A Medical Device Daily
ReGen Biologics (Hackensack, New Jersey) reported that on Friday it completed the first of a two stage private placement of roughly $7 million of common stock. The second stage is estimated to result in the placement of about $3 million in additional common stock, providing for a total of nearly $10 million in combined gross proceeds, ReGen noted.
The company said the proceeds would support the launch of its Menaflex product in the U.S., which recently received FDA clearance.
Sanderling Venture Partners led the transaction with a new investment of about $4 million. Investors in the second stage of this financing are holders of options issued by the company in connection with an earlier private placement.
"We are delighted with the success of this first stage of the financing," said Gerald Bisbee Jr., PhD, CEO/chairman. "Sanderling Venture Partners has been a longstanding source of leadership and support to ReGen and an enthusiastic proponent for the importance of biological technology and the company's Menaflex product."
ReGen issued roughly 2 million shares of common stock at $3.50 a share and provided 15% warrant coverage with a five-year term and an exercise price of $1.20 a share. The terms of the second stage will be identical, the company said. Investors in the first stage also converted about $3 million in previously issued convertible notes payable into roughly 989,000 common shares at closing.
"The purpose of this financing is to provide sufficient capital for the launch of the Menaflex product in the U.S., which currently represents the largest single world market for similar arthroscopic surgery products." Bisbee said. "We are excited to bring this groundbreaking product to U.S. surgeons and patients in support of improving the standard of care for meniscus treatment."
ReGen is an orthopedic products company that develops tissue growth and repair products for U.S. and global markets. Its first approved product using its biological collagen scaffold technology is the Menaflex collagen meniscus implant, which is cleared for sale in Europe and other countries and marketed through ReGen's European subsidiary, ReGen Biologics AG. ReGen received FDA clearance in the U.S. for the Menaflex device in December.
In other financing activity:
•Lifeline Biotechnologies (Reno, Nevada) said that the company, through its subsidiary First Warning Systems, is reviewing all available options to secure funding. This strategy will be structured to enable the completion of development of its First Warning System, the company said, and the "highly anticipated" launch of its commercialization phase.
Lifeline said it is focused on obtaining a FDA 510(k) clearance, and completing hardware upgrades for new technologies in anticipation of market introduction this year. Of the roughly $138 billion spent on cancer each year, Lifeline's detection device will boast the potential to save the healthcare industry billions of dollars a year, the company said.
Lifeline said it has, in the past year, filed for a patent on the recent technological advancements of the First Warning System, which has achieved the robust capability of identifying and classifying abnormalities of the breast with sensitivities of 95% to 100% and specificities of 87% to 90%.
•The LCA-Vision Full Value Committee said it has filed with the Securities and Exchange Commission a preliminary consent statement to undertake a consent soliciation to reconstitute the board of LCA-Vision (Cincinnati).
The committee, formed by a group of former LCA-Vision management – including founder and former CEO Stephen Joffe, MD, formed late last year, saying it wanted to save the company from its current path to self-destruction.' The company responded last month with a letter to the group saying it is concerned about its recent operating results, but that it disagrees with the group's description of its conditions as dire' or its prognosis as poor.'
Collectively, the group owns 11.4% of LCA-Vision, which operates 77 LasikPlus fixed-site laser vision correction centers in 33 states in the U.S (Medical Device Daily, Dec. 15, 2008).
In the most recent filing, the committee expressed its concern that the company is experiencing a serious financial and operating crisis. Specifically, the committee said that "in a very short period of time, over 90% of the company's value has been wiped out under the existing executive management team and board of directors." The filing pointed out that since Steven Straus was hired as CEO by the company's board in November 2006, LCA-Vision shares have dropped from $32.71 to $3.12, the closing price on the day before the group disclosed its 11.4% position in a previous SEC filing.
•Crdentia (Dallas, Texas), a provider of healthcare staffing solutions, said it has finalized its transaction, initiated in August, to complete the company's non-reporting status. In conjunction with this, the reverse stock split (1,000:1) has been accomplished in conjunction with its