBI Medical International (Mahwah, New Jersey) reported that it has completed a private placement with a group of institutional and other investors for 21 million shares of its common stock at a purchase price of 50 cents per share, for expected gross proceeds of $10.5 million and net proceeds of about $9,665,000.

Investors will also receive 5.25 million five-year warrants to purchase shares of common stock at an exercise price of 75 cents per share, and 5.25 million five-year warrants to purchase shares of common stock at an exercise price of $1.25.

After giving effect to the shares of common stock issued upon completion of the transaction, the company's issued and outstanding common shares total 65,257,155 shares.

DOBI said proceeds from the transaction will be used primarily to complete its clinical trial research study as the final step in its PMA application to the FDA for the ComfortScan breast imaging system. Additionally the proceeds will be used to support continuing product development and international sales and marketing efforts.

The company also reported that it has reduced the conversion price of its Series A preferred stock from $1.78 per share to $1.31 per share.

C.E. Unterberg, Towbin acted as the placement agent and Greenberg Traurig acted as counsel for DOBI in the offering.

DOBI is a microcap, development-stage, medical imaging company working to create a new means for the improved diagnosis of cancer through the detection of abnormal vascularization associated with tumors.