A Medical Device Daily

Stentys (Paris/Princeton, New Jersey) said it has secured the second tranche of its Series B financing from Sofinnova Partners and SEP-closing an additional $4.2 million investment from new investor Crédit Agricole Private Equity, bringing the total B round financing to more than $22 million.

"I am delighted to see Stentys reinforce its financial base," said Jacques Séguin, MD, PhD, co-founder and chairman of Stentys. "I am more than ever convinced that the company is uniquely positioned to develop its breakthrough approach for treating acute myocardial infarction and bifurcation lesions."

Stentys was founded in 2006 to develop a new-generation stent designed for treatment of acute myocardial infarction and coronary artery bifurcations. According to the company, treatment of acute myocardial infarction accounts for 50% of stent implantations worldwide, a $5 billion market. However, existing balloon-expandable stents do not ensure optimal contact with the artery wall, and clotting can occur between the stent and the coronary wall and within the stent itself, the company said.

Stentys said its self-expanding stent is constantly applied to the vessel surface and ensures immediate and permanent optimal apposition during thrombus and vessel spasm relief, therefore avoiding any malapposition and subsequent clotting.

"Stentys has completed an initial 40-patient clinical trial demonstrating safety and efficacy of the stent. This second financing tranche of the Series 'B' round will enable Stentys to obtain CE marking and begin European marketing of the first self-expanding stent platform for the treatment of myocardial infarction," said Stentys CEO Gonzague Issenmann.

Antoine Papiernik, managing partner with Sofinnova Partners, Stentys' initial and largest institutional investor, said, "The ability of the company to add an investor to the syndicate in this very difficult financing environment bears strong testimony to the strength of the Stentys' platform."

In other financing activity, Ophthlamic Imaging Systems (OIS; Sacramento, California), a digital imaging company, said it has signed a purchase agreement with U.M. AccelMed for a $6 million private placement of the company's common stock and warrants to be completed in two installments.

OIS may issue up to an aggregate of 13,214,317 shares of its common stock and warrants to purchase up to an aggregate of 4,404,772 shares of its common stock. The company intends to use the net proceeds for working capital and general corporate purposes.

The first installment of $4 million was completed on June 24. In the first installment OIS sold 9,633,228 shares of common stock at a purchase price of $0.415 a share and issued three-year warrants to purchase up to 3,211,076 shares of common stock at $1 a share. The second installment of $2 million, consisting of 3,581,089 shares of common stock at a purchase price of $0.558 a share and warrants to purchase 1,193,696 shares of common stock at $1 a share, is expected to be completed by April 15, 2010, subject to certain conditions. The warrants to be issued in the second installment will expire three years from the date of completion of the first installment.

In connection with the private placement, the board of directors of OIS appointed Dr. Uri Geiger and Moshe (Mori) Arkin from AccelMed to the board, effective June 24.

On that date, OIS entered into an asset purchase agreement with MediVision Medical Imaging (Yokneam, Israel), the majority shareholder of OIS, to purchase substantially all of MediVision's assets. As payment for such assets, OIS agreed to assume certain liabilities, including, among other things, a bank loan outstanding in an amount not to exceed $1,500,000 and all intercompany indebtedness owed to OIS with a principal amount not to exceed $4,200,000. The closing of the asset purchase is subject to a number of conditions, including the approval of the asset purchase by the shareholders of MediVision. If approved by MediVision shareholders, and if the other conditions of closing are satisfied, the asset purchase is expected to close in September.

In terms of the $1,500,000 loan agreement OIS assumed on behalf of its agreement with MediVision, on June 24 OIS entered into a direct letter agreement with United Mizrahi Bank. The new loan accrues interest at LIBOR plus 4.75%. Principal payments will be made in 18 equal monthly installments beginning January 31, 2011.

Pursuant to the asset agreement with MediVision, OIS entered into an escrow agreement pursuant to which MediVision agreed to deposit in an escrow account 3,793,452 shares of OIS common stock it owns on the first installment closing date and, subject to the status of certain indebtedness, another 2,000,000 shares of OIS common stock it owns on the closing date of the asset purchase agreement. Upon MediVision's failure to meet certain obligations as specified under the asset purchase agreement, the shares of OIS common stock held in escrow will be distributed to OIS or sold and the proceeds thereof distributed to OIS.

On June 24, OIS entered into an extension agreement with the holders of its 6.5% convertible notes due April 30, 2010, of which an aggregate principal amount of $1,375,000 remains outstanding. The holders agreed to extend the payments by 18 months, such that the next payment will be due Dec. 31, 2010, and extend the maturity date of the notes to Oct. 31, 2011.

OIS makes digital imaging systems and informatics solutions for the eye care market. AccelMed is an investment firm focusing on established, late stage medical device companies.